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УДК 347.(77+78) 3 (89) 2016 © Науководослідний інститут інтелектуальної власності Національної академії правових наук України, 2016 ЗМІСТ Розвиток сфери інтелектуальної власності Orliuk O. The role of legal science in the process of reforming intellectual property sphere in Ukraine: achievements, objectives, mission (Орлюк О. Роль правової науки у процесі реформування сфери інтелектуальної власності в Україні : досягнення, завдання, місія) ....... 5 Kashyntseva O. Modern values of harmonization of human rights and intellectual property rights in health care (Кашинцева О. Сучасні цінності гармонізації прав людини та прав інтелектуальної власності в сфері охорони здоров’я) .............................................. 14 Комерційна таємниця Androshchuk H. Protection of trade secrets in international legal doctrines: strategies to achieve employee loyalty (Андрощук Г. Захист комерційної таємниці в зарубіжній правовій доктрині: стратегії забезпечення лояльності працівників) ...................................................... 19 Захист прав Zerov K. Problems of identification of a copyright infringer for works posted on the Internet (Зеров К. Проблеми ідентифікації особи-порушника авторського права на твори, розміщені в Інтернеті) ........................................................ 30 Íàóêîâî-ïðàêòè÷íèé æóðíàë ЗАСНОВНИК Науково-дослідний інститут інтелектуальної власності Національної академії правових наук України Cвідоцтво про державну реєстрацію КВ № 10573 від 07.11.2005 р. Рекомендовано до друку вченою радою НДІ інтелектуальної власності НАПрН України (протокол № 07 від 31.05.2016 р.). Редакція: Орлюк О. П. — головний редактор, Петренко С. А. — заступник головного редактора, Петренко І. І. — відповідальний секретар, Мацкевич О. О. — редактор, Осипова А. О. — літературний редактор Адреса редакції: 03680, МСП, м. Київ-150, вул. Казимира Малевича, 11, корп. 4 Тел.: 228-21-37, 228-22-16 Тел./факс: 200-08-76 www.inprojournal.org e-mail: [email protected], [email protected] Надруковано з оригінал-макета в ТОВ «НВП “Інтерсервіс”», вул. Бориспільська, 9. Свідоцтво: серія ДК № 3534 від 24.07.2009 року. Здано до набору 07.06.2016 р. Підписано до друку 21.06.2016 р. Формат 70х108/16. Папір офсетний. Друк офсетний. Наклад 300 примірників. ISSN 23080361

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Page 1: Íàóêîâî-ïðàêòè÷íèé æóðíàë 3 (89) 2016ndiiv.org.ua/Files2/2016/0316.pdfНаціональної академії правових наук України, 2016

УДК 347.(77+78)

3 (89) 2016

© Науково�дослідний інститут інтелектуальної власностіНаціональної академії правових наук України, 2016

ЗМІСТ

Розвиток сфери інтелектуальної власності

Orliuk O. The role of legal science in the processof reforming intellectual property sphere inUkraine: achievements, objectives, mission(Орлюк О. Роль правової науки у процесі реформування сфери інтелектуальної власностів Україні : досягнення, завдання, місія) ....... 5

Kashyntseva O. Modern values of harmonizationof human rights and intellectual property rights in health care (Кашинцева О. Сучасніцінності гармонізації прав людини та прав інтелектуальної власності в сфері охорони здоров’я) .............................................. 14

Комерційна таємниця

Androshchuk H. Protection of trade secrets in international legal doctrines: strategiesto achieve employee loyalty (Андрощук Г. Захисткомерційної таємниці в зарубіжній правовійдоктрині: стратегії забезпечення лояльностіпрацівників) ......................................................19

Захист прав

Zerov K. Problems of identification of a copyright infringer for works posted on the Internet (Зеров К. Проблемиідентифікації особи-порушника авторськогоправа на твори, розміщені в Інтернеті) ........................................................30

Íàóêîâî-ïðàêòè÷íèé æóðíàë

ЗАСНОВНИКНауково-дослідний інститутінтелектуальної власностіНаціональної академії правових наук України

Cвідоцтво про державну реєстраціюКВ № 10573 від 07.11.2005 р.

Рекомендовано до друку вченоюрадою НДІ інтелектуальної власності НАПрН України (протокол № 07 від 31.05.2016 р.).

Редакція:Орлюк О. П. — головний редактор,Петренко С. А. — заступник головногоредактора,Петренко І. І. — відповідальнийсекретар,Мацкевич О. О. — редактор,Осипова А. О. — літературнийредактор

Адреса редакції: 03680, МСП, м. Київ-150, вул. Казимира Малевича, 11,корп. 4Тел.: 228-21-37, 228-22-16 Тел./факс: 200-08-76www.inprojournal.org e-mail: [email protected], [email protected]

Надруковано з оригінал-макета в ТОВ «НВП “Інтерсервіс”», вул. Бориспільська, 9.Свідоцтво: серія ДК № 3534 від 24.07.2009 року.

Здано до набору 07.06.2016 р. Підписанодо друку 21.06.2016 р. Формат 70х108/16.Папір офсетний. Друк офсетний.Наклад 300 примірників.

ISSN 2308�0361

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Наукова рада журналу:

Довгерт А. С., чл.-кор. НАПрНУ,д. ю. н., проф; Кузнєцова Н. С.,акад. НАПрНУ, д. ю. н., проф.;Майданик Р. А.., акад.. НАПрНУ,д. ю. н., проф.; Малишева Н. Р..,д. ю. н., проф.; Патон Б. Є., през.НАНУ, д. т. н.; Петришин О. В.,д. ю. н., професор, академік НАПрНУ,президент НАПрНУ; Притика Д. М.,акад. НАПрНУ, д. ю. н.; Стефанчук Р. О., чл.-кор. НАПрНУ,д. ю. н.; Тацій В. Я., почесний през.НАПрНУ, д. ю. н., академік НАНУ;Шемшученко Ю. С., акад. НАНУ,акад. НАПрНУ, д. ю. н.,Маркевич Р., PhD hab. (Польща)

Редакційна колегія журналу:

Мироненко Н. М. , д. ю. н., головаредакційної колегії, Дорошенко О. Ф., к. ю. н., заступ-ник голови редакційної колегії,Андрощук Г. О., к. е. н.,Атаманова Ю. Є., д. ю. н., Бутнік-Сіверський О. Б., д. е. н.,Васильєва В. А., д. ю. н.,Галиця І. О., д. е. н., Гетманцев Д. О., д. ю. н.,Дроб’язко В. С., к. філол. н,Захарченко Т. Г., заслуженийюрист України, Канзафарова І. С.,д. ю. н., Комзюк Л. Т., к. ю. н.,Копиленко О. Л., д. ю. н.,Коссак В. М., д. ю. н., Крупчан О. Д.,д. ю. н., Москаленко В. С.,заслужений юрист України,Панов М. І., д. ю. н., Пічкур О. В.,пр. наук. співроб., Сімсон О. Е.,д. ю. н., Солощук М. М., к. т. н.,Теплюк М. О., д. ю. н.,Тихий В. П., д. ю. н., Юрченко О. М., д. ю. н.

Іноземні члени редколегії:

Армаза-Армаза Е. Х., PhD(Іспанія), Нєвенґловскі A., д-рправа (Польща), Пеліова Я., PhD(Словаччина), Рамальхо А., PhD(Нідерланди), Тєлєц І., JUDr.(Чехія), Цвікла Л., PhD hab.(Польща), Шакель Н., к.ю.н.(Білорусь)

Теорія і практика інтелектуальної власності � 3/20162

Журнал засновано в лютому 2002 року,перейменовано у листопаді 2005 року,

внесено до переліку фахових виданьВАК України з юридичних наук

Shabalin A. The court order proceedings of civil procedural law of Ukraine: scientific issues and practices (Шабалін А. Наказне провадження в цивільному процесі України:наукові питання та практика) ........................41

Погляд науковця

Chaban O. Duty of confidentiality and duty of openness in health law of Ukraine and the United Kingdom of Great Britain and Northern Ireland (Чабан О. Обов’язок зберігати відомості про стан здоров’я конфіденційними та обов’язок надання інформації про стан здоров’я пацієнту в Україні та Сполученому Королівстві ВеликоїБританії та Північної Ірландії) ...................... 48

Kashkanova N. The role of deontological norms in formation of legislation regulating the procedure of medical and biological research involving humans (Кашканова Н. Роль деонтологічних норм у формуванні законодавства,що регулює порядок проведення медико-біологічнихдосліджень за участі людини) ........................ 55

Chomahashvili O. Parliamentary hearings in Ukraine: the experience and prospects (Чомахашвілі О. Парламентські слухання в Україні: досвід та перспективи) ...................67

Журнал внесено до бази даних Index Copernicus Journals MasterList.

ICV Index 2014: 44.63

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© The Scientific and Research Institute of Intellectual Property of the NationalAcademy of Legal Sciences of Ukraine, 2016

UDC 347.(77+78)

3 (89) 2016

CONTENT

Development of intellectual property sphere

Orliuk O. The role of legal science in the process of reforming intellectual property sphere in Ukraine: achievements, objectives, mission .................... 5

Kashyntseva O. Modern values of harmonizationof human rights and intellectual property rightsin health care ..................................................... 14

Trade secret

Androshchuk H. Protection of trade secrets in international legal doctrines: strategiesto achieve employee loyalty ...............................19

Defense and remedies

Zerov K. Problems of identification of a copyright infringer for works posted on the internet ................................................... 30

Shabalin A. The court order proceedings of civil procedural law of Ukraine: scientific issues and practices ........................................... 41

Scientist’s view

Chaban O. Duty of confidentiality and duty of openness in health law of Ukraine and the United Kingdom of Great Britain and Northern Ireland ........................................ 48

Scientific and practical journal

FOUNDERThe Scientific and ResearchInstitute of Intellectual Propertyof the NALS of Ukraine

Certificate of state registrationКV № 10573 issued 07.11.2005.

The issue is recommended by theScientific Council of the S&R IIPof the NALS of Ukraine (Minutes№ 07 of the 31.05.2016).

Editorial:O. Orlyuk — Chief Editor,S. Petrenko — Deputy Chief Editor,I. Petrenko — AdministrativeSecretary.O. Matskevych — Editor and Layout Designer,A. Osypova — Proofreader,

Editorial address:11 Kazymyra Malevycha Str.,13th floor, Kyiv, Ukraine, 03680Tel./fax: 200-08-76 Tel.: 228-21-36www.inprojournal.orge-mail: [email protected],[email protected]

Printed at “Interservis”. 9Boryspilska Str. Certificate DK № 3534issued 24.07.2009.

Sended to the printer 07.06.2016.Passed for printing 21.06.2016.Format 70x108/16. Offset paper.Offset printing. Circulaion 300 ex.

ISSN 2308�0361

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Kashkanova N. The role of deontological norms in formation of legislation regulating the procedure of medical and biological research involving humans .............................................. 55

Chomahashvili O. Parliamentary hearings in Ukraine: the experience and prospects ....... 67

Scientific Council:A. Dovgert, associate member of theNALSU, PhD hab., prof.; N. Kuznetsova, academician of theNALSU, PhD hab., prof.; R. Maydanyk, academician of theNALSU, PhD hab., prof.; N. Malysheva, PhD hab., prof.; B. Paton, the President of NASU,PhD hab.; O. Petryshyn, PhD hab.,academician the NALSU, Presidentof the NALSU; D. Prytyka, academi-cian of the NALSU, PhD hab.;R. Stefanchuk, associate member ofthe NALSU, PhD hab.; V. Tatsiy, theHonorary President of the NALSU,academician of the NANU, PhD hab.; Y. Shemshuchenko, academician of the NANU and NALSU, PhD hab.,R. Markiewicz, dr hab. (Poland)

Editorial board:N. Myronenko, PhD hab. (head ofthe editorial board), O. Doroshenko,PhD (deputy of the head of the editorial board), H. Androschuk,PhD, Yu. Atamanova, PhD hab.,O. Butnik-Siverskyi, PhD hab.,V. Vasylyeva, PhD hab.,I. Halytsya, PhD hab.,D. Hetmantsev, PhD hab.,V. Drobyazko, PhD, T. Zakharchenko,honored lawyer of Ukraine,I. Kanzafarova, PhD hab., L.Komziuk, PhD, O. Kopylenko, PhDhab., V. Kossak, PhD hab.,O. Krupchan, PhD hab., V. Moskalenko, honored lawyer ofUkraine, M. Panov, PhD hab., O. Pichkur, O. Simson, PhD hab.,M. Soloschuk, PhD, M. Teplyuk,PhD hab., B. Tykhyi, PhD hab.,O. Yurchenko, PhD hab.

Foreign members:E. J. Armaza-Armaza, PhD (Spain),A. Niewęgłowski, Dr. adiunkt.(Poland), I. J. Péliová, PhD (SlovakRepublic), A. Ramalho, PhD (the Netherlands), І. Telec, JUDr.(Czech Republic), L. Ćwikła, Ph.D.hab. (Poland), Shakel N., PhD.(Belarus)

The magazine is founded in February 2002,renamed in November 2005,

included in the list of specialized publica�tions on legal sciences of HAC of Ukraine

4 Theory and practice of intellectual property � 3/2016

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Теорія і практика інтелектуальної власності � 3/2016

РОЗВИТОК СФЕРИ ІНТЕЛЕКТУАЛЬНОЇ ВЛАСНОСТІ

5

THE ROLE OF LEGAL SCIENCEIN THE PROCESS OF REFORMING

INTELLECTUAL PROPERTYSPHERE IN UKRAINE:

ACHIEVEMENTS, OBJECTIVES,MISSION

Intellectual property is an integralpart of international trade and globaleconomy. However, since intellectualproperty rights are private and regionalby their nature, the question arises as towhether it is possible to provide effectiveprotection of intellectual property rightsduring the era of globalization. The rapidpace of international trade, interconnec-tion of economic systems and known con-sequences of ineffective protection atlevel of certain national legal systemsforce countries to rethink the nature andways to improve protection of intellectu-al property rights.

The countries are searching for theopportunities to create a favourable cli-mate to attract investments and stimu-late economic activity to make it more in-tensive. For its achievement it is impor-tant to create a strong and balanced

intellectual property mode, which shouldpromote commercial and industrial ac-tivities in general. In support we can citethe report of the leader of the World In-tellectual Property Organization in 2015«Breakthrough innovation and economicgrowth», which states that «intellectualproperty is at the centre of innovativegrowth of the national economies» [1].Currently the work of WIPO in thesphere of protection of rights is specifiedbased on the Strategic goal VI, deter-mined during the adoption of the Agendafor development [2]. According to theStrategic goal VI ensuring respect for IPin a sustainable manner is a broad con-cept, within which security and protec-tion of intellectual property rights shallbe performed taking into account the in-terests of socio-economic developmentand consumer protection.

ISSN 2308-0361

Орлюк О. Роль правової науки у процесі реформування сфери інтелекту-альної власності в Україні : досягнення, завдання, місія.

Автор аналізує кроки України у розвитку законодавства у сфері інтелектуальноївласності. Крім цього, автор аналізує досягення Науково-дослідного інституту інте-лектуальної власності НАПрН України у розбудові системи інтелектуальної власно-сті України та знайомить читачів з цілями та завданнями його діяльності.

Ключові слова: інтелектуальна власність, освіта, наука, законопроекти, НДІ інте-лектуальної власності НАПрН України, реформування законодавства

Olena Orliuk,Doctor of Juridical Science, professor, corresponding member of the NALS of Ukraine, Director of the IntellectualProperty Research Institute of the NALS of Ukraine; acting Head of the Department of Intellectual Property of Taras Shevchenko National University of Kyiv

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О. Орлюк

Теорія і практика інтелектуальної власності � 3/20166

РОЗВИТОК СФЕРИ ІНТЕЛЕКТУАЛЬНОЇ ВЛАСНОСТІ

European experience can be used as amodel while viewing prospects for the de-velopment of protection of intellectualproperty rights. Nevertheless formationof a single European market requires theharmonization of respective nationallaws of the EU Member States, as well asimproving the protection of intellectualproperty rights at the international level.The importance of the latter is proved bythe provisions on the expansion of EUcompetence in the field of trade-relatedintellectual property rights in the Treatyof Nice of the EU as of February 26,2001, which entered into force since Feb-ruary 1, 2003. Protection of intellectualproperty as an inalienable human rightis proclaimed in part 2 of article 17 of theCharter of Fundamental Rights of theEuropean Union. The text of the Charterwas not included to the Lisbon Treaty asof December 13, 2007, but its provisionsare mandatory. The article 6 of the EUTreaty stipulates that «The EU respectsthe rights, freedoms and principles setout in the Charter of Human Rights» [3].

For Ukraine, a member of most inter-national treaties in the field of intellectu-al property, and country working to-wards European integration in the early2000s, the issue of adequate protectionand security of Intellectual Propertyrights has a particular meaning. Havingconcluded in 1994 Agreement on partner-ship and cooperation with the EU andthe WTO after joining in 2008 (whichcaused application of Agreement ontrade aspects of intellectual propertyrights [4]), Ukraine committed to ensurethe protection of intellectual property atthe level similar to the EU one.

Association Agreement betweenUkraine, of the one part, and the Euro-pean Union, the European Atomic Ener-gy Community and their Member States,of the other part, was ratified as of Sep-tember 16, 2014 by the Parliament ofUkraine and the European Parliament [5];Chapter 9 is devoted directly to the intel-lectual property. Article 157 of theAgreement defines the main two objec-

tives in this area: a) facilitate the produc-tion and commercialization of innovativeand creative products in the Parties; and(b) achieve an adequate and effectivelevel of protection and enforcement of in-tellectual property rights.

Necessity to create conditions for theproper protection of intellectual propertyis also understood at domestic politicallevel. Sustainable Development Strategy«Ukraine–2020» was approved by the De-cree of the President of Ukraine as ofJanuary 12, 2015. According to [6], IPRprotection is defined as a vector of reformof national security direction. Under-standing of the role of intellectual prop-erty is also defined in government docu-ments.

Therefore, adequate and effective pro-tection of intellectual property rights re-lates to strategic areas of reforming ofnational legislation and law enforcementwith regard to European integration vec-tor for development. In this directionsubstantial role belongs to professionalsinvolved in the process of preparation ofthe updated legislation.

Such professionals in the country areexperts of the Intellectual Property Re-search Institute of the National Academyof Legal Sciences of Ukraine, which re-cently celebrated its 15th anniversary [7].Today it is recognized as a national cen-tre of expertise in the field of intellectualproperty; it deals not only with the fun-damental and applied scientific develop-ments concerning law and economics ofintellectual property, but also with thedirect practice. Such combination of prac-tical experience and theoretical researchmakes it possible to perform the tasks ef-ficiently.

At this stage, Ukraine is at the pointwhere legislation on copyright and relat-ed rights, in the field of industrial prop-erty shall be revised and new require-ments and obligations shall be appliedthat are specified in the AssociationAgreement of Ukraine with the EU. Ex-isting problems shall be also taken intoaccount in the process of legislation re-

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О. Орлюк

7

РОЗВИТОК СФЕРИ ІНТЕЛЕКТУАЛЬНОЇ ВЛАСНОСТІ

Теорія і практика інтелектуальної власності � 3/2016

forms: ones associated with poor qualityof protection documents, patent trollingphenomenon, and possibility of adminis-trative appeal against protection docu-ments, decrease of the load of the courtsystem and so on. The country shallgradually introduce alternative methodsof dispute settlement in order not to set-tle disputes solely in court.

Within each of these areas the expertsof our Institute together with the special-ists from the Ministry of Economic De-velopment and Trade of Ukraine (here-inafter referred to as MEDT), nationalsystem of intellectual property protec-tion, representatives of professional envi-ronment in this area are actively work-ing on a comprehensive change of legisla-tion in the field of copyright, industrialproperty, protection of intellectual prop-erty rights and so on.

An institutional reform of the nation-al system of intellectual property protec-tion is performed alongside with legisla-tive reforms in Ukraine. Thus, the Insti-tute involves the working group bringingtogether representatives of public au-thorities, patent office, professional insti-tutions in the field of intellectual proper-ty, public organizations, etc., aiming atdrawing of a draft law which will deter-mine the principles of the National Sys-tem of Intellectual Property Legal Pro-tection. According to the Concept of re-forming of this sector [8] approved by theGovernment of Ukraine, developmentand implementation of state policy in thefield of intellectual property is the re-sponsibility of MEDT. The National Of-fice of Intellectual Property is formed onthe basis of the State Intellectual Proper-ty Service being liquidated and theUkrainian Intellectual Property Insti-tute (Ukrpatent). Nowadays the workinggroup is engaged in issues of determiningthe legal status and tasks that must besolved by national system of legal protec-tion of intellectual property in Ukraine.

Joint efforts will hopefully lead to thelegislative changes in the field of intellec-tual property, significantly enhance the

protection of intellectual property, andcreate a much better basis for the compli-ance with the rights of owners, to a sig-nificant reduction in counterfeiting, tocease the mass violations of intellectualproperty rights on the Internet.

The Institute pays much attention tothe issue of high quality legislative sup-port. Since its establishment until nowour irrevocable priority refers to re-searches, accumulation of unique knowl-edge and their continuous implementa-tion, assistance to citizens, legal entitiesand state in solving practical issues re-lated to creation and use of intellectualproperty.

The range of our scientific and practicalinterests includes among others tradition-al areas of intellectual property — copy-right, related rights, trademarks for goodsand services, geographical items, patents,utility models, industrial designs — butnot limited to them. During 15 years theInstitute performed 24 developments byfundamental and applied themes.

The results of Institute’s activitycover more than 300 draft legal acts de-veloped by the Institute independently orwith involvement of other entities to per-form development or review work. Legalexamination of draft laws and other legalacts, development of recommendationsand proposals is a form of implementa-tion of the main results of our activity.Now the focus in legislative activities isthe European integration towards the re-newal of national legislation in the fieldof intellectual property.

This is due to the challenges faced byUkraine. In particular, specialists of theInstitute are actively involved in the ac-tivity of MEDT and other ministries (in-cluding the Ministry of Agriculture, Min-istry of Health), involved in drawing thedraft laws aimed at implementation ofthe Association Agreement betweenUkraine and the EU. The developinglaws include:

•Draft law «On amendments to somelegislative acts of Ukraine relatingto improvement of legal protection of

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intellectual (industrial) property»(patent trolling)

•Draft law «On amendments to somelegislative acts of Ukraine relatingto enforcement of liability and pro-tection of rights in the sphere of in-tellectual property)

•Draft law «On amendments to somelegislative acts of Ukraine relatingto improvement of legal protection ofgeographical items»

•Draft law «On amendments to somelegislative acts of Ukraine relatingto improvement of protection for lay-out of a semiconductor product» (in-tegrated microcircuits — masswork)

•Draft law «On amendments to somelegislative acts of Ukraine in thefield of copyright and related rights»

•Draft law «On amendments to somelegislative acts of Ukraine relatingto improvement of protection of in-ventions (utility models)»

•Draft law «On amendments to somelegislative acts of Ukraine (relatingto improvement of protection of in-tellectual property rights)».

The agenda includes the issue of thedevelopment of amendments to theCriminal Code of Ukraine and the Cus-toms Code of Ukraine.

Ad hoc committee of the VerkhovnaRada of Ukraine on Science and Educa-tion approved the IT environment draftlaw amending copyright and relatedrights in respect of the allocation ofrights for the service objects of intellectu-al property rights.

However, in addition to specific legis-lation on intellectual property, changesshall be made also in the Civil Code ofUkraine, where volume 4 is dedicated tointellectual property rights. Intellectualproperty shall be recognized as a com-modity in the Commercial Code ofUkraine. In addition, there shall bearranged the system of balance and off-balance accounting of intellectual proper-ty. It is also necessary to review themethodology for assessing the value ofintangible assets, adopted by the State

Property Fund of Ukraine more than tenyears ago. Activity of the Institute sup-ports these findings. As a certified evalu-ator the Institute is involved in assess-ment and audit of intellectual property.Specifically, certified evaluators devel-oped over 60 assessment findings on pro-prietary rights for intellectual property,customers of which often were the lead-ing national brands.

As for the practical component of theInstitute, the first is the provision of oraland written consultations on issues re-lating to law and economics of intellectu-al property, civil, civil procedure, busi-ness, finance right and so on. Specialistsof the Institute are involved to the regis-tration of rights for works, objectsof patent right, means of individualiza-tion, acting also as patent attorneys. Inaddition, during the years of work our ex-perts prepared more than 100 scientificexpert reports upon request of higherand central government authorities, car-ried out about 300 scientific researchesordered by public and private organiza-tions and over 470 researches ordered byregional entities, including local self-gov-ernment entities and local authorities.This experience is useful in the process ofreforming of the intellectual propertyprotection system. After all, now Ukraineinitiates the issue of creation of a body tocombat piracy and the possibility to at-tract the Anti-Corruption Bureau tostrengthen the protection of intellectualproperty rights. Ensuring control overroyalties and license fees shall be en-trusted to the authorities of the StateFiscal Service of Ukraine, and thus thereshall be a high quality financial legisla-tion, which will properly reflect intellec-tual property issues.

The leading role in the practice of theInstitute refers to the judicial and specialstudies of intellectual property. Duringthe past period of time the legal expertscertified by the Ministry of Justice ofUkraine carried out more than 1 700 re-search works. Our experts, including ex-perienced lawyers and advocates repre-

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sent the interests of entities of intellectu-al property rights within judicial andnon-judicial settlement of disputes; rep-resent interests of entities of intellectualproperty rights in case of illegal use of in-tellectual property, as well as at unfaircompetition in administrative and judi-cial bodies.

Thus nowadays this experience willbe useful for the High Specialized Courtfor Intellectual Property [9] foundedin Ukraine, which will start its activitiesin 2017.

Within the judicial reform being im-plemented in the country, there are sig-nificant alterations proposed to the civiland economic process applying directlyto the protection of intellectual property.In particular, the Council for Judicial Re-form presented the Draft amendmentsto the Civil and Commercial ProcedureCodes, the Code of administrative pro-ceedings [10]. Alterations include expan-sion of court remedies and evidenceforms (including electronic evidenceas the independent means). Protection ofrights shall not be restricted by the man-ner specified by law or contract, but in-volve also another way, effectively pro-tecting such rights. Effective mechanismsare offered to ensure the claim and evi-dence (including expanding the ways theclaim provision, widely used counter in-junction, compensation for damage causedby unreasoned claim or evidence). Thecourt will perform the role of arbitratoronly and will never act as investigator.

There are also proposed changes inorder to simplify and accelerate the pro-ceedings of simple and less significantcases; to ensure thorough preparationand review of complex cases; to ensurethe timeliness of the case and legal cer-tainty; introduction of «electronic court»and so on. In the course of reform thereare the proposed mechanisms to preventabuse of procedural rights. The latter in-volves prevention from «clone claims»and other manipulation tools for casesdistribution, deliberate prolongation ofthe case, manipulation of jurisdiction

and effective responsibility measures forabuse of rights. It is extremely importantfor intellectual property rights, becausethe disputes of intellectual property in-fringement can be settled during the longterm (for years). In this sense we feel ex-tremely positive to create a specializedcourt for intellectual property issues.

Moreover, the countries all over theworld have a broad experience in thisfield. Typical samples of a special patentcourt are used in the United States ofAmerica, Austria, Germany, Sweden,Great Britain, South Korea, Taiwan andothers. At the beginning of 2004 the Eu-ropean Commission proposed to found apatent court to settle disputes on intellec-tual property; it starts its activities now.

Effective, qualified settlement of dis-pute arising from infringement of intellec-tual property rights is crucial for Ukraine.After all, nowadays legal procedure has aprevailing role in the procedures relatingto protection of the rights. Over the pastdecade the number of passed judgments isabout 18 000. And a number of such dis-putes is growing.

To protect intellectual property rightsa court shall implement tribunal and in-ternational commercial arbitration. Inaddition, mediation shall take at last itsplace. Country faces overdue need for ac-tive use of ways alternative to judicial oneto protect intellectual property rights.

In addition, strengthening the role ofthe Antimonopoly Committee of Ukraineis essential in the process of suspension ofunfair competition, inherent to the intel-lectual property. In this context the coun-try shall also benefit from the experienceof European countries and may be basedon European directives in this area.

Ukraine has to aim at participationof its representatives in working groupsof the European Committee on monitoringintellectual property rights infringement.Active cooperation shall be arranged withlaw enforcement agencies, including Eu-ropol, customs, special European organi-zations established to combat infringe-ments of intellectual property rights.

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However, in the future the decisiverole in improving the protection of intel-lectual property, in our opinion, shouldbe played not only by the state govern-ment (legislative, executive and judicia-ry), but also to science and education.

Role of legal science is extremely im-portant in this process. Relevant direc-tions for finding ways to protect intellec-tual property rights are reflected in thePriority areas of legal science develop-ment in 2016–2020, approved by the Na-tional Academy of Legal Sciences ofUkraine in March 2016 [11]. Experts ofour Institute actively participated intheir development.

Decisions taken at parliamentary andcommittee hearings on intellectual prop-erty for the past 15 years, were preparedwith participation of specialists of the In-stitute. Most of the directions of reformsin this area as set out in numerous fun-damental and applied researches of theInstitute [7, 12]. Today, according to thePriority areas of legal science develop-ment the Institute is developing a strate-gy for the development for the next fiveyears, taking into account the underlyingproblems requiring solving at the level ofnational policy. For example, the direc-tion of legal maintenance of national se-curity and international law stipulatesthe drawing of the draft law «On legalprotection of secret inventions», whichwill include study of the experience ofNATO countries, offer incentive mecha-nisms to encourage the creation and useof secret inventions and protection of therights of inventors.

Currently the Institute continuesworking on a number of laws, includingthe draft law relating to issues of legalprotection and enforcement of intellectu-al property rights in the field of nationaldefense. Thus, it is offered to makeamendments and alterations to the Com-mercial Code of Ukraine, Laws ofUkraine «On the State Defense Order»,«On the assessment of property, propertyrights and professional valuation activi-ties in Ukraine», «On state control over

international transfers of military anddual-use» and so on.

In addition, within academic pursuitsexperts of the Institute focus their effortsupon scientific and practical develop-ments in intellectual property field, cou-pled with issues of human rights; nation-al security and defense; IT business;biotechnology, biosafety, green ecology;energy-saving technologies and so on.

From the start of its activity the Insti-tute made efforts to create a nationalschool of intellectual property rights.Today the results of scientific work of theIntellectual Property Research Instituteinclude more than 50 monographs, 20manuals and more than 20 commentsand guidelines. Our Institute preparesthe thesis for the degree of Doctor of Sci-ence in Philosophy (PhD) and Doctor ofScience.

Currently, there are reasons to talkabout intellectual property right as ashaped phenomenon (not just as an insti-tution of civil law). Intellectual propertyis now perceived as a complex legal area,including knowledge of the history, theo-ry of law, civil, criminal, administrative,financial, tax, customs and many otherlegal aspects. In fact, a scientific plat-form has been created for 15 years, gath-ering supporters of this trend. Over theyears we have established close coopera-tion with all scientific and educationalcentres of Ukraine and many European(Polish, Slovak, German, and Baltic) in-stitutions specializing in this area.

One of the basic problems for Ukraineis the building of legal culture of «fairuser». Achieving of this objective shall beone of the educational tasks. It shall betaken into account at formation of neweducational standards, including intel-lectual property ones.

Specialists of the Institute are in-volved to organization or teaching mas-ter programs on intellectual propertythroughout Ukraine. Today IntellectualProperty education is available in Kyiv,Kharkiv, Dnipro, Odesa, Lviv, Sumy etc.It may refer to a degree of legal, econom-

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ic, technical direction, with a focus oncreativity, invention, law, management.Ukraine has founded special master pro-grams on intellectual property, takinginto account the experience in teaching ofintellectual property disciplines in majorEuropean centres, including Munich,Turin, Bilbao and others.

Thus, Taras Shevchenko NationalUniversity of Kyiv founded the Depart-ment of Intellectual Property three yearsago. The department has three accredit-ed master’s programs: 1) for lawyers it is«Intellectual Property Rights»; 2) inter-disciplinary master's program «Intellec-tual Property» (which includes law, eco-nomics, management of intellectualproperty disciplines for people with dif-ferent education); 3) master’s program«Intellectual Property» accredited jointlywith the Baltic University — Mykolas-Romeris University (double diploma ofUkraine and the EU, in English). Howev-er, at this time less than 100 experts inthe field of IP graduate in Ukraine peryear. It absolutely does not reflect thereal needs of the state, as it needs notjust lawyers.

Institute initiated and conducts dur-ing the third consecutive year the Sum-mer School on Intellectual Property incooperation with National TarasShevchenko University of Kyiv and theState Intellectual Property Service ofUkraine, which invite leading experts inthis field. Ukraine actively conducts na-tional student competitions and contentson intellectual property; for many yearsthe Institute is also involved in theirarrangement.

It should be noted that one of the ac-tivities of the Institute since its estab-lishment is spreading knowledge on in-tellectual property in Ukraine. Today theInstitute does its best to meet the needsof society for information on various as-pects of law and economics of intellectualproperty. Specialists of the Institute areinvolved in educational projects aimedparticularly at increasing legal aware-ness of citizens.

In this relation, we believe that one ofthe main objectives of science and educa-tion is systematic and continuous conduc-tion of various scientific and educationalactivities, programs and active work withthe media to expand the cultural level ofthe population at 180 degrees — to the di-rection corresponding to the view of thecivilized world in relation to intellectualproperty rights. The international com-munity is actually interested in adequatesecurity and even more, in adequate pro-tection of intellectual property rights: tostop infringement, to ensure royalty pay-ment, to suspend sites with illegally pro-duced items, to ensure that counterfeit isnot the norm no more. If we try to makethe country attractive to foreign invest-ment, we have to ensure the appropriatelevel of protection. No one expects thechanges to effectively start operatingwithin six months, but the world shall seethat we are making certain steps.

We consider the popularization ofknowledge on intellectual property as themission of our Institute. We are workingon a strategy of national policies on intel-lectual property. Efforts are made to intro-duce in Ukraine the policy aimed at devel-oping the creative economy, creativity andinventiveness. We believe that educationalprograms shall promote basic questions ofintellectual creativity in mass media, onTV and radio. Mass media should presentthe achievements of science, because wehave them and the problem is only theirpromotion and popularization. It shall benoted that it is much easier to work withthe younger generation in Ukraine. Afterall, it is not necessary to argue with theyoungsters that intellectual propertyrights shall also be respected. State «intel-lectual property» policies had been imple-mented for 20–30 years in developed coun-tries of the world, countries that made eco-nomic breakthroughs. In our country, thispolicy also has its time lag. We have to actwithout waiting for immediate results, butseeing the ultimate goal ahead.

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Список використаних джерел / List of references

1. World Intellectual Property Report 2015 «Breakthrough Innovation and EconomicGrowth», http://www.wipo.int/edocs/pubdocs/en/wipo_pub_944_2015.pdf.

2. The 45 Adopted Recommendations under the WIPO Development Agenda,http://www.wipo.int/ip-development/en/agenda/recommendations.html#f.

3. Treaty of Lisbon amending the Treaty on European Union and the Treaty estab-lishing the European Community, 13.12.2007, http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=OJ%3AC%3A2007%3A306%3ATOC.

4. Угода про торговельні аспекти прав інтелектуальної власності (УгодаТРІПС) від 15.04.1994 р. [Електронний ресурс]. — Режим доступу :http://zakon4.rada.gov.ua/laws/show/981_018.

Uhoda pro torhovelni aspekty prav intelektualnoi vlasnosti (Uhoda TRIPS)vid 15.04.1994 r. [Elektronnyi resurs]. — Rezhym dostupu :http://zakon4.rada.gov.ua/laws/show/981_018.

5. Угода про асоціацію між Україною, з однієї сторони, та Європейським Сою-зом, Європейським Співтовариством з атомної енергії і їхніми державами-членами, з іншої сторони: ратифікована 16 вересня 2014 року ВерховноюРадою України та Європейський парламентом [Електронний ресурс]. —Режим доступу : http://www.kmu.gov.ua/kmu/control/uk/publish/article?art_id=246581344&cat_id=223223535.

Uhoda pro asotsiatsiiu mizh Ukrainoiu, z odniiei storony, ta Yevropeiskym Soiuzom,Yevropeiskym Spivtovarystvom z atomnoi enerhii i yikhnimy derzhavamy-chle-namy, z inshoi storony: ratyfikovana 16 veresnia 2014 roku Verkhovnoiu RadoiuUkrainy ta Yevropeiskyi parlamentom. [Elektronnyi resurs]. — Rezhym dostupu :http://www.kmu.gov.ua/kmu/control/uk/publish/article?art_id=246581344&cat_id=223223535.

6. Указ Президента України № 5/2015 «Про Стратегію сталого розвитку«Україна — 2020» від 12.01.2015 р. [Електронний ресурс]. — Режим доступу :http://www.president.gov.ua/documents/18688.html.

Ukaz Prezydenta Ukrainy № 5/2015 «Pro Stratehiiu staloho rozvytku «Ukraina —2020» vid 12.01.2015, http://www.president.gov.ua/documents/18688.html.

7. Науково-дослідний інститут інтелектуальної власності: 2001 — 2016 рр.Історія, досягнення, перспективи розвитку / за ред. О. П. Орлюк ; [уклала :Яшарова М. М.]. — К. : НДІ ІВ НАПрН України, Інтерсервіс, 2016. — 108 с.

Naukovo-doslidnyi instytut intelektualnoi vlasnosti: 2001–2016. Istoriia, dosiahnen-nia, perspektyvy rozvytku / za red. O. P. Orliuk ; [uklala : Yasharova M. M.], K. :NDI IV NAPrN Ukrainy, Interservis, 2016, 108 s.

8. Концептуальні засади реформування сфери інтелектуальної власності :Міністерство економічного розвитку і торгівлі України: презентація накруглому столі 16.05.2016 р. [Електронний ресурс]. — Режим доступу :http://www.me.gov.ua/Documents/Detail?lang=uk-UA&id=727fc030-84ff-4e45-acae-ccc412cd212f&title.

Kontseptualni zasady reformuvannia sfery intelektualnoi vlasnosti : Ministerstvoekonomichnoho rozvytku i torhivli Ukrainy: prezentatsiia na kruhlomu stoli16.05.2016, http://www.me.gov.ua/Documents/Detail?lang=uk-UA&id=727fc030-84ff-4e45-acae-ccc412cd212f&title.

9. Закон України «Про судоустрій і статус суддів», підписаний ПрезидентомУкраїни 13.07.2016 р. [Електронний ресурс]. — Режим доступу :http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=59259

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Zakon Ukrainy «Pro sudoustrii i status suddiv», pidpysanyi Prezydentom Ukrainy13.07.2016, http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=59259

10.Рада з питань судової реформи: 13 головних змін в господарському та ци-вільному процесі: презентація на круглому столі 31 березня 2016 р. [Елек-тронний ресурс]. — Режим доступу : jrc.org.ua.

Rada z pytan sudovoi reformy: 13 holovnykh zmin v hospodarskomu ta tsyvilnomuprotsesi: prezentatsiia na kruhlomu stoli 31.03.2016, jrc.org.ua.

11.Стратегія розвитку наукових досліджень Національної академії правовихнаук України на 2016–2020 роки, затверджені Загальними зборами НАПрНУкраїни 03.03.2016 р. [Електронний ресурс]. — Режим доступу :http://www.aprnu.kharkiv.org/doc/strategiya.pdf.

Stratehiia rozvytku naukovykh doslidzhen Natsionalnoi akademii pravovykh naukUkrainy na 2016–2020 roky, zatverdzheni Zahalnymy zboramy NAPrN Ukrainy03.03.2016, http://www.aprnu.kharkiv.org/doc/strategiya.pdf.

12.Архів науково-практичного журналу «Теорія і практика інтелектуальноївласності» за 2006–2016 роки [Електронний ресурс]. — Режим доступу :http://ndiiv.org.ua/ua/journal-archive.html, http://www.inprojournal.org/uk/category/archiv-nomeriv.

Arkhiv naukovo-praktychnoho zhurnalu «Teoriia i praktyka intelektualnoi vlasnosti»2006–2016, http://ndiiv.org.ua/ua/journal-archive.html, http://www.inprojournal.org/uk/category/archiv-nomeriv.

Надійшла до редакції 18.06.2016 р.

Орлюк О. Роль правовой науки в процессе реформирования сферы интел-лектуальной собственности в Украине: достижения, задачи, миссия. Авторанализирует шаги Украины в развитии законодательства в сфере интеллектуальнойсобственности. Помимо этого, автор анализирует достижения Научно-исследователь-ского института интеллектуальной собственности НАПрН Украины в развитии сис-темы интеллектуальной собственности Украины и знакомит читателей с целями и за-дачами его деятельности.

Ключевые слова: интеллектуальная собственность, образование, наука, законо-проекты, НИИ интеллектуальной собственности НАПрН Украины, реформированиезаконодательства

Orliuk O. The role of legal science in the process of reforming intellectualproperty sphere in Ukraine: achievements, objectives, mission. The author ana-lyzes the steps taken by Ukraine in the development of legislation in the field of intellec-tual property. In addition, the author analyzes the achievement of the Intellectual Proper-ty Research Institute of the NALS of Ukraine in the development of intellectual propertyof Ukraine and acquaints readers with the goals and objectives of its activities.

Keywords: intellectual property, education, science, laws, Institute of Intellectual Prop-erty NALS of Ukraine, law reform

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Кашинцева О. Сучасні цінності гармонізації прав людини та прав інте-лектуальної власності в сфері охорони здоров’я.

Стаття присвячена міждисциплінарним аспектам сучасних цінностей гармонізаціїправ людини і прав інтелектуальної власності в сфері медицини і фармації.Необхідність пошуку балансу прав людини та прав інтелектуальної власності виник-ла для України відповідно до міжнародних зобов’язань. Сучасні цінності прав люди-ни розбалансовано сучасними установками і загальними принципами права інтелек-туальної власності. Очевидно, що ця проблема постала не лише перед Україною.Дисбаланс між правами з прав людини і прав інтелектуальної власності складаєтьсяз двох основних частин: порушення прав людини на етапі отримання науковихрезультатів в галузі біомедицини та фармації, які можуть бути захищені в режиміправа інтелектуальної власності; та порушення прав людини на етапі захисту об’єктівінтелектуальної власності в біомедицині та фармації.

Національна патентна реформа націлена на гармонізацію прав людини та правінтелектуальної власності, шляхом впровадження гнучких положень Угоди ТРІПС,впровадження виключення Болар, розробка дієвих механізмів примусового ліцензу-вання, тощо.

Ключові слова: права людини, інтелектуальна власність, моральні та етичні цін-ності, медицина, фармація

Oksana Kashyntseva,Head of the Center for Harmonization of Human Rights andIntellectual Property Rights of the Intellectual PropertyResearch Institute of the NALS of Ukraine, PhD in Law

MODERN VALUES OF HARMONIZATION OF HUMAN RIGHTS

AND INTELLECTUAL PROPERTYRIGHTS IN HEALTH CARE

The interdisciplinary sphere of ethicalvalues of harmonization of human rightsand intellectual property rights in thehealth care (medicine and pharmacy) hasarisen for Ukraine in accordance with in-ternational obligations. While providingthis research it was determined that theethical values of human rights are sys-tematically misbalanced by modern atti-tudes and general principles of intellectu-al property law (hereinafter — IP Law) inthe sphere of medicine and pharmacy. Itbecame obvious that ignorance of mainethical values of public interest is not onlythe features of Ukrainian national IP Law

doctrine but of international IP Law doc-trine as well. The misbalance betweenhuman rights and intellectual propertyrights has two main parts:

(i) violations of human rights on thestage of the obtaining of the scientif-ic results in medicine and pharmacywhich could be protected in theregime of IP Law; and

(ii)violations of human rights on thestage of protection of the intellectualproperty objects in medicine andpharmacy.

The biggest challenge is to determinethe balance between the intellectual

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property rights and human rights. Weclearly understand that such balance hasinternal contraventions which demandsabsolutely new attitude to its resolve onthe basis of the principle of «responsibleinnovation» in biomedicine and pharmacy.

Theoretical position of the research ofthe mentioned issues is based on the ex-perience of the Center for Harmonizationof Human Rights and IP Rights of Intel-lectual Property Research Institute ofNational Academy of Law Sciences ofUkraine (hereinafter — IP Research In-stitute of NALSU). The main achieve-ment of the abovementioned Center inUkraine is the creation of the opinion inUkrainian scientific society that respon-sible innovations in the sphere of bio-medicine and pharmacy are oriented notonly towards competition and economicgrowth, but also towards values tran-scending an individual. The strategy ofUkrainian patent reform, in the sphereof medicine and pharmacy on the onehand has taken progressive Europeanstandards of protection of intellectualproperty objects in the sphere of medi-cine, but on the other — goes towards therethinking of general principles of futureof intellectual property doctrine on thebasis of necessity of resolving of socialand ethical concerns.

The Scientific Conception of Harmo-nization of Human Rights and IP Rightsis an integral part of the National Policyof the Development of Law in Ukraineadopted in March 4, 2016 by the Nation-al Academy of Law Sciences of Ukraine.The author of the presented researchis a scientific supervisor of PhD studentsof IP Research Institute of NALSU.

The methodology which should be usedin the research of balance of human rightsand intellectual property Rights is a com-parative analysis of the various paradigmsin ethics, deontology, philosophy of science,law and bioethics from the point of harmo-nization of the interests of researcher, in-ventor, individuals as an object of the bio-medical research and public interest andits impact into the future IP Law.

And the objectives of the research areto consolidate modern morality, ethics ofscience and law on the basis of the secu-lar background into the modern doctrineof IP Law in the sphere of biomedicineand pharmacy and to contribute such re-sults into international doctrine of IPLaw and bioethics. The main result ofproviding research could be transmutedinto the new doctrine of IP Law whichhas to be based in the modern values ofhuman rights.

It is possible to presume the success-ful cooperation between different scien-tific institutions which could create mod-ern interdisciplinary paradigm of humanvalues in IP Law.

To achieve the mentioned goal theCenter for Harmonisation of HumanRights and IP Right determines thestrategy which includes the following is-sues:

(i) ethical justification and scientific va-lidity of biomedical researches in-volving human beings (ethical re-sponsibility in a protocol design) andthe protection of the result of suchresearch in the object of IP Law;

(ii) the social and law-making role ofethical review committees;

(iii)ethical review of external sponsoredresearch including the ethics of en-suring risks and potential benefits;

(iv)ethical and legal aspects of organiza-tion of biobanks;

(v) ethical and psychological aspects ofindividual informed consent (compre-hension, renewing, cultural consider-ation, use medical records and biolog-ical specimens collected for other pur-poses, wave of consent requirements,consent of vulnerable individuals);

(vi)ethics of using identifiable and non-identifiable materials of human be-ings;

(vii) ethics of researches using health-related registries (databanks ofgenetic, cancer registries etc.);

(viii) ethical and moral requirements ofthe patentability of the intellectualproperty objects;

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(ix)the world experience in the field ofworking out of national legislation inthe sphere of protection of HumanRights in biomedicine and pharmacyfrom the point of the principles of themain international conventions, inparticular, the legislation regulatingaspects of prenatal genetic research-es and legal status of human embryoand public interest;

(x) comparative analysis of the legal pro-tection of the objects of biotechnolo-gies (in particular human beings) asthe objects of the Patent Law in EUcountries, USA and Canada;

(xi)comparative analysis of the legalprotection of assessments to treat-ments and pharmaceuticals on thebasis of avoiding the economical dis-crimination.

The modern Ukrainian situation, theexistence of political will and interna-tional support give the big chance to re-form Ukrainian patent system in thesphere of medicine and pharmacy in ac-cordance with the highest standards ofrule of human rights.

Let us pay proper attention to changeswhich take place in the internationallegal doctrine of Intellectual Property.

The World Intellectual Property Orga-nization Committee on the Law ofPatents was meeting this summer.Among the agenda items: updates to theinternational patent system, exceptionsand limitations to patents, quality ofpatents, patents and health, confidential-ity of client-patent advisor communica-tions, and technology transfer. A recentdeveloped country proposal relates to in-creased work-sharing among patent of-fices. Also on the table this week is a newproposal to study the assessment of in-ventive step by patent practitioners [1].

This is only the first step in the frameof EU. Regarding the least-developingcountries history has deeper legal roots.

The main international document inthe frame of WTO which in one handstrictly regulated intellectual propertysphere and in other hand gives the liber-

al flexibilities for the least-developmentcountries in the health care sector.

So on the one hand the TRIPS Agree-ment [2] sets out detailed obligationsin respect of the protection of inven-tions, including:

•to recognize patents for inventions inall fields of technology, with limitedexceptions;

•not to discriminate with respect to theavailability or enjoyment of patentrights;

•to grant patent rights for at least20 years from the date of application;

•to limit the scope of exceptions topatent rights and to grant compulsorylicenses only under certain conditions;

•to effectively enforce patent rights.But in other hand the country-mem-

bers of WTO should comply with theminimum standards of the TRIPS Agree-ment. Moreover, they can adopt mea-sures which are conducive to social andeconomic welfare (Article 7 of the TRIPSAgreement), such as those necessary toprotect public health, nutrition and thepublic interest in sectors of vital impor-tance for their socio-economic and tech-nological development. Countries canalso adopt measures to prevent the abuseof intellectual property rights (Article 8.1and 8.2 of the TRIPS Agreement) [3].

The strategy of Ukrainian patent re-form in the sphere of health care shouldbe harmonized to the European Legisla-tion, the legal protection shall not extendto such technology objects:

•therapeutic and surgical methods oftreatment of humans and animals;

•methods of diagnostic and preven-tion of diseases that may be used fortreatment of humans and animals;

•human organism on the differentstages of growth and developmentand simple discovery of elements of ahuman being, for example sequenceor partial sequence of the genes;

•new use of known substance;•new forms of previously known sub-

stances such as: salts, esters, ethers,polymorphs, metabolites, isomers,

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isomers mixtures, combination ofknown compounds and other de-rivate forms of previously knownsubstances.

We also would like to use the Polishexperience of modern understading ofthe abuse of intellectual property rights.Thus, according to Article 68 of IdustrialProperty Law of Poland: «Uprawniony zpatentu lub z icencji nie może nadużywaćswego prawa, w szczególności przezuniemożliwianie korzystania z wynalazkuprzez osobę trzecią, jeżeli jest onokonieczne do zaspokojenia potrzeb rynkukrajowego, a zwłaszcza gdy wymaga tegointeres publiczny, a wyrób jest dostępnyspołeczeństwu w niedostatecznej ilościlub jakości albo po nadmiernie wysokichcenach» [4].

So we shall not ignore the possibilityto determine the abuse of rights derivingfrom the patent in medical field. The per-son who owns the intellectual propertyrights for an invention (utility model) in amedical sphere on the basis of a patent ora license agreement, has no the right toprevent third parties to use the invention(utility model) for public health protectionwhen it leads to a violation of the humanright of access treatment due to lack ofmedicine in Ukraine or high prices.

The dispute about the abuse of intel-lectual property rights shall be settled ina court on the basis of claim of any per-son who considers that his rights or legit-imate interests affected by the abuse ofintellectual property rights or the suit ofthe central body of executive power,which formulates and implements poli-cies in the field of healthcare.

The dispute about the abuse of rightsderiving from the patented invention inmedical field as a result of the issuanceof a supplementary protection certificateshall be resolved in court at the suit ofany person who considers that his rightsor legitimate interests affected by theabuse of intellectual property rights orthe suit of the central executive bodythat forms and implements policy inhealth care.

The other important modern value ofIP Law is the Bolar provision. In patentlaw, the research exemption is an exemp-tion to the rights conferred by patents,which is especially relevant to medicines.According to this exemption, despite thepatent rights, providing the researchesand tests for preparing regulatory ap-proval, for instance by the FDA in theUnited States or by the State ExpertCenter of Ministry of Health of Ukrainedoes not constitute infringement for alimited term before the expired of patenvalidity.

«The principle behind the Bolar ex-emption is that generic companies shouldbe in a position to take the necessarypreparatory measures in order to be ableto enter the market without delay oncepatent protection expires» [5].

This exemption allows generic manu-facturers to prepare generic drugs in ad-vance of the patent expiration.

The next important mechanism to im-plement modern values in IP Law is touse the mechanism of compulsory licens-ing in ordre public by the legal instru-ments of intellectual property and anti-monopoly legislation.

Summarizing mentioned above we de-clare our openings for all scientific dis-cussions regarding the experience of im-plementation of ethical norms and moralstandards into the legislation in thesphere of harmonization of human rightsand intellectual property rights, legalregulations of biomedical researches onhuman beings with the purpose of legit-imization of such scientific results.

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Список використаних джерел / List of references

1. WIPO Patent Law Committee Undertakes Many Issues This Week [in]: IntellectualProperty Watch, http://www.ip-watch.org/2016/06/27/wipo-patent-law-commit-tee-undertakes-many-issues-this-week.

2. Agreement on Trade-Related Aspects of Intellectual Property Rights,https://www.wto.org/english/docs_e/legal_e/27-trips.pdf.

3. Correa Carlos. Integrating public health concerns into patent legislation in develo-ping countries, University of Buenos Aires, Argentina, South Cinter, 2000, P. 20.

4. Ustawa z dnia 30.06.2000 r. Prawo własności przemysłowej,www.uprp.pl/uprp/redir.jsp?place=GalleryStats&id=37064.

5. Decision T 0223/11 dated 22 May 2012 of the Board of Appeal 3.3.02 of the Euro-pean Patent Office.

Надійшла до редакції 29.05.2016 р.

Кашинцева O. Современные ценности гармонизации прав человека и правинтеллектуальной собственности в сфере здравоохранения. Статья посвященамеждисциплинарным аспектам современных ценностей гармонизации прав человекаи прав интеллектуальной собственности в сфере медицины и фармации. Необходи-мость поиска баланса прав человека и прав интеллектуальной собственности возник-ла для Украины в соответствии с международными обязательствами. Современныеценности прав человека разбалансированы современными установками и общимипринципами права интеллектуальной собственности. Очевидно, что данная проблемавозникла не только перед Украиной. Дисбаланс между правами по правам человека иправам интеллектуальной собственности состоит из двух основных частей: нарушенияправ человека на этапе получения научных результатов в области биомедициныи фармации, которые могут быть защищены в режиме права интеллектуальной соб-ственности; и нарушения прав человека на этапе защиты объектов интеллектуальнойсобственности в биомедицине и фармации.

Национальная патентная реформа нацелена на гармонизацию прав человекаи прав интеллектуальной собственности, путем внедрения гибких положений Согла-шения ТРИПС, внедрение исключения Болар, разработка действенных механизмовпринудительного лицензирования и т. д.

Ключевые слова: права человека, интеллектуальная собственность, моральныеи этические ценности, медицина, фармация

Kashyntseva O. Modern values of harmonization of human rights and intel-lectual property rights in health care. The article is devoted to interdisciplinary as-pects of modern values of harmonization of human rights and intellectual property rightsin the sphere of medicine and pharmacy. The necessity to find a balance between humanrights and intellectual property rights arose in Ukraine in accordance with internationalobligations. Modern human rights values unbalanced by modern facilities and the gener-al principles of intellectual property rights. It is obvious that the problem arose not onlyfor Ukraine. The imbalance between the rights of human rights and intellectual propertyrights consists of two main parts: the human rights violations at the stage of obtaining scien-tific results in biomedicine and pharmacy, which can be protected in the mode of IP rights;and human rights violations during the protection of intellectual property in biomedicineand pharmacy.

National patent reform aims to harmonize rights and intellectual property rights, byimplementing flexible provisions of the TRIPS Agreement, implementation Bolar excep-tion, development of effective mechanisms for compulsory licensing, and so on.

Keywords: human rights, intellectual property, moral and ethical values, medicine,pharmacy

РОЗВИТОК СФЕРИ ІНТЕЛЕКТУАЛЬНОЇ ВЛАСНОСТІ

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Андрощук Г. Захист комерційної таємниці в зарубіжній правовій доктри-ні: стратегії забезпечення лояльності працівників.

Комерційна таємниця нерозривно пов’язана з поняттям конкуренції, тому що самеконкуренція є одним з найважливіших факторів ефективного розвитку ринкової еко-номіки. Конкурентна боротьба неминуче припускає забезпечення збереження в таєм-ниці відомостей, оволодіння якими сторонніми особами призведе до послаблення еко-номічних позицій підприємства або завдання значної шкоди.

Законодавство, що регулює питання комерційної таємниці (в більшості країн ціправовідносини регулюються законодавством про захист від недобросовісної конку-ренції), запобігає промисловому шпигунству (несанкціонованому доступу до такої ін-формації) завдяки тому, що воно передбачає притягнення до відповідальності осіб,винних в отриманні доступу до інформації незаконними способами.

Сьогодні окремі суперечливі норми, що регулюють питання, пов’язані з комерцій-ною таємницею, містяться в різних нормативно-законодавчих актах. Спеціального за-кону про охорону комерційної таємниці в Україні й досі немає. Водночас, окремі спеці-альні закони з охорони комерційної таємниці сьогодні діють в Молдові (1994 р.), Кир-гизстані (1998 р.), Туркменістані (2000 р.), Азербайджані (2001 р.), Росії (2004 р.),Таджикистані (2008 р.), Білорусі (2013 р.).

У сучасних умовах жорсткої конкуренції вирішальну роль в охороні інтелектуаль-ної власності (ІВ) підприємства відіграють його працівники. Незважаючи на існуван-ня цілої низки юридичних і технічних механізмів охорони ІВ, одним з найскладнішихзавдань, яке доводиться вирішувати підприємствам в сфері охорони ІВ, є, як і раніше,забезпечення лояльності з боку працівників. Працівники — найбільша загроза. Відо-ма статистика (дані Інтерполу), згідно з якою 25 % службовців фірми готові продати їїсекрети в будь-який час кому завгодно, 50 % йдуть на це залежно від обставин і лише25 % є патріотами цього підприємства. У статті роз’яснюється необхідність включеннядо стратегії охорони комерційної таємниці підприємств такого ключового елемента, яквисока лояльність з боку працівників. Розглянуто основні шляхи та способи забезпе-чення довіри і відданості з боку працівників, що запобігає несанкціонованому розго-лошенню ними комерційних секретів підприємства.

Щодо роботодавця працівник автоматично зобов’язаний зберігати конфіденцій-ність. Однак в умовах високої мобільності робочої сили, «психологічні договори» вияв-ляються ненадійними. Це означає, що офіційні юридично оформлені контракти набу-вають все більшого значення. Такі контракти або положення, що в них містяться,зміцнюють юридичну охорону комерційної таємниці і забезпечують підприємству без-пеку у разі виникнення судового спору.

Статистичні дані свідчать, що майже 80 % працівників малих і середніх підпри-ємств лояльні до своїх підприємств, тоді як у великих компаніях цей показник стано-вить менше 50 %. Законодавство про охорону комерційної таємниці покликане забез-печити баланс між різними варіантами політики в галузі конкуренції. З одного боку,

Hennadiy Androshchuk,head of Laboratory for legal support for science and technologydevelopment of the Intellectual Property Research Institute ofthe NALS of Ukraine, PhD in economics, associate professor

PROTECTION OF TRADESECRETS IN INTERNATIONAL

LEGAL DOCTRINES: STRATEGIES TO ACHIEVE

EMPLOYEE LOYALTY

КОМЕРЦІЙНА ТАЄМНИЦЯ

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Г. Андрощук

Introduction. Trade secret is closelyconnected with the notion of competition,because competition is one of the mostimportant factors of effective develop-ment of a market economy. Competitionwill inevitable involve the need to ensureconfidentiality of information which, ifbecomes known to outside parties, maylead to the weakening of the economic po-sition of the enterprise or cause it a sub-stantial harm.

With the transition of our state to-wards the market economy, the newterms associated with the market econo-my terms have come into use in theUkrainian legislation, such as «confiden-tial information», «commercial secret»,«bank secret» and «know-how». Whereasissues relating to protection of state se-crets are thoroughly regulated by theUkrainian legislation, the issues relatingto commercial secrets and protectionthereof are among the least developed inthe Ukrainian economics and law science.In fact there is no any practical experi-ence concerning application of provisionsof the existing legislation relating to com-mercial secrets. Over the last 6 years thebodies of the Antimonopoly Committee ofUkraine have eradicated only 11 cases in-fringements specified in articles 16–19 (il-legal collection, disclosure and use ofcommercial secrets) of the Law ofUkraine «On protection from unfair com-petition» [1]. And it is understandable,

because the prevailing majority of suchcases are of a latent (hidden) nature.

Presently there are assorted conflict-ing provisions which regulate issues con-cerning commercial secrets and whichare contained in different regulatory andlegal acts. Ukraine still does not have asingle law dedicated to protection of com-mercial secrets. However, separate lawson protection of commercial secrets arecurrently in force in Moldova (1994), Kyr-gyzstan (1998), Turkmenistan (2000),Azerbaijan (2001), the Russian Federa-tion (2004), Tajikistan (2008), Belarus(2013) [2].

In the modern conditions of harsh com-petition, it is employees of an enterprisewho play a decisive part in protecting itsintellectual property (hereinafter — IP).Despite the availability of a series oflegal and technical mechanisms of IPprotection, one of the most challengingtasks that businesses face in the area ofIP protection is (as it has been in thepast) to ensure employee loyalty. In thispaper we explain the need to include inthe strategy of protection of commercialsecrets of enterprises such a key elementas high degree of loyalty of employees.Let’s look at the principal ways andmeans of achieving trust and commit-ment on the part of employees and pre-venting, by doing that, the unauthorizeddisclosure of commercial secrets of theenterprise by its employees.

необхідно заохочувати інновації і творчість та забезпечити охорону компаніям, що ін-вестують кошти в інноваційну і творчу діяльність. З іншого, необхідно заохочуватиздорову конкуренцію і свободу зайнятості. Про складність таких різних і нерідко кон-фліктуючих політичних підходів свідчить застосування в країнах загального права«доктрини неминучого розкриття» і «доктрини трампліна».

Саме тому організаційні та адміністративні заходи захисту конфіденційної інфор-мації необхідно поєднувати з соціально-психологічними. Серед соціально-психологіч-них заходів захисту можна виділити два основних напрямки: це, по-перше, правиль-ний підбір і розстановка кадрів і, по-друге, використання матеріальних і моральнихстимулів.

Західні фахівці з економічної безпеки вважають, що від правильного підбору, роз-становки і стимулювання персоналу збереження фірмових секретів залежить, як міні-мум, на 80 %!

Ключові слова: конкуренція, комерційна таємниця, конфіденційність, економічнабезпека, лояльність працівників

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A saying «he who controls informationcontrols the world» is very well suited forthe entire concept of strategic use of com-mercial secrets. Using commercial secretsfor strategic purposes, an enterprise oftenachieves a significant competitive edge onthe market. Besides, owing to such se-crets the enterprise may create a marketniche that will be practically inaccessiblefor competitors. Frequently enough, en-terprises attain competitive advantagesbecause they do not disclose strategic in-formation or maintain its confidentialitysufficiently long, since laws (of most coun-tries) normally prohibit third parties touse or copy secrets or confidential infor-mation without its owner’s permission.Legislation that regulates issues relatingto commercial secrets (in most countriessuch legal relationships are regulated bylaws on protection from unfair competi-tion) prevents commercial espionage(unauthorized access to such information)by establishing responsibility of individu-als gaining access to information by illegalmeans [3, 4, 5]. Commercial secret is notthe only instrument for IP protection,and, if used properly, it will complementand step up efficiency of other means ofprotection. By successfully protectingtheir commercial secrets, enterprises alsostrengthen their other IP assets, for ex-ample, Coca-Cola Company by protectingits secret formula as a commercial secretalso strengthens its trademark*.

Considering volatility of market con-ditions and taking into account that com-

mercial secrets can be disclosed by thirdparties themselves, businesses are ad-vised not only to protect already existingcommercial secrets, but also work con-stantly on creating new know-how tomaintain their competitiveness. Besides,it may also prove useful in the event ofunforeseen disclosure of commercial se-crets, because the enterprise will be ablein such a case to switch to manufacturinga new and better product or to imple-menting a more effective business plan.

Definition of commercial secrets.To be regarded as commercial secret and,consequently, to qualify for legal protec-tion, information must meet the follow-ing three principal requirements: 1) thisinformation must be confidential or mustbe distributed on conditions of confiden-tiality; 2) the information must havecommercially valuable due to its confi-dentiality; 3) under certain conditions,the owner of the information must applynecessary steps to maintain its confiden-tiality. A commercial secret may be anykind of information, including formulas,methods, models, financial data, busi-ness plans, client lists, undisclosed prod-ucts, etc., which the enterprise deemsvaluable and which gives the enterprisean advantage over its competitors [3].

Positive and negative aspects ofprotection of commercial secrets.When making a decision on whether ornot to apply the mechanism of protectionof commercial secrets, one must consideradvantages and drawbacks of such pro-

* There are well-known international examples where extensive and reliable protection of productionsecrets is ensured by developers themselves. Thus, the Coca-cola extract production secret is known only totwo persons and has been kept undisclosed since 1886. This secret has been insured against commercialespionage in the amount of 43 million dollars. The secret of production of Cologne № 4711 in Germany hasbeen under protection already for 190 years; it has been seventy years as the secret of composition of theworld’s best French perfume Chanel № 5, which includes over 100 different fragrance oils and essences;also protected are the secret tobacco mix of Marlboro cigarettes, the secret ingredients of French liqueursBenedictine and Chartres. The same holds true for Pepsi cola. Back in 1903 the obscure pharmacistBraham from North Carolina (the USA) invented the dark-brown syrup that he dubbed Pepsi, which meansenergizing or invigorating. This syrup is currently used by 1300 PepsiCo plants located in all parts of theworld. Its production secret is known only to 3 members of the board of directors of PepsiCo. Only they holdthe keys to the safe where the recipe of this concentrate is kept; they can open the safe only together andthey are not allowed to be together in one airplane, train or car — if anything happens to one of them, twoothers will stay alive. And just in case a copy of the safe key is held at the bank which finances the com-pany [6].

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tection relative to other methods of IPprotection. The advantages of commer-cial secrets are as follows: 1) they entailno registration costs; 2) such protectionis not limited in time; 3) protection ofcommercial secrets becomes effective im-mediately; 4) to establish such protec-tion, the commercial secret does not haveto disclosed or registered in a govern-ment agency. On the other hand, it hasthe following disadvantages: 1) if the se-cret is embodied in a product, third par-ties may themselves disclose the embod-ied in this product secret informationand use it legitimately by way of «reverseengineering»; 2) if a commercial secrethas been disclosure to the general public,no protection shall be granted; 3) protec-tion shall be granted only from the illegalaccess, use or disclosure of confidentialinformation; 4) protection of commercialsecrets is weaker than patent protection;5) commercial secret does not ensure pro-tection from those who independentlyreaches an idea that is analogous to theone kept as secret. The result is that un-patented commercial secret could bepatented by a person who independentlydevelops it. In this respect a commercialsecret is different from a patent on inven-tions which protects the owner of thepatent from those who managed to inde-pendently develop an analogous techni-cal solution. A law does not stipulate apunishment for a bona-fide disclosure,including such legitimate methods of dis-covery as: 1) independent creation; com-mercial secret does not involve exclusivity,therefore potentially anybody can discoveryour commercial secrets independentlyand use or patent them; 2) reverse engi-neering; this is a usual technique used tounderstand the mechanism of operation orcomponent parts of a product and whichmeans that a competitor examines theproduct with a view to reproducing it oreven manufacturing a better product [3].

However, many analysts believe thatprotection of the results of intellectualactivities in the regime of a commercialsecret has a more promising perspective

than patent protection. From the verybeginning patents were meant to stimu-late not making inventions commercialsecrets. For instance, in [7] it is indicatedthat: «... in the hierarchy of methods ofimproving competitiveness of innovativebusinesses, patent protection for manycompanies comes only fifth after protec-tion in the form of know-how, reducingthe length of the period for implementa-tion of the innovation, of production it-self, selling accompanying goods or ser-vices».

It should be noted that the costs asso-ciated with obtaining a patent for an in-vention of medium complexity and en-forcing this patent during the first threeyears (including patent attorney’s fees)may amount to 3 000–4 000 euros in Eu-ropean countries, 7 500 euros in the USA,and 9 600 euros — in Japan. The cost of aEuropean patent in eight countries is es-timated at 40 000 euros. Patenting theinventions under the Patent CooperationTreaty system involves additional, com-pared to the national patenting proce-dure, cost of 2 100 euros (3 800 euros ifpatent analysis is carried out) [8]. Be-sides, due to the high level of uncertaintyin patent protection and also high costsof obtaining and enforcing a patent, judi-cial costs relating to judicial settlementof disputes in the area of patent law andtheir complexity, the «patent wars» makesense only as a last-ditch effort for a fi-nancially able claimant.

Legal protection under the commer-cial secret regime has a string advan-tages compared to other forms of legalprotection. Such advantages include ab-sence of a mandatory registration re-quirement at the patent office, indefiniteterm of protection, fast achievement ofthe status of protected result of intellec-tual activities, universality of objects ofprotection, no need to pay a duty or dis-close the essence of the product subject toprotection. Of course, these particularfeatures of commercial secrets (know-how) make them a rather attractive in-strument of legal protection of the re-

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sults of intellectual activities for enter-prises of any ownership form. However,working with a production secret has itsdifficulties relating to the uncertainmechanism for the accounting of know-how and additional costs which accompa-ny this stage of working with it. On theone hand, under par. 4 of the Regulationon financial accounting «Accounting ofintangible assets» (RFA 14/2007), «pro-vided certain conditions are met ... intan-gible assets will include, for instance, sci-entific, literary and artistic creations;programs for computers, inventions; util-ity models ... production secrets (know-how); trade and service marks». Thismeans that in theory financial account-ing of know-how is possible [7].

Protection of commercial secrets. Dueto the modern achievements in the areaof communication technologies and thespeed at which information can be copiedand distributed, protection of commercialsecrets requires continuous daily efforts.To achieve this, an enterprise must:

•identify all valuable commercial se-crets and develop and implement apolicy and program for protection ofthe commercial secrets;

•communicate to the employees theimportance of protection of commer-cial secrets and explain the devel-oped protection policy and programto them;

•make a balanced decision on whichemployees «need to know or use» theinformation, and periodically revisethe list of such employees, and alsorestrict access to commercial secretsbased on what exactly the employees«need to know» or «need to use»;

•install devices limiting physical andtechnical access to commercial se-crets; • limit public access to theroom where commercial secrets arekept and ensure control over suchaccess;

•in order to prevent incidental or unin-tentional disclosure of information,mark secret or confidential all docu-ments containing commercial secrets;

•sign confidentiality agreements withall relevant employees, as well asthird persons who in one way or an-other may gain access to commercialsecrets of the enterprise.

Employees are the major risk.There are sad Interpol statistics, accord-ing to which 25 % of companies personnelare prepared to sell their secrets to any-body and anytime, 50 % may do it de-pending on circumstances and only 25 %are true patriots of their enterprises [3].

Competitive advantages that an en-terprise do badly needs can be ensuredby new and more advanced products andprocesses which cannot be copied. An in-cessant quest for creative and innovativeideas is an all-time problem. Some enter-prises even directly «steal» the employeesform their competitors in order to exploittheir creative and innovative capabili-ties, as well as their knowledge of secretsof successful activities of the competitorfor their own advantage. In most casesconfidential information is disclosed orused by the existing and particularly byformer employees of the enterprise.When a person is working for an enter-prise, it always has some «psychologicalaccord» with the employer. Unlike an of-ficially executed contract, such an accordis made up of a set of mutual expecta-tions in respect of the employee’s contri-bution to the operation of the enterprise,on the one hand, and of his reward for hiscontribution, on the other hand. Such ex-pectations, as a rule, develop and becomeunderstood in the course of the work forthe company. As employees integrateinto the company’s culture, they learnwhat exactly is acceptable and what isnot, what their duties are and what theyowe the company and what the companyowes them. In respect of the employee anemployee is required to maintain confi-dentiality automatically. However, underconditions of high level of freedom of em-ployment, «psychological accords» turnunreliable. This means that officially ex-ecuted legal contracts are gaininggreater importance. Such contracts or

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provisions contained therein strengthenthe legal protection of commercial secretsand ensure enterprise’s security if a judi-cial dispute arises. There exist severalkinds of contract provisions which an en-terprise may include in employment con-tracts with its employees with a view toensuring protection of one’s confidentialinformation.

•Firstly, it is the provision on mutualnondisclosure obligations, whereboth parties agree not to disclose anyconfidential information subject tothe contract. Such provisions shouldbe included in contracts of any kind,be it a contract with full-time staffemployees, interns, temporary hire,shareholders, clients, or anybodyelse who can gain access to the com-mercial secrets of the enterprise.

•Secondly, there is an equally impor-tant competition waiver clause,under which employees give up theirrights to carry out similar activitiesor hold a similar job position withcompetitors of the employer andeven to start up one’s own businessusing for this purpose the informa-tion of the employer enterprise. Aprovision on competition waivershould include the following obliga-tions: not to hold several jobs, not tocompete with the employer, not toset up a competing company and notto entice one’s colleagues to startworking for a competing company.However, in certain countries it isnot allowed to include such provi-sions, whereas in most other coun-tries it is required that such limita-tions must be reasonable.

Such a provision exists, in particular,in German competition law. A similar ar-ticle was included in the draft Law ofUkraine «On protection from unfair com-petition». However, in the course of thepreparation of the draft law for the sec-ond reading this provision was notbacked by the deputies, because, in theirview, it was infringing on human rights.The result is that now in Ukraine it is

rather common for former employees tostart work for competitive entities, suchas banks, insurance companies, etc. Theauthor believes that it is time to revisethis legislative provision in the light ofthe existing international expertise andnational experience.

Confidentiality agreements: ab-sence of full guarantee. The task ofpreserving commercial secrets is everpresent due to the constant fear of theirpossible disclosure. As a rule, major risksare posed by employees themselves, sincethere are no guarantees that signingwith them «non-disclosure agreements»and «agreements on competition waiver»will suffice to prevent use or unautho-rized disclosure of confidential informa-tion by the employees who quit workingfor the company. In any case, the compe-tition waiver clause does not ensure fullguarantee here, because often it is sub-ject to limitations regarding its durationand geographical coverage.

In the past two decades the world ofbusiness and work conditions have beenthrough substantial changes. In the past,a hired employee used to be sure work forthe company for the rest of his life,whereas the employer would expect fromhim full loyalty to the enterprise. Be-sides, employees in those times werecommitted to their employer. However,with the onset of «globalization», whenemployees began to be confronted withproblems of restructuring, relocation ofcompanies to other regions and theirfragmentation, the attitude toward em-ployee started changing sharply [9]. Em-ployers have began to «infringe on therules», mutual obligations stopped beingobserved and were revised, an employeewas no longer expected to provide ser-vices and show commitment indefinitely,job hopping became usual as people con-stantly sought higher-pay jobs or betterworking conditions. Under modern condi-tions it is difficult to achieve loyalty andtrust in the work place. According to thestudy of American labor market carriedout in 2000 by human resource consul-

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tants for the Fortune Company, employ-ees’ loyalty to their employers dependedon the size of the enterprise. The statis-tics demonstrated that almost 80 percent of employees of medium-sized enter-prises were loyal to their enterprise,whereas in large companies this ratio isless than 50 per cent. The legislation pro-tection of commercial secrets seeks to en-sure a balance between different policyversions in the area of competition. Onthe one hand, it is necessary to encour-age innovation and creativity and to en-sure protection for the companies invest-ing funds in innovation and creativity.On the other hand, it is necessary to en-courage healthy competition and freedomof employment. Complexity of such dif-ferent and often conflicting political ap-proaches is reflected in the fact that com-mon law countries apply the «inevitabledisclosure» and «springboard» doctrines.

The «inevitable disclosure» doc-trine emerged in connection with theneed to resolve a problem of employees’migrating to other similar companies.The doctrine’s major principle is that theemployees who had access to confidentialinformation would inevitably disclosethis information to their future employ-ers, provided the latter operate in thesame area. What follows from this doc-trine is that even if an employee has goodintentions, he will automatically or in-stinctively pass the information, skillsand knowledge acquired on his previousjob to his next employer, id the latter car-ries out his activity in the same area. Inthis case the policy factors mentionedabove come into play. On the other hand,the society needs to protect confidentialinformation of its enterprises, although itmay not restrict freedom of employmentfor its members. Judicial rulings passedin this area depend on facts and circum-stances of each specific dispute. As arule, an injunction on the employee’sstarting work for another company is is-sued if it is established that there is ahigh probability of the former employee’spassing to his new employer the informa-

tion that is not generally known or can-not be easily «deduced» by the competi-tors in the respective sector. One mustdistinguish between specific confidentialinformation and the usual skills andknowledge acquired by an employee inthe course of his work for the previouscompany. The employee may not be de-prived of the right to use such acquiredskills and knowledge.

A case PepsiCo Inc. v Redmond pre-sents an example of application of thisdoctrine to prevent work of the employeefor the competing company. PepsiCo Inc.sought to obtain an injunction for theemployment of its former employee Red-mond by the Quaker Oats company,which at the time was a direct competitorof PepsiCo Inc. PepsiCo Inc. won in thisdispute because it was found that Red-mond would inevitably disclose PepsiCo’scommercial secrets and confidential in-formation to his new employer given thenature of the job offered to him at theQuaker company. The court also ruledthat Redmond may never disclose Pepsi-Co’s commercial secrets.

The «springboard» doctrine is ap-plied to prevent a former employee whohad access to the former employer’s con-fidential information from using such in-formation in his own interests to achievean unfair advantage over his former em-ployer.

An example of the use of this doctrineis a case Rodger Bullivant Ltd. v Ellis,where a managing director went to workfor the rival company and brought tech-nical and commercial documents, tradesecrets and information about clientele ofthe former employer. In this case of wasbeyond doubt that using this informationthe former employee would get an unfairadvantage and therefore the court pro-hibited such use of the information.

The springboard doctrine may also beused even if relevant information has al-ready entered the public domain, inorder to ban the former employee, whoacquired from his former employer spe-cific production knowledge and technical

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skills, to use these skills / knowledge tomanufacture a competing product. Thisis because such knowledge would give aformer employee an «unfair head start»in respect of those who have access to thepublished information.

It is not easy, however, to obtain acourt injunction, because the issue of con-fidentiality is of a complex nature: it isdifficult to clearly identify and delineatethe knowledge that the employee alreadyhad at the time of his being hired by thecompany, and the knowledge that he ac-quired during his work for the company.

In the last several decades changesoccurred in working conditions and, as aresult, in the degree of employee loyalty,which made incompliance with the psy-chological accord more likely. Therefore,greater attention must be paid to thetask of improving employee loyalty as away of ensuring protection of commercialsecrets. An employer will only benefitfrom this, because the taking of appropri-ate measures will improve productivityand, even more importantly, will tie em-ployees to their jobs, reduce personnelturnover and, as a result of this, mini-mize the risk of disclosure of commercialsecrets.

Raising the level of employee loy-alty. In the opinion of foreign experts,probability rate of a leak of data consti-tuting commercial secrets in connectionwith bribery, blackmail, hiring competi-tion’s personnel, planting of one’s agentsis 43 %; by obtaining information throughcommunication with colleagues — 24 %.Therefore, the firm’s personnel are, onthe one hand, the most important re-source for entrepreneurial activities,and, on the other hand — certain em-ployees due to various circumstancesmay cause significant losses and evenbankruptcy of the firm. Thus, in WesternEurope and in the USA the loss of 20 %of confidential information usually leadsto the firm’s collapse within a month [3].

That is why organizational and ad-ministrative measures aiming to protectconfidential information must be com-

bined with socio-psychological measures.The socio-psychological measures of pro-tection have two primary components:firstly, it is the proper selection andplacement of personnel, and secondly —use of material and moral incentives.Western economic security experts be-lieve that minimum 80 % of protection ofcompany secrets depends on proper se-lection, placement and motivation of thepersonnel!

Companies such as «Southwest Air-lines», «Toyota» and «Sysco», which seekto raise profits by caring of their employ-ees, have come to realize that ensuringemployee loyalty to the company’s causeneed be well integrated with its policy inthe area of human resources and com-mon business strategies. Loyalty on thepart of employees is not less importantthan loyalty on the part of customers, be-cause enterprises entrust their cus-tomers to their employees, and thereforeit is important to collect, summarize andinterpret information about employees tobe able to have a clear understanding oftheir needs and expectations. Relation-ships between the employer and employ-ees must be based on mutual respect andunderstanding, fair and just treatment ofemployees regardless of their job posi-tions. An important step on the way tothe higher employee loyalty to the enter-prise’s cause is communication. Expecta-tions of management may differ from ex-pectations of employees, and therefore itis necessary to clarify mutual expecta-tions in order for the both parties to un-derstand what exactly is needed, fromwhom and in what amount. Where man-agers enjoy their subordinate employee’srespect and trust — it is good for the in-terests of the business. Therefore, orga-nizing manager qualification improve-ment programs may help improve per-sonnel management skills and facilitateproblem solving in specific sectors. It isuseful to maintain proper communica-tions inside the company and it is impor-tant to listen to the employees’ opinion,since in this case the latter may feel that

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they are involved in the common causeand the enterprise may benefit from thisin terms of improved management andinside problem solving. Organization ofprograms such as inside forums, whereemployees would be given an opportunityto freely express their views and recom-mendations, could facilitate creation of afavorable work atmosphere. Besides, lis-tening to the employee’s views, companymanagers could identify «weak points»and «cells of dissatisfaction» and take ac-tion to eliminate them.

In the culture where there is «littlealienation from authorities», managerstreat their subordinates with respect anddo not mistreat them, employees are en-trusted with implementation of impor-tant assignments, and responsibility isborne by both parties or by the manageralone, who often assumes it singlehand-edly as a person responsible for manage-ment, and managers are often in touchwith the employees after work. Such amore collegial culture and the democraticand decentralized atmosphere in thework place greatly encourage higher loy-alty among employees and strengthenmutual trust by facilitating communica-tion between managers and employees.Employers, in their relationships withemployees, need to do their best todemonstrate their care of the latter. Be-sides, collegial environment and «littlealienation from authorities» form a sort ofa «family» atmosphere inducing a sense ofinvolvement. This, in its turn, helpsstrengthen loyalty with respect to the en-terprise. When developing a strategy forensuring employee loyalty to the cause ofthe enterprise, it is important to makesure that every employee understandswhat his role in the company is and howhe can contribute to achievement of theoverall success, because this willstrengthen his sense of involvement, self-respect and doing something meaningful,and will also step up his level of loyaltywith respect to the company.

Also very important for employees areproper work compensation, bonuses and

benefits. From the financial point ofview, wages of employees must fairly re-flect their work contribution. One of themethods of reconciling interests of theenterprise and interests of its employeesis the application of the profit-sharingmechanism, under which employees arepaid bonuses which depend on the com-pany’s profits. Ultimately, both employ-ees and employer are working on theircommon objective of ensuring mutualbenefits. For example, Procter and Gam-ble offers its employees a very attractiveshare of its profit, and many employeesof the company own its share worth thou-sands dollars. This makes employees feelinvolved and gives them certain financialbenefits.

Also important is to motivate employ-ees by ways other than material, for in-stance, in the form of announcing grati-tude, granting a leave, placing a photo-graph on the best employee board,making available for them training pro-grams, etc. The world’s largest privatesoftware developing company, SAS Insti-tute Inc., has the personnel turnover rateof 4 per cent. This relatively low rate isachieved also due to such employee bene-fits as daytime childcare service forworking mothers, organization of leisureand recreation activities, full health in-surance coverage, as well as a 35-hourwork week.

Controlling employees activities.Despite the importance of measures aim-ing to strengthen employee loyalty, em-ployers should not forget of protection ofcommercial secrets. For this purposethey must constantly control activities ofemployees. However, in doing this em-ployers must not step outside the estab-lished limitations and must always re-spect privacy of employees. At the sametime, excessive control may undermineemployee’s trust, because they may feelthat they are not trusted themselves.

Speaking to a resigning employ-ee. As an employment contract expires,it is important for the employer to have aconversation with the resigning employ-

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Список використаних джерел / List of references

1. Андрощук Г. О. Захист комерційної таємниці: методика розслідування зло-чинів / Г. О. Андрощук // Інтелектуальна власність. — 2008. — № 7. —С. 21–33, № 10. — С. 22–31, № 11. — С. 21–33.

Androshchuk H. O. Zakhyst komertsiinoi taiemnytsi: metodyka rozsliduvannia zlochyniv[in]: Intelektualna vlasnist, 2008, № 7, S. 21–33; № 10, S. 22–31; № 11, S. 21–33.

2. Андрощук Г. Институт коммерческой тайны в странах СНГ: правовойрежим и защита // XVII Международная научно-практическая конференция«Актуальне проблемы интеллектуальной собственности», Львов,21–25.02.2011 г. — С. 224–241.

Androshchuk G. Institut kommercheskoy tainy v stranah SNG: pravovoi rezhym i za-shchita, XVII Mezhdunarodnaia nauchno-prakticheskaia konferentsiia «Aktualnyeproblemy intellektualnoi sobstvennosti», Lvov, 21–25.02.2011, S. 224–241.

3. Андрощук Г. А. Экономическая безопасность предприятия: защита коммерческойтайны : монография / Г. А. Андрощук, П. П. Крайнев. — К. : Ин Юре, 2000. — 400 с.

Androshchuk H. A., Krainev P. P. Ekonomicheskaia bezopasnost predpriatia: zaschitakommercheskoi tainy, K. : In Yure, 2000, 400 s.

4. Андрощук Г. О. Конкурентне право: захист від недобросовісної конкуренції :навч. посібник / Г. О. Андрощук. — 3-є вид. стереотипне. — К. : ЗАТ «Ін-тінтел. власн. і права», 2004. — 304 с.

Androshchuk H. O. Konkurentne pravo: zakhyst vid nedobrosovisnoi konkurentsii, K. :ZAT «In-t intel. vlasn. i prava». 2004, 304 s.

5. Андрощук Г. А. Правовое регулирование защиты коммерческой тайны за ру-бежом / Г. А. Андрощук, П. П. Крайнев // Экономическая безопасность, раз-ведка и контрразведка — 2002. — № 1. — С. 18–45.

Androshchuk H. A., Krainev P. P. Pravovoe regulirovanie zaschity kommercheskoitainy za rubezhom [in]: Ekonomicheskaia bezopasnost, razvedka i kontrrazvedka,2002, № 1, S. 18–45.

ee and remind him of the obligation ofnon-disclosure of commercial secrets towhich the employee had access in thecompany, after termination of the em-ployment, and of the consequences of in-compliance. Such conversations may alsobe of value for the employer, who mayfind out about the plans of the formeremployee for the future, for instance, asto his intended place of employment.This information could let the employermore accurately evaluate the existingand potential risks of disclosure of hiscommercial secrets and identify his com-petitors.

Conclusion. As enterprises makea decision to keep certain informationconfidential, they must create a depend-able system for protection of such infor-mation [10, 11]. Also enterprises should

take measures to ensure psychologicalloyalty on the part of the employees tostep up the effectiveness of the signednon-disclosure agreements and competi-tion waivers and thus protect their com-mercial secrets. Therefore, enterprisesare advised to fully integrate measuresaimed to strengthen psychological loyal-ty of employees with their strategies inthe field of IP protection and their gener-al business strategies.

Г. Андрощук

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КОМЕРЦІЙНА ТАЄМНИЦЯ

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КОМЕРЦІЙНА ТАЄМНИЦЯ

6. Андрощук Г. Комерційна реалізація ноу-хау: зарубіжний досвід та вітчизня-на практика / Г. Андрощук // Міжнародний форум «Трансфер технологійта інновацій», Київ, 20–21.11.2008. — С. 90–108.

Androshchuk H. Komertsiina realizatsiia nou-khau: zarubizhnyi dosvid ta vitchyzni-ana praktyka, Mizhnarodnyi forum «Transfer tekhnolohii ta innovatsii», Kyiv,20–21.11.2008, S. 90–108.

7. Чайков М. Коллизии секрета производства (ноу-хау) / М. Чайков, А. Майкова.[Электронный ресурс]. — Режим доступа : http://www.avtonews.net/005/kollizii-sekreta-proizvodstva-nou-khau?page=0,1.

Chaikov M., Maikova A. Kollizii sekreta proizvodstva (know-how),http://www.avtonews.net/005/kollizii-sekreta-proizvodstva-nou-khau?page=0,1.

8. Андрощук Г. Зарубіжне патентування винаходів / Г. Андрощук // Теоріяі практика інтелектуальної власності. — № 6. — 2011.

Androshchuk H. Zarubizhne patentuvannia vynakhodiv [in]: Teoriia i praktyka in-telektualnoi vlasnosti, № 6, 2011.

9. Андрощук Г. Управление интеллектуальной собственностью при офшоринге:аспекты экономической безопасности / Г. Андрощук // Наука та інновації. —№ 1. — 2011. — С. 48–66.

Androshchuk H. Upravlenie itellektualnoi sobstvennostiu pri ofshoringe: aspekty ekon-omycheskoi bezopasnosti [in]: Nauka ta innovatsii, № 1, 2011, S. 48–66.

10.Марущак А. І. Правові основи захисту інформації з обмеженим доступом /А. І. Марущак. — К. : КНТ, 2007. — 208 с. .

Marushchak A. I. Pravovi osnovy zakhystu informatsii z obmezhenym dostupom, K. :KNT, 2007, 208 s.

11. Носік Ю. В. Право на комерційну таємницю в Україні : монографія /Ю. В. Носік. — К. : КНТ. — 2007. — 240 с.

Nosik Yu. V. Pravo na komertsiinu taiemnytsiu v Ukraini, K. : KNT, 2007, 240 s.

Надійшла до редакції 31.05.2016 р.

Андрощук Г. Защита коммерческой тайны в зарубежной правовой доктри-не: стратегии обеспечения лояльности работников. Исследуется роль коммер-ческой тайны в конкурентной борьбе. Разъясняется необходимость включения в стра-тегии охраны коммерческой тайны предприятий такого ключевого элемента, каквысокая лояльность со стороны работников. Рассмотрены основные пути и способыобеспечения доверия и преданности со стороны работников, что предотвращает несан-кционированный разглашению ними коммерческих секретов предприятия.

Ключевые слова: конкуренция, коммерческая тайна, конфиденциальность, эконо-мическая безопасность, лояльность работников

Androshchuk H. Protection of trade secrets in international legal doctrines:strategies to achieve employee loyalty. The article investigates the role of trade se-crets in the competition. It is explained the need to include into strategies for the protec-tion of trade secrets of enterprises of such a key element, as the high loyalty of employees.The basic ways and means to ensure the credibility and dedication on the part of employ-ees, which prevents unauthorized disclosure of these commercial secrets of the enterpriseare considered.

Key words: competition, trade secret, privacy, economic security, employee loyalty

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30Теорія і практика інтелектуальної власності � 3/2016

ISSN 2308-0361

Зеров К. Проблеми ідентифікації особи-порушника авторського права натвори, розміщені в Інтернеті.

У публікації розглянуто проблеми ідентифікації особи — порушника авторськихправ на твори, розміщені в мережі Інтернет. Автор класифікує таку ідентифікаціюна види залежно від особливостей протиправної поведінки особи на: 1) ідентифікаціюособи-власника веб-сайту; 2) ідентифікацію особи-користувача веб-сайту, що розмістивтвір; 3) ідентифікацію особи-користувача Р2Р-мережі; кожна з яких має свої особли-вості. Проаналізовано, що процес ідентифікації особи, що вчинила пряме порушенняавторських прав (користувача веб-сайту, що розмістив твір, та користувача Р2Р-мере-жі), поділяється на три стадії: 1) визначення і збирання IP-адрес; 2 ) знаходження від-повідності IP-адреси визначеним абонентам (користувачам) окремих інтернет посе-редників; 3) інформування чи направлення претензій особам щодо порушення нимиавторських прав та можливості подання (чи безпосередньо подання) проти них позо-вів. Автором зроблено висновок, що для ідентифікації особи-порушника (а не місця,дескоєно порушення) авторських прав на твори, розміщені в мережі Інтернет-виключ-но використання ІР-адреси недостатньо, тому необхідно використовувати додатковідокази в сукупності для встановлення причинново-наслідкового зв’язку між особою-абонентом (кінцевим користувачем), якому делеговано певну ІР-адресу, та порушен-ням авторського права.

Ключові слова: Інтернет, піратство, авторське право, ідентификація

Kostiantyn Zerov,postgraduate student of the Taras Shevchenko NationalUniversity of Kyiv; junior researcher of Intellectual PropertyResearch Institute of the NALS of Ukraine.

PROBLEMS OF IDENTIFICATIONOF A COPYRIGHT INFRINGER

FOR WORKS POSTEDON THE INTERNET

Topicality. Problem of identificationof an alleged infringer of copyright with-in the relative anonymity of Internetusers remains pending and unsolvedproblem of copyright protection for worksposted on the Internet. Without solvingthis issue it is almost impossible to deter-mine the entity of appropriate legal rela-tionship.

The relative anonymity of users has adual meaning. On the one hand, such ac-tivity in some way contributes to copy-right infringement. Ye. Mykhailenko em-phasizes that the problem is the mainsource of negative phenomena on the In-ternet [1, 9]. However, as fairly noted byO. Pastukhov, such anonymity is not a

specific problem of a copyright law,though it applies to all crimes and tortsoccurring through the Internet network[2, 57]. For example, distribution ofpornographic works, the legal relation-ship associated with protection againstdefamation, combating terrorism andseparatism manifestations indicate thesystemic nature of specified problem.However, we shall note that anonymouscharacter of connections does not preventfrom socially useful actions at all (e.g.,legal distribution of works).

On the other hand, the issue of anony-mous nature of Internet users shall beconsidered with the principle of propor-tionality of intellectual property rights

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(as well as other rights that may be sub-ject of infringing activity) and the rightfor freedom of expression, respect for pri-vate and family life. Thus, the Report ofthe Special Rapporteur on the promotionand protection of the right to freedom ofopinion and expression, which was pre-sented to the UN Council on HumanRights at XXIX meeting (as of May 22,2015) emphasized that encryption andanonymity, and the security concepts be-hind them, provide the privacy and secu-rity necessary for the exercise of theright to freedom of opinion and expres-sion in the digital age [3, clause 56].

Specified principle of proportionalityshall not interfere with measures takento search persons responsible for crimi-nal acts under national law, the Euro-pean Convention on protection of HumanRights and other fundamentals, andother international agreements in thefield of justice and policing, as noted, inparticular, in the «Declaration on free-dom of communication on the Internet»of the Committee of EC Ministers [4].

The relevance of the specified prob-lems concerns the fact that in copyright-based relations (as civil relations) prov-ing of a causal connection between theunlawful conduct of the person andcaused damage as one of conditions for li-ability on violation of intellectual proper-ty rights is vested upon the plaintiff, i.e.,copyright holder (or a person authorizedto act on the holder's behalf).

Within this study the author specifiedthe objective to analyze the main ap-proaches to identification of the person —an alleged infringer of copyright forworks posted on the Internet.

Analysis of key studies and publi-cations. The indicated problems almosthave not been studied within study ofproblems of intellectual property inUkraine. Still, there are respective re-

searches within information law field;specifically, M. Gutsaliuk paid attentionto the introduction of ID-web as a prereq-uisite for the Internet security.V. Butu-zov, V. Gavlovsky, V. Golubev, R. Kali-uzhny, V. Tsymbaliuk draw attention tothe need of development the InformationCode, building of appropriate institution-al structures of law enforcement agenciesto detect and investigate crimes relatedto the use of the Internet and etc. The is-sues of identification of users of socialnetworks on the Internet involvedS. Bartunov and A. Korshunov. Theissue of identifying the end-users of theInternet in copyright legal relationshiphas been the subject of a number of stud-ies of foreign authors, among which wecan emphasize T. Harding, D. Gold-schlag, M. Reed, P. Syverson, M. RobertFilby, and M. Piatek.

Summary of basic material. In ouropinion, problem of identification of a per-son — infringer of copyright for worksposted on the Internet — at the logicallevel of the Internet network structure*

shall indicatively considered depending onkinds of the illegal behaviour of a person.

1. Identification of a person — ownerof the website.

2. Identification of a person — userof the website who posted the work.

3. Identification of a person — userof the Р2Р network.

Each of the above situations has owncharacteristics, which are discussed below.

As of May 2016 in Ukraine the possi-bility to identify an individual — an in-fringer of copyright for works posted onthe Internet within the civil protection isprovided only within the judicial form ofprotection, namely in accordance withpart 1 article 133 of the Civil ProcedureCode of Ukraine for the person (here-inafter — the CPC of Ukraine), throughevidence provision. In accordance with

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* The author shares the approach proposed by J. Benkler; according to which there are defined the follow-ing hierarchical levels of information environment: level of content (information available to be viewedby a user); logic level (regulation of software, Internet protocols) and physical layer (hardware both of usersand Internet service providers) [5, 561–563].

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part 1 article 134 of the CPC of Ukraine,the statement on evidence provisionshall contain the following: evidence sub-ject to provision; circumstances to besubstantiated by the evidence; circum-stances indicating that provision of re-quired evidence may be impossible orcomplicated, and case that requires theevidence or the purpose of their provision[6]. The specified institution is usedmostly for «domain disputes» to identifythe registrant of the domain name*.

The draft law «On amendments tosome legislative acts of Ukraine on pro-tection of copyright and related rights onthe Internet» as of May 10, 2016 № 4629specifies provision of the copyright hold-er with an opportunity to receive the fol-lowing:

1) from the owner of the website - infor-mation that identifies a user of thewebsite, who, according to the entitypossessing copyright and (or) relatedrights or its authorized representa-tive, has posted on the website infor-mation violating the copyright and(or) related rights, and under condi-tion of availability of contact detailsof the userof the website, required tosend a petition to the court to consid-er the dispute in the court concern-ing illegality of the actions of suchuser at posting information on thewebsite;

2) from the hosting service provider -information that identifies theowner of the website, using hostingservices of the provider to host andprovide access to information, thataccording to the copyright and (or)related rights, violates copyright and(or) related rights, and contact infor-mation required to send a petition tothe court to consider the dispute inthe court concerning illegality of theactions of such owner of the web site[7, article 52-2].

We shall note that owner of the web-site in accordance with the provisions ofthe draft law № 4629 is recognized by do-main name registrant or other personwho defines the procedure and conditionsfor use of the website and (or) procedureof information posted there. In author’sopinion, such approach is justified, be-causes it is unconditionally imprudent toequate the website owner and domainname registrant, since the legal nature ofa website relates to copyright and do-main name delegation relates to the con-tractual relationship; the registrant ofthe domain name is not necessarily thesame person as the owner of the website(for example, contract on the use of thedomain name has been concluded).

The problem of identification of theowner of the website through a domainname registrant is the subject to besolved by ICANN at self-regulation level.Thus in December 2015 the GNSO coun-cil of ICANN adopted recommendations«Illustrative Disclosure Framework»,which provisions offer the procedure ofreceipt of information by the copyrightholders about registrants of domainnames (suspected of piracy), stored in aWHOIS — base from proxy — and priva-cy registrars accredited by ICANN. Inaddition, the registrar cannot refusethe-copyright holderas for disclosure of suchinformation because of the lack of a judg-ment, court summons, a civil suit or arbi-tration of the domain dispute accordingto the UDRP or URS procedures. More-over, refusal to disclose informationabout the registrant cannot be basedsolely on the fact that the request relatesto infringement of intellectual propertyby objectsposted on such website, not tothe domain name. The registrar of suchdomain name shall be notified about acomplaint and within 15 days may eitherabandon the domain name, or provide ev-idence of them being uninvolved to in-

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* However, if the website is in domain zone .ua it is enough to see the field «license» in WHOIS-serviceto identify the registrant. The value of this field corresponds to the certificate of Ukraine for trademarksand services.

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fringements of intellectual property, re-ferred to in the complaint. If they proveconvincingly, access will be denied to per-sonal information of the registrant of thedomain name [8].

However, in the draft law № 4629 theproblems of identification of a personwho is the user of P2P-network (directinfringer of copyright) are not taken intoaccount, what, in our opinion, is a signifi-cant drawback. Thus, according to theMPPA, in March 2016 copyright infringe-ment via P2P-networks accounted to38.1 % of the total number of infringe-ment of copyright for the works posted onthe Internet (see the picture above) [9].

The process of identification of theperson who committed direct copyrightinfringement (user of website who postedthe work and user of P2P network) in for-eign scientific literature is usually divid-ed into three stages [10, 36, 37].

The first stage consists of actions ofthe copyright holder (or a person autho-rized to act on the holder’s behalf) inorder to identify and collect IP-addresses(numerical sequence that serves as anidentifier of the Internet-server [11]).

Without IP-address the user can neithersend nor receive packets of data andother information useful for identifica-tion ofan alleged infringer.

The copyright holders use the follow-ing methods to identify and collect IP-ad-dresses of infringers ofcopyright withinoperation of P2P networks:

•Indirect identification of users, basedon a set of data about peers, return-ing from torrenttrackers.

•Direct identification of users. Accord-ing to Tom Harding, is based on con-nection with a torrent tracker tousers distributing certain files andfurther exchange of files with them.Direct identification looks to demon-strate that users are actually engag-ing in the file sharing [12, 8].

Both methods do not exclude the pos-sibility of errors and mistakes. Thus, ac-cording to research by American scien-tists M. Piatek, T. Kohno and A. Krish-namurthy, any Internet user can get awarning for copyright infringement be-cause of an artificial substitution of IP-address. Researchers received hundredsof actual reports on copyright infringe-

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Picture 1. Estimate of online piracy methods, March 2016 by number of users

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ment under DMCA law for computersand devices (including network printers)which have never been used (and couldnever been used) for spreading dissemi-nation of works on the Internet [13, 7].

In addition, there are certain techni-cal features that allow end-users to com-plicate their identification, while both ofthe above methods provide that usersconnect to the torrent server using IP ad-dresses delegated personally to them.For example:

1) use of VPN or PROXY servers. In ad-dition, such services are generallysubject to foreign law and do notkeep log files [10, 92] (files, contain-ing information about time, actionsand connections of certain persons);

2) D. Goldschlag, M. Reed, P. Syversonand M. Filby also note the possibilityof usingDarknet (Onion Routing /TOR) i.e., a sequence of intermediatenetworknodes with encryption oftransmitted information [14; 10, 93].

However, we shall note that there aretechnical means by which we can detectthe actual IP address of the user, evensuch user uses TOR browser [15], but itseems extremely complicated to use suchmeans in private legal relations.

3) also, according to Michael Piatek,users of P2P- networks use «black-lists» of known IP-addresses of copy-right holders (or their representa-tives) to prevent from such monitor-ing [13, 4; 10, 95].

The second stage of identification isto establish the matching of IP-addressto certain subscribers (users) of certainInternet intermediaries.

Foreign jurisprudence applies differentapproaches to solve the specified issue.

According to a research by S. B. Karu-naratne, for judicial practice in the USA,since 2003, the copyright holders apply-subpoenas to an Internet intermediaryfor identification of an alleged infringerto protect against copyright infringementof works posted on the Internet via tor-rent trackers (so-called «John Doe» in thecountries of the Anglo-Saxon law) —

users of Bittorent trackers involving In-ternet intermediaries for further identifi-cation of such users [16, 284–288; 17]. Insome cases the number of respondentstotalled more than 2 000 [18]. In addi-tion, according to the provisions of para-graph 5 part (h) § 512 of the DMCA lawthe Internet intermediary shall expedi-tiously disclose to the copyright holder orperson authorized by the copyright hold-er the information required by the subpoe-na, notwithstanding any other provision oflaw and regardless of whether the serviceprovider responds to the notification [19].

In the UK, in order to match the IP-address of a person the Norwich proce-dure is applied (it was first used inpatent case of Norwich Pharmacal Co.against Customs and Excise Commis-sioners [20]), which is a court order fordisclosure of documents or informationavailable to the third party regarding theidentity of an allegedinfringer of intellec-tual property rights. Adoption of the Dig-ital Economy Act (DEA) in 2010 [21]specified a special procedure of informingof the Internet intermediary by the copy-right holder about online copyright in-fringement (copyright infringement re-port, CIR); procedure of notificationabout received complaints performed bythe Internet intermediary towards itsuser; procedure to provide a list of in-fringers to the copyright holder (copy-right infringement list, CIL). In addition,the specified list under the provisionsof article 124 — under DEA law shall notcontain information that directly identi-fies the user. Only after specified actionsthe copyright holder may apply for re-ceipt of the order of Norwich.

According to provisions of article 15of Directive 2000/31/EU «On electroniccommerce» the Internet intermediariesare charged neither with general obliga-tion to monitor the information whichthey transmit or store, nor a generalobligation actively to seek facts or cir-cumstances indicating illegal activity.However, national legislation of EUMember States may establish obligations

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for information society service providerspromptly to inform the competent publicauthorities of alleged illegal activitiesundertaken or information provided byrecipients of their service or obligationsto communicate to the competent author-ities, at their request, information en-abling the identification of recipients oftheir service with whom they have stor-age agreements [22, article 15].

From 2006 to 2014 there was in forcethe EU Directive 2006/24/EU «On the re-tention of data generated or processed inconnection with the provision of publiclyavailable electronic communications ser-vices or of public communications net-works» [23], provisions of which were ap-plied to traffic and data about location ofboth legal entities and individuals, aswell as relevant data necessary to identi-fy the subscriber or registered user. Ac-cording to provisions of articles 5 and 6 ofthis Directive, the Internet intermedi-aries kept, in particular, informationabout access to the Internet, e-mail andInternet telephony: date and time of con-nection and disconnection of access to theInternet with the IP-address assigned bythe provider of access to the Internet aswell as ID of the subscriber or registereduser; date and time of connection anddisconnection of the service of email, overthe Internet, or Internet telephony. How-ever, they have to be kept for at least sixmonths and not more than two years.Such information was provided upon therequest of state authorities.

However, the European Court of Jus-tice within the joint case of C-293/12 andC-594/12 admitted the specified Direc-tive void from the date of its adoption, asits provisions interfered in a particularlyserious manner with the fundamentalrights of humans and citizens:the rightfor freedom of expression, respect for pri-vate life and the right for personal dataprotection [24].

In 2010 there was adopted the Law ofUkraine № 1819-VI «On Amendments toCertain Legislative Acts of Ukraine oncombating the spread of child pornogra-

phy» which introduced amendments tothe Law «On Telecommunications», inparticular part 2 article 39 «The opera-tors, telecommunication providers keepand provide information aboutconnectionof its subscriber in the manner pre-scribed by legislation». In addition, pur-suant to the provisions of parts 1 and 3 ofarticle 34 of the specified law, thetelecommunication operators and serviceproviders are obliged to provide and beresponsible for the safety of informationabout the user received at the conclusionof the contract, provided telecommunica-tion services, including receipt of ser-vices, their duration, subject, route oftransmission, etc. [25]. Regarding theabove mentioned, following shall be em-phasized:

First, the above provisions shall beconsidered within system connectionwith part 2 of article 32 of the Constitu-tion of Ukraine, according to which thecollection, storage, use and dissemina-tion of confidential information about aperson without its consent are not al-lowed, except in cases specified by law,and only for interests of national securi-ty, economic prosperity and humanrights.

Second, there is no special lawful pro-cedure concerning demanding informa-tion about connections of the subscriberfrom Internet intermediary under civillaw protection as of May 2016 (there areonly general provisions for evidence pro-vision in accordance with part1 of article133 of the CPC of Ukraine; collection ofevidence in case of criminal proceedingsor investigative proceedings (article93 ofthe Criminal Procedural Code ofUkraine, clause6, part 1 of article 8 ofthe Law of Ukraine «On Operative Inves-tigation Activities»), the draft № 4529also does not specify such procedure. Inour opinion, the legislation of Ukraineshall include a procedure for the possibil-ity of extra judicial claiming of the copy-right holder (or a person authorized toact on the holder's behalf) to an Internetintermediary with the requirement to

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provide a list of infringers of copyright —subscribers of such intermediary, takinginto account the principle of proportion-ality, specifying the list of informationrequired for filing such claim and liabili-ty for such information misuse.

In addition, it seems necessary topoint out certain features of this stage inUkraine. According to article 24 of theRules on provision and obtaining oftelecommunication services,approved bythe Cabinet of Ministers of Ukraine as ofApril 11, 2012 № 295 (hereinafter re-ferred to as the Rules) [26], while con-necting terminal equipment of the userto telecommunication network the opera-tor shall assign it a number or other net-work identifier (unique sequence of num-bers and/or symbols assigned to the sub-scriber’s terminal equipment and/or userin the telecommunication network or theInternet); and/or apply the personalnumber of the subscriber. However,these Rules do not specify the obligationof the Internet intermediary to provide«external» unique identifier (IP-address).According to some rate plans of certainUkrainian Internet intermediaries theallocation of fixed static IP-address is op-tional paid service.That is in relation tothe outside world such end-users canhave the same IP-address — the IP-ad-dress of Internet intermediary — it ex-tremely complicates matching of certainIP-address and certain subscribers (end-users) of such Internet intermediaries.For that matter it is appropriate to pro-vide in the Rules the duty of telecommuni-cation operator to assign to its subscribers«external» fixed static network ID.

The third stage is to inform or sendclaims to persons as for infringement ofcopyrights by them and the possibility of fil-ing (or direct filing) of claims against them.

As noted by M. Filby, this stage is themost complicated because it requires evi-dence for two components, namely:theestablishing of a connection between per-son — subscriber of the Internet interme-diary and the infringement, and provingthat the IP-address has in fact participat-

ed in unauthorized distribution of worksto a legally significant degree [10, 40].

In our opinion, certain caution shallbe ensured with respect to identificationof a person — infringer of copyright ex-clusively by IP address because IP ad-dress provides information only aboutthe source of connection — a particularplace (not the person), using which theuncertain number of hardware can con-nect to the Internet. For example, mail-box or telephone number may also beused by unspecified number of users.

Also an additional problem for end-users’ identification by IP-address is theactive development of the Internet ofthings. Thus, various stationary deviceswith an access to the Internet can makeconnections to the network offline, with-out participation of individuals them-selves. Identification of the person whocould program the respective devices forillegal activity scenarios, according to theauthor, is even more difficult task thanto identify the person accessing the In-ternet in «normal» mode.

Foreign experience shows that courtsin foreign countries also pay attention tothe examined problem:

In the UK the England and WalesHigh Court considering case of GoldenEyeand others against Telefonica [2012]EWHC 723 (Ch) specified that subscriberwith certain delegated IP-address wasnot necessarily the person who partici-pated in the infringement of the copy-right using P2P-network. There is anumber of alternatives, including:

•the IP-address identifies a computerand someone else in the same house-hold (whether a resident or visitor) wasusing the computer at the relevanttime (which might be with or withoutthe knowledge of the subscriber);

•the IP-address identifies a routerand someone else in the same house-hold (whether a resident or visitor)was using a computer communicat-ing via the same router (which mightbe with or without the knowledge ofthe subscriber);

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•the IP-address identifies a wirelessrouter with an insecure (either openor weakly encrypted) connection andsomeone outside the household wasaccessing the Internet via thatrouter (in all probability, without theknowledge of the subscriber);

•the IP-address identifies a computeror router, the computer or a comput-er connected to the router that hasbeen infected by a Trojan and some-one outside the household was usingthe computer to access the Internet(almost certainly, without theknowledge of the subscriber);

•the IP-address identifies a computer-which is available for public use, forexample in an Internet cafe or library[27, clause 103].

In the USA, for case of K-Beech, Inc.against John Does 1-37 (CV 11-3995(DRH)(GRB) the District Court of East-ern District of New York concluded thatsome IP-addresses could be delegated toorganizations providing Internet accessto their employees, clients or uncertainmembers (library, cafe) [28, 6–7].

In this regard it shall be noted that IP-address is not the only possible ID of theuser of the Internet. In particular, there isa MAC-address in addition to IP-address.While the IP-address can provide informa-tion about the location, the MAC-addressis a unique hardware address for each unitwhich is connected to the Internet [29]. Inthis case, one IP-address can at the sametime have only one correspondent MAC-address of the device connected to the In-ternet, such as router of the user (indicat-ed the technical information is available atinformation intermediaries). MAC-ad-dresses of certain devices connecting therouter are usually not stored, that is aproblem for public use networks. In addi-tion, the MAC-address, as well as the IP-address, can be technically changed.

Additional evidence required to con-firm identification of a person-infringer ofcopyright, in addition to IP and MAC-ad-dress, can include, for example, the con-clusions of a comprehensive examination

(computer and technical expertise and in-tellectual property items) as for availabil-ity of respective copies of works on hard-ware of persons-infringers of copyrightthat is confirmed with materials ofUkrainian court practice in the article176of the Criminal Code of Ukraine [30].

Conclusions1. Performed study indicates the ab-

sence of effective, reliable and promptmechanism of identification in the cur-rent actual legal regulation of the personviolating copyright for works postedonthe Internet.

2. Identification of aperson-infringerof copyright as for works posted on theInternet can be indicatively considereddepending on the characteristics of un-lawful behaviour of a person: 1) identifi-cation of the person-the owner of thewebsite; 2) identification of the person-the user of the website where the workwas posted; 3) identification of the userof P2P network

3. The process of identification of theperson who committed direct copyrightinfringement (the user of the websitewho posted the work and user of P2P net-work) is usually divided into threestages: 1) identification and collection ofIP-addresses; 2) detection of correspon-dence of the IP-addresses of to the speci-fied subscribers (users) of certain Inter-net intermediaries; 3) informing or send-ing claims to individuals regardinginfringement of copyright and the possi-bility of filing (or direct filing) of claimsagainst them.

4. In the decree of the Cabinet of Min-isters of Ukraine «On approval of rules ofprovision and receipt of telecommunica-tion services» dd. April 11, 2012 No. 295it is appropriate to specify the duty of thetelecommunication operator to assign toits subscribers the «external» fixed staticnetwork ID, as far as the procedure of al-location of fixed static IP-address as addi-tional paid service significantly compli-cates detection of correspondence of IP-address to certain subscribers (end-users)of such Internet intermediaries.

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Список використаних джерел / List of references

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Mihajlenko Ye. V. Problemy Informacionno-pravovogo regulirovanija otnoshenij vglobal'noj komp'juternoj seti Internet : avtoref. dis., М., 2004, 25 s.

2. Пастухов О. М. Авторське право у сфері функціонування всесвітньої інфор-маційної мережі Інтернет : дис. канд. юр. наук : 12.00.03 / Пастухов Олек-сандр Миколайович — К., 2002. — 173 с.

Pastukhov O. M. Avtorske pravo u sferi funktsionuvannia vsesvitnoi informatsiinoimerezhi Internet : dys., K., 2002, 173 p.

3. Report of the Special Rapporteur on the promotion and protection of the right tofreedom of opinion and expression[Electronic resource]. — Access mode :http://www.ohchr.org/EN/HRBodies/HRC/RegularSessions/Session29/Documents/A.HRC.29.32_AEV.doc.

4. Declaration on freedom of communication on the Internet (Adopted by the Committeeof Ministers on 28 May 2003 at the 840th meeting of the Ministers’ Deputies) [Elec-tronic resource]. — Access mode : http://www.osce.org/fom/31507?download=true.

5. Benkler Y. From Consumers to Users: Shifting the Deeper Structures of Regula-tion Toward Sustainable Commons and User Access / Yochai Benkler // FederalCommunications Law Journal. — 2000. — № 52. — P. 561–579.

6. Civil Procedure Code of Ukraine from 18.03.2004 № 1618-IV // Vidomosti Ver-hovnoyi Rady, 2004, № 40–41, 42, Art. 492 (with amendments).

7. The draft law of Ukraine «On amendments to some legislative acts of Ukraineon protection of copyright and related rights on the Internet» № 4629from 10.05.2016 [Electronic resource]. — Access mode :http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=59024.

8. Final Report on the Privacy & Proxy Services Accreditation Issues Policy Develop-ment Process [Electronic resource]. — Access mode :http://gnso.icann.org/en/issues/raa/ppsai-final-07dec15-en.pdf.

9. Ukrainian Anti-Piracy Association / Internet piracy [Electronic resource]. — Ac-cess mode : http://apo.kiev.ua/internet.phtml.

10. Filby M. Regulating File Sharing: Using Law, Internet Architecture, Markets andNorms to Manage the Non-Commercial Sharing of Digital Information /M. Filby. — Lexington, KY, USA, 2015. — 248 p.

11.Ip address. (n.d.). The American Heritage® Science Dictionary [Electronic re-source]. — Access mode: http://dictionary.reference.com/browse/ip address.

12.Harding T. BitTorrent tracking as a means of detecting illegal file-sharing / TomHarding // E-Commerce Law & Policy — 2013. — № 2. — P. 08–09.

5. Use of IP-address only is notenough for identification of the persons-infringers of copyright (rather than theplace where the infringement is commit-ted) for works posted on the Internet,thus it is necessary to use additional evi-dence to establish a causal connection be-

tween the person-subscriber (end-user),with certain delegated IP address, andcopyright infringement.

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13.Piatek M. Challenges and Directions for Monitoring P2P File Sharing Networks —or — Why My Printer Received a DMCA Takedown Notice [Electronic resource] /M. Piatek, T. Kohno, A. Krishnamurthy — Access mode : http://dmca.cs.washington.edu/uwcse_dmca_tr.pdf.

14.Goldschlag D. Onion Routing for Anonymous and Private Internet Connections[Electronic resource]/ D. Goldschlag, M. Reed, P. Syverson — Access mode :http://www.onion-router.net/Publications/CACM-1999.pdf.

15.Judge Confirms Carnegie Mellon Hacked Tor and Provided Info to FBI [Electron-ic resource]. — Access mode : http://gizmodo.com/judge-confirms-carnegie-mel-lon-hacked-tor-and-provided-1761191933.

16.Karunaratne S. The Case Against Combating BitTorrent Piracy Through MassJohn Doe Copyright Infringement Lawsuits / Sean B. Karunaratne // MichiganLaw Review. — 2012. — №111:283. — P. 283–309.

17.Borland J. RIAA sues 261 file swappers [Electronic resource]. — Access mode :http://www.cnet.com/news/riaa-sues-261-file-swappers/.

18.United States District court Northern district of California San Jose division.Case №: 10-CV-5865-PSG. Diabolic video productions, inc. V. Does 1-2099 [Elec-tronic resource]. — Access mode: http://cases.justia.com/federal/district-courts/california/candce/5:2010cv05865/235553/16/0.pdf?ts=1428874690.

19.Digital millennium copyright act Oct. 28, 1998 [H.R. 2281] [Electronic resource]. —Access mode : https://www.gpo.gov/fdsys/pkg/PLAW-105publ304/pdf/PLAW-105publ304.pdf.

20.Norwich Pharmacal Co v Customs and Excise Commissioners [1973] UKHL 6(26.06.1973) [Electronic resource]. — Access mode :http://www.bailii.org/uk/cases/UKHL/1973/6.html.

21.Digital Economy Act 2010 CHAPTER 24 [Electronic resource]. — Access mode :http://www.legislation.gov.uk/ukpga/2010/24/pdfs/ukpga_20100024_en.pdf.

22.Directive 2000/31/EC of the European Parliament and of the Council of 8 June2000 on certain legal aspects of information society services, in particular electron-ic commerce, in the Internal Market ('Directive on electronic commerce’) [Electron-ic resource]. — Access mode: http://eur-lex.europa.eu/legal-con-tent/EN/TXT/?uri=celex:32000L0031.

23.Directive 2006/24/EC of the European Parliament and of the Council of 15 March2006 on the retention of data generated or processed in connection with the provisionof publicly available electronic communications services or of public communicationsnetworks and amending Directive 2002/58/EC [Electronic resource]. — Access modehttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:105:0054:00-63:EN:PDF.

24.Court of Justice of the European Union press release № 54/14 Luxembourg,08.04.2014 Judgment in Joined Cases C-293/12 and C-594/12 Digital Rights Ire-land and Seitlinger and Others [Electronic resource]. — Access mode :http://curia.europa.eu/jcms/upload/docs/application/pdf/2014-04/cp140054en.pdf.

25.The Law of Ukraine»Onamendments to severallegislative acts of Ukraine on com-bating the spread of child pornography» from 20.01.2010 № 1819-VI. // Vido-mosti Verhovnoyi Rady — 12.03.2010 — № 10. — Art.105.

26.The Decree of the Cabinet of Ministers of Ukraine «On approval of rules of provi-sion and receipt of telecommunication services» from April 11, 2012 № 295.// Uri-adovyi kurier. — 2012. — № 109 (with amendments).

27.Golden Eye (International) Ltd & Anor v Telefonica UK Ltd [2012] EWHC 723(Ch) (26.03.2012) [Electronic resource]. — Access mode :http://www.bailii.org/ew/cases/EWHC/Ch/2012/723.html.

28.K-Beech, Inc. v. John Does 1-37, CV 11-3995 (DRH)(GRB) [Electronic resource]. — Access mode : http://www.technollama.co.uk/wp-content/uploads/2012/

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05/92100289-K-Beech-Order-amp-Report-amp-Recommendation-Ordered-5-1-12.pdf.

29.Mac address. Dictionary.com. The Free On-line Dictionary of Computing. Denis Howe.[Electronic resource]. — Access mode : http://dictionary.reference.com/browse/macaddress (accessed: January 09, 2016).

30.The sentence of the Nakhimov District Court of Sevastopol on the case№ 765/3456/13-к from 11.09.2013 [Electronic resource]. — Access mode :http://reyestr.court.gov.ua/Review/33485818.

Надійшла до редакції 29.05.2016 р.

Зеров К. Проблемы идентификации лица — нарушителя авторского правана произведения, размещенные в Интернет. В публикации рассмотрены про-блемы идентификации пользователя — нарушителя авторских прав на произведе-ния, размещенные в сети Интернет. Автор классифицирует такую идентификацию навиды в зависимости от особенностей противоправного поведения лица на: 1) иденти-фикацию лица — произведение; 3) идентификацию лица — пользователя Р2Р-сети;каждая из которых имеет свои особенности. Проанализировано, что процесс иденти-фикации лица, совершившего прямое нарушение авторских прав (пользователясайта, разместившего произведение, и пользователя Р2Р-сети), делится на три ста-дии: 1) определение и сбор IP-адресов; 2) нахождение соответствия IP-адреса опреде-ленным абонентам (пользователям) отдельных интернет посредников; 3) информиро-вание или направление претензий лицам о нарушении ими авторских прав и возмож-ности представления (или непосредственно представления) против них исков.Автором сделан вывод, что для идентификации личности — нарушителя (а не места,где совершено нарушение) авторских прав на произведения, размещенные в сети Ин-тернет-только использование IP-адреса недостаточно, поэтому необходимо использо-вать дополнительные доказательства в совокупности для установления причинно-следственной связи между лицом-абонентом (конечным пользователем), которому де-легирован определенный IP-адрес, и нарушением авторского права.

Ключевые слова: Интернет, пиратство, авторское право, идентификация

Zerov K. Problems of identification of a copyright infringer for works postedon the Internet. This publication examines the problems of identification of an allegedinfringer of copyright for works posted on the Internet. The author divides types of suchidentification depending on the characteristics of wrongful conduct on the person: 1) iden-tification of the person — the owner of the website; 2) identification of the person — theuser of the website where the work was posted; 3) identification of the user of P2P net-work, where each has its own characteristics. According to analysis, the process of identifi-cation of the person who committed direct copyright infringement (the user of the websitewho posted the work and user of P2P network) is usually divided into three stages:1) identification and collection of IP-addresses; 2) detection of correspondence of the IP-ad-dresses of to the specified subscribers (users) of certain Internet intermediaries; 3) inform-ing or sending claims to individuals regarding infringement of copyright and the possibili-ty of filing (or direct filing) of claims against them. The author concludes that use of IP-ad-dress only is not enough for identification of a person — infringer of copyright (rather thanthe place where the infringement is committed) for works posted on the Internet, thus it isnecessary to use additional evidence to establish a causal connection between the person —subscriber (end-user), with certain delegated IP-address, and copyright infringement.

Keywords: Internet, piracy, copyright, identification

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Шабалін А. Наказне провадження в цивільному процесі України: науковіпитання та практика. Стаття присвячена дослідженню процесуальних аспектів інсти-туту судового наказу в українському цивільному процесуальному праві. У статті дослід-жуються підстави запровадження наказного провадження в цивільний процес України,серед яких є й європейський правовий досвід щодо запровадження спрощених судовихпроцедур. Також у статті вказується, що на сьогоднішній день у країнах ЄвропейськогоСоюзу діють єдині спрощені судові процедури (Регламент ЄС 861/2007 — єдиний євро-пейський судовий наказ; Регламент ЄС 861/2007 — єдина європейська судова щодо ви-рішення невеликих (дрібних) спорів). У зв’язку із тим, у роботі вказується, що передУкраїною стоїть питання пов’язане з необхідністю адаптацією національного процесу-ального законодавства до вказаних єдиних європейських судових процедур, особливогозначення дане питання набуває у світі підписання Угоди про асоціацію між Україноюта ЄС (2014 р.).

У статті детально досліджуються структура наказного провадження. Так, зокрема,структура наказного провадження складається з стадій та етапів. Саме етапи і скла-дають основний зміст наказного провадження. Зазначається, що саме етапи наказно-го провадження саме реалізуються на першій стадії цього провадження. У цій статтівказується, що серед науковців існують різні точки зору щодо основних стадій та ета-пів наказного провадження. Так, О. Штефан виділяє 3 етапи наказного провадження,а А. Шабалін виділяє саме 3 стадії наказного провадження, до яких вказаних авторвідносить і стадію виконання судового наказу, що не виділяють інші дослідники-процесуалісти, зокрема й О. Штефан.

У роботі досліджуються порядок подачі заяви для видачі судового наказу, встанов-люються підстави видачі судового наказу (ст. 96 ЦПК України). Зазначається, що цейперелік підстав є вичерпним.

Розглянута процедура повідомлення боржника про виданий судовий наказ. Вказу-ється, що боржник повідомляється письмово судом про виданий судовий наказ, разоміз судовим наказом боржник повинен отримати й копію заяви про видачу судового на-казу та додані до неї документи.

Досліджена процедура апеляційного оскарження у справах наказного проваджен-ня. Аргументується, що така процедура оскарження судового наказу в апеляційномупорядку має свої особливості, з урахуванням особливості наказного провадження(ст. 103 ЦПК України).

Автором наголошується, що набрання судовим наказом законної сили залежитьвід строків його оскарження.

У статті досліджуються також й практичні аспекти наказного провадження. Так,зокрема зазначається, що на сьогоднішній день існує необхідність меж застосуваннянаказного провадження. Судовий наказ може бути досить ефективним при стягненніфінансової заборгованості, поверненні банківського депозити, ліцензійних виплатпов’язаних з використанням об’єкта інтелектуальної власності. Такий підхід є викра-деним з токи зору української судової практики.

Вказується, що запровадження процедура спрощеного судочинства повною міроювідповідає єдиній європейський правовій політиці.

Ключові слова: справи наказного провадження, судовий наказ, цивільний процес,наказне провадження, спір про право

Andrey Shabalin,lawyer, researcher of the Intellectual Property Research Institute of the NALS of Ukraine,scientific assistant of the department research of judicial studies and expert practice

THE COURT ORDER PROCEEDINGS OF CIVILPROCEDURAL LAW OF UKRAINE: SCIENTIFIC

ISSUES AND PRACTICES

ISSN 2308-0361

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The court order proceedings (writ pro-ceedings) fully corresponds with the Eu-ropean judicial system.

Today, Ukraine needs to adapt itsown legislation in accordance with Euro-pean law. Especially it is relevant inview of the Agreement of Ukraine andthe European Union — 21.03.2014 and27.06.2014).

Europe has the European Federal courtorder proceedings: Regulation (Directive)EU 1896/2006 and Regulation (Directive)EU 861/2007 — small litigation.

Ukraine has the national court orderproceedings of civil procedural law. Let'slook at this type of the procedure.

Part 1 of Article 124 of the Constitu-tion of Ukraine stipulates that justice inUkraine is administered exclusively bythe courts. Part 2 of the mentioned con-stitutional provisions says: the jurisdic-tion of the courts shall extend to all legalrelations that arise in the State. [1] Part1 of Article 2 of the Law of Ukraine «Onthe Judicial System» provides that thecourt shall administer justice based onthe rule of law, ensure everyone's right toa fair trial and respect for the rights andfreedoms guaranteed by the Constitutionand laws of Ukraine, as well as interna-tional treaties ratified by the VerkhovnaRada of Ukraine.

The formation of Ukraine as a social,democratic and based on the rule of lawprinciples state is not possible withoutan effective mechanism for the protectionof rights and freedoms, rights and inter-ests of legal entities, as well as the inter-ests of the state. Constitution of Ukraineadopted in 28.06.1996, and the Law ofUkraine «On the Judicial System andStatus of Judges» of 07.07.2010 № 2453-VI gives a significant role in this mecha-nism to justice as to the most effectiveand democratic way of protecting therights and interests secured by law.

It should be noted that for a long timecivil litigation proceedings were made inUkraine by the Civil Procedure Code ofthe Ukrainian Soviet Socialist Republicin edition of 1963 (hereinafter — the

CPC 1963.), that led to inconsistent legalstandards, inconsistencies to realitiesand needs of their political and socio-eco-nomic life and complications of litigation.In this connection in 18.03.2004 theVerkhovna Rada of Ukraine adopted anew Civil Procedural Code of Ukraine(hereinafter — the CPC of Ukraine),which came into force on 01.09.2005. Itwas the result of a long legislativeprocess, incorporated the latest achieve-ments of domestic and foreign legalthought and jurisprudence [2, 3].

According to the CPC of Ukraineamendment to rules and availability ofnew procedural institutes unknown inthe CPC 1963 are characteristic featuresof legal regulation of civil proceedings.One of such institutes is writ proceedings(court order proceedings).

In modern national legal literaturecourt order proceedings is defined as anindependent kind of civil procedure, per-formed by courts of general jurisdictionand aimed to enact the court order (awrit) [3, 315].

Consolidation in the current civil proce-dural legislation of Ukraine of the insti-tute of simplified proceedings is fully con-sistent with modern European legal prac-tice and the objectives set by the Law ofUkraine «On the National Program forAdaptation of Ukraine to the legislation ofthe European Union» of 18.03.2004№ 1629-IV, and Article 12 of the Law ofUkraine «On the basis of domestic and for-eign policy» 01.07.2010 № 2411-VI. In par-ticular, the Recommendation № R (81) 7 of14.05.1981 of the Committee of Ministersto member states on measures facilitat-ing access to justice and Recommendation№ R (84) 5 of 28.02.1984 on the principlesof civil procedure designed to improve thefunctioning of justice listed that for casesrelated to an undisputed right should beprovided particular rules for acceleratedlitigation of civil cases.

At present, the issuing of a writ hascertain stages. Thus, in the theory ofmodern civil procedure of Ukraine suchstages inherent to acting institute pro-

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ceedings are following: 1) logging of ap-plication for a writ, and 2) considerationof the application for the writ, and 3) theabolition of a writ (court order) [4, 140].

We must say that in modern legal sci-ence of Ukraine there are other positionsabout the stage of court order proceed-ings. Thus, A. Shabalin specifies the tar-get at such stages: 1) the court for is-suance of the court order (a writ); 2) thecourt of appeal court order; 3) executionof court order (a writ) [5, 9].

Let us consider the procedure for issu-ing court order (a writ) more detailed.

Legal regulation of the writ proceed-ings was provided in Chapter II of theCPC of Ukraine.

Thus, according to Article 95 of theCPC of Ukraine a writ court order is aspecial form of the judgment, issued afterconsideration of requirement under Arti-cle 96 of the CPC of Ukraine. Part 2 ofthis procedural rule provides that an ap-plication for a writ may be filed by theperson who has the right to claim, as wellas agencies and persons who legally havethe right to protect the rights and inter-ests of others. The list of reasons for issu-ing a writ is mentioned in Article 96 ofthe CPC of Ukraine. Thus, under thisprovision a writ can be issued, if there is:1) the claim for the recovery of accruedbut not paid amount of wages, and 2) theclaim for compensation costs for the de-tention of a defendant, a debtor, a childor vehicles of a debtor; 3) the claim ondebt recovery for housing and communalservices, telecommunications services,TV and radio broadcasting services basedon inflation and 3 % per annum, accruedby an applicant on debts, and 4) theclaim to award child support in theamount of thirty percent of the subsis-tence minimum for children of appropri-ate age, if this requirement is not relatedto the establishment or contesting pater-nity (maternity) and the need to involveother stakeholders, 5) the claim for re-fund defective goods, if there is an adju-dication which came into force , estab-lishing the fact of selling defective goods,

which was adopted in favor of an indefi-nite number of consumers [6].

An application for a writ court ordershall be lodged according to the generalrules of jurisdiction (Article 97 of theCPC of Ukraine).

According to Part 2 of Article 102of the СPС of Ukraine delivering of awrit is made without court sitting andsummons of the debtor for hearing oftheir explanations. Just these proceduralrules show the main features of simplici-ty of this form of civil proceedings.

Issued by a court, a writ must havea form and content provided by Article103 of the CPC of Ukraine. In particular,a writ must state: 1) the date of a writ de-livering; 2) the name of the court, thename of the judge who issued the writ(court order); 3) name (title) of a creditorand a debtor and their place of residenceor location, and 4) reference to the lawunder which subject the claim shall bemet, and 5) the amount of funds to be re-covered, and the account of a debtor (legalentity) in a banking institution, who mustpay the costs, if it was notified by the ap-plicant; 6) the amount of costs paid by theapplicant and subject to forfeiture in itsfavor of the debtor; 7) information aboutthe order and timing of application forcancellation of a writ (court order).

Part 2 of Article 103 of the CPC ofUkraine contains a provision accordingto which the writ must comply with theenforcement document, established bythe Law of Ukraine «On EnforcementProceedings» At the same time, accord-ing to paragraph 3 part 2 of Article 17 ofthe Law of Ukraine «On EnforcementProceedings» a writ is mentioned in thelist of executive documents subject to en-forcement by the state enforcement ser-vice (bailiffs) [6].

Thus, we can say that a writ combinesprocedural features of adjudication and ofan enforcement document simultaneously.

Prescription of Article 103 of the CivilProcedure Code of Ukraine stipulatesthat a writ is composed and signed by ajudge in two copies, one of each remains

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in the file of the case, and the second oneis sealed and issued to the plaintiff afterits entry into force [6].

The procedure is following.According to the prescriptions of para-

graph 1 of Article 104 of the CPC ofUkraine, after the delivering of a writ, acourt shall no later than the next daysend a copy to the debtor by a registeredletter with notification. Part 2 of this arti-cle states that with a copy of a writ thedebtor shall receive a copy of the applica-tion of a plaintiff with copies of docu-ments attached to it. The CPC of Ukraineestablishes clear requirements on fixingthe receipt of a copy of a writ by a debtorand the enclosed documents. Thus, in ac-cordance with paragraph 4 of Article 104of the CPC of Ukraine the day of receiv-ing of a writ copy by the debtor is consid-ered to be the date specified in the noticeof postal delivery. Another provision ofthe stated procedural rule stipulates thatif a debtor refuses to receive a copy of awrit or is missing by the mentioned ad-dress, the day of receiving of a writ copyby the debtor is considered to be the datewritten in a mail message of note aboutthe refusal of the debtor to obtain a copyof a writ or a note about the absence ofdebtor by the specified address.

The debtor, who does not agree withan issued writ, within ten days after re-ceiving a copy of a writ and the encloseddocuments, may apply for its cancella-tion. This statement shall be filed to thecourt which issued the writ in writing(Part 2 of Article 105 CPC of Ukraine).Procedural law provides that the applica-tion for cancellation of a writ shall in-clude: 1) name of the court to which ap-plication is made, and 2) the name (title)of the claimant and the debtor and thename (title) of a representative of thedebtor if the statement is filed by a rep-resentative, their place / residence or lo-cation, and 3) the writ that is challenged,and 4) a reference to the circumstancesindicating a complete or partial invalidi-ty of plaintiff's claims; 5) reference to evi-dence that the debtor proves his objec-

tion to the plaintiff's claims, and 6) list ofdocuments attached to the application.

The court fee for filing an application forcancellation of a writ should not be paid.

Procedural law sets deadlines for a de-cision on acceptance or not by a court anapplication for cancellation of a writ —one day after the acceptance (Part 4 ofArticle 105-1 of the CPC of Ukraine). Part3 of Article 105-1 of the CPC of Ukrainestipulates that the submitted applicationfor cancellation of a writ is not consid-ered, if it does not comply with the law,and if an application is accepted for con-sideration the court issues a ruling. Acourt shall send to a creditor and debtor acopy of the court ruling on the adoption ofan application on the abolition of a writnot later than the next day after its adop-tion, both parties shall be notified of thetime and place of consideration of this ap-plication (Part 5 of Article 105-1 CPC ofUkraine) [6].

Application for cancellation of a writshall be considered by the court withinten days of the enactment of the courtruling of adoption of this application forconsideration in open court hearing (Part 6of Article 105-1 CPC of Ukraine). Theprocedure for the examination of the ap-plication is provided by Section 7 of Arti-cle 105-1 of the CPC of Ukraine. Thus, inaccordance with this provision a chair-man opens the hearing and finds out whoof the summoned persons are present, es-tablishing their identity, examines thecredentials of representatives and thennotifies about the content of the applica-tion for cancellation of a writ and listensto opinions of the persons involved inconsidering of such an application. Fromthe above mentioned it is not difficult tosee that the phase of cancellation of awrit is the only stage of acting proceed-ings in which there is a trial.

According to the results of considera-tion of the application for cancellation ofa writ the court may make such decisions(judgments): 1) to leave the applicationon cancelling of a writ without satisfac-tion; 2) to cancel the writ and explain

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that requirements stated by a plaintiffcan be considered in action proceedingsin compliance with the general rules onfiling a claim, and 3) to change a writ.This list is exhaustive.

The current procedural law providesfor the possibility of an appeal in cases ofwrit proceedings the civil cases.

The right of appeal is provided by theConstitution of Ukraine, in particular,paragraph 8 of Part 2 of Article 129. Arti-cle 125 of the Basic Law stipulates that ap-pellate courts act under the law. Appellatecourts constitute the second tier of the sys-tem of courts of general jurisdiction.

At the same time the procedure of ap-peal in writ proceedings has its owncharacteristics. According to the CPC ofUkraine, a collector and a debtor havethe right to appeal. The objects of appealin simplified proceedings include: 1) aruling to refuse to accept the applicationon delivering of a writ, and 2) a ruling torefuse to accept the application on can-cellation of a writ, and 3) a writ with acourt ruling on refusal to cancel a writ,and 4) an amended writ (court order).

A form and a content of the complaintmust comply with the article 295 of theCPC of Ukraine. The appeal shall be filedby the trial court to the Court of Appealwithin five days of the trial court pro-ceeding ruled on writ proceeding.

General criteria on which the Court ofAppeal issues a ruling extend to the pro-ceedings of the writ proceedings exceptfor the grounds for cancellation of a writ,which were separately regulated. Thus,part 1 of Article 309-1 of the CPC ofUkraine stipulates that a writ shall becancelled in appeal if the Court of Appealfinds no legal dispute between a creditorand a debtor, by which the claim wasmade under the first paragraph of Article96 of the CPC of Ukraine. In this case awrit is cancelled on the basis of studyingof substantive and legal composition.

The ruling of a court of appeal on awrit shall come into force upon its adop-tion (declaration), as in other types ofcivil proceedings. According to the CPC

of Ukraine, appeal ruling is final in sim-plified proceedings.

The law on civil procedure establishes aspecial moment of a writ entry into force.Thus, in the case of filing of an appeal, awrit (an amended writ) shall come intoforce after the adjudication of such com-plaints, if not cancelled (part 2 of Article106 of the CPC of Ukraine). At the sametime, part 1 of Article 106 of the CPC ofUkraine stipulates that in case of non re-ceipt of the debtor's application for cancel-lation of a writ within three days after theexpiration of the filing, a writ shall comeinto force and the court issues it to a collec-tor to further its implementation.

Describing the court order proceedingsin Ukraine, it is worth saying that thereare differences between the Europeancourt order proceedings Regulation (Direc-tive) EU 1896/2006 and Regulation (Direc-tive) EU 861/2007 — small litigation). TheEuropean court order proceedings con-tains no court of appeal, there is no accu-rate list of judicial decisions for the shar-ing of the court order proceedings. The is-sues of implementation of procedures ofEuropean law are needed to be studied.

It is necessary to increase the numberof reasons for issuing of court order.These lawsuits may be financial debts,the return of the bank deposit, license fee(pay for a license for the intellectualproduct). Ukrainian court practice itselfshows relevant court order proceedingsin such court cases.

Summarizing all the above mentioned,we would like to emphasize, the instituteof court order proceedings raised the pri-ority of the judicial forms of defense andconsiderably simplified the procedure ofcivil rights protection. The court orderproceedings (writ proceedings) includedin the one orbit with European legal poli-cy and the fundamental objectives ofdemocracy. Heightening of the case ofcourt cases examined in order court orderproceedings (writ order proceedings) in-creases the efficiency of protection of therights and economic rights.

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Список використаних джерел / List of references

1. Конституція України (The Constitution of Ukraine) прийнята на п’ятій сесіїВерховної Ради України 28.06.1996 р. // Офіційний Інтернет-сайт ВерховноїРади України [Електронний ресурс]. — Режим доступу:http://zakon1.rada.gov.ua/laws/show/254%D0%BA/96-%D0%B2%D1%80.

The Constitution of Ukraine.2. Чернооченко С. І. Цивільний процес : вид. 2-ге; перероб. та доп. : навчальний

посібник / С. І. Чернооченко. — К. : Центр навчальної літератури, 2005. —472 с.

Chernochenko S. I. Civil Procedural of Ukraine. The textbook. Kyiv, 2005. — 472 totalpages.

3. Штефан М. Й. Цивільне процесуальне право України: Академічний курс : під-руч. для студ. спец. вищ. навч. зал. / М. Й. Штефан. — К. : Ін Юре, 2005. —624 с.

Shtefan M. I. Civil Procedural Law of Ukraine. The Academic tutorial. Kyiv, 2005. —624 total pages.

4. Штефан О. О. Цивільне процесуальне право України : навч. посіб. / О. О. Ште-фан. — К. : Юринком Інтер, 2009. — 360 с.

Shtefan O. O. Civil Procedural Law of Ukraine. The textbook. Kyiv, 2009. — 360 totalpages.

5. Shabalin A. V. The court order proceedings in the civil trail: The dissertation for thescientific degree of candidate of science in law, speciality 12.00.03 — Civil law andcivil process; family law; international private law. — The F. G. Burchak Scientific-Research Institute of Private Law and Business of National Academy of Law Sci-ences of Ukraine, Kyiv, 2015 — 213 total pages.

6. Цивільний процесуальний кодекс України від 10.03.2004 р. № 1618-IV // Офі-ційний Інтернет-сайт Верховної Ради України [Електронний ресурс]. —Режим доступу : http://zakon1.rada.gov.ua/ laws/show/1618-15.

The Civil Procedural Code of Ukraine.

Надійшла до редакції 05.06.2016 р.

Шабалин А. Приказное производство в гражданском процессе Украины:научные вопросы и практика. В статье исследованы теоретические вопросы приказ-ного производства, в частности генезис приказного производства в украинском процес-суальном законодательстве.

Отмечается, что в ЕС приказное производство идёт по пути унификации, что обуслов-лено действием единых европейских судебных процедур (Регламент ЕС 861/2007 — еди-ный европейский судебный приказ; Регламент ЄС 861/2007 — единая европейская су-дебная процедура относительно разрешения небольших (мелких) споров).

Отмечается, что в структуре приказного производства выделяются как стадии (рас-смотрения дела судом первой инстанции, пересмотр судебных решений по делам при-казного производства, исполнения судебного приказа), так и этапы, которые про-являют свою особенность и реализуются исключительно на первой стадии, являющей-ся стадией рассмотрения дел в суде первой инстанции. Отмечается, что насегодняшний день в процессуальной науке существует несколько подходов в вопросемодели приказного производства, а именно eго структуры. Так, одни ученные указы-вают на существования трёх этапов приказного производства (Е. Штефан), другие ука-зывают на наличие трёх стадий данного производства (А. Шабалин), к которым отно-сится и стадия исполнения судебного приказа.

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В работе непосредственно исследованы процессуальные особенности возможностиразрешения дел приказного производства, а именно: порядок подачи заявления о вы-несении судебного приказа, открытия приказного производства, выдача и отмена су-дебного приказа судом первой инстанции, а также уделено внимание особенностям пе-ресмотра судебных решений, постановляемых судом в делах приказного производства.

Также в статье были исследованы и практические вопросы приказного производ-ства, в частности возможности применения судебного приказы к взысканию финансо-вой задолженности, взысканию лицензионных платежей за использования объекта ин-теллектуальной собственности, возвращения банковского депозита.

Ключевые слова: дела приказного производства, судебный приказ, гражданскийпроцесс, приказное производство, спор о праве

Shabalin A. The court order proceedings of civil procedural law of Ukraine:scientific issues and practices. In the article the theoretical issues of court procedure,in particular the genesis of the court order in Ukrainian procedural legislation are investi-gated.

It is noted that in the court order proceedings of the EU is moving towards unification,which is caused by the action of the common European judicial proceedings (EU Regula-tion 861/2007 — European single judicial order; ЄS Regulation 861/2007 — European sin-gle judicial procedure for resolution of small (small) disputes).

It is noted that in the structure of the court order procedure stand out as stages (exam-ination of the case by the court of first instance, the revision of judgments in cases of courtorder procedure, the court order of execution), and steps that show the feature and imple-mented exclusively in the first stage is the stage of consideration of cases in court of firstinstance. It is noted that today in the procedural science, there are several approaches tothe issue of court order procedure models, namely its structure. For example, some scien-tists point out the existence of the three stages of production clerk (O. Shtefan), otherspoint out the presence of three stages of production (A. Shabalin), which include the stageof execution of a court order.

The article directly investigates the procedural peculiarities of the possibility of solvingcases of court order procedure, namely, the order of submission of the application for acourt order, the opening of court order procedure, issuance and cancellation of a courtorder by the court of first instance, but also focus on the peculiarities of judicial review ofdecisions, decides court in matters of court order procedure.

Also in the article it has been investigated practical issues of court order procedure, inparticular the possibility of using court orders to collect financial debt collecting royaltiesfor the use of intellectual property, the return of the bank deposit.

Keywords: civil cases of the court order proceedings, court order proceedings (writ pro-ceedings), court order (a writ), doctrines of civil procedure, controversy about claim

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Ethical rules and principals play vitalrole in any profession as they form aground for professional codes and latereven for legal norms. Ethics in medicineis especially important as medical profes-sion deals with the individuals, theirhealth and the health of the nations ingeneral.

A lot of researchers and practitionersdevoted important part of their scientificworks to the ethical issues in medicineand in particular to the confidentiality is-sues in health care system. As examplesof this researches we would like to referto the article of J. De Bord, W. Burke andD. M. Dudzinski, who give a generaloverview of confidentiality issue, analyzethe influence of privacy on public health,examine cases when confidentiality canbe legally broken [1], M. Beech who scru-tinizes cases when the dilemmas mightarise between the necessity to maintainthe patient’s confidentiality and the ne-

cessity to open it in the research «Confi-dentiality in health care: conflicting legaland ethical issues» [2], S. Vekovshynina,V. Kulinichenko, N. Kovalenko who ex-amine the evolution of such ethics rulesand duties as confidentiality and respectfor autonomy from the time of the Hippo-cratic Oath to the modern days [3].

This article and my dissertation re-search in general was influenced a lot byexpert views in the sphere of bioethics ofOksana Kashyntseva who paid importantattention to the issues of influence of ethi-cal and legal norms on the legitimacy of thescientific result in the sphere of biomedicalresearch [4], to the ethics and patent law inhealth care in Ukraine etc. [5].

Dame F. Caldicott report — review ofinformation sharing to ensure and to finda balance between the protection of pa-tient information and the use and shar-ing of information to improve the patientcare had a significant impact on our sci-

DUTY OF CONFIDENTIALITY AND DUTY OF OPENNESS

IN HEALTH LAW OF UKRAINE AND THE UNITED KINGDOM OF GREAT

BRITAIN AND NORTHERN IRELANDOlena Chaban,applicant for PhD of the Kiev University of Law of the NALSof Ukraine, civil and labour law department

Чабан О. Обов’язок зберігати відомості про стан здоров’я конфіденційнимита обов’язок надання інформації про стан здоров’я пацієнту в Україні таСполученому Королівстві Великої Британії та Північної Ірландії.

Стаття присвячена аналізу двох обов’язків: зберігати інформацію про стан здоров’яконфіденційною та надавати інформацію про стан здоров’я пацієнта; проведено порів-няльний аналіз зазначених обов’язків в законодавстві України та СполученогоКоролівства Великої Британії та Північної Ірландії; розроблено пропозиції щодо допов-нень існуючого законодавства України з метою приведення його у відповідність до най-кращих європейських практик та гуманістичних цінностей.

Ключові слова: біоетика, обов’язок конфіденційності, право на інформацію, медичнеправо, приватність, розкриття інформації, порушення конфіденційності, баланс прав

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УДК:347.121.2

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entific position too [6]. In terms of philo-sophical and theoretical grounds and«support» for our research we haveanalysed the works of G. W. F. Hegel,J. Bentham, L. Portes «A la recherched’une éthique médicale», T. Beauchampand J. Childress, P. Lambert «Le secretprofessionnel», M. Wilpart, S. Denis,A. Maitrot de la Motte et al.

As the ethical issues of use and shar-ing information are so often discussed,reviewed and analyzed, in our article wepay our attention to the duty of confiden-tiality and duty of openness in medicalprofession exclusively in Ukraine and inthe United Kingdom of Great Britain andNorthern Ireland (hereinafter — theUK). The comparative approach is cho-sen to learn what kind of legal normsregulating the said duties exist in thelaw of the mentioned countries, to showhow differently and or similarly the du-ties are regulated in the precedent andcontinental legal systems and to clarifythe importance of the right balance of theduties to the medical profession and tothe human being and health care in gen-eral. The objective of this article is also toseek how Ukrainian law may be amend-ed in order to meet the best Europeanpractice and values.

To begin our research we are referringto one of the oldest binding document formedical professionals in history — theHippocratic Oath and internationalnorms regulating the duties under thequestion.

The Hippocratic Oath is known for itsconfidentiality duty imposed on the doc-tors: «And whatever I see or hear in peo-ples lives during the treatment, or evenoutside the treatment, that ought not bemade public, I will pass over in silence,considering such things to be reservedsecrets» [7]. Later the above mentionedduty becomes one of the important ele-ments of professional ethics and incorpo-rated into the Ethical Professional codesas well as into the legal norms. But, inthe said Oath the approach is quiet pa-ternalistic [8], as the physician decides

himself what is better for the patient; so,the principle of patient autonomy andbalance of different rights of the personare absent in this document.

The other paper proclaiming the dutyof confidentiality is the WMA Interna-tional Code of Medical Ethics adopted bythe 3rd General Assembly of the WorldMedical Association, London, in October1949. In conformity with the said Code aphysician shall respect a patient’s rightto confidentiality. But in contrast to theHippocratic Oath this privacy is not ab-solute as the Code defines ethical to dis-close confidential information when thepatient consents to it or when there is areal and imminent threat of harm to thepatient or to others and this threat canbe only removed by a breach of confiden-tiality [9].

In more recent WMA document - Dec-laration of Lisbon on the Rights of thePatient adopted by the 34th World Med-ical Assembly, Lisbon, Portugal in Sep-tember/October 1981 we find a sort of de-finition what kind of health informationshall be treated as secret. So, in confor-mity with the said Declaration all identi-fiable information about a patient’shealth status, medical condition, diagno-sis, prognosis and treatment and allother information of a person kind mustbe kept confidential, even after death.And all identifiable patient data must beprotected [10].

In the Universal Declaration ofHuman Rights we find general obligationsto safe the privacy of the person and to re-spect the honor and reputation (art. 12)[11]. As health data may include all kindof private information including informa-tion on family life, and as health data is sosensitive that it may influence on person’sreputation and even good name — honor,the cited article and document in generalshall be treated as ground and basis fornational detailed regulations of healthdata confidentiality duty.

Despite the number of Internationalnorms and Codes, the national law ofeach country while incorporating the

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said international general rules has itsown peculiarities in regulating the saidsphere of social relations. This articleconcentrates on the overview of theUkrainian and the UK law as examplesof how national legislators regulate theduty of confidentiality and the duty ofopenness, their differences.

The duty of confidentiality is regulat-ed in the Ukrainian law by Constitutionas Fundamental Law, by Civil law andProcedure, by Criminal law and proce-dure and by special laws and norms suchas «the Fundamentals of legislation ofUkraine on health care», «Oath of a doc-tor» etc.

Thus, in the article 32 of the Constitu-tion of Ukraine like in the Universal Dec-laration of Human Rights we find a gen-eral obligation to safe the privacy of theperson and the rules for the collection,storage, use and dissemination of confi-dential information about a person [12].More explicit obligation to keep healthdata as confidential information is im-posed by the article 286 of the Civil Codeof Ukraine; under the said legal norm anatural person shall have the right tohealth secrecy, to the secrecy of the fact ofaddressing for medical aid, to the confi-dentiality of the diagnosis and informa-tion received during medical examina-tion. Moreover, a natural person shall beobliged to refrain from dissemination ofthe above indicated information whichshe/he got to know in the process of per-forming his/her functions or from othersources [13]. The article 40 of «The Fun-damentals of legislation of Ukraine onhealth care» stipulates the obligation ofmedical staff and other persons who hap-pen to learn the health information dur-ing their professional activity to keep thesaid information confidential except theexpress cases when the said informationcan be disclosed in conformity with thelaw of Ukraine [14]. «Oath of a doctor»,enacted by the Order of President ofUkraine on the 15th of June 1992, № 349bounds a doctor with medical secret andwith medical obligation to comply with

the rules of professional ethics in general;in addition, under the said document thedoctor has no right to hide the truth fromthe patient except cases when the truthmay be harmful for the patient [15]. Asadditional step to guarantee the profes-sional secret, the legislator introducescertain restrictions to the list of the per-sons who can be examined as witness incivil and criminal procedure. In the CivilProcedural Code of Ukraine, the article51 stipulates that persons obliged by lawto keep in secret information that had en-trusted to them in connection with theirofficial or professional status are not enti-tled to examination as witness [16]. TheCode of Criminal Procedure of Ukraineexplicitly defines professionals such asdoctors, psychologists as persons who cannot be examined as witness about whatcame to their knowledge in the dischargeof professional activities unless the per-son who entrusted them such informationhas released them from the duty to keepprofessional secret (article 69) [17].

Furthermore, the Criminal Code ofUkraine stipulates punishment for ille-gal disclosure of the confident informa-tion. The example of if is the article 145of the Criminal Code of Ukraine statingthat the willful disclosure of the confi-dential information by a person to whomit was available in connection withhis/her professional or official duties,where such disclosure caused any graveconsequences, — shall be punished by afine up to 50 tax-free minimum incomes,or community service for a term up to240 hours, or deprivation of the right tooccupy certain position or engage in cer-tain activities for a term up to threeyears, or correctional labor for a term ofup to two years. Moreover, in conformitywith the article 132 of the Criminal Codeof Ukraine disclosure by a medical offi-cer, an auxiliary employee who obtainedthe information without authorization,or a member of medical profession — ofinformation on medical examination forHIV, or any other incurable contagiousdisease dangerous to the person’s life, or

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AIDS and its results that became knownto them in connection with their officialor professional duties, — shall be pun-ished by a fine of 50–100 tax-free mini-mum incomes, or community service fora term up to 240 hours, or correctionallabor for a term up to two years, with orwithout deprivation of the right to occu-py positions or engage in certain activi-ties for a term up to three years [18].

As for the duty of openness, in theUkrainian medical law there are somestatements that bind the medical profes-sionals with the duty of being open withthe patients. These are the article 285 ofthe Civil Code of Ukraine, the article 39of «The Fundamentals of legislation ofUkraine on health care», the «Oath of adoctor» etc. Nevertheless, it goes aboutthe duty of a doctor to be sincere with thepatient mainly on the diagnosis. For in-stance, the article 285 of the Civil Code ofUkraine gives the right to the natural per-son of age to reliable and complete infor-mation on the state of his/her health, in-cluding access to the relevant medical doc-uments concerning his/her health. Buteven this right is not absolute — in casethe information about the illness of a nat-ural person may aggravate his/her state ofhealth or may ruin the process of treat-ment, medical staff shall have the right toprovide incomplete information about thestate of health of the person and to limitaccess to certain medical documents. Thisis in our opinion quiet arguable statementand may give in some circumstances toomuch of power over the patient. Moreover,in the Ukrainian law, the duty of open-ness in contrast to the duty of candour im-plemented in the UK, covers the duty ofmedical professional to provide the pa-tient with all relevant information on thepatients’ health, but it does not explicitlycover the duty of medical staff to notify apatient on the mistakes made by the saidprofessional or other incidents that mayoccur in the process of treatment includ-ing breach of the health secrecy or proba-bility that the health data confidentialitymight be broken.

The duty of candour in the UK wasinitially offered by Robert Francis QC,Chairman of the Inquiry into MidStaffordshire NHS Foundation Trust.[19]. As a result of discussions of prosand contras of the said implementation,the duty of candour became bounding forall registered providers since 1 April2015 in UK. Thus under the Regulation20 of the Health and Social Care Act2008 (Regulated Activities) 2014: Ahealth service body must act in an openand transparent way with relevant per-sons in relation to care and treatmentprovided to service users in carrying on aregulated activity. As soon as reasonablypracticable after becoming aware that anotifiable safety incident has occurred ahealth service body must notify the rele-vant person that the incident has oc-curred, and provide reasonable supportto the relevant person in relation to theincident, including when giving such no-tification. The said notification must —be given in person by one or more repre-sentatives of the health service body,provide an account, which to the best ofthe health service body’s knowledge istrue, of all the facts the health servicebody knows about the incident as at thedate of the notification, advise the rele-vant person what further enquiries intothe incident the health service body be-lieves are appropriate, include an apolo-gy, and be recorded in a written recordwhich is kept securely by the health ser-vice body. To avoid the misinterpretationof the terms, the said Regulation pro-vides such definitions as «apology»,«moderate harm», «moderate increase intreatment», «notifiable safety incident»,«severe harm», «prolonged psychologicalharm», «relevant person» etc. [20]. Inconformity with the said duty the breachor possible breach of confidentiality shallbe advised and notified. We find thiskind of obligation imposed on the med-ical professionals as highly progressiveand human oriented as on the one handit is an additional guarantee for keepingthe health data accurately and with all

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Список використаних джерел / List of references

1. De Bord J. Confidentiality [Electronic resource] / Jessica De Bord, Wylie Burke,Denise M. Dudzinski. — Access mode: https://depts.washington.edu/bioethx/topics/confiden.htm.

2. Beech M. Confidentiality in health care: conflicting legal and ethical issues. [Elec-tronic resource] / M. Beech. — Access mode : http://www.ncbi.nlm.nih.gov/pubmed/17305035.

3. Вєковшиніна С. В. Сучасна медична етика: від Гіппократа до біоетики [Електрон-ний ресурс] / С. В. Вєковшиніна, В. Л. Кулініченко, Н. В. Коваленко. — Режим до-ступу : http://www.google.com.ua/url?url=http://www.umj.com.ua/wp/wp-con-tent/uploads/archive/37/pdf/540_ukr.pdf%3Fupload%3D&rct=j&q=&esrc=s&sa=U&ved=0ahUKEwiSmua2g8_LAhXoCpoKHWaVDp0QFggVMAA&usg=AFQjCNFqe-0K7J4m5Pq39wzkccQjuxBiJA.

S. V. Viekovshynina, V. L. Kulinichenko, N. V. Kovalenko. Suchasna medychna etyka:vid Hippokrata do bioetyky.

4. Кашинцева О. Вплив етико-правових норм на легітимність наукового резуль-тату у сфері біомедичних досліджень / О. Кашинцева // Теорія і практикаінтелектуальної власності. — 2014. — № 6. — С. 13–20.

Kashyntseva O. Vplyv etyko-pravovykh norm na lehitymnist naukovoho rezultatuu sferi biomedychnykh doslidzhen [in]: Teoriia i praktyka intelektualnoi vlasnosti2014, № 6, S. 13–20.

due responsibility, and on the otherhand, it is a fair tool to control the physi-cian-patient communications, relationsand confidentiality-ethics compliance.

As for the duty of confidentiality, inaddition to the precedents, it is mainlyregulated in UK by The Data ProtectionAct 1998 that governs rights for the indi-viduals who are alive to access their ownrecords, and that defines physical ormental health or condition as «sensitivepersonal data» [21], by The Access toHealth Records Act 1990 that definesrights of access to the health records ofthe deceased patient [22], and by theMedical Reports Act 1988 stipulating theright for individuals to have access to re-ports, relating to themselves that aredone by medical professionals for insur-ance and employment purposes [23].

So, this brief overview of the UK lawin the mentioned aspects shows that, onthe one hand, it is very structured; and,on the other hand, it forms coherent sys-tem respecting the balance. As it is im-possible to seek confidence of patientwithout keeping the health data confiden-tial and at the same time it is highly im-portant to know how to share the health

information with other medical staff inorder to provide the high quality medicalservices and medical treatment; how toadvise openly and in a correct way a pa-tient on diagnosis and other health rele-vant information, the grain of truth shallbe found in the equilibrium of the differ-ent rights. As we see in Ukraine there issufficient quantity of legal norms to regu-late the duty of confidentiality and dutyof openness, but they are not composingan integrated system — each particularduty is governed separately. Moreover, inour opinion the duty of openness inUkraine shall be expanded. And keepingin mind that Ukrainian law has featuresmainly of continental legal system, andtends to the explicit regulation and dog-matism, the Ukrainian patient in addi-tion to the existing norms shall have ex-plicit right to be notified of the medicalincident that occurred or may occur in-cluding the breach of confidentiality. Toimplement this, the article 285 of theCivil Code of Ukraine as well as other rel-evant norms shall be amended with theabove mentioned statements.

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5. Kashyntseva O. Ethics and patent law in health care: Ukrainian reform [Electronicresource] / O. Kashyntseva. — Access mode : http://medicallaw.org.ua/fileadmin/user_upload/PDF/_%E2%84%96_16_KASHYNTSEVA.pdf.

6. Fiona Caldicott report [Electronic resource]. — Access mode :www.gov.uk/government/publications/the-information-governance-review

7. The Hippocratic Oath in Latin with English Translation. Latin by Albrecht de Haller[Electronic resource]. — Access mode : http://www.academia.edu/263872n8/The_Hippocratic_Oath_in_Latin_with_English_translation.

8. Вєковшиніна С. В. Сучасна медична етика: від Гіппократа до біоетики [Електрон-ний ресурс] / С. В. Вєковшиніна, В. Л. Кулініченко, Н. В. Коваленко. — Режим до-ступу : http://www.google.com.ua/url?url=http://www.umj.com.ua/wp/wp-con-tent/uploads/archive/37/pdf/540_ukr.pdf%3Fupload%3D&rct=j&q=&esrc=s&sa=U&ved=0ahUKEwiSmua2g8_LAhXoCpoKHWaVDp0QFggVMAA&usg=AFQjCNFqe-0K7J4m5Pq39wzkccQjuxBiJA.

S. V. Viekovshynina, V. L. Kulinichenko, N. V. Kovalenko. Suchasna medychna etyka:vid Hippokrata do bioetyky.

9. Internationl Code of Medical Ethics adopted by the 3rd General assebly of the WorldMedical Association, London, October 1949 [Electronic resource]. — Access mode :www.wma.net

10. Declaration of Lisbon on the Rights of the Patient adopted by the 34th World MedicalAssembly, Lisbon, Portugal in September/October 1981 [Electronic resource]. — Ac-cess mode : www.wma.net

11. Universal Declaration of Human Rights adopted by the Resolution of the GeneralAssembly of UNO in Paris, December 1948 [Electronic resource]. — Access mode :https://www.google.com.ua/search?client=opera&rls=ru&q=Universal+declarati on+o f+Human+r ight s&source id=opera&ie=ut f -8&oe=ut f -8&chan-nel=suggest&gws_rd=ssl.

12. Конституція України [Електронний ресурс] // ВідомостіВерховної РадиУкраїни. — 1996. — № 30. — Cт. 141. — Режим доступу :http://zakon5.rada.gov.ua/laws/show/254к/96-вр

Konstytutsiia Ukrainy, http://zakon5.rada.gov.ua/laws/show/254k/96-vr13. Цивільний Кодекс України [Електронний ресурс] // Відомості Верховної

Ради України. — 2003. — №№ 40–44. — Ст. 356. — Pежим доступу :http://zakon5.rada.gov.ua/laws/show/435-15.

Tsyvilnyi Kodeks Ukrainy, http://zakon5.rada.gov.ua/laws/show/435-15.14. Закон України «Основи законодавства України про охорону здоров’я»

від 19.11.1992 р. [Електронний ресурс] // Відомості Верховної РадиУкраїни. — 1993. — № 4. — Cт. 19. — Режим доступу :http://zakon3.rada.gov.ua/laws/show/2801-12.

Osnovy zakonodavstva Ukrainy pro okhoronu zdorovia,http://zakon3.rada.gov.ua/laws/show/2801-12.

15. Указ Президента України «Про Клятву лікаря» від 15.06.1992 р. № 349[Електронний ресурс]. — Pежим доступу :http://zakon3.rada.gov.ua/laws/show/349/92.

Pro Kliatvu likaria: Ukaz Prezydenta Ukrainy vid 15.06.1992 r. № 349,http://zakon3.rada.gov.ua/laws/show/349/92

16. Цивільний процесуальний кодекс України від 18.03.2004 р. [Електронний ре-сурс] // Відомості Верховної Ради України. — 2004. — № 40–41, 42. —Ст. 492. — Pежим доступу : http://zakon5.rada.gov.ua/laws/show/1618-15

Tsyvilnyi protsesualnyi kodeks Ukrainy vid 18.03.2004,http://zakon5.rada.gov.ua/laws/show/1618-15

17. Кримінальний процесуальний кодекс України: Закон України від 13.04.2012 р.[Електронний ресурс] // Відомості Верховної Ради України. — 2013. —№ 8–10, № 11–12, № 13. — Ст. 88. — Pежим доступу:http://zakon5.rada.gov.ua/laws/show/4651-17.

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Kryminalnyi protsesualnyi kodeks Ukrainy vid 13.04.2012, http://zakon5.rada.gov.ua/laws/show/4651-17

18. Кримінальний кодекс України: Закон України від 05.04.2001 р. [Електроннийресурс] // Відомості Верховної Ради України. — 2001. — № 25–26. — Ст. 131.Pежим доступу : http://zakon3.rada.gov.ua/laws/show/2341-14.

Kryminalnyi kodeks Ukrainy vid 05.04.2001, http://zakon3.rada.gov.ua/laws/show/2341-14

19. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. ExecutiveSummary [Electronic resource]. — Access mode : http://webarchive.nationalarchives.gov.uk/20150407084003/http://www.midstaffspublicinquiry.com/report; used inconformity with http://www.nationalarchives.gov.uk/doc/open-government-li-cence/version/3.

20. The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014№ 2936 [Electronic resource]. — Access mode : http://www.legislation.gov.uk/ukdsi/2014/9780111117613/regulation/20; used in conformity withhttp://www.nationalarchives.gov.uk/doc/open-government-licence/version/3.

21. The Data Protection Act 1998 [Electronic resource]. — Access mode :http://www.legislation.gov.uk/ukpga/1998/29/contents; used in conformity withhttp://www.nationalarchives.gov.uk/doc/open-government-licence/version/3.

22. The Access to Health Records Act 1990 [Electronic resource]. — Access mode :http://www.legislation.gov.uk/ukpga/1990/23/contents; used in conformity withhttp://www.nationalarchives.gov.uk/doc/open-government-licence/version/3.

23. Medical Reports Act 1988 [Electronic resource]. — Access mode :http://www.legislation.gov.uk/ukpga/1988/28/contents; used in conformity withhttp://www.nationalarchives.gov.uk/doc/open-government-licence/version/3.

Надійшла до редакції 20.03.2016 р.

Чабан Е. Обязанность сохранять сведения о состоянии здоровья конфи-денциальными и обязанность предоставлять информацию о состоянии здо-ровья пациента в медицинском праве Украины и Объединенного Королев-ства Великобритании и Северной Ирландии. Статья посвящена анализу двухобязанностей: сохранение сведений о состоянии здоровья конфиденциальными и пре-доставление информации о состоянии здоровья пациенту; сравнительному изучениюуказанных обязанностей в законодательстве Украины и законодательстве Объеди-ненного Королевства Великобритании и Северной Ирландии; разработке модифика-ций украинского законодательства с целью приведения его в соответствие с наилуч-шими европейскими практиками и гуманистическими ценностями.

Ключевые слова: Биоэтика, обязанность сохранения конфиденциальности сведе-ний о состоянии здоровья, обязанность предоставления информации о состоянии здо-ровья пациенту, медицинское право, приватность, раскрытие информации, наруше-ние конфиденциальности, баланс прав

Chaban O. Duty of confidentiality and duty of openness in health law ofUkraine and the United Kingdom of Great Britain and Northern Ireland. This ar-ticle is dedicated to the analysis of the duty of confidentiality and duty of openness in thehealth law of Ukraine and the UK, to the comparative examination of the principle of bal-ance of different duties and rights implemented and used in the above mentioned coun-tries; to the elaboration of amendments to the health law of Ukraine in order to make itmeeting the best European practice and human right values.

Key words: Bioethics, duty of confidentiality, duty of openness, health law, privacy, dis-closure, breach of confidentiality, balance of different rights

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ISSN 2308-0361

The range of problems of legal regula-tion of medicobiological experiments onhumans has historical patterns of its ori-gin, formation and development. It char-acterizes the current state of scientificknowledge and it needs its research andrethinking with a glance to the currentprocesses of development of society, pub-lic institutions, medical and biologicalsciences. In scientific literature scholarsreasonably noted that experiments in thesphere of medicine, including experimen-tations on human, have deep historicalroots, arising from the moment of real-ization of the idea of treatment possibili-

ty, and the effectiveness of treatment isbased on previous experimental activi-ties. That is why, one should agree withthe opinion of scientists that experimentswith different degree of complexity wereconducted since the medicine appeared.They began with magic rituals when ma-gicians and sacerdotes treated in tem-ples, they were conducted by the firstdoctors who noted in their minds effectsof the random drugs, and fixed themwith further verification [1, 219].

The medicobiological experiment de-velops with the development of mankind,expanding its scope of application, meth-

Nataliya Kashkanova,postgraduate student of Kiev University of law of the NAS of Ukraine

Кашканова Н. Роль деонтологічних норм у формуванні законодавства,що регулює порядок проведення медико-біологічних досліджень за участі людини.

Стаття присвячена проблематиці правового регулювання медико-біологічного екс-перименту на людях. Зокрема автором розглядається фактори, що зумовили появуправового регулювання застосування медико-біологічного експерименту на людях,які мають складний характер та пов’язані із необхідністю забезпечення особистихправ і свобод людини, націлені на недопущення їх порушення. Окремо автором аналі-зується, вітчизняне законодавство України в сфері охорони здоров’я, яке на націо-нальному рівні забезпечує правове регулювання окремих питань проведення медико-біологічних експериментів на людях. Автор робить висновки про необхідність науко-вого переосмислення особливостей договірного регулювання відносин призастосуванні медико-біологічних експериментів на людях та наголошує на потребі ви-роблення єдиних доктринальних підходів до вдосконалення законодавства Українита приведення його у відповідність з міжнародними правовими стандартами в сферіохорони здоров’я. Разом з тим, автор звертає також увагу на необхідність подальшогоґрунтовного наукового дослідження особливостей кримінально-правових відносин,що виникають в результаті проведення таких експериментів на людях.

Ключові слова: права людини, біомедичні дослідження, клінічні випробування, лі-карські засоби, інформована згода, зародження і становлення правового регулюванняздійснення медико-біологічного експерименту на людях

THE ROLE OF DEONTOLOGICAL NORMS IN FORMATION OF LEGISLATION REGULATING

THE PROCEDURE OF MEDICAL AND BIOLOGICAL RESEARCH INVOLVING

HUMANS

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ods of realization, expanding range of ex-perimental subjects, which included indi-viduals too. This highlights the necessityto establish requirements for medicobio-logical experiment not only as a phenome-non of medicine and biology, but also asa legal phenomenon. This is primarily dueto the need of ensuring, safety and protec-tion of the rights and freedoms of naturalpersons as an experimental subject.

The current state of medical and bio-logical sciences is determined by consid-erable intensification, among other relat-ing to:

•Firstly, expansion of the boundariesof medicobiological intervention inthe human organism;

•Secondly, increasing of the risk ofmedicobiological experiments;

•Thirdly, the needs for the inventionof new methods and ways of coun-tercheck and fighting against peo-ple’s diseases;

•Fourth, the need to counter illegaluse of human organism for medicalexperiments.

The deepening of socio-economic strat-ification of society, the expansion andstrengthening of world’s conflicts increas-es the risk of excessive use of these fac-tors and involvement of a person in par-ticipation in medicobiological experi-ments under influence of socio-economicsituations of life or due to violence. Allthis determines the necessity of improve-ment of legal support of medicobiologicalexperiments, especially in terms of guar-antee, safeguarding and protection ofrights of a human (an experimental sub-ject), development of effective mechanismof the implementation of relevant legalnorms regulating the exercise of medico-biological experiments on humans.

To be sure, the key problem of modernperiod of development of medicobiologi-cal experiments in Ukraine is the issue ofcompliance of legal regulations withneeds of society; compliance of medicaland biological sciences with the timely,complex and effective adjustment of suchrelations.

That is why, a key topic in modernconditions of development of society andstate, medical and biological sciences isthe research of issues of state regulationof medicobiological experiments with theaim to develop a common conceptual po-sition on improving of the legislation ofUkraine in the context of maximizing en-surance, safeguarding and protection ofthe rights of individuals-patients.

Factors that determined the appear-ance of legal regulation of the use ofmedicobiological experiment on humansare complex, connected to the need to en-sure individual rights and freedoms,aimed at preventing violations. In legalliterature, such factors include, preemi-nently, the specific historical events thatled to the need for «inclusion» of legalmeans to regulation of the relevant phe-nomena and processes of medical and bi-ological nature. In particular, history hasevidences of medicobiological experi-ments on humans that were horrific bycontent and results and were conductedby Japanese doctors on prisoners of1939–1945; German doctors on Jews,Gypsies and prisoners from Soviet armyduring the World War II [2, 15].

There are well-known facts of medicalexperiments on humans in the early XXth

century by Russian researchers [3, 11]and in the middle of the XXth century byAmerican doctors [4, 9, 10]. All these ex-periments on humans were tragic andsparked considerable public outcry.These facts required an appropriate re-sponse from the side of the internationalcommunity and introduction of appropri-ate legal regulation of biomedical experi-ments on humans in order to safeguardand protect human subjects.

Legal regulation of exercising of medico-biological experiments on humans is deter-mined by: the regularities of medicine; thespecifics of medical researches realization;the aim to protect the human-experimentalsubject and minimize the risk of negativeconsequences for their life and / or health.

The explanation of it is that each newmedicine discovery signifies, if not life

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saving, but at least facilitates serious ill-nesses for many people. However, study-ing of each new discovery at a certainstage of investigation there appears aneed to check means or a method on theperson, the results of action of which cannot be predicted with certainty i.e. volun-tarily expose a person or even a group ofpeople with unknown, possibly danger-ous medical means and methods on con-ditions of minimizing the risk of negativeconsequences. To get rid completely ofthe risk is not possible in such medicalresearch. That is why the appearance oflegal norms in the field of biomedical ex-periments is determined by the need forconsistent protection of a human, onwhom new methods or therapies are test-ed. Accordingly, it allows to reduce a riskand prove it, in order a person does notbecome an object of not prepared experi-ments or too long checking methods withmore damaging consequences than itoriginally expected [5].

It should be admitted that in generallegal regulation today is one that comesfrom the condition of medicobiological re-searches. Today, the medicine can notfully develop without searching of newtreatments, diagnostics and prevention,which, in turn, is usually accompaniedby the need for medical experiments. Thetask of legal regulation, the task ofhealth law in general must be to create aclear, thoughtful, and detailed (in per-spective with the legislative confirma-tion) conditions of legitimacy of such ex-periments realization [6, 345].

In other words, the development ofmedical science and practice inevitablylinked to researches on humans. Andsuch studies demand proper legal regula-tion. The awareness of this made themankind to seek the line that separates«the criminal experimentation on hu-mans» and the necessary researchprocess, and such margin is establishedand guaranteed from the side of law [7].

It should be noted, that legal regula-tion of realization of medicobiological ex-periments on humans has objectively de-

termined character associated with thelevel of development of society, healthand life sciences, awareness of social im-portance and social danger of medicobio-logical experiments. Taking this into ac-count, we consider it appropriate to gen-eralize the system of factors thatdetermined the creation and formation oflegal regulation of realization of medico-biological experiments on humans, andtoday directly influence its development.They include:

•Legal factors, relating to the absenceor imperfection of existing legalmeans to ensure the rights and free-doms of persons who are subjects ofexperiment; activation of legislativeactivities of the international com-munity to ensure the rights and free-doms in the process of conducting ofmedicobiological experiments, toprevent violent involvement for thehuman in realization of medicobio-logical experiments;

•Humanistic factors related to aware-ness of the necessity of introductionor strengthen of safeguarding andprotection of the rights and freedomsof persons who are subjects of experi-ment concerning the prevention ofrealization of medicobiological exper-iments against a human’s will, theneed of conditions of getting the ab-solute consent, preventing of unduerisk to their life and health, and totheir descendants; respect forhuman rights and freedoms in con-ducting of biomedical experiments;non-admission of repetition of mis-takes in realization of medicobiologi-cal experiments, which caused dam-age to life or health of a human, thatwere in history;

•Scientific factors relating to enablingof development of medical and bio-logical sciences, to provide growth ofnew knowledge and rethinking of ex-isting, aimed at the establishment ofpatterns of various diseases, mecha-nisms of their development, elabora-tion and testing of the effectiveness

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of new methods of prevention andtreatment;

•Economic factors, which stipulatethe need of invention of new meansand methods of prevention andtreatment, which in future will givethe opportunity to save the healthand lives of people, to make meansand methods of treatment more eco-nomically accessible to people;

•Social factors, the content of which isthe level and peculiarities of devel-opment of society that is aware ofgeneral social purpose of medicobio-logical experiments on humans,their level of danger, and the neces-sity of proper legal regulation of re-alization of medicobiological experi-ments.

Aforementioned factors determinedthe initiation of legal regulation of the re-alization of medicobiological experimentson humans, its formation and are subse-quently determining the development ofsuch regulation.

Within the legal science problems oflegal regulation the implementation ofconducting of medicobiological experi-ments on humans was singled out inthe 30s of XXth century, which took placeunder the influence of medical experi-ments that were conducted during theWorld War I and the War of Japan andChina, resulting in the harm of hundredsof thousands of people.

Such experiments were about en-durance tests for the human body fromthe effects of temperature: developmentof methods of people’s reanimation fromthe negative impact of temperature con-ditions; experiments during which thehuman-subjects were infected with sexu-ally transmitted diseases, and who laterbecame the object of research on the pe-culiarities of the diseases progression.But the most significant impact on theappearance of the first law acts in thesphere of legal regulation of medicobio-logical experiments was the Nurembergtrial on Nazi doctors. The horrors of med-ical experiments made by Nazi doctors

on prisoners in concentration camps ofDachau, Auschwitz, Buchenwald andothers were impressive with their cruel-ty, scope and absurdity. As a result, theproblem of medicobiological experimentson humans was recognized as violating ofpersonal rights and freedoms and is notonly a medical, bioethical issue, but alsoan issue of international legal character.The danger of uncontrollable medicobio-logical experiments, their dehumanizednature was recognized. The preamble ofthe Judgement of the Nuremberg Tri-bunal [8] directly indicates that theseverity of testimony that lie before us,makes us to conclude that some types ofmedical experiments on humans general-ly meet the ethical standards of the med-ical profession only if their conduct islimited with appropriate, clearly definedframes. Moreover, the document includ-ed the separate section — admissibilityof medical experiments. The project of thatelement of the sentence was created byAmerican medical experts — Leo Alexan-der and Andrew Ivy, who studied the med-ical experiments conducted by Nazi doc-tors and proposed principles of admissibili-ty of medical experiments [9, 172].

Later the above-noted text would beknown as the Nuremberg Code (here-inafter — the Code), which at the inter-national legal level entrenched the lawnorms that regulated the requirementsfor conducting of medical experiments ona human. With the adoption of the men-tioned Code the researches on problemsof legal regulation of medical experi-ments on humans became more active.A special attention is given by the schol-ars to the principles embodied in theCode, namely absolute consent of a per-son to the experiment; orientation of theexperiment towards socially positive re-sults; avoidance of all excessive physicaland mental suffering and injury; imper-missibility of the experiment upon condi-tion that a priori there are grounds tosuspect the possibility of death or indi-vidual injuries of the subject; the degreeof the risk associated with the experi-

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ment must never exceed the humanitari-an importance of the problem to besolved by this experiment etc. The above-noted international act actually comesout of the impressions that was made bymedical researches during the WorldWar II, and is aimed at enabling counter-measures against antihumanity ofmedicobiological experiments on hu-mans. The Code actually formed thebasis of legal regulation of medicobiologi-cal experiments on humans. In legal lit-erature scholars unambiguously draw at-tention to the fundamental importance ofthe Code in the system of medical lawsources, which recognized principles ofmedical experiments on humans. Scien-tists draw attention to the role and per-spective of the provisions of the Code, itsplace in the process of establishing oflegal regulation of medicobiological ex-periments [10].

The attention should also be paid tothe provisions of the Universal Declara-tion of Human Rights proclaimed by theGeneral Assembly of the United Nationson 10.12.1948. It does not contain theprovisions regulating the conducting ofmedicobiological experiments, at thesame time it enshrines fundamentalhuman rights. According to Art. 1 allhuman beings are born free and equal indignity and rights. They are endowedwith reason and conscience and shouldact towards one another in a spirit ofbrotherhood. In addition to that Art. 3and 5 establishes that everyone has theright to life, liberty and security of per-son. No one shall be subjected to tortureor to cruel, inhuman or degrading treat-ment or punishment. The realization ofmedicobiological experiments on humansis based on these rights and freedomswhat is the foundation of humanity of ex-periments prohibition of violation ofhuman rights and freedoms [11].

In the same context in the legal litera-ture are analyzed the provisions of theConvention on Human Rights and Fun-damental Freedoms of 04.11.1950 [12],which stipulates the prohibition of tor-

ture (Art. 3); the right to liberty and se-curity (Art. 5); the right to an effectiveremedy (Art. 13) etc. [13].

Particular scientific interest to theproblems of legal regulation of medicobi-ological experiments increases in the60–70s of the XXth century. During thisperiod the practical work in the sphere ofmedicobiological experiments becamemuch more active, new medical technolo-gies were arising and developing. As a re-sult, in 1964 the European Social Char-ter was adopted, the provisions of whichcontinued legal regulation of rights andfreedoms. The content of the above-notedCharter did not directly stipulate theconditions and procedures of medicobio-logical experiments, at the same time theprovisions dealing with the safeguardingand protection of human rights and free-doms were regulated there [14].

Significant importance in the system ofmedical law sources, especially concerningissues of medicobiological experiments,has the Declaration of Helsinki (Declara-tion of Helsinki of the World Medical As-sociation «Ethical Principles for MedicalResearch Involving Human Subjects»from 06.01.1964) [15]. The World MedicalAssociation developed the Declaration ofHelsinki as a statement of ethical princi-ples for medical researches involvinghuman subjects, including researches onidentifiable human material and data.Ethical principles enshrined in the Decla-ration of Helsinki, were the object of re-search of scientists in the field of law, andare an element in historiography of scien-tific regulation of realization of medicobio-logical experiments on humans.

Also the valuable importance in thesystem of medical law sources has the In-ternational Covenant on Civil and Politi-cal Rights [16], Art. 7 of which stipulates:no one shall be subjected to torture or tocruel, inhuman or degrading treatment orpunishment. In particular, no one shallbe subjected without his free consent tomedical or scientific experimentation. Inturn, the provisions of the InternationalCovenant on Economic, Social and Cul-

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tural Rights (ICESCR) [17], stipulatesthat the States Parties to the presentCovenant undertake to respect the free-dom indispensable for scientific researchand creative activity (part 3 of Art. 15).

In 80–90s the problems of legal sup-port of realization of medicobiological ex-periments were continued to be exploredwith renewed vigor that was connectedwith the intensification of researches inthe sphere of medicine, focusing on hu-manities researches, and the develop-ment of legal regulation of medicobiologi-cal experiments on the legislative level ofUkraine.

During this period on the internation-al level was adopted Convention for theProtection of Human Rights and Dignityof the Human Being with regard to theApplication of Biology and Medicine:Convention on Human Rights and Bio-medicine (ETS-164) from 04.04.1997[18], ratified by Ukraine in 2002 [19]. Inthe content of this Convention for thefirst time it was introduced the conceptof professional standards, was stipulatedthat any intervention in the healthsphere, including scientific researches,must be carried out in accordance withcorrespondent professional obligationsand standards. The issues of consent onhuman medical experiments are the sub-ject to above-noted Convention. It is alsodefined the conditions for the protectionof persons who are not able to give suchconsent, is enshrined the provisions con-cerning the protection of persons suffer-ing from mental disorders etc.

It should be noted that with the inde-pendence of Ukraine gave a start for de-veloping of the national legislation ofUkraine in the health sector, which en-sures the legal regulation of certain is-sues of medicobiological experiments onhumans on the national level.

According to Art. 28 of the Constitu-tion of Ukraine no one without their con-sent can be subjected to medical, scientif-ic, or other experiments [20]. The Law ofUkraine «Fundamentals of the Legisla-tion of Ukraine on Health Care» concedes

the realization of medicobiological exper-iments on humans under conditions of:available socially useful purpose; scien-tific feasibility of medicobiological experi-ments; publicity of experiment applica-tion; the subject’s full awareness of theimpact of medicobiological experiment onthe organism; exceeding of probability ofsuccess over the risk of causing seriousconsequences to the health or life of thesubject; the subject’s voluntary consentto the experiment; preservation of thenecessary medical confidentiality [21].

In turn, the provisions of the Law ofUkraine «On Medicinal Products» stipu-late the order of clinical testing of medic-inal products that may be conducted onlywith the purpose of determination or con-firmation of the efficacy and safety ofmedicinal product and only in specializedmedical institutions after the mandatoryassessment of ethical and moral andlegal aspects of the program of clinicaltesting by ethics committees [22].

The beginning of the XXI century be-comes decisive for the further implemen-tation, and, the most important, im-provement of the legal regulation ofmedicobiological experiments on hu-mans. This is determined by a significantintensification of scientific researches inthe sphere of medical experiments, theappearance and introduction of new nan-otechnologies in medical practice that en-hanced the problems of moral and ethicalprinciples of intervention into thehuman’s nature, their life and health.

Within bioethics the social mecha-nisms are being formatted. Such mecha-nisms provide the development of codesof ethics, laws, increasing of responsibili-ties of professionals — doctors and biolo-gists, extension of their duties vested notonly on personal, but also on the legallevel. All nanobiotechnologies andnanomedicine, enriched by new experi-mental and clinical studies are the basisfor their implementation to medical prac-tice; they require mandatory moral, ethi-cal, bioethical and legal qualification. Asa result of discoveries and achievements

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in molecular biology, genetics, nanomor-phology, nanopharmacology, evolution-ary biology the unprecedented opportuni-ties to change human nature are opened.Many of these achievements aimed athuman benefit, but there is also a dangerto use them in another way [23].

During this period the issues of priori-ty of ethical and moral principles in con-ducting of experimental medical activitywith the impact on the human body be-come actual, because they have to be em-bodied in any scientific-research medicalresearch experiment. In conformity withthis, in S. Pustovit’s opinion, two mainmechanisms of ethical regulation of sci-entific projects are following: 1) the pro-cedure for obtaining of informed consentof a subject; 2) the ethical (bioethical) ex-amination of the project [24].

Special scientific attention is given tothe complex of issues related to the defin-ition of the new role and place of biomed-ical research and medicobiological exper-iments in modern legal, medical, geneticsciences and philosophy. Within statedscientists tries to consider the functionaluse of the medicobiological experimentthrough the prism of axiological and an-thropological grounds and variousmethodological principles (transdiscipli-nary methodology) that navigate or payattention of modern researcher to the is-sues of human vital activity in the con-text of cutting-edge biotechnologies andthe necessity for moral and legal regula-tion biosafety of a human [25].

Prominent scientific attention is dri-ven to the legal status and activity of theCommission (committee) on ethics. Oneof the important duties of the control ofthe compliance of the content of medico-biological experiments with the require-ments for scientific researches is placedon them [26].

It should be noted that the year of2000 was marked by the adoption of anumber of legal regulations that speci-fied the number of provisions of laws inthe field of use of medicobiological exper-imentation. In particular, the Ministry of

Health of Ukraine on 23.09.2009 adoptedthe Decree № 690 «The Procedure forConducting Clinical Trials of MedicinalProducts and Expert Evaluation of Mate-rials Pertinent to Clinical Trials andModel Regulations of the Ethics Commit-tee». It defined the basic requirementsfor conducting of clinical testing of medi-cinal products that may be held with theparticipation of patients (volunteers) byfull or reduced program, including test-ing the bioavailability / bioequivalence aswell as international multicenter clinicaltrials. The document identifies generalprinciples of clinical trials, the basic re-quirements for the protection of subjects,evaluation of ethical, moral, legal aspectsof the testing, and the procedure of itsholding. Clinical testing conducted inhealthcare facilities that have a licenseto practice medicine and a certificate ofaccreditation issued by the Ministry ofHealth or its authorized body [27].

Particularly crucial for the further de-velopment of medicobiological experi-ment on doctrinal and practical legal lev-els was the traditional Congress ofBioethics. Starting in 2000 and up to pre-sent there were only five scientific eventsinvolving leading experts in the spheresof medicine, law, philosophy etc., eachthem examined the complex key prob-lematic issues related to the need to cre-ate an appropriate legal framework inthe field of medical services, further de-velopment of studies of bioethical issues,introduction into a customary practice ofthe principles of bioethics, broadening ofteaching of bioethics at school, creationof openness of academic and medical in-stitutions, protecting of human rightsand dignity in view of the current appli-cation of biologic and medical achieve-ments.

The abovementioned facts give rea-sons to say that the problem of legal reg-ulation of realization of biomedical ex-periments on humans reveals throughthe features of the condition andprospects of development of society. Thedevelopment of medicine determines the

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emergence of a significant number of va-rieties of medicobiological experimentson humans which needs the doctrinalclassification and further legal distinc-tion on the legislative level.

Therefore, the problem of the legalstatus of medicobiological experiment re-quires its thorough scientific investiga-tion, identification of features of civillegal relations arising as a result ofmedicobiological experiments on hu-mans.

Summarizing the abovementioned,the author maintains positions about thenecessity of scientific rethinking of thecharacteristics of contractual regulationof relations in the application of medico-biological experiments on humans, inview of the peculiarities of modern medi-cine, international and national law

norms. However, the absence of the uni-fied science-based concept of reforming ofthe regulation of medicobiological experi-ments requires new unified doctrinal ap-proaches to improving the legislation ofUkraine and brings it in accordance withinternational legal standards in healthcare. The development of medical prac-tice requires the development trends andways of further improving the medicobio-logical experiment as complex legal phe-nomenon. In conclusion, the authorwould also like to indicate the necessityof further comprehensive research of fea-tures of criminal and legal relations aris-ing as a result of realization of medicobi-ological experiments on humans.

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4. Этическая экспертиза биомедицинских исследований. Практические реко-мендации / под общей ред. Ю.Б. Белоусова. — М., 2005. — С. 9–10.

Éticheskaya ékspertiza biomedytsinskikh issledovaniy. Prakticheskie rekomendatsii,pod red. Yu. B. Belousova, M., 2005, S. 9, 10.

5. Дзвонів Г. Р. Медичне право : навчальнийпосібник. / Г. Р. Дзвонів, Н. І. Ма-хонько. — 2009 [Електронний ресурс]. — Режим доступу :http://yport.inf.ua/meditsinskoe-pravo-uchebnoe.html.

H. Dzvoniv, N. Makhonko. Medychne pravo : navchalnyi posibnyk., 2009,http://yport.inf.ua/meditsinskoe-pravo-uchebnoe.html.

6. Стеценко С.Г. Медичне право України : підручник / С.Г.Стеценко,В.Ю.Стеценко, І.Я.Сенюта; за заг. ред. д.ю.н., проф. С.Г. Стеценка. — К. :Правова єдність, 2008. — 507 с.

Stetsenko S., Stetsenko V., Senyuta I. Medychne pravo Ukrayiny : pidruchnyk, K.:Pravova yednist, 2008, 507 s.

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7. Асплунд Щ. Использование принципов научно-доказательной медициныв клинической практике / Щ. Асплунд // Рос.семейный врач. — 2000. — № 3. —С. 57–58., Гринхальх Т. Основы доказательной медицины : учебн. пособ. /Т. Гринхальх. — М. : ГЭОТАР-МЕД, 2004., Booth A., Searching for evidence: prin-ciples and practice / A. Booth, A. J. Rourke // Evidence-BasedMedicine. — 1999. —№4. — P. 133–136.

Asplund O. Ispolzovaniye printsipov nauchno-dokazatel'noy meditsiny v klinicheskoypraktike [in] Ros. semeynyi vrach, 2000, № 3, S. 57—58., Grinkhalkh T. Osnovydokazatelnoj meditsyny: uchebnoe posobie, M. : GÉOTAR-MED, 2004., Booth A.,Rourke A. Searching for evidence: principles and practice [in]: Evidence-BasedMedicine, 1999, № 4, P. 133—136.

8. Нюрнбергский кодекс 1947 г. [Электронный ресурс]. — Режим доступа :http://www.psychepravo.ru/law/int/nyurnbergskij-kodeks.htm.

Nyurnbergskiy kodeks 1947 g., http://www.psychepravo.ru/law/int/nyurnbergskij-kodeks.htm.

9. Юдин Б. Г. Горький юбилей / Биоэтика: принципы, правила, проблемы /Б. Г. Юдин ; под ред. Б.Г. Юдина. — М. : Эдиториал УРСС, 1998.

Yudin B., Gorkiy yubilej / Bioétika: printsipy, pravila, problemy, M. : ÉditorialURSS, 1998, s. 172.

10.МоисеевС. Медицина, основанная на доказательствах / С. Моисеев // Врач. —2000. — № 12. — С. 4–8., Ellis J. In-patient medicine is evidence based / J. Ellis,I. Mulligan, D. L. Sackett // Lancet. — 1995. — Vol. 346. — P. 407–410.; WulffH. R. Rational Diagnosis and Treatment / H. R. Wulff, P. C. Guitzsche. Ratio-nal. — 2nd ed. — Oxford : Blackwell Science, 2000.

Moiseev S. Meditsina, osnovannaya na dokazatel'stvakh [in]: Vrach, 2000, № 12,S. 4–8., Ellis J., Mulligan I., Sackett D. L. In-patient medicine is evidence based[in]: Lancet, 1995, Vol. 346, S. 407—410; Wulff H., Guitzsche P., Rational Diagno-sis and Treatment; 2nd ed.,Oxford: Blackwell Science, 2000.

11.Загальна декларація прав людини (рос/укр) від 10.12.1948 р. [Електроннийресурс]. — Режим доступу: http://zakon4.rada.gov.ua/laws/show/995_015.

Zahalna deklaratsiya prav lyudyny vid 10.12.1948,http://zakon4.rada.gov.ua/laws/show/995_015.

12.Конвенція про захист прав людини і основоположних свобод від 04.11.1950 р.[Електронний ресурс]. — Режим доступу :http://zakon4.rada.gov.ua/laws/show/995_004.

Konventsiya pro zakhyst prav lyudyny i osnovopolozhnykh svobod vid 04.11.1950,http://zakon4.rada.gov.ua/laws/show/995_004.

13. Крылова Н. Проведение биомедицинских исследований на человеке / Н. Кры-лова [Електронний ресурс]. — Режим доступу : http://www.narcom.ru/publ/info/467.

Krylova N. Provedenie biomeditsynskikh issledovaniy na cheloveke,http://www.narcom.ru/publ/info/467.

14.Європейська соціальна хартія ( ETS N 35 ) (укр/рос) від 18.10.1961 р. № ETS№ 35 [Електронний ресурс]. — Режим доступу :http://zakon4.rada.gov.ua/laws/show/994_300.

Yevropeyska sotsialna khartiya (ETS № 35) vid 18.10.1961,http://zakon4.rada.gov.ua/laws/show/994_300.

15.Гельсінська декларація Всесвітньої медичної асоціації «Етичні принципимедичних досліджень за участю людини у якості об’єкта дослідження»[Електронний ресурс]. — Режим доступу : http://zakon4.rada.gov.ua/laws/show/990_005.

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Helsinska deklaratsiya Vsesvitnoyi medychnoyi asotsiatsiyi «Etychni pryntsypy me-dychnykh doslidzhen za uchastyu lyudyny u yakosti obekta doslidzhennya»,http://zakon4.rada.gov.ua/laws/show/990_005.

16.Міжнародний пакт про громадянські і політичні права від 16.12.1966 р.[Електронний ресурс]. — Режим доступу :http://zakon4.rada.gov.ua/laws/show/995_043?nreg=995_043&find=1&text=%EC%E5%E4&x=-842&y=-15589#w11.

Mizhnarodnyi pakt pro hromadyanski i politychni prava vid 16.12.1966,http://zakon4.rada.gov.ua/laws/show/995_043?nreg=995_043&find=1&text=%EC%E5%E4&x=-842&y=-15589#w11.

17.Міжнародний пакт про економічні, соціальні і культурні права від16.12.1966 р. [Електронний ресурс]. — Режим доступу :http://zakon4.rada.gov.ua/laws/show/995_042.

Mizhnarodnyy pakt pro ekonomichni, sotsialni i kulturni prava vid 16.12.1966,http://zakon4.rada.gov.ua/laws/show/995_042.

18.Конвенція про захист прав і гідності людини щодо застосування біології тамедицини: Конвенція про права людини та біомедицину [Електронний ре-сурс]. — Режим доступу : http://zakon4.rada.gov.ua/laws/show/994_334.

Konventsiya pro zakhyst prav i hidnosti lyudyny shchodo zastosuvannya biolohiyita medytsyny: Konventsiya pro prava lyudyny ta biomedytsynu,http://zakon4.rada.gov.ua/laws/show/994_334.

19.Список подписаний и ратификаций Конвенции о защите прав и достоинствачеловека в связи с применением достижений биологии и медицины: Конвенцияо правах человека и биомедицине (ETS № 164) (Овьедо, 04.04.1997 г.) [Электрон-ный ресурс]. — Режим доступа : http://zakon4.rada.gov.ua/laws/show/994_529.

Spisok podpisanij i ratyfykatsyi Konventsii o zaschste prav i dostoinstva cheloveka vsvyazi s primeneniem dostizheniy biologiy i meditsyny: Konventsia o pravakh che-loveka v biomeditsyne (ETS № 164) (Oviedo, 04.04.1997,http://zakon4.rada.gov.ua/laws/show/994_529.

20.Конституція України від 28.06.1996 р. / Konstytutsiya Ukrayiny.21.Закон України «Основи законодавства України про охорону здоров’я» від

19.11.1992 р. № 2801-XII Osnovy zakonodavstva Ukrayiny pro okhoronuzdorov'ya.

22.Закон України «Про лікарські засоби» від 04.04.1996 № 123/96-ВР.Zakon Ukrayiny «Pro likarski zasoby». 23.Чекман С. Сучасні основи біоетики медико — біологічних досліджень /

С. Чекман, В. Ф. Шаторна, Я. С. Яскевич, В. І. Гарець, О. О. Савенкова,М. І. Загородний // Вісник проблем біології і медицини. — 2011 — Вип. 3. —Т. 3 (89). — С. 30–33.

S. Chekman, V. Shatorna, Ya. Yaskevych, V. Harets, O. Savenkova, M. Zahorodniy,Suchasni osnovy bioetyky medyko-biolohichnykh doslidzhen [in]: Visnyk problembiolohiyi i medytsyny, 2011,Vyp. 3, T.3 (89), S. 30–33.

24.Пустовіт С. В. Біоетичні принципи та механізми регулювання медико-біо-логічних досліджень / С. В. Пустовіт // Современные проблемы токсиколо-ги. — № 4. — 2010. — С. 5–9.

S. Pustovit, Bioetychni pryntsypy ta mekhanizmy rehulyuvannya medyko-biolohich-nykh doslidzhen [in] Sovremennye problemy toksikologii, № 4, 2010, S. 5–9.

25.Яскевич Я. С. Биомедицинские исследования в контексте трансдисципли-нарно-синергетической методологии / Я. С. Яскевич // Інтегративна ант-ропологія. — 2014. — № 1 (23). — С. 4–15; Биоэтика. Вопроссы и ответы /под. ред. Б. Г. Юдина, П. Д. Тищенко. — М. : Прогресс — Традиция, 2005.

Н. Кашканова

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65

Ya. Yaskevych, Byomeditsynskie issledovania v kontekste transdistsiplinarno-siner-geticheskoi metodologii [in]: Intehratyvna antropolohiya, 2014, № 1(23), S. 4–15.,Bioétika. Voprossy i otvety / pod. red. B. Yudyna, P. Tyshchenko, M. : Prohress-Tradytsiya, 2005.

26.Етичні комітети: становлення, структура, функції / під ред. В. Л. Куліні-ченка, С. В. Всковшиніної. — К. : Видавець Карпенко В.М., 2002. — 160 с.;Мальцев В. И. Независимые этичекие комитеты: регламент работы и за-дачи / В. И. Мальцев, Т. К. Ефимцева // Український медичний часопис. —2000. — 2 (16) — С. 48–51.; Пустовіт С. В. Біоетичні принципи та механіз-ми регулювання медико-біологічних досліджень / С. В. Пустовіт // Совре-менные проблемы токсикологи. — №4. — 2010. — С. 5–9.

Etychni komitety: stanovlennya, struktura, funktsiyi [Pid red. V. Kulinichenka,S. Vskovshyninoyi], K.: Vydavets, Karpenko V., 2002, 160 s.; Maltsev V., T. Efymt-seva, Nezavisimye étichekie komitety: reglament raboty i zadachi [in]: Ukrayinskiymedychnyy chasopys. — 2000. — 2 (16) — S. 48–51.; S. Pustovit, Bioetychnipryntsypy ta mekhanizmy rehulyuvannya medyko-biolohichnykh doslidzhen [in]:Sovremennye problemy toksikolohii, №4 2010, S. 5–9.

27.НАКАЗ МОЗ Про затвердження Порядку проведення клінічних випробуваньлікарських засобів та експертизи матеріалів клінічних випробувань і Типо-вого положення про комісії з питань етики [Електронний ресурс]. — Режимдоступу : http://zakon4.rada.gov.ua/laws/show/z1010-09; Наказ МОЗ ТИПО-ВЕ ПОЛОЖЕННЯ про комісію з питань етики [Електронний ресурс]. —Режим доступу: http://zakon4.rada.gov.ua/laws/show/z1462-12.

Nakaz MOZ Pro zatverdzhennya Poryadku provedennya klinichnykh vyprobuvanlikarskykh zasobiv ta ekspertyzy materialiv klinichnykh vyprobuvan i Typovohopolozhennya pro komisiyi z pytan etyky,http://zakon4.rada.gov.ua/laws/show/z1010-09; Nakaz MOZ Typove polozhennyapro komisiyu z pytan etyky http://zakon4.rada.gov.ua/laws/show/z1462-12.

Надійшла до редакції 19.04.2016 р.

Кашканова Н. Роль деонтологических норм в формировании законода-тельства, регулирующего порядок проведения медико-биологических иссле-дований с участием человека. Статья посвящена проблематике правового регули-рования медико-биологического эксперимента на людях. В частности автором рас-сматриваются факторы, обусловившие появление правового регулированияприменения медико-биологического эксперимента на людях, имеющих сложный ха-рактер и связаных с необходимостью обеспечения личных прав и свобод человека, на-целенные на недопущение их нарушения. Отдельно автором анализируется, отече-ственное законодательство Украины в сфере здравоохранения, которое на националь-ном уровне обеспечивает правовое регулирование отдельных вопросов проведениямедико-биологических экспериментов на людях. Автор делает выводы о необходимо-сти научного переосмысления особенностей договорного регулирования отношенийпри использовании медико-биологических экспериментов на людях и подчеркиваетнеобходимость выработки единых доктринальных подходов к совершенствованию законо-дательства Украины и приведения его в соответствие с международными правовымистандартами в сфере здравоохранения. Вместе с тем, автор обращает также вниманиена необходимость дальнейшего тщательного научного исследования особенности уго-

Н. Кашканова

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ловно-правовых отношений, возникающих в результате проведения таких экспери-ментов на людях.

Ключевые слова: права человека, биомедицинские исследования, клинические ис-пытания, лекарственные средства, информированное согласие, зарождения и станов-ления правового регулирования осуществления медико-биологического экспериментана людях

Kashkanova N. The role of deontological norms in formation of legislationregulating the procedure of medical and biological research involving humans

This article is devoted to the problems of legal regulation of medical and biological ex-periments on humans. In particular, the author examined the factors determined the ap-pearance of legal regulation of the use of medicobiological experiments on humans thathave a complex nature and related to the need to ensure individual rights and freedoms,aimed at preventing violations. Separately, the author analyzed the national legislation ofUkraine in the health sector, which on the national level provides legal regulation of cer-tain issues of medicobiological experiments on humans. The author made conclusionsabout the necessity of rethinking of the peculiarities of contractual regulation of relationsin the application of medicobiological experiments on humans, and emphasized the needto develop a unified doctrinal approach to improving the legislation of Ukraine and bringit in accordance with international legal standards in health care. At the same time, theauthor also noted the need for further comprehensive scientific research of the features ofcriminal and legal relations arising as a result of such experiments on humans.

Keywords: human rights, biomedical research, clinical trials, medical products, in-formed consent, appearance and formation of legal regulation, realization of medical andbiological experiments on humans

Н. Кашканова

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ISSN 2308-0361

Чомахашвілі О. Парламентські слухання в Україні: досвід та перспективи.В статті увага приділена вивченню теоретичної та нормативно-правової основи по-

рядку проведення парламентських слухань в Україні та окресленню межі обов’язко-вості; розглянуто практику проведення парламентських слухань в Україні на прикла-ді екологічної сфери та розглянути виконання прийнятих вказівок; проаналізованоситуацію сьогодення у сфері проведення парламентських слухань та сформульованопропозиції щодо розвитку цього питання. Пропонується розглядати парламентськіслухання не тільки як форму парламентського контролю, а і як спосіб зворотногозв’язку з об’єктом управління. Докладно розглянуто питання правових та організацій-них засад проведення парламентських слухань.

Досліджено теоретичну та нормативно-правову основу порядку проведення парла-ментських слухань в Україні. Автор наголошує, що положення про проведення парла-ментських слухань у Верховній Раді України не визначає наслідки неприйняття Вер-ховною Радою України Постанови щодо схвалення рекомендацій учасників слухань.Розглянувши практику проведення парламентських слухань на прикладі екологічноїсфери є очевидним, що більшість прийнятих вказівок не були виконані. Проаналізу-вавши ситуацію у сфері проведення парламентських слухань були сформульованітакі пропозиції щодо розвитку: створення належної нормативно-правової основи орга-нізації і проведення парламентських слухань, з метою повноцінного використання по-тенціалу контрольної функції парламенту; посилення інформування широкого загалусуспільства щодо змістовного наповнення парламентських слухань; залучення фахів-ців та експертів до участі у парламентських слуханнях з подальшим опублікуваннямїх виступів.

Ключові слова: проведення парламентських слухань, парламентський контроль,контрольна функція парламенту, екологічні права.

Оlena Chomahashvili, head of the commercial designations Department of industrial property of the IntellectualProperty Research Institute of the NALS of Ukraine, PhD in Law, associate professor

PARLIAMENTARY HEARINGS IN UKRAINE:THE EXPERIENCE AND PROSPECTS

ПОГЛЯД НАУКОВЦЯ

Parliamentary hearings are essentialfor the proper performance of the Verk-hovna Rada of Ukraine of its functions.They are held to examine issues of publicinterest and require legislative regula-tion. Parliamentary hearings influencethe planning bill works because their rec-ommendations are determined by legisla-tion to be developed and adopted for theregulation of certain spheres of social rela-tions. They also generally act as a guide-

line for design norm of the state becausetheir results are recommended to take notonly in laws but in other regulations.

Parliamentary hearings contribute tothe transparency of the parliament, assoon as they are conducted publicly andopenly with direct radio broadcast andtheir transcripts posted on the official web-site of the Verkhovna Rada of Ukraine. Inaddition, due to the active participation ofthe public they are effective means of dia-

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logue between the government and societyin whole.

At the same time the parliamentaryhearings require certain improvementsand implementation of the recommenda-tions [1, 5].

Parliamentary hearings are an inte-gral part of parliamentary government,they have a particular place and role inthe multifaceted activities of representa-tive bodies and held to examine issues ofpublic interest and require legal regula-tion at all [2].

The purpose of the research is to ana-lyze the current legislation of Ukraineand generalize the practice of parliamen-tary hearings to determine the legalbasis of positive changes, implementa-tion of the adopted recommendations;formulate the algorithm of necessary ac-tions to improve the dialogue betweenthe public and government.

We propose to consider parliamentaryhearings not only as a form of parliamen-tary control, but also as the way of feed-back control object [1, 97].

Parliamentary hearings held in Par-liament to examine issues of public inter-est and require legislative regulation.

Parliamentary hearings held duringthe session, usually not more than once amonth during the week, which is givenfor work within committees, fractions(parliamentary groups).

The proposal for parliamentary hear-ings shall be made on the basis of a deci-sion taken by corresponding with issuesin a draft resolution of the VerkhovnaRada, which has determined the themeof the parliamentary hearings and dateof the meeting. Only one thematic issuecan be offered for the discussion at theparliamentary hearings.

The issue of parliamentary hearingsis included in the agenda of the parlia-mentary session without a vote.

The decision on the subject, date andtime of the parliamentary hearings isadopted by the Parliament no later than30 days before the elections. In the deci-sion of the Verkhovna Rada of Ukraine is

also indicated a committee or committeesresponsible for preparation of parliamen-tary hearings.

The decision of parliamentary hear-ings of the Verkhovna Rada is publishedin the Voice of Ukraine within 10 daysafter the date of its adoption.

The proposals to hold parliamentaryhearings on the issues that have been thesubject of the Verkhovna Rada of the cur-rent convocation may be made no earlierthan one year after the previous parlia-mentary hearings in regard of the topic.

Many representatives are invited toparticipate in the hearings in the Parlia-ment. Among them are the representa-tives of public authorities, local govern-ments, political parties and other associ-ations, academic institutions, membersof the public who want to take part inparliamentary hearings and filed nolater than five days by the committeethat is preparing for hearings.

The committee, which is preparing tohold parliamentary hearings, makes alist of invitees for hearings, conductshearings and parliamentary order of per-formances of participants. The list of in-vitees for parliamentary hearings is sub-mitted for the approval to the Chairmanof Verkhovna Rada of Ukraine no laterthan three days before the elections.

Parliamentary hearings are conduct-ed publicly and openly with direct radioand, if necessary, TV broadcasting.

During the parliamentary hearingsthe Parliament during the plenary ses-sion adopts a resolution of VerkhovnaRada of Ukraine, which approves the rel-evant recommendations [2].

Legal regulation of the organizationand conduct of parliament and commit-tee hearings in Ukraine. Therefore, ourresearch highlights some of their results.An analysis of regulations on holdinghearings in committees of the VerkhovnaRada of Ukraine and the parliamentaryhearings in the Parliament of Ukrainefollows that order of hearings and ad hocspecial parliamentary commission re-mains unresolved.

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At the same time, the practice of tem-porary special commissions of the Verk-hovna Rada of Ukraine suggests thatsuch commissions are formed to prepareand review the most important laws (e.g.laws amending the Constitution ofUkraine). Taking into account, the Regu-lations on hearings in committees of theVerkhovna Rada of Ukraine should beextended to temporary special commis-sion regards the powers of commissionsfor the preparation and preliminary con-sideration of the bills.

In case if the status of investigationcommissions is irregular at law, the Par-liament should regulate the procedure ofsuch commissions at least by appropriateresolution that would have endorsed theRegulation on the hearings in the inves-tigation of the Verkhovna Rada ofUkraine.

The regulations on holding of parlia-mentary hearings in the Verkhovna Radaof Ukraine, providing mandatory involve-ment in hearings of representativesof state and local authorities, politicalparties and other associations, academicinstitutions, the public, do not specifythe criteria for «selection» of participantsmechanisms to ensure participation inhearings of representatives from all (or atleast most) stakeholders.

The Parliamentary hearings on as-signed role in the legislative process andimplementation of control powers strong-ly suggest norm Regulations on holdingof parliamentary hearings in the Verk-hovna Rada of Ukraine, according towhich hearings a draft decision on the re-sults of hearings shall be distributed tothe deputies the Verkhovna Rada ofUkraine beforehand.

In other words, a hearing conductedafter the result, approximately known inadvance, which eliminates the need forits conduct. The corresponding provi-sions deserve the critical evaluation.

As it was mentioned above, the lack oflegal regulation of the conduct of parlia-mentary and committee hearings is thefact that the persons concerned have ac-

tually deprived of the right to make pub-lic its position on issues that are dis-cussed at the hearings if they cannot be-cause of regulatory restrictions publicizethis position in his speech (speech) dur-ing the hearings.

This assertion is supported by the factthat under the provisions the burden ofpreparation of analytical materials forthe parliamentary hearings rests withthe Cabinet of Ministers and other exec-utive bodies and local authorities. Theapparatus of the Verkhovna Rada ofUkraine should be obliged to reproduceand distribute to the participants thehearings materials submitted by repre-sentatives of all stakeholders.

As the authors of the study say [3],critical assessment of merits and stan-dards of provisions under which MPs ma-terials prepared for parliamentary hear-ings, given 5 days before the hearing,and other participants in the hearing —on the day of their conduct during regis-tration. In this approach, the majority ofparticipants will not be able to fully ac-quaint with the contents of these materi-als, make comments and suggestionssubmitted for discussion. In their view,failing production of sufficient copies ofinformation and analytical materials, thelatter would be placed on the official web-site of the Supreme Council for 5 days be-fore the hearing so that the public hear-ings and participants could get acquaint-ed with them.

Below it is discussed the content ofthe recommendations of the parliamen-tary hearings and investigated their sta-tus of their implementation. Since thesubject of parliamentary control is thework of the Government, and not the en-tire system of executive power, the au-thor examined the content of the recom-mendations of the participants in thehearing only in the part that directly re-lates to the Cabinet of Ministers ofUkraine.

The authors did not aim to examineand analyze the performance of any andall recommendations of the seminar par-

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ticipants addressed the Cabinet of Minis-ters of Ukraine, limited only by clearly de-fined guidelines (e.g. for a defined norma-tive acts, drafting legislation, increase / de-crease in funding of certain programs etc.).

Such approach is due primarily to thefact that the lack of clearly definedguidelines makes virtually impossible tocontrol the completeness and timelinessof their implementation.

Also, the authors did not consider thecontent and results of the implementa-tion of the recommendations provided bythe Government taking certain organiza-tional and administrative measures.This is because the content of the in-structions of the Cabinet of Ministers ofUkraine.

The basic source of the study are thebills that were or are under considerationof the Verkhovna Rada of Ukraine, regu-lations of the Cabinet of Ministers, theVerkhovna Rada of Ukraine on the rec-ommendations of the parliamentaryhearings and for the information of theCabinet of Ministers heard during thedays of the Government in the Parlia-ment of Ukraine, laws of Ukraine (amongthem stands out separately by the Statebudget of Ukraine for the relevant years),speeches of representatives of the Gov-ernment during the Days of the Govern-ment in the Parliament of Ukraine, andother publicly available printed and elec-tronic sources of reliable information.

Failure execution / partial execution /failure of certain recommendations wereconsidered in this study, the authorsstarted from the following. Implementa-tion guidelines means its full implementa-tion in the prescribed recommendationterm (if the timing of the recommenda-tions provided, the implementation of rec-ommendations considered its performancewithin a reasonable time — that is one totwo years or until the next parliamentaryhearings on similar issues, starting fromthe date of adoption of the Resolution onguidelines implementation of which issubject to analysis). In partial fulfillmentof recommendations of the authors im-

plies its partial implementation (i.e. theextent narrower than foreseen recommen-dation) in the prescribed period or recom-mendation within reasonable time.

Under the guidelines author under-stands its failure to fully or failure with-in a fixed or reasonable time. As the re-sults of the monitoring results of imple-mentation of the recommendations of theparliamentary hearings the author foundthe main reasons for failure of guidelinesof developed proposals for improving theorganization and conduct of parliamen-tary hearings and monitoring their im-plementation. Parliamentary hearingson environmental issues «On compliancewith environmental legislation inUkraine, implementation areas and im-prove environmental policy» (29.11.2000)(On recommendations of parliamentaryhearings on compliance with environ-mental legislation in Ukraine, and direc-tions of improvement of environmentalpolicy (№ 2130-III of 07.12.2000).

The content of hearings and recom-mendations of participants of parliamen-tary hearings held on 29.11.2000 is a re-sult of discussion of the issue of compli-ance with the requirements ofenvironmental legislation in Ukraine andways of implementation and improve-ment of environmental policy. It was saidthat in recent years in Ukraine wereformed the foundations of environmentallaw, made structural reforms in the fieldof environment and natural resources,laid the foundations of a new environ-mental policy and mechanisms of its im-plementation. At the same time, the lackof a clear strategy for reforming society,inconsistency of reforms in the field of en-vironment and natural resources, uncoor-dinated and inconsistent actions of cen-tral and local executive authorities andlocal governments do not promote properefficiency and effectiveness of program el-ements. Basic directions of the state poli-cy in the field of the environment, naturalresources and environmental safety wereapproved by the Verkhovna Rada ofUkraine in March 1998.

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Financing of environmental programsand environmental protection measuresare inadequate. The inertia in imple-menting of market mechanisms of finan-cial support for environmental activitieshas led to the steady decline of invest-ments in this area. It is under-fundedprotection measures and sustainable

land use. There is the need of internal co-ordination and further improvement anddevelopment of existing environmentallegislation and economic mechanisms ofnature.

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Список використаних джерел / List of references

1. Parliamentary hearings — an important factor in improving national legislation:Proceedings of the Round Table / under the general editorship V. Zaichuk. — K. :Institute of Legislation of the Verkhovna Rada of Ukraine, 2012. — 269 p.

2. Regulations of the Verkhovna Rada of Ukraine [Electronic resource]. — Accessmode : http://zakon2.rada.gov.ua/laws/show/1861-17/paran22#n22.

3. [Electronic resource]. — Access mode : http: //parlament.org.ua/index.php? Action =publication & id = 8 & ar_id = 1081 & iar_id = 678 & as = 2.

4. Paliament [Electronic resource]. — Access mode : parlament.org.ua.5. The Law of Ukraine «On Committees of the Verkhovna Rada of Ukraine»

(Supreme Council of Ukraine, 1995, № 19, p. 134, 1998 r., № 40-41, p. 250, 2000,№ 12, Art. 96, № 13, p. 107).

Надійшла до редакції 27.05.2016 р.

Чомахашвили А. Парламентские слушания в Украине: опыт и перспек-тивы. В статье внимание уделено изучению теоретической и нормативно-правовой ос-новы порядка проведения парламентских слушаний в Украине и обрисовке пределовобязательности; рассмотрена практика проведения парламентских слушаний в Ук-раине на примере экологической сферы и рассмотреть выполнение принятых указа-ний; проанализирована ситуация в сфере проведения парламентских слушанийи сформулированы предложения по развитию этого вопроса. Предлагается рассматри-вать парламентские слушания не только как форму парламентского контроля, но икак способ обратной связи с объектом управления. Подробно рассмотрены вопросыправовых и организационных основ проведения парламентских слушаний.

Исследовано теоретическую и нормативно-правовую основу порядка проведенияпарламентских слушаний в Украине. Автор отмечает, что положение о проведении пар-ламентских слушаний в Верховной Раде Украины не определяет последствия неприня-тия Верховной Радой Украины Постановления об принятия рекомендаций участниковслушаний. Рассмотрев практику проведения парламентских слушаний на примере эко-логической сферы очевидно, что большинство принятых указаний не были выполнены.Проанализировав ситуацию в сфере проведения парламентских слушаний были сфор-мулированы следующие предложения по ее развитию: создание надлежащей норматив-но-правовой базы организации и проведения парламентских слушаний, с целью полно-ценного использования потенциала контрольной функции парламента; усиление ин-формирования широкой общественности общества по содержательному наполнению

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ПОГЛЯД НАУКОВЦЯ

парламентских слушаний; привлечение специалистов и экспертов к участию в парла-ментских слушаниях с последующим опубликованием их выступлений.

Ключевые слова: проведение парламентских слушаний, парламентский контроль,контрольная функция парламента, экологические права

Chomahashvili O. Parliamentary hearings in Ukraine: experience andprospects. In the article attention is paid to the theoretical and legal foundations of theorder of parliamentary hearings in Ukraine and outlining their mandatory limits. It isanalysed the practice of parliamentary hearings in Ukraine on the example of the environ-mental sector and consider the fulfillment of instructions; the today situation in parlia-mentary hearings and formulated the proposals for the development of this issue. It is pro-posed to consider the hearings not only as a form of parliamentary control, but also asa way of feedback of control object. Details analysis of legal and institutional frameworkof parliamentary hearings was made.

The theoretical and legal basis of the order of parliamentary hearings in Ukraine wasstudied. The author emphasizes that provision of parliamentary hearings in the Parlia-ment of Ukraine does not determine the consequences of the rejection of the VerkhovnaRada of Ukraine Resolution on approval of the recommendations of the seminar partici-pants. Having examined the practice of holding parliamentary hearings on the example ofthe environmental sphere is obvious that most of the taken steps were not met. After ana-lyzing the situation in the parliamentary hearings there were formulated following pro-posals for development of them: an appropriate regulatory basis for the organization andholding of the parliamentary hearings, in order to fully exploit the potential of the controlfunction of Parliament; strengthening of informing the public about the social content ofparliamentary hearings; involvement of specialists and experts to participate in the hear-ings, followed by the publication of their performances.

Key words: parliamentary hearings, parliamentary control, the control function of Par-liament, the environmental law

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Теорія і практика інтелектуальної власності � 3/2016 73

Вартість передплати на 2016 р. у грн

Індекс 2 міс. 4 міс. 6 міс. 12 міс.

Фізичні та юридичні

особи23594 35 70 105 210

2016 Subscription prices in UAH

Index 2 months 4 months 6 months 12 months

Idividuals and legal

bodies23594 35 70 105 210

Ø À Í Î Â Í ² × È Ò À × ² !

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74 Теорія і практика інтелектуальної власності � 3/2016

ДО ВІДОМА АВТОРІВ

Редакція приймає рукописи статей, що раніше не друкувалися, на електроннихносіях, набраних у програмі MS Word, обсягом до 12 сторінок (шрифт — Times NewRoman, розмір — 14, інтервал — 1,5).

Статті повинні відповідати вимогам ВАК України щодо наукових робіт, обов’язко-во мати рецензію й анотації російською та англійською мовами (з перекладом трьомамовами прізвища й імені автора і назви статті). Прохання до авторів: разом з матеріа-лами надсилати свою фотографію. Ілюстративний матеріал має бути у форматі .tifабо .jpg, розміром 300 dpi.

До статей дописувачів, які не мають наукового ступеня, обов’язково мають додава-тися: рецензія кандидата чи доктора наук відповідного фаху, витяг з протоколу засі-дання кафедри про рекомендацію статті до друку, засвідчені належним чином.

Стаття має містити такі відомості (з нового абзацу через один рядок):1) з лівого краю аркуша одним рядком — прізвище та повне ім’я автора (авторів)

українською мовою; науковий ступінь, вчене звання чи інша інформація, що стосу-ється наукової діяльності автора (-ів); назва установи, організації, де працює автор(автори);

2) з лівого краю аркуша вгорі — УДК;3) посередині наступного рядка — назва статті;4) з нового абзацу українською мовою анотація (3–4 речення); 5) з нового абзацу ключові слова (до 6 слів або словосполучень) українською мовою;6) текст статті;7) список літератури наводять згідно з ДСТУ 7.1:2006, оформлюють як прикінцеві

примітки, тобто у [ ], відповідно до вимог ВАК України за Формою 23.Усі цитати автор зобов’язаний звірити з першоджерелами. Список літератури на-

водять у порядку згадування в роботі (не потрібно робити текстових посилань у на-писаному, лише цифри у квадратних дужках (наприклад, [12, 43]);

8) після статті з нового абзацу — анотації: російською — прізвище та повне ім’я автора (авторів), назва статті, текст анотації

(3–4 речення), ключові слова (до 6 слів або словосполучень);англійською — прізвище та повне ім’я автора (авторів), назва статті, текст розши-

реної анотації (1–1,5 сторінки А4, 3–5 тис. знаків), ключові слова (до 6 слів або слово-сполучень);

якщо стаття написана іншою мовою (польською, іспанською тощо) — прізвищета повне ім’я автора (авторів), назва статті, текст анотації мовою статті (3–4 речення),ключові слова (до 6 слів або словосполучень);

10) інформація про автора (авторів).У файлі статті, на наступному аркуші подають відомості про автора (співавторів):• прізвище, ім’я та по батькові;• контактна інформація (номер телефону, електронна пошта, поштова адреса).Редакція лишає за собою право на редагування та скорочення рукописів. За досто-

вірність інформації та статистичних даних, які містяться в рукописах, відповідаль-ність несе автор. Редакція не завжди поділяє позицію авторів публікацій. Редакціятакож лишає за собою право повертати матеріали авторам для виправлення виявле-них помилок і доопрацювання, скорочувати та редагувати надані тексти. Статті, по-дані з порушенням вказаних вимог, не публікуються. Листування з дописувачамине ведеться.

Надіслані до редакції матеріали авторам не повертаються. Повторне видання ста-тей, розміщених на шпальтах журналу «Теорія і практика інтелектуальної власності»,можливе лише за згодою редакції.

Автор, який подав матеріали до друку, вважається таким, що погоджується на по-дальше безоплатне їх розміщення на сайті НДІ інтелектуальної власності та Націо-нальної бібліотеки України імені В. І. Вернадського.

Відтворення матеріалів журналу або їхніх частин будь-якими засобами чи в будь-якійформі, зокрема і в Інтернеті, забороняється без письмового дозволу редакції журналу.

Особисті немайнові права є невідчужуваними та належать авторам статей. Майно-ві права інших авторів належать цим авторам.

Більш детальна інформація на сайті — www.ndiiv.org.ua/ua/zhurnal-teorija-i-praktyka-intelektualnoji-vlasnoci.html

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ФОТОЗВІТ

75

Урочисте засідання Вченої ради НДІінтелектуальної власності НАПрН України,присвячене 15-тій річниці його заснування

16 червня 2016 р.

Ceremonial meeting of Scientific Councilof the Scientific and Research Institute of Intel-lectual Property of the NALS of Ukraine devotedto 15th anniversary of its foundation

June 16, 2016

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ФОТОЗВІТ

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