council of europe activities to fight counterfeit ... · operation proposals to the committee of...

Council of Europe activities to fight counterfeit/falsifieddi l d t & i il imedical products & similar crimes

MEDICRIME ConventionPractical measures & assistance

IX Encuentro de Autoridades Competentes en Medicamentos de los Países

Iberoamericanos (EAMI)“Desafíos Regulatorios de la Globalización y el

Acceso a Medicamentos de Calidad”o a d a o d a dadSantiago de Chile

26‐28 de Septiembre, 2012

Dr Sabine WALSER, EDQM (DBO)

OverviewO e e

• 1. Key points: MEDICRIME Conventioney po ts C Co e t o• 2. What are counterfeit medical products-

similar crimes?s a c es• 3. The problem is widespread...• 4 What is a Council of Europe Convention?4. What is a Council of Europe Convention?• 5. What is the purpose of the MEDICRIME

Convention?Convention?• 6. Why should counterfeiting medicines-

similar crimes be considered offences?similar crimes be considered offences? • .

OverviewO e e• 7. How does the MEDICRIME Convention ensure co-

operation between health-police-customs officials?operation between health police customs officials?• 8. Is the MEDICIME Convention globally

applicable? pp• 9. What about criminals abusing the internet?• 10. Follow-up and implementation? p p• 11. Context – what is the Council of Europe?• - Its role in criminal law ?Its role in criminal law ?• - The role of the European Directorate for the

Quality of Medicines & HealthCare (EDQM), Q y ( Q ),Council of Europe

1. Key points: MEDICRIME Conventioney po ts C Co e t o

First international treaty• criminalising: intentional- manufacturing of counterfeit medical products;g p ;- supplying, offering to supply and trafficking in

counterfeit medical products;- falsification of documents;- the unauthorised manufacture or supply of medicinal pp y

products or the marketing of medical devices that do not comply with conformity requirements(“ i il i ”)(“similar crimes”)

1. Key points: MEDICRIME Conventioney po ts C Co e t oProtects patients through preventing & combattingCounterfeiting of medicines & similar crimesCounterfeiting of medicines & similar crimes• Framework for national and international cooperation,• Global vocation – open for signature by all states

f• Measures for crime prevention involving also the private sector

• Active follow up of implementation: Committee of the p psignatory states (“parties”)

•• 28 October 2011: Opening for signature Moscow RUF• 28 October 2011: Opening for signature, Moscow, RUF • 20 September 2012-19 signatures: AR, AT, BE, CH,

CYP, DK, F, FIN, DE, ISR, ICE, IT, LUX, LIE, MD, PT RUF TRK UKR tifi dPT, RUF, TRK, UKR - ratified

2. What is a counterfeit medical product/similar crime?crime?

• Counterfeit medical product =f l t ti f d t id tit /• false representation of product identity/source (label) (Art 4)

• Similar crimes = (slide 4)Similar crimes = (slide 4)

• All types of medical products affected:• All types of medical products affected:• the Convention covers:• medicines for human & veterinary use, medical y

devices, active substances, excipients, components & accessories of medical devices, trial/study medicines.

• ExamplesExamples

2. What is a counterfeit medical product/similar crime?crime?

• Criminal BEHAVIOUR affecting: →• products protected under intellectual property rights +

generics + non-protected products

• Important:• Counterfeit = false (”...passing of as genuine...”)

without connotation of Intellectual Property Rightswithout connotation of Intellectual Property Rights (IPR)

• Protection medicinal PRODUCTS, human use, & DISTRIBUTION CHAIN from contamination with falsified medicinal products: ← EU Directive 2011/62 pon Falsified Medicines

The MEDICRIME Convention does NOT targete C Co e t o does O ta get• (legal) generic medical products authorised for marketing

by a competent authority (around the world)y p y ( )• IPR-holders can seek legal recourse via specific IPR

legislation.• breaches of quality norms, good practices/ standards in

the manufacture and distribution of medical products (non-intentional)(non intentional)

does NOT regulate:• production distribution of medical products & businesses• production, distribution of medical products & businesses

(e.g. internet pharmacies, brokers) where legal

3 . The problem is wide spread..... 3 e p ob e s de sp ead• Global threat for particularly vulnerable,

patients & health care system integritypatients, & health care system integrity• Linked to organised crime• generates substantial profit – low risk of interception –generates substantial profit low risk of interception

mild penalties• Abuse of the internet: not always obvious for users

whether e-pharmacies operate legally

• MEDICRIME Convention legal framework for world-wide fight against counterfeiting medical products/similar crimes

3 . The problem is wide spread..... 3 e p ob e s de sp ead

4 . What is a Council of Europe convention .... at s a Cou c o u ope co e t o• international criminal law treaty• binding for signatories• binding for signatories• follow-up of implementation• MEDICRIME Convention:• MEDICRIME Convention: • 47 of Council of Europe member states, observer

states states having negotiated can signstates, states having negotiated can sign

• any other state in the world i• any other state in the world can sign (invitation Committee of Ministers) & participate in international co-operation under the Convention. e a o a co ope a o u de e Co e o

5 . What is the purpose .... 5 at s t e pu pose

PREVENT and COMBAT medicrime• PREVENT and COMBAT medicrimethrough• criminalising offences,• protecting victims,p g ,• promoting national & international

cooperationcooperation

6 . Why is medicrime a criminal offence? 6 y s ed c e a c a o e ce• Genuine medical products: highly trained

professionals strict controls by public authorities –professionals, strict controls by public authorities ensuring best possible medication outcome.

• Counterfeit medical products/similar crimes: individuals or organisations quick profitcrimes: individuals or organisations - quick profit, risking health and undermining trust in authorities & healthcare systems.y

• Attack right to live (European Human Rights Convention)– withholding possible treatment to ) g ppatients

7 . How cooperation of officials ensured...? o coope at o o o c a s e su ed• Art 17 /Art 22 ....Legal minimum for states parties• NATIONAL: innovative concept: points of contactp p

within the national health, medicines reference laboratories, police and customs authorities

• → exchange of information & assistance in the operational g pmanagement of cases on a national level.

• INTERNATIONAL: Single points of contact (SPOCs)• INTERNATIONAL: Single points of contact (SPOCs) → trans-border co-operation with SPOCs from other countries (effective implementation/ follow-up Convention.

• Best practice: Model for a network between SPOCs (Council of Europe) (all countries encouraged to follow)

8 . Criminals abusing the internet.... 8 C a s abus g t e te et

• 50% of medicines purchased on internet• ....50% of medicines purchased on internet sites that conceal their real address are counterfeit (WHO)counterfeit. (WHO).

h f h f C• The use of the internet for MEDICRIME as an aggravating circumstance, raising the l l f i (A 13)level of sanctions (Art 13).

9. Global vocation of the MEDICRIME Convention.... • All states affected by counterfeiting of medical

products & similar crimes: production, transit, p p , ,market place

• → the Convention is open for participation by b b hnon-member states upon invitation by the

Committee of Ministers of the Council of Europe. Th i i l l t d d i• The criminal law concepts and measures used in the Convention are globally applicable.

• July 2012: Guinea invited to sign• July 2012: Guinea invited to sign• Morocco: June 2012 requested to be invited to

signsign

10. Context: The Council of Europe• Founded on 5 May 1949 by 10 states• Founded on 5 May 1949 by 10 states• International organisation based in Strasbourg (France)(France)

• Pan-European membership: 47 member states in Europein Europe

• Observer states: Holy See, United States, Canada, Japan MexicoJapan, Mexico

• Mr Thorbjorn Jagland, Secretary General since 1 October 2009 (Norwegian)October 2009 (Norwegian)

Human Rights DemocracyHuman Rights... Democracy... Rule of Law

Objectives:• to protect human rights, democracy and the rule of

law;• to promote awareness and encourage the development of• to promote awareness and encourage the development of

Europe's cultural identity and diversity; • to find common solutions to the challenges facingto find common solutions to the challenges facing

European society; • to consolidate democratic stability in Europe by backing

political, legislative and constitutional reform.

The Council of EuropeThe Council of EuropeNOT to get confused with…

• Distinct from the European Unionp• European Council: The EU's main decision-making

body. It defines the general political direction and y g ppriorities of the European Union.

E opean Union (EU) I ’ i i• European Union (EU): It’s a unique economic and political partnership between 27 European countries⇒ 498 million citizens⇒ 498 million citizens.

Role in the criminal law field….

• Since 1958.... activities in the field of crime prevention and crime control.

• The European Committee on Crime Problems (CDPC) → priorities for inter-governmental legal co-operation proposals to the Committee of Ministers onoperation, proposals to the Committee of Ministers on activities in the fields of criminal law and procedure, criminology and penology, gy p gy,

• - elaborates conventions, agreements, recommendations and reports

• - criminological research conferences and colloquia, and conferences of directors of prison administrations.

The EDQM E Di t t f thThe EDQM European Directorate for the Quality of Medicines & HealthCare (EDQM),

Council of Europe Directorate General of DemocracyVi iVision: leadership in protecting public health by:• enabling the development,

ti th i l t ti• supporting the implementation, • monitoring the application

of quality standards for safe medicines and their safeof quality standards for safe medicines and their safe use. Our standards are recognised as a scientific benchmark world-wide. The European Pharmacopoeia is legally binding in European Union member states.

Convention on the Elaboration of a European Pharmacopoeia i t ti l di i b t t & b.. international dimension: member states & observers

Current EDQM priorities promoting medicines quality & protection from medicrime ....medicrime ....

Medicines of insufficient quality?Pharmacopoeia Europaea standards p p

Counterfeiting of medical products and similar crimes (Medicrime)?(Medicrime)?risk management & prevention of medicrimeEuropean Network: Official Medicines Control Laboratories (OMCL) mass serialisation services (eTACT) to protect the legalmass-serialisation services (eTACT) to protect the legal production/distribution chain

support for the implementation of the MEDICRIME Convention Consumers’ unawareness of risks of buying medicines via unauthorised distribution channels & risk-taking behaviour? Recommendations for good practices for mail ordered medicines Models for consumer awareness campaigns, risk-communication, identification of signals of health damage

EDQM- Risk management & prevention of MedicrimeMedicrime

• Committee of Experts on minimising public health risks posed by counterfeiting of medical products & similarposed by counterfeiting of medical products & similar crimes

• Members: states parties of the Convention on the Elaboration of a European Pharmacopoeia

• Other Council of Europe member states; Consulting experts (hearings); Guest - experts

• Tasks: • 1. networking (health/law enforcement/Laboratory)• 2 risk management & prevention tools/approaches;• 2. risk management & prevention –tools/approaches; • 3. support for the implementation of national/international specific

legislation (MEDICRIME Convention)↨↨

• 4. training (for teams of health/law enforcement officials)

Committee of Experts on minimising public health risks posed by counterfeiting of medical products & similar

icrimes

• 1. Networking M d l N t k f SPOC f b ti t f iti f• Model: Network of SPOCs for combating counterfeiting of medical products and similar crimes involving threats to public health (2009 rev 2010)

Structure of the network

National SPOC (Coordination of the network of

International

Co-operation between national SPOCs

Co-operation with PRsfrom commercial and industrial sectors

(co-operation between all national SPOCs

SPOC for

Regulatory Authority (RA) medicianl products for human and veterinary use and medical devices. incl. Official Medicines Control Laboratories/Reference Laboratories

SPOC for

Customs

SPOC for

Police

Preferably: SPOC for

Justice

Competent Authorities for Medical Devices

1. Networking- Council of Europe Best practice Model g p p

• (3.) Purpose Thi d l ld id b i f t i i f i th i• This model could provide a basis for countries reinforcing their existing networks or establishing a new national SPOC network.…a multisectorial approach for detection, communication, investigation and prosecution. The lack of communication, information exchange and joint operational action between them gives the lead to the criminals, waste of time/ resources. g ,

• (5. Objective, procedures..)

• (6.) Profile and function of a SPOC within the national network and for international cooperationnetwork and for international cooperation

• ......

2. Risk management & prevention –tools/approaches

• A. Risk communication (models/publication)• Link: “Risk communication model” on: www edqm eu go to go to• Link: Risk communication model on: www.edqm.eu – go to go to

healthcare -How to minimise public health risks posed from counterfeit medical products/similar crimesmedical products/similar crimes “Risk communication-Medicrime”, 11/2011

• B. Identification of signals of health damage (pilot study/tool)• Tool identify, evaluate and report signals of health damage due to

counterfeit/falsified medical products and similar crimes at the time of / panamnesis

• C Inventory of experiences (analytical data) with confirmed• C. Inventory of experiences (analytical data) with confirmed cases of medicrime – OMCL network (database) –planned extension risk management information (other public administrations)

3. Support for the practical implementation of national/international MEDICRIME Conventionnational/international MEDICRIME Convention

• Council of Europe & Danish Health and Medicines Authority toCouncil of Europe & Danish Health and Medicines Authority to boost the fight against medicrime in Europe & other regions of the world International Conference 16 May 2012 in Copenhagen• International Conference, 16 May 2012 in Copenhagen

• …the conference adopted a structured approach supporting the implementation of the Council of Europe MEDICRIME Convention

• Step “O” identify co-operation partners• Step “1”: make an analysis• Step 1 : make an analysis• Step “2”: map next practical steps towards implementation….

• Link: www.edqm.eu – go to healthcare/Medicrime Convention

4. Training…. g

A vehicle for know-how-transfer, networking, practicing t l / h i f ti htools/approaches, information exchangeAim: ongoing training platform to support member states health & law enforcement authoritiesstates, health & law enforcement authoritiesApproach:

national teams of police customs & health authorities- national teams of police, customs & health authorities- evaluated & followed up by trainers’ board- train the trainers approach – national authorities to co-- train the trainers approach – national authorities to co-organise with training platform regional/local training- national authorities propose participantsp p p p- regular surveys of training needs & impact- beginners & advanced level training

4. Training g

Results: 2007 – on going 160 officials trained (Europe &Results: 2007 on going 160 officials trained (Europe & other regions) • 6 beginners training courses; 2 advanced level training g g ; g

courses• Lisbon 2010 regional training: teams of health &

enforcement officials from countries represented in the EAMIin preparation: specific training for SPOCs (December• in preparation: specific training for SPOCs (December 2012); beginners’ training for CIS (November 2012)

• Link: “Counterfeit medicines training” on:Link: Counterfeit medicines training on: www.edqm.eu – go to healthcare

CoE/EDQM anti-counterfeiting strategy: Protection of legal product and legal chainProtection of legal product and legal chain

Medicrime

Police, Customs & H lth MedicrimeHealth

authorities

Inspection

Testing

What is mass serialisation?

• Unique identifierhuman readablehuman readable machine readable

• Distinguishes items from each other

EDQM Traceability service -eTACT

PharmacyInternetMail-order

DistributionManufacture Patients

Generation of UMI = Unique Medicine

Mail-order

= Unique Medicine Identifier

VerificationVerification of UMITraceability &Traceability &Traceability &

Verificationof UMI

eTACT Why a Public Pan-European Governance Model (1)

• Confidentiality of data– Preventing conflict of intesrest between usersPreventing conflict of intesrest between users

and administrators of system• Regulatory bodies to be integratedg y g• Different national systems without pan-European

governance => lack of interoperability• Cost control

• phasing of implementation i f l• economies of scale

eTACT -Why a Public Pan-European Governance Model (2)

• Extensive EDQM ability to guarantee confidentiality

• Certification of Active Pharmaceutical Ingredients (APIs)(APIs)

• Preventing mass serialisation from being used for blurring g g gthe border between patient information and advertising

General overview of eTACT

Phase 3:Service

development

Phase 1:

2a: System development

2b:Workshops

Phase 1:Concept

development

Phase 2: Live demo2010 20122009-2010 2010 – 2012 From 2013

eTACT BenefitseTACT Benefits

Creates a harmonised approach• Inter-operable and flexible

P fid i li f dProtects confidentiality of data • Public governance

Allows patients to verify their medicines

eTACT- Medicrime (legal treaty) &- an instrument for authorities and stakeholders notably- an instrument for authorities and stakeholders, notably

patients, to verify the authenticity of a medicineare two important preconditions for effectively combating and p p y gpreventing counterfeiting of medical products.

The adoption of the MEDICRIME convention and EDQM‘s traceability project, eTACT, are significant contributions to this fightfight.

Current EDQM anti-counterfeiting priorities..... • pluriannual strategy 2012-2015• pluriannual strategy 2012-2015• Goals:• Safe access to human/veterinary medicines for• Safe access to human/veterinary medicines for

patients/consumers – empowered to avoid unsafe products• Support the implementation of the Medicrime Convention, pp p ,

focus on regulatory systems/procedures, interdisciplinary cooperation (e.g. SPOCs), drug enforcementK h f ffi i l li i M di i i i &• Know-how for officials – application Medicrime provisions & best practice models

• Value: value for states’ cooperation under Medicrime• Value: value for states cooperation under Medicrime, synergies in protecting the legal chain and combating crime, establishment of strong evidence base for best practices, experiences, new criminal trends, harm, impact evaluation

Thank you for your attention!Thank you for your attention!

More information:More information:www.coe.int

www edqm euwww.edqm.euwww.coe.int/medicrime

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