contents wma general assembly, –7 october 2007 · medical journal vol. 53 no. 3, september 2007...
TRANSCRIPT
WorldMMeeddiiccaall JJoouurrnnaall
Vol. No. 3, September 200753
OFFICIAL JOURNAL OF THE WORLD MEDICAL ASSOCIATION, INC.
G 20438
Contents
EEddiittoorriiaall 57
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MMeeddiiccaall EEtthhiiccss aanndd HHuummaann RRiigghhttss
The Ethics of Stem Cell Research 74
Ethics and Human Rights news 75
HIV and Human Rights Handbook 76
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FFuunnddaammeennttaallss iinn MMeeddiiccaall EEtthhiiccss 76
TToobbaaccccoo CCoonnttrrooll
Report on Progress made in the
Second Session of the Conference
of the Parties, WHO Framework
Convention on Tobacco Control,
Bangkok, Thailand, 30. June – 6. July 2007 77
WWHHOO
New world observatory launched with Spain 79
WHO launches ‘‘Nine patient safety solutions’’
to save lives and avoid harm 80
WHO and manufactorers move ahead
with plans for H5N1 influenza global
vaccine stockpile 81
WHO releases findings from research
project on travel and blood clots 81
Safe blood for mothers 82
Improved meningitis vaccine for Africa
could signal eventual end to deadly scourge 83
WMA General Assembly,
Copenhagen 3rd
–7th
October 2007
00_US_03_2007.qxd 19.09.2007 17:45 Seite 1
Website: http://www.wma.net
WMA Directory of National Member Medical Associations Officers and Council
Association and address/Officers
WMA OFFICERSOF NATIONAL MEMBER MEDICAL ASSOCIATIONS AND OFFICERS
i see page ii
President-Elect President Immediate Past-PresidentDr. J. Snaedal Dr. N. Arumagam Dr. Kgosi LetlapeIcelandic Medical Assn. Malaysian Medical Association The South African Medical AssociationHlidasmari 8 4th Floor MMA House P.O Box 74789 200 Kopavogur 124 Jalan Pahang Lynnwood Ridge 0040 Iceland 53000 Kuala Lumpur Pretoria 0153
Malaysia South Africa
Treasurer Chairman of Council Vice-Chairman of CouncilProf. Dr. Dr. h.c. J. D. Hoppe Dr. J. E. Hill Dr. K. IwasaBundesärztekammer American Medical Association Japan Medical AssociationHerbert-Lewin-Platz 1 515 North State Street 2-28-16 Honkomagome10623 Berlin Chicago, ILL 60610 Bunkyo-kuGermany USA Tokyo 113-8621
JapanSecretary GeneralDr. O. KloiberWorld Medical AssociationBP 63 01212 Ferney-Voltaire CedexFrance
ANDORRA SCol’legi Oficial de MetgesEdifici Plaza esc. BVerge del Pilar 5,4art. Despatx 11, Andorra La VellaTel: (376) 823 525/Fax: (376) 860 793E-mail: [email protected]: www.col-legidemetges.ad
ARGENTINA SConfederación Médica ArgentinaAv. Belgrano 1235Buenos Aires 1093Tel/Fax: (54-11) 4381-1548/4384-5036E-mail:[email protected]: www.comra.health.org.ar
AUSTRALIA EAustralian Medical AssociationP.O. Box 6090Kingston, ACT 2604Tel: (61-2) 6270-5460/Fax: -5499Website: www.ama.com.auE-mail: [email protected]
AUSTRIA EÖsterreichische Ärztekammer(Austrian Medical Chamber)
Weihburggasse 10-12 - P.O. Box 2131010 WienTel: (43-1) 51406-931/Fax: -933E-mail: [email protected]
REPUBLIC OF ARMENIA EArmenian Medical AssociationP.O. Box 143, Yerevan 375 010Tel: (3741) 53 58-68Fax: (3741) 53 48 79E-mail:[email protected]: www.armeda.am
AZERBAIJAN EAzerbaijan Medical Association5 Sona Velikham Str.AZE 370001, BakuTel: (994 50) 328 1888Fax: (994 12) 315 136E-mail: [email protected] / [email protected]
BAHAMAS EMedical Association of the BahamasJavon Medical CenterP.O. Box N999Nassau Tel: (1-242) 328 1857/Fax: 323 2980E-mail: [email protected]
BANGLADESH EBangladesh Medical AssociationBMA Bhaban 5/2 Topkhana RoadDhaka 1000Tel: (880) 2-9568714/9562527Fax: (880) 2-9566060/9568714E-mail: [email protected]
BELGIUM FAssociation Belge des SyndicatsMédicauxChaussée de Boondael 6, bte 41050 BruxellesTel: (32-2) 644-12 88/Fax: -1527E-mail: [email protected]: www.absym-bras.be
BOLIVIA SColegio Médico de BoliviaCalle Ayacucho 630TarijaFax: (591) 4663569E-mail: [email protected]: colegiomedicodebolivia.org.bo
BRAZIL EAssociaçao Médica BrasileiraR. Sao Carlos do Pinhal 324 – Bela VistaSao Paulo SP – CEP 01333-903
Tel: (55-11) 317868-00/Fax: -31E-mail: [email protected]: www.amb.org.br
BULGARIA EBulgarian Medical Association15, Acad. Ivan Geshov Blvd.1431 SofiaTel: (359-2) 954 -11 26/Fax:-1186E-mail: [email protected]: www.blsbg.com
CANADA ECanadian Medical AssociationP.O. Box 86501867 Alta Vista DriveOttawa, Ontario K1G 3Y6Tel: (1-613) 731 8610/Fax: -1779E-mail: [email protected]: www.cma.ca
CHILE SColegio Médico de ChileEsmeralda 678 - Casilla 639SantiagoTel: (56-2) 4277800Fax: (56-2) 6330940 / 6336732E-mail: [email protected]: www.colegiomedico.cl
Title page: The Rigshospitalet, Copenhagen founded as King Frederik’s Hospital in 1757 celebrates its 250 anniversary this year. It became the State Hospital in 1910 and is now integrated in the Copenhagen Hospital Corporation. With extensive resources and research activities it serves as the national specialist referral hospital for Denmark.
Below: The Headquarters of the Danish Medical Association which is hosting the General Assembly of the World Medical Association this year, has been located in this attractive building since 1948.
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CHINA EChinese Medical Association42 Dongsi XidajieBeijing 100710Tel: (86-10) 6524 9989Fax: (86-10) 6512 3754E-mail: [email protected]: www.chinamed.com.cn
COLOMBIA SFederación Médica ColombianaCarrera 7 N° 82-66, Oficinas 218/219Santafé de Bogotá, D.E.Tel/Fax: (57-1) 256 8050/256 8010E-mail: [email protected]
DEMOCRATIC REP. OF CONGO FOrdre des Médecins du ZaireB.P. 4922Kinshasa – GombeTel: (243-12) 24589 Fax (Présidente): (242) 8846574
COSTA RICA SUnión Médica NacionalApartado 5920-1000San JoséTel: (506) 290-5490Fax: (506) 231 7373E-mail: [email protected]
CROATIA ECroatian Medical AssociationSubiceva 910000 ZagrebTel: (385-1) 46 93 300Fax: (385-1) 46 55 066E-mail: [email protected]: www.hlk.hr/default.asp
CZECH REPUBLIC ECzech Medical AssociationJ.E. PurkyneSokolská 31 - P.O. Box 88120 26 Prague 2Tel: (420-2) 242 66 201-4 Fax: (420-2) 242 66 212 / 96 18 18 69E-mail: [email protected] Website: www.cls.cz
CUBA SColegio Médico Cubano LibreP.O. Box 141016717 Ponce de Leon BoulevardCoral Gables, FL 33114-1016United StatesTel: (1-305) 446 9902/445 1429Fax: (1-305) 4459310
DENMARK EDanish Medical Association9 Trondhjemsgade2100 Copenhagen 0Tel: (45) 35 44 -82 29/Fax:-8505E-mail: [email protected]: www.laegeforeningen.dk
DOMINICAN REPUBLIC SAsociación Médica DominicanaCalle Paseo de los MedicosEsquina Modesto Diaz Zona UniversitariaSanto DomingoTel: (1809) 533-4602/533-4686/533-8700Fax: (1809) 535 7337E-mail: [email protected]
ECUADOR SFederación Médica EcuatorianaV.M. Rendón 923 – 2 do.Piso Of. 201P.O. Box 09-01-9848GuayaquilTel/Fax: (593) 4 562569E-mail: [email protected]
EGYPT EEgyptian Medical Association„Dar El Hekmah“42, Kasr El-Eini StreetCairoTel: (20-2) 3543406
EL SALVADOR, C.A SColegio Médico de El SalvadorFinal Pasaje N° 10Colonia MiramonteSan SalvadorTel: (503) 260-1111, 260-1112Fax: -0324E-mail: [email protected]@hotmail.com
ESTONIA EEstonian Medical Association(EsMA)Pepleri 3251010 TartuTel/Fax (372) 7420429E-mail: [email protected]: www.arstideliit.ee
ETHIOPIA EEthiopian Medical AssociationP.O. Box 2179Addis AbabaTel: (251-1) 158174Fax: (251-1) 533742E-mail: [email protected] /[email protected]
FIJI ISLANDS EFiji Medical Association2nd Fl. Narsey’s Bldg, Renwick RoadG.P.O. Box 1116SuvaTel: (679) 315388/Fax: (679) 387671E-mail: [email protected]
FINLAND EFinnish Medical AssociationP.O. Box 4900501 HelsinkiTel: (358-9) 3930 91/Fax-794E-mail: [email protected]: www.medassoc.fi
FRANCE FAssociation Médicale Française180, Blvd. Haussmann 75389 Paris Cedex 08Tel/Fax: (33) 1 45 25 22 68
GEORGIA EGeorgian Medical Association7 Asatiani Street380077 TbilisiTel: (995 32) 398686 / Fax: -398083E-mail: [email protected]
GERMANY EBundesärztekammer (German Medical Association)Herbert-Lewin-Platz 110623 BerlinTel: (49-30) 400-456 369/Fax: -387E-mail: [email protected]: www.bundesaerztekammer.de
GHANA EGhana Medical AssociationP.O. Box 1596AccraTel: (233-21) 670-510/Fax: -511E-mail: [email protected]
HAITI, W.I. FAssociation Médicale Haitienne1ère Av. du Travail #33 – Bois VernaPort-au-PrinceTel: (509) 245-2060Fax: (509) 245-6323E-mail: [email protected]: www.amhhaiti.net
HONG KONG EHong Kong Medical Association, Chi-naDuke of Windsor Building, 5th Floor15 Hennessy RoadTel: (852) 2527-8285Fax: (852) 2865-0943E-mail: [email protected]: www.hkma.org
HUNGARY EAssociation of Hungarian MedicalSocieties (MOTESZ)Nádor u. 36 – PO.Box 1451443 BudapestTel: (36-1) 312 3807 – 311 6687Fax: (36-1) 383-7918E-mail: [email protected]: www.motesz.hu
ICELAND EIcelandic Medical AssociationHlidasmari 8200 KópavogurTel: (354) 8640478Fax: (354) 5644106E-mail: [email protected]
INDIA EIndian Medical AssociationIndraprastha MargNew Delhi 110 002Tel: (91-11) 23370009/23378819/23378680Fax: (91-11) 23379178/23379470E-mail: [email protected]
INDONESIA EIndonesian Medical AssociationJalan Dr Sam Ratulangie N° 29Jakarta 10350Tel: (62-21) 3150679Fax: (62-21) 390 0473/3154 091E-mail: [email protected]
IRELAND EIrish Medical Organisation10 Fitzwilliam PlaceDublin 2Tel: (353-1) 676-7273Fax: (353-1)6612758/6682168Website: www.imo.ie
ISRAEL EIsrael Medical Association2 Twin Towers, 35 Jabotinsky St.P.O. Box 3566, Ramat-Gan 52136Tel: (972-3) 6100444 / 424Fax: (972-3) 5751616 / 5753303E-mail: [email protected]: www.ima.org.il
JAPAN EJapan Medical Association2-28-16 Honkomagome, Bunkyo-ku
Tokyo 113-8621Tel: (81-3) 3946 2121/3942 6489Fax: (81-3) 3946 6295E-mail: [email protected]
KAZAKHSTAN FAssociation of Medical Doctors of Kazakhstan117/1 Kazybek bi St.,AlmatyTel: (3272) 62 -43 01 / -92 92Fax: -3606E-mail: [email protected]
REP. OF KOREA EKorean Medical Association302-75 Ichon 1-dong, Yongsan-guSeoul 140-721Tel: (82-2) 794 2474Fax: (82-2) 793 9190E-mail: [email protected] Website: www.kma.org
KUWAIT EKuwait Medical AssociationP.O. Box 1202 Safat 13013Tel: (965) 5333278, 5317971Fax: (965) 5333276E-mail: [email protected]
LATVIA ELatvian Physicians AssociationSkolas Str. 3Riga1010 LatviaTel: (371-7) 22 06 61; 22 06 57Fax: (371-7) 22 06 57E-mail: [email protected]
LIECHTENSTEIN ELiechtensteinischer ÄrztekammerPostfach 529490 VaduzTel: (423) 231-1690Fax: (423) 231-1691E-mail: [email protected]: www.aerzte-net.li
LITHUANIA ELithuanian Medical AssociationLiubarto Str. 22004 VilniusTel/Fax: (370-5) 2731400E-mail: [email protected]: www.lgs.lt
LUXEMBOURG FAssociation des Médecins etMédecins Dentistes du Grand-Duché de Luxembourg29, rue de Vianden2680 LuxembourgTel: (352) 44 40 331Fax: (352) 45 83 49E-mail: [email protected]: www.ammd.lu
MACEDONIA EMacedonian Medical AssociationDame Gruev St. 3P.O. Box 17491000 SkopjeTel/Fax: (389-91) 232577E-mail: [email protected]
MALAYSIA EMalaysian Medical Association4th Floor, MMA House124 Jalan Pahang53000 Kuala LumpurTel: (60-3) 40413740/40411375
Association and address/Officers
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Association and address/Officers
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Fax: (60-3) 40418187/40434444E-mail: [email protected]: http://www.mma.org.my
MALTA EMedical Association of MaltaThe Professional CentreSliema Road, Gzira GZR 06Tel: (356) 21312888Fax: (356) 21331713E-mail: [email protected]: www.mam.org.mt
MEXICO SColegio Medico de MexicoFenacomeHidalgo 1828 Pte. D-107Colonia Deportivo Obispado Monterrey, Nuevo LéonTel/Fax: (52-8) 348-41-55E-mail: [email protected]: www.cmm-fenacome.org
NAMIBIA EMedical Association of Namibia403 Maerua Park – POB 3369WindhoekTel: (264) 61 22 44 55/Fax: -48 26E-mail: [email protected]
NEPAL ENepal Medical AssociationSiddhi Sadan, Post Box 189Exhibition RoadKatmanduTel: (977 1) 4225860, 231825Fax: (977 1) 4225300E-mail: [email protected]
NETHERLANDS ERoyal Dutch Medical AssociationP.O. Box 200513502 LB UtrechtTel: (31-30) 28 23-267/Fax-318E-mail: [email protected]: www.knmg.nl
NEW ZEALAND ENew Zealand Medical AssociationP.O. Box 156Wellington 1 Tel: (64-4) 472-4741Fax: (64-4) 471 0838E-mail: [email protected]: www.nzma.org.nz
NIGERIA ENigerian Medical Association74, Adeniyi Jones Avenue IkejaP.O. Box 1108, MarinaLagosTel: (234-1) 480 1569, Fax: (234-1) 492 4179E-mail: [email protected]: www.nigeriannma.org
NORWAY ENorwegian Medical AssociationP.O.Box 1152 sentrum0107 OsloTel: (47) 23 10 -90 00/Fax: -9010E-mail: [email protected]: www.legeforeningen.no
PANAMA SAsociación Médica Nacionalde la República de PanamáApartado Postal 2020
Panamá 1Tel: (507) 263 7622 /263-7758Fax: (507) 223 1462Fax modem: (507) 223-5555E-mail: [email protected]
PERU SColegio Médico del PerúMalecón Armendáriz N° 791Miraflores, LimaTel: (51-1) 241 75 72Fax: (51-1) 242 3917E-mail: [email protected]: www.cmp.org.pe
PHILIPPINES EPhilippine Medical AssociationPMA Bldg, North AvenueQuezon CityTel: (63-2) 929-63 66/Fax: -6951E-mail: [email protected]: www.pma.com.ph
POLAND EPolish Medical AssociationAl. Ujazdowskie 24, 00-478 WarszawaTel/Fax: (48-22) 628 86 99
PORTUGAL EOrdem dos MédicosAv. Almirante Gago Coutinho, 1511749-084 LisbonTel: (351-21) 842 71 00/842 71 11Fax: (351-21) 842 71 99E-mail: [email protected]: www.ordemdosmedicos.pt
ROMANIA FRomanian Medical AssociationStr. Ionel Perlea, nr 10Sect. 1, BucarestTel: (40-1) 460 08 30Fax: (40-1) 312 13 57E-mail: [email protected]: ong.ro/ong/amr
RUSSIA ERussian Medical SocietyUdaltsova Street 85119607 Moscow Tel: (7-095)932-83-02E-mail: [email protected]: www.russmed.ru
SAMOA ESamoa Medical AssociationTupua Tamasese Meaole HospitalPrivate Bag – National Health ServicesApiaTel: (685) 778 5858E-mail: [email protected]
SINGAPORE ESingapore Medical AssociationAlumni Medical Centre, Level 22 College Road, 169850 SingaporeTel: (65) 6223 1264Fax: (65) 6224 7827E-Mail: [email protected]
SLOVAK REPUBLIC ESlovak Medical AssociationLegionarska 481322 BratislavaTel: (421-2) 554 24 015Fax: (421-2) 554 223 63E-mail: [email protected]
SLOVENIA ESlovenian Medical AssociationKomenskega 4, 61001 LjubljanaTel: (386-61) 323 469Fax: (386-61) 301 955
SOMALIA ESomali Medical Association14 Wardigley Road – POB 199MogadishuTel: (252-1) 595 599Fax: (252-1) 225 858E-mail: [email protected]
SOUTH AFRICA EThe South African Medical Associa-tionP.O. Box 74789, Lynnwood Rydge0040 PretoriaTel: (27-12) 481 2036/2063Fax: (27-12) 481 2100/2058E-mail: [email protected]: www.samedical.org
SPAIN SConsejo General de Colegios MédicosPlaza de las Cortes 11, Madrid 28014Tel: (34-91) 431 7780Fax: (34-91) 431 9620E-mail: [email protected]
SWEDEN ESwedish Medical Association(Villagatan 5)P.O. Box 5610, SE - 114 86 StockholmTel: (46-8) 790 33 00Fax: (46-8) 20 57 18E-mail: [email protected]: www.lakarforbundet.se
SWITZERLAND FFédération des Médecins SuissesElfenstrasse 18 – C.P. 1703000 Berne 15Tel: (41-31) 359 –1111/Fax: -1112E-mail: [email protected]: www.fmh.ch
TAIWAN ETaiwan Medical Association9F No 29 Sec1An-Ho RoadTaipeiTel: (886-2) 2752-7286Fax: (886-2) 2771-8392E-mail: [email protected]: www.med.assn.org.tw
THAILAND EMedical Association of Thailand2 Soi SoonvijaiNew Petchburi RoadBangkok 10320Tel: (66-2) 314 4333/318-8170Fax: (66-2) 314 6305E-mail: [email protected]: www.medassocthai.org
TUNISIA FConseil National de l’Ordredes Médecins de Tunisie16, rue de Touraine1002 Tunis Tel: (216-71) 792 736/799 041Fax: (216-71) 788 729E-mail: [email protected]
TURKEY ETurkish Medical AssociationGMK Bulvary
Sehit Danis Tunaligil Sok. N° 2 Kat 4Maltepe 06570AnkaraTel: (90-312) 231 –3179/Fax: -1952E-mail: [email protected]: www.ttb.org.tr
UGANDA EUganda Medical AssociationPlot 8, 41-43 circular rd.P.O. Box 29874 KampalaTel: (256) 41 32 1795Fax: (256) 41 34 5597E-mail: [email protected]
UNITED KINGDOM EBritish Medical AssociationBMA House, Tavistock Square London WC1H 9JPTel: (44-207) 387-4499Fax: (44- 207) 383-6710E-mail: [email protected] Website: www.bma.org.uk
UNITED STATES OF AMERICA EAmerican Medical Association515 North State StreetChicago, Illinois 60610Tel: (1-312) 464 5040Fax: (1-312) 464 5973Website: http://www.ama-assn.org
URUGUAY SSindicato Médico del UruguayBulevar Artigas 1515CP 11200 MontevideoTel: (598-2) 401 47 01Fax: (598-2) 409 16 03E-mail: [email protected]
VATICAN STATE FAssociazione Medica del VaticanoStato della Città del Vaticano 00120 Città del Vaticano Tel: (39-06) 69879300Fax: (39-06) 69883328E-mail: [email protected]
VENEZUELA SFederacion Médica VenezolanaAvenida OrinocoTorre Federacion Médica VenezolanaUrbanizacion Las MercedesCaracasTel: (58-2) 9934547Fax: (58-2) 9932890Website: www.saludfmv.orgE-mail: [email protected]
VIETNAM EVietnam Medical Association(VGAMP)68A Ba Trieu-StreetHoau Kiem DistrictHanoiTel/Fax: (84) 4 943 9323
ZIMBABWE EZimbabwe Medical AssociationP.O. Box 3671Harare Tel: (263-4) 791553Fax: (263-4) 791561E-mail: [email protected]
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OFFICIAL JOURNAL OFTHE WORLD MEDICAL
ASSOCIATION
Hon. Editor in ChiefDr. Alan J. Rowe
Haughley Grange, StowmarketSuffolk IP14 3QT
UK
Co-EditorsProf. Dr. med. Elmar Doppelfeld
Deutscher Ärzte-VerlagDieselstr. 2
D–50859 KölnGermany
Dr. Ivan M. Gillibrand19 Wimblehurst Court
Ashleigh RoadHorsham
West Sussex RH12 2AQUK
Business ManagersJ. Führer, D. Weber
50859 KölnDieselstraße 2
Germany
PublisherTHE WORLD MEDICAL
ASSOCIATION, INC.BP 63
01212 Ferney-Voltaire Cedex, France
Publishing HouseDeutscher Ärzte-Verlag GmbH, Dieselstr. 2, P. O. Box 40 02 65,
50832 Köln/Germany, Phone (0 22 34) 70 11-0,Fax (0 22 34) 70 11-2 55,
Postal Cheque Account: Köln 192 50-506, Bank: Commerzbank Köln No. 1 500 057,
Deutsche Apotheker- und Ärztebank,50670 Köln, No. 015 13330.
At present rate-card No. 3 a is valid.
The magazine is published quarterly.
Subscriptions will be accepted byDeutscher Ärzte-Verlag or the World
Medical Association.
Subscription fee € 22,80 per annum (incl. 7 %MwSt.). For members of the World MedicalAssociation and for Associate members thesubscription fee is settled by the membershipor associate payment. Details of AssociateMembership may be found at the WorldMedical Association website www.wma.net
Printed byDeutscher Ärzte-Verlag
Köln – Germany
ISSN: 0049-8122
The second half of the 20th century and the beginning of this one have experienced unprece-dented and ever increasing rapidity of technological development, scientific discovery,research and the production of innovative diagnostic tools and therapeutic agents. All havehad enormous impact on medical practice, some have posed major ethical problems and –not to be disregarded – increased public expectations of scientific discoveries and theirapplication in medicine, together with calls for, and the need of consequent changes in med-ical practice.
In parallel, the huge expansion in the availability and accessibility of information aboutmedicine, medicines and medical research through the growth of communication via themass media and IT development, has played a major role in changes taking place in theorganisation and the conduct of medical practice. At the same time it has also, through theinstant availability on information via the media (both TV and the web) supplied com-pelling information about the increasing instances of natural disasters and their conse-quences. The instant availability of information has also highlighted to a wider public theproblems of disparity in the provision of health care in differing parts of the world. Theimpact of information about the incidence of infectious diseases and the reality of the roleof poverty in disease, relayed through media readily accessible in the home, conveys aneven more realistic and compelling image of catastrophes, diseases and poverty, than thatpreviously available through the spoken or written word.
The impact of these developments has had substantial political, social and economic effectsin both developed and developing countries, leading to consequent changes in medicalpractice and its organisation, as well as challenges to the nature of the role of physicians inhealth care.
These developments have had far reaching impacts on the medical profession, includingeffects on basic medical education, postgraduate education, licensing and regulation, con-tinuing professional development and re-accreditation, not to mention the nature of healthcare and the delivery of medical care. All of this has been accompanied by the increasingburden of administrative, managerial functions and economic constraints.
On a number of occasions in these columns we have commented on these trends, the chal-lenges which they are producing and the increasing need for the medical profession toaddress them. Indeed, some of the issues have already been addressed in various parts ofthe world (1) (2), and a Charter (3) endorsed by a number of organisations in at least 28countries. (see annex to paper on Professionalism in this issue).
At its next meeting in October, the WMA Council will be considering these issues and withthis in mind , the current issue of WMJ is substantially devoted to a paper on the issue ofMedical Professionalism, in particular the role of the National Medical Associations. Aswill be seen, this paper highlights important problems which should be considered urgent-ly by individual physicians in whatever aspect of medical practice as well as NMA’s.
The inclusion of this substantial paper has substantial constraints on the normal contents ofthe journal which we will include in the next issue. While this topic has already beenaddressed in some parts of the world, we hope that it will stimulate further debate and con-tribute to a clear affirmation of the qualities of medical professionalism in the 21st century.
Alan J. Rowe
(1) Royal College of Physicians “Doctors’ in Society: Medical Professionalism in a changing World.Report of a Working Party of the Royal College of Physicians, London: RCP 2005 (2) Rosen R, DewarS., On being a doctor Medical Professionalism in a changing world Kings Fund Publications 2004 (3) Medical Professional Project. Medical Professionalism in the new millennium. A physician charter.Ann. Intern. Med 2002 136 (3) 243-246
Editorial
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“social contract” between medicine andsociety. In contrast, nearly no attention hasbeen given to a consideration of medicalprofessionalism from the point of view oforganized medicine (1), in particular theNational Medical Association (NMA).
The intent of this paper is to briefly reviewthe current literature and thinking on med-ical professionalism, to highlight some ofthe various roles played by different med-ical organizations, and to examine the inter-section between medical associations andprofessionalism. Finally, specific areas areproposed where representative medicalassociations might become involved in set-ting guidelines or developing policies inorder to assist the collective profession, andby extension its individual members, main-tain and enhance medical professionalismfor the benefit of patients and the professionalike.
Medical Professionalism:Where do we stand?
Over the past few years, several articleshave been published that have helped to re-focus the debate and discussion on medicalprofessionalism (2-8). The reason for thisrenewed interest generally varies by situa-tion and locality. Certainly in someinstances, it has been triggered by high-pro-file medico-legal cases involving physicianmisconduct or clinical misadventures and asubsequent public perception that thereexists a desire by the members of the pro-fession to “protect their own” in these situ-ations. In other cases, the technological rev-olution and resultant change in access tomedical information have caused physi-cians and others to re-examine the nature of
the physician-patient relationship and theinteractions between these two parties. Instill others, discussion has focused on theduty of physicians to society, and the needto establish an updated and modernized“social contract” between society and themedical profession.
While a simple definition of medical pro-fessionalism that satisfies everyone’srequirements does not appear to exist, forthe purposes of this document it will bedefined generally as follows:
Medical professionalism describes theskills, attitudes, values and behaviours com-mon to those undertaking the practice ofmedicine. It includes concepts such as themaintenance of competence for a uniquebody of knowledge and skill set, personalintegrity, altruism, adherence to ethicalcodes of conduct, accountability, a dedica-tion to self-regulation, and the exercise ofdiscretionary judgment. Professionalism isalso the moral understanding among med-ical practitioners that gives reality to what iscommonly referred to as the social contractbetween medicine and society. This contractin return grants the medical profession amonopoly over the use of its knowledgebase, the right to considerable autonomy inpractice and the privilege of self-regulation.
In February of 2002, the Annals of InternalMedicine published an article entitled“Medical Professionalism in the NewMillennium: A Physician Charter” (2) writ-ten by Canadian, European and Americanphysicians. This document has engenderedmuch discussion, and the reaction to theconcepts it proposes has been both positiveand negative. The essential premise of theCharter (2) is that professionalism is thebasis of medicine’s contract with society,which demands placing the interests ofpatients above those of the physician, set-ting and maintaining standards of compe-tency and integrity and providing expertadvice to society on matters of health. Itlays out 3 fundamental principles (primacyof patient welfare, patient autonomy andsocial justice) and 10 professional responsi-bilities (commitments to: professional com-petence, honesty with patients, patient con-fidentiality, maintaining appropriate rela-tions with patients, improving quality of
Professionalism and the Medical Association
Jeff Blackmer MD MHSc FRCPC
Executive Director, Office of Ethics, Canadian MedicalAssociation
Introduction
Medical professionalism, and an examina-tion of exactly what it means to be a profes-sional in today’s society, have received sig-nificant attention in the medical, scientificand lay press over the past few years. Theaccelerated development of medical andcommunication technologies, improve-ments in access to medical information forthe public and direct to consumer advertis-ing, have all changed the way in whichphysicians and their patients interact. Whileat times this change has been positive (forexample, through its empowerment ofpatients to make medical decisions on theirown behalf), at other times the impact hasbeen negative, with many physicians feel-ing pressured to prescribe medications ororder tests they might not have otherwisechosen.
In some locations, the very nature of themedical system itself forces physicians toassume an entrepreneurial role and encour-ages them to aggressively promote theirown medical services. These types of activ-ity may be seen as being incompatible withthe traditional role of the physician as analtruistic and selfless healer.
These changes and others have caused abroad re-examination of the nature andmeaning of medical professionalism, whatit means to be a physician in today’s societyand culture, and the dynamic of the doctor-patient relationship.
Traditionally, nearly all of the focus of thediscussion and debate in the literature onmedical professionalism has been centredon attempts at arriving at a definition of theconcept of professionalism, the particularobligations of individual physicians and the
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care, improving access to care, a just distri-bution of resources, scientific knowledge,managing conflicts of interest and profes-sional responsibilities including self-regula-tion).
While several bodies and organizationshave adopted this Charter (see Appendix 1for a complete list), others have been equal-ly quick to point out its shortcomings (9-10). However, few would be likely to arguethat it has not had a positive effect in renew-ing and reinvigorating the debate and dia-logue on the topic.
Recent developments in Britain are perhapsespecially illustrative of much of the pre-sent public and professional discourse onthis complex issue. They also serve to high-light the relatively large and diverse numberof relevant groups and stakeholders with aninterest in the issue, including physicianrepresentative bodies such as NationalMedical Associations. These developmentshave included, among others, the following:
- The King’s Fund published a discussionpaper in 2004 entitled “On being a doc-tor: Redefining medical professionalismfor better patient care” (11). This docu-ment argues that the medical professionas a whole needs to demonstrate betterits duty to serve patients’ interests inorder to show its ability to respond tochanging public expectations. It notesthat the “compact” between physicians,the health care system and patients haschanged since the inception of the NHSin 1948, and suggests that a new com-pact is required that will show a higherlevel of responsiveness to patient inter-ests and a focus on identifying profes-sional standards that are more in tunewith current values and expectations.
- Subsequently, the Royal College ofPhysicians published a working partyreport in December 2005 entitled“Doctors in society: Medical profession-alism in a changing world.” (12) The aimof this working party was “To define thenature and role of medical professional-ism in modern society”. They definemedical professionalism as a set of val-ues, behaviours and relationships thatunderpin the trust the public has in doc-tors. The values identified as being of
particular importance are integrity, com-passion, altruism, continuous improve-ment, excellence and working in partner-ship with other members of the healthcare team. They suggest that these valuesshould form the basis for a new moralcontract between the profession andsociety.
- In 2006, the British Department ofHealth released a report authored by theChief Medical Officer, Sir LiamDonaldson, entitled “Good doctors, saferpatients: Proposals to strengthen the sys-tem to assure and improve the perfor-mance of doctors and to protect the safe-ty of patients” (13). This report is aimedparticularly at the topic of regulation ofthe medical profession, which in Britainis performed under the auspices of theGeneral Medical Council (GMC). Itnotes that in the early 1990’s, a series ofhighly public medical scandals in theUnited Kingdom gave rise to mountingpublic concern.
The report itself was commissioned fol-lowing the fairly scathing report of theShipman Inquiry, chaired by Dame JanetSmith (14), which was extremely criticalof the GMC in arguing that its culture,membership, methods of operation andgovernance structures were too likely tosupport the interests of doctors ratherthan protect patients. The Donaldsonreport notes that the current global trendis a move away from pure self-regulationto regulation in partnership between theprofession and the public. The reportrecommends a regular assessment ofphysicians’ clinical skills, a reshaping ofthe role, structure and functions of theGMC and an extension of medical regu-lation to the local level to create astronger interface with the health caresystem.
For many in the medical profession, theDonaldson report represents much of thecurrent angst with respect to the poten-tial weakening or total loss of physicianself-regulation, which for the majority ofdoctors is one of the key pillars of med-ical professionalism. There appears to bea concerning trend in many parts of theworld whereby governments and others
are challenging and eroding the conceptof physician self-regulation (and indeedthe self-regulation of other professionsas well).
- The British Medical Association (BMA)released a report on “Regulation of themedical profession” in March 2007 (15).It is critical of both the Donaldson reportand the resulting government WhitePaper, “Trust, Assurance and Safety: Theregulation of health professionals in the21st century” (16) which was publishedin February 2007. The government doc-ument contains a series of proposals that,according to the BMA, would add up tothe loss of professionally-led medicalregulation. These proposals include:removal of the adjudication functionfrom the GMC, having GMC Councilmembers appointed rather than elected ,and a new composition of the GMCCouncil with 50:50 lay and medicalmembers. The BMA argues that with astate owned medical system (the NHS),and an appointed regulatory body, physi-cians might find themselves compro-mised in their ability to use their clinicalindependence to ensure optimal patientmanagement, thus diminishing theirmedical professionalism.
It is against this backdrop of recent publica-tions and events, and ongoing develop-ments in the United States, Europe, Canada,Australia, New Zealand, Hong Kong andelsewhere, that the roles of the various bod-ies and stakeholders in medicine and healthcare will be considered.
Organisational roles: Who does what?
The number and types of organisationsinvolved in educating, licensing, regulatingand representing physicians vary signifi-cantly depending on the individual countryor geographic region. In some locations, inspite of the obvious challenges and poten-tially significant conflicts of interest, thesame body or organisation assumes severalof these roles. In general, one or moreorganisations are involved in the followingareas of activity:
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1) Education: Educational standards andcurriculum setting are required forundergraduate medical education (i.e.medical schools) and postgraduate med-ical education (i.e. internship and resi-dency training). In some places the sameorganization will be involved in both,while in many places these roles are sep-arated. As well, many countries havebodies that oversee and accredit continu-ing medical education (CME) initiativesthat help to ensure that practicing physi-cians have access to educationalresources throughout the life cycle oftheir careers. Educational organizationsmay also administer examinations toensure the adequacy of the knowledgeand clinical skills of the physician-in-training, and may grant certificates ofgeneral or specialty designations on suc-cessful completion of the training pro-gramme and examinations.
2) Licensing: After physicians have com-pleted their training, most places requirethem to obtain a license for the practiceof medicine, usually within a specificfield or area of expertise. The require-ments for licensure (and training back-ground) may vary significantly by coun-try or region. In some situations, exten-sive testing and examination require-ments will also exist. In some countries,a separate license is required to practicein different parts of the country, with dif-ferent standards in each region and notransportability of licensure.
3) Regulation: The licensed, practicingphysician is generally held to a certainstandard that they must meet in an ongo-ing fashion in order to continue to prac-tice medicine. This standard, and theway in which it is enforced, may alsovary significantly. The specific bodyinvolved in regulation may also varyboth between and within countries
Traditionally, as for many of the “learnedprofessions”, physicians have been heldresponsible for professionally-led self-regulation, which many see as a privi-lege that must be continually earned. Inpractice, this requires physicians to formorganizations that will receive allega-tions of professional misconduct or clin-
ical negligence, investigate the com-plaints, render a judgement and impose apenalty. This activity and process is gen-erally separate from the legal or civil lit-igation systems of that country.
The rationale for self-regulation is thatphysicians, by virtue of their extensiveeducational requirements and theirunique grasp of a complex body of med-ical knowledge, obtained through yearsof training and experience, are felt to bein the best situation to be able to judgetheir peers.
The argument against self-regulation isthat it may be perceived as being overlyself-serving and that the majority of themembers of a profession will inherentlywant to “protect their own”, so thatphysicians who misbehave or under-per-form clinically will not be properly cen-sured or reprimanded by their peers. As aresult, many countries have developed asystem of regulation whereby lay mem-bers of the public participate actively inthe process. In almost all cases, thesepublic members make up a minority ofthe total membership of the regulatorybodies.
Many regulatory bodies have alsoassumed the role of ensuring that physi-cians remain up-to-date in their clinicalknowledge and skills. This “revalida-tion” activity varies significantly bycountry. In some situations, it is a matterof providing proof that a physician isparticipating in CME activities on a reg-ular basis, while in others the practicingphysician may be required to repeat in-depth testing and examination on a regu-lar basis in order to maintain theirlicense to practice. Where no evidenceexists to link the particular standard ofrevalidation to quality of patient care andoutcomes, this activity may understand-ably be of some concern to physicians.
4) Representation: In nearly every country,there exists an association or organiza-tion that represents the interests of physi-cians (as exists for most professions).Some countries may have one or morecompeting organizations of this type.Most commonly (although not always),this body takes the form of a National
Medical Association, whose name gen-erally consists of the name of the countryfollowed by the Medical Associationdesignation (for example, ChileanMedical Association, Indian MedicalAssociation, Russian MedicalAssociation and so on).
Some have argued that the roots of mod-ern representative medical associationsdate back to the formation of guilds inthe 12th and 13th centuries (17). Thefeatures of guilds at that time includedthe power of association and self-regula-tion (including training), control over themeans of production or workplace, con-trol of the market and power over rela-tions with the state. However, it may bemore accurate to say that today’s med-ical associations represent the concept offreedom of coalition that evolved fol-lowing Napoleon’s dissolution of theguilds and his introduction of a democra-tic system in the early 1800’s.
The type and degree of specific activityin today’s medical association can vary.In many instances, they provide specificbenefits to their members, including theability to connect with a network of theirpeers. In some countries, the NMA isinvolved in advocacy activities on behalfof its membership. This can include lob-bying governments for improved work-ing conditions and health care systemreform, and often includes lobbying onbehalf of patients to improve the leveland quality of the care they receive.
In other countries, the NMA also acts asa bargaining body for its membership sothat it negotiates contracts and fee struc-tures on their behalf. In some situations,the association may actually have anofficial “union” designation. OtherNMA’s have also assumed various edu-cational and regulatory roles.
Given the large number of roles undertakenby the NMA’s of some countries, it is notsurprising that conflicts occasionally arisein the course of their activities. For exam-ple, an association that is actively advocat-ing on behalf of its membership might notbe seen as being able to also assume a reg-ulatory role that requires it on occasion topublicly censure some of its members, or
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remove their license to practice medicine.In the case of those NMA’s that negotiatecontracts on behalf of their membership,some have questioned whether they canalso be legitimately involved in setting stan-dards of professional behaviour and codesof conduct.
The next section of this paper will explorethe intersection between medical profes-sionalism and the representative medicalassociation.
Professionalism and Medical Associations
The following quote probably best summa-rizes the concerns that most commonlyarise at the intersection of representativemedical associations and medical profes-sionalism (1):
“ Medicine is, in essence, a moral enter-prise, and its professional associationsshould therefore be built on ethicallysound foundations. At the very least,when physicians form associations, suchoccasions should promote the interestsof those they serve. This, sadly, has notalways been the case, when economic,commercial, and political agendas sooften take precedence over ethical oblig-ations. The history of professional med-ical associations reflects a constant ten-sion between self-interest and ethicalideals that has never been resolved.”
Most would agree that representing the eco-nomic, commercial and political interests ofphysicians and organized medicine as awhole is a legitimate and important under-taking, and likely one best done by a bodywith democratic representation of the pro-fession. In many cases (though certainly notall), this representation and the resultantadvocacy also serve to further the cause ofpatients and improve the care that theyreceive.
The greater concern arises when the actions(or inactions) of an NMA appear to serveonly their own self-interests. If individualphysicians have an obligation to put thecare of their patients above all else, shouldthis obligation extend as well to their repre-
sentative associations? If we are to say thataltruism and integrity are key values for themedical professional, are they by extensionkey values for the professional’s associationas well?
The argument has been made (1) that:
“…effacement of self-interest is the dis-tinguishing feature of a true professionthat sets it apart from other occupa-tions….When physicians form associa-tions, they should make this promise col-lectively…. Without such a commit-ment, they easily degenerate into self-serving trade associations, lobbies orunions….In a properly conceived pro-fessional association, physicians shouldassociate to improve the care of the sick,to advance the health of the public, andto ensure that their fellow associates arefaithful to that mission…Associationsshould be aware of the dangers offocussing attention on the economic con-cerns of their members at the expense oftheir more important public and profes-sional responsibilities.”
According to this argument, physician asso-ciations should make an active and consid-ered decision: to represent the vested inter-ests of their members, or of their patients,but in general probably not both, as theinterests of the two groups will too often bemutually exclusive.
All professions are represented in some wayby a body or organization that serves to fur-ther their particular needs and interests.Without this, that particular professionwould soon disappear from the horizon asmembers of other more organized and moreably represented professions, slowly (orrapidly) eroded its place in the social order.It is patently impossible to make the argu-ment that physicians do not require collec-tive representation. Like all other profes-sions, they will be legitimately concernedabout their work environment and safety,educational and promotional opportunities,salary levels, and all the other thingsemployed persons need to care about.
However, medicine is substantively differ-ent from most other professions, and thefundamental difference is its commitment
to the welfare of the individual patient, andthe tradition of placing the interests of thispatient above those of the medical practi-tioner. How can we reconcile these compet-ing principles? Can a medical associationserve both its members and the patients theycare for?
The 1991 President’s Address to the AnnualMeeting of the House of Delegates of theAmerican Medical Association (AMA) (18)by Dr. John Ring provides some direction inthis regard. The address states, inter alia:
“The new AMA has chosen the rightroad for medicine: the course of profes-sionalism, of patient advocacy, and ofpersonal sacrifice. It is the way of help-ing doctors be better doctors – not neces-sarily richer, not necessarily more pow-erful, not necessarily more authoritative– but better doctors…
The new AMA is a confluence of profes-sionals whose clear agenda is the healthof the American people. …We are a doc-tor’s organization, working for the goodof our patients, rather than a pressuregroup aiming for political power as away to build organizational predomi-nance, to create personal prestige, or toline our own pockets…
Professionalism is our very identity asdoctors. And the basic act of profession-alism is a doctor looking after a patient:the doctor-patient relationship. We canaccept nothing that threatens this rela-tionship by trying to turn medicine into amere trade, a dispassionate business ven-ture, an impersonal public utility.”
Dr. Ring goes on to describe a new AMAinitiative examining the issue of access tocare. Clearly, the interests of both patientsand physicians are served by improvingaccess to care. He uses this as a prototypicalexample of where the AMA should befocusing its efforts. From this, we under-stand that organized medicine has a legiti-mate claim at representing its own interests,and that this representation can and shouldbe done by a representative medical associ-ation. However, these interests, like those ofthe individual physician, should not super-sede or replace the interests of patients inthe collective.
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Perhaps the vision statement of theCanadian Medical Association (19) bestcaptures the preferred approach. In describ-ing its vision, it lists only two aims: “Ahealthy population and a vibrant medicalprofession.” The promotion of both idealscan and should coexist in the same repre-sentative medical association. But the rankordering of these priorities, which is clearlynot random, should not change.
The next section will examine specificissues and areas where medical associationscan set guidelines, policies and standards toadvance the professionalism of the associa-tion and its members while also striving toserve the best interests of patients and soci-ety.
Potential areas of activity
There are several potential areas where rep-resentative medical associations mightbecome actively involved in promoting andenhancing professionalism within the asso-ciation and for their membership. What fol-lows is a discussion of some of these areas,recognizing that others are likely to exist aswell.
1) Pandemic and disaster preparedness
Since the experience with the Severe AcuteRespiratory Syndrome (SARS) epidemic of2003, there has been much discussion in themedical literature regarding issues of pro-fessionalism and medical care during a cri-sis situation, be it pandemic or otherwise(20-23). Although it is generally acceptedthat physicians and other health care work-ers have a duty to provide care in such a sit-uation, several important questions havebeen raised as part of the broader discus-sion. These include:
- What exactly is the obligation of healthcare providers during a pandemic? Is itto provide care to all those in needregardless of the level of personal risk?
- Do physicians and others have a right torefuse to provide care when their ownhealth (or that of their family) is at risk?
- Is the provision of services during a pan-demic based in whole or in part on theobligation of governments and others to
provide reciprocal services to physi-cians? If this reciprocity is not honoured,are physicians then absolved of theirobligations?
Clearly, these are questions not easilyanswered. While some have argued thatphysicians and other health care workersappear to have an absolute obligation toprovide care regardless of the circum-stances in which they find themselves (24,25), others have argued that this obligationmay vary depending on the particular situa-tion and circumstances (26-28). There areclearly compelling arguments to be madeon both sides. The professional obligationsof physicians in this situation are also wellset out in various codes of ethics and regu-latory documents.
Traditionally, physicians have respected theprinciple of altruism, whereby, throughouthistory, they have set aside concern for theirown health and well-being in order to servetheir patients. While this has generally man-ifested itself primarily as long hours awayfrom home and family, and a benign neglectof personal health issues, at times moredrastic sacrifices have been required.During previous pandemics, physicianshave served selflessly in the public interest,often at great risk to their own well-being(although it should be noted that there arealso isolated historical exceptions of physi-cians who have fled from such situations;Galen and Sydenham both fled frompatients with contagious epidemic diseases)(29).
Since the experience of SARS, the conceptsof reciprocity and reciprocal obligationshave received significant attention fromphysicians and others both in and outside ofthe health care field. During this crisis,many health care workers found themselvesassuming great personal risk, sometimeswith very little support and assistance fromgovernments, hospitals, health districts andothers. Several physicians and nurses con-tracted the virus, and some of these died asa result. It has become increasingly clearthat more support will be expected duringthe next public health crisis, particularly indeveloped countries that have the necessaryresources to provide this support.
As the University of Toronto Joint Centrefor Bioethics report, “We stand on guard forthee” (30), states:
“(The substantive value of) reciprocityrequires that society support those whoface a disproportionate burden in pro-tecting the public good, and take steps tominimize burdens as much as possible.Measures to protect the public good arelikely to impose a disproportionate bur-den on health care workers, patients andtheir families.”
Some of these reciprocal obligations, whichshould be undertaken by governments, hos-pitals, and others, might include:
- Physicians and the associations that rep-resent them should be more involved inplanning and decision making at thelocal, national and international levels.In turn, physicians and the associationsthat represent them have an obligation toparticipate in these discussions.
- Physicians should be made aware of aclear plan for resource utilization,including:
- clearly defined physician roles andexpectations, especially for thosepracticing outside of their area ofexpertise;
- vaccination/treatment plans – clarifi-cation of whether health care workers(and their families) will have prefer-ential access based on the need tokeep caregivers healthy and on thejob;
- triage plans, including how the triagemodel might be altered and plans toinform the public of such.
- Physicians and health care providersshould have access to the best equipmentneeded and should be able to undergoextra training in its use if required.
- Physicians and health care providersshould have access to up-to-date, realtime information. They should be keptinformed about developments locallyand globally.
- Resources should be provided for back-up and relief of physicians and healthcare workers.
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- Physicians and health care providersshould receive financial compensation tocover expenses such as lost wages, lostgroup earnings, overhead, medical care,medications, rehabilitative therapy, andother relevant expenses in case of quar-antine, clinic cancellations or illness.
- Families should receive financial com-pensation in the case of a physician fam-ily member who dies as a result of pro-viding care during a health care crisis.
- Physicians should be given expandedliability coverage as required, particular-ly for those practicing outside of theirarea of expertise.
- Psychological and emotional counsellingand support should be provided in atimely fashion for physicians, health careproviders, their staff and family mem-bers.
It should be noted that meeting these recip-rocal obligations might not be possible inless developed countries which lack suffi-cient resources to do so. For example, incountries with few resources and poor infra-structure, even providing soap for all healthcare workers might be difficult. In this case,situational reciprocity must be ensured; thatis, health care workers should be providedwith whatever resources are available inorder to optimise patient care and the safetyof the workers.
What NMA’s can do on the issue of disasterand pandemic preparedness
National Medical Associations can developguidelines on disaster and pandemic pre-paredness that will specifically outline fortheir membership exactly what is expectedof them in such a situation, and what theirprofessional obligations entail. They canalso assist their members, and the public, byhelping ensure that governments, hospitalsand others understand and meet the recipro-cal obligations (as outlined above) that willbe critically important for ensuring the careand safety of patients and physicians alikeduring a pandemic or other public healthemergency.
2) Conscientious objection
In this context, conscientious objection is aterm generally used to refer to a situation
where a physician or other health careworker refuses to provide treatment or ther-apy on the grounds that such provisionwould violate their strongly held moralprinciples. The concept originated duringwartime tension between religious freedomand patriotic obligations (31) and was sub-sequently co-opted during the reproductiverights debates of the 1960 and ‘70s
The most common examples in the litera-ture and in day-to-day medical practice con-tinue to involve reproductive medicine:specifically, the provision of therapeuticabortion services and access to contracep-tive devices and medication. More recently,the issue of access to post-coital contracep-tion and abortifacient options has garneredmuch attention, from both the physician andpharmacist perspective, with reports ofpharmacists refusing to dispense emergencycontraception dating back to 1991 (32). Thepast several years have seen an increase inlegislative initiatives, particularly in theUnited States under the current Republicanadministration, designed to protect healthcare providers who refuse to participate inspecific reproductive procedures or prac-tices (33).
Other less common issues sometimesreferred to during a discussion of conscien-tious objection include euthanasia, physi-cian assisted suicide, assisted reproductivetechnologies, assistance during executionsand experimentation on human embryos(34).
A recent New England Journal of Medicinearticle has served to highlight the scope ofthe issue, at least in the United States (35).According to a survey of 1144 physicians,most physicians (63%) believe that it is eth-ically permissible for physicians to outlinetheir moral beliefs and objections to theirpatients. The majority (86%) also agree thatphysicians must present all options regard-ing specific therapies and treatments to theirpatients – which of course means that asizeable minority of 14% of physicians arenot providing all the information requiredby their patients. In addition, 71% of physi-cians feel that a doctor has an obligation torefer a patient to another clinician to obtaina service to which the referring physician ismorally opposed.
There are several possible advantages inallowing physicians to invoke the conceptof conscientious objection as a reason forrefusing to participate in certain proceduresor therapies. It allows the physician to staytrue to their morals and values; in general,society does not require professionals toforsake their morals upon entry into a par-ticular profession. It allows medical profes-sionals to exercise their independent judge-ment. And the right to refuse to participatein acts that conflict with personal, ethical,moral or religious convictions is generallyaccepted as an essential element of a freeand democratic society (33).
There are also several possible downsideswhen physicians invoke the right of consci-entious objection. This practice may limitaccess to care and consequently have adetrimental impact on the health of patients.It can serve to impose the values and per-sonal morals of the physician on the patient.It may be in direct opposition with theobligation of the physician to provide carewithout discrimination. Furthermore, pro-fessional autonomy is not without its limitsand the interests of the patients are general-ly held to take precedence over those of thephysician. Finally, the practice can intro-duce elements of inefficiency, inequity andinconsistency into a medical system (36).
While there are clearly arguments to bemade on both sides of the issue, someauthors have particularly strongly heldbeliefs. In a recent article in the BritishMedical Journal, Savulescu (36) claimsthat:
“A doctor’s conscience has little place inthe delivery of modern medical care.What should be provided is defined bythe law and consideration of the just dis-tribution of finite medical resources,which requires a reasonable conceptionof the patient’s good and the patient’sinformed desires. If people are not pre-pared to offer legally permitted, effi-cient, and beneficial care because it con-flicts with their values, they should notbe doctors.”
There seems to be general agreement in themedical and ethics literature, current Codesof Medical Ethics and legislative approach-es on several issues. First, it would appear
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that physicians and other health careproviders have at least a limited right torefuse to participate in certain procedures ortherapies if these are in opposition to theirvalues and beliefs. However, one needs todistinguish this right from the right to refuseto refer a patient to a clinician who will pro-vide these services. While there is somedebate about this issue, the majority of thecurrent literature, if not current policy andlegislation, appears to support the obliga-tion to refer (33, 36, 37, 38).
From the perspective of the NationalMedical Association, this issue wouldappear to provide fertile ground for policydevelopment and professional guidance.
What NMA’s can do on the issue of consci-entious objection
It is suggested that policy development inthis area should consider and address atleast 6 aspects of the issue:
1) The concept of conscientious objection,its history and its current use should becarefully and comprehensively outlined.
2) In general terms, there appears to beagreement that physicians have a right tostay true to their personal values andmorals and to exercise their independentprofessional judgement. They also havethe right to inform their patients of such,but not in a way that is unduly coerciveor argumentative.
3) Physicians should understand that theyshould not refuse to provide urgentlyneeded care by using the concept of con-scientious objection. A distinction mustbe made between an acute situationwhere immediate care is required to savea life or maintain health, as opposed to aless acute situation where there is timefor a patient to seek medical serviceselsewhere.
4) Physicians should not obstruct, activelyor passively, patients from receiving carefrom another clinician. Although healthprofessionals may have a right to object,they do not have a right to obstruct (33).
5) Physicians should provide their patientswith all the information they requireregardless of the personal values of thephysician. For patients to give valid
informed consent, they have to beinformed of the relevant alternatives andtheir risks and benefits in a reasonable,complete and unbiased way. This con-cept is one of the central tenets of mod-ern medical ethics and cannot be under-mined based on conscientious objection.
6) NMA’s should address the issue ofwhether or not the conscientious objec-tor has a duty to refer the patient toanother clinician for services the objec-tor will not provide. Clearly wordedguidance in this area will be of benefit topatients and physicians alike.
While some NMA’s may elect to includethis information within the context of arelated policy (for example, a policy ontherapeutic abortion), because the conceptof conscientious objection can apply in sev-eral different types of clinical situations, itis suggested that it is preferable to developa separate policy that can be used in multi-ple circumstances.
3) Self-regulation
The general concept of self-regulation hasbeen outlined above in the section on orga-nizational roles. In some parts of the world,the term “self-governance” is used inter-changeably with self-regulation, while inother areas the regulatory function is felt tobe one part of the overall governance func-tion. For ease of understanding, the term“self-regulation” will be used in this docu-ment.
It is fair to say that the vast majority of rep-resentative medical associations, if not allof them, support and encourage the conceptof self-regulation of the medical profession.From a physician standpoint, it would notbe advantageous to have their actions orclinical decisions evaluated by lay peopleand members of the public who are not like-ly to have the necessary training or experi-ence to make those judgements. In addition,this is an area where individual physicianscan demonstrate their collective sense ofresponsibility rather than through some-times abstract principles or declarations.
From the standpoint of the general public,they need to have confidence that the regu-
lation of physicians is fair, open and trans-parent and that physicians are held liable forany clinical or professional transgressionsin a significant and meaningful way so thatsuch transgressions will not be repeated inthe future. They need to be confident thatself-regulation does not mean self-protec-tion. Some degree of public involvement inregulatory bodies is now generally wellaccepted, but physicians usually becomeconcerned when consideration is given tohaving these organizations constituted witha public majority, meaning that decisionmaking will then be outside the control ofthe profession.
According to the website of the College ofPhysicians and Surgeons of Ontario (39),the self-regulatory body for physicianspracticing in this Canadian province, therelationship between the College, the pro-fession and the public is as follows:
“The College of Physicians andSurgeons of Ontario governs the practiceof medicine in the public interest. It doesnot exist to protect the medical profes-sion. The profession’s interests are wellrepresented by other bodies, includingthe Canadian Medical Association.
The medical profession has been permit-ted by legislation to play a leading role inthe protection of the public. It does thisthrough the College. This is what ismeant by „self-regulation.“ Self-regula-tion should never be confused with pro-fessional autonomy. The profession,through the College, is always account-able to the public.”
It is not uncommon for there to be a some-what strained relationship between repre-sentative medical associations and thoseorganizations involved in physician self-regulation. While the public may see regu-latory bodies as occasionally overly protec-tive of physicians and not always acting inthe best interests of the public, some physi-cians find them unnecessarily intrusive,interventionist and restrictive when itcomes to regulating the day-to-day practiceof medicine. However, in order to preservethe privilege of self-regulation, the medicalprofession must be clearly seen to be actingin the best interests of the public and not ofthe profession itself.
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The concept of self-regulation of the med-ical profession presents a situation whererepresentative medical associations mayfind themselves with a choice to make,between representing the desire of theirmembership for more freedom to practicemedicine in a fully autonomous way withlittle “unnecessary” regulatory intrusion,versus supporting the public desire tostrengthen the regulatory oversight ofphysicians and increase the transparency ofthe system. As suggested previously, andfor reasons outlined above, the interests ofthe public and patients should take prece-dence in this type of situation.
What NMA’s can do on the issue of self-regulation
This does not mean that NMA’s shouldacquiesce to any and all demands of regula-tors and the public. It does mean that theyshould support, through policy, advocacyand action, legitimate efforts to improve thequality of medical care and outcomesthrough regulatory oversight of their physi-cian members.
Unduly intrusive activities that have notbeen shown to improve the quality ofpatient care are not necessarily appropriate.Efforts at revalidation of physicians shouldnot simply be exercises intended to reassurethe public and legislators, but should trulystrive to improve the quality of medicalpractice, and should be based on solid evi-dence demonstrating that the means usedwill be efficient and effective. It may be upto NMA’s to help ensure that this evidenceexists and is incorporated in a meaningfulway.
NMA’s should develop policy or positionstatements clarifying their support for self-regulation and outlining the importance ofthis concept to the maintenance of medicalprofessionalism. They should assist theirmembers in understanding that self-regula-tion cannot be perceived as being protectiveof physicians, but must maintain the sup-port and confidence of the general public.
4) Interactions between physicians andindustry
Perhaps nowhere in medicine today is thepotential for conflict of interest greater thanin the interaction between physicians and
private industry. These industries caninclude pharmaceutical companies, medicaldevice manufacturers and makers of otherproducts like baby formulas. In short, anyprivate interest whose income generationdepends on physician prescription orapproval of their product.
From a business standpoint, the model isfairly simple. In most businesses, the prod-uct is marketed directly to the publicthrough means such as advertising andword of mouth campaigns. However, inmedicine, the companies must go throughthe “middle man”, the physician. The physi-cian must prescribe a product, usually amedication, which is then purchased by theconsumer, their patients. Sound and accept-ed business practice means that the compa-nies will mount marketing and advertisingcampaigns to influence physician prescrib-ing patterns in favour of their company,thereby increasing their income and marketshare.
The pharmaceutical industry has tradition-ally denied that they attempt to influencephysician prescribing behaviour, insteadinsisting that their marketing efforts aresimply intended to educate physicians onnew products in order to ensure that theirprescribing choices are well-informed andbased on the latest available scientific liter-ature. However, there is now much evi-dence to the contrary.
To start with, the information presented tophysicians is usually extremely biased,often inaccurate, and intended to portray thetarget product in a favourable light. ASpanish study revealed that 44.5% of theinformation provided by pharmaceuticalrepresentatives to family physicians is fac-tually erroneous and is biased towards theirown products (40). An Argentinean study(41) concluded that 46% of referencesgiven in literature distributed by industryrepresentatives did not concur with theclaims made in the company’s literature. AGerman study (42) found that 94% of theinformation in brochures for doctors had nobasis in scientific evidence; while manybrochures had cited publications that couldnot be found, the majority of informationfound in them did not accurately reflect thepublications that they cited.
This mounting body of evidence hardlysupports the industry argument that physi-cian education is the true intent of its infor-mation dissemination. Clearly the purposeis instead to provide information in such away that physicians will view the product ina more favourable light and be more likelyto prescribe it to their patients.
Secondly, a significant number of formerpharmaceutical representatives and industryinsiders have recently come forward toreveal the internal machinations of the busi-ness. One states: “An unofficial, and moreaccurate, job description for a sales repwould be: Change the prescribing habits ofphysicians.” (43). Another says: “It is myjob to figure out what a physician’s priceis…everything is for sale and everything isan exchange” and “It’s my job to constantlysway the doctors. Doctors are neithertrained nor paid to negotiate. Most of thetime they don’t even realize that’s whatthey’re doing.” Perhaps most concerning,this same former representative (43) wenton to write:
“The concept that reps provide necessaryservices to physicians and patients is afiction. Pharmaceutical companies spendbillions of dollars annually to ensure thatphysicians most susceptible to marketingprescribe the most expensive, most pro-moted drugs to the most people possible.If detailing were an educational service,it would be provided to all physicians,not just those who affect market share.Every piece of information provided iscarefully crafted, not to assist doctors orpatients, but to increase market share fortargeted drugs.”
Finally, an increasing number of studies arerevealing that pharmaceutical marketingdoes impact physician prescribing habits(44-48). The old argument that “it just does-n’t affect me” does not hold water anymore,nor does the assertion that “It may influencemy colleagues, but it does not influenceme”.
Given the current lack of public funding forCME events and medical research, and theresulting reliance of these important activi-ties on private industry funding, mostphysicians seem to be in agreement thatbanning all forms of contact between physi-
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cians and industry is not feasible or perhapseven desirable. However, there is clearly aneed to develop policies and guidelines inthis area to help regulate the relationship inorder to avoid the appearance or presence ofreal or perceived conflicts of interest.
The bodies setting these policies can varyand may include some or all of the follow-ing:- government and legislators, medicalregulators, physician representative associ-ations, medical specialty groups, and theindustry itself. The argument is made herethat these policies should be developed andled by the profession, should be clear andtransparent and should ensure that anyinteractions taking place between physi-cians and industry will be only for the clearbenefit of patients, not of for physicians orindustry.
What NMA’s can do on the issue of interac-tions between physicians and industry
National medical associations can andshould develop clear and comprehensivepolicy in this area to ensure that their mem-bers do not find themselves in a position ofconflict of interest. They should widely dis-tribute these policies to their membershipand others, and undertake educational ini-tiatives to clarify their importance, intentand content. They should use their advoca-cy capabilities to help ensure that thesephysician-led guidelines become theaccepted standard for all the other partici-pants involved, including industry.
At a minimum, these guidelines shouldaddress the following topics:
- a clear explanation of the issue and theconcept of conflicts of interest
- gifts to physicians, including social sci-ence literature on gift giving
- drug samples and their impact on pre-scribing behaviour and drug costs
- educational and promotional materialsaimed at physicians
- CME events (including electronically-delivered CME) and sponsorship,including physician payment for partici-pation
- physician participation and patient enrol-ment in industry-sponsored research tri-
als, including physician payment for par-ticipation
- disclosure obligations for physicianssubmitting research or providing educa-tional sessions
- physician participation as medical advi-sors or on advisory boards, and the dis-tinction between these activities andmarketing
-peer selling and direct physician promotionof individual products or companies
- how medical students and residentsshould approach the issue
Those NMA’s without sufficient resourcesto develop their own policy in this area maywish to adopt the policy of other NMA’s orof the World Medical Association (49).
Physician representative associationsshould also give careful consideration todeveloping stringent internal policy forgoverning relationships between the organi-zation and third parties. This will serve toset an example for the membership andensure that the association itself is able toavoid situations of conflict of interest (a les-son learned painfully by the AmericanMedical Association during a brief sponsor-ship deal with Sunbeam in the 1990’s).
5) Interprofessionalism
Traditionally, and until relatively recently,health care had been delivered in what canbest be described as a multidisciplinarymodel of teamwork. In this model, eachmember of the health care team fulfilled acertain well-defined and predetermined rolewith little or no overlap between the activi-ties of the team members. Ultimate deci-sion-making authority rested nearly alwayswith the physician.
More recently, this model has evolved intoone of interdisciplinary team care (or “inter-professionalism”) whereby the members ofthe team work collaboratively together tohelp ensure optimum patient care and out-comes. In this model, there may be someoverlap between the roles and responsibili-ties of the team members, based on what isin the best interests of the individual patientat that particular point in time. For example,
a speech and language pathologist mightprescribe a specific dysphagia diet based ontheir clinical assessment, or a pharmacistmight renew a prescription without consult-ing the physician. Unfortunately, studieshave shown that even in this model the pro-vision of health services is still oftenfraught with interprofessional conflict, dis-sension and misunderstandings (50).
In the current context of limited healthhuman resources, and particularly limitedphysician resources, it makes inherent senseto take full advantage of the abilities of eachmember of the health care team. Thesemembers can include, but are not limited to,physicians, physician assistants, nurses,nurse practitioners, pharmacists, occupa-tional and physical therapists, psycholo-gists, speech and language pathologists,social workers and dieticians.
In general terms, the move towards inter-professionalism has particularly impactedon the role and responsibilities of the physi-cian, as many of the expanded roles of teammembers have been into areas traditionallyoccupied by the physician on the team.While physicians have by and large accept-ed and sometimes actively embraced suchchanges, particularly where they have beenshown to impact positively on patient careand outcomes (although it should be notedthat such an impact has not been conclu-sively proven) (51), they have also shownwell-placed concern when warranted.Although physicians have been often criti-cized as “defending their turf” or beingunwilling to relinquish complete controlover patient care, there are justifiable rea-sons to approach interprofessionalism withcaution. It should also be noted that theassumption of traditional physician dutiesby other professions is not a new concept,as witnessed by the undertaking of surgeryby barbers and the medical treatment ofpatients by apothecaries.
It is at times unclear as to who has ultimateresponsibility for patient care. If everyoneis responsible, then no one is truly responsi-ble. In addition, when physicians providedirect medical care and there is a mishap,then medico-legal liability, once estab-lished, is usually fairly straightforward. Inan interprofessional model of care, the
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physician may not be constantly aware ofservices or recommendations being provid-ed by other team members, yet the patientand their lawyers may expect the physicianto assume ultimate liability for this care ifharm occurs. Where individual liabilityends and group liability begins might notalways be clear.
Different professions may have differentCodes of Ethics with different values, stan-dards and priorities. As a recent example,while the American Psychiatric Association(52) has clearly stated that sharing clinicalknowledge for the purpose of using thisinformation to torture or gain admissionsfrom terrorism suspects is unprofessionaland unacceptable behaviour, the AmericanPsychological Association has elected notto take this stance (53, 54). When compet-ing principles of various team membersoccur during patient care, how are we todetermine which one will win out?
There are professional divisions based ondemographics, gender composition, class oforigin of members, educational attainment,status and relative size and source of prima-ry income; these have all been cited asobstacles to the development of interdisci-plinary collaboration in the health field(51). Medicine is a long-established andfairly large profession whose memberscome mostly from a well-educated, small,upper class and earn a high income. Thus, itis argued that:
“The raw power of medicine, combinedwith a high degree of professional self-confidence developed by doctors andconsciousness of these differences inprestige among other occupationalgroups, contributes to a degree of mutu-al wariness and defensiveness as eachoccupation attempts to defend its ownterritory. For most of the twentieth cen-tury the health division of labour hasbeen organised and hierarchically struc-tured around the dominant profession ofmedicine. However, over recent decadesmedicine’s claims to autonomy anddominance have been increasingly chal-lenged by non-medical groups.” (51)
Interdisciplinary relationships are also oftenpolitical. Different occupational groupsattempt to establish clear professional
demarcations and demand that their exper-tise be recognized. They construct their owndistinct codes and standards and advancewhat they deem to be their own ethical the-ories (for example, “medical ethics” versus“nursing ethics”) (55).
Different professions may use differentstandards to judge the acuity of a case or sit-uation. When other professionals then applytheir own frames of reference to make senseof a situation, they may differ intensely overthe priority the case is assigned (51). Thismay be a source of significant conflictamongst team members.
Professional differences may also havebeen reinforced by various court decisions.For example, decisions by the Englishcourts in the early twentieth century empha-sized the responsibility of medical practi-tioners and the subservient nature of nurses(56). Although more recent court decisionshave not been quite as harsh, there are thosewho feel that the earlier approach still hassome influence on attitudes to the responsi-bilities of those offering care to patients(51).
Unfortunately, relationships between healthcare professionals remain fraught withorganizational, status and value differences(55). An Australian survey of hospitaladmissions reported that problems with pro-fessional interactions were the most com-mon cause of preventable disability or deathin the intensive care unit, and were twice ascommon as those due to poor medical skill(57).
There is a significant body of work on thetopic of interprofessional education andtraining at the medical school and under-graduate level (58 - 61) but relatively littleguidance when it comes to educating post-graduate trainees or practicing physicians.While tomorrow’s physicians may be wellequipped to work in collaborative practicemodels, today’s physicians may requireextra guidance and training in this area, asmany of the skills and concepts required arenot necessarily inherently known.
What NMA’s can do on the issue of inter-professionalism
In spite of the many challenges of interpro-fessionalism and interdisciplinary models
of care, it is clearly a concept that is becom-ing firmly entrenched in today’s patient caresettings. In order to optimise patient careand outcomes, physicians must be able towork collaboratively with a wide variety ofhealth professionals in different settings.Representative medical associations canassist their members (as well as theirpatients and other health care professionals)by developing policy and guidance in thiscomplex area. Such policy should ideallyinclude:
- a review and definition of the concept ofinterprofessionalism with attention givento both the medical and non-medical lit-erature
- a clarification of the relevant medico-legal liability issues, including the needfor all team members (and not just physi-cians) to carry liability insurance; thismay need to be done in partnership withlocal and/or national medical malprac-tice insurance carriers where appropriate
- an approach towards education in thisarea for medical students, postgraduatemedical trainees and physicians in prac-tice, as well as other health care profes-sionals who will be working in the teamsetting
- an integrated or separate policy or docu-ment outlining the issue of scopes ofpractice for the various health care pro-fessions, including the fact that roles andscopes must be in keeping with the rele-vant training and expertise and shouldnot exceed the capabilities of a givenfield (for example, professionals nottrained to provide a diagnosis should notbe licensed to do so; this is not in keep-ing with clinical or ethical standards andis a potential threat to patient care andwell-being)
- a clarification on potentially competingethical principles and Codes of Ethics toensure that physicians understand theirindividual obligations in this regard
6) Clinical practice guidelines (CPGs)
Clinical practice guidelines or CPG’s, aresystematically developed statements thataim to help physicians and patients reach
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the best possible health care decisions (62).While they have been in existence for along time, recent years have seen an explo-sion in their numbers. They go beyond sys-tematic reviews of the literature by recom-mending what should and should not bedone in specific clinical circumstances.
Generally, CPG’s are developed by a groupof writers with representatives from clinicalmedicine, research, and epidemiology,among other disciplines. The body or orga-nization sponsoring their development mayvary significantly, from an uninterestedthird party (rare), to a medical society orassociation (more common) to a diseasespecific organization (perhaps increasinglycommon). The funding for each type ofgroup may also vary, with differing degreesof private and public sponsorship. Privatesponsorship usually comes from partieswith a vested interest in the outcome of theprocess, particularly the pharmaceuticalindustry (and less commonly the insuranceindustry). Pharmaceutical companies canbenefit from the outcome of a CPG eitherthrough the recommendation of a specifictherapeutic agent or a lowering of thethreshold required before the use of anagent. Sometimes the source of financialsponsorship is made transparent, but it isnot uncommon for it to remain relativelyanonymous (or hidden).
Not only the process itself, but also theactual participants in the process, may alsobe subject to potential conflicts of interest.This has been the focus of much debate inthe medical and scientific literature as oflate (63-65). Two recent publications havehelped to outline the scope of this problem.One study (66) notes that 87% of authors ofCPG’s had some form of interaction withthe pharmaceutical industry. Fifty eight per-cent had received financial support to per-form research and 38% had served asemployees or consultants for a pharmaceu-tical company. Only 2 published CPG’s outof 44 examined made declarations regard-ing the personal financial interactions ofindividual authors with drug companies.Another report (67) on more than 200CPG’s from various countries deposited in2004 with the United States NationalGuideline Clearinghouse found that morethan one third of the authors declared finan-
Potential area of activity What NMA’s can do
1) Pandemic and disasterpreparedness
– develop guidelines on disaster and pandemic preparednessthat will specifically outline for their membership exactlywhat is expected of them in such a situation, and what theirprofessional obligations entail
– assist their members, and the public, by helping ensure thatgovernments, hospitals and others understand and meet thereciprocal obligations that will be critically important forensuring the care and safety of patients and physiciansalike during a pandemic or other public health emergency
2) Conscientious objection – outline the concept of conscientious objection, its historyand its current use
– assist members to understand that they should not refuse toprovide urgently needed care by using the concept of con-scientious objection
– assist members to understand that they should not obstruct,actively or passively, patients from receiving care fromanother clinician
– address the issue of whether or not the conscientious objec-tor has a duty to refer the patient to another clinician forservices the objector will not provide
3) Physician self regulation
– support, through policy, advocacy and action, legitimateefforts to improve the quality of medical care and out-comes through regulatory oversight of their physicianmembers
– help ensure that efforts at revalidation of physicians are notsimply exercises intended to reassure the public and legis-lators, but truly strive to improve the quality of medicalpractice, and are be based on solid evidence demonstratingthat the means used will be efficient and effective
– develop policy or position statements clarifying their sup-port for self-regulation and outlining the importance of thisconcept to the maintenance of medical professionalism
– assist their members in understanding that self-regulationcannot be perceived as being protective of physicians, butmust maintain the support and confidence of the generalpublic.
4) Physician-industryinteractions
– develop clear and comprehensive policy in this area toensure that their members do not find themselves in a posi-tion of conflict of interest
– widely distribute these policies to their membership andothers, and undertake educational initiatives to clarify theirimportance, intent and content
– use their advocacy capabilities to help ensure that thesephysician-led guidelines become the accepted standard forall the other participants involved, including industry
– give careful consideration to developing stringent internalpolicy for governing relationships between the organiza-tion and third parties
Table 1 – Summary of potential areas of NMA activity
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cial links to relevant drug companies withnearly 70% of panels being involved, andalmost half of the CPG’s providing noinformation about conflicts of interest.
It is increasingly clear that the problem ofconflicts of interest in the development ofCPG’s is widespread and under-reported.While there are those who argue that it isnot possible to develop CPG’s withoutusing authors linked to industry, since theseauthors are experts in the field and aresought both by the companies and the bod-
ies producing the CPG’s, some organiza-tions have taken steps to remedy this situa-tion. Various guidelines have been devel-oped to ensure that any possible conflictsare declared to all those involved in theprocess of CPG development and that thosewith conflicts are given reduced or modi-fied roles. For example, since 1999 theNational Institute for Health and ClinicalExcellence (NICE) has provided guidanceon appropriate clinical practice withinBritain’s National Health Service. NICE
has taken steps to avoid situations arisingfrom potential conflicts of interest, requir-ing members of its advisory bodies todeclare financial and other interests. If aconflict is identified, the individual will berequired to step down and not take part inthe decision-making process (68).
Other criticisms of CPG’s have included thefact that some leave little room for devia-tion in the case of individual patients whoseneeds may differ, that they may presentphysicians with difficult medico-legal situ-ations if CPG’s are held to be the standardof care, and that they may provide reasonsfor insurers to deny coverage.
While National Medical Associations havenot been traditionally involved in the actualdevelopment of CPG’s, there may well bean important role for them to play in theprocess of ensuring the highest standards ofcare based on the use of recent, high quali-ty, unbiased CPG’s by practicing clinicians.There are some good examples of NMA’swho have become involved in this area.
The American Medical Association, togeth-er with the Agency for Healthcare Researchand Quality and the American Associationof Health Plans, initially assisted in thedevelopment of the National GuidelineClearinghouse in the United States(www.guideline.gov). The NationalGuideline Clearinghouse is a comprehen-sive database of evidence-based clinicalpractice guidelines and related documents.Its mission is “to provide physicians, nurs-es, and other health professionals, healthcare providers, health plans, integrateddelivery systems, purchasers and others anaccessible mechanism for obtaining objec-tive, detailed information on clinical prac-tice guidelines and to further their dissemi-nation, implementation and use” (69).
The Canadian Medical Association, on itswebsite at www.cma.ca, provides its mem-bership with access to a service called CMAInfobase. This site provides access to CPG’swhich are produced or endorsed in Canadaby a national, provincial/territorial orregional medical or health organization,professional society, government agency orexpert panel. In addition, the CMA and oneof its provincial divisions, the OntarioMedical Association, have combined with
Potential area of activity What NMA’s can do
5) Interprofessionalism – develop policy and guidance in this complex area, includ-ing:
– a review and definition of the concept of interprofessional-ism
– a clarification of the relevant medico-legal liability issues– an approach towards education in this area for medical stu-
dents, postgraduate medical trainees and physicians inpractice, as well as other health care professionals who willbe working in the team setting
– an integrated or separate policy or document outlining theissue of scopes of practice for the various health care pro-fessions
– a clarification on potentially competing ethical principlesand Codes of Ethics to ensure that physicians understandtheir individual obligations in this regard
6) Clinical practice guidelines
– provide physicians with access to recent, high quality,unbiased CPG’s by:
– actively screening guidelines for their membership – providing a quality rating for each guideline – organizing the many thousands of CPG’s into areas of clin-
ical content and relevancy– selecting the most appropriate and relevant guidelines for
use by their members – providing a clearinghouse for the screened and selected
CPG’s with membership access on its website or otherlocation
7) Organizational ethics – develop thoughtful and well-articulated mission, visionand values statements that are produced with input fromassociation staff
– develop internal organizational policies and codes whichaddress specific ethical and professional issues
– make efforts to promote the above policies and documents– measure and evaluate the impact of these policies, and
keep them updated in an ongoing fashion– ensure that the physician membership of the association is
aware of these internal policies
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the Ontario Ministry of Health and LongTerm Care to form the Guidelines AdvisoryCommittee (GAC) (70). For selected topicsrelevant to clinicians, patients and thehealth care system, the GAC identifies,rates and endorses the best available guide-line (71). The GAC uses the Appraisal ofGuidelines, Research and Evaluation(AGREE) tool to assess the quality ofCPG’s. The AGREE tool was created andvalidated for physicians to use in ratingguidelines according to their process ofdevelopment by identifying the factors thatare considered important in judging theirquality (72). On the CMA website, a ratingof the quality of the guideline developmentprocess for those guidelines that have beenreviewed by the GAC is included.
What NMA’s can do on the issue of clinicalpractice guidelines
Providing physicians with access to recent,high quality, unbiased CPG’s will enhancemedical professionalism by increasing thequality of patient care and outcomes andensuring that patients everywhere receivethe same high standard of care. Although itis probably not reasonable to expect NMA’sto participate in the production of the guide-lines themselves, given the relative intensi-ty of resources required to do so, they canassist in the process by:
- actively screening guidelines for theirmembership using a validated tool suchas AGREE
- providing a quality rating for each guide-line based on a validated tool such asAGREE
- organizing the many thousands of CPG’sinto areas of clinical content and rele-vancy
- selecting the most appropriate and rele-vant guidelines for use by their members(for example, there are over 300 EnglishCPG’s on the management of high cho-lesterol, and NMA’s could review theseand choose the highest quality 2 or 3CPG’s)
- providing a clearinghouse for thescreened and selected CPG’s with mem-bership access on its website or otherlocation (which also provides a direct
benefit of membership in the associa-tion)
7) Organizational ethics and profession-alism
Organizational ethics has been defined as“the articulation and application of the con-sistent values and moral positions of anorganization by which it is defined, bothinternally and externally” (73). It is general-ly articulated via values statements, missionand vision statements, organizational codesof ethics, policies addressing specific ethi-cal issues, and especially through its effectson the attitudes and activities of everyoneassociated with the organization.
This represents in many cases a relativelynew approach to the consideration of ethicsin organizations, particularly healthcareorganizations. With the Enron scandal (74)and other recent developments in the busi-ness world and elsewhere, organizationalethics have become increasingly importantboth in practice and to reassure stakeholdersand others that an ethics framework is inplace.
While the medical literature in this areafocuses on healthcare organizations such ashospitals, health care districts and healthmaintenance organizations (HMO’s) (74-76), the general principles of this approachcan be applied to representative medicalassociations as well. While these associa-tions serve an important role in helping toguide their individual member physicians inprofessional and ethical standards, as out-lined in previous sections of this paper, hav-ing robust internal policies will also help toset a high standard of behavior and providean example of professionalism from withinthe organization.
There are four important strategies that canbe used to help build a solid ethics infra-structure in a medical organization (77).These include:
1) Conducting a formal process to clarifyand articulate the organization’s valuesand link them to the mission and visionstatements. This should include buildingthe mission, vision and values statementsinto the introduction of the strategic
plan, involving all employees in thedesign of the mission, vision and valuesstatements, using facilitated groupapproaches to discuss these statementsand using team building strategies toenhance organizational values.
2) Facilitating communication and learningabout ethics and professionalism.Specific strategies include:
a. placing mission and vision statements inhighly visible locations throughout theorganization
b. offering training programmes thatencourage interaction about the organi-zation’s values
c. using role playing, case studies andlunchtime educational sessions to facili-tate communication about ethics andprofessionalism
d. engaging employees in values clarifica-tion techniques
3) Creating structures that encourage andsupport the culture. These structuresshould be multiple, interconnected anddiffused throughout the organization,and ideally should include an ethicsinfrastructure with sufficient dedicatedstaff and resources.
4) Creating processes to monitor and offerfeedback on ethical performance.Specific strategies include:
a. using ethics and professionalism audits
b. examining processes and/or outcomes ofethical decision making
c. regular evaluation of the organization’smission, vision and values statements
The American Medical Association haspublished a document entitled“Organizational ethics in healthcare: towarda model for ethical decision-making byprovider organizations” (78). While thedocument specifically notes that its focus ison organizations that provide health care toindividual patients, and not other organiza-tions such as associations of health careprofessionals, several of the principlesreviewed are of relevance. For example, thedocument discusses in some detail the pri-oritization of competing principles to help
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organizations understand that patient healthis their ultimate priority, regardless of othercompeting considerations. The paper alsoprovides an overview of various sources oforganizational ethics for provider organiza-tions, including business ethics, profession-al accountability and law and social con-text.
What NMA’s can do on the issue of organi-zational ethics
It is very important that a representativemedical association exhibit strong organiza-tional ethics. Not only does this assist withensuring the proper prioritisation of associ-ation objectives and strategies, it also helpsdemonstrate to the physician membershipthe importance the organization places onethics and professionalism. An NMA can-not expect its membership to respect andfollow the ethical codes and policies it pro-duces without first setting the same highstandards for the NMA itself. Associationscan do this by:
- developing thoughtful and well-articu-lated mission, vision and values state-ments that are produced with input fromassociation staff and physicians
- developing internal organizational poli-cies and codes which address specificethical and professional issues (forexample, harassment in the workplace,individual and organizational conflict ofinterest, and professional interactionswith outside third parties)
- making efforts to promote the abovepolicies and documents, including themboth during orientation of new staff, andin an ongoing manner through retreatsand educational sessions
- measuring and evaluating the impact ofthese policies, and keeping them updatedin an ongoing fashion
- ensuring that the physician membershipof the association is aware of these inter-nal policies via mailings, journals andwebsites
Summary
In many respects, medical professionalismis currently at a crossroads. The nature ofthe physician-patient relationship continuesto evolve, as physicians struggle to redefinetheir role in an ever-changing society that isin the midst of a technological revolution.Threats to medical self-regulation andevolving physician scopes of practice havecaused many practicing doctors to questionwhether the profession itself will ever bethe same.
At the same time, change often representsopportunity. Many have seized this chanceto try to redefine the concept of medicalprofessionalism and refocus attention on thesanctity of the physician-patient relation-ship. New social contracts have beendevised to help physicians understand howto balance their competing priorities androles. Task forces have been formed, reportshave been written and hands have beenwrung. Whether all this activity will have alasting impact remains to be seen.
Representative physician organizations arein a unique position. They serve in manyinstances as the public face of the profes-sion, and help make known and understoodthe views of physicians on important mat-ters. They also have the opportunity to bestandard-setters for the profession, to helpshape and mould the ongoing evolution anddevelopment of medical professionalism.While the literature to date focuses withnear exclusivity on the roles and obligationsof individual physicians, there is much thatmedical associations can do, both internallyand externally, to advance and promote theconcept. Whether this is done in isolationfrom, or together with, other relevant med-ical and non-medical bodies will varydepending on individual circumstances.
The objective of this paper has been toexamine medical professionalism throughthe lens of the representative medical asso-ciation rather than the individual clinician.Through providing both general and specif-ic, concrete suggestions and examples ofcurrent and future potential activities whichmight be undertaken, it is hoped that it willadd in a positive and constructive way tothe preservation of what most doctors con-
sider to be at the core of medicine: the roleof the physician as healer and professional.
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Appendix 1
Organizations that have endorsed thePhysician Charter:Accreditation Council for Graduate MedicalEducationAdministrators of Internal MedicineAlliance for Academic Internal MedicineAmerican Academy of Allergy, Asthma andImmunology American Academy of Dermatology American Academy of Family PhysiciansAmerican Academy of Neurology American Academy of OphthalmologyAmerican Academy of Orthopaedic Surgeons American Academy of Otolaryngology–Headand Neck Surgery American Academy of PediatricsAmerican Academy of Physical Medicine andRehabilitation American Board of Medical SpecialtiesAmerican Board of Allergy and ImmunologyAmerican Board of AnesthesiologyAmerican Board of Colon and Rectal Surgery American Board of Dermatology American Board of Emergency Medicine American Board of Family Practice American Board of Internal MedicineAmerican Board of Medical Genetics American Board of Neurological Surgery American Board of Nuclear MedicineAmerican Board of Obstetrics and GynecologyAmerican Board of Ophthalmology American Board of Orthopedic SurgeryAmerican Board of OtolaryngologyAmerican Board of PathologyAmerican Board of Pediatrics American Board of Physical Medicine andRehabilitation American Board of Plastic SurgeryAmerican Board of Preventive Medicine American Board of Psychiatry and Neurology American Board of RadiologyAmerican Board of SurgeryAmerican Board of Thoracic Surgery American Board of UrologyABIM FoundationAmerican College of Dentists American College of Medical GeneticsAmerican College of Obstetricians andGynecologists American College of PhysiciansAmerican College of Radiology American College of Surgeons ACP Foundation American Orthopaedic AssociationAmerican Osteopathic AssociationAmerican Psychiatric Association American Society of Anesthesiologists
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American Society of Clinical Pathologists American Society of Plastic Surgeons American Urological Association Association of Academic Physiatrists Association of American Medical Colleges Association of Physicians of Ireland Association of Physicians of Malta Association of Professors of Medicine Association of Program Directors in InternalMedicineAssociation of Subspecialty ProfessorsAustrian Society of Internal Medicine Belgian Society of Internal Medicine Clerkship Directors in Internal MedicineChinese Medical Doctors AssociationCollege of Physicians and Surgeons of BritishColumbia Council of Deans, Association of CanadianMedical Colleges Council of Medical Specialty Societies Czech Society of Internal Medicine Danish Society of Internal Medicine Estonian Society of Internal Medicine European Federation of Internal MedicineFederation of Royal Colleges of Physicians ofUnited Kingdom Federation of State Medical Boards Finnish Society of Internal Medicine French Society of Internal Medicine German Society of Internal Medicine Hellenic Society of Internal Medicine
Hungarian Society of Internal Medicine Icelandic Society of Internal MedicineIsraeli Society of Internal Medicine Italian Society of Internal Medicine Latvian Society of Internal Medicine Lithuanian Society of Internal Medicine Luxembourg Society of Internal Medicine Medical Council of CanadaMinistero della Salute Netherlands Society of Internal Medicine North American Society of RadiologistsPolish Society of Internal Medicine Portuguese Society of Internal Medicine Residency Review Committee for InternalMedicine Royal Australasian College of Physicians andSurgeons Royal College of Physicians of Edinburgh Royal College of Physicians of IrelandRoyal College of Physicians of London Royal College of Physicians and Surgeons ofCanada Slovak Society of Internal Medicine Slovenian Society of Internal Medicine Society of Neurological Surgeons ociety ofNuclear Medicine Society of Thoracic SurgeonsSpanish Society of Internal Medicine Swedish Society of Internal Medicine Swiss Society of Internal Medicine Turkish Society of Internal Medicine
embryos for research is usually very rigor-ous. Some countries restrict the embryoniccell lines that their researchers are allowedto use to ones that have been derived inaccordance with strict ethical requirements.The introduction of human stem cells intoanimals is either forbidden or severely lim-ited.
The ethical issues of stem cell research havebeen widely discussed by medical associa-tions and scientific organizations, includingthe following:
• In 2006 the WMA Assembly adopted aStatement on Assisted ReproductiveTechnologies that deals in part with stemcell research:
– Due to the special nature of humanembryos, research should be carefullycontrolled and should be limited toareas in which the use of alternativematerials will not provide an adequatealternative.
– Views, and legislation, differ onwhether embryos may be createdspecifically for, or in the course of,research. Physicians should act inaccordance with national legislationand local ethical advice.
– Cell nuclear replacement may also beused to develop embryonic stem cellsfor research and ultimately, it is hoped,for therapy for many serious diseases.Views on the acceptability of suchresearch differ and physicians wishingto participate in such research shouldensure that they are acting in accor-dance with national laws and local eth-ical guidance.
• The WMA is currently considering aProposed Statement on Stem CellResearch for possible adoption at itsOctober 2007 Assembly in Copenhagen.
• In 2003 the American MedicalAssociation adopted a policy onCloning-for-Biomedical-Research thatreads in part: „While the pluralism ofmoral visions that underlie this debatemust be respected, physicians collective-ly must continue to be guided by theirparamount obligation to the welfare oftheir patients. In this light, cloning-for-
The Ethics of Stem Cell ResearchDr. John Williams(from WMA Ethical issues of the month)
During the past decade a great deal of scien-tific research activity has been devoted tohuman stem cells. Considerable progresshas been made in deriving and replicatingcell lines and in understanding cell biology.The ultimate goal of this activity is to devel-op therapeutic applications of this knowl-edge, but it is still uncertain how successfulthis quest will be.
From the outset stem cell research hasraised ethical issues over and above thoseassociated with other types of medicalresearch. The principal cause of ethicaluncertainty and conflict has been the use ofhuman embryos as the source of stem cellsfor research. Despite claims that adult stemcells may be equally suitable for therapeutic
purposes, there is a strong consensus amongscientists working in this field that embryostem cells are better suited for research pur-poses. However, since the derivation ofthese cells requires the destruction of theembryo, the question arises whether or notsuch research is fundamentally unethical.
Proponents of embryo stem cell researchare not insensitive to the special ethical sta-tus of the human embryo and there has beensubstantial agreement on certain limitationsto such research. Ethical guidelines andnational legislation generally prohibit thecreation of embryos for research, allowingresearch only on embryos created but nolonger wanted for reproductive purposes.The consent process for the donation of
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biomedical-research is consistent withmedical ethics. Every physician remainsfree to decide whether to participate instem cell research or to use its products.“
• The Australian Medical Association hasexpressed support for embryonic stemcell research.
• The British Medical Association is like-wise in favour of embryonic stem cell
research: „The BMA supports the use ofcarefully controlled research, includingresearch using human embryos wherenecessary for the development of tissuefor transplantation and the developmentof methods of therapy for mitochondrialdiseases.“
• The International Society for Stem CellResearch website includes a number of
ethics-related documents, such as TheEthics of Human Embryonic Stem CellResearch.
• The U.S. National Institutes of Healthwebsite provides a useful set ofresources on this topic: BioethicsResources on the Web – Stem CellResearch.
Presumed Consent for removalof organs from dead patients
While “presumed consent” for the removalof organs from dead patients for transplantpurposes exists in a number of countries,this does not apply in the United Kingdom.The U.K Chief Medical Officer, Sir LiamDonaldson, in his annual report (1) hasraised the issue again. Commenting that inthe UK it is estimated that of the total 7234on the UK waiting list for transplants oneperson dies each day, he proposes that inview of the shortage of donated organs theprinciple of “presumed consent“ should beintroduced. This would mean that organs“donated” for transplant would at least dou-ble to meet present demands. He furthersuggest that those wishing to “opt out” ofdonation in the event of their death shouldbe specifically registered (a system whichin a number of countries is implemented inso – called ”hard” and “soft” ways – seebelow).
The report comments on the experience ofother countries. Acknowledging “there havebeen concerns that such an approach wouldbe viewed as totalitarian” the report contin-ues “However, as long as the option to vol-untarily opt out from the system is bothavailable and easily accessible and strictmeasures are applied to protect vulnerablegroups, the experience shows that such asystem can command public confidence.”
In the “hard“ version presumed consentallows organs to be removed unless theindividual had formally registered an objec-tion during his lifetime and no accountwould be taken of the views of relatives.
In the “soft” version presumed consentwould permit removal of organs unless:- the person had registered an objection
during their lifetime;- it is clear form information provided by
the relatives that the individual hadexpressed an objection to donation buthad not officially registered this;
- it is clear that removal of organs wouldcause major distress to the relatives.
“On the State of the Public Health: Annualreport of the Chief Medical Officer 2007”HMSO com 7093
UK Human Fertilisation andEmbryology Authority (HFEA)issues statement on licensing ofhuman-animal hybrids.The UK HFEA, following a detailed andcomprehensive consultation on the licens-ing of human animal hybrids and chimeraresearch which involved both scientists andthe wider public issued a statement on itsdecision taken at its recent meeting.
“Having looked at all the evidence, theAuthority has decided that there is no fun-damental reason to prevent cytoplasmichybrid research. However, public opinion isvery finely divided with people generallyopposed to this research unless it is tightlyregulated and is likely to lead to scientificor medical advancements. It continues”This is not a total green light to cytoplas-mic hybrid research, but recognition that hisarea of research can, with caution and care-ful scrutiny, be permitted. Individualresearch teams should be able to undertakeresearch projects involving the creation ofcytoplasmic hybrid embryos if they candemonstrate, to the satisfaction of theHFEA licence committee, that their plannedresearch project is both necessary and desir-able and meets the standards required by theHFEA for any embryo research.”
The authority indicated that its licence com-mittee will now look at the details of thetwo research application referred to it earli-er this year and hope to have a decision inNovember.
Currently Stem Cell Nuclear Transfer usinganimal eggs is permitted in some countries,often under special conditions, whereas inother its is specifically forbidden.
www.hfea.gov.uk/en/1581.html accessed11/09/2007
Ethics and Human Rights news
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WMA CPD course in Medical Ethics-Fundamentals in Medical EthicsThe World Medical Association, in cooperation with the Norwegian Medical Association has developed a web-based continuing professional development course on Medical Ethics.
Working through the course should enable participants to:– understand the role of ethics in medicine;– recognise ethical issues when the arise in practice;– deal with these issues in a systematic manner
The course, which is now online has been accredited by the Norwegian Medical Association with 8 hours/pointsin post-graduate and continuing education. On completion of the course, the tests and evaluation an accredi-tation/certificate will be issued if desired.
Further details of the WMA courses are accessible through the WMA website www.wma.net. More courses andversions of existing courses are being developed.
Current courses:– Doctors working in Prison: human rights and ethical dilemmas.– Fundamentals of Medical Ethics
Medical Ethics and Human Rights
HIV and Human Rights Handbook
A new Handbook on HIV and HumanRights was launched by the Office of theHigh Commissioner for Human RightsOHCR) and the Joint UN Programme onHIV/AIDS (UNAIDS) at the EighthInternational Congress on AIDS in Asia andthe Pacific held in Sri Lanka 19-23 August2007. This is intended to help nationalhuman rights institutions to include HIV intheir human rights mandates, providing anoverview of the role of human rights inresponding to the HIV epidemic. It includessuggestions for activities which could becarried out by national human rights institu-tions in their existing work and collaborat-
ing with national AIDS programmes.UNAIDS Executive Director Peter Piot isreported as saying that “ This is a criticaltime for national human rights institutionsto engage in the AIDS response. W e haslearned that we will not succeed unless weaddress discrimination, gender inequalityand other human rights abuses that drive theepidemic”.
UN Human Rights Commissioner forHuman Rights Louise Arbour referred tothe Handbook as” an essential guide fornationals institutions in their efforts toensure that States are held accountable for
protecting the rights of people living withHIV.
In 2006, countries committed themselves toachieve universal access to HIV prevention,treatment, care and support by 2010.As theyscale up their efforts towards this goal it isessential that they deal with the stigma, dis-crimination and gender inequality that havebeen identified as major obstacles to univer-sal access.
Copies of the Handbook are available fromOHCR and UNAIDSUN press release and OHCHR mediarelease 27/28.08.07
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Tobacco Control – new guideline
Report on Progress made in the Second Session of the Conference of the Parties, WHO Framework Convention on Tobacco Control,Bangkok, Thailand, 30. June – 6. July 2007
Dr. Song Lih Huang, MD, MSc.
Secretary General
Taiwan International Medical Alliance
Each year tobacco use causes approximate-ly 5 million deaths worldwide. Because ofthe increasing prevalence of tobacco use inmany developing countries, it is estimatedthat by the year 2030, the death toll willincrease to 10 million per year, with 70%coming from middle- and low-incomecountries. Although deaths associated withtobacco use are preventable, it would takesociety an extraordinary effort for the pre-vention to be effective. In view of the cross-border nature of tobacco trade, and the vastdifferences among governments on the con-cept and practice of tobacco control, it wasrecognized in the late 1990s that a globalhealth treaty could help individual countriesto strengthen legislative and regulatorymeasures
The WHO Framework Convention onTobacco Control (FCTC) was adoptedunanimously by the 56th World HealthAssembly on 21 May 2003, and the FCTCentered into force in February 2005 after 40countries had ratified it. Two Conferencesof the Parties (COP) have been held, thefirst in February 2006 (Geneva) and the sec-ond in 30 June – 6 July, 2007 (Bangkok).At the second COP, the parties:
adopted a guideline on protectionfrom exposure to tobacco smoke(Article 8 of FCTC); see also annex.
• set up an international negotiating bodyto prepare a protocol on illicit trade witha timetable which envisages its readinessfor adoption at the fourth COP in 2010;
• agreed to ask the secretariat to work onguidelines on Article 11 (packaging andlabeling of tobacco products) and Article13 (regulations on domestic and cross-
border tobacco advertising, promotionand sponsorship) with the aim of adopt-ing these guidelines at the third COP in2008;
• agreed to work on guidelines on Article5.3 (protection from tobacco industryinterference), Article 12 (education,communication, training and publicawareness) and Article 14 (cessation);
• agreed to continue with work on Article9 and 10 (product testing, measurementand disclosure) and 17 (economicallyviable alternative activities); and
• agreed to set aside funding for all theseactivities.
The official documents about FCTC andCOP can be found on WHO websites(http://www.who.int/tobacco/framework/enand http://www.who.int/gb/fctc/). Usefulinformation is also available at theFramework Convention Alliance website(http://www.fctc.org/).
It was quite remarkable to be able to makesuch progress during any internationalmeeting, reflecting the fact that most coun-tries have begun to realize the magnitude ofdamage done by tobacco use. However, thechallenges for medical professionals in eachcountry still lie ahead. Three types of effortwill require medical professionals to takeactions in order to save millions of lives.
First, not all countries have ratified theFCTC. There are currently 148 parties(including the European Community) to theFCTC. Understandably, several Africancountries which rely on the exportation oftobacco leaves as their major revenue willcertainly need to find ways for alternativeagricultural or other income-generatingactivities before the governments will com-ply with the goals of reducing world tobac-co consumption. On the other hand, almostall industrialized countries have ratified the
FCTC, with the notable exceptions of USAand Russia. The health professionals inthese countries have to exert their utmostinfluence on the government to give priori-ty to the health of people both domestic andabroad.
Secondly, the FCTC and its associatedagreements are instruments meant to assistindividual government in the legislative andimplementation processes towards tobaccocontrol. Take “the guideline for the protec-tion from exposure to tobacco smoke” forexample. This guideline will be helpful topeople exposed to secondhand smoke onlyif the governments are willing and able tomake effective laws or policies to restrictsmoking in public places. The health pro-fessionals in each country should try to con-vince law makers of the necessity, urgency,and feasibility of taking effective measures,citing the international health treaty and theexamples of successes from many countrieswith various cultural characteristics. TheFCTC has been very helpful in movingcountries forward in tobacco control as theinternational treaty makes the issue moreprominent on the political agenda andhealth professionals should take advantageof this.
The third challenge is for medical profes-sionals of the rich countries which benefitfrom the tobacco industry. One of the majorissues during the third COP was Article 13(Tobacco advertising, promotion and spon-sorship). As the barriers to internationaltrade are diminishing, cross-border adver-tising and promotion are becoming moredifficult to regulate. This is particularly soin developing countries which have limitedresources and capability for monitoring andlaw enforcement. Another formidable chal-lenge for these countries is the need to enactstrong legislation controlling foreign com-
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panies, and facing the possibility of direconsequences involving international tradearbitration. Cross-border advertising andpromotion do not come out of thin air. Theyare sophisticated products of tobacco com-panies (often based in rich countries) withthe sole purpose of addicting boys and girlsof less privileged countries. Medical profes-sionals in rich countries have the moral dutyto try to limit the political power of thetobacco industry. It is an act that can protectthe future lives and fortunes of people.
As stated above, agreements made at thesecond COP will continue to be worked on,and hopefully will yield meaningful resultsin the third and fourth COPs. The adoptedguideline has started to serve the purpose ofprotecting people from exposure to tobaccosmoke, and the protocols being developednow promise to help countries deal withillicit trade and advertisement/promotionwhich are hard to control by any singlecountry. The progress on this internationalhealth treaty is to be celebrated, but itawaits the effort of each country to consoli-date the benefits of FCTC. Medical profes-sionals should stay involved and play moreactive roles in this regard.
Annex 1 (Extract from Guidelines onprotection from tobacco smoke)
The following extracts from this docu-ment set out the objectives and mainprinciples upon which the Guidelines onimplementing Article 8 of the FCTCadopted by the 2nd FCTC COP at theBangkok meeting, are based.
“Purpose of the guidelines
1 Consistent with other provisions of theWHO Framework Convention and theintentions of the Conference of Parties(COP), these guidelines are intended toassist Parties (to the convention) in meet-ing their obligations under Article 8.They draw on the best available evi-dence and the experiences of Parties thathave successfully implemented effectivemeasures to reduce exposure to tobaccosmoke.
2 The guidelines contain agreed uponstatements of principles and definitionsof relevant terms, as well as agreed uponrecommendations for the steps required
to satisfy the obligations of theConvention. In addition, the guidelinesidentify the measures necessary toachieve effective protection the hazardsof second-hand tobacco smoke. Partiesare encouraged to use these guidelinesnot only to fulfil their legal duties underthe Convention, but also to follow bestpractices in protecting public health.
Objectives of the guidelines
These guidelines have two related objec-tives. The first is to assist Parties in meetingtheir obligations under Article 8 of theWHO Framework Convention, in a mannerconsistent with the scientific evidenceregarding exposure to second hand tobaccosmoke and the best practice worldwide inthe implementation of smoke-free mea-sures, in order to establish a high standardof health. The second objective is to identi-fy key elements and legislation necessary toeffectively protect people from exposure totobacco smoke, as required by Article 8.
Underlying considerationsThe development of these guidelines hasbeen influenced by the following funda-mental considerations.a) The duty to protect from tobacco smoke,
embodied in the text of Article 8, isgrounded in fundamental human rightsand freedoms. Given the dangers ofbreathing second-hand tobacco smoke,the duty to protect from tobacco smokeis implicit in, inter alia, the right to lifeand the right to the highest attainablestandard of health, as recognized bymany international legal instruments(including the Constitution of the WorldHealth Organisation, the Convention onthe Rights of the Child, the Conventionon the elimination of all forms ofDiscrimination Against Women and theCovenant on Economic, Social andCultural Rights), as formally incorporat-ed into the Preamble of the WHOFramework Convention and as recog-nized in the constitutions of manynations.
b) The duty to protect individuals fromtobacco smoke corresponds to an obliga-tion by governments to enact legislationto protect individuals against threats totheir fundamental rights and freedoms.
This obligation extends to all persons,and not merely to certain populations.
c) Several Authoritative scientific bodieshave determined that second-hand tobac-co smoke is a carcinogen. Some Partiesto the Framework Convention (forexample Finland and Germany) haveclassified second-hand tobacco smoke asa carcinogen and included the preventionof exposure to it at work in their healthand safety legislation. In addition to therequirements of Article 8 therefore,Parties may be obligated to address thehazard of exposure to tobacco smoke inaccordance with their existing workplacelaws or other laws governing exposure toharmful substances, including carcino-gens.
Statement of Principles (shortened ver-sion edited by Dr. Song Lhi)*
Principle 1
6. Effective measures to provide protectionfrom exposure to tobacco smoke require thetotal elimination of smoking and tobaccosmoke in a particular space or environmentin order to create a 100% smoke-free envi-ronment laws. There is no safe level ofexposure to tobacco smoke, and approachesother than 100% smoke-free environmentlaws, including ventilation, air filtration andthe use of designated smoking areas(whether with separate ventilation systemsor not), have repeatedly been shown to beineffective.
Principle 2
7. All people should be protected fromexposure to tobacco smoke. All indoorworkplaces and indoor public places shouldbe smoke-free.
Principle 3
8. Legislation is necessary to protect peoplefrom exposure to tobacco smoke. Voluntarysmoke-free policies have repeatedly beenshown to be ineffective.
Principle 4
9. Good planning and adequate resourcesare essential for successful implementationand enforcement of smoke-free legislation.
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Principle 5
10. Civil society has a central role in build-ing support for and ensuring compliancewith smoke-free measures, and should beincluded as an active partner.
Principle 6
11. The implementation of smoke-free leg-islation, its enforcement and its impact
should all be monitored and evaluated. Thisshould include monitoring and respondingto tobacco industry activities.
Principle 7
12. The protection of people from exposureto tobacco smoke should be strengthenedand expanded, if necessary; such actionmay include new or amended legislation,
improved enforcement and other measuresto reflect new scientific evidence and case-study experiences.
GENEVA – At the second GlobalConsultation on Transplantation the WorldHealth Organization presented countriesand other stakeholders with a blueprint forupdated global guiding principles on cell,tissue and organ donation and transplanta-tion.
Those principles aim to address a number ofproblems: the global shortage of humanmaterials – particularly organs – for trans-plantation; the growing phenomenon of‘transplant tourism’ partly caused by thatshortage; quality, safety and efficacy issuesrelated to transplantation procedures; trace-ability and accountability of human materi-als crossing borders.
Stakeholders agreed to the creation of aGlobal Forum on Transplantation to bespearheaded by WHO, to assist and supportdeveloping countries initiating transplanta-tion programmes and to work towards aunified global coding system for cells, tis-sues and organs.
A central theme of the discussions wasWHO’s concern over increasing cases ofcommercial exploitation of human materi-als.
“Human organs are not spare parts,“ saidDr. Howard Zucker, WHO AssistantDirector-General of Health Technology andPharmaceuticals. “No one can put a priceon an organ which is going to save some-one’s life.“
“Non-existent or lax laws on organ dona-tion and transplantation encourage com-mercialism and transplant tourism,“ said Dr.Luc Noel, in charge of transplantation atWHO. “If all countries agree on a commonapproach, and stop commercial exploita-tion, then access will be more equitable andwe will have fewer health tragedies.“
Transplantation is increasingly seen as thebest solution to end-stage organ failure.End-stage kidney disease, for instance, canonly be repaired with a kidney transplant.Without it, the patient will die or requiredialysis for years, which is an expensiveprocedure and often out of reach of poorerpatients. Transplantation is the only optionfor some liver conditions, such as severecirrhosis or liver cancer, and a number ofserious heart conditions.
Recent estimates communicated to WHOby 98 countries show that the most soughtafter organ is the kidney. Sixty-six thousandkidneys were transplanted in 2005 repre-senting a mere 10 % of the estimated need.In the same year, 21 000 livers and 6 000hearts were transplanted. Both kidney andliver transplants are on the rise but demandis also increasing and remains unmatched.
Reports on ‘transplant tourism’ show that itmakes up an estimated 10 % of global trans-plantation practices. The phenomenon hasbeen increasing since the mid-1990’s, coin-ciding with greater acceptance of the thera-peutic benefits of transplantation and with
progress in the efficacy of the medicines –immuno-suppressants – used to prevent thebody’s rejection of a transplanted organ.
The principles put forward by WHO under-score that the person – whether recipient ofan organ or a donor – must be the main con-cern both as patient and as human being;that commercial exploitation of organsdenies equitable access and can be harmfulto both donors and recipients; that organdonation from live donors poses numeroushealth risks which can be avoided by pro-moting donation from deceased donors; andthat quality, safety, efficacy and transparen-cy are essential if society is to reap the ben-efits transplantation can offer as a therapy.
“Live donations are not without risk,whether the organ is paid for or not. Thedonor must receive proper medical follow-up but this is often lacking when he or sheis seen as a means to making a profit,“added Dr. Luc Noel. “Donations fromdeceased persons eliminate the problem ofdonor safety and can help reduce organ traf-ficking.“
WHO action on transplantation will beaided by a global observatory set up inMadrid under the auspices of theGovernment of Spain. The observatory,which is linked to the WHO GlobalKnowledge Base, will provide an interfacefor health authorities and the general publicto access data on donation and transplanta-
WHO proposes global agenda on transplantation
New world observatory launched with Spain
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tion practices, legal frameworks and obsta-cles to equitable access.
Background
Figures collected by WHO and collated bythe global observatory come from question-naires answered by 98 countries represent-ing just under 5.5 billion people, that is,about 82 % of the world’s population. Thecountries were distributed in the followingmanner: 41 from the European region; 21from North and South America; 13 from theWestern Pacific region; 12 from the EasternMediterranean; eight from South East Asia;and three from Africa.
In 2005, 66 000 kidney transplants wereperformed, 60 % of which in industrializedcountries. Seventy-five per cent of the morethan 21 000 liver transplants and 6 000 hearttransplants were performed in industrial-ized and emerging economies.
Observatory link:http://www.transplant-observatory.orgUsername: rticx\carmonaPassword: Omsmc789
Global Knowledge Base link:http://www.who.int/transplantation/knowledge-base/en/
work is addressing several vital areas of riskto patients. Clear and succinct actions con-tained in the nine solutions have proved tobe useful in reducing the unacceptably highnumbers of medical injuries around theworld.“
The nine solutions are now being madeavailable in an accessible form for use andadaptation by WHO Member States to re-design patient care processes and makethem safer. They come under the headingsof: Look-Alike; Sound-Alike medicationnames; patient identification; communica-tion during patient hand-overs; perfor-mance of correct procedure at correct bodysite; control of concentrated electrolytesolutions; assuring medication accuracy attransitions in care; avoiding catheter andtubing misconnections; single use of injec-tion devices; and improved hand hygiene toprevent health care-associated infection.
The Patient Safety Solutions, a core pro-gramme of the WHO World Alliance forPatient Safety, brings attention to patientsafety and best practices that can reducerisks to patients. It ensures that interven-
tions and actions that have solved patientsafety problems in one part of the world aremade widely available in a form that isaccessible and understandable to all. TheJoint Commission on Accreditation ofHealthcare Organizations and JointCommission International were officiallydesignated as a WHO Collaborating Centreon Patient Safety (Solutions) in 2005.
In the past 12 months, the WHOCollaborating Centre on Patient Safety(Solutions) has brought together more than50 recognized leaders and experts in patientsafety from around the world to identify andadapt the nine solutions to different needs.An international field review of the solu-tions was conducted to gather feedbackfrom leading patient safety entities, accred-iting bodies, ministries of health, interna-tional health professional organizations andother experts.
‘‘These solutions offer to WHO MemberStates a major new resource to assist theirhospitals in avoiding preventable deathsand injuries,“ says Dr Dennis S. O’Leary,president of the Joint Commission.„Countries around the world now face boththe opportunity and the challenge to trans-late these solutions into tangible actions thatactually save lives.“
The patient Safety Solutions focus on thefollowing challenges:
1. Look-Alike, Sound-Alike MedicationNames
2. Patient Identification3. Communication During Patient
Hand-Overs4. Performance of Correct Procedure at
Correct Body Site5. Control of Concentrated Electrolyte
Solutions6. Assuring Medication Accuracy at
transitions in Care7. Avoiding Catheter and Tubing Mis-
Connections8. Single Use of Injection Devices9. Improved Hand Hygiene to Prevent
Health Care-Associated Infection.
For more Information or to view the com-plete Patient Safety Solutions, please go to:
www.jointcommissioninternational.org/solutions
Medical Injuries
WHO launches ‘‘Nine patient safety solutions’’to save lives and avoid harm
WASHINGTON/GENEVA – The WorldHealth Organization has launched ‘‘Ninepatient safety solutions“ to help reduce thetoll of health care-related harm affectingmillions of patients worldwide.
‘‘Recognizing that health care errors affectone in every 10 patients around the world,the WHO’s World Alliance for PatientSafety and the Collaborating Centre havepackaged nine effective solutions to reducesuch errors,“ said WHO Director-GeneralDr Margaret Chan. ‘‘Implementing thesesolutions is a way to improve patient safe-ty.“
The most important knowledge in the fieldof patient safety is how to prevent harmfrom happening to patients during treatmentand care. The nine solutions are based oninterventions and actions that have reducedproblems related to patient safety in somecountries.
Sir Liam Donaldson, Chair of the Allianceand Chief Medical Officer for England,said: ‘‘Patient safety is now recognized as apriority by health systems around the world.The Patient Safety Solutions programme of
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H5N1 Avian `Flu
WHO and manufactorers move ahead with plans for H5N1 influenza global vaccine stockpile
The World Health Organization hasannounced that it is working with vaccinemanufacturers to move ahead on plans tocreate a global stockpile of vaccine for theH5N1 avian influenza virus.
The announcement follows a request by theWorld Health Assembly in May for WHO toestablish an international stockpile of H5N1vaccine.
WHO also welcomed the announcement byGlaxoSmithKline that it will contribute tothe H5N1 global vaccine stockpile.Omninvest of Hungary, Baxter and SanofiPasteur have also indicated their willing-ness to make some of their H5N1 vaccineavailable.
‘‘This is another significant step towardscreating a global resource to help the worldand especially to help developing countriesin case of a major outbreak of H5N1 avianinfluenza,“ said Dr Margaret Chan, WHODirector-General.
‘‘WHO welcomes this contribution fromthe vaccines industry and is also workingwith countries to develop capacity for theproduction of influenza vaccines.“
Further work is needed on detailed opera-tional planning for the stockpile, includinghow and under which conditions it will bedeployed, as well as regulatory aspects ofthe vaccine.
As well as developing a stockpile of H5N1vaccine, other measures being taken byWHO to prepare for a potential influenzapandemic include:
• rapid containment plans to stop a pan-demic using public health measures (iso-lation, quarantine of contacts, personalhygiene and social distancing) and anti-virals;
• assistance to countries to increase vaccineproduction capacity, including researchand promoting the transfer of technologyto developing countries.
WHO releases findings from research project on travel and blood clotsRisk of VTE is higher after travel of more than four hours but is still relatively low
during travel where the passenger is seatedand immobile for over four hours, whetherin a plane, train, bus or car. However, it isimportant to remember that the risk ofdeveloping VTE when travelling remainsrelatively low,“ says Dr Catherine LeGalès-Camus, WHO Assistant Director-General for Noncommunicable Disease andMental Health.
This study did not investigate effective pre-ventive measures against DVT and VTE.However, experts recognize that blood cir-culation can be promoted by exercising thecalf muscles with up-and-down movementsof the feet at the ankle joints. Moving feet inthis manner encourages blood flow in thecalf muscle veins, thus reducing blood stag-nation. People should also avoid wearingtight clothing during travel, as such gar-ments may promote blood stagnation.
GENEVA – The World Health Organizationreleased results from Phase 1 of the WorldHealth Organization research into globalhazards of travel project. Findings indicatethat the risk of developing venous throm-boembolism (VTE) approximately doublesafter travel lasting four hours or more.However, the study points out that evenwith this increased risk, the absolute risk ofdeveloping VTE, if seated and immobile formore than four hours, remains relativelylow at about 1 in 6000.
The two most common manifestations ofVTE are deep vein thrombosis (DVT) andpulmonary embolism.
The study showed that plane, train, bus orautomobile passengers are at higher risk ofVTE when they remain seated and immo-bile on journeys of more than four hours.This is due to a stagnation of blood in the
veins caused by prolonged immobility,which can promote blood clot formation inveins.
One study within the project examiningflights in particular, found that those takingmultiple flights over a short period of timeare also at higher risk. This is because therisk of VTE does not go away completelyafter a flight is over, and the risk remainselevated for about four weeks.
The report showed that a number of otherfactors increase the risk of VTE during trav-el, including obesity, being very tall or veryshort (taller than 1.9 meters or shorter than1.6 meters), use of oral contraceptives, andinherited blood disorders leading toincreased clotting tendency.
‘‘The study does confirm that there is anincreased risk of venous thromboembolism
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Phase I of the research project concludesthat there is a need for travellers to be givenappropriate information regarding the riskof VTE by transport authorities, airlines,and medical professionals. Further studieswill be needed to identify effective preven-tive measures. This will comprise Phase IIof the project, which requires additionalfunding before it can begin.
Individuals with questions regarding pre-vention of VTE should consult their physi-cians before travelling.
Background to the WRIGHT project:
In 2000, following the death from pul-monary embolism of a young Englishwoman who returned on a long-haul flightfrom Australia. Media and public attention
was focused on the risk of thrombosis inlong-haul travellers. In the same year, areport from the Select Committee onScience and Technology of the UnitedKingdom House of Lords recommendedresearch into the risk of DVT. Following aconsultation of experts convened by WHOin March 2001, the WRIGHT project wasinitiated. Phase 1 was funded by the UKGovernment (Department for Transport andDepartment of Health) and the EuropeanCommission.
The objectives of Phase I were to confirmwhether the risk of VTE is increased by airtravel and to determine the magnitude ofrisk.The studies were conducted under theauspices of WHO and performed by aninternational collaboration of researchers
from the Universities of Leiden, Amster-dam, Leicester, Newcastle, Aberdeen andLausanne.
There were five studies:
• a population-based case control study toinvestigate the risk factors of VTE;
• two retrospective cohort studies amongemployees of international organizationsand Dutch commercial pilots to investi-gate the actual risk of VTE related to airtravel; and
• two pathophysiological studies to inves-tigate the influence of immobility onVTE related to travel and the influence,if any, of low oxygen and low pressure inthe cabin of aircraft on VTE related totravel.
Safe blood for mothersNew WHO survey on blood safety and donation
GENEVA — On the occasion of WorldBlood Donor Day, the theme of which thisyear is Safe blood for safe motherhood, theWorld Health Organization launched a newinitiative to improve the availability and useof safe blood to save the lives of womenduring and after childbirth. The initiative isthe beginning of a broader blood safetyagenda (redefined in Ottawa) aiming towork towards universal access to safe bloodtransfusion in support of the MillenniumDevelopment Goals.
On 14 June, WHO also released data col-lected from 172 countries on trends in blooddonation, access and testing.
Globally, more than 500 000 women dieeach year during pregnancy, childbirth or inthe postpartum period – 99% of them in thedeveloping world – an estimated 25% ofthose deaths are caused by severe bleedingduring childbirth, making this the mostcommon cause of maternal mortality.
Severe bleeding during delivery or afterchildbirth contributes to around 34% ofmaternal deaths in Africa, 31% in Asia and
21% in Latin America and the Caribbean.As pregnant women are one of the maingroups of patients requiring blood transfu-sion in developing countries, together withchildren they are particularly vulnerable toblood shortages and to HIV, hepatitis B andhepatitis C infections through unsafe blood.
‘‘If current trends continue, the world willfail to meet target 5 of the MillenniumDevelopment Goals to reduce maternalmortality,“ said Dr Margaret Chan, WHODirector-General. ‘‘We must do everythingwe can to improve the chances of womenduring and after childbirth.“
Blood transfusion has been identified as oneof the eight key life-saving interventions inhealthcare facilities providing emergencyobstetric care. Timely, appropriate and safeblood transfusion during and after labourand delivery can make the differencebetween life and death for many womenand their newborns.
The Global Initiative on Safe Blood forSafe Motherhood aims to improve access tosafe blood to manage pregnancy-related
complications as part of a comprehensiveapproach to maternal care. This includesgood antenatal care, prevention and timelytreatment of anaemia, assessment of theneed for transfusion and safe blood transfu-sion given only when really required. WHOwill strengthen the capacity of blood banksand district hospitals for improving mater-nal health through the provision of technicalsupport in the areas of voluntary blooddonation, safe blood collection, qualityassured testing and best clinical practices.WHO will train clinicians, nurses, techni-cians and other key health personnel at dis-trict level facilities through its regional net-works across the world.
The lack of access to safe blood for womenreflects the general situation in developingcountries. Developing countries are hometo more than 80% of the world’s population,yet they currently represent only 45% of theglobal blood supply.
Out of 80 countries that have donation ratesof less than 1% of the population (fewerthan 10 donations per thousand people), 79
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are in developing regions; it is generallyrecommended that 1-3% of the populationgive blood to meet a country’s needs.
The WHO survey, conducted in 172 coun-tries covering 95% of the world’s popula-tion and based on 2004 data, shows thatsome progress has been made since thebeginning of the millennium towards ensur-ing a safer, more adequate supply of blood.One of the survey’s indicators was theimplementation of voluntary, unpaid blooddonation, which remains a mainstay ofWHO recommendations to ensure a safeand sufficient blood supply.
In 2004, 50 countries had achieved 100%voluntary unpaid blood donation, comparedwith 39 countries in 2002. Three of the 11new countries achieving this are categorizedas least developed. More and more coun-tries are moving towards voluntary blooddonation. In 2002, 63 countries were col-lecting less than 25% of their blood fromvoluntary unpaid donors. By 2004, this hadfallen to 46 countries.
Testing of blood for major infections suchas HIV/AIDS, hepatitis B and C is alsoincreasing, although in many countriesthere are few indicators showing if the test-ing is carried out according to qualityassured procedures. Out of 40 countries insub-Saharan Africa, 28 countries have yet toestablish national quality systems.
Worldwide, the highest rate of infection isfound among donors who give blood formoney or other form of payments. 41 of 148countries (28%) that provided data onscreening for transfusion-transmissibleinfections were not able to screen the donat-ed blood for one or more of the markers.
On 9-11 June, Ottawa was the venue for aglobal consultation organized by WHO withthe collaboration and support of theGovernment of Canada and the Canadianand French blood services. Around 100experts in transfusion called on govern-ments, international agencies and non-governmental organizations to work togeth-er towards universal access to safe bloodtransfusion by 2015 in support of theMillennium Development Goals to reducematernal and child mortality and prevent thetransmission of HIV, hepatitis and otherlife-threatening infections through unsafeblood and blood products.
Background to World BloodDonor Day
While most countries celebrated WorldBlood Donor Day on 14 June, this year’smain event was hosted by the Governmentof Canada. Festivities took place in Ottawa,in the presence of the Canadian Minister of
Health and guests from WHO and otherinternational partners.
WHO works with partners internationallyand in countries to promote better bloodcollection practices, 100% voluntary,unpaid blood donation policies, qualityassured blood testing and rational use ofblood.
WHO, the International Federation of theRed Cross and Red Crescent Societies, theInternational Society of Blood Transfusionand the International Federation of BloodDonor Organizations joined forces in 2004to celebrate for the first time World BloodDonor Day — a tribute to voluntary, unpaidblood donors who altruistically give ofthemselves to improve and save lives. In2005 the World Health Assembly voted aresolution to make World Blood Donor Dayan annual event. Since then, the Day hasbecome a vehicle to launch national andregional awareness and advocacy cam-paigns to encourage blood donation andsafer practices in blood transfusion.
Blood safety data are collected bienniallyby WHO through a comprehensive surveyaddressed to national governments.
Highlights of the data available on:http://www.who.intienity/worldblooddonorday/resources/Data.xls
Improved meningitis vaccine for Africa could signal eventual end to deadly scourgeSuccessful Vaccine Trial Promises Long-Term, Low-Cost Protection From Epidemics in Africa
GENEVA – The Meningitis Vaccine Project(MVP) has released new data on the perfor-mance of a meningitis vaccine in WestAfrican children, suggesting that the newvaccine – expected to sell initially for 40US cents a dose – will be much more effec-tive in protecting African children and theircommunities than any vaccine currently onthe market in the region.
MVP, a partnership between the WorldHealth Organization and the Seattle-basednonprofit, PATH, is collaborating with avaccine producer, Serum Institute of IndiaLimited (SIIL), to produce the new vac-cine against serogroup A Neisseria menin-gitidis (meningococcus). The preliminaryresults of their study, a Phase 2 vaccinetrial, reveal that the vaccine could eventu-
ally slash the incidence of epidemics in the“meningitis belt,” as 21 affected nations ofsub-Saharan Africa are collectivelyknown. The vaccine is expected to blockinfection by the serogroup A meningococ-cus, and therefore extend protection to theentire population, including the unvacci-nated, a phenomenon know as “herdimmunity.”
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“When it becomes part of the public healtharsenal, this vaccine will make a real differ-ence in Africa,” said Dr. F. Marc LaForce,MVP director. “The vaccine will allowelimination of the meningococcal epi-demics that have afflicted the continent formore than 100 years.”
The new meningococcal conjugate vaccinetrial, in 12- to 23-month-olds in Mali andThe Gambia, shows that the vaccine wassafe, and that it produced antibody levelsalmost 20 times higher than those obtainedwith the marketed polysaccharide (un-con-jugated) vaccine. This means that protectionfrom serogroup A meningococcal meningi-tis is expected to last for several years.
‘‘This important study brings real hope thatthe lives of thousands of children,teenagers, and young adults will be savedby immunization and that widespread suf-fering, sickness and socioeconomic disrup-tion can be avoided,” said Dr. MargaretChan, Director-General of the World HealthOrganization.
“Elimination of these epidemics with wideuse of the meningococcal A conjugate vac-cine is now a likely possibility over the nextfew years,” said LaForce. “People betweenthe ages of 1 and 29 years of age will beprotected by receiving a single dose in largemass vaccination campaigns. The largecampaigns are expected to create herdimmunity, and eventually, elimination of thedisease.”
As a result of the encouraging preliminaryfindings of this Phase 2 clinical study, SIILand MVP will proceed with a Phase 2/3study where the vaccine will be tested in 2-to 29-year-olds—the population that will bemostly targeted by mass vaccination cam-paigns. Testing will take place in Mali, TheGambia, and at least one other Africancountry. An additional clinical study is
planned for this summer in India, where thevaccine will be licensed.
“Serum Institute of India is dedicated todeveloping safe, effective, and affordableproducts for the poorest countries in theworld,” said Dr. Cyrus Poonawalla,Chairman of SIIL. “These results confirmand extend the observations made last yearin our Phase 1 study in India. The new con-jugate vaccine has an excellent safety pro-file in young children, and it is immunolog-ically superior to the polysaccharide vac-cine.”
A conjugate vaccine joins (or “conjugates”)sugars from the meningococcal bacteriumwith a protein, which in turn stimulatesimmune cells. These cells then produceantibodies to meningitis, protecting theindividual from infection. A total of 600toddlers participated in the Phase 2 study.They were enrolled at two clinical sites inAfrica: Center for Vaccine Development(CVD)-Mali and the Medical ResearchCouncil (MRC) Laboratories in TheGambia. Dr. Brown Okoko, principal inves-tigator at the MRC site in Basse, said, “Theclinical teams at MRC and CVD-Mali iden-tify with the vision, mission, and mandateof the Meningitis Vaccine Project. We areall highly motivated and very proud to beable to contribute to the development of avaccine that is critically needed in Africa.”
Dr. Samba Sow, principal investigator atCVD-Mali, said, “Some of the families whoparticipated in the study have lost severalmembers of their family to meningococcalmeningitis. Those who have not been direct-ly affected know the terrible impact that thedisease has on the community. There is a lotof support for the clinical study and the newvaccine in the Bamako community.”
iGATE Clinical Research International, acontract research company in Mumbai,
India, is providing data management ser-vices.
“The plans for the future are quite ambi-tious,” said LaForce. “With the successfulcompletion of the Phase 2 study, and oncefunding is secured, we plan to do a demon-stration study next year in a hyperendemiccountry where we will take the vaccine topublic-health scale by immunizing theentire population between the ages of 1 and29. If all continues to go well in testing andduring the demonstration study, the newvaccine, which will be priced at about 40cents per dose, could be introduced inAfrica within the next two to three years.”
Meningitis is one of the world’s most dread-ed infectious diseases. Even with antibiotictreatment, at least 10 percent of patients die,with up to 20 percent left with permanentproblems, such as mental retardation, deaf-ness, epilepsy, or necrosis leading to limbamputation.
The most prominent groups of meningococ-ci are A, B, C, Y, and W135. While groupsA, B, and C are responsible for the majorityof cases worldwide, group A causes deadly,explosive epidemics every 8 to 10 yearspredominantly in what is known as theAfrican “meningitis belt,” an area thatstretches from Senegal and The Gambia inthe West to Ethiopia in the East. The belthas an at-risk population of about 430 mil-lion. The largest epidemic wave everrecorded in history swept across the entireregion in 1996–1997, causing over 250,000cases and 25,000 deaths. Africa has beenrelatively spared in recent years, but lastyear’s 41,526 reported cases and the 47,925cases reported from 1 January to 6 May2007 bring the fear that a new epidemicwave may have begun in sub-SaharanAfrica.
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