{"id":3582,"date":"2017-01-19T17:01:05","date_gmt":"2017-01-19T17:01:05","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/wmj22.pdf"},"modified":"2017-01-19T17:01:05","modified_gmt":"2017-01-19T17:01:05","slug":"wmj22-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/publicaciones\/world-medical-journal\/wmj22-2\/","title":{"rendered":"wmj22"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

wmj22<\/a><\/p>\n

No. 2, May 2009
\nEditor in Chief
\nDr. P\u0113teris Apinis
\nLatvian Medical Association
\nSkolas iela 3, Riga, Latvia
\nPhone +371 67 220 661
\npeteris@nma.lv
\neditorin-chief@wma.net
\nCo-Editor
\nDr. Alan J. Rowe
\nHaughley Grange, Stowmarket
\nSu\ufb00olk IP143QT, UK
\nCo-Editor
\nProf. Dr. med. Elmar Doppelfeld
\nDeutscher \u00c4rzte-Verlag
\nDieselstr. 2, D-50859 K\u00f6ln, Germany
\nAssistant Editor Velta Poz\u0146aka
\nwmj-editor@wma.net
\nJournal design and
\ncover design by J\u0101nis Pavlovskis
\nLayout and Artwork
\nThe Latvian Medical Publisher \u201cMedic\u012bnas
\napg\u0101ds\u201d, President Dr. Maija \u0160etlere,
\nHospit\u0101\u013cu iela 55, Riga, Latvia
\nCover painting :The picture is of the man
\nwho \ufb01rst was called doctor in Iceland,
\nHrafn Sveinbjarnarson (a name which is usual
\ntoday as well). He was born in 1166 and died
\nin 1213. He traveled to Norway, England,
\nFrance and Italy where it is believed that he
\nstudied medicine at the University of Salermo.
\nOne of the sagas written in the 12th
\nand 13th
\ncentury was dedicated to him and tells stories
\nof his abilities to heal and cure patients with
\nvarious illnesses.
\nPublisher
\nThe World Medical Association, Inc. BP 63
\n01212 Ferney-Voltaire Cedex, France
\nPublishing House
\nDeutscher-\u00c4rzte Verlag GmbH,
\nDieselstr. 2, P.O.Box 40 02 65
\n50832 K\u00f6ln\/Germany
\nPhone (0 22 34) 70 11-0
\nFax (0 22 34) 70 11-2 55
\nBusiness Managers J. F\u00fchrer, D. Weber
\n50859 K\u00f6ln, Dieselstr. 2, Germany
\nIBAN: DE83370100500019250506
\nBIC: PBNKDEFF
\nBank: Deutsche Apotheker- und \u00c4rztebank,
\nIBAN: DE28300606010101107410
\nBIC: DAAEDEDD
\n50670 K\u00f6ln, No. 01 011 07410
\nAt present rate-card No. 3 a is valid
\nThe magazine is published quarterly.
\nSubscriptions will be accepted by
\nDeutscher \u00c4rzte-Verlag or
\nthe World Medical Association
\nSubscription fee \u20ac 22,80 per annum (inkl. 7%
\nMwSt.). For members of the World Medical
\nAssociation and for Associate members the
\nsubscription fee is settled by the membership
\nor associate payment. Details of Associate
\nMembership may be found at the World
\nMedical Association website www.wma.net
\nPrinted by
\nDeutscher \u00c4rzte-Verlag
\nK\u00f6ln, Germany
\nISSN: 0049-8122
\nDr. Yoram BLACHAR
\nWMA President
\nIsrael Medical Assn
\n2 Twin Towers
\n35 Jabotinsky Street
\nP.O. Box 3566
\nRamat-Gan 52136
\nIsrael
\nDr. Kazuo IWASA
\nWMA Vice-Chairman of Council
\nJapan Medical Assn
\n2-28-16 Honkomagome
\nBunkyo-ku
\nTokyo 113-8621
\nJapan
\nDr. Mukesh HAIKERWAL
\nWMA Chairperson of the Finance
\nand Planning Committee
\n58 Victoria Street
\nWilliamstown, VIC 3016
\nAustralia
\nDr. Dana HANSON
\nWMA President-Elect
\nFredericton Medical Clinic
\n1015 Regent Street Suite # 302,
\nFredericton, NB, E3B 6H5
\nCanada
\nDr. J\u00f6rg-Dietrich HOPPE
\nWMA Treasurer
\nBundes\u00e4rztekammer
\nHerbert-Lewin-Platz 1
\n10623 Berlin
\nGermany
\nDr. Guy DUMONT
\nWMA Chairperson of the Associate
\nMembers
\n14 rue des Tiennes
\n1380 Lasne
\nBelgium
\nDr. J\u00f3n SN\u00c6DAL
\nWMA Immediate Past-President
\nIcelandic Medicial Assn
\nHlidasmari 8
\n200 Kopavogur
\nIceland
\nDr. Eva NILSSON-
\nB\u00c5GENHOLM
\nWMA Chairperson of the Medical
\nEthics Committee
\nSwedish Medical Assn
\nP.O. Box 5610
\n11486 Stockholm
\nSweden
\nDr. Karsten VILMAR
\nWMA Treasurer Emeritus
\nSchubertstr. 58
\n28209 Bremen
\nGermany
\nDr. Edward HILL
\nWMA Chairperson of Council
\nAmerican Medical Assn
\n515 North State Street
\nChicago, ILL 60610
\nUSA
\nDr. Jos\u00e9 Luiz GOMES DO
\nAMARAL
\nWMA Chairperson of the Socio-
\nMedical-A\ufb00airs Committee
\nAssocia\u00e7ao M\u00e9dica Brasileira
\nRua Sao Carlos do Pinhal 324
\nBela Vista, CEP 01333-903
\nSao Paulo, SP
\nBrazil
\nDr. Otmar KLOIBER
\nWMA Secretary General
\n13 chemin du Levant
\nFrance 01212 Ferney-Voltaire
\nFrance
\nWorld Medical Association O\ufb03cers, Chairpersons and O\ufb03cials
\nO\ufb03cial Journal of The World Medical Association
\nOpinions expressed in this journal \u2013 especially those in authored contributions \u2013 do not necessarily re\ufb02ect WMA policy or positions
\nwww.wma.net
\n43
\n\u201cGlass Pearls for Diamonds\u201d
\nIt is encouraging to see that gender di\ufb00erences in medicine now
\nget more attention. In this issue Petra Th\u00fcrmann gives a general
\noverview of gender-speci\ufb01c di\ufb00erences in pharmacotherapy putting
\na spot on an obvious concern in medicine we have long overlooked.
\nIt may not be of any use to blame somebody for this long-lasting
\nnegligence,but it is clear that continuing \u201cas-we-have-always-done-
\nit\u201dis no option. Petra Th\u00fcrmann distinguishes between sex as a bio-
\nlogical category and gender as a broader socio-biological concept.
\nAlthough overlooking the biological di\ufb00erences for ages, there will
\nbe more and even more painful revelations when we look deeper
\ninto the sociological di\ufb00erences in medical treatment.
\nWMA Past President Jim Appleyard, reminds us that likewise, our
\nhome has not been made when it comes to children.Their weakness
\nis re\ufb02ected in our apparent inability to properly include them in
\nmedical research and development.The balance between safeguard-
\ning children and providing the necessary research inclusion is – and
\nmost likely will remain – one of the most di\ufb03cult and mind twisting
\nethical challenges. Like the research on and for incapacitated pa-
\ntients and persons this question deserves our attention and care, our
\nengagement and, most di\ufb03cult, our dispassionate conclusions.
\nBut not only when looking at gender and age di\ufb00erences; inequi-
\nties are a far bigger problem than we are obviously willing to admit.
\nSearching ways to bring them to the attention of the individual phy-
\nsician and his daily practices is the focus of WMA president Yoram
\nBlachar. His Israeli Medical Association and many other groups
\nhave looked into ways of not only describing but also improving
\nthe chances for patients to get the treatment they need and want,
\nirrespective of their social, ethnic and economic background. His
\ncall comes in a time when societies and governments,politicians and
\neconomists highlight the problem, while at the same time their pro-
\nposals and laws turn medicine more and more into an odd mixture
\nof state control and commodity business,including direct or indirect
\nrationing which of course increases the existing inequalities.
\nIn the a\ufb04uent countries of this world the relation of physician to
\npopulation is 1\/500 or better. In the poorest countries of this world
\nthis goes down to 1\/50.000. Just by statistical numbers the chance
\nfor people in poor countries to see a physician is 100 times lower
\nthan in the rich countries. In reality it is even worse: Calling the
\nchance of an ordinary person in Malawi seeing a physician, as \u201cnil\u201d,
\nis a fair statement.
\nTo cope with that situation the World Health Organization has
\ncrafted the strategy of task shifting, which means shifting profes-
\nsional tasks to lay persons. To be quite frank the health professions\u2019
\norganizations don\u2019t like it. There is a good reason why nurses, mid-
\nwifes, physiotherapists, dentists, pharmacists and physicians are
\ntrained for years and years, have to be registered, to do continuing
\nprofessional development, satisfy quality controls, undergo supervi-
\nsion, be subject to recerti\ufb01cation etc.
\nDo we however, or more importantly, does this world have a choice?
\nWithout the involvement of lay people in health care there will be
\nno health care for many, if not most people in this world. It is not
\nthe question of whether we do it, rather one of how task shifting is
\nimplemented.
\nTask shifting, especially when done to save money, may result in the
\nexodus of even the last health professionals in a respective country
\nor region. Even worse, a badly managed tuberculosis programme or
\na botched anti-retroviral treatment campaign for HIV can turn out
\nas into a real nightmare and public health catastrophe.
\nIn her contribution Lea Wapner explains the common position
\nof the health professions to the method of task shifting. It takes a
\nproactive yet cautious approach, trying to avoid the danger of task
\nshifting spiralling down the health care systems of poor countries
\neven more.
\nInterestingly the concept of task shifting is being driven by the rich
\ncountries, the Europeans, the Canadians and the US, including the
\nprivate donor organizations.Their interest in this issue must be un-
\nder scrutiny as those countries at the same time are the main recipi-
\nents of the emigrating health professionals from the poor countries.
\nOne must no be a cynic to see what appears to be the bottom line:
\n\u201cthe rich countries trading in glass pearls for diamonds\u201d.
\nWMA past president J\u00f3n Sn\u00e6dal reports on a \ufb01rst WMA seminar on
\nhuman resources issues, which are occur in di\ufb00erent countries in dif-
\nferent appearances as \u201cscope of practice\u201dor \u201cskill-mix\u201dissues or some-
\ntimes only as an increased in delegation of tasks. The seminar has
\nbeen partnered by the Global Health Workforce Alliance (GHWA) a
\ngroup consisting of donors and partners in global humanitarian help.
\nIt is attached to the WHO in Geneva. GHWA is now developing
\nprogrammes to help poor countries train and retain their workforce
\nwhen implementing task shifting. The health professions closely co-
\noperate with GHWA in their programme for \u201cPositive Practice Envi-
\nronments\u201d to improve the workplace for all people working in health
\ncare. A challenge which, by the way, does not only a\ufb00ect the poor
\ncountries \u2013 just the opposite As long as the rich countries do not get
\ntheir human resource issues in order, the poor countries will continue
\nto su\ufb00er from an enormous brain drain.
\nDr. Otmar Kloiber, WMA Secretary General
\nEditorial
\n44
\nWMA news
\nYoram Blachar
\nFor over 150 years, the existence of health
\ninequality has been acknowledged world-
\nwide. However, despite the magnitude of
\nwritten documentation accumulated over
\nthis lengthy period, it is only within the last
\nthree decades that countries have been able
\nto provide conclusive evidence of the social
\nand economic consequences of inequality
\nin health and healthcare services. Health
\ninequalities extract a heavy human cost in
\nterms of morbidity and mortality rates, as
\nwell as from the moral implications of dis-
\ncrimination, even if unintended, among
\npopulations. They also result in economic
\nexpenses such as rising costs for preventa-
\ntive healthcare and days lost at work. It is
\nfor these reasons that health inequality is
\nand should be a top priority for legislation
\nall over the world.
\nIn 1971, an English family doctor, Julian
\nTudor Hart, coined the Inverse Care Law.
\nThis law states that \u201cthe availability of good
\nmedical care tends to vary inversely with
\nthe need for it in the population served.\u201d
\nDr. Hart came to this conclusion after
\nworking in the coal mining region of Wales.
\nThe signi\ufb01cance of his declaration lies in his
\nstatement that the quality of services pro-
\nvided by the health system, and all its com-
\nponents, is not in line with the true health
\nneeds of the various population groups, es-
\npecially those on the fringes of society.
\nIn Israel, as in many countries, health dis-
\nparities and inequalities span the ethnic,
\nsocio-economic, geographic and other de-
\nterminants. Some of these are readily ap-
\nparent. For example, Arab men and women
\nhave higher mortality rates as compared to
\ntheir Jewish counterparts, even when the
\nrates are standardized according to age.
\nDespite a large decrease in infant mortality
\nrates since the founding of the state,the rate
\nfor Arab populations remains twice that of
\nJewish populations.Jewish immigrants from
\nEthiopia are at a disadvantage in terms of
\nunderstanding physician instructions, re-
\nceiving quality healthcare and having their
\ndisease and treatment properly surveyed.
\nCitizens located in peripheral regions have
\nless accessibility to a number of specialty
\nservices as compared to those living in the
\ncentral areas of the country. Other factors
\nare more insidious, such as the \ufb01ndings that
\nlow levels of education results in higher
\nsmoking levels among Jewish and Arab
\npopulations. Social factors such as unem-
\nployment or social exclusion also impact on
\nhealth and the provision of services.
\nHealth inequalities manifest themselves
\nnot only as di\ufb00erences in morbidity and
\nmortality rates, but also as di\ufb00erences in
\nhealth risks, accessibility to and usage of
\nservices, provision of quality healthcare, and
\ntreatment outcomes. The main causes for
\nthese inequalities are socio-economic dif-
\nferentials, determined by varying levels of
\nsalary, acquired knowledge, occupation and
\noccupational hazards, housing, exposure to
\npollution, infectious diseases, and regional
\nviolence. Many of these elements are a di-
\nrect result of national governmental poli-
\ncies,but the healthcare system itself also has
\na great in\ufb02uence on the creation of health
\ninequalities, particularly in the areas of sup-
\nplying and \ufb01nancing healthcare services. It
\nis crucial that physicians continue to impact
\ngovernment so that they devise public poli-
\ncy that will minimize the inequalities in our
\nhealthcare system. The reasons for health
\ninequality are complex and include the na-
\ntional level (governmental policy concern-
\ning social inequality in general and health
\ninequality in particular); the health system
\n(the Health Ministry, healthcare organiza-
\ntions, and hospitals); medical professionals;
\nand the population itself.
\nIn the United Kingdom, national programs
\naimed a coping with inequalities in health
\nand bridging gaps began with The Black
\nReport, published in 1980. In 2003 a prac-
\ntical document, Tackling Health Inequalities:
\na Programme for Action, was published. In
\nSweden, also in 2003, The National Objec-
\ntives for Public Health in Sweden was pub-
\nlished and referred extensively to di\ufb00erences
\nin Health. In Holland a plan to reduce so-
\ncioeconomic inequalities in health was im-
\nplemented in 2001. In the USA, the results
\nof the Unequal Treatment study appeared
\nin 2002. In the study, conducted by USA
\nhealth institutes, signi\ufb01cant di\ufb00erences
\nwere found in medical treatment results be-
\ntween population groups, according to race
\nand ethnic background. The Israeli govern-
\nment has contributed to e\ufb00orts to minimize
\nhealth inequalities when in 1995 it passed
\nthe National Health Insurance Law. The
\nintention of this law was to guarantee that
\nall Israeli citizens are entitled to basic health
\ncare coverage.
\nAs healthcare professionals we must be
\naware of these inequalities and not only
\ntake responsibility for any contributions we
\nmight inadvertently make to the problem,
\nbut also advocate on behalf of our patients.
\nWe must provide uniform quality treat-
\nment, while remaining culturally sensitive
\nto our patients\u2019 speci\ufb01c needs. We must
\neducate those entering the profession about
\nthis large-scale problem and train them in
\nspeci\ufb01c ways to reduce the range and extent
\nof health inequalities.
\nThe Role of the Physician in Combating
\nInequalities in Health
\n45
\nWMA news
\nHowever, actions alone will not lead to
\nsigni\ufb01cantly minimizing health inequality.
\nTherefore, comprehensive policy must be
\nformulated, which will lead to coordinated
\nactivities between the health system and
\nparallel systems, including the following:
\nDecision-maker awareness should be in-
\ncreased concerning the grave signi\ufb01cance
\n(health, economic and social) for all of the
\nexisting situation.
\nMedical professional awareness should be
\nincreased concerning the serious implica-
\ntions of health inequality.
\nWe all need to act in order to:
\nPrevent the medical outcome of social,\u2022
\neconomic and cultural inequality.
\nIdentify and tackle existing health in-\u2022
\nequality in order to minimize it.
\nA multi-annual program must be deter-
\nmined to meet the de\ufb01ned needs of popula-
\ntion groups.The di\ufb00erence in infrastructure
\nand services between the peripheral and
\ncentral regions must be recti\ufb01ed urgently in
\na planned a\ufb03rmative action process.
\nDoctors stand in the forefront of providing
\nmedical services to the population. The in-
\nability to \ufb01nance the required treatment con-
\nstitutes a digression from the basic principles
\nof any national medical insurance law.
\nHealthcare services must be adapted lin-
\nguistically and culturally to the target popu-
\nlation,whether in the format of information
\nprovided o the individual and population
\ngroups, in the use of signs in di\ufb00erent lan-
\nguages or professional translation rather
\nthan untrained family members, and in sen-
\nsitivity to the cultural nuances important to
\ndi\ufb00erent ethnic groups.
\nMedical professionals should be provided
\nwith knowledge and skills aimed at training
\nthem to work with multicultural populations.
\nThis training must constitute an integral part
\nof professional studies on all levels (including
\nmedical specialization), especially for those
\nwho are already working in the system.
\nOur work is not done until everyone will be
\nable to bene\ufb01t from quality healthcare ser-
\nvices, regardless of socio-economic status,
\nethnic origin, or locale.
\nDr. Yoram Blachar, WMA President
\nDuring the last years, three issues have been
\ndiscussed inside the WMA in di\ufb00erent
\nworkgroups, Medical Workforce, Task
\nShifting and Prescribing. The General As-
\nsembly (GA) in Seoul decided to continue
\nto work on these issues in a seminar with
\ninput from other stakeholders. Further-
\nmore it was decided by the GA to accept
\nthe invitation of the Icelandic Medical As-
\nsociation to organize the seminar in Reyk-
\njavik, Iceland in March 2009.The Secretary
\nof the WMA and the o\ufb03ce of the IcMA
\ntook on the task to organize the seminar.
\nThe idea of this seminar was very well ac-
\ncepted by the member associations of the
\nWMA (the NMA\u00b4s) as well as by our par-
\ntners in the Health Service.The three inter-
\nnational associations of health professionals
\ninvited to speak accepted and sent high level
\npersons to the seminar. These associations
\nwere the International Council of Nurses
\n(ICN), the International Pharmaceutical
\nFederation (FIP) and the World Confed-
\neration for Physical Therapy (WCPT).
\nOther stakeholders were the WHO and the
\nGHWA and the last one agreed to \ufb01nance
\nnot only their own representative to attend
\nbut also three representatives from Africa.
\nThe attendance was very good as over 50 repre-
\nsentatives from all continents participated.The
\nseminar was held in a new hotel and confer-
\nence facilities at the Grand Hotel in Reykjavik.
\nThe Health Minister of Iceland addressed the
\nmeeting at the beginning and the \ufb01rst day was
\ndedicated to input from outside presentations
\nas well as reports from many di\ufb00erent NMA\u00b4s
\nHuman Resources for Health
\nand the Future of Health Care
\nWMA Seminar in Reykjavik (March, 8th
\n-9th
\n2009)
\n46
\nWMA news
\ndescribing their own experience in task shift-
\ning and professional collaboration.The second
\nday was used primarily for the workgroups
\nwhich used ideas from the \ufb01rst day for their
\nown work. This was facilitated by the rappor-
\nteur of the meeting prof.Vivianne Nathanson
\nfrom the BMA.
\nAs one of the promoters for this seminar I
\nam very pleased with the outcome for many
\nreasons.To work in a seminar like this helps
\nthe members of the WMA to come to con-
\nclusions in important issues. The WMA
\nrelies entirely on the NMA\u00b4s for making
\ndecisions on di\ufb00erent issues. The discus-
\nsions are most often taking place in the
\nstanding committees during council meet-
\nings or at the GA where the time frame is
\ntight. The outcome then relies mostly on
\nthe work of those NMA\u00b4s which are best
\nprepared for the issue and others might not
\nbe able to contribute so much. Workgroups
\ncreated by the WMA usually do not meet
\nbut rely mostly on the chair of the work-
\ngroup to prepare a draft of a document to be
\ndiscussed electronically and then at the next
\nmeeting. The electronic method is theoreti-
\ncally valuable and gives all in the workgroup
\nthe same possibility to participate but in
\nreality this is not always so. By discussions
\non speci\ufb01c issues in a seminar, the NMA\u00b4s
\npresent will then be better prepared for the
\n\ufb01nal decisions made at the following meet-
\ning. It is also a pleasure for me to be able to
\norganize such a seminar in my own country
\nand give the participants an opportunity to
\ncome to a country that has up to now not
\nhosted a WMA meeting.Lastly,in my work
\ninside the WMA I have promoted dialog
\nwith those we have common interests with
\nor are important recipients of our ideas and
\nwe are many that share this viewpoint. By
\nthat I mean on one hand other health pro-
\nfessionals and on the other the WHO and
\norganisations linked to the WHO like the
\nGHWA. It was a pleasure to witness a suc-
\ncessful WMA work on very important is-
\nsues. There will be continuous dialog at the
\nCouncil meeting in May in Tel Aviv and
\nthe \ufb01nal outcome will hopefully be reached
\nat the GA in New Dehli next October.
\nDr. J\u00f3n Sn\u00e6dal , Immediate Past-President
\nWMA, Icelandic Medical Association
\n47
\nWMA news
\nTai Joon Moon
\nThe WMA General Assembly Seoul,hosted
\nby the Korea Medical Association (KMA),
\ntook place over four days, beginning Octo-
\nber 15, 2008. Korea was overwhelmed with
\npride and honour to welcome the WMA
\nGeneral Assembly, which was the highlight
\nevent of the year for Korea as it celebrates
\nits 120th
\nanniversary of modern medicine
\nand the centennial of KMA. Modern medi-
\ncine was \ufb01rst introduced to Korea through
\nmedical missionaries from countries such
\nas Canada and the U.S. Since then Kore-
\nan medicine has continued its growth and
\nadvancement, including during times of
\nwar and rapid economic development. Ex-
\nchange with the international community
\nhas played a vital role in Korea\u2019s medical
\nprogress.
\nThe General Assembly discussed an agenda
\n\ufb01lled with a broad range of key topics. Of
\nparticular note, a revision of the WMA
\nDeclaration of Helsinki was adopted, as
\nwas a new policy, the WMA Declaration of
\nSeoul on Professional Autonomy and Clini-
\ncal Independence. The GA also decided to
\ndevote its next Scienti\ufb01c Session on Health
\nand the Environment.
\nThe Declaration of Helsinki on Ethical
\nPrinciples for Medical Research Involving
\nHuman Subjects, the focal point of keen at-
\ntention, was amended after several years of
\nintensive review to better address recent so-
\ncial and medical developments. Di\ufb00erence
\nof opinion did remain on the use of place-
\nbos, but, fortunately the Assembly managed
\nto reach a last minute agreement.
\nThe Declaration on Professional Autonomy
\nand Clinical Independence was proposed
\namidst a huge amount of attention and an-
\nticipation from the 90,000 Korean physi-
\ncians. On behalf of my Korean colleagues,
\nI express deep gratitude for the unanimous
\nadoption of the Declaration and the hon-
\nor of having it named the Declaration of
\nSeoul. The document includes statements
\nhighly relevant to Korea\u2019s current reality.
\nKorea began o\ufb00ering universal health in-
\nsurance in 1989. As a result, Koreans have
\ncome to receive medical care without having
\nto worry about excessive \ufb01nancial burdens,
\nincluding medicare bene\ufb01ts to the under-
\nprivileged 10% of the population. However,
\nthe payment system has created complicated
\nrelationships among the government, physi-
\ncians and insurers. In particular, the physi-
\ncian-patient relationship has su\ufb00ered from
\nconfusion on a number of fronts. Signi\ufb01cant
\nsacri\ufb01ce by physicians was required before
\nthe system stabilized and it was our dedica-
\ntion to patient care that enabled the system
\nto succeed. However, excessive interference
\nand regulation by the government has cre-
\nated severe friction between the government
\nand KMA. Some Korean patients, accus-
\ntomed to traditional medicine, demanded
\nnon-scienti\ufb01c treatments. For instance, Ko-
\nrean physicians had to overcome the beliefs
\nof some patients who strongly believed that
\nvisits to the doctor could not be complete
\nwithout a shot. The Seoul Declaration will
\nprovide practical support to Korean phy-
\nsicians who face such issues daily and will
\nserve as an important guideline in the future.
\nI imagine other nations with medical insur-
\nance are experiencing similar issues. There
\noften is a fundamental misunderstanding as
\nto who exactly is the medical provider. As
\nphysicians, we constantly need to be vigilant
\nagainst government or insurer attempts to
\ntake on the role of a provider and interfere
\nin the physician-patient relationship.
\nIn addition to the main business of the
\nGeneral Assembly, the Scienti\ufb01c Session on
\nHealth and Human Rights attracted great
\nattention from not only physicians but also
\nthe media. Deputy High Commissioner
\nof the UN High Commission for Human
\nRights, Kyung-Hwa Kang, was sent by the
\nUN Secretary General to speak about glob-
\nal human right issues related with health.
\nOther renowned speakers addressed topics
\nranging from poverty, human rights abuses
\nby political suppression, torture, human
\nrights abuses of prison inmates, the envi-
\nronment and human rights and medical ed-
\nucation on human rights. During my talk, I
\nintroduced Dr. Oliver Avison, a missionary
\ndoctor who had come to Korea in the late
\n19th
\ncentury and single-handedly corrected
\nserious social discrimination prevalent at
\nthe time in Korea.Through the true story of
\nDr. Avison, I wanted to emphasize the re-
\nsponsibility we share for human rights and
\nto demonstrate that we can muster enough
\npower and in\ufb02uence to make a di\ufb00erence if
\nonly we have the will.
\nI earnestly urge the WMA to continue to
\nexpand our horizons and presence in areas of
\ntraditional interest, such as ethics and phy-
\nsician-patient rights, as well as other critical
\nissues,such as human rights and the environ-
\nment.Even though physicians alone may not
\nbe able to solve all the human rights prob-
\nlems around us, the 2008 Scienti\ufb01c Session
\nwas meaningful in itself for inspiring every-
\none to speak up and demand change.
\nThe Seoul General Assembly also adopted
\nan emergency resolution that re\ufb02ects our
\nconcern as physicians regarding the cur-
\nrent global economic crisis. The resolution,
\nwhich passed unanimously, calls upon all
\ngovernments to maintain a high standard
\nUpon the Completion of the WMA General
\nAssembly Seoul
\n48
\nWMA news
\nof medical care and not to curb investments
\nnecessary for patient care despite economic
\nchallenges.I applaud the WMA for address-
\ning this crisis with a very timely response.
\nA special seminar on smoking cessation
\nprovided a series of presentations from top
\nspeakers and succeeded in attracting audi-
\nences beyond expectations. I hope that the
\nspecial seminar has motivated a more ag-
\ngressive response on the part of the WMA,
\nnational associations and individual physi-
\ncians to curtail the detrimental health and
\n\ufb01nancial impact of smoking. I promise an
\naugmented e\ufb00ort by KMA on this front in
\nthe future.
\nThe Seoul General Assembly was attended
\nby the President, the Prime Minister and
\nthe Minister for Health, Welfare and Fam-
\nily A\ufb00airs of the Republic of Korea, all
\nof whom paid high tribute to physicians\u2019
\ncontribution to extended human life and
\nexpressed their gratitude for physicians\u2019 ef-
\nforts. This should be accepted as their deep
\nhomage to not just KMA but all physicians
\naround the world \u2013 the 8 million colleagues
\nunder the WMA umbrella.
\nThe wide variety of topics on the General
\nAssembly agenda contributed greatly to en-
\nriching the outcomes of the meeting. The
\nsophisticated manner of proceeding and the
\nhigh level of participation both left indelible
\nimpressions on Korean members.I express my
\ndeepest gratitude to the WMA leadership \u2013
\nDr. Snaedal, Dr. Blachar, Dr. Arumugam, Dr.
\nHill and Dr. Kloiber – as well as the leaders
\nof each country, without whose contributions
\nthe KMA would not have been able to com-
\nplete this grand mission with such positive re-
\nsults.KMA now closes its \ufb01rst centennial and
\nprepares for its next. We pledge to continue
\nour endeavor to become better physicians and
\nmore ethical physicians serving our patients. I
\nam grateful to share this noble journey with
\neveryone in the WMA family.
\nTai Joon Moon, MD, PhD, President
\nEmeritus, KMA Chair, KMA
\nOrganizing Committee for WMA
\nGeneral Assembly Seoul 2008
\nLeah Wapner
\nThe WMA was faced with a daunting task
\nat its recent meeting in Reykjavik when
\ndiscussing the topic of task shifting. As the
\nWMA represents over 80 national medi-
\ncal associations, it is inevitable that diverse
\nand sometimes opposing views on the im-
\nplementation of task shifting will arise. For
\nexample, the British Medical Association
\nencourages the use of multi-disciplinary
\nteams while the Spanish Medical Associa-
\ntion is strongly opposed to the implemen-
\ntation of task shifting in any form. Both
\nthese associations’ views must be taken into
\naccount, along with over 80 others, for the
\nWMA to adopt a resolution of any scope
\non the topic.
\nThe \ufb01rst global conference on task shifting
\nwas held in Addis Ababa, Ethiopia in January
\n2008. Attendance included representatives of
\ngovernments, agencies, professional associa-
\ntions (such as the WMA), education, training
\nand research institutions.The conference end-
\ned with a declaration acknowledging the exist-
\ning shortage of healthcare workers and calling
\nfor action to be taken by the various parties
\ninvolved. The Addis Ababa Declaration per-
\nceived action as necessary in order to address
\nthe human resource constraints obstructing
\nthe implementation of UN Millennium De-
\nvelopment Goals which include: the reduction
\nof child mortality, improvement of maternal
\nhealth and the achievement of universal ac-
\ncess to HIV and AIDS services by 2010. In
\nresponse to the Addis Ababa Declaration, the
\nWorld Health Professional Alliance adopted
\ntwelve points on task shifting that were en-
\ndorsed by the WMA in May 2008.
\n1) Skill mix decisions should be country-speci\ufb01c
\nand take account of local service delivery needs,
\nquality and e\ufb00ectiveness factors, e\ufb03ciency, the
\ncurrent con\ufb01guration of health services and
\navailable resources, as well as production and
\ntraining capacity, and include the health pro-
\nfessions in decision-making.
\nCountry-speci\ufb01c guidelines are necessary
\nfor many reasons.The extent of a shortage in
\nhealth professionals di\ufb00ers between di\ufb00er-
\nent locales and perspectives for dealing with
\nshortages also di\ufb00er. Di\ufb00erent countries
\nare faced with di\ufb00erent health threats, with
\nsome threats being easier to deal through
\nthe use of task-shifted positions than oth-
\ners. Additionally, each country has its own
\nhistory of the evolution of di\ufb00erent health
\ncare disciplines. The creation of country-
\nspeci\ufb01c solutions allow for the maintenance
\nof the highest level of care.
\n2) Roles and job descriptions should be de-
\nscribed on the basis of the competencies re-
\nquired for service delivery and constitute part
\nof a coherent, competency-based career frame-
\nwork that encourages progression through life-
\nlong learning and recognition of existing and
\nchanging competence.
\nCompetency is very di\ufb03cult to de\ufb01ne.
\nEven if a de\ufb01nition of competency can be
\nagreed upon and su\ufb03cient data is available,
\ncomparing competencies is still a challeng-
\nWords from Reykjavik on Task Shifting as a
\nResponse to the Global Shortage in Health
\nCare Providers
\n49
\nWMA news
\ning feat. However, competency must be
\nachieved, as it is insu\ufb03cient to simply sta\ufb00
\nhealth care positions if workers are not able
\nto provide quality care. Once task shifting
\nhas been implemented, the level of health-
\ncare will deteriorate if healthcare personnel
\nare not exposed to new advances.
\n3) There needs to be su\ufb03cient health profession-
\nals to provide the required selection, training,
\ndirection, supervision, and continuing educa-
\ntion of auxiliary workers.
\nWhile the implementation of task shift-
\ning increases the amount of health workers
\navailable to implement more simple tasks,
\ntask shifting cannot blur the boundaries of
\neach health discipline. Keeping health dis-
\nciplines well-de\ufb01ned will assure that the ed-
\nucation, progression and de\ufb01nition of new
\nareas for expansion of the profession are in
\nthe hands of the correct individuals. It is the
\ntask of physicians to determine the require-
\nments for task shifted positions as they are
\ncurrently the ones performing these tasks.
\n4) Regulations for assistive personnel and
\ntask-shifting need to be set with the professions
\ninvolved. It should be clearly stated who is re-
\nsponsible for supportive supervision to assistive
\npersonnel. In any case the curriculum develop-
\nment, the teaching, supervision and assessment
\nshould always involve the health professionals
\nfrom whom the task is being shifted.
\nThe creation and implementation of a prop-
\ner legal and social framework is necessary to
\nuphold such regulations.
\n5) There must be adequate planning and
\nmonitoring to avoid the danger of generating
\na fragmented and disjointed system that fails
\nto meet the total health needs of the patient, of-
\nfers a series of disconnected and parallel services
\nthat are both ine\ufb03cient and confusing, and
\nmay lead to de-motivation and high attrition
\nrates.
\n6) Assistive personnel need compensation and
\nbene\ufb01ts that equal a living wage, a safe work-
\nplace and adequate supplies to ensure their own
\nsafety and that of patients. At the same time
\nthey should be expected to work within the code
\nof conduct of their employer.
\n7) Deploying assistive personnel will increase
\ndemand on health professionals in at least three
\nways:
\nincreased responsibilities as trainers and\u2022
\nsupervisors, taking scarce time away from
\nother tasks;
\nhigher numbers will be needed to take care\u2022
\nof the new patients generated by successful
\ntask-shifting;
\nhealth professionals will be faced with patients\u2022
\nwho have more complex health needs (the
\nsimpler cases will be covered by task-shifting)
\nand thus require more sophisticated analyti-
\ncal, diagnostic, and treatment skills.
\nThe use of assistive personnel should not be
\nimplemented as a cost-saving measure.New
\nsta\ufb00 requires adequate compensation.
\n8) There needs to be credible analysis of the eco-
\nnomic bene\ufb01t of task shifting to ensure equal
\nor better bene\ufb01t, i.e. health outcomes, cost ef-
\nfectiveness, productivity, etc. Ongoing evalua-
\ntion, particularly in skill-mix changes and the
\nintroduction of new cadres and or new models
\nof care, should systematically consider the im-
\npact on patient and health outcomes as well as
\non e\ufb03ciency and e\ufb00ectiveness.
\nCredible analysis is di\ufb03cult to execute. Inde-
\npendent analysis is even more di\ufb03cult as there
\nare so many di\ufb00erent vested interests at play in
\nthe implementation of task shifting. Analysis
\nmust take place over an extended amount of
\ntime as the results of task shifting can rarely be
\nsu\ufb03ciently observed immediately.
\n9) When task shifting occurs in response to spe-
\nci\ufb01c health issues such as HIV, regular assessment
\nand monitoring should be conducted on the en-
\ntire health system of the country concerned. In
\nparticular, quality assessment linked to overall
\nhealth outcomes of the population is essential to
\nensure that programs are improving the health
\nof patients across the health care system.
\nMaintaining focus on the patient is of ut-
\nmost importance when instituting task
\nshifting.Measurable quality indicators must
\nbe developed to assess an improvement or
\ndeterioration in the level of health. Assess-
\nment must be done for both intermediate
\nand long-term evaluation.
\n10) Assistive workers should not be employed at
\nthe expense of unemployed and underemployed
\nhealth professionals. Task-shifting should be
\ncomplemented by fair and appropriate remu-
\nneration of health professionals and improve-
\nment of their working conditions.
\nThe \u201cturf war\u201d issue cannot be ignored. This
\nissue must be taken into account both for
\nthe profession giving up its practices and for
\nthe profession acquiring additional tasks.
\nSelf-interests of the many di\ufb00erent players
\ninvolved in task shifting must be acknowl-
\nedged. For example, the World Bank and
\nnational governments have interests in sav-
\ning funds.Nurses are interested in acquiring
\nmore responsibilities. Physicians are inter-
\nested in transferring responsibilities. With
\nall these battling interests, it is important to
\nrelay its concern that preserving one’s pro-
\nfession is legitimate.
\n11) Where task shifting is meant as a long-
\nterm strategy it needs to be sustainable. If
\nmeant as short term, there needs to be a clear
\nexit strategy.
\n12) Assistive workers need to be integrated into
\nhealth care delivery systems and treated as part
\nof the team.
\nRegardless of existing shortages, the end re-
\nsult and the most important outcome of task
\nshifting must be the creation of teamwork.
\nIn conclusion, task shifting remains a topic
\nwhich challenges the global medical com-
\nmunity. The Seminar at Reykjavik aided in
\nclarifying some of the most pertinent issues,
\nbut the World Medical Association is still
\nfaced with the great challenge of creating a
\npolicy which is acceptable to all, or at least
\nmost, its members.
\nLeah Wapner, Secretary General,
\nIsrael Medical Association
\n50
\nMedical Ethics, Human Rights and Socio-medical a\ufb00airs
\nNachiappan Arumugam
\nThere are many requirements for the pro-
\nvision of e\ufb00ective and responsive health
\nsystems and we all recognise that a criti-
\ncal ingredient is a su\ufb03cient and appropri-
\nately trained workforce. Currently there is
\na growing challenge to maintain the needed
\nnumbers, quality, mix and distribution of
\npersonnel to meet the healthcare needs of
\nthe population The health workforce in-
\ncludes physicians, nurses, public health
\nworkers, policy makers, administrators,
\neducators, clerical sta\ufb00, scientists, pharma-
\ncists and health managers amongst others.
\nThe myriad of di\ufb00erent healthcare groups
\nwith overlapping skills and responsibilities
\nand maldistribution has brought about fric-
\ntion and disagreements. Various attempts at
\ndeveloping systems to achieve an amicable
\nworking relationship between the di\ufb00erent
\ncadres of workers in the healthcare system
\nhave met with various levels of success.
\nThe conference today on Human resources
\nfor Health and the future of health care in
\nthe world is focusing on some issues per-
\ntaining to task shifting. We have already
\nheard about the working arrangements in
\nmany countries between healthcare workers,
\ncomplementing one another in many areas
\nwhile locked in disagreement in other areas.
\nIn this presentation I am going to outline
\nthe development of human resources over
\nthe years in Malaysia and how an external
\norganisation like ASEAN (Association of
\nSouth East Asian Nations) and regional and
\ninternational treaties have and might a\ufb00ect
\nmedical human resources in the future.
\nTask shifting is not a new concept in Malay-
\nsia; it existed \ufb01fty years ago, when Malaysia
\nobtaineditsindependence.Atindependence,
\nthere were only forty-two primary health
\ncare facilities in the country, and medical
\ncare to the majority of the population was
\ncon\ufb01ned mostly to traditional remedies.
\nThe healthcare facilities that were present
\nat that time had only a limited number of
\ndoctors and a considerable amount of the
\nwork was delegated to hospital assistants
\nand midwives. Since then the health care
\nin Malaysia has notably undergone radical
\nchange through systematic planning and
\nbuilding of healthcare facilities. The Prima-
\nry health care facilities have grown to more
\nthan three thousand, comprising of health,
\ncommunity and mobile clinics. A range of
\ncomprehensive public health services na-
\ntionwide is provided, through wide varieties
\nof clinics and hospitals.
\nThe healthcare system in Malaysia currently
\ncomprises of both a public and a private
\nsector. The government, committed to the
\nprinciples of universal access to health care,
\nprovides both primary health and tertiary
\nhealth care to all, for free or at a minimum
\ncost. The service provided by the govern-
\nment is complemented, by a private health-
\ncare sector,which o\ufb00ers a more personalised
\nand luxury care.Over the last few years with
\ngrowing a\ufb04uence, the demand for private
\nhealth care has been escalating and the
\nnumber of new private healthcare facilities
\nhas increased rapidly.
\nMan power planning and training has been
\none of the cornerstones of the growth of
\nthe Malaysian health care system. Health
\nmanpower planning has been and is a chal-
\nlenge in Malaysia as it is in many parts of
\nthe world. Initially there were only a few
\ntraining centres in the country and the
\nmanpower needs were supplement by over-
\nseas trained sta\ufb00, but steadily the number
\nof local institutions training workers has in-
\ncreased and the country is nearly attaining
\nself su\ufb03ciency. Strategic manpower plan-
\nning and training was instituted many years
\nago to \ufb01ne tune training to the demands of
\nthe country, but the goal to achieving suf-
\n\ufb01ciency in healthcare manpower has been
\nelusive. The growing number of new medi-
\ncal facilities, increasing scope of medical
\npractice and changing world environment
\nhas constantly distorted and outstripped the
\nnumber of trained personnel.
\nThere has always been some movement of
\ndoctors and other healthcare workers espe-
\ncially nurses to and from other countries
\nwithout grossly disturbing the total man
\npower equilibrium. In recent times many
\nexternal factors have upset this delicate bal-
\nance. Globalisation has made it easier for
\nhealthcare workers to work in other coun-
\ntries either on a temporary or permanent
\nbasis. It is established that International
\nmigration has risen sharply in the recent de-
\ncade and has been described as \u201cone of the
\nde\ufb01ning issues of the 21st
\ncentury\u201d. Globali-
\nsation with rapid universal commercialisa-
\ntion, the availability of unrestricted infor-
\nmation and relatively easy travel has fuelled
\nthis evolution This movement of large num-
\nbers of healthcare personnel from country
\nto country including Malaysia has caused
\nuncertainty in the training, employment
\nand retention of healthcare professionals. In
\nthis uncertain healthcare workers market as
\nmany Malaysians go overseas to work the
\ncountry has had to recruit workers from
\nother countries to run the services here.
\nThe Association of Southeast Asian Na-
\ntions (ASEAN) is a geo-political and eco-
\nnomic organization of 10 countries located
\nin Southeast Asia which was formed on 8
\nAugust 1967 by Indonesia, Malaysia, Phil-
\nippines, Singapore, and Thailand. Since
\nthen, membership has expanded to in-
\nclude Brunei, Myanmar, Cambodia, Laos
\nand Vietnam. These countries have di\ufb00er-
\nent political systems \u2013 democracies of dif-
\nTask Shifting on Health Care
\n51
\nMedical Ethics, Human Rights and Socio-medical a\ufb00airs
\nfering standards, communist regimes and
\nmonarchies. These countries are at di\ufb00erent
\nlevels of economic development and their
\nhealthcare standards and availability to the
\ncitizens are grossly di\ufb00erent. In spite of all
\nthese di\ufb00erences this grouping is commit-
\nted to its aims – the acceleration of eco-
\nnomic growth, social progress and cultural
\ndevelopment among its members, and has
\ndrawn up many treaties to help move the
\nagenda forward.
\nThe regional grouping has made the most
\nprogress in economic integration, aiming
\nto create an ASEAN Economic Commu-
\nnity (AEC) by 2015. The AEC would have
\na combined population of over 560 million
\nand total trade exceeding US$ 1400 billion.
\nThe foundation of the AEC is the ASEAN
\nFree Trade Zone (AFTA), a common ex-
\nternal preferential tari\ufb00 scheme to promote
\nthe free \ufb02ow of goods within ASEAN. The
\nAFTA is an agreement by the member na-
\ntions of ASEAN concerning local manu-
\nfacturing in all ASEAN countries. The
\nAFTA agreement was signed on 28 January
\n1992. An ASEAN Framework Agreement
\non Trade in Services was adopted at the
\nASEAN Summit in Bangkok in Decem-
\nber 1995. Under AFAS, ASEAN Member
\nStates enter into successive rounds of nego-
\ntiations to liberalise trade in services with
\nthe aim of submitting increasingly higher
\nlevels of commitments. AFAS is aimed at
\nsubstantially eliminating restrictions to
\ntrade in trade in services among ASEAN
\ncountries in order to improve the e\ufb03ciency
\nand competitiveness of ASEAN services
\nsuppliers.
\nAFAS provides the broad guidelines for
\nASEAN Member Countries to progressive-
\nly improve market access and ensure equal
\nnational treatment for services suppliers
\namong ASEAN countries. All AFAS rules
\nare consistent with international rules for
\ntrade in services as provided by the General
\nAgreement on Trade in Services (GATS)
\nof the World Trade Organisation (WTO).
\nIn fact, liberalisation of services trade under
\nAFAS shall be directed towards achieving
\ncommitments beyond Member Countries\u2019
\ncommitments under GATS, or known as
\nthe GATS-Plus principle.
\nMutualRecognitionArrangements(MRAs)
\nare the more recent development in ASEAN
\nco-operation on trade in services. MRAs
\nenable the quali\ufb01cations of professional
\nservices suppliers to be mutually recogn-
\nised by signatory member countries, hence
\nfacilitating easier movement of profes-
\nsional services providers in ASEAN region.
\nASEAN Member Countries continue to
\nwork on further expanding the negotiations
\nto cover all sectors and all modes of supply.
\nThe ASEAN Economic Community Blue-
\nprint adopted by the ASEAN Leaders at
\nthe 13th ASEAN Summit on 20 November
\n2007 in Singapore sets out concrete steps to
\nbe taken to achieve a free \ufb02ow of services by
\n2015 with \ufb02exibility.MRA on Nursing Ser-
\nvices signed on 8 December 2006 in Cebu,
\nthe Philippines. MRA on Medical Practi-
\ntioners, MRA on Dental Practitioners, and
\nMRA Framework on Accountancy Services
\nall signed on 26 February 2009 in Cha-am,
\nThailand.
\nTask shifting refers to shifting of tasks from
\none cadre of healthcare worker to a lower-
\nlevel cadre or shifting tasks to a new cadre.
\nThough there has not been any recent policy
\non task shifting, there is a historical legacy
\nallowing less specialised health workers to
\nprovide some of the healthcare services.The
\nprovision of healthcare in the remote areas,
\nespecially in the eastern part of the country,
\nhas always been laden with di\ufb03cult. Gen-
\nerally para-medical sta\ufb00s that have been
\ncredentialed and registered have played a
\ncrucial role in providing healthcare in these
\nregions with some amount of supervi-
\nsion. The involvement of the communities,
\nthrough volunteer health workers, has also
\nhelped to extend health services to the re-
\nmote areas and disseminate public health
\nmatters. The policy of the government is to
\ntrain su\ufb03cient medical personnel to ful\ufb01l
\nthe manpower needs and this is re\ufb02ected on
\nthe increase from one medical school \ufb01fty
\nyears ago to twenty medical schools today
\nand the establishment of many other train-
\ning facilities.
\nWhile we are debating the role of di\ufb00erent
\nhealthcare worker and their responsibilities
\nlets us also not overlooks how all the new
\ntreaties, groupings, technology and globali-
\nsation will a\ufb00ect the healthcare worker and
\nthe delivery of healthcare.
\nDr. Nachiappan Arumugam,
\nImmediate Past-President WMA,
\nMalaysian Medical Association
\nCPME Subcommittees,Board and General
\nAssembly met on 13 th
\nand 14 th
\nMarch
\n2009 in Prague.
\nThe following policy
\ndocuments were adopted:
\nCPME reaction to the Green Paper on the
\nEuropean Workforce for Health
\nAlthough the Green Paper addresses most
\nof the CPME\u2019s concerns, CPME would
\nlike to highlight some of the issues and put
\nthem higher on the priority list.These issues
\nare: the scope of the workforce for health,
\nageing of the population, sustainability of
\nhealth systems, demography and the pro-
\nmotion of a sustainable health workforce,
\nPublic Health capacity, training and man-
\naging mobility, global migration of health
\nworkers, impact of new technology, and the
\nrole of health professional entrepreneurs.
\nIn addition to the considerations regard-
\ning these issues, CPME wants to steer clear
\nCPME Board meeting
\n14th
\nMarch 2009 outcomes
\n52
\nCPME news
\nfrom any healthcare-system discussion and
\nparticularly on their respective advantages
\nor disadvantages. In the case of entrepre-
\nneurial stimulation the above mentioned ar-
\nguments show that a strict equality between
\npublic and private sectors would be needed
\nin order to achieve the proposed actions.
\nIn its response, CPME identi\ufb01es several
\nclear positions that it will submit to the Eu-
\nropean Commission for consideration.
\nCPME reaction to the Communication
\nfrom the European Commission on tele-
\nmedicine
\nTelemedicine can make physical distance
\nbetween patients and physicians a less im-
\nportant factor. Telemedicine can therefore
\nprovide better access to health care to people
\nin remote areas, improve the quality of life
\nof chronically ill patients and reduce hos-
\npital stays. Subsequently, this will not only
\nbe to the advantage of patients, but also ad-
\nvantageous for relatives and the health care
\nsector in general.
\nAlthough telemedicine could also enhance
\ninequity in health care. CPME therefore
\ncalls on health authorities and govern-
\nments to ensure that new technology must
\nbe available to all, irrespective of their social
\nor economic background. Furthermore, it is
\nalso the task of governments to \ufb01nd ways to
\ncontain the rising costs of providing health
\ncare and to \ufb01nd a\ufb00ordable ways to provide a
\nreasonable level of care.
\nThe development of telemedicine will most
\nlikely continue to be technological and mar-
\nket driven. Health care for the ageing popu-
\nlation and self-management of chronic dis-
\neases will in the near future become a huge
\nmarket for health care delivery. CPME
\ntherefore stresses that physicians must have
\na central role in the development of tele-
\nmedicine and that the development should
\nnot be driven mainly by industry. Physician
\ninput is needed to ensure that telemedicine
\nis developed in the best interest of the pa-
\ntient, as well as to the bene\ufb01t of the medical
\nprofession.
\nLegal Control of Tobacco Products
\nThe toll of disease and death caused by the
\nuse of tobacco products as recommended
\nby their manufacturers is immeasurably
\ngreater than that attributed to the abuse of
\nany drug which is universally classi\ufb01ed as
\n\u00abdangerous\u00bb and subject to criminal sanc-
\ntions. Therefore, The CPME calls for the
\ntobacco manufacturing industry to be given
\nten years’ notice of the Committee’s inten-
\ntion to press for tobacco products to be
\nclassi\ufb01ed as dangerous drugs and controlled
\naccordingly. The CPME however strongly
\nbelieves that smokers and users of other
\nmanufactured tobacco products should not
\nbe incriminated.
\nAchieving Healthcare information for all
\nby 2015
\nThe CPME recognises that the availability
\nof relevant, reliable health information con-
\ntributes to prevent death and su\ufb00ering and
\nto increase the e\ufb03ciency of health systems.
\nThe CPME supports e\ufb00orts to improve the
\navailability of healthcare information for
\nprofessionally isolated healthcare providers
\nin Europe.
\nTherefore,the CPME supports HIFA20151
\nand calls upon other European medical and
\nhealth professional organisations and scien-
\nti\ufb01c societies to do the same and to actively
\ncontribute to the international dialogue.
\nEnd Water Poverty
\nIn order to address the global crisis in water
\nand sanitation, CPME joins the End Wa-
\nter Poverty campaign2
\nand urges individual
\nmember associations to do the same.CPME
\ncalls on Governments to establish a Global
\n1 HIFA2015 is an international campaign and
\nknowledge network with more than 2000 mem-
\nbers from 135 countries worldwide. http:\/\/www.
\nhifa2015.org
\n2 End Water Poverty is an international campaign,
\ndriven by a growing coalition of organisations, call-
\ning for immediate action and for water resources to
\nbe protected and shared equitably. http:\/\/www.end-
\nwaterpoverty.org
\nFramework for Action to ensure sanitation
\nand water for all; and to ful\ufb01l the commit-
\nment made in the EU Agenda for Action
\non the Millennium Development Goals.
\nMental Health in workplace settings
\nThe CPME recognizes the importance of
\nmental health in workplace settings and
\nstrongly believes that having healthy work-
\ning environments with the right preventive
\nmeasures in place will contribute to a drop
\nin work related mental health problems, a
\ndrop in absenteeism due to mental health
\ndisorders, a drop in accident related to work
\nrates, an increase in self-con\ufb01dence and
\nemployee morale in work populations and
\nemployees who are healthy and \ufb01t.
\nThe CPME endorses the WMA Declara-
\ntion of Helsinki
\nThe CPME endorsed the WMA Declara-
\ntion of Helsinki on Ethical principles for
\nmedical research involving human subjects,
\nas adopted by the WMA General Assembly
\nin Seoul, Korea in October 2008.
\nAt its General Assembly meeting in Prague
\non 14 March 2009, the CPME elected the
\nPresident and Executive Committee for the
\nperiod 01\/01\/2010 to 31\/12\/2011:
\nPresident:\u2022 Dr Radziwill, Poland
\nVice Presidents:\u2022
\nDr Montgomery, Germany
\nDr Kubek, Czech Republic
\nDr Lemye, Belgium
\nDr Pruckner, Austria
\nTreasurer:\u2022 Dr Fjeldsted, Iceland
\nAll CPME Policy documents are available
\nat: http:\/\/www.cpme.eu\/policy.php
\nFor more information about CPME, con-
\nsult our website: http:\/\/www.cpme.eu
\n53
\nCPME news
\nCPME representing 2 million physicians,
\nis delighted that the Members of the Eu-
\nropean Parliament have adopted the Cer-
\ncas Report on the amendment of Directive
\n2003\/88\/EC concerning certain aspects of
\nthe organisation of working time.
\nThe European Working Time Directive is
\nthe cornerstone of labour protection in the
\nEU. Since there is a very strong link be-
\ntween doctors’ and patients’ health, CPME
\nwelcomes Parliament\u2019s vote. Any amend-
\nment to this Directive that would imply a
\ndeterioration of the social conditions and
\ndiscrimination of the medical profession
\nshould be rejected.
\nWe therefore congratulate the European
\nParliament for sharing their position with
\n2 million physicians and advocating that:
\nThere should be a maximum average\u2022
\nworking week of 48 hours
\nAll time spent at the premises of the\u2022
\nemployer should be counted as working
\ntime,as it is already recognised by the Eu-
\nropean Court of Justice.
\nCPME celebrates this victory and will con-
\ntinue the European movement to improve
\ndoctors\u2019 working conditions. We encour-
\nage the Parliament to keep a \ufb01rm stance on
\nthese basic principles towards the Council
\nduring the conciliation phase.
\nAll documents mentioned are also
\navailable directly on CPME website
\nwww.cpme.eu
\nEuropean Physicians
\nCongratulate the
\nParliament for
\nAdopting the Cercas
\nReport
\nWhat is the Added Value of EU Health
\nPolicies for National Health Systems?
\nOn 23 April 2009, the European Parliament ENVI Working Group on Health held a
\ndebate on \u201cWhat is the Added Value of EU health policies for National Health Systems?\u201d
\nDuring the discussions, there was a special emphasis on the \ufb01nancial crisis and its implica-
\ntions on the Health Gap between \u201cOld\u201d and \u201cNew\u201d Member States.
\n\u201cFirst I would like to congratulate the
\nCPME for having organised this get to-
\ngether and I hope it will be the start of a
\nlong running initiative.
\nIt is important at EU level to have structured
\nand competent groups in order to support
\nhealth related initiatives and to counterbal-
\nance other pressure groups having category
\ninterests opposing our health objectives.
\nWe need a strong representation of patients
\nand consumers but it is also important to have
\nby our side the health care providers groups
\nand \ufb01rst amongst them, the physicians.
\nAt political level the many physicians in the
\nEuropean Parliament can be instrumental
\nin shaping EU health policies. Who else
\nbut the physicians can advocate for and lead
\nhealth actions?
\nThis is even more important at EU level
\nconsidering the e\ufb00orts that are sometimes
\nrequired to demonstrate the added value of
\nhealth initiatives at EU level.
\nIndeed the fact that the Member States re-
\ntain their competences in organising, pro-
\nviding and funding the provisions of health
\ncare for their citizens should never be a rea-
\nson for us to disregard the added value we
\ncan bring to their policies due to other EU
\nspeci\ufb01c \ufb01elds of competences but also due
\nto the huge potential of cooperation which
\nexists in Europe.
\nHealth is always di\ufb03cult to promote when
\nit interferes with economic interests and
\nprivate behaviours. Health initiatives could
\nbe seen either to be going against short term
\neconomic gains, or interfering too much
\nwith peoples’ lives.
\nFor all these reasons it is important to be
\nable to build strong cases for justifying
\nthose health actions where general interest
\nshould prevail.
\nLiving in a media driven society where the
\nloudest voice seems often to be the right
\none, and where unfortunately there still
\na lack of active and vocal pro-health lob-
\nbies, it has became indispensable to advo-
\ncate, justify and actively promote any public
\nhealth initiative.
\nIn the recent past we observed how other
\ninterest groups are organised.
\nA good example was seen during the recent
\ndiscussions on the nutrition pro\ufb01les initia-
\ntive which should implement the legislation
\non nutritional and health claims, where it
\nwas very clear that the \u00abagri and food lob-
\nby\u00bb promoted their ideas loudly, some of
\nthem being good I admit, but most of them
\nbeing only in defence of their own sectored
\ninterests.
\nThe voices of consumers, patients and phy-
\nsicians have not been heard loud enough in
\nsuch a context to counterbalance their argu-
\nments.
\n\u201cEU Added-Value in health policies during the \ufb01nancial crisis\u201d
\nSpeech by Commissioner Androulla Vassiliou
\n54
\nCPME news
\nMore generally in terms of securing public
\nhealth objectives, forums like this one today
\ncan help to e\ufb00ectively contribute to creating
\na \u00abhealth\u00bb minded network to help achieve
\nour policy objective of promoting public
\nhealth strategies more strongly.
\nAnd the promotion of public health strate-
\ngies will become even more important in a
\ntime of economic crisis.
\nA key challenge facing Europe and the
\nworld at this moment is to prevent the eco-
\nnomic crisis spiralling into a health crisis.
\nWe know from past experience that in
\ntimes of crisis health outcomes are greatly
\na\ufb00ected by changes in the resources avail-
\nable for health systems.
\nMany of the human consequences of reces-
\nsion are becoming apparent \u2013 consequences
\nsuch as higher unemployment; reductions
\nin income; and widespread stress and inse-
\ncurity. Economic crisis could also lead to a
\nfood crisis in terms of nutrition and quality
\nstandards.
\nMany other repercussions may only become
\nnoticeable some years from now \u2013 such as
\nlower productivity and lower labour partici-
\npation due to poor health.
\nHence it is vital that we re\ufb02ect all togeth-
\ner upon these challenges and focus our
\nthoughts on what needs to be done to miti-
\ngate or prevent a worsening of our public
\nheath status.
\nIndeed one of the political consequences of
\nthe current crisis is that it should strengthen
\nthe case for targeted EU actions on health
\npolicy.
\nI could also take another example where
\nhealth systems in EU will be at stake: the
\ndemographic shift in Europe’s population.
\nThe consequences of our ageing population,
\nwill, if nothing is done, have a signi\ufb01cant
\nimpact on the \ufb01nancing of European wel-
\nfare systems, including healthcare.
\nOne way to relax somehow the pressure
\non these systems would be to develop new
\ntechnologies at EU level, to increase econo-
\nmies of scales and to spread and make avail-
\nable robust health technology assessments
\nin order to spend the available budget in the
\nmost e\ufb03cient ways.
\nIn this and in other areas, we need to rec-
\nognise that action at EU level can play an
\nimportant role to ensure positive synergies
\namong the Member States through coop-
\neration and coordination.
\nIf we consider the existing gaps and diver-
\ngences between our Member States I be-
\nlieve that the EU can also assist those states
\nwhich aim at modernising their healthcare
\nand public health schemes, in particular by
\nhelping national health systems to \ufb01nd al-
\nternative and modern ways of ensuring cost
\ne\ufb00ectiveness and optimal use of resources.
\nAnother relevant area is that of rare diseases.
\nNot all Member States have the resources
\nor expertise to provide e\ufb00ective treatment
\nfor every rare disease.
\nThis is one the reason why the Commission
\nis promoting the creation of European Ref-
\nerence Networks on particular conditions.
\nThis aspect is duly taken into account in the
\nproposal for a directive on patients rights in
\ncross border health care.
\nThese networks should give patients better
\nopportunities to gain access to diagnosis
\nand treatment and will avoid duplication of
\ne\ufb00orts by Member State.
\nThe good health of citizens demands long-
\nterm investment. And investment in good
\nhealth does not only mean healthcare and
\ntreatment, but also health promotion and
\nprevention.
\nIn time, this investment will pay o\ufb00 \u2013 in
\nquality of life, in lower healthcare bills and
\nin a more productive workforce.
\nWorking with health stakeholders is a key
\npart of our health strategy. And it is obvi-
\nous to me that to respond e\ufb00ectively to the
\nchallenges of the present \ufb01nancial crisis we
\nneed their contribution.
\nI therefore want to engage with networks
\nof health professionals such as the Standing
\nCommittee of European Doctors (CPME),
\nto raise awareness about health issues and
\nhelp move these issues further up the politi-
\ncal agenda.
\nAs a body representing all medical doc-
\ntors in the EU, the CPME is in a unique
\nposition to o\ufb00er broad expertise in matters
\nrelated to medicine and the medical profes-
\nsion, on which the Commission can build.
\nI encourage you to be more present, more
\nvocal in helping me to implement those
\npolicies which our citizens need to bene\ufb01t
\nfrom better health conditions. In your ac-
\ntions coordination with those of your col-
\nleagues sitting in the European Parliament
\nwill be essential.
\nThis year is an important year for the Euro-
\npean Union \u2013 a year to re\ufb02ect on priorities
\nto be determined at European level, but also
\na year when politicians will be absorbed in
\ntrying to tackle the e\ufb00ects of a deep eco-
\nnomic crisis.
\nDiscussions on the future Community bud-
\nget post-2013 will start later this year and
\ncontinue into next year. Much will depend
\non the new Commission and the new Par-
\nliament to de\ufb01ne the ambition and resourc-
\nes for future European health policy.
\nThe Commission is making every e\ufb00ort
\nto help \ufb01nd solutions to the problems we
\nface \u2013 to pool resources; to bring people and
\ninstitutions together; and to achieve econo-
\nmies of scale.
\nI sincerely hope that you will be part of this
\ne\ufb00ort and help us to strengthen EU health
\npolicy.
\nYou have a central role to play: play it!\u201d
\n55
\nCPME news
\n\u201cI am happy to have the opportunity to
\nspeak about the consequences of the current
\neconomic crises on health care in Eastern
\nEurope.
\nThe economic crisis in Eastern Europe is
\npart of the global \ufb01nancial meltdown that
\ncan be traced to the real estate crisis in the
\nUnited States and the crash of several \ufb01nan-
\ncial pyramids. The result was a break-down
\nin the \ufb01nancial systems of many countries,
\nincluding Latvia. In Latvia this crisis was
\nintensi\ufb01ed by the state\u2019s takeover of the
\ncountry\u2019s largest private bank at the end of
\n2008. In this takeover, the state invested in
\nthe bank an expenditure that corresponds to
\none and a half times the annual budget for
\nhealth care in Latvia.
\nThese expenses led to a sizable decrease in
\nthe health care budget of Latvia. The cut in
\nhealth care occurred despite recommenda-
\ntions made by the World Health Organi-
\nzation to avoid compromising health care
\nduring the economical crisis. These rec-
\nommendations were documented in state-
\nments: the \u00abImpact of the global \ufb01nancial
\nand economic crisis on health\u00bb by the Direc-
\ntor-General of World Health Organization,
\nDr. Margaret Chan, in 2008 and \u201cResolu-
\ntion on the Economic Crisis: Implications
\nfor Health\u00bb, adopted by the World Medical
\nAssociation General Assembly in 2008.
\nSince its independence until recently, the
\nde\ufb01cit of the Latvian budget never exceeded
\n3%. The current forecast is that the nation\u2019s
\nbudget de\ufb01cit could reach a staggering 7 to
\n10 %. As a result of this de\ufb01cit, the coun-
\ntry started to cut expenses \u2013 it chopped 9%
\nfrom the health care budget in December
\n2008, and another 6% in February, 2009.
\nWe are now faced with the prospect of de-
\ncreasing the health care budget by an ad-
\nditional 20% to 40%.
\nI would like to bring to your attention what
\nhappened in a small African counrty, that
\nwas noted in the world press. Cote d\u2019Ivoire
\nhas one doctor for 6000 inhabitants and
\none nurse for more than 2000 inhabitants.
\nAt the same time there are 800 unemployed
\ndoctors in the country. This situation was
\ncaused by directives from the World Bank
\nand the International Monetary Fund to
\ndecrease the number of state employees.The
\nnumber of doctors was lessened, but not the
\nnumber of army o\ufb03cers and civil servants.
\nIt is too early to compare the situation in
\nCote d\u2019Ivoire to the predicaments of Latvia,
\nLithuania, Hungary
\nand Romania, the
\neconomic crisis we
\nare facing raises the
\nspectre of patients
\nreceiving greatly re-
\nduced or no health
\ncare services at all.
\nHow did we arrive in
\nthis predicament? I
\nwill take Latvia as an
\nexample and then ex-
\npand the discussion.
\nIn the late 1980\u2019s
\nhealth care in Soviet
\nLatvia was regard-
\ned as the best in the USSR (which might
\nnot be saying much): maternal and infant
\nmortality rates were comparable to those
\nin Western Europe, primary and secondary
\nhealth care was good, and other indicators
\nwere also close to Western Europe.
\nWith the dissolution of the Soviet Union,
\nthe communist economic system was re-
\nplaced by a free market economy.The newly
\nindependent and semi- independent states
\nwere confronted with economic breakdown,
\nhigh unemployment and social inequality.
\nHealth-wise this manifested itself as de-
\npression, alcoholism, high use of tobacco,
\npoor nutrition, family instability, stress-
\nrelated disorders, increased mortality from
\ncardiovascular diseases,high rates of suicide,
\naccidents in general and a sharp decline in
\nthe provision of health care.There even was
\na term created \u201ctransition time losses.\u201d In
\nByelorussia, Lithuania, Latvia and Estonia
\nthe life expectancy of men dropped by three
\nto 3 1\/2 years decrease for men and that of
\nwomen decreased by 1 1\/2 to two years.
\nIn Latvia,as well as other Eastern European
\ncountries, countless changes and reforms
\n\u201cEconomic Crises on Health Care in Eastern Europe\u201d
\nSpeech by Editor-in Chief of WMJ P\u0113teris Apinis
\nCommissioner Androulla Vassiliou
\nDr. Peteris Apinis, Editor-in-Chief of the World Medical Journal
\nDr. Michael Wilks, President Standing Committee of European
\nDoctors (CPME)
\nThe current co\u2013chairmen of the Health
\nWorking Group Prof. Georgs Andrejevs, MEP
\nProf. Victorio Prodi, MEP
\n56
\nCPME news
\nwere undertaken. The road was not entirely
\nsmooth, however. In medical care, multiple
\nnew medical establishments developed.
\nThese small institutions competed with each
\nother, following the dictum of \u201cmedicine as
\na source of pro\ufb01t\u201d. A typical scene was this:
\nin a small town – on one side of the street
\nwas a hospital with a new computerized to-
\nmography unit; on other side of the street
\nwas an out-patient clinic that also needed
\ncomputerized tomography to keep up. One
\nof these devices had been bought by loan,
\nanother \u2013 by leasing, so both of them were
\nacquired under long-term \ufb01nancial com-
\nmitments.
\nThis situation was not unique to health
\ncare: Banks and commerce sectors adver-
\ntised credits on goods and consumer credit
\nexpanded very quickly in the new national
\neconomic system. In medicine, suppliers
\nwere ready give credit to hospitals and other
\nhealth institutions, asking for long-term
\npaybacks. But at the same time, there was
\na decrease in the production industry. Fac-
\ntories were taken down and housing built.
\nThere was a dramatic price increase in real
\nestate and a quickly expanding \u201cbubble\u201dthat
\n\ufb01nally broke.
\nIn several Eastern European countries,
\nshort-term credits exceed more than 80% of
\nthe budget of the hospitals. Many munici-
\npalities became insolvent this year because
\nthey took big credits to purchase devices for
\ntheir local hospitals. It has been mentioned
\nin the press that many of the acquired de-
\nvices bought by Eastern European coun-
\ntries were overpriced and not adequately
\nequipped.This raises the concern of whether
\ncorruption played a role in these purchases.
\nLet us talk about reimbursed medication.
\nThe di\ufb00erence between reimbursed medi-
\ncation expenditure in Eastern Europe and
\nWestern Europe is ten fold. Latvia is bud-
\ngeted to spend 42 Euros per capita for reim-
\nbursed medication (last year it was 48 Eu-
\nros). In comparison, in the European Union
\nthe expenditure for medication reimburse-
\nment is 350 Euros per capita. In Latvia the
\nTOTAL expenditure of the state health
\ncare system is only
\n336 Euros per capita.
\nPatient payment for
\ncertain services is in-
\ncreased to 75%.
\nWe are now threat-
\nened with another
\n20% cut in the health
\nbudget of Latvia in the
\nsecond half of 2009.
\nThis would bring
\ndown the Latvian per
\ncapita health expen-
\nditure to a mere 269
\nEuros on average. It
\nis not surprising that,
\naccording to the Con-
\nsumer Health Index
\nprepared by Swedish expert Arne Bjornberg
\nand Czech Professor Marek Ulrich, Latvia
\noccupies the last position – number 31.
\nWe may still be ahead of Byelorussia,
\nUkraine and Moldova, but to be with them
\ncannot be the aim for Latvia, a member
\nstate of European Union. In the European
\nUnion public health is measured in terms of
\nprimary health care specialist accessibility,
\nthe number of neglected cases of cancer,the
\nincidence of heart attacks in di\ufb00erent age
\ngroups, infant mortality rates, accessibility
\nof mammography, lost life years, etc. All
\nthese indicators are impaired by the huge
\n\ufb01nancial di\ufb03culties, as well as bureaucratic
\nobstacles.
\nI don\u2019t want to bother you with statistical
\ndata about the concerns of Latvia,the Baltic
\nStates or Eastern Europe. All the statisti-
\ncal indicators for the health status of the
\npopulation are on a strong decline in East
\nEuropean countries, especially when com-
\npared with the health status of people living
\nin Western European countries.
\nI would like to say a few words about the
\nmigration of health professionals. Approxi-
\nmately 10% of our graduates go to work in
\nWestern European clinics during the \ufb01rst
\nyear after receiving their medial diplomas.
\nAnother 10% disappear from Latvian pa-
\ntient care step by step as they continue to
\nlearn, move on to science, to pharmacologi-
\ncal \ufb01rms or research or even worse, into the
\nbusiness world unrelated to health care.
\nA major problem for Latvia is the recruit-
\nment of doctors and nurses to other West
\nEuropean countries. In Latvia, at least two
\ncompanies constantly work to recruit medi-
\ncal sta\ufb00 to go to French and English speak-
\ning countries as well as to Scandinavia.
\nEvery doctor or nurse who leaves Latvia is
\nreally great loss to the country.Western Eu-
\nrope takes away our intellectual potential by
\no\ufb00ering higher salaries.
\nIn 2006 the European Commission issued
\na document: \u201cHealth in Europe: strategic
\napproach.\u201d This marked the starting point
\nfor a new health care strategy. In October
\n2007 the Commission accepted the White
\nPaper \u201cTogether for Health: A Strategic
\nApproach for the EU 2008-2013\u201d.
\nThe European Union has decided to give
\nmore political strength to health care. The
\nEU signi\ufb01ed that Europe had to recognize
\ncitizens\u2019 health as a political, and not only
\nsocio-economic, priority. To ensure the
\nwell-being of European citizens, the impor-
\ntance of collaboration of European Union
\nmember states in the health care \ufb01eld was
\ndelineated as a very important aspect. The
\nExpenditure for pharmaceuticals for
\nambulatory care (EUR per capita) \u2013 2008
\nLatvia Estonia,
\nLithuania
\nHungary,
\nSlovenia,
\nCech Republic (average)
\nEU (average)
\n57
\nCPME news
\nEuropean Union determinated that the
\nhealth of European citizens is a common
\nproblem and should be solved in collabora-
\ntion and not independently.
\nThe Lisbon Strategy sets health as a main
\npriority in one\u2019s life,so member states should
\nsupport health prevention and health care
\nwith e\ufb00ective policies. Even more, there it is
\nclearly stated that each member state is re-
\nsponsible for the health status of its citizens.
\nBut, as a \ufb01nal consequence this must also
\nmean that Europe is responsible for health
\nstatus of each European citizen. This Lis-
\nbon document also de\ufb01nes the fundamental
\nprinciples for further development of health
\ncare prevention in Europe.The second prin-
\nciple is that the health of each citizen is the
\nmain treasure of each member state and the
\nwhole Union.
\nThe European Union should support ac-
\ntively \u2013 and I mean politically as well as
\n\ufb01nancially – the health care systems in the
\nnew member states.
\nWe need to stop cutting the health cares
\nsystems by 30 % now!
\nFor sick people this support will mean res-
\ncue for a cancer patient whose treatment
\nwill otherwise no longer be \ufb01nanced; it will
\nmean a rescue for a pneumonia patient who
\ncannot pay for the antibiotics \u201cout of pock-
\net\u201d. And for healthy people it will mean a
\nboost for the economy. Investing in health
\ngives a far higher return than all the money
\nEuropean governments are currently pump-
\ning into questionable banks.
\nHow can the European Union help its new
\nmember states, which are struggling? Here
\nare some concrete suggestions:
\nWe have very little resources to pay for\u2022
\noutpatient medicines. Thus, many minor
\nailments go untreated and become worse,
\nresulting in hospitalization. The Europe-
\nan Union could help with medicine com-
\npensation for next 2 years by investing 4
\nbillion Euros per year in Eastern Europe
\n(it is 120 million for Latvia).
\nWhere rural hospitals cannot be main-\u2022
\ntained, small rural hospitals can be closed
\nor the number of hospital beds decreased.
\nHowever, this creates social tension, loss
\nof jobs and is not an inexpensive propo-
\nsition. The European Union can provide
\nthe \ufb01nancial means to be able to deal with
\nthese situations.
\nThe European Union could help to pro-\u2022
\nvide su\ufb03cient transportation for emer-
\ngency and non-emergency patients, es-
\npecially if health care facilities become
\ninaccessible when local facilities close.
\nMedical professionals in Eastern Europe\u2022
\nare interested in treating patients from
\nGermany, the United Kingdom and other
\nEuropean countries. High quality care
\ncan be o\ufb00ered inexpensively in the new
\nmember states of the European Union
\nif health care facilities are expensive or
\nstrained in your home country. It would
\nbe good to erase national boundaries for
\nhealth care in the European Union.
\nIn conclusion, I appeal to You, the honour-
\nable Commissioners and you \u2013honourable
\nmembers of the European Parliament, to
\ndirect your attention to problems of health
\ncare in East Europe and to support the de-
\nvelopment of appropriate policy and the
\nnecessary \ufb01nancial means. Maintaining
\nhealth of the people is not a cost, but rather
\na solid investment. In these times this may
\nbe the only investment that for sure will pay
\no\ufb00. Don\u2019t miss this opportunity.
\nWithout your attention and e\ufb00orts the
\nhealth care situation in East Europe, es-
\npecially in the rural areas, will further de-
\nteriorate and put the lives and the health of
\nmany people in those regions at risk.
\nThank you for giving me the opportunity
\nto report how the current economic crisis
\nin Eastern Europe has a\ufb00ected health care
\nin your new member states. I hope this will
\nencourage you to act.\u201d
\nThe 2nd
\nannual Hospice and Palliative Care
\nin Developing Countries conference is be-
\ning held in Fresno, California, USA. UCSF
\nFresno auditorium, Friday, September 18 &
\nSaturday, September 19, 2009. Representa-
\ntives from South America,Africa,S.E.Asia,
\nand North America will be presenting. We
\nare reaching out to medical professionals
\nthat may wish to attend, and to those that
\nmay be interested in exhibiting sponsorship
\nopportunities.
\nOur objectives are to:
\nUnderstand how di\ufb00erent cultures view\u2022
\ndeath and dying;
\nRecognize volunteer, educational, and\u2022
\npartnership opportunities in developing
\ncountries;
\nIdentify factors in\ufb02uencing healthcare ac-\u2022
\ncess rural vs. urban;
\nLearn the complexity and magnitude\u2022
\nof treating HIV\/AIDS in children and
\nadults su\ufb00ering from TB, Dysentery,
\nCancer, Malaria, and malnutrition;
\nUnderstand WHO pain management\u2022
\nprotocols and compounding end of life
\nmedications
\nUnderstand ELNEC International\u2019s in-\u2022
\n\ufb02uence in developing countries.
\nFurther information, including \ufb02yers which
\ncould be distributed, can be obtained by
\ncontacting Nancy Hinds at nancy@hind-
\nshospice.org or Jill Hu\ufb00
\nJill Hu\ufb00t, Community Development
\nCoordinator, Hinds Hospice
\nwww.hindshospice.org
\nThe 2nd
\nAnnual Hospice and Palliative
\nCare Conference
\n58
\nMedical Ethics, Human Rights and Socio-medical a\ufb00airs
\nJames Appleyard
\nAround 10 million children worldwide un-
\nder the age of 5 die every year according
\nto recent statistics from the World Health
\nOrganisation. Many of these deaths are
\nfrom treatable conditions, the most com-
\nmon of which is pneumonia. Others in-
\nclude diarrhoea,, malnutrition, malaria, and
\nHIV AIDS. Few countries are on track to
\nachieve WHO Millennium Developmental
\nGoal (MDG) No 4, which aims to reduce
\nby two-thirds, between 1990 and 2015, the
\nmortality of children under 5 years [1].
\nEven though e\ufb00ective interventions exist,
\nthese may entail the use of essential medi-
\ncines, which are not available in dosage
\nforms for children, particularly in low and
\nmiddle income countries. Lack of the avail-
\nability of these essential interventions has
\nbeen identi\ufb01ed as a major reason for coun-
\ntries not making adequate progress towards
\ntheir MDGs.
\nIt is essential to increase awareness of the
\nproblem, implement known e\ufb00ective inter-
\nventions and understand how to be more ef-
\nfective in achieving progress through audit
\nand research.
\nFurthermore Physicians in all countries are
\ntaking signi\ufb01cant risks when they treat chil-
\ndren with medications that may have not
\nbeen adequately tested for their e\ufb03cacy and
\nsafety during childhood [2].Such treatment
\ndecisions have to be taken in everyday clini-
\ncal practice. They tend to be based on trial
\nand error from the physicians\u2019 personal ex-
\nperience, advice from colleagues, anecdotal
\nreports from the literature and extrapola-
\ntions from adult studies. In addition, medi-
\ncation errors are a constant hazard in paedi-
\natric clinical practice. Continuous changes
\nof the dosage regime that are necessary dur-
\ning a child\u2019s growth and development make
\nthe calculation of the correct dose for each
\nchild di\ufb03cult. The frequent use of o\ufb00-label
\nmedicines with extemporaneous formula-
\ntions or physician or nurse-made manipula-
\ntions provide optimal conditions for these
\nmedication errors [1].
\nIngredients or excipients for improving
\nsolubility, sterility and the taste of children\u2019s
\nmedicines may also cause toxicity (e.g. ben-
\nzyl alcohol and diethylene glycol). Severe
\nadverse drug reactions in children are not
\nalways fully reported. Some of the most
\ndramatic examples of these are the apnoea
\ncaused by too large a dose of phenobar-
\nbitone, pethidine and prostaglandin, convul-
\nsions following the administration of theo-
\nphylline and hepatic failure associated with
\nhigh doses of paracetamol (acetaminophen).
\nRecognising these signi\ufb01cant risks in the
\ncare of their patients, practicing pediatri-
\ncians, particularly in the USA, pressed for
\nchanges in the regulation of medicines for
\nchildren. In 1996, the American Academy
\nof Pediatrics (AAP) [3] reported that only
\na small fraction of all drugs and biological
\nproducts marketed in the U.S. at that time
\nhad had clinical trials performed in paediat-
\nric patients. A majority of marketed drugs
\nare not labeled for use in paediatric patients.
\nThe AAP also pointed out that many drugs
\nused in the treatment of both common
\nchildhood illnesses and more serious condi-
\ntions carried little information in the labels
\nabout use in paediatric patients.
\nIn order to address these inadequacies, the
\nFood and Drug Administration (FDA)
\npublished (http:\/\/www.fda.gov\/) regulations
\nthat ensure that manufacturers speci\ufb01cally
\nexamine the drugs\u2019 e\ufb00ects on children if the
\nmedications are to have clinically signi\ufb01-
\ncant use in children. Paediatric research has
\nsince been encouraged by the paediatric ex-
\nclusivity provision of the ensuing Food and
\nDrug Administration Modernisation Act
\nof 1997. This extended patent protection
\nto give pharmaceutical companies an addi-
\ntional six months of marketing exclusivity if
\nthey do studies in children requested by the
\nFDA. The FDA\u2019s \u201cpediatric rule\u201d required
\npaediatric studies under certain circum-
\nstances [4].
\nIn January 1997 the National Institute of
\nHealth in the United States, a major funder
\nof clinical research worldwide, developed
\nthe policy that children (de\ufb01ned as individ-
\nuals under the age of 21) must be included
\nin all human subjects research, conducted
\nor supported by the NIH, unless there are
\nscienti\ufb01c and ethical reasons not to include
\nthem.
\nIn the European Union, the Council re-
\nsolved in 2000 to set their objectives for reg-
\nulation on medicinal products for pediatric
\nuse, which aimed to stimulate research into
\nand to increase the availability of medicines
\nfor children [5]. Draft regulations were
\nconsulted upon in 2004, which proposed
\nthe establishment of a European Paediatric
\nBoard with the European Medicines Evalu-
\nation Agency, that all new medicines should
\nhave a paediatric investigation plan with a
\nsix month extension in patent term, and a
\nnew system of granting paediatric use mar-
\nketing authorizations (PUMAs) for existing
\nproducts. These regulations took e\ufb00ect in
\n2006 and have already had a positive e\ufb00ect
\non promoting research in Europe (http:\/\/
\nec.europa.eu\/enterprise\/pharmaceuticals\/pae-
\ndiatrics\/medchild_en.htm).
\nClinical Research on Children
\nAn ethical imperative
\n59
\nMedical Ethics, Human Rights and Socio-medical a\ufb00airs
\nThe WHO publication Child Health Re-
\nsearch \u2013 a foundation for improving Child
\nHealth [6] asserts that \u201cChild health re-
\nsearch must address the leading causes and
\ndeterminants of morbidity and mortality at
\ndi\ufb00erent stages of a child\u2019s development and
\nidentify and implement interventions that
\naddress these causes.\u201d Six main areas for re-
\nsearch are identi\ufb01ed:
\nDescriptive epidemiology and burden\u2022
\nof disease: To describe the scale of the
\nproblem and identify the causes of child
\nillness and death in di\ufb00erent communi-
\nties;
\nAetiology and mechanisms of disease\u2022 :
\nTo understand the determinants of child-
\nhood disease;
\nDevelopment of interventions\u2022 : To de-
\nsign the most appropriate strategies to
\nimprove child health
\nImpact and evaluation of intervention\u2022 :
\nTo measure the e\ufb00ect of the implemented
\nstrategies including new medications and
\nraise new research questions;
\nHealth systems\u2022 : To increase the e\ufb00ec-
\ntiveness of child health interventions and
\nservices;
\nHealth policy\u2022 : To analyse retrospectively
\nand monitor prospectively the scaling up
\nof child health and nutrition interven-
\ntions.
\nThere are currently several layers of \u201cprotec-
\ntions\u201d for child subjects in clinical research.
\nThe regulatory oversight available in each\u2022
\ncountry.
\nSpeci\ufb01c guidance, e.g., I.C.H. Good\u2022
\nClinical Practice \u2013 in the absence of com-
\npliance with such guidance, most ethical
\npharmaceutical companies will not con-
\nduct a clinical trial [6, 7, 9].
\nProfessional ethical codes of practice\u2022
\nsuch as the Declaration of Helsinki [8]
\nprovide the external governance of medi-
\ncal researchers, who individually need to
\ninternalise the principles to form their
\nprofessional conscience \u2013 an essential in-
\nternal governance.
\nEstablishment of local research eth-\u2022
\nics committees and institutional review
\nboards in the USA which provide essen-
\ntial ethical scrutiny by their professional
\nand lay membership.
\nNo clinical research project should proceed
\nwithout the informed consent of parents
\nand consent\/assent of the child.
\nIn my view it has now become an ethi-
\ncal imperative, in the words of the Ethics
\nCommittee of the Conference of European
\nSpecialists in Paediatrics [5] that \u201cChildren
\nshould share in the bene\ufb01ts from scienti\ufb01c
\nresearch relevant to their individual age-
\nrelated health needs.\u201d
\nAlthough FDA, the European Commission
\nand WHO have brought a new emphasis on
\nresearch on drug development for children,
\nthere remains a reluctance to include chil-
\ndren in this research and especially in clini-
\ncal trials.There are several reasons for this:
\nBecause of a child\u2019s increased vulnerabil-\u2022
\nity,there is an understandable parental re-
\nluctance to add any risk to their children\u2019s
\nwelfare;
\nChildren have di\ufb00erent physiological,\u2022
\npsychological and pathogenic features oc-
\ncurring at the di\ufb00erent ages and stages of
\ntheir growth and development from the
\npremature newborn infant through ado-
\nlescence;
\nRisks to child subjects are increased both\u2022
\nin the short and long term;
\nBecause of the complexity, high cost and\u2022
\nrelatively low \ufb01nancial return, pharma-
\nceutical companies reluctance to invest in
\nthis \ufb01eld;
\nAnd importantly,outside North America,\u2022
\nEurope and Japan there is a lack of uni-
\nversal ethical and regulatory guidance for
\nresearchers and sponsors upon which pa-
\nrental trust depends.
\nEvery child and young person under eigh-
\nteen has rights and responsibilities that are
\nprotected by the United Nations Conven-
\ntion on the Rights of the Child (UNCRC).
\nThe Convention was adopted by the United
\nNations General Assembly in 1989 and has
\nbeen rati\ufb01ed by 191 out of 193 countries,
\nterritories and states, making it a truly glob-
\nal bill of rights (see note.) UNICEF uses
\nthe UNCRC as a framework for its work
\nfor all the world\u2019s children.
\nBut there is a lack of universal ethical guid-
\nance. The WMA\u2019s current initiative is seeks
\nto redress this. Families with children need
\nto understand the need for clinical research,
\nhave con\ufb01dence in the research process (the
\nresearch protocols), and trust those who
\nconduct research on their children \u2013 ex-
\nperienced paediatric researchers and their
\nteams
\nCodes of professional ethics have been de-
\nveloped. Following the original Declara-
\ntion of Helsinki in 1964, which did not in-
\nclude any reference to the speci\ufb01c needs of
\nchildren, the Belmont Report in the United
\nStates highlighted three ethical principles \u2013
\nrespect for persons (autonomy), bene\ufb01cence
\nand justice. Recent publicity about adverse
\nevents in clinical trials has heightened pub-
\nlic anxiety and revealed the serious failures
\nrelated to issues of non malfeasance, hon-
\nesty and transparency.
\nThese are underpinned in my view by seven
\ncore ethical principles [9], namely
\nAutonomy\u2022
\nBene\ufb01cence\u2022
\nNon malfeasance\u2022
\nFidelity\u2022
\nTruthfulness\u2022
\nCon\ufb01dentiality\u2022
\nJustice\u2022
\nThese principles need to support the state-
\nments in medical professional ethical codes
\nand codes of practice. They should be inter-
\nnalized to form the medical conscience of
\nthe physician and physician researcher upon
\nwhich the trust by children and their fami-
\nlies can be built.
\nThe recently revised WMA Declaration of
\nHelsinki (2008) encompasses these princi-
\nples. The Declaration is the only universal
\nguide to medical ethical practice in all the
\nnations of the world Child subjects, how-
\never, need special protections beyond those
\nimportant general principles that apply
\nto all research subjects [8]. In the revised
\n60
\nMedical Ethics, Human Rights and Socio-medical a\ufb00airs
\nDeclaration, children are included under
\nthe safeguards required for \u201cincompetents\u201d
\nas is illustrated by the relevant paragraphs:
\n11, 12, 27 and 28.
\nParagraph 11: For a potential research sub-
\nject who is incompetent, the physician must seek
\ninformed consent from the legally authorized
\nrepresentative. These individuals must not be
\nincluded in a research study that has no likeli-
\nhood of bene\ufb01t for them unless it is intended to
\npromote the health of the population represent-
\ned by the potential subject, the research cannot
\ninstead be performed with competent persons,
\nand the research entails only minimal risk and
\nminimal burden.
\nParagraph 12: When a potential research sub-
\nject who is deemed incompetent is able to give
\nassent to decisions about participation in re-
\nsearch, the physician must seek that assent in
\naddition to the consent of the legally authorized
\nrepresentative. The potential subject’s dissent
\nshould be respected.
\nParagraph 27: For a potential research sub-
\nject who is incompetent, the physician must seek
\ninformed consent from the legally authorized
\nrepresentative. These individuals must not be
\nincluded in a research study that has no likeli-
\nhood of bene\ufb01t for them unless it is intended to
\npromote the health of the population represent-
\ned by the potential subject, the research cannot
\ninstead be performed with competent persons,
\nand the research entails only minimal risk and
\nminimal burden.
\nParagraph 28. When a potential research sub-
\nject who is deemed incompetent is able to give
\nassent to decisions about participation in re-
\nsearch, the physician must seek that assent in
\naddition to the consent of the legally authorized
\nrepresentative. The potential subject’s dissent
\nshould be respected.
\nThe general wording of the Declaration of
\nHelsinki [8] does not re\ufb02ect the integrity and
\nrelative autonomy of an \u201cincompetent\u201dperson
\nsuch as a child. Children di\ufb00er from adults
\nbiologically, with their increased vulnerability,
\nage speci\ufb01c needs with gradual maturation,
\nand growth and development potential.
\nThen there is the key issue of risk. The Dec-
\nlaration of Helsinki insists that the risk to
\nany subject who lacks competence is only
\n\u201cminimal.\u201d Yet in practice there is of ne-
\ncessity a hierarchy of risk for children that
\nneeds to be assessed in relation to the seri-
\nousness and severity of any clinical condi-
\ntion. Children and their families must be
\ncon\ufb01dent that the necessary safeguards
\nrelated to the risk taken by their child are
\nin place. This underpins the trust in their
\nphysician researcher.
\nThe WMA Declaration of Ottawa on the
\nRight of a Child to Healthcare (1998) in-
\ncludes a short protective sentence on Re-
\nsearch under the General Principle 4: \u201cto
\nprotect every child from unnecessary diag-
\nnostic procedures, treatment and research.\u201d
\nIn order to both promote yet protect chil-
\ndren in medical research, a proposed State-
\nment on \u201cEthical Principles for Medical
\nResearch on Child Subjects\u201d was referred
\nby the Associate Members to the WMA
\nCouncil at the General Assembly in Co-
\npenhagen in 2007. The Council decided to
\nset up a working group to revise the Decla-
\nration of Ottawa and include a section on
\nResearch in Children within it. This signi\ufb01-
\ncant revision is now out for consultation.
\nThere needs to be clear statements on the
\nethical principles that \ufb02ow from the fact
\nthat children involved in research need spe-
\ncial protection. Each statement that follows
\nis both self standing and inter related to the
\nothers.
\nScienti\ufb01c necessity
\nThere must be a scienti\ufb01c necessity for\u2022
\nany research to be undertaken on chil-
\ndren, i.e., children should not be enrolled
\nin a clinical investigation unless abso-
\nlutely necessary to answer an important
\nscienti\ufb01c question about the health and
\nwelfare of children.
\nBiomedical studies involving children as\u2022
\nresearch subjects should be focused on
\nthe knowledge of epidemiology, patho-
\ngenesis, diagnosis and treatment of dis-
\neases or conditions of childhood.
\nA child should not be involved in research\u2022
\nthat can be carried out on laboratory
\nmodels, animal subjects or adult persons.
\nPhysicians must respect the personhood\u2022
\nand relative autonomy of a child.
\nConsent
\nThe issues of consent, assent and dissent\u2022
\nare of key concern in the pediatric age
\ngroup which are not speci\ufb01cally covered
\nby the Declaration of Helsinki.
\nChildren are minors who have not reached\u2022
\nthe legal age for self responsible consent.
\nInformed\u2022 consent means the permission
\nof the child’s parents or legal represen-
\ntative for the participation of their child
\nin a research study, following su\ufb03cient
\ninformation to enable them to make an
\ninformed judgment.
\nInformed\u2022 assent means the agreement of
\nthe child to participate in the research,
\nfollowing information being provided in
\na form understandable to his\/her age
\nWhere possible, the consent of both par-\u2022
\nents should be sought prior to enrolling a
\nchild in a biomedical research project.
\nThere must be no forced or undue in\ufb02u-\u2022
\nence, \ufb01nancial or otherwise on the child’s
\ndecision to participate in the research or
\non the parent\u2019s\/legal representative’s per-
\nmission.
\nThe refusal to participate in the research-\u2022
\ndissent – by a child, if capable, must be
\nrespected.
\nRisk
\nRisk is de\ufb01ned as potential harm (real or\u2022
\ntheoretical) or potential consequence of
\nan action. It may be physical, psycho-
\nlogical, or social, and may be immediate
\nor delayed. It may vary according to age
\ngroups. Risk should be assessed in terms
\nof probability, magnitude and duration.
\nThere is thus a need to balance the poten-\u2022
\ntial direct or indirect bene\ufb01ts to children
\nwith the degree of risk involved in the
\nresearch.
\nPhysicians should avoid unnecessary\u2022
\nrisks, discomfort, stress or potential harm
\nleading to physical, psychological, social,
\nspiritual impairment
\n61
\nMedical Ethics, Human Rights and Socio-medical a\ufb00airs
\nMinimal\u2022 risk involves routine procedures,
\nquestionnaires, observation and measure-
\nments
\nA minor increase over minimal risk may\u2022
\nbe undertaken when:
\n– the research is concerned with diagno-
\nses and treatment and the direct and
\nindirect bene\ufb01ts to the child subject
\noutweigh the known or anticipated
\nrisks involved;
\n– where the research is likely to yield
\njusti\ufb01able generaliseable knowledge
\nof vital importance about the child’s
\ndisorder or condition, which is of vital
\nimportance for the understanding or
\namelioration of the disorder or condi-
\ntion;
\n– the research presents a reasonable op-
\nportunity to further the understanding,
\nprevention, or alleviation of a serious
\nproblem a\ufb00ecting the health or welfare
\nof children;
\n– the research provides the only oppor-
\ntunity to identify, prevent or alleviate a
\nrare disease con\ufb01ned to childhood.
\nStudy Protocols
\nStudy protocols and study designs must\u2022
\nbe child speci\ufb01c and include the scienti\ufb01c
\njusti\ufb01cation for the research.
\nThe performance of a study must be guar-\u2022
\nanteed to be conducted by experts compe-
\ntent in childhood diseases and disorders,
\nempathetic and truly conversant with
\nchildren, parents and the legal require-
\nments where the interests of the child are
\nparamount.
\nCon\ufb01dentiality
\nAll personal and health related informa-\u2022
\ntion collected and stored about the child
\nsubject and the family must remain con-
\n\ufb01dential.
\nResearch Ethics Committees
\nThe interests of the child subject should\u2022
\nalways be represented on independent
\nresearch ethics committees by members
\nwho are knowledgeable in pediatric,clini-
\ncal, psychosocial and ethical issues.
\nThese statements should act within the
\nDeclaration of Ottawa as reference ethical
\nstandards for all physicians and physician
\nresearchers throughout the world, against
\nwhich they will be judged by their peers.
\nEach national medical association can de-
\nrive from them local culturally sensitive
\nguidelines. With the trust that is earned
\nwhen medical researchers act in an ethi-
\ncal and transparent manner to prevent the
\nethical abuses of the past [12] and to plan
\nfor the future [13,14], it is hoped that more
\nparents will recognize the bene\ufb01ts that re-
\nsearch on their children can bring to them
\nand all children worldwide.
\nReferences
\n1. World Health Organisation. Better medicines
\nfor children: 60th World Health Assembly, Ge-
\nneva, Switzerland, 14-23 May 2007 [homep-
\nage on the Internet]. [cited 2009 March 30];
\nAvailable from http:\/\/www.who.int\/gb\/ebwha\/
\npdf_\ufb01les\/WHA60\/A60_25-en.pdf
\n2. Seyberth HW,Demotes \u2013 Mainard J,Wrobel P.
\nDeveloping a European framework for research
\non children\u2019s medicines. Paediatric Nephrology
\n2005; 1537-1540.
\n3. Unapproved uses of approved drugs: the phy-
\nsician, the package insert, and the Food and
\nDrug Administration: subject review. American
\nAcademy of Pediatrics Committee on Drugs.
\nPediatrics 1996; 98(1): 143-5.
\n4. Additional Safeguards for Children in Clini-
\ncal Investigations of FDA-Regulated Products.
\nFood and Drug Administration. 21 CFR Parts
\n50 and 56, 2007.
\n5. Ethical principles and operational guidelines
\nfor good clinical practice in paediatric research.
\nRecommendations of the Ethics Working
\nGroup of the Confederation of European Spe-
\ncialists in Paediatrics (CESP). Eur J Pediatr
\n2004 Feb; 163(2): 53-7.
\n6. World Health Organisation. Child health re-
\nsearch \u2013 A foundation for improving child
\nhealth. 2002.
\n7. Clinical Investigation of Medicinal Products in
\nthe Paediatric Population. Guideline for Good
\nClinical Practice. Food and Drug Administra-
\ntion, 2000.
\n8. Clinical Investigation of Medicinal Products
\nin the Pediatric Population. ICH Harmonised
\nTripartite Guideline. Food and Drug Admin-
\nistration, 2000.
\n9. World Medical Association Declaration of
\nHelsinki: ethical principles for medical research
\ninvolving human subjects [homepage on the
\nInternet]. [cited 2009 March 30]; Available
\nfrom https:\/\/www.wma.net\/e\/policy\/b3.htm
\n10. Appleyard WJ. Who cares?: the Declaration of
\nHelsinki and The Conscience of physicians.Re-
\nsearch Ethics Review 2008; 4: 106-111.
\n11. World Medical Association Declaration of Ot-
\ntawa on the rights of the child to health care
\n[homepage on the Internet]. [cited 2009 March
\n30]; Available from https:\/\/www.wma.net\/e\/
\npolicy\/c4.htm
\n12. Krugman S. Experiments at the Willowbrook
\nState school. Lancet 1971; 1(7706): 966-7.
\n13. Choonara I. Regulation of drugs for children in
\nEurope. BMJ 2007; 335(7632): 1221-2.
\n14. Sammons HM, Gray C, Hudson H et al. Safety
\nin paediatric clinical trials \u2013 a 7-year review.
\nActa Paediatr 2008; 97(4): 474-7.
\nNote
\nThe 1989 United Nations Convention on the
\nRights of the Child (CRC) is a comprehensive
\nhuman rights treaty which enshrines speci\ufb01c
\nchildren\u2019s rights in international law.These rights
\nde\ufb01ne universal principles and standards for the
\nstatus and treatment of children worldwide.
\nHuman rights are founded on respect for the
\ndignity and worth of each individual, regard-
\nless of race, gender, language, religion, opinions,
\nwealth or ability and therefore apply to every
\nhuman being everywhere.
\nThe Convention on the Rights of the Child is
\npresently the most widely rati\ufb01ed international
\nhuman rights treaty \u2013 all UN member states
\nexcept for the United States and Somalia have
\nrati\ufb01ed the convention.
\nIn addition, the CRC is the only international
\nhuman rights treaty which includes civil,politi-
\ncal,economic,social and cultural rights,and sets
\nout in detail what every child needs to have for
\na safe, happy and ful\ufb01lled childhood. It is the
\nmost complete statement of children\u2019s rights
\never produced and has 41 substantive articles.
\nJames Appleyard, MD FRCP
\nFRCPCH,Children\u2019s Physician
\nPresident of the WMA (2003\/2004)
\n62
\nMedical Ethics, Human Rights and Socio-medical a\ufb00airs
\nPetra A. Th\u00fcrmann
\nBackground \u2013 gender-speci\ufb01c
\ndi\ufb00erences in physiology, aging
\npopulation and social aspects
\nThe terms sex and gender are frequently
\nused and also frequently misunderstood
\nin medical science. Whereas sex relates to
\nthe biological concept, gender includes so-
\ncial background, culture and history [1].
\nHowever, it is not always possible to make
\na clear distinction between these aspects of
\nlife, since social behaviour may have an in-
\n\ufb02uence on biological aspects. For example,
\nsmoking results in enzyme induction and
\nthereby explains di\ufb00erences in drug me-
\ntabolism. In this articles, the terms sex and
\ngender will be used as appropriately as pos-
\nsible, keeping in mind the aforementioned
\nconsiderations.
\nIt is a widely acknowledged fact that gen-
\nder di\ufb00erences do exist in relation to the
\nfrequency, perception and peculiarities of
\nsymptoms and diseases, with myocardial
\ninfarction being one of the most promi-
\nnent and typical examples [2]. Due to dif-
\nferences in the physiology between sexes,
\ndi\ufb00erences in drug absorption, distribution
\nand metabolism can be assumed and will be
\naddressed in this article. More over, physi-
\nological sex di\ufb00erences on the level of re-
\nceptors and enzymes result in variances in
\ndrug e\ufb00ects, e\ufb03cacy and safety pro\ufb01le.
\nThe following example highlights the in-
\nterplay between pharmacology, epidemiol-
\nogy and society: in the German Network
\nof Regional Pharmacovigilance Centers,
\nadverse drug reactions (ADRs) resulting in
\nhospitalisation are documented [3].Women
\nare at least twice as likely as men to su\ufb00er
\nfrom severe dehydration and electrolyte
\ndisturbances [4]. One explanation is the
\nhigher prescribing frequency of these drugs
\nto women, as well as the fact that there are
\nmore aged women than men. In addition,
\nanimal experiments show a higher sensitivi-
\nty of female rats to thiazide and loop diuret-
\nics when compared to male animals [5,6].
\nThese observations stimulated further re-
\nsearch revealing pronounced sex di\ufb00erences
\nin the pharmacokinetics, for example, of
\ntorasemide, explaining stronger treatment
\ne\ufb00ects [7]. As a conclusion, the epidemio-
\nlogical observation can only be explained by
\na combination of sex and gender aspects.
\nSex-speci\ufb01c di\ufb00erences in
\npharmacokinetics
\nDue to sex di\ufb00erences in body weight, dis-
\ntribution of water,muscle and fat,di\ufb00erenc-
\nes in the pharmacokinetics of drugs can be
\nexpected. The most relevant di\ufb00erences are,
\nat present, known for drug metabolism, es-
\npecially via the cytochrome P450 enzymes,
\nwhich are responsible for major metabolic
\npathways.The most frequently involved en-
\nzyme is CYP3A4, which is expressed to a
\nhigher percentage in female than male liv-
\ners [8]. Substrates of this enzyme such as
\nmethylprednisolone, midazolam, nifedipine
\nund verapamil are therefore eliminated
\nsomewhat faster in women when compared
\nto men [9]. The betablocker metoprolol is
\nmainly metabolised via CYP2D6. Follow-
\ning a 100 mg dose, women exhibit 40 %
\nhigher plasma levels than men and an ap-
\nproximately two-fold higher area under the
\nconcentration\/time curve (AUC) [10]. This
\nresults in more pronounced e\ufb00ects on blood
\npressure and heart rate. Women su\ufb00er more
\nfrequently than men from serious ADRs
\nfollowing betablockers metabolised via
\nCYP2D6 (metoprolol, propranolol, carve-
\ndilol, nebivolol). For those betablockers that
\nare independent of that enzyme no sex dif-
\nferences occurred [11]. Since betablockers
\nin daily practice are carefully titrated, these
\ndi\ufb00erences go in most cases unnoticed and
\nbecome obvious only after gender-sensitive
\nstatistical evaluation of databases.
\nThe enzyme CYP1A2 metabolising, for ex-
\nample, theophylline and ca\ufb00eine, exhibits
\na slightly lower activity in women than in
\nmen, resulting in approximately 35 % high-
\ner plasma levels of clozapine in comparison
\nto men. Likewise, plasma levels of the anti-
\ndepressants \ufb02uvoxamine and sertraline are
\n70 \u2013 100 % and 50 \u2013 70 % higher in female
\nthan in male patients, respectively [12].
\nSex-speci\ufb01c di\ufb00erences occur within other
\nmetabolic pathways as well [13]. A remark-
\nable \ufb01nding in cancer chemotherapy may
\nbe used for illustration: 5-\ufb02uorouracil is
\nmetabolised more slowly in women than in
\nmen [14], resulting in approx. 25 % higher
\nplasma levels associated with a signi\ufb01cantly
\nhigher toxicity during chemotherapy in pa-
\ntients with colorectal cancer [15].
\nSex, gender and di\ufb00erences
\nin e\ufb00ects of drug therapy
\nAs already shown in the introductory ex-
\nample, pharmacodynamis play a major \u2013 al-
\nthough not well-studied \u2013 role in sex-di\ufb00er-
\nences of drug therapy. In patient-controlled
\nanalgesia, men required 40 % higher mor-
\nphine doses than women to control pain
\nfollowing major abdominal surgery [16].
\nIn general, women show a greater response
\nthan men to kappa-opioids, e.g. pentazo-
\ncine, and they more frequently experience
\nGender-speci\ufb01c Di\ufb00erences in
\nPharmacotherapy
\n63
\nMedical Ethics, Human Rights and Socio-medical a\ufb00airs
\nopioid-associated side e\ufb00ects such as vom-
\niting and respiratory depression [17].
\nWith regard to psychotropic drugs, one
\nshould keep in mind that depression is
\nmore frequently diagnosed in women and
\nsymptoms are di\ufb00erent between genders
\n[18]. Besides the already-described di\ufb00er-
\nences in pharmacokinetics of psychotropic
\ndrugs, pre-menopausal women especially
\ntend to respond better to selective sero-
\ntonin-reuptake-inhibitors (SSRI) than to
\ntricyclic antidepressants or norepinephrine-
\nreuptake-inhibitors [19]. Interestingly, re-
\nsponse of post-menopausal women seems
\nto be comparable to men [20].
\nThe most extensively studied medical spe-
\ncialty with respect to sex and gender is the
\ncardiovascular \ufb01eld. Acetylsalicylic acid
\n(ASS) given for primary prevention of
\nmyocardial infarction does not reduce these
\nevents in women when compared to men,
\nbut lowers the risk for stroke signi\ufb01cantly \u2013
\nby 17 %; only women above the age of 65
\nyears bene\ufb01t from primary prevention with
\nASS [21]. However, in secondary preven-
\ntion both sexes show comparable e\ufb03cacy
\nwith respect to cardiovascular morbidity
\nand mortality [22].
\nThe therapeutic bene\ufb01t of cardiac glyco-
\nsides seems to be rather limited in women,
\nas shown by a retrospective analysis of the
\nDIG trial [23]. However, cardiac glycosides
\nare still widely prescribed and an analysis of
\nGerman ADR-data showed that more than
\ntwo-thirds of all serious ADRs related to
\nthese drugs occur in women. In about 90 %
\nof these ADRs the low body weight and the
\nslow elimination rate of frail elderly women
\nhas apparently not been considered [24].
\nEven in oncology sex and gender-di\ufb00erenc-
\nes may appear. In a retrospective analysis of
\n227 patients (80 females) with non-small-
\ncell lung cancer receiving chemotherapy
\nwith carboplatin and paclitaxel, remarkable
\ndi\ufb00erences appeared for tumor type, treat-
\nment response and overall survival. Be-
\nneath numerable considerations one aspect
\nseems noteworthy: 83 % of male patients
\nwere smokers and only 24 % of the female
\npatients. As shown by molecular pathol-
\nogy, adenocarcinoma of smokers exhibit
\na certain RAS-mutation, whereas tumors
\nof non-smokers are more likely to develop
\nmutations in the epidermal growth-factor
\n(EGFR) signalling pathway. This may re-
\nsult in malignancies with di\ufb00erent prog-
\nress characteristics and di\ufb00erences in the
\nresponse to drugs such as ge\ufb01tinib, which
\ninhibits the EGFR-tyrosine kinase [25].
\nWomen experience more
\nside e\ufb00ects than men
\nThe higher reported rate of side e\ufb00ects in
\nwomen may be a result of the higher likeli-
\nness to talk with their doctors and the higher
\ndrug consumption of females. However, the
\nobserved frequency of ADRs per 10.000 pa-
\ntient-months is higher in females compared
\nto males across all age groups,irrespective of
\ndrug consumption [26]. It remains unclear
\nwhy women report more ACE-inhibitor-
\nassociated cough than men [27] or more
\nfrequently develop cutaneous reactions to
\nnevirapine [28]. It has been demonstrated
\nin animal experiments [29] and epidemio-
\nlogical studies that females have a higher
\nrisk for QT-prolongation when compared
\nto males, irrespective of drug class and in-
\ndication [30, 31]. Even di\ufb00erences detected
\nin women during the menstrual cycle could
\nbe demonstrated [32]. It should be noted
\nin this context, that QT-prolongation is an
\nADR that resulted in market withdrawal or
\nrestriction of use for numerous drugs such
\nas astemizole, terfenadine, grepa\ufb02oxacin,
\ncisapride and budipine.
\nTreatment with neuroleptics may lead to
\nhyerprolactaemia and other metabolic dis-
\nturbances, which occur more frequently in
\nfemale than in male patients and increase
\nthe risk for osteoporosis particularly in fe-
\nmales [33]. Since osteoporosis in general is
\na problem more strongly related to the fe-
\nmale sex, potential pro-osteoporotic side ef-
\nfects warrant closer surveillance in women.
\nIn a randomised, controlled trial compar-
\ning metformin, glyburide and rosiglitazone
\nover 4 years, the number of fractures under
\nrosiglitazone was twice as high as in the
\nother treatment groups (5.1 %, 3.5 % and
\n9.3 %, respectively) in female study par-
\nticipants \u2013 in male patients no di\ufb00erences
\nwere seen in this regard [34]. Rosiglitazone
\ngiven over 14 weeks to post-menopausal
\nwomen reduced bone density measured at
\nthe proximal femur by 1.9 % in comparison
\nto placebo with 0.2 % (p = 0,003) [35].
\nOpportunities for research \u2013
\nactions required
\nThere are numerous indicators suggestive
\nof sex- and gender-speci\ufb01c di\ufb00erences in
\npharmacotherapy. Particularly the accu-
\nmulation of side e\ufb00ects in women should
\ngenerate research questions considering sex
\nand gender e\ufb00ects. Even today, women ap-
\npear to be underrepresented in clinical tri-
\nals investigating e\ufb03cacy and safety of new
\ndrugs and results are not presented in a sex-
\nsensitive manner [36,37]. Trials submitted
\nto the US Food and Drug Administration
\nbetween 1995 and 1999 were analysed with
\nrespect to sex-distribution: approximately
\n25% of trial participants were female and
\nduring phase II and III women were ap-
\nparently equally represented [38]. However,
\nthis relates only to those trials, where the
\nsex of participants was recorded: in a con-
\nsiderable number of studies this was not the
\ncase, despite e\ufb00ectual guidelines. A recent
\nevaluation of the European Agency EMEA
\nrevealed that in some indications women
\nwere not enrolled in clinical trials accord-
\ning to the expected female prevalence for a
\ngiven condition investigated [39].
\nIn conclusion, pharmacokinetic di\ufb00er-
\nences between sexes tend to be small, but
\nmay result in higher rates of side e\ufb00ects in
\nwomen. The simple approach of consider-
\ning body weight and renal function (espe-
\ncially in frail elderly women) before each
\nprescription could contribute markedly to
\nsafety of drug therapy in males and females
\nas well. Complex sex and gender di\ufb00erences
\nin pathophysiology and pharmacodynam-
\nics remain obscure for many symptoms and
\nconditions and \ufb01ndings are often obtained
\nby chance and lead to surprise.
\n64
\nMedical Ethics, Human Rights and Socio-medical a\ufb00airs
\nConcerning clinical research, some aware-
\nness of the relevance of sex and gender has
\nbeen achieved, however stringent follow-up
\nand transfer of existing data into medical
\npractice is still in its infancy.
\nThe author reports no con\ufb02ict of interest
\nReferences
\nKim JS, Nafziger AN. Is sex or is it gender? Clin1.
\nPharmacol Ther 2000;68:1-3.
\nPatel H, Rosengren A, Ekman I. Symptoms in2.
\nacute coronary Syndromes: does sex make a dif-
\nference? Am Heart J 2004; 148: 27-33.
\nSchneeweiss S, Hasford J, G\u00f6ttler M, et al. Ad-3.
\nmissions caused by adverse drug events to internal
\nmedicine and emergency departments in hospi-
\ntals: a longitudinal population-based study. Eur J
\nClin Pharmacol 2002;58:285-291.
\nTh\u00fcrmann P, Janhsen K, Werner U, et al. Sex-dif-4.
\nferences in the rate of adverse drug reactions asso-
\nciated with diuretics. D\u00fcsseldorf: German Medi-
\ncal Science GMS Publishing House; 2008 (http:\/\/
\nwww.egms.de\/en\/meetings\/gaa2008\/08gaa11.
\nshtml).
\nChen Z, Vaughn DA, Fanestil DD. In\ufb02uence of5.
\ngender on renal thiazide diuretic receptor den-sity
\nand response. J Am Soc Nephrol 1994;5:1112-
\n1119.
\nBrandoni A, Villar SR,Torres AM. Gender-relat-6.
\ned di\ufb00erences in the pharmacodynamics of furo-
\nsemide in rats.Pharmacology 2004;70:107-112.
\nWerner D, Werner U, Meybaum A, et al. Deter-7.
\nminants of steady-state torasemide pharmacoki-
\nnetics: impact of pharmacogenetic factors, gender
\nand angiotensin II receptor blockers. Clin Phar-
\nmacokinet. 2008;47:323-332.
\nWolbold R, Klein K, Burk O, et al. Sex is a ma-8.
\njor determinant of CYP3A4 expression in human
\nliver. Hepatology 2003;38:978-988.
\nCotreau MM, Moltke LL, Greenblatt DJ. The9.
\nin\ufb02uence of age and sex on the clearance of cyro-
\nchrome P450 3 A substrates. Clin Pharmacokinet
\n2005;44:33-60.
\nLuzier AB, Killian A, Wilton JH, Wilson MF,10.
\nForrest A, Kazierad DJ. Gender-related e\ufb00ects
\non metoprolol pharmacokinetics and pharmaco-
\ndynamics in healthy volunteers. Clin Pharm Ther
\n1999;66:594-601.
\nTh\u00fcrmann PA, Haack S, Werner U, et al. Tolera-11.
\nbility of beta-blockers metabolized via cytochrome
\nP450 2D6 is sex-dependent. Clin Pharmacol Ther
\n2006;80:551-553.
\nMeibohm B, Beierle I, Derendorf H. How impor-12.
\ntant are gender di\ufb00erences in pharmacokinetics?
\nClin Pharmacokinet 2002;41:329-342.
\nTh\u00fcrmann PA, Hompesch BC (1998) In\ufb02uence13.
\nof gender on the pharmacokinetics and pharma-
\ncodynamics of drugs. Int J Clin Pharmacol Ther
\n36: 586-590.
\nGusella M, Crepaldi G, Barile C et al. Pharma-14.
\ncokinetic and demographic markers of 5-\ufb02uorou-
\nracil toxicity in 181 patients on adjuvant therapy
\nfor colorectal cancer. Ann Oncol. 2006;17:1656-
\n1660.
\nSloan JA,Goldberg RM,Sargent DJ,et al.Women15.
\nexperience greater toxicity with \ufb02uorouracil-based
\nchemotherapy for colorectal cancer. J Clin Oncol
\n2002;20:1491-1498.
\nPleym H, Spigset O, Kharasch ED, Dale O.16.
\nGender di\ufb00erences in drug e\ufb00ects: implications
\nfor anaesthesiologists. Acta Anaesthesiol Scan
\n2003;47:241-259.
\nZun LS, Downey LVA, Gossmann W, Rosen-17.
\nbaum J,Sussman G.Gender di\ufb00erences in narcot-
\nic-induced emesis in the ED. Am J Emerg Med
\n2002;20:151-154.
\nKornstein SG, Sloan DM, Thase ME. Gender-18.
\ndi\ufb00erences in depression and treatment response.
\nPsychopharmacol Bull 2002; 36: 99-112.
\nMartenyi F, Dossenbach M, Mraz K, Metcalfe S.19.
\nGender di\ufb00erences in the e\ufb03cacy of \ufb02uoxetine
\nand maprotiline in depressed patients: a double-
\nblind trial of antidepressants with serotonergic or
\nnorepinephrinergic reuptake inhibition pro\ufb01le.
\nEur Neuropsychopharmacol 2001;11:227-232.
\nKornstein SG, Schatzberg AF, Thase ME et al.:20.
\nGender di\ufb00erences in treatment response to ser-
\ntraline versus imipramine in chronic depression.
\nAm J Psychiatry 2000; 157:1445-1452.
\nRidker PM, Cook NR, Lee I-M et al. A ran-21.
\ndomized trial of low-dose aspirin in the primary
\nprevention of cardiovascular disease in women. N
\nEngl J Med 2005; 352: 1293-1304.
\nBerger J, Roncaglioni MC, Avanzini F, Pangrazzi22.
\nI,Tognoni G, Brown DL. Aspirin for the primary
\nprevention of cardiovascular events in women and
\nmen. JAMA 2006; 295: 306-313.
\nRathore SS, Wang Y, Krumholz HM. Sex-23.
\nbased di\ufb00erences in the e\ufb00ect of digoxin for
\nthe treatment of heart failure. N Engl J Med.
\n2002;347:1403-1411.
\nSchmiedl S, Szymanski J, Rottenkolber M, et al24.
\nf\u00fcr die Deutsche Pharmakovigilanz-Studiengrup-
\npe: Fingerhut \u2013 ein alter Hut? Eine Analyse sta-
\ntion\u00e4rer Aufnahmen durch digitalisassoziierte un-
\nerw\u00fcnschte Arzneimittelwirkungen. Med Klinik
\n2007;102:603-611.
\nYamamoto H, Sekine I, Yamada K, et al. Gender25.
\ndi\ufb00erences in treatmetn outcomes among patients
\nwith non-small cell lung cancer given a combi-
\nnation of Carboplatin and paclitaxel. Oncology
\n2008;75:169-174.
\nMartin R, Biswas PN, Freemantle SN, et al. Age26.
\nand sex distribution of suspected adverse drug re-
\nactions to newly marketed drugs in general prac-
\ntice in England: analysis of 48 cohort studies. Br J
\nClin Pharmacol 1998;46:505-511.
\nKubota K, Kubota N, Pearce GL, Inman WHW27.
\n(1996) ACE-inhibitor-induced cough, an adverse
\ndrug reaction unrecognised for several years: stud-
\nies in Prescription-Event Monitoring. Eur J Clin
\nPharmacol 49:431-437.
\nPitche P, Drobache\ufb00-Thiebaut C, Gavignet B,28.
\nMercier M, Laurent R. Cutaneous drug-reac-
\ntions to nevirapine: study of risk factors in 101
\nHIV-infected patients. Ann Dermatol Venereol
\n2005;132:970-974.
\nEbert SN,Liu XK,Woosley RL: Female gender as29.
\na risk factor for drug-induced cardiac arrhythmias:
\nevaluation of clinical and experimental evidence. J
\nWomen\u2019s Health 1998;7:547-557.
\nDrici MD, Clement N. Is gender a risk factor for30.
\nadverse drug reactions? The example of drug-in-
\nduced long QT syndrome.Drug Saf 2001;24:575-
\n585.
\nThe University of Arizona College of Pharmacy.31.
\nhttp:\/\/www.azcert.org\/medical-pros\/drug-lists\/
\ndrug-lists.cfm (last access March 22nd 2009)
\nRodriguez I, Kilborn MJ, Liu XK, Pezzullo JC,32.
\nWoosley RL: Drug-induced QT prolongation in
\nwomen during the menstrual cycle. JAMA 2001;
\n285:1322-26.
\nAichhorn W, Whitworth A, Weiss EM, Mark-33.
\nsteiner J: Second-generation antipsychotics. Is
\nthere evidence for sex di\ufb00erences in pharmacoki-
\nnetic and adverse e\ufb00ect pro\ufb01les? Drug Saf 2006;
\n29: 578 \u2013 598.
\nKahn SE, Zinman B, Lachin JM, et al. Diabetes34.
\nOutcome Progression Trial (ADOPT) Study
\nGroup. Rosiglitazone-Associated Fractures in
\nType 2 Diabetes. Diabetes Care 2008;31:845-
\n851.
\nGrey A, Bolland M, Gamble G, et al. The per-35.
\noxisome proliferator-activated receptor-\u03b3 agonist
\nrosiglitazone decreases bone formation and bone
\nmineral density in healthy postmenopausal wom-
\nen: a randomized, controlled trial. J Endocrinol
\nMetabol 2007;92:1305-1310.
\nPinn VW. Sex and gender factors in medical stud-36.
\nies. Implications for health and clinical practice.
\nJAMA 2003;289:397.
\nLee PY, Alexander KP, Hammill BG, Pasquali37.
\nSK, Peterson ED. Representation of elderly per-
\nsons and women in published randomized trials of
\nacute coronary syndromes. JAMA 2001;286:708-
\n713.
\nEvelyn B,ToigoT,Banks D,et al.Women`s partic-38.
\nipation in clinical trials and gender-related label-
\ning. A review of new molecular entities approved
\n1995-1999. FDA, 2001, August 24: http:\/\/www.
\nfda.gov\/cder\/reports\/womens_health\/women_
\nclin_trials.htm (last access: March 22nd 2009)
\nM\u00fcllner M, Vamvakas S, Rietschel M, van Zwi-39.
\neten-Boot BJ. Are women appropriately repre-
\nsented and assessed in clinical trials submitted
\nfor marketing authorization? A review of the da-
\ntabase of the European Medicines Agency. Int J
\nClin Pharmacol Ther 2007;45:477-484.
\nTenter U, Th\u00fcrmann PA.:References to sex-spe-40.
\nci\ufb01c di\ufb00erences of drug e\ufb00ects in german SPCs
\nfor new entities from 1999 \u2013 2004. Int J Clin
\nPharmacol Ther 2006;44:531 (abstr.)
\nPetra A. Th\u00fcrmann, Prof. Dr. med. Philipp
\nKlee-Institute of Clinical Pharmacology,
\nHELIOS Klinikum Wuppertal,Chair
\nof Clinical Pharmacology,
\nUniversity of Witten\/Herdecke
\n65
\nMedical Ethics, Human Rights and Socio-medical a\ufb00airs
\nThe development of Bioethics in Ukraine
\nis an example for other countries. First, lo-
\ncal Bioethical Committees in Ukraine were
\ncreated in 1992 in two organizations: the
\nInstitute for Occupational Health of Acad-
\nemy of Medical Science of Ukraine in the
\nscope of Ukrainian\/American Chernobyl
\nOcular Study (UACOS) and in the Insti-
\ntute of Obstetrics and Gynecology of Acad-
\nemy of Medical Science of Ukraine in the
\nscope of the joint Ukrainian-USA Project
\n\u201cMother and Child\u201d.
\nThese two inter-governmental projects have
\nbeen performed jointly with Columbia Uni-
\nversity and the University of Illinois in the
\nUnited States. For these projects, informed
\nconsent forms for medical examinations of
\nsubjects, the Declaration of rights of patients
\nand,separetely,of investigators,and other re-
\nlated documents [ 1, 2] have been developed
\nand adopted in both the Ukraine and the
\nUSA.The Statutes of the committees dealing
\nwith medical aspects of these projects were
\nadopted by the Government of Ukraine and
\nthe USA. Historically, resolution of dissimi-
\nlar or even con\ufb02icting bioethical restrictions
\nbetween participating countries has been
\nachieved on an ad hoc basis.
\nThe next step was taken in 1995.The model
\nof the Declaration of patients\u2019human rights
\nsupport was adopted in Ukraine. Standard
\ndocuments have been developed for re-
\nviewing medical ethical aspects of scienti\ufb01c
\nprojects with human participation. These
\ndocuments were tested in twelve regions of
\nUkraine before implementation into medi-
\ncal practice.
\nTen year ago, owing to the initiative of the
\nPresidium of National Academy of Scienc-
\nes of Ukraine (NAS), and to Boris Paton,
\nPresident of the National Academy of Sci-
\nences, systematic and successive activity in
\nthe \ufb01eld of bioethics began at the national
\nlevel. The Committee on Bioethics, estab-
\nlished as a branch of the Presidium of NAS
\nof Ukraine, takes an advisory, organizing
\nand coordinating role, aiming to reach the
\nlevel of the international community in this
\nrespect.
\nThe Committee on Bioethcs deals with all
\naspects of ethics in science and practical
\naspects of medical ethics and international
\nactivity. At the First National Congress on
\nBioethics in September 2001, with interna-
\ntional participation, a set of standardized
\ndocuments was adopted. This accomplish-
\nment provided great support for next steps
\nof development [ 3].
\nThis was extremely important for fur-
\nther development of the collaboration of
\nUkrainian scientists with foreign partners.
\nWithin that period such international or-
\nganizations as UNESCO, WHO, and the
\nCouncil of Europe placed bioethics among
\npriority subjects. Ukraine was determined
\nto join the world in this important subject.
\nAlso, in our country, bioethics was preceded
\nby a thousand years of experience in medi-
\ncal ethics and doctor\u2019s deontology, based on
\nestablished universal ethics and morals.
\nUnder this commission, more than 250
\nbioethical committies and associations now
\nwork in all parts of Ukraine. All this was
\ndone with the enthusiastic participation of
\npeople who understand the requirements of
\na new moral approach to the relationship
\nbetween patients and doctors.The members
\nof this commission are prominent scientists,
\npublic decision-makers and other individu-
\nals, such as Academician Elena Lukyanova,
\nVice-Director of the Institute of Obstetric
\nand Gynecology Academy of Medical Sci-
\nences of Ukraine (AMS), Professor Nikolay
\nKiselyov, Director of the Institute of Phy-
\nlosophy of NAS, Vice-President of AMS,
\nProfessor Yuriy Zozulya, Director of the
\nInstitute of Neurosurgery of AMS, Leader
\nof the Parlament administration, Vadim
\nDemchenko, Main Editor of the newspa-
\nper \u201cMirror of Week\u201d Vladimir Mostovoy
\nand a number of other participants totaling
\ntwenty-one people.
\nThis Commission is a top-level organization
\nin the country. The head of this Commission
\nis Professor Kundiiev, member of NAS and
\nAMS, Vice-President of AMS of Ukraine.
\nThe Commission organizes its meetings one
\nor two times each month. The main task
\nfor these meetings is to develop answers to
\nhighly important issues for Ukrainian soci-
\nety, e.g., attitudes toward cloning or discus-
\nsions on the discrepancy in the ethical review
\nof the investigation protocol for executors of
\nlarge multicentral medical scienti\ufb01c projects
\nwith human subjects involved.The Commis-
\nsion, as an advisory board, develops reccom-
\nmendations for executors, members of the
\nparliament or for other governmental orga-
\nnizations, such as the Ministry of Health of
\nUkraine and others. Once or twice a month
\nmembers of this Commission have articles
\npublished in newspapers or are interveiwed
\non television.
\nDuring voting, under the Statute of this
\nCommission, members of this organization
\nmust reach consensus on important solu-
\ntions concerning human rights.
\nOn the other side, intensive e\ufb00orts in bio-
\nethics have brought to light information
\nobstacles in common aproaches to main
\nprinciples of bioethical reviews, driven by
\never-accelerating biotechnological innova-
\ntion wherein developments are ultimately
\ndependent on constantly increasing needs
\nfor human and animal subjects for clinical
\ntrials. These facts and the current unprec-
\nedented movement toward globalization of
\nall aspects of life,including scienti\ufb01c health-
\nrelated research, serve only to increase the
\nsense of urgency for all countries to accept
\nand apply internationally agreed, at least
\nminimum, bioethical principles for policy
\nstandards. They should be incorporated as
\ncritical components of Good Laboratory
\nPractice and Good Clinical Practice, related
\nto studies standards, respectively.
\nIn view of such questions and under the gov-
\nerning body of the National Bioethics Com-
\nDevelopment of Bioethics in Ukraine
\n66
\nMedical Ethics, Human Rights and Socio-medical a\ufb00airs
\nmittee, medical ethics problems are solved
\nin the Independent Ethics Committies of
\nAcademy of Medical Sciences of Ukraine in
\nMinistry of Health of Ukraine and under the
\nUkrainian Medical Association.
\nThe UACOS experience, which was pro-
\ngrammatically organized around protocols
\nexisting in many western countries, can
\nserve as a model for the design and imple-
\nmentation of the administrative infrastruc-
\nture necessary to apply bioethical standards,
\nbeing fully consistent with modern society
\nin the twenty-\ufb01rst century.
\nOver the past 10 years there have been nu-
\nmerous successes. The most signi\ufb01cant re-
\nsult is that bioethics took its proper place in
\nthe activity of the majority of high-pro\ufb01le
\nmedical and biological institutions; bioeth-
\nics is taught at biological faculties and in
\nhigher medical educational institutions and
\neven at high schools and universities. At the
\nsame time, there are many complicated is-
\nsues that remain to be solved.
\nIn recent times, as a result of scienti\ufb01c and
\ntechnological progress, rapid development
\nin life sciences, and the deciphering of the
\nhuman gene, we face more and more acute
\nproblems and contradictions that require
\nmoral judgments to resolve. What is pos-
\nsible for science and technology and what
\nis morally purposeful and acceptable? Our
\nethical views and principles should be based
\non an understanding of these di\ufb00erences.
\nWe wrestle with questions of strategies for
\nmass prevention of morbidity, via vaccina-
\ntion in particular, to which the attitude in
\nrecent times is ambivalent. New issues arise
\nrelated to assistive technologies, the scales
\nof which ever increase each year. Now, in
\nUkraine, about 4,500 children have been
\nborn as a result of such technologies. We
\nmust remember that the \ufb01rst of these was a
\ngirl,Katya,born in 1991 in Kharkiv. Within
\nthis period of demographic crisis, more at-
\ntention should be paid to these technologies
\nand to the problem of transplantation of
\norgans and tissues. In Ukraine, these issues
\nare regulated by the legislation; though it is
\nnot yet perfect.There are similar regulations
\nin other countries as well. Despite such
\nregulations, there are often media reports
\nabout abuse in these spheres, particularly
\nwith respect to the sale of organs and tissue.
\nCompromising ethics for \ufb01nancial gain in
\nthis regard is a serious problem, indicating
\nclearly that regulation alone will not solve
\nall problems. E\ufb00orts to educate the public
\nand inform social opinion through innova-
\ntive approaches must be prioritized.
\nUse of genetically modi\ufb01ed organisms and
\nfood products, as well as genetic tests, create
\ngreat concern in society. Discussions around
\nthe problem of cloning a human and his\/her
\norgans remain complex and di\ufb03cult. Great
\nattention is now being paid to issues related
\nto stem cells.
\nWhat is the driver of moral assessment in
\nterms of implementation of new technolo-
\ngies as they relate to human life? It is, \ufb01rst
\nof all, respect for human dignity and pro-
\ntection of human rights, raising the respect
\nfor human life to its highest value. Unfor-
\ntunately, this key question of bioethics, and
\nethics in general in society, remains a sec-
\nondary one, resulting in a great number of
\nsocial and socio-political contradictions.
\nPharisaism is a becoming more and more
\nprevalent \u2013 temples are being built while
\nmoral principles are in ruins. There is some-
\ntimes an impression that people lose the
\nability to honestly analyze their reality.
\nIt is necessary to realize that changes have
\ntaken place that a\ufb00ect our understanding of
\nlife \u2013 indeed, the role of life itself on the
\nearth \u2013 and these changes require proper
\naction at the national, regional and inter-
\nnational levels. One such event was the
\nadoption by UNESCO in October 2005 of
\nthe Universal Declaration on Bioethics and
\nHuman Rights. The Declaration highlights
\nthat moral responsibility and analysis of
\nethical problems should be an integral part
\nof the scienti\ufb01c and technological progress
\nand that bioethics should play a leading role
\nin decision-making when progress and new
\ndevelopments raise di\ufb03cult issues.
\nOf course, we should agree with this.
\nStrictly speaking, the key is the need to
\neliminate the gap between two branches of
\nknowledge \u2013 natural and humanitarian.The
\nbridge between the two should join scien-
\nti\ufb01c and technological achievements and
\nmoral and ethical principles. Van R. Potter,
\nthe founder of bioethics, called it a bridge
\nto the future.
\nIn Europe, and in the world in general,
\npriority signi\ufb01cance was given to bioethics
\nafter the adoption of the Universal Declara-
\ntion of UNESCO in 2005.The Ukraine has
\nmade a signi\ufb01cant e\ufb00ort,in the aftermath of
\nthis Declaration, to take two steps forward
\nin this respect.
\nThe work of the National Board is executed
\nand will be performed by the Committee on
\nBioethics of the National Academy of Sci-
\nences of Ukraine. Boris Paton, President
\nof Academy, who supports this work, will
\npromote this activity in the future. We are
\ncon\ufb01dent of this commitment.
\nIn the ever-increasing search for new tech-
\nnologies, moral principles are often neglect-
\ned. We often forget the purpose for which
\nwe pursue advancement. Human rights and
\nhuman dignity become detached from tech-
\nnological progress. Again, we can take stem
\ncells as an example. There is no doubt that
\nthe pluripotential of stem cells gives us great
\nhope for breakthroughs in medicine; we see
\non the horizon new methods of treatment
\nof many diseases for which medicine today
\nis essentially powerless. There is a need for
\nconsensus on many issues related to embry-
\nonic tissues and cells of an adult person. We
\nhave no \ufb01rm answers to the question about
\nthe role of somatic mutations, about the ac-
\ntion of viruses, or why there are so few stem
\ncells in the healthy man, whereas the need
\nin them is very high. In order to respond
\nto these and many other questions, funda-
\nmental research is being conducted, namely
\nwithin a new Institute of Regenerative and
\nGenetic Medicine, formed within the sys-
\ntem of the Academy of Medical Sciences of
\nUkraine.
\n67
\nMedical Ethics, Human Rights and Socio-medical a\ufb00airs
\nMeanwhile, very often commercial inter-
\nests prevail. Currently, stem cells are widely
\nused in many clinics, including in countries
\nwhere their use is forbidden by legislation.
\nThe principle laid down in the Universal
\nDeclaration on the Human Genome and
\nHuman Rights and the International Dec-
\nlaration on Human Genetic Data, adopted
\nby UNESCO, provides for maximum di-
\nrect and indirect bene\ufb01ts for patients and
\nthose participating in research in the use of
\nachievements and scienti\ufb01c knowledge. It
\nalso stresses the need to ensure that, in med-
\nical practice, the use of new technologies
\ncause no harm. It is necessary to do one\u2019s
\nbest to avoid any risks.This principle is often
\nviolated in respect of not only novel technol-
\nogies, but in such spheres as clinical trials of
\npharmacological preparations. The number
\nof clinical trails themselves is notable. Over
\nthe last ten years there have been 2,200 such
\ntrials in Ukraine, far more than in any other
\nEuropean countries. The question is \u2013 why?
\nTo begin, such trials are less expensive to
\nconduct in our country. Second, regulations
\nrelated to trials of new drugs are not as strict
\nas in Western countries.
\nThe low cost of clinical trials in Ukraine is
\ndue to not only poor salaries of physicians
\nand scientists but also to very low expenses
\nrelated to health and life insurance in the
\ncase of negative e\ufb00ects from testing new
\nmedicines. In the USA, for instance, insur-
\nance for such cases amounts to 1.5 million
\ndollars, in Ukraine, 7.5 thousands Hryvna
\n(Ukrainian Currency), i.e. one thousand
\ntimes less. In EU countries, clinical trials
\nare not pro\ufb01table for pharmaceutical com-
\npanies for the same reasons. Under such
\ncircumstances Ukraine and the health of its
\npopulation can be considered at-risk. We
\nmust not forget about the tragedy caused by
\nthalidamid exposure.
\nThe number of establishments responsible
\nfor clinical trials is constantly increasing;
\npresently, there are nearly 400 of them. It is
\nclear that requirements of Bioethical Com-
\nmittees should be ever stricter; the level of
\nknowledge of members of these commit-
\ntees should be higher to avoid mistakes
\nand violations. Revised requirements for
\naccreditation and attestation of, at the very
\nleast, heads of committees of di\ufb00erent levels
\nshould be developed as soon as possible.
\nThe pharmacological market, with its re-
\nlations, is developing rapidly in Ukraine.
\nWhen medical and social direction do not
\nprevail to regulate this market, it turns into
\nnaked business, where extravagant incomes
\nare achieved at the expense of human suf-
\nfering.
\nLet us take at least one example. It is logi-
\ncal to suppose that, as cardiovascular disease
\nis the highest cause of morbidity, priority
\nshould be given to it in terms of develop-
\nment of treatment and disease prevention.
\nHowever, aggressive advertising interferes
\nin this process, pushing other priorities
\non patients. That is why the advertising of
\npharmacological preparations in most cases
\nis forbidden. The same should be done in
\nUkraine.
\nCurrently, great hopes for mankind rest on
\nthe development of nanotechnologies. Not
\nonly scientists, but politicians as well, speak
\nabout this now. Much can be done with
\ntheir use in medicine,beginning with devel-
\nopment of new drugs and diagnostics facili-
\nties, removal of pollutants, new methods of
\ntreatment and prevention. However, world
\nsocial opinion is divided between hopes for
\nthe bene\ufb01ts, and fear of the potential harm-
\nful e\ufb00ect on the environment, their use for
\nthe development new-generation weaponry,
\nand so on.
\nWith this in view, UNECSCO was com-
\npelled to gather experts to examine the vex-
\ning ethical and political questions related
\nto the application of nanotechnologies in
\ngeneral and in medicine in particular. The
\ndiscussions resulted in the article \u201cNano-
\ntechnologies,Ethics and Policy\u201d.We plan to
\nestablish a chair of \u201cNanotechnologies and
\nEthics\u201d in Kyiv as an international Board.
\nWe should emphasize one more peculiarity
\nof the III National Congress on Bioethics.
\nMuch attention was paid to the position of
\nethics in science. Very interesting reports on
\nthese problems were given at plenary and
\nsectional meetings. In particular, report by
\nPopovich,Naumovets and other members of
\nthe Academy of Sciences were delivered.We
\nwould like to underline that these questions
\nwere focused directly on the Conference of
\nEuropean Federation of the Academy of
\nSciences, which \ufb01nished its work in 2008 in
\nLisbon.The focus was the need to be guided
\nby the \u201cCode of Ethics of a Scientist\u201d, high-
\nlighting the need for moral responsibility for
\nfalsi\ufb01cation of data and plagiarism,as well as
\nfor the signi\ufb01cance and reliability of the pre-
\nsented information. It also focused on the
\nneed for research to be well conceived and
\nindependent, for reasonable use of resources
\nin order to avoid unnecessary expenses, and
\nto address improper behavior of partners in
\ninternational projects.
\nUnfortunately, the number of cases of in-
\nfringement of ethical principles in scienti\ufb01c
\nresearch in medicine has not decreased. It
\nis therefore timely that the National Acad-
\nemy of Sciences takes the role of an active
\nleader and guide of ethical principles in all
\nbranches of scienti\ufb01c and practical activity
\nin Ukraine.
\nWe can conclude that the development of
\nbioethics and the adoption of general ethics
\nprinciples in medical society will move us
\ntowards better protection of human rights
\nand human dignity in Ukraine.
\nReferences:
\n1. Faden RR, Beauchamp TL. A history and
\ntheory of informed consent. New-York: Oxford
\nUniversity Press, 1986.
\n2. Kundiiev II,Vitte PN,Lyzogub VG,Stepanen-
\nko A. Creation a national infrastructure for
\ngood clinical practice in clinical trials in
\nUkraine.Pharmaceutical Medicine 2008; 22(6):
\n355-358.
\n3. Kundiiev I., ed. Anthology of bioethics. Lviv:
\nBaK, 2003.
\nI. Kundiiev, P. Vitte, M. Chaschin
\nUkrainian Medical Association,
\nNational Academy of Sciences of Ukraine,
\nInformational Center on Bioethics
\n68
\nInternational, Regional and NMA news
\nVivienne Nathanson
\nThe British Medical Association celebrated
\nits 175th
\nbirthday two years ago. During our
\nlong existence we have developed many fac-
\nets, many sides to the personality that faces
\nour members, and the stakeholders with
\nwhom we engage.
\nEstablished \ufb01rst as a voluntary professional
\nassociation we are also a major medical pub-
\nlisher and a trade union. The three major
\nstrands of activity \ufb01t together in a complex
\nmesh with interactions in unexpected areas.
\nFor doctors in the UK we o\ufb00er services which
\nsupport them in their workplaces and in their
\ntraining from the day they arrive at medical
\nschool until well after retirement. And in our
\nprofessional association role we help doctors
\nmake a di\ufb00erence to the health and wellbeing
\nof the wider public,not only the individual pa-
\ntients so many are treating every day.
\nOne of the BMAs earliest reports was an
\ninvestigation into Quackery. In the 1830s a
\nlarge percentage of those practising as doc-
\ntors in the UK had no quali\ufb01cation. The
\nreport led to the establishment of the Gen-
\neral Medical Council and the registration of
\nmedical practitioners \u2013 including recogni-
\ntion of speci\ufb01c quali\ufb01cations. We remain
\ninvolved in similar areas today, working to
\nhelp groups of other healths professions, to
\nestablish themselves as registered practitio-
\nners, especially a few of the complemen-
\ntary and alternative therapies. The motive
\nis exactly the same \u2013 only through restrict-
\ning practice to those on a register can you
\nassure patients and potential patients that
\ntheir therapist has gone through a course
\nof training and should be practising to an
\nagreed high standard.
\nOur trade union work absorbs most of the
\nBMAs resources; rightly so as this is work
\nthat enables our members to practice as
\ndoctors in settings that will enable them to
\ndeliver high quality care to their patients,
\nand to be appropriately rewarded for this
\nwork. There is, it seems, always at least one
\nof the major branches of practice which has
\na national standard contract up for nego-
\ntiation with the government and with the
\nemployers organisations. In the current
\nglobal economic crisis such negotiations are
\ncomplex and di\ufb03cult, but we rightly have a
\nreputation for tough negotiation. The other
\nside of the union work is local representa-
\ntion \u2013 sadly doctors like all other workers
\ncan run into trouble with their employers
\nand our role is to represent them. As an ad-
\njunct to this we have a 24 hour telephone
\nhelp line with counsellors to help members
\nin distress and which is frequently accessed
\nby those facing a hostile work environment.
\nOur publishing continues with the BMJ
\nPublishing Group \u2013 a wholly owned sub-
\nsidiary. Its best known brand is the British
\nMedical Journal, published weekly in Eng-
\nlish and weekly or monthly in other lan-
\nguage editions. It also publishes more than
\n24 other journals, many in partnership with
\nspecial interest groups. The editor of the
\nBMJ has complete editorial independence;
\nsometimes uncomfortable for the BMA,
\nbut essential if it is to remain a high status,
\nindependent peer reviewed journal.
\nA major area of expansion for the BMJ over
\nthe last decade has been the production of
\nlearning and knowledge tools for doctors.
\nBMJ Learning on-line has more than 450
\nmodules for continuing professional devel-
\nopment. Most are designed for doctors, but
\nthe expertise has been recognised by other
\ngroups of health workers and the BMJ has
\nbeen commissioned to produce modules for
\nnurses and paramedics.
\nSome work appears to fall between the trade
\nunion and the professional association \u2013 in-
\ncluding work on task shifting, human re-
\nsources for health and medical migration.The
\nBMA does not get precious about this; work
\nis done by those with the right skill set and
\nmuch of it crosses internal boundaries. Key to
\neverything is networking.The group, working
\nto make sure that the views of doctors is an
\nessential part of planning for the NHS-wide
\ninformation technology developments in the
\nUK, works with doctors from all branches of
\npractice and with experts from \ufb01elds such as
\nethics to ensure that both clinical practicalities
\nand ethical principles are upheld.
\nBut to the public the face they see most
\noften is the professional side of the BMA.
\nFrom the directorate of Professional Activi-
\nties we produce materials designed to help
\ndoctors be the very best they can be in their
\nmedical careers, and we also work to keep
\nthe environment in which they work con-
\nducive to clinical excellence.
\nA set of activities that straddles this apparent
\ndivide is the lobbying work we carry out on
\nthe health of the public. We know – because
\nthey tell us \u2013 that our members care deeply
\nabout the major health problems that we see
\nacross our population. Most are working with
\nindividuals to deal with those problems, but
\nthey want to have a bigger impact.The e\ufb00ects
\nof using tobacco is a clear example.Individual
\ndoctors see patients with heart disease, with
\ncancers,with end-stage respiratory failure as a
\nresult of their cigarette smoking.They want to
\nhelp the individuals but also to turn back the
\ntide, to have a real impact in preventing these
\nillnesses. Only a small number work in re-
\nsearch,epidemiology or public health,and the
\nThe British Medical Association \u2013 a world of
\nservice for doctors
\n69
\nInternational, Regional and NMA news
\nBMA works with and for the greater number
\nin trying to reduce this disease burden.
\nFor several decades we have not only lob-
\nbied government for better tobacco control
\nmeasures, but also commissioned research
\nand published on a wide variety of aspects.
\nMany of our publications are metanalyses of
\nclinical papers, leading to conclusions and
\npolicy directions. One example was a report
\non the evidence of the harmful e\ufb00ects of sec-
\nond hand or passive smoking, published in
\ntime to in\ufb02uence the four governments in
\nthe UK in their deliberations of whether the
\nfour countries should go smoke free in public
\nplaces. This work was not a one-o\ufb00. It fol-
\nlowed several decades of reports on related
\nissues which are part of a network of con-
\ntributions that have signi\ufb01cantly reduced the
\nnumber of smokers in the UK. Sadly, there is
\na great deal more to do; too many children
\nand young adults are still starting to smoke
\nand many will \ufb01nd quitting di\ufb03cult or im-
\npossible.We will not stop this work until no-
\none in the UK ever starts smoking and all
\nexisting smokers have successfully quit.
\nThere is a nice interaction here with the
\nBMJ. It was here that Richard Doll and
\nAustin Bradford Hill published their semi-
\nnal work on the e\ufb00ects of smoking on the
\nlives of doctors. By showing over 50 years
\nago that doctors who smoked died younger
\nthan doctors who did not, Doll and Brad-
\nford Hill had a salutary e\ufb00ect on smoking
\nrates amongst doctors.UK doctors\u2019smoking
\nrates are about 2.5% against a population
\nrate of near 25%. Doctors were signi\ufb01cantly
\na\ufb00ected not just by knowing that smok-
\ning kills but speci\ufb01cally that smoking kills
\ndoctors. Perhaps this is a lesson we have
\nbeen slow to learn in directing and design-
\ning anti-smoking messages for population
\nsub groups. When we make the message
\nrelevant it is more likely to aid behaviour
\nchange than when it is general.
\nToday the BMA is working with others to try
\nto persuade the Westminster parliament to
\nlegislate for a ban on point of sale advertising
\nof cigarettes and an end to cigarette vending
\nmachines. Here another UK development
\ncomes into play.We now have four legislatures
\nand we saw with smoke-free public places
\nthat administrations in Scotland, Wales and
\nNorthern Ireland were keen willing and able
\nto pass banning laws. That helped get West-
\nminster to do the same for England. It may
\nwell be that enthusiasm for more legislation
\nis stronger in these other countries and those
\nof us in England will then use that to help us
\npersuade Westminster to follow suit. For the
\nWMA this may be an important lesson as
\nwell. Are we good at asking countries where
\ndesirable legislation has been passed how it
\nhappened? Do we exchange information reg-
\nularly? And if not,why do we not do this?
\nThere are other major public health challeng-
\nes today that are mimicking tobacco in their
\ncomplexity and in the impact they are having
\non shortening lives and stretching health care
\nbudgets. The two biggest of such challenges
\nare alcohol and obesity. The BMA is facing
\nthese as it faced tobacco; we are working with
\nlarge numbers of other interested parties, we
\nare engaging doctors throughout the UK, we
\nare looking for policies that work and we are
\ntrying to make sure that the lessons of what
\nworked and what did not work with tobacco
\nare learned. In both cases we need policies
\nthat involve many government departments.
\nAlcohol abuse in not just a health problem.
\nIt clearly causes problems for law and order
\nand is encouraged by tax and pricing poli-
\ncies (to simplify a complex matrix) and by
\nsmuggling. So we have to work with a series
\nof government departments and encourage
\nthem to think in a joined up manner.We also
\nhave to encourage all politicians to look at
\nthe long term. Major advances from changes
\nin diet and exercise will take many years to
\nproduce signi\ufb01cant changes in health expen-
\nditure. Political short-termism must not stop
\nexpenditure for longer term bene\ufb01ts.
\nClimate change is another public health
\nchallenge, but one on which action in one
\ncountry alone will have relatively little im-
\npact.There are still some who do not believe
\nthe science. The science is, of course com-
\nplex, and di\ufb00erent elements have di\ufb00erent
\nlevels of \u201cproof \u201d. Our policy is to say that
\nthe science is what it is, but that we are see-
\ning the planet warm and there are clear con-
\nsequences that follow from that. We add to
\nthis that carbon emissions are a signi\ufb01cant
\nelement and that doctors have two roles to
\nplay in reducing these \u2013 the \ufb01rst as in\ufb02uen-
\ntial citizens and societal leaders in demon-
\nstrating that they will make changes to their
\nlifestyles, and the second is to try to reduce
\nthe carbon impact of health care systems.
\nIn my professional lifetime I can make a
\ncase that medicine has been revolutionised
\nby plastics and disposables. That comes at a
\ncarbon cost. In addition health care build-
\nings are designed for a variety of e\ufb03ciency
\nfactors, and we must add carbon emission
\ne\ufb03ciency to that matrix. The BMA pub-
\nlished advice last year on these areas and we
\nare already updating that web resource.
\nThere are many ethics departments in uni-
\nversities around the UK, as with the rest of
\nthe world, producing ethics materials and
\npublication of enormous intellectual rigour.
\nWhy does the BMA still publish advice in
\nthe face of this glut of competitors? Sim-
\nply, because we know doctors, we know
\ntheir work-place, we know the clinical situ-
\nations in which they have to make ethical
\njudgements. As one academic philosopher
\nsaid: \u201cThe BMA advice has to be, and is,
\npractical and relevant to the doctor in the
\nclinical situation.The fact that it is also aca-
\ndemically excellent is a great bonus.\u201d Com-
\nmon problems include questions about data
\nprotection, con\ufb01dentiality and information
\ngovernance as well as speci\ufb01c matters such
\nas withdrawing and withholding treatment,
\nand non-treatment decisions. And again the
\nBMA gets into lobbying mode.
\nIn January 2009 the government published
\nthe Coroners and Justice Bill. Our parlia-
\nmentary o\ufb03ce noticed that clause 152 would
\nallow government ministers to share infor-
\nmation from databases between government
\ndepartments to enable public policy, after
\nbalancing the e\ufb00ects against individual rights.
\nThere were no limits to this provision, and it
\nexplicitly stated that this could include setting
\naside other laws or regulations that stopped
\nsuch data sharing. For doctors this was a po-
\ntential catastrophe; no doctor would be able
\n70
\nInternational, Regional and NMA news
\nto assure a patient that information in their
\npersonal health record would be immune to
\nsuch sharing as no-one could know what
\nministers might \ufb01nd desirable in the future.
\nWe worked with the media, with other pro-
\nfessional bodies including those representing
\nlawyers and the public, to raise concerns as
\nwell as going both to parliamentarians and
\nto ministers. No one was able to tell us of a
\nproblem to which this was the solution. The
\nintense lobbying got a result \u2013 the clause was
\nremoved from the bill. Although the govern-
\nment has committed to return to the issue in
\nother legislation it will be, they assure us, in a
\nmodi\ufb01ed form. We continue to press for the
\ncomplete exclusion of personal, identi\ufb01able
\nhealth information from any such legislation.
\nSo far we have achieved a victory \u2013 one that
\nwill help to maintain that trust between doc-
\ntor and patient over information given to us
\nby patients for the purposes of their care. But
\nwe will continue to watch and to press for dis-
\ncussion before a new clause is drafted so that
\npatients are protected and doctors do not \ufb01nd
\nthemselves in a no-win situation.
\nSometimes work on legislation is far less pub-
\nlic.Weworkwiththosedraftingandamending
\nlegislation to make sure it works in the inter-
\nests of patient care not against it.These teams
\nof people working on legislation are grateful
\nfor our expertise in understanding the impact
\nof the words they write on clinical practice
\nand on our ability to \ufb01nd viable alternatives
\nthat achieve worthwhile goals without dam-
\naging trust or other elements of patients care.
\nIn some cases we presage that work by calling
\ntogether interested experts from around the
\nhealth care world to make sure we have a com-
\nmon\u201cbottom line\u201don what is acceptable or not
\nin the draft legislation.
\nThe ethics team produce books on ethics and
\nlaw, and on human rights as well as guidance
\nnotesandon-line\u201cbooklets\u201dformembers.They
\nare also working with the BMJ \u2013 another nice
\ncollaboration \u2013 to produce ethics e-learning
\nmodules. And of course their web pages and
\nadvice enjoy thousands of hits by members re-
\nfreshing their personal ethics expertise.
\nEvery day at the BMA is di\ufb00erent. But there
\nare common threads. Our \u201craison d\u2019etre\u201d is
\nto help doctors. We do that by negotiating
\nadvantageous contracts and by ensuring that
\nthe conditions in which they work also work
\nfor optimal medical practice. And we try to
\nhelp them by providing education and learn-
\ning support materials. As one of our lea\ufb02ets
\nsays \u2013 \u201cthe BMA \u2013 a World of Service\u201d.
\nDr. Vivienne Nathanson, Director of Profes-
\nsional Activities, British Medical Association
\nLiu Zhi
\nThe Chinese Medical Association (CMA) is
\na non-pro\ufb01t registered academic and com-
\nmonweal corporate body voluntarily formed
\nby Chinese medical science and technology
\nprofessionals, and an important social force
\nin the development of medical science and
\ntechnology in China.
\nThe CMA, established in 1915, now has 84
\nspecialty societies under its umbrella, cover-
\ning all medical \ufb01elds.The CMA has a mem-
\nbership of about 460,000,and publishes 119
\nmedical journals, one medical information
\nnewsletter and one popular magazine. The
\nCMA is closely related to the local medical
\nassociations in the provinces, municipalities
\nand autonomous regions. The CMA Head
\nO\ufb03ce is in Beijing.
\nThe CMA mission includes uniting medi-
\ncal professionals, upholding medical ethics,
\nand advocating social integrity. It operates
\nwith democratic principles, supports free-
\ndom of scholarship, and seeks to raise tech-
\nnical skills of the medical professionals. It
\npromotes the prosperity and development
\nof medical science and technology, and the
\npopularization of medical science and tech-
\nnology knowledge. It promotes the growth
\nof medical science and technology work
\nforces and the integration of medical sci-
\nence and technology with China\u2019s economic
\ndevelopment. All these are for the purpose
\nof providing services for its members and
\nfor medical professionals, for the health of
\nthe Chinese people, and for socialist mod-
\nernisation in China.
\nThe scope of the work of the CMA includes:
\norganising academic exchange programs on
\nmedical science and technology, publishing
\nmedical journals and electronic audio-visual
\nproducts, promoting international academic
\nexchange programs and co-operation, carry-
\ning out continuing medical education projects,
\norganizing technical appraisal of medical proj-
\nects,selecting and presenting awards for excel-
\nlence in medical and technological research
\nand publications, \ufb01nding, recommending and
\ntraining outstanding medical talents, organis-
\ning technical assessment of medical incidents,
\nundertaking projects entrusted by the govern-
\nment, promoting transformation and practical
\napplication of medical research results, and
\nrelaying suggestions and requests from the
\nmedical professionals to the government and
\nserving as an important linkage between med-
\nical circles and the government.
\nThe President of the CMA is prof. Zhong
\nNanshan (Academician of the Chinese Acad-
\nemy of Engineering, and Director of the
\nGuangzhou Institute of Respiratory Diseases).
\nFull time Vice President and Secretary Gen-
\neral of the CMA is prof.Wu Mingjiang.
\nLiu Zhi,Director,Department of International
\nRelations, Chinese Medical Association
\nChinese Medical Association (CMA)
\n71
\nInternational, Regional and NMA news
\nSince 1847, the American Medical Asso-
\nciation (AMA) has fought for high quality
\nhealth care for all Americans, and to improve
\npublic health at home and abroad. The AMA
\nmission statement, which has remained un-
\nchanged for more than a century, provides
\nour compass: \u201cTo promote the art and sci-
\nence of medicine and the betterment of public
\nhealth.\u201d As the largest association of Amer-
\nica\u2019s physicians, the AMA represents certain
\ncore values, including leadership, excellence,
\nintegrity and ethical behavior. Through these
\nbenchmarks, the AMA stands as an essential
\npart of the professional life of every physician.
\nThe AMA shares these goals and values with
\nthe World Medical Association.
\nAMA Advocacy Agenda
\nWhile the AMA plays a role on the interna-
\ntional health care stage,physicians face press-
\ning concerns here in the United States. Over
\nthe decades, the U.S. health care system has
\ndeveloped weaknesses that leave too many
\npatients without regular access to quality care.
\nThat is why the AMA is promoting compre-
\nhensive health care reform. The global eco-
\nnomic slump that has also created economic
\nuncertainty in the U.S. is contributing to the
\nsense of urgency that the nation\u2019s health care
\nsystem needs fundamental changes in order to
\ncontrol costs, improve quality, expand cover-
\nage and enhance value. The AMA is playing
\nan important role in shaping the debate. As
\nthe largest body of America\u2019s physicians, and
\nguardian of their patients,the AMA is willing
\nto listen to all sides of the arguments,consider
\nthe nuances of each,and work toward the best
\npossible solutions.
\nReforming America\u2019s
\nhealth care system
\nIn the U.S., 2008 was a national election
\nyear. The AMA seized the opportunity to
\nunveil the Voice for the Uninsured cam-
\npaign, which educated candidates, voters
\nand the media about the ongoing problem
\nof people who lack health care coverage in
\nthe U.S.Through advertising,appearances at
\npublic events and through the news media,
\nthe AMA transmitted its plan for universal
\nhealth insurance coverage to government
\no\ufb03cials, elected leaders and patients. The
\nAMA held meetings and follow-up con-
\nversations with the major presidential cam-
\npaigns to educate them about the AMA\u2019s
\nProposal for Expanding Coverage and
\nChoice.
\nThe AMA launched the Voice for the Un-
\ninsured Campaign website to showcase the
\nAMA proposal and give the 46 million
\nAmericans without health insurance a voice
\nto tell their story.The success of this initiative
\nampli\ufb01ed the AMA\u2019s voice as a champion for
\nhealth system reform. It was another reason
\nwhy America\u2019s physicians will have a role in
\nthe 2009 e\ufb00orts to expand health insurance
\nand in other health care initiatives.To achieve
\nthese goals, the AMA is working with many
\ndiverse organizations representing patients,
\nhospitals, insurers and employers to identify
\ncommon ground on approaches to compre-
\nhensive health system reform. This e\ufb00ort
\nshares a common message: in order to \ufb01x
\nthe ailing economy, the U.S. needs reforms
\nthat address the related problems of health
\ncare costs and the uninsured. The issues the
\ncountry\u2019s health care system faces have been
\ndecades in the making,but the need for solu-
\ntions is immediate.
\nThe Uninsured
\nAt the center of the AMA\u2019s vision is the
\nbelief that every American, regardless of
\nmeans, should have access to health insur-
\nance. Every patient should maintain the
\nfreedom to choose his or her own physi-
\ncians and health plans, and maintain con-
\ntrol over his or her own care. That includes
\nthe 46 million Americans who do not have
\nhealth insurance. They live sicker and die
\nyounger. Four out of \ufb01ve uninsured persons
\nare in a family where at least one person is
\nemployed. This is not just a statistic, it is
\na serious public health problem and a poor
\nuse of national resources.
\nAmerica\u2019s current health insurance problems
\nbegan during World War II. At that time,
\nPresident Franklin Roosevelt imposed wage
\nand price controls to counter wartime in\ufb02a-
\ntion. Since employers couldn\u2019t raise wages,
\nother means were sought to reward Ameri-
\ncan workers. One way was for employers to
\nstart paying for employees\u2019 health insurance
\ncosts. From there, employer-based health
\ninsurance became the dominant means of
\ncoverage in the United States.
\nThe AMA \u201cPlan for Reform\u201d, which rests
\non three pillars, calls for an end to linking
\nhealth insurance to employment, which is
\nno longer practical in the modern economy.
\n1) Provide tax credits for the purchase of
\nhealth insurance. This would enable pa-
\ntients to buy their own health insurance
\nplan they could take with them from job
\nto job.
\n2) Promote individual ownership of plans.
\nPatients could choose their own doc-
\ntor, their own hospital and the coverage
\nthey want in their price range.
\n3) Reform the insurance market through
\nmore competition and less insurer in-
\nterference and bureaucratic meddling.
\nSome of these solutions have been incorpo-
\nrated into government proposals for health
\ncare reform. But much work remains to be
\ndone.
\nMedicare Payment
\nThe AMA is also active in e\ufb00orts to reform
\nMedicare, the government-run health care
\nplan for Americans over the age of 65 and
\nwith severe disabilities. A seemingly an-
\nnual problem faced by physicians who treat
\nMedicare patients is that the reimburse-
\nThe American Medical Association
\nand the WMA
\nGlobal Partners for Physicians
\n72
\nInternational, Regional and NMA news
\nment for medical care is threatened with
\ncuts. The formula that determines Medi-
\ncare payments is based on the US gross na-
\ntional product, and not on the actual cost of
\nproviding that care.
\nIn 2008, physicians faced a 10.6 percent
\ncut in Medicare payments. A cut this steep
\nwould cause senior citizens to lose access to
\ncare by driving physicians away from the
\nMedicare program. Physicians and patients
\nacross the country worked together to over-
\nride a presidential veto of the legislation \u2013 a
\nremarkable event that rarely happens in our
\ncountry. Physicians and seniors won this
\nbattle because they contacted Congress by
\nthe tens of thousands and because the AMA
\nran powerful advertisements on TV and in
\nlocal newspapers encouraging lawmakers to
\nprotect access to care for the elderly.
\nHowever, this victory is only temporary.The
\n\ufb02awed system for reimbursing physicians
\nfor treating Medicare patients will result in
\npayment cuts to physicians of 21 percent in
\n2010. Unless the formula is changed, cuts
\nwill total 40 percent by 2015. However,
\nphysician practice costs will increase by least
\n20 percent over this same time period. That
\nis why the AMA is working with Congress
\nand the President to build a system that im-
\nproves quality and better protects access to
\ncare for seniors.
\nCost of Care
\nThe AMA is also developing strategies to
\nrestrain rising costs while maintaining qual-
\nity of care. Medical science and technology
\nhave moved forward at a lightning pace.
\nThe AMA wants to \ufb01nd new ways to enable
\ndoctors to use promising new technology
\nwhile developing new methods to measure
\nand improve the quality of care.
\nPhysician Autonomy
\nThe AMA believes that America\u2019s patients
\nwill be best served when our country elimi-
\nnates the disproportionate in\ufb02uence of in-
\nsurers and government on medical decisions.
\nThese important decisions must be placed
\nback in the hands of the
\npatient and the physi-
\ncian.The AMA has also
\nbeen active on behalf of
\nphysicians when the is-
\nsues turn to the business
\nof medicine. One such
\narea is in obtaining an-
\ntitrust relief. The AMA
\nseeks to make it possible
\nfor physicians to negoti-
\nate as a group, instead of
\nas individuals, to coun-
\nter the powerful advan-
\ntage held by insurance
\ncompanies.
\nMedical Workforce
\nConsidering the con-
\n\ufb02icts with the health
\ninsurance industry, the
\nproblem of medical li-
\nability lawsuits and
\nerratic Medicare reim-
\nbursement, America
\ncould face a shortage of
\nphysicians in some \ufb01elds
\nby the year 2020. The
\nAMA seeks to increase
\nmedical school class
\nsize, allow for additional
\nresidency slots to train
\nphysicians, and improve
\nthe distribution of phy-
\nsicians to underserved
\nand undersupplied spe-
\ncialties, especially in the
\nprimary care \ufb01eld.
\nQuality of Care
\nThe AMA is not only concerned with the
\nquantity of physicians serving American
\npatients, but also with the quality of care.
\nThe AMA\u2019s e\ufb00orts in clinical quality im-
\nprovement begin with performance mea-
\nsure development \u2013 measures designed by
\nphysicians for physicians.
\nThe AMA houses a group called\u201cThe Physi-
\ncian Consortium for Performance Improve-
\nment\u201d.The Consortium works with national
\nquality groups and government agencies to
\ndevelop \u201cquality measures\u201d that doctors can
\nrely upon. To date, the Physician Consor-
\ntium for Performance Improvement has de-
\nveloped more than 250 individual measures
\ncovering 42 clinical topics. They were de-
\nveloped by the Consortium in collaboration
\nwith specialty societies, and often with the
\nNational Committee for Quality Assurance.
\nFor ease of use, each measurement set can
\nbe implemented in practices using di\ufb00er-
\nent data sources and can be integrated with
\nboth paper and electronic medical records.
\n73
\nInternational, Regional and NMA news
\nIn other words, rather than the government
\ntelling doctors what is best, the AMA is
\nhelping the government understand what is
\nbest, as determined by scienti\ufb01c research.
\nOther Issues
\nThe AMA is also encouraging more atten-
\ntion to issues across the health care spec-
\ntrum, such as:
\nDirecting more resources and e\ufb00ort to-\u2022
\nward disease prevention;
\nHelping Americans lead more healthful\u2022
\nlifestyles;
\nEliminating gaps in care, particularly for\u2022
\nracial and ethnic minorities, the elderly,
\nand low-income families;
\nPreparing adequately for large-scale\u2022
\nhealth care emergencies.
\nDespite its problems,the U.S.health care sys-
\ntem does have real strengths. One is choice:
\npatients can choose the kind of insurance they
\nwant,their physicians and their hospitals. The
\nU.S.systemalsohasatremendousabilitytoin-
\nnovate and generally has convenient access to
\ntreatment and procedures without long waits.
\nThe American system of medical education is
\nhighly respected. Promising students from all
\nover the world hope to train in U.S. medical
\nschools,which teach the advanced techniques,
\ntreatments and procedures that make the sci-
\nence of American medicine among the best
\nin the world.
\nIn the United States, the \ufb01nancial crisis
\nhas a\ufb00ected everyone\u2019s life. But America\u2019s
\nphysicians will not be deterred from their
\nresponsibilities to patients and their com-
\nmunities. The AMA will continue to help
\ndoctors help patients, champion the art and
\nscience of medicine, advocate for the in-
\nterests of member physicians and provide
\nthem with the tools and resources they need
\nto succeed, through good times and bad.
\nThe AMA\u2019s Role in WMA
\nThe AMA\u2019s active participation in the WMA
\nhas provided the opportunity to work with our
\ncolleagues to pursue solutions to global health
\nproblems. This sort of interaction is irreplace-
\nable as the world becomes smaller and the
\nglobal village larger. Microbes do not respect
\nborders, as international outbreaks of SARS,
\nmalaria and the West Nile virus attest.
\nThe international public health agenda is
\nso vast that no single sector or organization
\ncan succeed alone. Bridges need to be con-
\ntinually built and ties renewed.Through the
\nAMA\u2019s membership and involvement in the
\nWMA, the AMA:
\nStrengthens its own policy development;\u2022
\nIdenti\ufb01es emerging issues and \ufb01nds solu-\u2022
\ntions to common problems;
\nFul\ufb01lls a professional obligation to share\u2022
\nknowledge;
\nIdenti\ufb01es new ways to educate and assist\u2022
\nphysicians worldwide.
\nThe AMA believes it is important that the
\nWMA succeed and thrive in its mission to
\n\ufb01nd common ground among the world\u2019s
\nphysicians. That is why the AMA works
\nto help shape the structure and governance
\nprocedures of the WMA. The AMA has
\nhelped establish bylaws and operating poli-
\ncies, promoted the per capita membership
\nsystem in the Assembly and Council, and
\ndrafted new bylaws that required each na-
\ntional medical association to certify the
\ncharacter, integrity, and competence of their
\nmembers who run for WMA o\ufb03ces.
\nThe AMA has made signi\ufb01cant contribu-
\ntions to WMA policy on professional lia-
\nbility,medical education,ethical research on
\nhumans, bioterrorism, alcohol and health,
\ntobacco use, and obesity. Most recently, the
\nAMA has worked toward revisions to the
\nDeclaration of Helsinki, called for reduc-
\ntions in mercury use and dietary sodium in-
\ntake, and urged more cooperation between
\nhuman and veterinary medicine.
\nThese changing times bring new challenges.
\nMeeting them will require the uni\ufb01ed ef-
\nforts of physicians and patients not just in
\nthe United States, but around the world.
\nThat is why the AMA values its involve-
\nment with the World Medical Association
\nso highly, and encourages all physicians in
\nevery country to do the same.
\nAMA, Communications Department
\nI.The French Medical Association
\n(AMF) was established on
\n22 December 1992.
\nThe association\u2019s purpose are: research, ac-
\ntivities, studies or common actions accord-
\ning to European,international or worldwide
\nguidelines concerning health in the teach-
\ning of medicine, medical science, medical
\npractice, medical ethics and medical care
\ninsofar as the doctors represented in AMF
\ncan achieve it.
\nII.The Association is composed of:
\nFounding members:
\nThe National Order of Physicians\u2022
\n(CNOM)
\nThe Confederation of French Medical\u2022
\nUnions (CSMF)
\nThe Federation of the Doctors in France\u2022
\n(FMF)
\nThe French Mutual Insurance of Health\u2022
\nCorps (MACSF)
\nThe Medical Insurance and Professional\u2022
\nDefence Society (Le Sou M\u00e9dical)
\nMembers:
\nThe \u201cPasteur Mutualit\u00e9\u201d group\u2022 (AGMF)
\nThe Former Interns Association\u2022 (AIHPP)
\nThe French Medical Association
\n(L\u2019 Association M\u00e9dicale Fran\u00e7aise)
\n74
\nInternational, Regional and NMA news
\nIII. AMF\u2019s Operative \ufb01elds:
\nWithin the AMF and within international
\nmedical organisations, the AMF seeks to
\nachieve the best possible standards: in eth-
\nics, training, healthcare quality, professional
\npractices,publichealth,andhumanrightsas-
\nsociatedwithindividualandcollectivehealth.
\nThe AMF helps practitioners, protects pa-
\ntients, provides accurate information and
\nrepresents health professionals.
\nIV. Current policy:
\nextension of the AMF
\nBy communicating to medical professionals
\nthe French medical practices embodied by
\nthe AMF.
\nBy accessing and participating actively
\nwithin the International Medical represen-
\ntative bodies:
\nCurrently : World Medical Association\u2022
\n(AMM \/ WMA) created on 18 Septem-
\nber 1947 in Paris (initiated especially by
\nPr. E. MARQUIS).
\nIn the future: the European Forum of\u2022
\nMedical Associations (EFMA), etc …
\nV. AMF participating in
\nongoing activities:
\nThe International Code of Medical Ethics\u2022
\nPatient\u2019s rights, the children’s rights
\nTask delegating\u2022
\nMedical liability, professional autonomy\u2022
\nHealth and environment, health alerts\u2022
\nMedical participation in capital punish-
\nment cases, etc …
\nVI. AMF work in progress
\nAMF assists the Medical Associations of
\nFrench-speaking countries and developing
\ncountries to participate, alongside and after
\ntheir approval, in activities in international
\nmedical bodies.
\nThe AMF contributes, through its cross-\u2022
\nrepresentation, to providing medical
\nterms in French and French-speaking
\nsocial-professional topics both in Europe
\nand internationally.
\nThe AMF wishes to contribute to a \u00abmed-\u2022
\nical diplomacy by and for the doctors\u00bb in
\norder to save the profession\u2019s autonomy,
\nnotably through meetings, team work,
\nseminars: Tuberculosis, HIV \/ AIDS,
\nparasitic, environmental, Helsinki Dec-
\nlaration, counterfeiting, insurance, com-
\npensation, autonomy and professional re-
\nsponsibility, and assistance to colleagues
\nin di\ufb03culty.
\nVII. AMF Projects:
\nPresent and defend in France the funda-
\nmental principles of medical practice: ethics,
\nresponsibility,solidarity,liberal spirit,justice,
\npublic health management, risk compensa-
\ntion, training, skills and best practices.
\nDevelop a collaborating spirit with other
\nindependent Medical Associations in order
\nto compare, propose, take up and con\ufb01rm
\nactivities after debate and consensus.
\nMaintain the profession\u2019s international au-
\ntonomy within representative bodies and
\nspread proven knowledge.
\nRecall and develop the French medical
\npresence in the AMM (WMA) since its
\ninception in 1947.
\nVIII.Through its international
\ncontacts, the AMF promotes
\ninformation sharing
\namong practitioners
\nparticularly regarding their demands on
\nhealth systems, contracts, professional in-
\nsurance and medical risk insurance and the
\nvarious unions and scienti\ufb01c activities in
\nFrance and abroad.
\nIX. By cross-representation based on the
\nAMF one can learn about the policies of
\ncontinuing medical education, prevention
\nof medical accidents, updating of knowl-
\nedge and assistance to colleagues.
\nX.The AMF is able to assume future part-
\nnerships within the framework of actions
\nfalling within the scope de\ufb01ned by its stat-
\nutes.
\nThe AMF is helped by its members to be
\ninformed of developments in the health sys-
\ntem and contributes to the achievement of
\nnational economic policy and research.
\nFor more information, join us on the site
\nhttp:\/\/www.assmed.fr
\nDr. Louis-Jean Calloc’h, Secretary General,
\nThe French Medical Association
\nParis:working party of AMF with the Medical Associations of Mali, from the Senegal, from Cote
\nd’Ivoire and their Presidents
\nParis: working party of AMF with the Medi-
\ncal Association Canadian (CMA) and its
\nPresident the Dr. Ouellet
\n75
\nInternational, Regional and NMA news
\nThe Belgian Association of Medical Trade
\nUnions (ABSyM) was created in 1963 to
\n\ufb01ght the law that would \ufb01x the conditions
\nof medical practice. After long and unsuc-
\ncessful negotiations, the medical body went
\non strike. It was the \ufb01rst medical strike in
\nthe world.
\nThe government eventually agreed to change
\nthe law and a system of agreement between
\ndoctors and mutual insurance companies
\nwas set up. This system has allowed the co-
\nexistence of a social \ufb01nancing and a liberal
\npractice ever since.
\nEvery year in the beginning and every other
\nyear now, the medical trade unions and the
\nmutual companies negotiate an agreement
\nabout fees and practice conditions.
\nFrom 1993, the agreement must be done
\ninside a \ufb01xed budget.
\nIndividual doctors may decline the agree-
\nment and ask for free fees. They have a
\nmonth at their disposal to do so.The agree-
\nment is only enforced if 60 % of doctors (at
\nleast 50 % of specialists and 50 % of GPs)
\ndon\u2019t decline this agreement. If they accept
\nthe agreement, they are entitled to receive
\nan amount (currently 3000 \u20ac) for their re-
\ntirement pension.As self-employed,doctors
\nare only entitled to a very low legal pension
\n(about 800 \u20ac a month).
\nUp to now, between 80 and 90 % of doc-
\ntors accept the agreement every time. Only
\ntwice in 45 years have medical trade unions
\nrejected any agreement. On these occa-
\nsions, the minister proposed an agreement
\nto individual doctors, but their agreement
\nwas refused by more that 50 % of specialists
\nand 50 % of GPs in the whole country.This
\nagreement was not able to be enforced.
\nWhat is characteristic of Belgian practice is
\na large freedom for the doctor, but also for
\nthe patient.
\nDoctors are free to accept the agreement or
\nnot, but if they accept it they are still free to
\ndo it only for a part of their working time.
\nIn that case, they must notify the periods
\nof time when they respect the fees of the
\nagreement and the periods when they do
\nnot.
\nIf they don\u2019t mention it, they are considered
\nas committed for their whole activity, but
\nthey are still free to set fees if the patient
\nhas any special requirements (for instance
\nan individual room in hospital). On the
\nother hand, fees resulting from the agree-
\nment are not very high (about 22 \u20ac for a
\nconsultation).
\nPatients also have freedom of choice. They
\nmay choose their doctor. They may consult
\na specialist without being referred by a GP.
\nThey may go directly to the hospital if they
\nneed.They may call an ambulance.They may
\nchoose their hospital.They may change doc-
\ntors without any administrative or \ufb01nancial
\nsanction. They may have a second opinion
\nwithout di\ufb03culty.
\nThere is no waiting list and the average time
\ndevoted by doctors to their patient in a face
\nto face meeting is about twenty minutes.
\nIf access to health care is easy,it is not free of
\ncharge. Patients have to pay a contribution.
\nThis contribution varies with the patient\u2019s
\nincome. About 20 % of the population enjoy
\na preferential reimbursement.
\nPatients with chronic illness or families with
\nhigh expenses in health care have care free
\nof charge when they have reached a certain
\nlevel of expenses every year.
\nABSyM is in favour of this patient contri-
\nbution instead of rationing.
\nAs one can see, the ABSyM\u2019aims are to de-
\nfend Hippocratic principles:
\nfreedom of choice for the patient\u2022
\ndoctor\u2019s independence\u2022
\nmedical secrecy\u2022
\nbut also to defend access to health care\u2022
\nfor everybody and to promote quality of
\ncare and risk management.
\nWith regard to quality, ABSyM negotiated
\na free system in 1993. This system has been
\nimplemented since 1994.
\nDoctors who follow CME attend a local
\nPeer Review and those who commit them-
\nselves to comply with quality norms are ac-
\ncredited.
\nAccreditation is not only a label of qual-
\nity. It also entitles the accredited doctor to
\nhigher fees and such doctors receive a yearly
\nlump sum (600 \u20ac) to insure an independent
\nCME.
\nAccreditation is free, but more than 85 % of
\ndoctors are accredited.
\nUnfortunately, not everything is perfect.
\nBecause of chronic overspending, measures
\nof cost containment have been taken and
\ndoctors are more and more under pressure.
\nThe medical control service has been given
\nlarge prerogatives to investigate medical ac-
\ntivities, with penalties for doctors who have
\nnot complied with the rules.
\nThe medical advisers of mutual insurance
\ncompanies may limit access to expensive
\ndrugs, and there are more and more restric-
\ntions for access to new drugs and new tech-
\nnologies.
\nThe administrative load is taking more and
\nmore doctors time at the expense of the
\ntime devoted to patients.
\nWhile the budget is now balanced, patients
\nand doctors may pay the price with the free-
\ndom that they had enjoyed up to now.
\nRoland LEMYE, President, ABSyM
\nLiberal practice in Belgium
\n76
\nInternational, Regional and NMA news
\nVasile Astarastoae
\nThe Romanian College of Physicians was
\nfounded in 1995. At the end of last year, a
\nnew board has been elected. Prof. Dr. Vasile
\nAstarastoae is the new president, replacing
\nProf.Dr.Mircea Cinteza,who has led the or-
\nganization for a decade.The Romanian Col-
\nlege of Physicians is also led by three vice-
\npresidents:Prof.Dr.VladTica,Dr.Gheorghe
\nBorcean and Dr. Constantin Carstea.
\nThe Romanian College of Physicians is orga-
\nnized and functions within the provisions of
\nthe Act no.95\/2006,as the physicians\u2019national
\nprofessional organization,being an institution
\nof public interest, non-governmental, non-
\npolitical and without patrimonial purpose.
\nThe Romanian College of Physicians is a
\njuridical entity and has institutional auton-
\nomy in its relation with any public authority,
\nexerting its attributes without any possibil-
\nity of interference.
\nThe Romanian College of Physicians has as
\nits main objective the control and surveil-
\nlance of the practice of medical profession,
\nthe application of laws and rules that orga-
\nnize and establish the practice of the pro-
\nfession, the representation of the physician\u2019s
\ninterests and the observance of the prestige
\nof the medical profession within society.
\nOne of the main concerns of the organiza-
\ntion is physicians\u2019 emigration. Romania has
\nonly half of the necessary number of physi-
\ncians. There are counties which do not have
\nat least one cardiologist or one endocrinolo-
\ngist. In Botosani county, there is no cardi-
\nologist.A number of 98 towns or villages do
\nnot have a family doctor. In these circum-
\nstances, Romania\u2019s joining the European
\nUnion has allowed very many physicians to
\nleave and work in a country belonging to
\nthe EU. Last year, approximately 4% of the
\ntotal number of physicians have left Roma-
\nnia, according to a recent study made by the
\nRomanian College of Physicians. Almost
\n500 physicians have left the capital, Bucha-
\nrest. Within the last two years, 10 % of the
\nmedical sta\ufb00 has worked in a EU country.
\nFrance, Germany and Great Britain are the
\nfavourite destination countries for Roma-
\nnian physicians. The most required special-
\nties in these countries are: family medicine,
\nanaesthesiology and psychiatry.\u201cWe are fac-
\ning a crisis as to the number of the medical
\nsta\ufb00,a crisis that nobody wants to admit\u201d,says
\nProf. Dr. Vasile Astarastoae, president of the
\nRomanian College of Physicians. Another
\ngoal of the Romanian College of Physicians
\nare the Guidelines of Medical Practice. \u201cThe
\nguidelines of medical practice will be made
\nup according to the priorities related to the
\nstate of health in Romania. The Romanian
\nCollege of Physicians will coordinate both
\nthe making up of the medical guidelines and
\nwill also monitor their implementation\u201d, said
\nProf. Dr. Vasile Astarastoae, the President of
\nthe Romanian College of Physicians.
\n\u201cIt is demonstrated that the guidelines of
\nclinical practice are e\ufb00ective means of chang-
\ning the process of medical assistance and im-
\nproving the results in the sanitary \ufb01eld. Be-
\ning one of the instruments which help health
\nprofessionals and organizations to improve
\nthe quality of the patients\u2019 treatment, the
\nguidelines o\ufb00er the persons who use them
\nthe possibility to improve the way in which
\ndecisions are taken, improving team work,
\nsharing their knowledge based on experience
\nand reducing the changes in practice. At the
\nsame time, the guidelines permanently bring
\nto date the knowledge of health profession-
\nals and make them give up the methods used
\nuntil that moment in order to follow the best
\nrecommended practice\u201c, declared Prof. Dr.
\nVlad Tica, Vice-president of the Romanian
\nCollege of Physicians. Last year, in Romania
\nthere have been endorsed the Guidelines of
\nObstetrics and Gynaecology. 11 guidelines
\nare elaborated and other 15 are still to be elab-
\norated. \u201dA priority of the Romanian College
\nof Physicians is the making up of a Guide of
\nGuidelines which should o\ufb00er the common
\nmethodology in elaborating all guidelines.We
\nhave suggested this guide to the European
\nUnion of Specialist Doctors (UEMS), the
\nRomanian College of Physicians being the
\nonly representative body from Romania that
\nhas been accepted within this imposing insti-
\ntution. In the European countries, the aver-
\nage time for elaborating a guide is 18 months\u201d
\nadded Prof.Dr.Vlad Tica.
\nLast year, the Romanian College of Phy-
\nsicians has become a full member of the
\nUEMS. In this position, the representative
\nof the Romanian College of Physicians,Prof.
\nDr. Vlad Tica made two important sug-
\ngestions. The \ufb01rst refers to the possibility
\nto award international credits for national
\nactivities, which are ranked as high qual-
\nity. Now, EACCME (the European institu-
\ntion for awarding the credits of continuous
\nmedical education) has as its goal rising the
\nphysicians\u2019 level of knowledge, free move-
\nment,equal accreditation.We have suggested
\nthat, if a national CME activity is ranked as
\ngood, CME credits could be also recognized
\nin Europe. This way, we can increase physi-
\ncians\u2019access as 80% of the scienti\ufb01c activities
\nare national. The second suggestion we have
\nsent to UEMS is related to the Guidelines
\nof Medical Practice. UEMS does not have
\na textbook connected to the elaboration of
\nguidelines. For this reason we have thought
\nto make up a Guide of Guidelines, which
\nshould receive UEMS approval. We must
\nmake up a guide of good quality,otherwise it
\nwillnotbeapproved\u201d,saidProf.Dr.VladTica.
\nVasile Astarastoae, President of the Romanian
\nCollege of Physicians
\nThe Romanian College of Physicians
\n77
\nInternational, Regional and NMA news
\nThe Icelandic Medical Association (IcMA)
\nwas founded in 1918, thus it was 90 years
\nold last year. Iceland is a volcanic island
\nin the mid north Atlantic ocean, its size is
\n103 000 square kilometres which is almost
\nthe size of England, but the island is very
\nthinly populated as the population is only
\n320 000.
\nThe IcMA has available several small cot-
\ntages in Iceland that members can rent.This
\nis popular for hiking during the summer.
\nWhen the IcMA was founded in 1918, Ice-
\nland was still a part of the Danish kingdom.
\nThe Republic of Iceland was established in
\n1944. Approximately 80 % of the popula-
\ntion lives in south west region of Iceland,
\nin and around the capital Reykjavik. The
\nUniversity of Iceland in Reykjavik was es-
\ntablished in 1911 by fusion of pre-existing
\nschools that gave training in medicine,
\nlaw and theology. There is one University
\nhospital in Reykjavik and three regional
\nsmaller ones in rural Iceland. Some smaller
\nhospitals are also in suburban Reykjavik
\nand surrounding area with speci\ufb01c tasks in
\nco-operation with the University Hospi-
\ntal. Most Icelandic doctors have graduated
\nfrom the Medical Faculty of the University
\nof Iceland, but have received their specialist
\ntraining overseas. Currently there are 1800
\nmembers of the IcMA and approximately
\n1200 are active at home. There is currently
\nno shortage of doctors, and neither is there
\nany unemployment amongst the profession.
\nIcelandic doctors commonly live and work
\nin the Scandinavian countries, USA, UK,
\nNetherlands and several other countries,
\nmostly in Europe.
\nThe IcMA consists of nine di\ufb00erent region-
\nal societies. It is a small association even if
\nover 90 percent of active doctors in Iceland
\nare members, and its function is not stipu-
\nlated in any law. It is not obligatory to be
\na member of the association if you work
\nin Iceland as a doctor, but if you receive a
\nsalary by a contract the
\nIcMA negotiates with the
\ngovernment you have to
\npay dues to the association
\nwhich is the same amount
\nas the membership fee.
\nThe IcMA is both a trade
\nunion and professional so-
\nciety. The main purpose of
\nthe society according to its statutes is:
\nTo enhance the wellbeing and honour\u2022
\nof the Icelandic medical profession, to
\nenlarge their acquaintance and aware-
\nness of society matters.
\nTo safeguard the independence of doc-\u2022
\ntors and watch over their interests.
\nTo enrich the further education of doc-\u2022
\ntors and interest them in professional
\nmatters.
\nTo enhance doctors\u2019co-operation in all\u2022
\nmatters that lead to progress in health
\na\ufb00airs
\nTo participate internationally to fur-\u2022
\nther the common interests of doctors.
\nTo work towards better health of the\u2022
\npublic and be opinion makers in health
\na\ufb00airs.
\nWorking towards these goals the o\ufb03ce has a
\ntotal sta\ufb00 of 3.5 people, one is a doctor who
\nis President of the IcMA and a CEO is a
\nlawyer.The board of the IcMA has 9 mem-
\nbers and have a role in co-operating with
\nthe authorities, both inside the ministries
\nand in parliament.The opinion of the IcMA
\nis often taken into consideration, during the
\nlaw-making process. Most of health care
\nis run by the public sector, even if private
\nenterprise is permitted. The private part of
\nthe health sector is to a great extent sub-
\nject to contracts with the National Health
\nInsurance, since we do not have any private
\nhealth insurance in Iceland.
\nNew Honorary Members of the
\nIcelandic Medical Association
\nThe IcMA takes very seriously its social
\nresponsibilities. Ethical issues, professional-
\nism and matters of good conduct are writ-
\nten into the statutes of the IcMA and its
\nEthical Code and we urge ours members to
\nwork and live by them. Continuous medi-
\ncal education and personal development
\nat home is prioritised in the IcMA\u2019s work
\nas is international participation. IcMA is a
\nfounding society both in the European and
\nglobal context. We currently have focused
\nupon Nordic co-operation, when working
\nboth in the Permanent Committee of Eu-
\nropean Medicine (CPME) and the World
\nMedical Association (WMA), since there
\nwe feel most similarities.
\nDr. J\u00f3n Sn\u00e6dal , Immediate Past-President
\nWMA, Icelandic Medical Association.
\nThe Icelandic Medical Association
\nThe General assembly of Icelandic Medical As-
\nsociation in September 2008, elected two Hon-
\norary Members nominated by the board. Dr. Jon
\nSn\u00e6dal and Dr. Stefan B. Matthiasson. Dr.
\nSn\u00e6dal, has through many years worked in
\nmedical ethics both at home and Internationally.
\nDr. Sn\u00e6dal is since 2004 president of the IcMA\u2019s
\nethical committee. He is past President of World
\nMedical Association. Dr. Stefan B. Matthias-
\nson has for many years worked for IcMA in the
\n\ufb01eld of Continuous Medical Education. He was
\nPresident of CME Committee for The Reykja-
\nvik and Icelandic Medical Associations 1987-
\n2001.Here seen with the President of IcMA Dr.
\nBirna Jonsdottir, from right Dr. Sn\u00e6dal, Dr.
\nJonsdottir and Dr. Matth\u00edasson.
\n78
\nInternational, Regional and NMA news
\nArmin Ehl
\n\u201cThis is not a doctors\u2019 strike, this is a slave
\nrevolt!\u201d This is what was written on many
\nof the hand-painted banners during the
\ngreat doctors\u2019 strikes in the years 2005 and
\n2006. Although, at the beginning of the
\nstrike campaign, this slogan seemed some-
\nwhat exaggerated to many German citizens,
\neveryone in our country knew what it was
\nall about after \ufb01fteen weeks of the doctors\u2019
\nstrike. There is a great discrepancy between
\nthe often used image of the \u201cdemigods in
\nwhite\u201d and the workaday reality in German
\nhospitals. Reducing this discrepancy has
\nbeen the job of the Marburger Bund since
\nits foundation in 1947.
\nOf course, there have been many develop-
\nments in the German health care system
\nduring the more than 60 years since its
\nfoundation. The professional situation of
\ndoctors has changed signi\ufb01cantly through
\nlegislation and the increasing economisa-
\ntion of the health care system. Nevertheless
\nthe motives which led to the foundation of
\nthe Marburger Bund remain relevant: hu-
\nmane working conditions, performance-re-
\nlated remuneration, state-of-the-art medi-
\ncal quali\ufb01cation as well as quality-focused
\npost graduate training for doctors.
\nDoctors in Germany are unionised either
\nvoluntarily or as mandatory members in
\nvarious organisations.In Germany there are,
\nin total, about 312,000 physicians in gainful
\nemployment. All of them are mandatory
\nmembers of one of the 17 State Chambers
\nof Physicians in Germany, one for each fed-
\neral state (only North-Rhine Westphalia
\nhas two Chambers of Physicians). These
\nState Chambers have joined forces to form
\nthe German Medical Association, which is
\nthe head organisation of the so-called doc-
\ntors\u2019self-administration.The responsibilities
\nof the Chambers include, amongst others,
\nthe representation of vocational interests of
\nall physicians and the promotion of a stan-
\ndardised code of professional duties and
\nguidelines for medical activities in all \ufb01elds
\nas well as for further vocational training.
\nAmong the physicians in gainful employ-
\nment, about 140,000 are self-employed in
\nprivate practice, as general practitioners or
\nas medical specialists. The doctors in pri-
\nvate practice have joined to form the Kas-
\nsen\u00e4rztlichen Vereinigungen (Regional
\nAssociations of Statutory Health Insur-
\nance physicians). These KVs are somewhat
\nlike \u201cco-operatives\u201d that conclude frame-
\nwork agreements \u2013 particularly with the
\nover 200 statutory health funds in Ger-
\nmany \u2013 regulating the payment of doctors
\nin private practice for services rendered to
\nthose citizens covered by a public health in-
\nsurance plan. (In Germany about 90% of
\nthe population are members of a statutory
\nhealth fund, the remaining 10% are covered
\nby private insurance). At the moment there
\nis great cause for dissatisfaction in Germany
\namong doctors in private practice because
\nthe overall payment is too low and the
\nrepartition of these poor means among the
\ndi\ufb00erent branches and regions in Germany
\nis very controversial.
\nIn addition to self-employed physicians,
\napproximately 148,000 physicians are em-
\nployed, mostly by the approximately 2100
\nGerman hospitals. These physicians are
\nrepresented by Marburger Bund. The in-
\nterests of employed physicians are manifold
\nand are re\ufb02ected in the work of Marburger
\nBund. First of all, Marburger Bund is the
\norgan representing medical interests vis-\u00e0-
\nvis politics on a regional, respectively na-
\ntional, as well as on a European level. Last
\nyear, for example, the reform of hospital
\nfunding was an important issue in Ger-
\nmany. Together with hospital operators, the
\nGerman Medical Association (B\u00c4K) and
\nthe trade unions for the care sector Mar-
\nburger Bund constituted an active coalition
\nthat culminated in a demonstration of more
\nthan 130,000 employees of German hos-
\npitals at the Brandenburg Gate in Berlin.
\nRegular talks with the Federal Ministry of
\nHealth and Social Security \u2013 and even talks
\nwith Federal Chancellor Merkel \u2013 showed
\nthe importance of Marburger Bund.
\nOn a European level we are greatly con-
\ncerned at the moment about the proposed
\namendment of the EU Working Time Di-
\nrective.For many years Marburger Bund has
\nfought for on-call services to be counted as
\nlabour time and for weekly working hours
\nto be limited for physicians. The European
\nCourt of Justice con\ufb01rmed in two impor-
\ntant rulings [SIMAP 2000, Dr. J\u00e4ger (Mar-
\nburger Bund member) 2003] that on-call
\nservices are to be counted as full labour time,
\nthereby strengthening explicitly the labour
\nprotection of physicians,as well as declaring
\nillegal mammoth services of 30 hours at a
\nstretch or a weekly working time of over 70
\nhours. And now the clock is to be turned
\nback due of economic reasons. Marburger
\nBund is in close contact with the European
\nParliament and provides arguments for the
\nmaintenance of the protective function of
\nthe Working Time Directive and against
\nthe continued exploitation of physicians.
\nFrom Slave Revolt
\nto Chamber Presidency
\nMarburger Bund in turbulent times
\n79
\nInternational, Regional and NMA news
\nMali is located in the heart of West Africa
\nsurrounded by eight neighbouring countries
\nand with no land access to the sea. It is a
\nvast country spread over 1 242 238 square
\nkm and inhabited by 13 518 000 people.
\nThe population is mainly rural engaged into
\nagriculture, cattle breeding and \ufb01shing ac-
\ntivities. The main agricultural products are
\ncotton, millet and rice. The economic fea-
\ntures of the country are changing with the
\nfast growing gold mining industry.The cap-
\nital city is Bamako where more than 3 mil-
\nlion Malians live and contribute to improve
\nnational wealth. Across centuries, several
\nfamous empires have emerged and waned
\nin Mali, making this country a unique place
\nfor cultural tourism.
\nDivided into eight administrative regions,
\nMali became independent from France on
\n22nd
\nSeptember 1960. French has remained
\nthe o\ufb03cial language.
\nOnly later, in 1985 the law No
\n185\/AN-RM
\nwas promulgated which authorised private
\npractice for health related professions. Sub-
\nThis leads us to the second pillar of work of
\nthe Marburger Bund, which has become in-
\ncreasingly important during the past years,
\nnamely, Marburger Bund as the doctors\u2019
\ntrade union. Until 2005 there was a collec-
\ntive labour agreement in force for all public
\nservants, and this also applied to employed
\nphysicians. It was, however, too undi\ufb00er-
\nentiated. The working conditions of physi-
\ncians in hospitals are in no way comparable
\nto those of lawyers in public service or of
\nteachers in schools.There is another consid-
\nerable di\ufb00erence to the other professional
\ncategories: physicians are scarce and many
\npositions in hospitals remain vacant for a
\nlong time. After all, German physicians,
\nunlike teachers and lawyers, are very much
\nin demand abroad, where they \ufb01nd, more
\noften than not, better working conditions
\nand higher remuneration.All this prompted
\nMarburger Bund to demand a speci\ufb01c la-
\nbour agreement for physicians in 2005.
\nWhen the employers refused to split phy-
\nsicians o\ufb00 from the overall labour agree-
\nment that applied to all public servants, it
\nled to the above-mentioned doctors\u2019 strike.
\nUniversity hospitals were on strike for 15
\nweeks with another seven weeks at the ap-
\nproximately 700 municipal hospitals. In
\nparticular, the long weekly working hours
\n(keyword: slave revolt) played an important
\nrole in the public debate and brought the
\npublic to our side. As a result Marburger
\nBund obtained its own wage agreements
\nand considerably better working conditions
\nin the hospitals. The pictures of the strike
\nwent around the world and encouraged
\nmany medical organisations abroad to take
\na similar approach in their countries. Thus,
\nthe emancipation of German hospital phy-
\nsicians and of Marburger Bund became the
\nrole model for many others. Frank Ulrich
\nMontgomery, our chairman at that time,
\nRudolf Henke, our current chairman and
\nthe signing author, were engaged in many
\ndebates about this in other countries and at
\nthe annual meetings of the World Medical
\nAssociation, the Standing Committee of
\nEuropean Doctors (CPME) and the Eu-
\nropean Forum of Medical Associations and
\nWHO (EFMA).
\nThe strikes also brought about unprecedent-
\ned solidarity among physicians. Many phy-
\nsicians, apolitical up until that time, came
\nto join the Marburger Bund, making us a
\nvery strong organisation.There are currently
\n108,000 members, creating one of the the
\nbiggest medical association, with free mem-
\nbership in Europe.
\nTo round o\ufb00 the representation of interests
\nfor employed physicians, there is the work
\nwithin the medical chambers. For years we
\nhave been playing an important part in deci-
\nsionmakingwithintherelevantbodiesofthe
\nmedical self-administration, with respect to
\nthe training of physicians,the code of medi-
\ncal ethics, as well as post graduate medical
\ntraining. Marburger Bund is represented in
\nthis process by excellent personalities such
\nas Prof. Karsten Vilmar, honorary president
\nof the German Medical Association and
\nhonorary chairman of Marburger Bund, or
\nProf. J\u00f6rg-Dietrich Hoppe, president of the
\nGerman Medical Association and honorary
\nchairman of Marburger Bund, as well as by
\nmany other members of Marburger Bund in
\nprominent positions.
\nFinally we have concluded a frame contract
\nwith a bank and several insurance compa-
\nnies so that our members may be assisted in
\nnearly all aspects of life by their union.Thus,
\nbecoming a member of Marburger Bund is
\nreally worth it. We stand for the interests of
\nemployed physicians and therefore \u2013 as we
\nsee it \u2013 also for the interests of patients.The
\nstronger the union, the better the represen-
\ntation of interests of employed physicians.
\nWe do not get anything for free, we have to
\n\ufb01ght for everything as the recent past has
\nshown. Repartition of the sparse funds will
\nbecome increasingly di\ufb03cult in our society,
\na problem which can only be solved by a
\nwell organised medical profession.
\nThe representation of physicians is getting
\nmore and more international. We are ex-
\ntremely interested in \ufb01nding similar medi-
\ncal unions in as many European countries as
\npossible and throughout the world, in order
\nto reach agreements with them and to pool
\nour resources, if required. Therewith, we
\nwant to ensure that in all the countries phy-
\nsicians are not treated anymore as \u201cslaves\u201d
\nbut adequately, as be\ufb01ts their position as
\nhigh-level service providers in the society.
\nArmin Ehl, Secretary General,
\nMarburger Bund, Berlin
\nMali National Board of Physicians
\n(Ordre National des Medecins du Mali)
\n80
\nInternational, Regional and NMA news
\nThe World Confederation for Physical
\nTherapy (WCPT) was founded in 1951 in
\nCopenhagen, Denmark, with 11 founding
\nmember organisations. Today, representing
\n101 member organisations and more than
\n300 000 physical therapists worldwide,
\nWCPT provides the sole international voice
\nfor the physical therapy profession (called
\nphysiotherapy in some countries). WCPT\u2019s
\nmission is to improve the quality of global
\nhealth by representing physical therapy
\nand physical therapists internationally, col-
\nlaborating with national and international
\norganisations, supporting communication
\nand information exchange among regions
\nand member organisations of WCPT and
\nby encouraging high standards of physical
\ntherapy research, education and practice.
\nHistorically, two world wars resulted in un-
\nprecedented numbers of casualties on all
\nsides. Physical therapy played an important
\npart in the huge advances made in the man-
\nagement of traumatic injuries. The contri-
\nbution of physical therapy to restore body
\nfunctioning was clear and the concept of re-
\nhabilitation was extended to include thera-
\npeutic activities supporting participation in
\nlife areas such as work and leisure.
\nsequently the law No
\n86-35\/AN-RM insti-
\ntuted the National Board of Physicians.
\nThe National Board of Physicians is com-
\nposed of one National Council, several
\nCentral and Regional Councils.
\nThe mission of the Board of the National
\nCouncil is to:
\nEnsure that principles of morality,\u2022
\nprobity, and dedication essential for
\npracticing the profession are respected
\nthroughout the whole country with
\nhelp from the Central and regional
\nCouncils;
\nEnsure the defence of the honour and\u2022
\nindependence of the profession;
\nEnsure that all members adhere to pro-\u2022
\nfessional duty and that Deontological
\nethics code rules are followed.
\nMain tasks of the Board of the National
\nCouncil are:
\nTo address any issue in relation with\u2022
\nthe Board;
\nTo pronounce disciplinary sanctions;\u2022
\nTo help resolve con\ufb02icts between phy-\u2022
\nsicians on one side and between physi-
\ncian and clients;
\nTo manage the property of the Board\u2022
\nincluding the \ufb01nancial resources from
\nmembers regular contributions and
\nfrom others sources allowed by law
\nwith the aim to cover Board \ufb01nancial
\nresponsibilities with regard to the rights
\nof the members and their families;
\nTo create and liven up the Board news-\u2022
\nletter;
\nTo evaluate suggestions and make pro-\u2022
\nposals to improve the quality of medi-
\ncal activity.
\nThe Board of the National Council is com-
\nposed of:
\nTen members elected at the General\u2022
\nAssembly of the physician members of
\nthe Board;
\nTwo additional members practicing\u2022
\nmedicine and residing in Bamako.
\nThe Board of the National Council is as-
\nsisted by three experts representing various
\nadministrations. These experts can advise
\nbut cannot vote. They represent the follow-
\ning structures:
\nMinistry of Health\u2022
\nMinistry of Justice\u2022
\nFaculty of Medicine, at the University of\u2022
\nBamako.
\nAs of today the Board has registered 2,300
\nmedical doctors across Mali. By law, a phy-
\nsician cannot practice medicine in Mali if
\nnot registered with the Board of the Na-
\ntional Council.
\nThe Board of the National Council has es-
\ntablished working relationships with dif-
\nferent institutions across Africa. Among
\nthose are the West African Organization
\nfor Health (OOAS) of the ECOWAS
\n(Economical Community of West Afri-
\ncan States), the Economical and Monetary
\nUnion of West Africa (UEMOA).The UE-
\nMOA has established recently a network
\nof Chairs of National Boards of Physicians
\nfrom West African member countries of
\nthe UEMOA. The aim is to ease the free
\nmovement of physicians and to strengthen
\ntheir right to set up in any country in the
\nUEMOA area.
\nThe Mali National Board of Physicians is
\nmember of the World Medical Association
\nsince the General Assembly held in Seoul,
\nSouth Korea, in October 2008.
\nAlhousseini AG Mohamed, President of Mali
\nNational Board of Physicians
\nAlhousseini AG Mohamed
\nMovement for Health: the Role of the World
\nConfederation for Physical Therapy (WCPT)
\n81
\nInternational, Regional and NMA news
\nThe \ufb01rst decade of its existence was a time
\nfor the Confederation to create a global
\npro\ufb01le, particularly among o\ufb03cial bodies.
\nWCPT made contact with the United Na-
\ntions (UN) and its agencies and entered into
\no\ufb03cial relations with WHO in 1956.
\nThe Physical Therapy Profession
\nToday, physical therapists provide evidence
\nbased services for individuals and popu-
\nlations to develop, maintain and restore
\nmaximum movement and functional ability
\nthroughout the lifespan. Physical therapy is
\nconcerned with identifying and maximis-
\ning quality of life and movement potential
\nwithin the spheres of promotion, preven-
\ntion, treatment\/intervention, habilitation
\nand rehabilitation. This encompasses physi-
\ncal,psychological,emotional,and social well
\nbeing. Physical therapy involves the inter-
\naction between physical therapist, patients\/
\nclients, other health professionals, families,
\ncare giver, and communities in a process
\nwhere movement potential is assessed and
\ngoals are agreed upon, using knowledge and
\nskills unique to physical therapists. Physical
\ntherapists are active members of multipro-
\nfessional teams. How the skills of quali\ufb01ed
\nprofessionals, including physical therapists,
\nare used to best e\ufb00ect across the full path-
\nway of care and across settings is vital to
\nclinically and cost e\ufb00ective health service
\ndelivery. Taking a patient-centred, \ufb02exible,
\ncollaborative and open approach, acknowl-
\nedging the competencies of each profes-
\nsional group, is essential to this.
\nMembership and Governance
\nWCPT members are national professional
\nassociations representing physical thera-
\npists.They are organised in \ufb01ve regions: Af-
\nrica, Asia Western Paci\ufb01c, Europe, North
\nAmerica Caribbean and South America,
\nwhich assist the development of the profes-
\nsion in their geographic area. WCPT\u2019s sev-
\nen subgroups are organised to promote the
\nadvancement of physical therapy, and the
\nexchange of scienti\ufb01c knowledge in speci\ufb01c
\n\ufb01elds of interest.
\nWCPT holds a general meeting every four
\nyears.The meeting approves changes to arti-
\ncles of association,elects the president,vice-
\npresident and members of the executive
\ncommittee, approves policies and debates
\nmotions. The executive committee agrees
\nthe priorities for the four year period.
\nWCPT Activities
\nA range of position papers and policies on
\nvarious aspects of the profession provide
\ninformation for WCPT\u2019s member organi-
\nsations, individual physical therapists, gov-
\nernments, international non-governmental
\norganisations, the media and the public.
\nExamples of policies include a description
\nof the profession, entry-level curriculum
\nguidelines, standards of practice and disas-
\nter management and preparedness.
\nMany policy areas are further supported
\nby project work. For example, following
\nthe earthquake which struck in May 2008
\nin Sichuan, China, in co-ordination with
\nHandicap International, WCPT issued a
\ncall for physical therapists to assist in the
\npost-disaster rehabilitation. In addition,
\nwhile China is not a member organisation
\nof WCPT, representatives have visited to
\nadvise on the development of education
\nprogrammes and the profession.
\nA common set of data items to describe the
\nmember organisations of WCPT, the regu-
\nlation of the profession, the education of
\nphysical therapists and elements of practice
\nin the countries represented is currently un-
\nder development. The aim of the collection
\nis to provide information for representation
\nof the profession by WCPT on the global
\nstage, but also for use by regions and mem-
\nber organisations for regional and national
\nstrategic policy setting.
\nA key element of e\ufb00ective practice is good
\ninformation on the way people function and
\ncommunication of information across ser-
\nvice settings and between professionals. In
\nthis regard WCPT supports the use of the
\nInternational Classi\ufb01cation of Function-
\ning, Disability and Health (ICF). An active
\nprogramme of education, resource sharing
\nCatherine Sykes Tracy Bury Brenda Myers
\n82
\nInternational, Regional and NMA news
\nThe International Relations Committee of the American College
\nof Surgeons requests posters from sister societies around the world
\nfor public display at the 95 Annual Clinical Congress, which will
\ntake place 11-15 October 2009 in Chicago, Illinois.
\nWe will have space to display approximately ten posters. Therefore,
\nwe will mount the \ufb01rst ten suitable posters that we receive. Please
\nnote that we would prefer to receive posters from societies, publi-
\ncizing the activities of the societies, rather than posters from indi-
\nvidual members of those societies.
\nIf your society would care to participate in this display, please send a
\nposter to the following address:
\nMs Kate Early International Liaison Section American College of
\nSurgeons 633 North St Clair Street Chicago, IL 60611-3211 USA
\nWe would like to receive all posters by Monday,28 September 2009
\nin order to convey them to the convention center in a timely man-
\nner. Should you have questions, please contact Ms. Early via email,
\nat kearly@facs.org.
\nThank you in advance for your interest in this request. I hope to
\ngreet many of you in Chicago.
\nHugoV. Villar, MD, FACS
\nChair, International Relations Committee
\nand participation in collaborative work with
\nWHO has resulted in a range of ICF appli-
\ncations by physical therapists as evidenced
\nin the research literature.
\nWCPT\u2019s programme of work on evidence
\nbased practice (EBP) includes providing
\nan on-line resource facilitating access to a
\nwealth of materials that will support physi-
\ncal therapists in providing e\ufb00ective practice.
\nThis includes access to on-line journals and
\ndatabases, clinical guidelines and method-
\nological support.
\nCommunication
\nCongress: Every four years WCPT hosts
\na scienti\ufb01c congress showcasing advance-
\nments in physical therapy research, practice
\nand education.
\nWebsite: The WCPT website is the main
\nmeans by which WCPT can communicate
\nwith members, providing the profession
\nworldwide with a valuable range of mate-
\nrial, such as policy statements, brie\ufb01ng pa-
\npers and access to on-line resources as well
\nas the opportunity to exchange information
\nand share expertise.
\nWCPT News: WCPT News keeps the
\nmembership informed about professional
\ndevelopments and global programmes and
\npolicies a\ufb00ecting physical therapists.
\nWorld Physical Therapy Day: World Physi-
\ncal Therapy Day falls on 8th September ev-
\nery year, and is an opportunity for physical
\ntherapists from all over the world to raise
\nawareness about the crucial contribution
\nthe profession makes to keeping people
\nwell, mobile and independent. WCPT sup-
\nports this with a \u2018toolkit\u2019 made up of online,
\ninexpensively produced materials for mem-
\nbership organisations to use.
\nRepresentation
\nWCPT o\ufb03cers represent the profession at
\nthe WHO, the UN and other global fora.
\nIn 2008, in collaboration with the World
\nHealth Professions\u2019 Alliance, the Confed-
\neration was involved in the organisation of
\nthe \ufb01rst-ever inter-professional and inter-
\nnational conference on regulation of health
\nprofessionals in Geneva, Switzerland.
\nAs part of its work to identify and imple-
\nment solutions to the health workforce
\ncrisis, WCPT has joined with the world’s
\nleading health and hospital professional
\nassociations to deliver a Positive Practice
\nEnvironments campaign. Supported by
\nfunding from the Global Health Workforce
\nAlliance the campaign produced the \ufb01rst-
\never joint guidelines on incentives for the
\nretention and recruitment of health profes-
\nsionals.
\nGlobal Health
\nPhysical therapists are exercise specialists.
\nThere is abundant evidence for the bene\ufb01ts
\nof exercise and the contribution of physical
\ntherapy in relation to cardiovascular dis-
\nease, diabetes, arthritis, mental illness and
\nrecovery from trauma. In addition, physical
\ntherapists implement strategies to prevent
\nand manage the consequences of physical
\ninactivity associated with ageing and a wide
\nrange of chronic diseases.
\nFurther work is required to look at provision
\nof services in areas of severe shortage. This
\nremains a signi\ufb01cant challenge for all pro-
\nfessions and a focus for further research and
\npolicy development. The way to progress
\nthis is through multi professional collabora-
\ntion that embraces innovation and recogn-
\nises the evolving scope of practice and com-
\npetencies of each professional group.
\nTo address many of the issues that a\ufb00ect
\nglobal health WCPT is working with pro-
\nfessional associations, governmental and
\nnon-governmental international agencies,
\nunderlining the profession\u2019s commitment to
\ncollaborative practice.
\nVisit: www.wcpt.org
\nCatherine Sykes, Professional Policy Advisor,
\nTracy Bury, Professional Policy Advisor,
\nBrenda Myers, Secretary General
\nAmerican College of Surgeons
\n95th
\nAnnual Meeting
\n83
\nInternational, Regional and NMA news
\nSince 1968, the American College of Surgeons has o\ufb00ered Inter-
\nnational Guest Scholarships to competent young surgeons from
\ncountries other than the United States or Canada who have dem-
\nonstrated strong interests and accomplishments in teaching and
\nresearch. Applications are now being accepted for International
\nGuest Scholarships for the year 2010. The deadline for receipt
\nof scholarship applications and all supporting documents is 1
\nJuly 2009.
\nEach Scholarship o\ufb00ers a stipend of $8,000 US, participation in
\nthe Clinical Congress, and the expectation of visits to several North
\nAmerican clinical and research sites of the Scholar’s choice. A men-
\ntor will be assigned to assist the Scholar in planning his\/her tour.
\nI seek your cooperation in publicizing the availability of the
\nInternational Guest Scholarships. The International Relations
\nCommittee of the College has requested that the requirements for
\nthe International Guest Scholarships be widely distributed in your
\ncountry. This goal can be e\ufb00ectively accomplished by sharing the
\ninformation about the program requirements.
\nThis information is available in English from the College’s Web
\nsite at this location: http:\/\/www.facs.org\/memberservices\/igs.html.
\nApplicants are welcome to read the requirements, and then apply
\nto the program by using the link to the direct, online application
\nform at the bottom of the requirements page. The requirements
\nare also available in Spanish (http:\/\/www.facs.org\/memberser-
\nvices\/igsespanol.html) and in French (http:\/\/www,facs.org\/mem-
\nberservices\/igsfrancais.html). Please note that all applications
\nmust be submitted in English,
\nSurgeons interested in applying for these Scholarships must
\napply directly from the College’s Web site. Questions may be di-
\nrected to Ms. Kate Early, International Liaison Administrator, at
\nthe College’s airmail address shown on our stationery, via fax at
\n312-202-5021, or via email at kearly@facs.org,
\nI would greatly appreciate your cooperation in disseminating this
\ninformation in order to ensure a large number of excellent pro-
\nspective scholarship applicants. To date. International Guest
\nScholarships have been awarded to 220 promising young surgeons
\nworldwide (1968-2009).
\nPaul E. Collicott, MD, FACS
\nDirector, Division of Member Services
\nContents
\nEditorial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
\nThe Role of the Physician
\nin Combating Inequalities in Health. . . . . . . . . . . . . . . . . . . . . 44
\nHuman Resources for Health
\nand the Future of Health Care . . . . . . . . . . . . . . . . . . . . . . . . . 45
\nUpon the Completion of the
\nWMA General Assembly Seoul . . . . . . . . . . . . . . . . . . . . . . . . 47
\nWords from Reykjavik on Task Shifting as a Response to the
\nGlobal Shortage in Health Care Providers . . . . . . . . . . . . . . . . 48
\nTask Shifting on Health Care . . . . . . . . . . . . . . . . . . . . . . . . . . 50
\nCPME Board meeting 14th
\nMarch 2009 outcomes . . . . . . . . . 51
\nEuropean Physicians Congratulate
\nthe Parliament for Adopting the Cercas Report . . . . . . . . . . . . 53
\nWhat is the Added Value
\nof EU Health Policies for National Health Systems? . . . . . . . . 53
\nThe 2nd
\nAnnual Hospice and Palliative Care
\nin Developing Countries Conference . . . . . . . . . . . . . . . . . . . . 57
\nClinical Research on Children. . . . . . . . . . . . . . . . . . . . . . . . . . 58
\nGender-speci\ufb01c Di\ufb00erences in Pharmacotherapy . . . . . . . . . . . 62
\nDevelopment of Bioethics in Ukraine . . . . . . . . . . . . . . . . . . . . 65
\nThe British Medical Association \u2013
\na world of service for doctors. . . . . . . . . . . . . . . . . . . . . . . . . . . 68
\nChinese Medical Association (CMA) . . . . . . . . . . . . . . . . . . . 70
\nThe American Medical Association and the WMA . . . . . . . . . 71
\nThe French Medical Association . . . . . . . . . . . . . . . . . . . . . . . 73
\nLiberal practice in Belgium . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
\nThe Romanian College of Physicians . . . . . . . . . . . . . . . . . . . . 76
\nThe Icelandic Medical Association . . . . . . . . . . . . . . . . . . . . . . 77
\nBetween Slave Revolt and Chamber Presidency . . . . . . . . . . . . 78
\nMali National Board of Physicians . . . . . . . . . . . . . . . . . . . . . . 79
\nMovement for Health: the Role of the World Confederation
\nfor Physical Therapy (WCPT) . . . . . . . . . . . . . . . . . . . . . . . . . 80
\nEsteemed Colleague in Surgery. . . . . . . . . . . . . . . . . . . . . . . . . 82
\nCorrection: We apologise to the author of the article \u00bb National Helath Service(England) for the mis-spelling of his name at
\nthe beginning of the article (WMJ 55(1)). It should have read \u00bb Tom Frusher\u00bb.The contact e-mail address is
\nTFrusher@bma.org.uk
\nWMA news<\/p>\n"},"caption":{"rendered":"

wmj22 No. 2, May 2009 Editor in Chief Dr. P\u0113teris Apinis Latvian Medical Association Skolas iela 3, Riga, Latvia Phone +371 67 220 661 peteris@nma.lv editorin-chief@wma.net Co-Editor Dr. Alan J. Rowe Haughley Grange, Stowmarket Su\ufb00olk IP143QT, UK Co-Editor Prof. Dr. med. Elmar Doppelfeld Deutscher \u00c4rzte-Verlag Dieselstr. 2, D-50859 K\u00f6ln, Germany Assistant Editor Velta Poz\u0146aka wmj-editor@wma.net […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":940,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/wmj22.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3582"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=3582"}]}}