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wmj201501<\/a><\/p>\n

COUNTRY
\nvol. 61
\nMedicalWorld
\nJournal
\nOfficial Journal of The World Medical Association, Inc.
\nISSN 2256-0580
\nNr. 1, April 2015
\nContents
\nNew Trade Agreements and what They May Mean for Public Health and Health Care . . . . . \t1
\nReport on \u201cEthical Guidelines and Practices for U.S. Military Medical Professionals\u201d . . . . . \t3
\nSelf-care\u00a0\u2013 the CPME Statement: Quality and Safety, and Transparency! . . . . . . . . . . . . . . . . \t6
\nHealthcare in Camp Liberty, Baghdad, Iraq . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . \t8
\nThe Evolution of Research Ethics in South Africa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . \t13
\nNuclear War: A Greater Threat than Ebola . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . \t14
\nRationing and Differences in Care in Health Systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . \t17
\nLooking to the Life Sciences for a Healthier EU. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . \t22
\nThe Growing Importance of Health Technology Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . \t23
\nLost in Translation?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . \t28
\nThe doctor-patient-relationship revisited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . \t28
\nChronic Kidney Disease of Unknown Origin in Central America and Sri Lanka . . . . . . . . . . \t31
\nBeyond Chlor H\u00fchner & N\u00fcrnberger Bratw\u00fcrste:The Case for Physician & Organized
\nMedical Advocacy to Promote Health in Trade Agreement Negotiations . . . . . . . . . . . . . . . . \t35
\n1
\nEditorial
\nEditor in Chief
\nDr. P\u0113teris Apinis, Latvian Medical Association, Skolas iela 3, Riga, Latvia
\nPhone +371 67 220 661
\npeteris@arstubiedriba.lv, editorin-chief@wma.net
\nCo-Editor
\nProf. Dr. med. Elmar Doppelfeld, Deutscher \u00c4rzte-Verlag, Dieselstr. 2, D-50859 K\u00f6ln, Germany
\nAssistant Editor
\nInese Sviesti\u0146a, wmj-editor@wma.net
\nJournal design and
\ncover design by
\nP\u0113teris Gricenko
\nLayout and Artwork
\nThe Latvian Medical Publisher, \u201cMedic\u012bnas apg\u0101ds\u201d, President Dr. Maija \u0160etlere, Katr\u012bnas street 2, Riga, Latvia
\nPublisher
\nThe Latvian Medical Association, \u201cLatvijas \u0100rstu biedr\u012bba\u201d,
\nSkolas street 3, Riga, Latvia.
\nISSN: 2256-0580
\nDr. Xavier DEAU
\nWMA President
\nConseil National de l\u2019Ordre des
\nM\u00e9decins (CNOM)
\n180, Blvd. Haussmann
\n75389 Paris Cedex 08
\nFrance
\nDr. Donchun SHIN
\nWMA Chairperson of the Finance
\nand Planning Committee
\nKorean Medical Association
\n46-gil Ichon-ro
\nYongsan-gu, Seoul 140-721
\nKorea
\nProf. Dr. Frank Ulrich
\nMONTGOMERY
\nWMA Vice-Chairperson of Council
\nBundes\u00e4rztekammer
\nHerbert-Lewin-Platz 1 (Wegelystrasse)
\n10623 Berlin
\nGermany
\nDr. Margaret MUNGHERERA
\nWMA Immediate Past-President
\nUganda Medical Association
\nPlot 8, 41-43 circular rd., P.O.
\nBox 29874
\nKampala
\nUganda
\nDr. Joseph HEYMAN
\nWMA Chairperson
\nof the Associate Members
\n163\u00a0Middle Street
\nWest Newbury, Massachusetts 01985
\nUnited States
\nDr. Masami ISHII
\nWMA Treasurer
\nJapan Medical Assn
\n2-28-16 Honkomagome
\nBunkyo-ku
\nTokyo 113-8621
\nJapan
\nSir Michael MARMOT
\nWMA President-Elect
\nBritish Medical Association
\nBMA House,Tavistock Square
\nLondon WC1H 9JP
\nUnited Kingdom
\nDr. Heikki P\u00c4LVE
\nWMA Chairperson of the Medical
\nEthics Committee
\nFinnish Medical Association
\nP.O. Box 49
\n00501 Helsinki
\nFinland
\nDr. Miguel Roberto JORGE
\nWMA Chairperson of the Socio-
\nMedical Affairs Committee
\nBrazilian Medical Association
\nRua-Sao Carlos do Pinhal 324,
\nCEP-01333-903 Sao Paulo-SP
\nBrazil
\nDr. Ardis D. HOVEN
\nWMA Chairperson of Council
\nAmerican Medical Association
\nAMA Plaza, 330 N. Wabash,
\nSuite 39300
\n60611-5885 Chikago, Illinois
\nUnited States
\nDr. Otmar KLOIBER
\nSecretary General
\nWorld Medical Association
\n13 chemin du Levant
\n01212 Ferney-Voltaire
\nFrance
\nWorld Medical Association Officers, Chairpersons and Officials
\nOfficial Journal of The World Medical Association
\nOpinions expressed in this journal\u00a0\u2013 especially those in authored contributions\u00a0\u2013 do not necessarily reflect WMA policy or positions
\nwww.wma.net
\nIn a concise article [1] in this journal, Elizabeth Wiley and her co-
\nauthors analyse the current discussions and negotiations surround-
\ning upcoming trade agreements, which, if they come into effect, will
\nbe huge and unprecedented in terms of their in-depth regulation
\nand the combined economic power behind them. The trade agree-
\nments discussed, TTP (Trans Pacific Partnership), TTIP (Trans-
\natlantic Trade & Investment Partnership), CETA (Comprehensive
\nEconomic and Trade Agreement) and TiSA (Trade in Services
\nAgreement), essentially include most industrialized nations.
\nThe authors outline the possible effects on health and health care,
\nfrom public health legislation to the structure of health systems,and
\nexplain why the upcoming agreements could have negative effects
\nfor public health and health care systems within the countries con-
\ncerned, but also in so-called third countries, which at first glance
\nhave nothing to do with these agreements.
\nThe World Medical Association has never had a position on trade
\nagreements in general, but Wiley et al. demonstrate the relation of
\nthese upcoming trade agreements to our WMA policies, such as the
\nWMA Statement on Patient Advocacy and Confidentiality [2], the
\nWMA Statement on Social Determinants of Health [3] and the
\nWMA Statement on Patenting Medical Procedures [4].They argue
\nthat it is time to bring health into the arena.
\nThe Good,\u2026
\nFirst of all, our world is undeniably networked and our economies
\nare globally connected. This has enabled economic growth to take
\nplace globally and given some regions stability, peace and consider-
\nable prosperity.
\nSecondly, the medical profession has always been internationally
\norientated. Diseases don\u2019t recognise political borders boundaries
\nand are not confined by customs areas. International exchange and
\ncooperation is crucial for medicine. Both physicians and patients
\nmigrate:, and cross-boarder services are a reality.
\nThirdly, whoever has experienced life as an expatriate knows that
\nthere is more red tape than this world needs. Those who want to
\nconduct cross-border business will find that protectionism and
\nout-dated or simply meaningless regulation can be prohibitive, if
\nnot disastrous. Getting rid of unjustified regulation is not only
\nbeneficial for migrants or those carrying out business across bor-
\nders, it will also help those within countries who may likewise be
\ninhibited by it.
\nThe Bad,\u2026
\nThe upcoming trade agreements have been feted as generators of
\njobs and enhancers of business. But the euphoria of recent years has
\npassed.The last (2010\u20132014) European Union (EU) Commissioner
\nfor Trade,Karel de Gucht,speculated about an increase in EU GDP
\nof O.5 percent [5] and 400,000 new jobs. However, the tone has
\nrecently become more cautious. The suggested potentially positive
\neffects of TTIP now sound more like \u201cmaybes\u201d and the glorious
\nnumbers have also disappeared from the EU website [6].
\nThe creation of TTIP is one of the best kept secrets of our time.
\nVery few officials at the EU Commission in Brussels deal with the
\nUS delegation.The documents are not publically available, and only
\nunder immense public pressure has the EU Commission begun
\nto reveal its strategy in a piecemeal approach. A few MEPs have
\n\u201con-screen access only\u201d to the documents. However, the majority of
\nMEPs and national governments are not properly informed. Why
\nthe secrecy? This leads us to question who this protective shield is
\nbeing built to defend against? Why are industry leaders involved
\nin negotiations but not the Members of the European Parliament?
\nNot even the members of the committees concerned are able to ac-
\ncess printed copies, let alone the national governments of Member
\nStates. Are these shields meant to defend against the nations who
\nare not sitting around the table? Groups like Health Action Inter-
\nnational, Oxfam and M\u00e9decins Sans Frontiers (MSF) warn against
\nTTP [7] and TTIP [8], seeing in them a danger to poorer nations\u2019
\naccess to medicines.
\nOr has this veil of secrecy been created to defend against the elec-
\ntorate? Do we the people not have a right to know? Is it us mem-
\nbers of civil society who some politicians believe could endanger
\nthis huge step forward, as the rhetoric of our leaders constantly
\nsuggests?
\nIn its title, \u201cBeyond Chlor H\u00fchner and N\u00fcrnberger Bratwurst\u201d, the
\narticle by Wiley et al. already distances itself from the panicked re-
\nporting of the European and especially the German press,which for
\nmore than a year seized on issues such as US food industry practices
\nNew Trade Agreements and what They May Mean
\nfor Public Health and Health Care
\nBACK TO CONTENTS
\n2 3
\nU.S. military health care professionals serve
\nin a variety of settings, more diverse than
\nis typically found in the civilian environ-
\nment. In all settings, military and civilian,
\nhealth care professionals face innumerable
\nconflicts in the practice of their vocation. At
\ntimes,health care professionals who practice
\nin these settings may face ethical challenges
\nin honoring the ethical standards of their
\nprofession and obeying military orders or
\npolicies. Tensions can arise if the demands
\nof the mission or line command are at odds
\nor in tension with the duties to attend to the
\nhealth of those needing care.
\nIn particular, military personnel serving in
\ncombat zones might be confronted with nu-
\nmerous ethical and moral challenges. Most
\nof these can be resolved with effective com-
\nmunication, training, leadership, clear rules
\nof engagement, and unit cohesion and sup-
\nport. However, the very act of experiencing,
\nwitnessing, or participating in troubling
\nevents can undermine a Service member\u2019s
\nhumanity. An act of serious transgression
\nthat leads to serious inner conflict because
\nthe experience is at odds with core ethi-
\ncal and moral beliefs is called moral injury,
\nwhich can be long lasting and painful.
\nIn January 29, 2013 the Acting Under Sec-
\nretary of Defense for Personnel and Readi-
\nness requested the Defense Health Board
\n(DHB) review the unique challenges faced
\nby military medical professionals in their
\ndual-hatted positions as a military officer
\nand a medical provider.Two questions were
\nasked:
\n\u2022\t How can military medical professionals
\nmost appropriately balance their obliga-
\ntions to their patients against their obli-
\ngations as military officers to help com-
\nmanders maintain military readiness?
\n\u2022\t How much latitude should military
\nmedical professionals be given to refuse
\nparticipation in medical procedures or
\nrequest excusal from military operations
\nwith which they have ethical reservations
\nor disagreement?
\nThe DHB tasked its Medical Ethics Sub-
\ncommittee to conduct its review of military
\nmedical professional practice policies and
\nguidelines. The Subcommittee reviewed
\ncurrent civilian and military health care
\nmedical professional practice policies and
\nguidelines as well as medical ethics, educa-
\ntion and training in the Department of De-
\nfense (DoD) and in civilian institutions.The
\nSubcommittee members also held panel
\ndiscussions with the subject matter experts
\nand DoD personnel, including Active Duty,
\nNational Guard, Reserve, and retired mili-
\ntary health care medical professionals and
\nline officers as well as healthcare profession-
\nals in civilian institutions. Included among
\nthe civilian organizations were the World
\nMedical Association, American Medical
\nAssociation, American Nurses Association,
\nAmerican Psychiatric Association and the
\nAmerican Psychological Association.
\nOn February 11, 2015 the DHB unani-
\nmously approved the report \u201cEthical
\nGuidelines and Practices for U.S. Military
\nMedical Professionals\u201d. It is an effort that is
\nnotable for being well done. It is character-
\nized by thoroughness and a sensitivity to the
\nissues described.
\nThe Subcommittee developed its own prin-
\nciples to guide its review and deliberation:
\nContext: Military health care professionals
\nface unique challenges resulting from their
\ndual role as medical providers and military
\npersonnel. Throughout their careers, these
\nprofessionals may be required to plan and
\nparticipate in health care support for com-
\nbat operations, humanitarian assistance, di-
\nsaster response and other activities, which
\nmay be conducted in austere environments
\nwith limited resources. As health care pro-
\nviders, military medical professionals have
\nethical responsibilities to their patients,
\nwhich arise from a variety of legal, moral,
\nand professional codes as well as personal
\nmoral and religious beliefs of both the care-
\ngiver and the patient. However, military
\nhealth care professionals must weigh and
\nprioritize these ethical responsibilities with
\ntheir role as military officers.
\nOverarching Principle: DoD has a duty
\nto provide military health care professionals
\nwith the resources, tools, and knowledge to
\ndetermine the best course of action when con-
\nfronted with ethical dilemmas and a practice
\nenvironment in which they feel safe in rais-
\ning ethical concerns and confident they will
\nreceive support in seeking a fair and just reso-
\nlution to those concerns. In addition, DoD
\nalso has an obligation to assist professionals
\nin developing the resiliency to cope with and
\nrecover from the moral injury resulting from
\nconfronting intractable ethical dilemmas.
\nThe Guiding Principles provided herein
\nguided the DHB and the Medical Ethics
\nUNATED STATES OF AMERICA Medical EthicsEditorial
\nof disinfecting chicken with a chlorine solution and the fear that
\ntraditional food could be pushed from the market by low \u00adquality
\nimitations. However, the authors distance themselves from this
\npopulist type of criticism of the trade agreements only to tell us that
\nit could actually be far worse!
\nIndeed, as the real implications of the trade agreements slowly be-
\ncome apparent, the populist fears of chlorinated chicken and fake
\nBratwurst look pale and rather unimportant in comparison. It is
\npublic health at large and the values on which health care systems
\nare based, solidarity, equality and justice, which are under attack.
\nFrom what has so far leaked through the veil of secrecy, it seems
\nthat the only common denominator in these negotiations is a spirit
\nof mammon.
\nNational politicians don\u2019t get tired of reassuring us that health care
\nsystems and their social fabric will not be touched. Most impres-
\nsively, Japan\u2019s premier Shinzo Abe told us at the WMA Council
\nMeeting in Tokyo last April that the universal health care system
\nof Japan will be maintained and even suggested holding it up as an
\nideal to be exported.Likewise, European politicians repeatedly state
\nthat our social systems will not be touched [9].
\nReally? Even if no elements of the trade agreements would directly
\naffect the structure of our health care systems, the indirect effects
\nwould still be very real.The loss of jobs, the tearing down of protec-
\ntive regulation, the commoditization of health care, and the take-
\nover of public institutions by for-profit companies\u00a0\u2013 all of this could
\nthreaten the health care sector. However, as far as we know, health
\ncare is not even excluded. And why should it be [10]? In most of
\nour economies, health care systems are one of, if not the biggest,
\nidentifiable sectors of the economy.
\nAnd the Ugly
\nWhile the potential effects on public health, social structures and
\nhealth care systems are bad, there are aspects that may even be far
\nworse:The trade agreements foresee dispute settlement systems that
\nallow companies not only to litigate other companies, but also states
\nwhich are party to the agreements, in secret private courts. They
\nwill, in fact, constitute a private system without any controls that
\ncould ultimately not only undermine systems of justice, but may
\nlead governments and lawmakers to pre-emptively stall any public
\nhealth act that would run the risk of being sued by such a private
\ncourt, regardless of how important and relevant such acts may be.
\nThe development of public health would be seriously inhibited.This
\nmight be beneficial for industries producing or marketing unhealthy
\nproducts, however these agreements would place public health in
\ninvisible shackles.
\nOf course, since the negotiations are conducted in secret and we
\ndon\u2019t know what is in the agreements, it can be claimed that all
\nthese fears merely represent worst case scenarios. This is correct.
\nHowever, the burden of proof lies with those who are maintaining
\nthis secrecy. Only they have the means to produce evidence that
\npositive aspects will prevail and that harmful effects are defini-
\ntively ruled out.
\nRegardless of the outcome of the trade agreements, if they continue
\nin this way they will not be beacons of justice and democracy.
\nReferences
\n1.\t E. Wiley et al. Beyond Chlor H\u00fchner & N\u00fcrnberger Brat-
\nw\u00fcrste:\u2028The Case for Physician & Organized Medicine Ad-
\nvocacy to Promote Health in Trade Agreement Negotiations.
\nWorld Medical Journal 2015
\n2.\t World Medical Association. Statement on Patient Advocacy
\nand Confidentiality. 1993, 2006. Available at http:\/\/www.wma.
\nnet\/en\/30publications\/10policies\/a11\/
\n3.\t World Medical Association. Statement on Social Deter-
\nminantsof Health. 2011. Available at https:\/\/www.wma.net\/
\nen\/30publications\/10policies\/s2\/\u2028
\n4.\t World Medical Association. WMA Statement on Patenting
\nMedical Procedures, 2009. Available at https:\/\/www.wma.net\/
\nen\/30publications\/10policies\/m30\/
\n5.\t J. Crisp. De Gucht rejects claims Commission misrepresented
\nbenefits of TTIP. EurActiv.com, 09.09.2014 Available at http:\/\/
\nwww.euractiv.com\/sections\/trade-industry\/de-gucht-rejects-
\nclaims-commission-misrepresented-benefits-ttip-308292
\n6.\t E.Bonse.EU kippt TTIP-Versprechen.02.04.2015 Available at
\nhttp:\/\/www.taz.de\/1\/archiv\/?dig=2015\/04\/02\/a0104
\n7.\t N.N. Trans-Pacific Partnership Agreement\u00a0 \u2013 Trading Away
\nHealth. 18.08.2013. Available at http:\/\/www.msfaccess.org\/
\nspotlight-on\/trans-pacific-partnership-agreement
\n8.\t HAI and Oxfam. Joint Agency Briefing Paper\u00a0\u2013 Trading away
\naccess to medicines\u00a0 \u2013 Revisited. 29.09.2014. Available under
\nhttps:\/\/www.oxfam.org\/en\/research\/trading-away-access-med-
\nicines
\n9.\t F. Bermingham. EU Trade Commissioner Karel De Gucht
\nConfirms NHS Exemption from TTIP. International Business
\ntimes. 14.07.2014 Available at http:\/\/www.ibtimes.co.uk\/eu-
\ntrade-commissioner-karel-de-gucht-confirms-nhs-exemption-
\nttip-1456538
\n10.\tF. Bermingham. TTIP: Government Will Not Exclude NHS
\nFrom Free Trade Agreement. International Business times.
\n01.09.2014 Available at http:\/\/www.ibtimes.co.uk\/ttip-govern-
\nment-will-not-exclude-nhs-free-trade-agreement-1463454
\nOtmar Kloiber and Liene Puke
\nCecil B. Wilson
\nReport on \u201cEthical Guidelines and Practices
\nfor U.S. Military Medical Professionals\u201d
\nBACK TO CONTENTS
\n4 5
\nUNATED STATES OF AMERICA UNATED STATES OF AMERICAMedical Ethics Medical Ethics
\nSubcommittee in its review of the dual loy-
\nalties of military health care professionals:
\nI.These must take into consideration:
\n\u2003 a.\u2002\u0007The spectrum of health care profes-
\nsional ethical codes, laws and licensing
\nrequirements;
\n\u2003 b.\u2002\u0007Military professional ethics and codes;
\n\u2003 c.\u2002\u0007Medical education and continuing
\nmedical education both within and
\noutside of DoD;
\n\u2003 d.\u2002\u0007The spectrum of experiences of both
\ncivilian and military health care pro-
\nfessionals;
\n\u2003 a.\u2002\u0007The need for military health care pro-
\nfessionals to explore and address their
\nown and their patient\u2019s religious be-
\nliefs, ethics, and medical preferences;
\nand
\n\u2003 f.\u2002\u0007Recommendations of those within and
\noutside of DoD.
\nII. Provide guidance regarding how to best
\neducate and train military health care pro-
\nfessionals to recognize and determine the
\nbest course of action when ethical dilemmas
\narise.
\nIII. Acknowledge the moral injury that may
\noccur as a result of encountering an ethi-
\ncal dilemma and incorporate practices that
\nenhance resiliency and assist professionals
\nin coping with and recovering from these
\ninjuries.
\nIV.Provide guidance to ensure a support in-
\nfrastructure and environment is established
\nand maintained to provide military health
\ncare professionals a safe avenue to raise eth-
\nical concerns and seek timely assistance in
\ndetermining the best courses of action.
\nDefense Health Board –
\nFederal Advisory Committee
\nto the Secretary of Defense
\nThe Defense Health Board (DHB) is a
\nFederal Advisory Committee to the Secre-
\ntary of Defense that provides independent
\nadvice\/recommendations on matters relat-
\ning to operational programs, health policy
\ndevelopment, health research programs,
\nand requirements for the treatment and
\nprevention of disease and injury, promotion
\nof health and the delivery of health care to
\nDepartment of Defense (DoD) beneficia-
\nries.
\nMission
\nThe mission of the DHB is to provide in-
\ndependent authoritative advice to maximize
\nthe health, safety, and effectiveness of the
\nUnited States Armed Forces.
\nEthical Guidelines and
\nPractices for U.S. Military
\nMedical Professionals
\nFebruary 11, 2015
\nRecommendation 1: Department of De-
\nfense (DoD) should further develop and ex-
\npand the infrastructure needed to promote
\nDoD-wide medical ethics knowledge and
\nan ethical culture among military health
\ncare professionals, to include: a code of eth-
\nics; education and training programs; con-
\nsultative and online services; ethics experts;
\nand an office dedicated to ethics leadership,
\npolicy, and oversight.To achieve these goals,
\nDoD should form a tri-Service working
\ngroup with appropriate representation to
\nformulate policy recommendations on med-
\nical ethics.This should include development
\nof a DoD Instruction to guide development
\nof the infrastructure needed to support the
\nethical conduct of health care professionals.
\nIn addition, this working group should con-
\nsider the best ways to implement the rec-
\nommendations in this report.
\nRecommendation 2: Throughout its poli-
\ncies, guidance, and instructions, DoD must
\nensure that the military health care profes-
\nsional\u2019s first ethical obligation is to the pa-
\ntient.
\nRecommendation 3: DoD leadership, par-
\nticularly the line commands, should excuse
\nhealth care professionals from performing
\nmedical procedures that violate their pro-
\nfessional code of ethics, State medical board
\nstandards of conduct, or the core tenets of
\ntheir religious or moral beliefs. However,
\nto maintain morale and discipline, this ex-
\ncusal should not result in an individual be-
\ning relieved from participating in hardship
\nduty. Additionally, health care professionals
\nshould not be excused from militaryopera-
\ntions for which they have ethical reserva-
\ntions when their primary role is to care for
\nthe military members participating in those
\noperations.
\nRecommendation 4: DoD should formu-
\nlate an overarching code of military medical
\nethics based on accepted codes from various
\nhealth care professions to serve as a guide-
\npost to promote ethical leadership and set a
\nstandard for the cultural ethos of the MHS.
\nTo inform this process, the ethics codes of
\nrelevant health care professional organiza-
\ntions should be reviewed regularly and up-
\ndates should be made to the military medi-
\ncal ethics code as appropriate.
\nRecommendation 5: To provide formal
\nethics guidance, direction, and support to
\nthe MHS and its components, DoD and
\nthe Military Departments should:
\n\u2003a)\u2002\u0007Publish directives\/instructions re-
\ngarding the organization, composi-
\ntion, training and operation of medi-
\ncal ethics committees and medical
\nethics consultation services within the
\nMHS. DoD should review best prac-
\ntices at leading civilian institutions in
\nformulating this guidance.
\n\u2003b)\u2002\u0007Ensure military treatment facili-
\nties have access to consistent, high-
\nquality, ethical consultation services,
\nincluding designation of a respon-
\nsible medical ethics expert for each
\nlocation. For those facilities\/locations
\nwithout onsite medical ethics support,
\nDoD should ensure remote consulta-
\ntion is available.
\n\u2003 c)\u2002\u0007Provide a \u201creach back\u201d mechanism for
\ndeployed health care professionals to
\ncontact an appropriately qualified in-
\ndividual to assist in resolving an ethi-
\ncal concern that has not been resolved
\nthrough their chain of command.
\n\u2003 d)\u2002\u0007Develop a small cadre of clinicians
\nwith graduate level training in bioeth-
\nics to serve as senior military medical
\nethics consultants.
\n\u2003 e)\u2002\u0007Ensure that health care professionals
\nare knowledgeable about their rights
\nand available procedures for obtaining
\nethics consultation, expressing dissent
\nor requesting recusal from certain ob-
\njectionable procedures or activities.
\n\u2003 f)\u2002\u0007Review compliance with ethics direc-
\ntives and instructions as part of recur-
\nring health service inspections.
\nRecommendation 6: DoD should develop
\nclear guidance on what private health infor-
\nmation can be communicated by health care
\nprofessionals to leadership, and the justifi-
\ncations for exceptions to the rule for reasons
\nof military necessity.
\nRecommendation 7: DoD should pro-
\nvide military health care professionals with
\nprivileges similar to those of Chaplains and
\nJudge Advocates regarding their indepen-
\ndence and obligation to protect privacy and
\nconfidentiality while meeting the require-
\nments of line commanders.
\nRecommendation 8: DoD should provide
\nspecific education and training for health
\ncare professionals designated to serve as
\nmedical mentors or health care providers in
\nforeign health care facilities or in support
\nof humanitarian assistance or disaster relief
\noperations. Such education and training
\nshould cover cultural differences, potential
\nethical issues, rules of engagement, and ac-
\ntions that might be taken to avert, report,
\nand address unethical,criminal,or negligent
\nbehavior or practices.
\nRecommendation 9:DoD should create an
\nonline medical ethics portal.At a minimum,
\nit should include links to relevant policies,
\nguidance, laws, education, training, profes-
\nsional codes, and military consultants in
\nmedical ethics.
\nRecommendation 10: DoD should include
\nin professional military education courses
\ninformation on the legal and ethical limita-
\ntions on health care professionals regarding
\npatient care actions they may or may not
\ntake in supporting military operations and
\npatient information they may and may not
\ncommunicate to line leadership.
\nRecommendation 11: DoD should ensure
\nthat systems and processes are in place for
\ndebriefing health care professionals to help
\nthem transition home following deploy-
\nment. Debriefing should occur as a team
\nwhen possible. Not only could this help
\nmitigate potential moral injury in health
\ncare professionals, but it may also provide
\nlessons learned and case studies for inclu-
\nsion in ongoing training programs.
\nRecommendation 12: To create an envi-
\nronment that promotes ethical conduct and
\nminimizes conflicts of dual loyalty, DoD
\nleadership should emphasize that senior
\nmilitary health care professionals are full
\nmembers of the Commander\u2019s staff as an
\nadvisor on medical ethics as it relates to
\nmilitary readiness.
\nRecommendation 13: To minimize isola-
\ntion of health care professionals, the Mili-
\ntary Departments should make every effort
\nto ensure personnel who are deploying to
\nthe same location train together as a team
\nprior to deployment. Establishing relation-
\nships prior to deployment may enable better
\ncommunication and trust among line com-
\nmand and health care professionals in the
\ndeployed setting.
\nRecommendation 14: DoD should issue a
\ndirective or instruction designating mini-
\nmum requirements for basic and continuing
\neducation and training in military medical
\nethics for all health care professionals in
\nall components and indicate the appropri-
\nate times in career progression that these
\nshould occur.
\nRecommendation 15: To enhance ethics
\ntraining for military health care profession-
\nals and the line command, DoD should:
\n\u2003 a)\u2002\u0007Ensure pre-deployment and periodic
\nfield training includes challenging
\nmedical ethics scenarios and remind-
\ners of available resources and contact
\ninformation to prepare both health
\ncare professionals and line personnel.
\nCurricula should include simulations
\nand case studies in addition to didac-
\ntics.
\n\u2003 b)\u2002\u0007Provide a mechanism to ensure sce-
\nnarios and training curricula are
\ncontinually updated to reflect spe-
\ncific challenges and lessons learned
\nthrough debriefing from real-world
\ndeployments and garrison opera-
\ntions.
\n\u2003 c)\u2002\u0007Ensure key personnel returning from
\ndeployment who have faced signifi-
\ncant challenges provide feedback to
\nassist personnel preparing for deploy-
\nment
\nRecommendation 16: To enhance health
\ncare practices in the military operational
\nenvironment, DoD should:
\na)\u2002\u0007Update the Joint Knowledge Online
\nMedical Ethics and Detainee Health
\nCare Operations courses to improve the
\nefficiency with which the information is
\ncommunicated and maintain currency of
\nthe material.
\nb)\u2002\u0007Create a medical ethics course to cover
\nkey principles, ethical codes, and case
\nstudies applicable to both garrison and
\ndeployed environments, in addition to
\nproviding resources and appropriate
\nsteps to take when assistance is needed
\nin esolving complex ethical issues. This
\ncourse should be required for all health
\ncare professionals.
\nCecil B. Wilson, MD, MACP
\nPast President World Medical Association
\nBACK TO CONTENTS
\n6 7
\nIntroduction
\nSelf-care is gaining more and more atten-
\ntion in the European healthcare field these
\ndays and has become a central element in
\nthe strategy of many national health au-
\nthorities, EU bodies, as well as for the Eu-
\nropean Council and WHO\/Europe.
\nCPME (\u201cComit\u00e9 permanent des m\u00e9decins
\neurop\u00e9ens\u201d), the umbrella organization of
\nEuropean Doctors, has also recently issued
\na \u201cStatement on Self-Care\u201d, with a view to
\nthe future of self-care policy in the Euro-
\npean Union, and is actively participating in
\na EU tender on this topic.
\nBut first, what is self-care in the meaning of
\nall these political discussions?
\nSelf-care is considered as the ability of
\npatients to take measures to manage, es-
\ntablish and maintain their own health, or,
\nas the UK Department of Health put it in
\n2005\u00a0[1], self-care is \u201cthe actions people take
\nfor themselves, their children and their fami-
\nlies to prevent and care for minor ailments and
\nlong-term conditions and maintain health and
\nwell-being after an acute illness or discharge
\nfrom hospital\u201d.
\nSelf-care policy also refers to self-medi-
\ncation, but self-medication is no longer at
\nits core\u00a0\u2013 patient empowerment and health
\nliteracy are nowadays considered as the key
\naspects that determine self-care.
\nThis definition points to the fact that self-
\ncare has to do with 2 quite different topics:
\n\u2022\t on the one hand, self-care deals with the
\nso-called \u201cminor self-limiting ailments\u201d
\nwhich, in the meaning of self-care,
\nshould not request a medical consulta-
\ntion,
\n\u2022\t and on the other hand, self-care deals
\nwith two major elements of the future of
\nthe health system in our countries, which
\nare prevention and chronic diseases.
\nBehind the rising political activities about
\nself-care, there is not only the idea of pa-
\ntient empowerment, but also obvious finan-
\ncial and economic interests: self-care should
\nreduce costs of healthcare by reducing the
\nneed for medical intervention, in a time of
\nscarce financial resources\u00a0\u2013 an effect that re-
\nmains to be proven in a significant manner,
\nas the latest studies are mostly inconclusive
\nin this respect. And self-care is of course
\nalso a huge business for the pharmaceuti-
\ncal industry, bringing direct access to the
\npatients-consumers.
\nAll in all, this introduction shows that self-
\ncare can affect the very core of our health-
\ncare systems\u00a0\u2013 the finances and, most of all,
\nthe relationship Doctors have with the pa-
\ntients. In other words, transparency, ethics,
\nquality and safety are all involved.
\nThis is definitely a discussion\u00a0\u2013 one more!\u00a0\u2013
\nwhere we should be active to defend our
\nunderstanding of medicine!
\nQuality and safety
\nI don\u2019t think that Doctors have a problem
\naccepting that in many different situa-
\ntions patients can manage their own health
\nthemselves\u00a0 \u2013 either it is about minor ail-
\nments that seldom require a real medical
\nintervention (headache,common cold,indi-
\ngestion, backache or whatever) or it is about
\na chronic disease which the patient knows
\nvery well and is able to manage in normal
\ncircumstances.
\nBut our professional experience also tells
\nus how difficult it is to spot a not-so-minor
\npathology in the bulk of the everyday con-
\nsultation: we know all too well how dan-
\ngerous it may be to trivialize a symptom
\nwhich this time should not be overlooked!
\nPatients should definitely be protected from
\nthe consequences of undue trivialization of
\na symptom, and this concern must make us
\ncautious about promotion of self-care. At
\nthe same time as patients read on the inter-
\nnet or talk with their Doctor about self-care
\npossibilities, they should also learn about
\nthe limits: which is the acceptable dura-
\ntion of symptoms? Wwhat to expect from
\nan available treatment? wWhat to do if the
\nexpected results don\u2019t show?
\nThis is all about patient empowerment
\n(once again!). Clearly, empowerment also
\nmeans responsibiliy, for the patiet, and the
\nmeans to take on this responsibility\u00a0\u2013 in our
\nview, self-care cannot be supported with-
\nout making sure that quality and safety are
\nguaranteed in this situation just as they are
\nfor patients consulting a Doctor.
\nAnother element which should be men-
\ntioned in the discussion about quality
\nand safety in self-care is the influence of
\nthe pharmaceutical industry, which sees
\nhuge profit possibilities in addressing di-
\nSWISSSWISS Self-careSelf-care
\nSelf-care\u00a0\u2013 the CPME Statement:
\nQuality and Safety, andTransparency!
\nJacques de Haller
\nrectly the patients and selling the so-called
\n\u201cOTC\u201d (\u201cOver-The-Counter\u201d) medica-
\ntions. Advertisement and sponsoring of
\ninternet home-pages, or in the field of
\nchronic disease the sponsoring of patient
\ngroups, must be completely transparent
\nand in lie, to avoid unbalanced influence on
\nthe decisions being made by patients about
\ntheir treatment.This is clearly also a matter
\nof quality and safety!
\nThese short reflexions on quality and safey,
\nin consideration to self-cae, mean in fact
\nthat although we definitely, as Doctors,
\naren\u2019ot opposed to self-care and thereby to
\npatient empowerment, we cannot support
\nwithout precaution measures that can put a
\npatient at risk or make him\/her a victim of
\nmarketing campaigns.
\nIn other words, self-care is only to be seen
\nas a positive development if the quality of
\nthe treatment and the safety of the patients
\nare at the center of attention.This means ef-
\nficient regulations to keep marketing in line,
\nand the necessity for all involved healthcare
\nprofessionals to commit to sufficient and
\nadequate patient information.
\nThe CPME Statement
\non Self-Care
\nAcknowledging the importance of the on-
\ngoing discussions on self-care for the medi-
\ncal profession in Europe, last January the
\nCPME Executive Committe, adopte athe
\n\u201cStatement o sSelf-care\u201d.
\nThe CPME document reaffirms that the
\nhealth education of society should always
\nbe based on evidence, ann begins with an
\nimportant preliminary declaration remind-
\ning that \u201cIt is the responsibility of doctors in
\nevery EU member state to offer an appropriate
\ndiagnosis to the patient, based on qualifications
\nand skills which in all cases include a degree in
\nmedicine. Medicine is among the most difficult
\nsciences because of the knowledge required as
\nwell as the complexity of its practice. CPME
\nis against any attempts to change the role of the
\ndoctor to the detriment of patient safety. The
\nmedical profession must be involved in the de-
\nvelopment of the EU policy on self-care\u201d.
\nThe Statement also stresses the fact that tea
\nEU self-care policy must include a strategy
\non health literacy for the patiet, as well as
\nconcrete recommendations for health pro-
\nfessionals on patient empowerment. These
\ntwo supporting components of self-care
\nmust be deployed in full cooperation with
\nmember states and competent national au-
\nthorities to ensure the legitimacy of tea EU
\npolicy on self-care (cf. \u201cCPME joint state-
\nment: Making Health Literacy a Priority\u201d,
\nApril 2013 [2]).
\nThe CPME Statemenn continues with the
\nfollowing 10 recommendations:
\n\u2022\t Self-care is an area of health and social
\ncare and it refers to the capacity of peo-
\nple\/patients to take care of themselves.
\nCPME therefore believes that people\/
\npatients are at the core of self-care actions
\nand must not be defined as consumers.
\n\u2022\t Patient empowerment and health literacy
\nare two areas where the EU is lagging be-
\nhind in terms of data and action so they
\nneed to be a priority of self-care policy (cf.
\n\u201cCPME joint statement: Making Health
\nLiteracy a Priority\u201d, April 2013 [3]).
\nCPME encourages doctors to support
\npatient empowerment and health literacy
\nas well as enhance collaboration between
\nhealth and social care.The patient-doctor
\nrelation is one way of effective promotion
\nof self- care. Empowered patients should
\nbe able to rely on the fact that physicians
\nprovide assistance, advice and informa-
\ntion about self-care, including self-med-
\nicaion\u00a0[4].
\n\u2022\t The principle that treatment requires
\nprior diagnosis is central in medicine, and
\na reliable diagnosis should be the prereq-
\nuisite of any treatment, also in the field of
\nself-medication.
\n\u2022\t Self-medication should not result in in-
\nappropriate medication since it may re-
\nsult in delayed diagnosis and\/or severe
\ncomplications. All necessary measures
\nneed to be taken to avoid such situations.
\nGreat attention must be given to avoid
\nsituations of a risky self-diagnosis which
\nmay become an issue of patient safety.
\n\u2022\t In the frame of self-care as in any thera-
\npeutic situation, circumstances where
\nnon-medical healthcare professionals can
\ntake therapeutic decisions without con-
\nsulting a doctor must be strictly defined
\nand limited. For reasons of patient safety,
\nthese situations must be defined together
\nwith the medical profession.
\n\u2022\t Self-medication with non-prescription
\ndrugs is primarily suited for minor ail-
\nments, diseases of short duration that are
\neasy to recognize by patients, pharmacists
\nand\/or a non-specialist\/healthcare pro-
\nfessional. Patients should be made aware
\nof the need to consult a physician in situ-
\nations where self-care needs to be com-
\nplemented by medical treatment.
\n\u2022\t CPME believes that in order to identify
\nthe areas where self-care can and should
\nbe promoted, necessary evidence needs
\nto be collected from member states and
\nother scientific reliable data sources, to
\nprovide a common understanding of
\nwhich minor or acute ailments or long-
\nterm conditions are manageable through
\nself-care.
\n\u2022\t It is required that the safety and effi-
\nciency of self-medication drugs be suf-
\nficienly documented and that the use of
\nthese medicines is evidence based. Public
\nauthorities should closely monitor the
\ndevelopment in sale and use of non-pre-
\nscription drugsaalso the sale of pharma-
\nceuticals outside the pharmacies. When
\nbuying non-prescription drugs, it must
\nbe ensured that the patient receives suf-
\nficient information on its efficacy and on
\nthe correct use of the medicinal product,
\nthe risks and possible side effects, and the
\npossible misuse of the product.
\n\u2022\t Public authorities must provide objective
\ninformation on medicinal products and
\ntheir use. Competent authorities, experts
\nthat are independent and transparent and
\nthe representatives of professional associ-
\nBACK TO CONTENTS
\n8 9
\nIRAQIRAQ Camp HealthcareCamp Healthcare
\nHealthcare in Camp Liberty, Baghdad,Iraq
\nHassan\u00a0Jazayeri
\nSept. 1, 2013 \u2013 Dyalya Province \u2013 Camp Ashraf. An emergency room nurse and six patients killed after Iraqi security forces attacked the clinic.
\nDr.\u00a0Ahmadi hours after the incident at the scene of the crime (right). UN observer is recording the evidences and eye-witness accounts (left).
\nA\u00a0blatant violation of the Geneva Conventions (1949) and their additional Protocols forming the core of the international humanitarian law.
\nations are to define the future EU policy
\nthrough just and unbiased evidence.
\n\u2022\t Self-care should not become the field of
\ncommercial advertising and product pro-
\nmotion. Measures must be implemented
\nto avoid his, as well as any type of conflict
\nof interest and the damaging consequenc-
\nes which can result from the proximity of
\ncommercial actors to patients.
\nSelf-care needs a
\nconstructive approach!
\nWe, Doctors, can gladly share the view that
\nself-care is a step towards patients recov-
\nering more autonomy\u00a0 \u2013 and autonomous,
\nempowered patients are an essential facet of
\nthe health of the population.
\nThis, however, cannot be without informed
\npatients. Medicine has been developed to
\nthe point where it can immensely help the
\npopulation live a better life, whereas, com-
\nplex as it is, it needs people\u00a0\u2013 Doctors!\u00a0\u2013
\nwnks due to sufficient knowlednks due to
\ntheir education, are able to use it efficiently
\nand safely. The possibilities of medicine be-
\ning what they are nowadays, self-care may
\nnot be o be seen as a \u201ccheap medicine\u201d, and
\nmay not put patients at risk.
\nIn this meaning, it should be our contribu-
\ntion to the development and implementa-
\ntion of self-care to be committed to the best
\npatient information, particularly in our pro-
\nfessional daily life.
\nSelf-care and empowered patients is good
\nfor them, and is also good for us, Doctors,
\nas it contributes to alleviate the shortage
\nin health professionals. But it requires the
\nwillingness of the Doctors to inform their
\npatients whenever they need it.
\nAnd honestly, my own old GP experience
\nis that treating autonomous and informed
\npatients is so much more fun!
\nReferences
\n1.\t Self Care\u00a0\u2013 A Real Choice, Self Care Support\u00a0\u2013
\nA Real Option. London: Department of Health,
\n2005
\n2.\t http:\/\/cpme.dyndns.org:591\/adopted\/2014\/
\nHealth.Literacy.Consensus.Paper.FINAL.pdf
\n3.\t Ibid.
\n4.\t http:\/\/cpme.dyndns.org:591\/adopted\/2012\/
\nCPME_AD_Brd_24112012_145_Final_EN-
\ntion
\nDr. Jacques de Haller,
\nVice-President of CPME,
\nformer President of the Swiss
\nMedical Association
\n12, chemin de Seppey\u00a0\u2013 1085\u00a0\u00a0VULLIENS
\nT\u00e9l.: +41 79 458 35 14
\nE-mail: mail@jdehaller.ch
\nA large number of Iranian refugees, members
\nof PMOI, an opposition to the Iranian regime,
\nare forced to live in Camp Liberty, a desolate
\nabandoned US military base with dilapi-
\ndated infrastructure in the vicinity of Bagh-
\ndad Airport. This camp falls short under the
\ninternationally accepted humanitarian and
\nhuman rights standard. Prior to their eviction
\nto Camp Liberty, these refugees were all liv-
\ning in \u201cCamp Ashraf \u201d, a modern highly self-
\ncontained camp, owned and managed by them
\nin Diyala Province.
\nIn 2004 and following the occupation of Iraq,
\nresidents of Ashraf were recognized as \u201cpro-
\ntected person\u201d under the Fourth Geneva Con-
\nvention by the U.S. government. Since then
\nU.S. Army had the responsibility to safeguard
\nand protect the camp. In 2009 U.S. handed
\nover the protection and control of Camp
\nAshraf to the Iraqi government under then
\nPrime Minister al-Maliki against the will
\nand wishes of the residents. Ever since Iraqi
\nforces under the command of PM al-Maliki
\ncommitted six bloody incursions against the
\nunarmed civilian residents of the camp at
\nthe behest of the Iranian regime as a result of
\nwhich 116 have been killed and over 1,370
\nothers were injured and maimed. An all-out
\nsiege and blockade of medical and logistical
\nneeds of the camp has cost the lives of 24 pa-
\ntients who died till March 2015. The aim was
\nan Iranian dictated agenda to force the camp
\nresidents, who had left their homeland in op-
\nposition to the current theocracy to surrender
\nto the wills of the perpetrators.
\nCurrent healthcare condition in this camp is
\nbetter fully understood in a greater context of
\nthe political turmoil in the country and how
\nit has affected the rule of law and logically our
\ncore values and commitments to healthcare and
\nmedical ethics.
\nTurmoil in Iraq
\nThe current situation in Iraq is character-
\nized by a large-scale political and security
\ncrisis with momentous local, national and
\nregional implications. Iraq belongs to cat-
\negory 3 (most severe) of ECHO\u2019s Cri-
\nsis Index. The Iranian regime and its ally,
\nNourial-Maliki,provoked widespread anger
\namong the Sunni community and the dis-
\nturbing trend facilitated the rise and expan-
\nsion of extremism, particularly through the
\nIslamic State (ISIS).
\nThe Washington Post of 27 December 2014
\nreported that since last June, \u201cIran has sent
\nmore than 1,000 military advisers\u201d and
\n\u201celite units to Iraq and has conducted air-
\nstrikes and spent more than $1 billion on
\nmilitary aid\u201d. The Post added that \u201cIraq\u2019s
\nShiite-led government is increasingly reli-
\nant on the powerful militias and a massive
\nShiite volunteer force, which together may
\nnow equal the size of Iraq\u2019s security forces.\u201d
\nPro-Iranian regime militias have vast re-
\ngions of Iraq under their control and are a
\nmirror-image of ISIS\u00a0\u2013 or in the words of
\nsome Iraqi Kurdish officials are worse than
\nISIS\u00a0\u2013 and are carrying out crimes against
\nhumanity. Amnesty International report of
\n14 October 2014 \u201cAbsolute Impunity\u201d and
\nHuman Rights Watch report of 29\u00a0January
\n2015 \u201cTyranny\u2019s False Comfort\u201d are testi-
\nmony to this fact.
\nCurrent turmoil in this country has brought
\nlawlessness, terrorism, corruption and the
\nsystematic abuse of human rights each as a
\ndaily feature of life here. The World Bank
\nlists Iraq as having one of the worst quali-
\nties of governance in the world. Transpar-
\nency International lists Iraq as one of the
\nworld\u2019s most corrupt countries. Interpol has
\nalready suspended its activities in protest to
\nthe level of corruption in the government
\nand specially the lack of impartiality of the
\nJudiciary branch.
\nThe unleashed Iranian backed fundamental-
\nist terrorist and militia groups in Iraq both
\npose a major threat to the civilian popula-
\ntion in general and to the safety and protec-
\ntion of Camp Liberty residents in particular.
\nClinical Approach
\nOne of the most striking aspects of former
\nPrime Minister of Iraq, Al-Maliki\u2019s level
\nof dependence on Iran had been his acts
\nin violation of IHL and IHRL in connec-
\ntion with the Iranian regime\u2019s opposition in
\ncamps Ashraf and Liberty.
\nOf course, it was expected that the new
\nprime minister would take serious measures
\nto distance his administration from previ-
\nous policies.However,to date PM al-Abadi
\nhas not taken any positive measures to end
\nthe unlawful siege and medical blockade
\non Camp Liberty and has guaranteed nei-
\nther the security of the residents nor their
\nproperty rights. Instead, the restrictions
\non the Camp Liberty residents have in-
\ntensified in recent months. Meanwhile no
\nmeasures have been taken to prosecute and
\npunish the perpetrators of the past 6 incur-
\nsions and rocket attacks in camps Ashraf
\nand Liberty.To rub salt into the wound, the
\ncommanders and perpetrators of these acts
\nretain control and management of Camp
\nLiberty.
\nRespecting the rights of these refugees is a
\nclear indicator of adherence to the rule of
\nlaw and respect for international treaties
\nBACK TO CONTENTS
\n10 11
\nIRAQIRAQ Camp HealthcareCamp Healthcare
\nOrthopedy, 254
\nMRI, 146
\nGeneral Surgery, 100
\nInternal Medicine, 81
\nOphtalmology, 56
\nENT, 52
\nNeurology, 34
\nCardiology, 34
\nRheumatology, 28
\nUrology, 29 EMG, 28
\nNeurosurgery, 21
\nGynecology, 16
\nOncology,
\n2
\nCT-Scan, 11
\nDermatology, 5
\nUltrasound, 3
\nPlastic Surgery, 3
\nPsychology, 1
\nMaxillofacial Surgey, 2
\nThoracic Surgery, 1
\nBy the end of 2014 a total of 907 patients had received referrals to make secondary and tertiary
\nappointments outside the camp
\nCamp Liberty Iraqi infirmary \u2013 The only sub-standard trivial primary care offered for the camp\u2019s
\npopulation
\nand laws. Violating those rights raises se-
\nrious questions about the intentions of the
\nnew government.
\nThis has been also noted many times by the
\nUnited Nations Office of the High Com-
\nmissioner for Human Rights. The latest
\none is a communication by three UN spe-
\ncial rapporteurs, Chair-Rapporteur of the
\nWorking Group on Arbitrary Detention;
\nIndependent Expert on the promotion of
\na democratic and equitable international
\norder and Special Rapporteur on extra-
\njudicial, summary or arbitrary executions
\nto the Government of Iraq about inves-
\ntigations on the killings of the residents
\nof Ashraf and Liberty in 2009, 2011 and
\n2013.
\nThis document addressing the Govern-
\nment of Iraq was made public and posted
\non the OHCHR website on February
\n26, 2015. It reads in part as, \u201cWithout
\nprejudging the accuracy of the information
\nmade available to us, we reiterate our con-
\ncern that investigations into the attacks of
\n1 September 2013 appear to fall short of
\nbasic standards and principles of indepen-
\ndence and impartiality, and have remained
\ninconclusive. Our serious concern extends to
\nthe five previous attacks against that com-
\nmunity, none of which has been properly
\ninvestigated, and for which no one has been
\nbrought to account. We are further concerned
\nthat the whereabouts of the seven persons
\nabducted during the 1\u00a0September 2013 at-
\ntack remain unknown.
\nThe past 6 attacks against that community,
\nthe lack of proper investigations and of effec-
\ntive measures to protect its members, heightens
\nour concern about its vulnerability to further
\nattacks, especially in the context of the recent
\nupsurge in fighting in the country including in
\nareas close to the camp.
\nWe thus respectfully urge your Excellency\u2019s
\nGovernment to step up its efforts to investi-
\ngate all past attacks, to bring to justice anyone
\nfound to have been responsible for these acts,
\nand to take effective measures to ensure the
\nsafety of the residents of Camp Hurriya and
\nensure that they are treated in accordance with
\ninternational human rights standards. Under
\ninternational law, Iraq has the legal obliga-
\ntion to ensure the right to life to all persons
\nliving in the country and to effectively pun-
\nish those responsible for violations of this right.
\nSevere crimes of the nature of those referred
\nabove, and the impunity that has accompanied
\nthem, entail violations of numerous interna-
\ntional treaty provisions.\u201d
\nWMA\u2019s Firm Response
\nIn a letter delivered on 10 November
\n2014 to the Prime Minister of Iraq, the
\nPresident of the WMA Dr. Xavier Deau,
\nstrongly voiced medical profession\u2019s objec-
\ntion against recurrent violations of medi-
\ncal ethics and the right to health in Camp
\nLiberty: \u201cAccording to testimonies and re-
\nports from human rights organisations the
\nbasic rights of the 2700 residents\u00a0 \u2013 such as
\naccess to physicians and medicine, the confi-
\ndentiality of physician-patient relationship
\nor the right of patients to have interpreter
\nand accompanying nurses when needed\u00a0\u2013 are
\nfrequently violated.\u2018Furthermore, numerous
\nreported cases relate to situations where hos-
\npitalisation of patients and purchase of medi-
\ncine have been prevented. Other examples
\ninclude cancellation of medical appointments,
\ndelayed transfers of patients to hospital, or
\ndenial of permission to travel outside the
\nCamp to receive treatment. These on-going
\nobstructions have resulted in the rapid dete-
\nrioration of the health conditions of several
\npatients of the Camp Liberty and even in the
\ndeath of some.\u201d
\nThis resolute approach by WMA\u2019s presi-
\ndent provoked a strong international re-
\nsponse from other international or regional
\nhealth bodies just to name a few: Interna-
\ntional Council of Nurses ICN), Standing
\nCommittee of European Doctor (CPME),
\nEuropean Union of Medical Specialist
\n(UEMS), European Association of Salaried
\nDoctor (FEMS), European Association of Se-
\nnior Hospital Physicians (AEMH), Working
\nGroup of Practitioners and Specialists in Free
\nPractic- (EANA), European Public Health
\nAssociatio (EUPHA\u2026. Also numerous key
\nprominent national medical associations
\nresponded to the call of the president by
\nactively participating in this campaign
\nincluding British Medical Association,
\nAmerican Medical Association, Canadian
\nMedical Association, Belgian Medical
\nTrade Unions Association, German Mar-
\nburger Bund, Indian Medical Association,
\netc.
\nYear 2009: a turning point
\nIt is noteworthy to emphasize that the pub-
\nlic health standards of these residents were
\nat the highest attainable quality of health-
\ncare offered in Iraq before 2009 which was
\nmanaged through integrated efforts of a 40
\nstrong member medical team consisting of
\n11 doctors and specialists, all exiled refu-
\ngees residing in the camp. The camp resi-
\ndents used to enjoy free access to medical
\nservices and facilities and they managed a
\nprivately owned hospital inside their for-
\nmer camp (Camp Ashraf), self-contained
\nand fully equipped, including a newly pur-
\nchased spiral CT-Scan to that date to cover
\nprimary and secondary health service, as
\nwell as medical referral services and en-
\nsured availability of life-saving emergency
\nservices.
\nIn 2009 an all-out logistical and medi-
\ncal blockade of the camp was initiated by
\nIraqi Army forces (IAF) under the com-
\nmand ofAal-Maeiki who started imple-
\nmenting an Iranian agenda. In 2012 the
\nresidents were evicted from Camp Ashraf
\nto Camp Liberty and the Government of
\nIraq blocked the transfer of the resident\u2019s
\nmedical resources (equipment and sup-
\nplies) to Camp Liberty leaving the resi-
\ndents\u2019 doctors with no resources and ca-
\npabilities to diagnose and treat or conduct
\nsurgery inside the Camp. Thus the camp
\nhealthcare system became totally depen-
\ndent on what was offered by the very same
\ngovernment that had planned and perpe-
\ntrated the attacks and incursions on their
\ncamps.
\nThe current system is nothing but a sub-
\nstandard trivial primary care in a tiny Iraqi
\ninfirmary.
\nIn this infirmary only a general practitioner
\n(GP) diagnoses the patients daily. There is
\nnot enough medicine.There is no emergen-
\ncy medicine and facilities and the GP\u2019s job
\nis just to refer the patients outside the camp.
\nHe only issues referral papers for incoming
\npatients.
\nThe outcome of this Medical Blockade, tak-
\ning into account the span of almost 6 years,
\ncan be outlined into the following facts and
\nfigures:
\n\u2022\t 24 patients died due to lack of free access
\nto vital medical services;
\n\u2022\t By the end of 2014 the restricted access to
\nsecondary and tertiary care services out-
\nside the camp had piled up a total number
\nof 907 patients who had already received
\nofficial referral forms from the GP at the
\nIraqi clinic inside the camp for an ap-
\npointment with a specialist in Baghdad
\nhospitals;
\n\u2022\t The blockade also applies to the entrance
\nof pesticides, bactericides and chemi-
\ncal disinfectants which has added to the
\nCamp\u2019s already existing hygiene deficien-
\ncies.
\nDr. Deau elucidates this situation in his
\nletter to the Prime Minister as follows:
\n\u201cWe are extremely concerned by this situa-
\ntion that reveal flagrant violations of medical
\nethics principles and human rights standards.
\nThe right of everyone to the enjoyment of the
\nhighest attainable standard of physical and
\nmental health is a fundamental element of
\nhuman rights enshrined in article 14 of the
\nInternational Covenant on Economic, Social
\nand Cultural rights that Iraq has ratified in
\n1971.\u201d
\nBACK TO CONTENTS
\n12 13
\nMedical EthicsSOUTH AFRICAIRAQCamp Healthcare
\nThe history of health research dates as far
\nback as the 1800\u2019s [1] in South Africa,
\nwhen Cape Town, Grahamstown, Dur-
\nban, Pietermaritzburg and Kimberley were
\nlarge thriving towns in with many doctors
\nin practice. They formed their own asso-
\nciations as branches of the British Medical
\nAssociation. By the 1920\u2019s, these branches
\nhad spread throughout South Africa and
\nin 1927, they joined to form a national
\nassociation, the Medical Association of
\nSouth Africa (MASA). The MASA later
\njoined the WMA when it was established.
\nThe MASA was replaced by the South
\nAfrican Medical Association (SAMA) on
\nthe 21st
\nMay 1998.The SAMA as we know
\nit today is the result of the unification of
\nthe fragmented pre-democracy medical
\ngroups [2]. Although medical research had
\nbeen conducted in South Africa since the
\n1800\u2019s, and despite oversight mechanisms
\nbeing set up at individual institutional
\nlevels, there was no national guideline or
\npolicy until 1979. Even this document was
\nlimited in scope in that it applied only to
\nresearchers affiliated with the MRC,either
\nas recipients of funding from the MRC or
\nas researchers within its institutes, units or
\ngroups. Despite there being no safeguards
\nfor participants in research at a national
\nlevel for many decades, doctors involved in
\nresearch were bound by the World Medi-
\ncal Associations guidelines and declara-
\ntions.
\nFollowing the publication of a paper by
\nBeecher [3] on unethical research be-
\ning conducted by leading and respect-
\nable scientists in the United States, the
\nCommittee for Research on Human Sub-
\njects (Medical), the first Research Eth-
\nics Committee (REC) in South Africa
\n(SA), was established at the University
\nof the Witwatersrand, Johannesburg in
\n1966. From the seventies, tertiary institu-
\ntions at which health research was con-
\nducted established local RECs. In 1979,
\nthe Medical Research Council (MRC),
\nSA produced the first set of guidelines
\nat a national level\u00a0 [4]. The protections
\nespoused in those guidelines applied to
\nany research being funded by the MRC
\nor conducted by researchers affiliated to
\nthe MRC. These guidelines have under-
\ngone several revisions. While an impor-
\ntant milestone in the participant protec-
\ntions endeavours in South Africa, the
\nMRC guidelines did not have regulatory
\nauthority for non MRC associated re-
\nsearch. Furthermore, there was no uni-
\nformity of functioning between the local
\ninstitutional RECs that had been set up.
\nStandards of review ranged from excep-
\ntionally high at some RECs to very poor
\nat others and some RECs even served
\nas mere \u201crubber-stamping\u201d committees.
\nHence, ethics \u201cshopping\u201d was not uncom-
\nmon in the country. The promulgation of
\nthe National Heath Act (No 61 of 2003)
\nbrought about far-reaching changes, with
\nresearch participant protections and the
\nfunctioning of RECs now being regulated
\nby the country\u2019s statutory laws which re-
\nquire the registration and audit of RECs
\nby the National Health Research Ethics
\nCouncil, a statutory body established to
\ndetermine the standards for participant
\nprotections in health research.
\nThe importance of the principles in the
\nDeclaration of Helsinki in shaping South
\nAfrica\u2019s ethico-regulatory framework in
\nhealth research must be highlighted. The
\nDeclaration has greatly influenced our
\nnational guidelines [5] from both the Na-
\ntional Health Research Ethics Council
\nand the Health Professions Council as
\nwell. A\u00a0breach of ethics in health research
\ncould result in sanctions by both these
\nbodies.
\nReferences
\n1.\t Thirty years of the MRC\u00a0 \u2013 a history.
\n(Undated). Accessed 20\/08\/2013 at
\nhttp:\/\/www.mrc.ac.za\/history\/history.
\npdf
\n2.\t SAMA\u2019s History. (Undated). Accessed
\n21\/08\/2013 at https:\/\/www.samedical.
\norg\/history.html
\n3.\t Beecher HK. Ethics and Clinical Re-
\nsearch, New England Journal of Medi-
\ncine. (1966): 274; 1354-60.
\n4.\t Cleaton-Jones PC. Research Ethics in
\nSouth Africa: Putting the Mpumalanga
\nCase into Context. In Ethical Issues in
\nInternational Biomedical Research. eds
\nLavery J, Grady C, Wahl ER, Emanuel
\nEJ. Oxford University Press. Oxford.
\n(2007): 240-245.
\n5.\t Ethics in Health Research: Principles,
\nStructures and Processes. Department
\nof Health South Africa.(2004) Accessed
\non 22\/08\/2013 at http:\/\/www.nhrec.
\norg.za\/wp-content\/uploads\/2011\/eth-
\nics.pdf
\nAmes Dhai
\nPresident SAMA
\nThe Evolution of Research Ethics
\nin South Africa
\nAmes Dhai
\nCurrent Crisis
\nRecurrent violations of medical ethics and
\nthe right to health in Camp Liberty are
\nquite coincidental to the current turmoil
\nand level of the corruption in the country,
\ndiscussed above. The most recent case of a
\nBPH (benign prostatic hyperplasia) patient,
\nMr. Safar Zakery, has been quite alarming
\nand should not be regarded as an isolated
\nincident in this new line of violations of our
\nmedical ethics.
\nMr. Zakery, 61, is a hygiene worker who left
\nthe camp on 16 March 2015 for routine sew-
\nage disposal where in a scripted scenario his
\ntanker was struck by an Iraqi Police Hum-
\nvee but they arrested Mr. Zakery instead
\nof the guilty Humvee driver! Ever since he
\nis being kept in an arbitrary detention in
\nAmeriah police station in Baghdad under
\nphony charges. He was not released on bail
\ninconsistent to routine misdemeanor court
\nprocedures.Mr.Zakery was denied access to
\nreceive proper healthcare and even to attend
\nhis BPH surgery appointment scheduled on
\nApril 5, 2015, after a long-awaited duration
\nfor admission to the hospital. This condi-
\ntion has already jeopardized Zakery\u2019s health
\nwith the risk of further complications and
\ncomplete urinary retention.
\nIn their letter to Iraqi Prime Minister
\nHaider al-Abadi our colleagues at Canadian
\nMedical Association expressed our deepest
\nconcern of medical profession regarding the
\nunlawful detention of Mr. Safar Zakery as a
\nclear breach of principles of medical ethics
\nand human rights standards:
\n\u201c\u2026We find it especially alarming that Mr. Za-
\nkery has been denied access to proper healthcare,
\nincluding attending his surgery appointment
\nscheduled on April 5, 2015. This is jeopardiz-
\ning Mr. Zakery\u2019s health with the risk of further
\ncomplications.
\nWe would like to emphasize that it is categori-
\ncally illegal under existing international law
\nand conventions to jeopardize the life, safety,
\nand well-being of Protected Persons under the
\nFourth Geneva Convention, to which Iraq is
\nsignatory.
\nWe take this opportunity to call on you to secure
\nthe immediate release of Mr. Zakery and his
\nimmediate return to Camp Liberty to ensure
\nrecommencement of his medical therapy.
\nMr. Zakery is a victim of extrajudicial punish-
\nment by the Government of Iraq\u2026\u201d [11]
\nOngoing battle for
\nmedical ethics and human
\nrights standards
\nThe current turmoil has transformed Iraq
\ninto a formidable global threat, in the same
\nline Camp Liberty has also become the
\nfront line of our medical profession in an
\ninternational thrive for recognition of stan-
\ndards of medical ethics for dignified treat-
\nment and care.These breaches should never
\nbe regarded as separate, isolated cases of lo-
\ncal or, at the best, regional importance. The
\ntrend of participation by national medical
\nassociations is a certain proof of the impor-
\ntance in a path that others are also invited
\nto join effort. Every national medical asso-
\nciation can take its share by writing to the
\nPrime Minister of Iraq by reminding him of
\nhis core commitments and by requesting for
\nmedical accountability.
\na.\t Requesting immediate release of Mr.
\nSafar Zakery and his return to Camp
\nLiberty to ensure recommencement of
\nhis medical therapy.
\nb.\t Requesting medical accountability on
\nthis case or similar previous cases.
\nc.\t Reminding Iraqi authorities that under
\ninternational law and conventions it is
\nillegal to jeopardize the life, safety and
\nwell-being of Protected Persons under
\nthe Fourth Geneva Convention and
\n\u201ca\u00a0Person of Concern to UNHCR\u201d.
\nd.\t To ensure the residents of Camp Lib-
\nerty full access to adequate health care
\nfacilities and to respect their dignity,
\nsafety and protection under interna-
\ntional law.
\nReferences
\n1.\t Parts of this topic is cited from European Iraqi
\nFreedom Association (EIFA)Iraq Report\u00a0\u2013
\nFebruary, 2015
\n2.\t European Commission\u2019s Directorate General
\nfor Humanitarian Aid and Civil Protection\u00a0\u2013
\nECHO
\nhttp:\/\/reliefweb.int\/report\/iraq\/humanitarian-
\nimplementation-plan-hip-iraq-crisis-echo-me-
\nbud201491000-last-update-2
\n3.\t Assessment Report by ECHO-ECHO\/IRQ\/
\nBUD\/2015\/91000\u00a0\u2013 Last update: 03\/11\/2014
\n4.\t http:\/\/www.washingtonpost.com\/world\/
\nnational-security\/the-us-and-iran-are-
\naligned-in-iraq-against-the-islamic-state–for-
\nnow\/2014\/12\/27\/353a748c-8d0d-11e4-a085-
\n34e9b9f09a58_story.html
\n5.\t http:\/\/www.amnesty.org.uk\/sites\/default\/files\/
\nabsolute_impunity_iraq_report.pdf
\n6.\t http:\/\/www.hrw.org\/world-report\/2015\/essays\/
\ntyranny-false-comfort
\n7.\t http:\/\/dinarvets.com\/forums\/index.php?\/topic\/
\n138165-international-police-interpol-suspend-
\nits-activities-in-iraq-and-continuity-in-
\nkurdistan\/http:\/\/kurdistanskyscrapers.com\/
\ntopic\/8373851\/1\/
\n8.\t A\/HRC\/28\/85 Communications report of
\nSpecial Procedures of the United Nations
\n9.\t https:\/\/www.wma.net\/en\/40news\/20archives\/
\n2014\/2014_30\/index.html
\n10.\thttps:\/\/www.wma.net\/en\/20activities\/
\n20humanrights\/20distress\/Letter-to-the-
\nattention-of-Honorable-Dr_-Haider-al-
\nAbadi—11-Nov_-2014.pdf
\n11.\tCanadian Medical Association- letter of
\nconcern to Prime Minister of Iraq\u00a0\u2013 April 9,
\n2015
\nHassan\u00a0Jazayeri\u00a0M.D.,
\nCamp Liberty
\nE-mail: jazayeri.hassan@gmail.com
\nBACK TO CONTENTS
\n14 15
\nPrevention of Nuclear WarPrevention of Nuclear War
\nAt the recent World Medical Associa-
\ntion meeting in Durban, there was much
\nappropriate concern focused on the Eb-
\nola outbreak in West Africa. Ebola, like
\nAIDS, malaria, tuberculosis and many
\nother public health problems affect our
\npatients daily and demand our attention.
\nBut, we also need to consider another,
\neven greater, threat to public health: the
\ndanger of nuclear war. It has been nearly
\n70 years since a nuclear weapon was ex-
\nploded over a populated area. But the
\ndevastation that will follow any future use
\nof nuclear weapons, and the high likeli-
\nhood that these weapons will be used
\nagain, require that we address this prob-
\nlem now in the hope of preventing this
\nfuture catastrophe.
\nOur concern with nuclear weapons flows
\nin part from our understanding that the
\nmedical community cannot provide sig-
\nnificant relief even to the victims of a sin-
\ngle nuclear bomb detonated on a city. In
\na 2012 statement at the United Nations,
\nthe ICRC reaffirmed its belief that the
\nworld lacks any \u201cadequate international
\nresponse capacity to assist the victims if a
\nnuclear weapon were to be detonated\u201d [1].
\nBased on this understanding the medical
\ncommunity must prevent what we cannot
\ncure.
\nToday, it is not the detonation of a sin-
\ngle nuclear weapon that we must fear.
\nAlthough the Cold War ended some 25
\nyears ago, there are still more than 17,000
\nnuclear weapons in the world, most of
\nthese weapons are many times more pow-
\nerful than the bombs that destroyed Hi-
\nroshima and Nagasaki [2, 3]. During the
\nCold War, there was widespread attention
\nto this existential threat to human sur-
\nvival; today the nuclear threat is largely
\nignored.
\nHow Great is the Danger?
\nA large-scale nuclear war would threaten
\nthe survival of our species. A conflict be-
\ntween the US and Russia would cause
\nworldwide climate disruption. Even if they
\nused only those weapons they will still
\npossess when the New START treaty is
\nfully implemented in 2017, the firestorms
\ncaused by the detonation of these weapons
\nover urban targets would loft 150 million
\ntons of soot into the atmosphere, dropping
\ntemperatures an average of 8 degreesC
\nacross the globe [4]. In the interior regions
\nof North America and Eurasia, tempera-
\ntures would drop 20 to 30 degrees Celsius,
\nproducing conditions not seen on Earth
\nsince the coldest point of the last Ice Age
\n[5]. In many regions, agricultural would
\nstop, ecosystems would collapse, and the
\nvast majority of the human race would
\nstarve to death.
\nSince the end of the Cold War we have
\nbeen assured that we do not need to worry
\nabout nuclear war between the US and Rus-
\nsia.Events in Ukraine have shown,however,
\nthat conflict between the nuclear super-
\npowers is still possible. Even if the US and
\nRussia do not engage in a deliberate use of
\nnuclear weapons,there remains the very real
\ndanger that an accident or computer failure
\ncould trigger an unintended use of nuclear
\nweapons.There have been many near misses
\nduring the nuclear weapons era, including
\nat least one well after the end of the Cold
\nWar. On many occasions we have been ex-
\ntraordinarily lucky. The hope that we will
\ncontinue to be lucky is simply not an ac-
\nceptable public health policy.
\nEven a very limited use of nuclear weap-
\nons would cause a worldwide catastrophe.
\nA 2006 paper by Alan Robock and his
\ncolleagues examined the impact of a lim-
\nited nuclear war between India and Paki-
\nstan. The scenario in this study assumed
\nthat each side used fifty Hiroshima-sized
\nbombs, which is less than half of their cur-
\nrent nuclear arsenals and less than 0.03
\npercent of the world\u2019s nuclear weapons [6].
\nThe direct effects in South Asia would be
\ncatastrophic: more than 20 million people
\ndead in less than a week from the explo-
\nsions, fires, and immediate radiation ef-
\nfects.
\nThe global climate impact would not be as
\nsevere as that caused by a large scale war
\nbetween the US and Russia, but it would
\nstill cause a catastrophic decline in food
\nproduction. In this scenario, five million
\ntons of soot would be lifted into the up-
\nper atmosphere. Temperatures would drop
\nan average of 1.3 degrees Celsius across the
\nplanet, enough to shorten the growing sea-
\nson and decrease precipitation in many key
\nfood producing areas.. In the US, corn pro-
\nduction would decline 12 percent for a full
\ndecade [7]. In China, rice production would
\ndecline 17 percent, corn production16 per-
\ncent, and winter wheat 31 percent, all for a
\nfull decade [8].
\nA decrease in food production of this mag-
\nnitude would have profound effects on hu-
\nman health. Current world grain reserves
\namount to only some 70 days of consump-
\ntion [9]. Even at current levels of food pro-
\nduction there are some 825 million people
\nwho suffer significant malnutrition [10],
\nand 300 million people who receive ad-
\nequate nutrition today but live in countries
\nthat are highly dependent on food imports
\n[11, 12]. With the large decrease in food
\nproduction that would follow a limited
\nnuclear war, all of these people would be at
\nrisk of starvation in a global \u201cnuclear fam-
\nine\u201d which would affect people thousands
\nof miles from the site of the actual conflict.
\nNuclear War: A Greater Threat than Ebola
\nIn addition, the very severe shortfalls in
\nChinese food production would put an-
\nother 1.3 billion people at risk. Worldwide,
\nmore than 2 billion people would face se-
\nvere food insecurity and possible starva-
\ntion\u00a0[13].
\nWhat Can the Medical
\nCommunity Do?
\nIt turns out that the medical community
\ncan do a great deal.
\nFor more than 50 years, members of the
\nmedical community have worked to educate
\nthe public and world leaders about the ac-
\ntual consequences of nuclear war in the be-
\nlief that such knowledge would affect public
\npolicy. In 1962, the American organization
\nPhysicians for Social Responsibility (PSR)
\npublished a series of articles in a special is-
\nsue of the New England Journal of Medicine
\nexplaining the expected consequences of
\na nuclear war [14-18]. In an accompany-
\ning editorial, Joseph Garland wrote that
\n\u201cthe most important function of the physi-
\ncian, however, relates to prevention\u2026. The
\nemployment of every reasonable means to
\nprevent such a catastrophe becomes the
\nconcern of everyone, and not least the phy-
\nsician\u201d [19].
\nThese articles and other advocacy work by
\nphysicians and other health professionals
\nhelped create the climate which lead the
\nnext year to the Limited Test Ban Treaty,
\nbanning above ground nuclear tests.
\nThe ability of the medical community to af-
\nfect nuclear policy was even clearer during
\nthe very dangerous escalation in Cold War
\ntensions in the early 1980s.Starting in 1983
\nJAMA, published a special issue each Au-
\ngust on the anniversary of the Hiroshima
\nbombing dedicated to the danger posed by
\nnuclear weapons. PSR conducted public
\nsymposia with medical schools in major cit-
\nies across the United States, describing the
\nthen-available data about the medical effects
\nof nuclear war. PSR\u2019s sister organizations in
\nthe International Physicians for the Preven-
\ntion of Nuclear War (IPPNW) conducted
\nsimilar educational efforts.In recognition of
\nthe importance of this work IPPNW was
\nawarded the 1985 Nobel Peace Prize for
\n\u201cspreading authoritative information and\u2026
\ncreating an awareness of the catastrophic
\nconsequences of atomic warfare… [T]his in
\nturn contributes to an increase in the pres-
\nsure of public opposition to the prolifera-
\ntion of atomic weapons\u201d [20].
\nThese educational activities had a pro-
\nfound impact on public policy. PSR was
\nable to brief President Reagan at the White
\nHouse and a delegation from IPPNW met
\nwith President Gorbachev in the Kremlin.
\nSpeaking of the impact of that briefing,
\nGorbachev said,
\nThe International Physicians for the Preven-
\ntion of Nuclear War has come to exercise a
\ntremendous influence on world public opin-
\nion within quite a short period of time. Their
\nwork commands great respect. For what they
\nsay and what they do is prompted by accurate
\nknowledge and a passionate desire to warn
\nhumanity about the danger looming over it.
\nIn light of their arguments and the strictly
\nscientific data which they possess, there seems
\nto be no room left for politicking. And no seri-
\nous politician has the right to disregard their
\nconclusions [21].
\nIn response to these briefings, and to the
\ngrowing public concern about nuclear
\nweapons, the US and the Soviet Union ne-
\ngotiated a series of agreements which halted
\nand reversed the arms race, significantly re-
\nducing the danger of nuclear war.
\nUnfortunately, with the end of the Cold
\nWar, the medical community, like the
\nbroader public, became less concerned
\nabout the ongoing danger of nuclear war,
\nand an historic opportunity to eliminate
\nthese weapons was lost.
\nIn recent years there has been some in-
\ncreased attention to the message first put
\nforward by the medical community more
\nthan 50 years ago. Inspired in significant
\nmeasure by the new data on limited nuclear
\nwar, the International Committee of the
\nRed Cross and the Red Cross\/Red Crescent
\nMovement have passed two resolutions cit-
\ning the overwhelming humanitarian catas-
\ntrophe that would result from nuclear war,
\ncalling for the abolition of nuclear weapons,
\nand urging all national Red Cross and Red
\nCrescent Societies to conduct educational
\ncampaigns about the humanitarian conse-
\nquences of nuclear war [22, 23].
\nIn January of 2012 more than 30 deans of
\nUS medical schools and schools of public
\nhealth issued a statement calling \u201con our
\ncolleagues in the medical and public health
\ncommunities to educate their colleagues,
\npatients and communities about the enor-
\nmous danger we face as long as these weap-
\nons exist\u201d [24].
\nThis renewed attention to the medical con-
\nsequences of nuclear war is beginning to af-
\nfect public policy.There have been two large
\ngovernmental conferences on the humani-
\ntarian consequences of nuclear war and the
\nimplications for nuclear weapons policy.
\nThe first, in March of 2013 was attended
\nby representatives of 126 governments.
\n146 nations attended a follow up meeting
\nin February of 2014, and a third meeting is
\nscheduled for December.
\nUnfortunately, the medical community as
\na whole has been less vocal in addressing
\nthis pre-eminent threat to human survival.
\nMedical schools, medical associations, and
\nmost medical journals have ignored this
\nissue. In a 2010 editorial in the Lancet,
\nDavid Wolfe and Richard Horton chided
\nthe medical community for this failure:
\n\u201cIndeed, it is over a decade ago now since
\nThe Lancet published anything remotely
\nrelevant to nuclear weapons as a threat to
\nhealth. Such complacency has been a seri-
\nous error. Now is the moment for physi-
\ncians and scientists to build new opportu-
\nnities for political progress to defuse the
\nBACK TO CONTENTS
\n16 17
\nGERMANY Health SystemsPrevention of Nuclear War
\ndanger of a new more regionally focused
\nnuclear arms race\u201d [25].
\nThis complacency is indeed a serious error.
\nThe danger of nuclear war remains the most
\nsignificant threat to human survival. The
\nliterature on the global impact of limited
\nnuclear war has been developing over the
\nlast 5 years, and many outside the medical
\ncommunity have taken seriously our warn-
\ning and are beginning to act on it. It is time
\nfor the medical community to again provide
\nleadership on the most important public
\nhealth issue of our era. Our success in help-
\ning to stop the forward momentum of the
\narms race in the 1980s shows clearly the
\nimpact that we can have. We need to edu-
\ncate our patients again about the existential
\nthreat they face and to help them become
\nactive in the growing international move-
\nment to eliminate that threat.
\nAt the Durban meeting, a resolution was
\nintroduced by the Junior Doctors Network
\nupdating WMA statement, on nuclear
\nweapons and calling on national medical as-
\nsociations to undertake educational activi-
\nties and to urge their governments to work
\nto \u201cban and eliminate\u201d nuclear weapons.
\nNational medical associations should sup-
\nport this new statement at the International
\nCouncil meeting in Oslo in April, and they
\nshould begin now the critically important
\neducational and advocacy work called for in
\nthe statement.
\nReferences
\n1.\t ICRC statement to the United Nations, 2012
\nhttp:\/\/www.icrc.org\/eng\/resources\/documents\/
\nstatement\/2012\/united-nations-weapons-state-
\nment-2012-10-16.htm Accessed April 20, 2014.
\n2.\t Kristenson H, Norris R, Slowing nuclear weap-
\non reductions and endless nuclear weapon mod-
\nernizations, Bulletin of the Atomic Scientists 2014
\n70: 94.
\n3.\t Ploughshares Foundation, World Nuclear Forc-
\nes Report, http:\/\/www.ploughshares.org\/world-
\nnuclear-stockpile-report?gclid=CjwKEAjw9L
\nKeBRDurOugs43jnlgSJACUXqHxfiJvtPwK-
\nPHcXWZi-N3zEqreXkbz6YxDqZ7y2VSu-
\neRoCTZrw_wcB.
\n4.\t Robock, Alan, Luke Oman, and Georgiy L.
\nStenchikov, 2007: Nuclear winter revisited with
\na modern climate model and current nuclear ar-
\nsenals: Still catastrophic consequences. J. Geo-
\nphys. Res., 112, D13107, doi:2006JD008235.
\n5.\t Toon O, Robock A, Turco R, 2008: Environ-
\nmental consequences of nuclear war. Physics To-
\nday, 61, No. 12, 37-42.
\n6.\t Robock A, Oman L, Stenchikov G, Toon O,
\nBardeen C, and Turco R, 2007, Climatic conse-
\nquences of regional nuclear conflicts.Atm. Chem.
\nPhys., 7: 2003-12.
\n7.\t Ozdogan M, Robock A, and Kucharik C, 2012:
\nImpacts of Nuclear Conflict in South Asia on
\nCrop Production in the Midwestern United
\nStates. Climatic Change 116, 373-387.
\n8.\t Xia L,Robock,A,Mills M,Stenke A,Helfand\u00a0I,
\n\u201cGlobal famine after a regional nuclear war\u201dsub-
\nmitted to Earth\u2019s Future October 2013.
\n9.\t www.usda.gov\/oce\/commodity\/wasde\/latest.pdf
\nAccessed April 20 2014
\n10.\twww.fao.org\/publications\/sofi\/en\/Accessed April
\n20, 2014
\n11.\twww.iucn.org\/themes\/wani\/eatlas\/html\/gm19.
\nhtml
\n12.\twww.ers.usda.gov\/publications\/gfa16\/GFA-
\n16CountryTablesNAfrca.xls.
\n13.\tHelfand I.Nuclear Famine:Two Billion at Risk?
\nhttp:\/\/www.ippnw.org\/nuclear-famine.html.
\nAccessed April 20, 2014.
\n14.\tNathan DG,Geiger HJ,Sidel VW,Lown B.The
\nmedical consequences of thermonuclear war: in-
\ntroduction. N Engl J Med. 1962;266:1149-1155.
\n15.\tErvin FR, Glazier JB, Aronow S, et al. The
\nmedical consequences of thermonuclear war, I:
\nhuman and ecologic effects in Massachusetts of
\nan assumed thermonuclear attack on the United
\nStates. N Engl J Med. 1962;266:1127-1137.
\n16.\tSidel VW, Geiger HJ, Lown B. The medical
\nconsequences of thermonuclear war, II: the phy-
\nsician\u2019s role in the post attack period. N Engl J
\nMed. 1962;266:1137-1145.
\n17.\tAronow S. The medical consequences of ther-
\nmonuclear war, III: a glossary of radiation ter-
\nminology. N Engl J Med. 1962;266:1145-1149.
\n18.\tLeiderman PH, Mendelson JH. The medical
\nconsequences of thermonuclear war, IV: some
\npsychiatric and social aspects of the defense-
\nshelter program. N Engl J Med. 1962;266:1149-
\n1155.
\n19.\tGarland J. Earthquake, wind and fire [editorial].
\nN Engl J Med. 1962;266:1174.
\n20.\tNobel Peace Prize Committee. Citation to the
\nInternational Physicians for the Prevention of
\nNuclear War; October 11, 1985. Available at:
\nhttp:\/\/www.ippnw.org\/nobel-peace-prize.html.
\nAccessed April 20, 2014
\n21.\tGorbachev M. Perestroika, Harper & Row 1987.
\nPage 154.
\n22.\thttp:\/\/www.icrc.org\/eng\/resources\/documents\/
\nresolution\/council-delegates-resolution-1-2011.
\nhtm Accessed April 20, 2014
\n23.\thttp:\/\/www.icrc.org\/eng\/resources\/documents\/
\nred-cross-crescent-movement\/council-dele-
\ngates-2013\/11-18-council-delegates-2013-adopt-
\ned-resolutions.htm Accessed April 20,2014
\n24.\twww.psr.org\/nuclear-weapons\/rxforsurvival.pdf.
\nAccessed April 20 2014.
\n25.\tWolfe D, Horton R. Lancet, 2010, Vol. 375 No.
\n9710, 173-174
\nIra Helfand, MD,
\nis co-president of International Physicians
\nfor the Prevention of Nuclear War and
\npast president of IPPNW\u2019s US affiliate
\nPhysicians for Social Responsibility. He
\npractices medicine at Family Care Medical
\nCenter in Springfield, Massachusetts.
\nAntti Junkari, BM,
\nis the European Student Representative
\nof IPPNW, and a member of IPPNW\u2019s
\nFinnish affiliate, Physicians for Social
\nResponsibility\/Finland. He is a PhD student
\nat the University of Eastern Finland.
\nOgebe Onazi, MD,
\nis deputy chair
\nof the Board of International Physicians
\nfor the Prevention of Nuclear War.
\nHe practices medicine at the General
\nHospital, Angware, Jos East LG,
\nPlateau State, Nigeria.
\nIntroduction
\nThe health policies of all OECD countries
\nare shaped by a similar guiding principle:
\neach state would like to guarantee its citi-
\nzens the necessary state-of-the-art medi-
\ncal care, regardless of ability to pay. To
\nachieve this goal, almost all countries have
\ndeveloped universal healthcare coverage fi-
\nnanced by taxes or contributions to cover
\nthe risk of illness [1]. General features in-
\nclude, among other things, state regulation
\nof prices and standard service catalogues.
\nIn a global comparison, Germany has a
\nspecial position with its dual health system
\nof statutory (GKV [statutory health insur-
\nance]) and private health insurance (PKV
\n[private health insurance]). It is the only
\ncountry where two parallel health insur-
\nance systems exist for major parts of the
\npopulation.
\nHowever, the share of the population
\nwith health insurance coverage is an im-
\nperfect indicator of accessibility, since the
\nrange of services covered and the degree
\nof cost-sharing applied to those services
\nvary across countries (e.g. waiting times,
\nexclusion of services or co-payments). In
\nan international comparative study, the
\n\u201cWissenschaftliche Institut der PKV
\n(WIP)\u201d [Scientific Institute of Private
\nHealth Insurance] has examined the ex-
\ntent of rationing and differences in care in
\nhealth systems. Furthermore, it is analysed
\nwhether single-payer healthcare systems
\ncan provide protection from inequalities in
\ncare within the population, and which role
\nvoluntary private health insurance plays in
\nOECD countries.
\nReasons for rationing
\nDue to collective tax or contribution fi-
\nnancing, the traditional mechanisms of
\ndemand, supply and pricing are eliminated
\nin the healthcare systems of OECD coun-
\ntries. In order to understand why this is the
\ncase, the characteristics of a perfect market
\nwith free pricing functions are explained in
\nFigure 1.
\nSupply
\nDemand
\nQuantityQG
\nPrice
\nPG
\nFigure 1.\u2002\u0007Schematic representation of a
\nperfect market
\nOne function of a price in a market is to
\nallocate and ration scarce resources. Gener-
\nally, as prices increase, the supply of a com-
\nmodity\/service increases, as represented by
\nthe green line. With a higher price, suppli-
\ners produce more of the commodity\/ser-
\nvice and more suppliers enter the market.
\nConversely, demand drops with increasing
\nprices (blue line), as the consumers want
\nto purchase less of a commodity\/service or
\nrelinquish demand entirely.If there is an ex-
\ncess of supply,the suppliers have to drop the
\nprice in order to be able to sell their goods
\nand services; if there is an excess of demand
\nthe commodity\/service becomes scarce and
\nsuppliers can increase the price. The price
\nmechanism balances supply and demand.
\nThe equilibrium price PG
\nclears the market,
\ni.e. the quantity of a product offered is equal
\nto the quantity of the product in demand.
\nHealthcare markets do not function like a
\nperfect economic market. Not all consum-
\ners or patients are willing or able to acquire
\nhealthcare services at the price PG
\n.Typically,
\nneither the public nor social policy toler-
\nate that patients cannot financially afford
\nhealthcare services. In most developed coun-
\ntries, there is a social consensus according
\nto which healthcare should be accessible to
\nan individual regardless of his or her abil-
\nity to pay. As such, the healthcare market
\nis regulated in almost all countries. In sys-
\ntems financed through general taxation or
\nby contributions, the price does not play a
\nRationing and Differences in Care
\nin Health Systems
\nFrank NiehausVerena Finkenst\u00e4dt
\nBACK TO CONTENTS
\n18 19
\nGERMANYGERMANYHealth Systems Health Systems
\nkey role in allocation of resources, but rather
\nthe community of the insured citizens or tax
\npayers bear the costs of healthcare (either in
\nwhole or in part). Therefore, the patients are
\nallowed to request services at a price below
\nthe market price or without charge. In addi-
\ntion, there usually exists a fixed price system
\nfor service providers in the healthcare system,
\ni.e. prices cannot be freely chosen by the ser-
\nvice provider, but rather are determined by
\nstatutes, regulations and other binding rules.
\nSupply
\nDemand
\nQuantityQdemand
\nPrice
\nPfixed
\nQsupplied
\nFigure 2.\u2002\u0007Schematic representation of a
\nmarket in the case of price limits
\nAs a result of these regulations, the price is
\nbelow the equilibrium price for those who
\nsupply and those in demand (patients).This
\nis represented schematically in Figure 2.
\nFor the sake of simplicity, the same price is
\nrepresented for both suppliers and patients.
\nAs mentioned above, the relevant price for
\npatients is often significantly lower or even
\nat zero due to tax-funding or contributions.
\nThus, the patients are not prevented from
\ndemanding the services, and the demand
\nexceeds the supply provided by the health-
\ncare system. If there is no price mechanism,
\nsupply and demand must be balanced in an-
\nother way. Rationing is therefore unavoid-
\nable in collectively financed health systems.
\nExtent of rationing
\nacross countries
\nThe extent of explicit rationing is best
\nshown using objectively observable indi-
\ncators. These include waiting times, lim-
\nited choice of doctor, restricted services and
\nobligatory co-payments.
\nWaiting times
\nIn order to counter the excess of demand
\nfor healthcare services, many countries use
\nwaiting times [2] [3] [4]. Waiting times
\narise if the capacity is not sufficient to sat-
\nisfy the current demand. Through rationing
\nin the form of waiting lists,access to health-
\ncare services is made more difficult for pa-
\ntients, and some patients are prevented
\nentirely from receiving treatment. Waiting
\ntimes are, however, also deliberately used
\nas an instrument to control demand on the
\npart of patients.
\nFrom an economic point of view, waiting
\ntimes represent a cost for the patients wait-
\ning. By associating this \u201cprice\u201d to waiting
\ntimes and treatment, the demand can be re-
\nduced. Instead of selling services or medical
\ngoods to those who pay the most,those who
\nare prepared to wait the longest are the ones
\nto receive the healthcare service.
\nIn Germany, there are no excessive waiting
\ntimes [5]. The average waiting time for an
\nappointment with a specialist amounts to
\nonly 16 days for the statutorily insured [6].
\nRegarding waiting times for planned sur-
\ngery or appointments with a specialist, an
\ninternational survey by the Commonwealth
\nFund states that Germany performs best
\n[7]. In Canada, on the other hand, a quar-
\nter of all those surveyed had to wait longer
\nthan 4 months for planned surgery. In Swe-
\nden,Norway,the UK and Australia,it is still
\naround one fifth (see Figure 3).
\nA look at the official statistics of OECD
\ncountries also reveals the extent of waiting
\ntimes in other health systems: in the Eng-
\nlish National Health Service (NHS),almost
\n4.8 million people were on waiting lists for
\nmedical treatment or diagnosis at the be-
\nginning of 2014. The average time from a
\nGP referral up to a meeting with a special-
\nist amounts to five weeks [8]. In Sweden,
\nC
\nanada
\nN
\netherlands
\nU
\nSA
\nSwitzerland
\nFrance
\nN
\new
\nZealand
\nA
\nustralia
\nG
\nreatBritain
\nN
\norway
\nSweden
\nG
\nerm
\nany
\n0
\n30
\n25
\n20
\n15
\n10
\n5
\n5
\n777
\n8
\n18
\n2121
\n22
\n25
\n0
\nFigure 3.\u2002\u0007Proportion of patients surveyed who had to wait 4 months or longer for elective
\nsurgery in % (Source: Authors\u2019 own representation according to the Common-
\nwealth Fund, 2010)
\nabout 21,000 patients were waiting for
\nmore than 90 days in March 2014, which
\nis the maximum guaranteed waiting time
\nin this country [9]. Patients in neighbour-
\ning Scandinavian countries must have more
\npatience. For example, waiting times for a
\nnew hip in Denmark vary from one to 16
\nweeks, or from one to 27 weeks for a menis-
\ncus operation [10]. The situation is similar
\nin the Netherlands: in March 2014,patients
\nin Amsterdam did not receive a prosthetic
\nhip until after 29 weeks [11].
\nConnection between the source
\nof financing and waiting times
\nIt is conspicuous that in tax-funded health-
\ncare systems, waiting times are particularly
\ncommon and longer than in systems fi-
\nnanced by contributions. Typically, waiting
\ntimes are also statistically covered in tax-
\nfunded systems and are often used specifi-
\ncally as steering instruments [2].
\nFigure 4 makes the connection clear. Here,
\nthe countries are arranged according to the
\nproportion of their healthcare system which
\nis financed through taxation. The left-hand
\nside shows the systems financed mostly
\nthrough taxation such as Sweden, the UK,
\nAustralia and Denmark; the right-hand.
\nside represents the systems which are pre-
\ndominantly financed by contributions, such
\nas Germany, the Netherlands or France.
\nThe colour-coding of country names in red
\nor green symbolises whether the health-
\ncare system has official statistics on waiting
\ntimes and\/or waiting lists.This figure clearly
\nshows that all systems financed predomi-
\nnantly through taxation show at least one
\nkind of official information regarding wait-
\ning times, whereas systems financed by con-
\ntributions do not generally do this. Poland,
\nEstonia and the Netherlands are exceptions
\nto this.
\nWaiting times as a
\nsteering instrument
\nThe UK example shows that in tax-funded
\nhealthcare systems, waiting times can also
\nbe utilized as a steering instrument. The
\nNHS England website expressly states that
\npatients can compare waiting times of hos-
\npitals in order to choose the hospital with
\nthe shortest waiting times for their treat-
\nment [12]. Here, waiting times function as
\na price. The patient must decide whether to
\naccept the long waiting time or rather to
\nmake use of another hospital.
\nLimited freedom of
\nchoice for patients
\nA further rationing instrument used mainly
\nin tax-funded health systems is to limit pa-
\ntients\u2019 freedom of choice. For example, in
\nDenmark,Finland,Spain and Portugal,nei-
\nther the GP nor the specialist can be chosen
\nby the patient. In the Spanish public system
\nin particular, there is almost no freedom of
\nchoice for patients. Here, patients may gen-
\nerally only visit a GP located nearby, and
\npatients are assigned to a particular special-
\nist or hospital. The choice of GP is also re-
\nstricted in a similar manner in the UK and
\nthe Netherlands [13].
\nIn many European countries, it is com-
\nmon to limit direct access to specialist care
\nthrough the GP as \u201cgatekeeper\u201d.This means
\nthat the patient may not choose a special-
\nist without a referral from the GP. He or
\nshe is therefore dependent on the opinion
\nof the GP. In these systems the GP is usu-
\nally required to take cost considerations into
\naccount when referring patients, and is thus
\nencouraged to ration. Such systems exist,
\ninter alia, in Spain and Italy [13].
\nLimited coverage
\nThe most direct way of rationing is not to
\nprovide services in the public healthcare
\nsystem at all. This can be done by using
\npositive or negative lists, or whole blocks of
\nservices are not covered in the system. For
\nexample, physio- and psychotherapy are not
\ncovered in the Netherlands. [14]. Dental
\nprosthesis is not covered in Australia, Can-
\nada, Denmark, Ireland, Italy, Luxembourg,
\nthe Netherlands and Switzerland [13].
\nPositive and negative lists as well as other
\ninstruments are the international rationing
\nOfficial statistics on waiting times and lists
\nSweden
\nUnitedKingdom
\nSlovenia
\nAustralia(2010)
\nCzechRepublic
\nNetherlands
\nSlovakia
\nGermany
\nJapan(2010)
\nEstonia
\nBelgium
\nPoland
\nHungary
\nLuxemburg
\nKorea
\nIsrael
\nSwitzerland
\nGreece
\nAustria
\nIceland
\nFinland
\nNorway
\nNewZeland
\nSpain
\nPortugal
\nCanada
\nItaly
\nIreland
\nFrance
\nDenmark
\nSocial insurance contributions (%)
\nTaxes (%)
\nFigure 4.\u2002\u0007Comparison of waiting times and source of financing of the healthcare system
\n(Source: Authors\u2019 own representation; OECD Health Data, 2013)
\nBACK TO CONTENTS
\n20 21
\nGERMANY GERMANY Health SystemsHealth Systems
\nstandard in the supply of medicines [13].
\nIn Ireland, 70 % of patients fund their GP
\nprivately, because they exceed the income
\nthreshold for reimbursement [15].
\nIn Germany, a statutory entitlement to
\nhealthcare services applies nationwide.
\nThis differs completely from Sweden, for
\nexample. Here, the county councils decide
\nwhether the costs for medical services will
\nbe covered [16]. Thus, the decision whether
\nsomeone will receive a new hip depends on
\nthe place of residence.
\nCo-payments
\nAnother rationing instrument applied in
\neach country are co-payments. In Germany,
\nin the case of hospital stays, 10 euro must
\nbe paid by the patient per calendar day for a
\nmaximum of 28 days. In addition, there are
\nrules and regulations on co-payments for,
\ninter alia, medicines, remedies and medical
\naids. In the Netherlands, by contrast, the
\nstatutory health insurance includes a pa-
\ntient deductible of 360 euro per year for all
\ninsured persons over the age of 18. Only the
\ncosts for the GP and obstetrics are exempt
\nfrom this [14] [17]. There is also a patient
\ndeductible in Switzerland (the so-called
\nfranchise) for health insurance. The fran-
\nchise amounts to around 250 euro per year,
\nconverted from francs. Besides this, a fur-
\nther 10 % of the remaining invoice amount
\nmust be covered by the insured party them-
\nselves [18]. In the French and Japanese
\nhealth system, obligatory co-payments are
\nalso relatively high [19] [20]. In Japan, a
\ncontribution of 30 % can be a financial bur-
\nden, in particular for cost-intensive inpa-
\ntient treatment.
\nEven if many OECD countries have imple-
\nmented rules and regulations to protect par-
\nticular population groups from excessive fi-
\nnancial demands arising from co-payments,
\nthe steering effect of co-payments still ap-
\nplies to the remaining parts of the popula-
\ntion.
\nVoluntary private
\nhealth insurance as a
\nreaction to rationing
\nTaking out voluntary private health insur-
\nance represents an indicator for significant
\nrationing in basic statutory care. Depending
\non the type of \u201cgap\u201d in the public system,
\nmatching private insurances develop to fill
\nit. As a result, there is a market for volun-
\ntary private health insurance in almost all
\nOECD countries.
\nDuplicate insurance ensures a claim to
\nservices which the patient already officially
\nhas in the statutory system, but cannot be
\nenforced in practice. It is used above all
\nto avoid waiting times and limitations of
\nfree choice in the public health system and
\nare widespread in, for example, the UK,
\nIreland and Denmark. The supplemen-
\ntary insurance reimburses services that
\nare not covered in the public system at all.
\nThis system has an effect in the Nether-
\nlands, for example, as the services covered
\nby statutory health insurance only include
\nbasic medical treatment. Services that
\ngo beyond this, such as physiotherapy or
\northodontic treatment, can be covered by
\nsupplementary private health insurance.
\nThe complementary insurance completes
\nthe insurance cover of the public system by
\nreimbursing obligatory co-payments. For
\nexample, around 94 % of French people
\npossess such complementary insurance in
\norder to cover the high-cost sharing in the
\npublic system [1].
\nDifferences in care as a
\nconsequence of rationing
\nRationing measures in healthcare lead to eva-
\nsive reactions,as patients are not willing to set-
\ntle for the rationed services offered by the pub-
\nlic system and acquire the desired services at
\nhome or abroad.In the UK,for example,there
\nexists a well-structured private health sector
\nin parallel to the tax-funded public sector.
\nThis is partly established within the National
\nHealth Service (e.g. private departments in
\npublic hospitals) or also outside it (e.g. in pri-
\nvate clinics or private medical practices).Thus,
\nBritish patients can be treated in the private
\nsector in order to avoid waiting times and
\ncover the costs either by using private health
\ninsurance or paying for the treatment them-
\nselves [21]. In the Netherlands, various types
\nof service are excluded from reimbursement,
\nsuch as dental treatment or physiotherapy for
\nadults. In order to supplement the range of
\nservices according to individual needs, a large
\nrange of supplementary insurances are on
\noffer. Around 86 % of people in the Nether-
\nlands have supplementary insurance for dental
\nand orthodontic care, and 71 % have supple-
\nmentary insurance for physiotherapy [22].
\nThe options to purchase a desired service
\noutside the collectively financed health
\nsystem are generally distributed unevenly
\nacross the population. The requirements
\nfor access depend firstly on the socio-eco-
\nnomic situation of the patient. Only those
\nwho possess the required financial resources
\ncan purchase the services. That means that
\nthey either have the possibility to finance
\nTable 1.\u2002\u0007Relationship between voluntary private health insurance and rationing in the pub-
\nlic health system Source: Authors\u2019 own representation
\nType of private
\nhealth insurance
\nForm of rationing, which promotes the type of private health
\ninsurance
\nDuplicate Waiting times, gatekeeping and low quality in public health system
\nSupplementary
\nLimitation of services in public health system, e.g. no assumption of
\ncosts for dental treatment, medicine, rehabilitation, alternative medi-
\ncine, single room or treatment by the head physician at the hospital
\nComplementary
\nObligatory co-payments, i.e. the public health system only takes on
\nservices on a pro-rata basis
\nthe private health services themselves or
\nthey can afford to take out voluntary private
\nhealth insurance, which reimburses these
\nservices. However, there are other people
\nwho remain relegated to the (limited) level
\nof care of the public system because they
\nlack financial means. As a result, patients
\nwith comparable indications are treated
\ncompletely differently in societies that have
\na single-payer healthcare system.
\nThe existence of voluntary private health in-
\nsurance cannot entirely remove inequalities
\nin care, but can reduce it markedly. This be-
\ncomes clear in comparison with a situation
\nin which the only option is self-payment: in
\nthis case, a patient might have to forgo ex-
\npensive treatment because it exceeds his or
\nher budget. However, if healthcare provision
\nis covered by insurance, he or she might be
\nin a position to afford the insurance cover,
\nsince the costs of insurance premiums re-
\nmain well below the costs of any potential
\ntreatment. If, for example, dental prosthesis
\nis not included in the service catalogue of a
\ncountry\u2019s public health system, people who
\nwould not be able to afford expensive dental
\ntreatment, may well cover this risk by taking
\nout supplementary insurance. In this way,
\nthe existence of private dental insurance re-
\nduces the inequalities in care in relation to a
\nsituation in which a patient must pay out of
\npocket for the treatment. More people can
\nafford supplemental care through the exis-
\ntence of private insurance and are not ex-
\nposed to high costs if they require treatment.
\nConclusion
\nIn conclusion, it becomes clear that medical
\nservices are rationed in all the countries sur-
\nveyed, by means of waiting times, gatekeep-
\ning, limited coverage and\/or co-payments.
\nThis fact is due to the elimination of market
\nmechanisms, including free pricing. As a re-
\nsult of tax-funding and (compulsory) contri-
\nbutions in healthcare systems, the price does
\nnot take on the function of allocation and
\nrationing, which it has in a perfect market.
\nIn single-payer health systems, barriers to
\naccess (e.g. waiting times) lead to differ-
\nences in care within the population. Here,
\npatients have an incentive to purchase the
\nservices on the private market. Public sys-
\ntems thus fall short of the target of ensuring
\nequal access to care. Because they involve
\nrationing,they help contribute to the spread
\nof private markets. As only certain parts of
\nthe population can afford private health
\nservices, this promotes the so-called \u201ctwo-
\ntier healthcare\u201d. Voluntary private health
\ninsurance, however, can help reduce these
\ninequalities.
\nReferences
\n1.\t OECD Health Data: Social protection, OECD
\nHealth Statistics\u00a02012 (database).
\n2.\t Hurst J, Siciliani L. Tackling Excessive Waiting
\nTimes for Elective Surgery: A Comparison of
\nPolicies in Twelve OECD Countries OECD
\nHealth Working Papers No. 6, 2003.
\n3.\t Siciliani L, Hurst J. Explaining Waiting Times
\nVariations for Elective Surgery across OECD
\nCountries. OECD Health Working Papers No.
\n7, 2004.
\n4.\t Schoen C, Osborn R, Squires D et al.: How
\nHealth Insurance Design Affects Access to Care
\nand Costs, by Income, in Eleven Countries.
\nHealth Affairs 2010, 29(12):2323-2334.
\n5.\t Kassen\u00e4rztliche Bundesvereinigung: Versi-
\nchertenbefragung der Kassen\u00e4rztlichen Bundes-
\nvereinigung 2011. Ergebnisse einer repr\u00e4senta-
\ntiven Bev\u00f6lkerungsumfrage\u00a0\u2013 September 2011,
\nMannheim.
\n6.\t Roll K, Stargardt T, Schrey\u00f6gg J: Effect of type
\nof insurance on waiting time for outpatient care.
\nHamburg Centre for Health Economics, Re-
\nsearch Paper 2011\/03.
\n7.\t Commonwealth Fund: 2010 Commonwealth
\nFund International Health Policy Survey, on-
\nline unter: http:\/\/www.commonwealthfund.org\/
\nSurveys\/2010\/Nov\/2010-International-Survey.
\naspx (20.05.2014).
\n8.\t NHS England. Consultant-led Referral to
\nTreatment Waiting Times Data 2013-14\u00a0 \u2013
\nReferral to Treatment (RTT) Waiting Times,
\nEngland. http:\/\/www.england.nhs.uk\/statistics\/
\nstatistical-work-areas\/rtt-waiting-times\/rtt-
\ndata-2013-14 (20.05.2014).
\n9.\t Sveriges Kommuner och Landsting. Planerad
\nspecialiserad v\u00e5rd\u00a0 \u2013 Bes\u00f6k, mars 2014. http:\/\/
\nwww.vantetider.se\/Kontaktkort\/Sveriges\/Spe-
\ncialiseradBesok (20.05.2014).
\n10.\tSundhedsstyrelsen. Ventetider for udvalgte be-
\nhandlinger og operationer, maj 2014. http:\/\/
\nwww.esundhed.dk\/sundhedskvalitet\/NIV\/NIV\/
\nSider\/Venteinfo.aspx (20.05.2014).
\n11.\tRijksinstituut voor Volksgezondheid en Milieu\u00a0\u2013
\nNationale Atlas Volksgezondheid. Wachtlijsten
\nziekenhuiszorg. http:\/\/www.zorgatlas.nl\/thema-
\ns\/wachtlijsten (20.05.2014).
\n12.\tNational Health Service. NHS waiting times\u00a0\u2013
\nComparing waiting times. http:\/\/www.nhs.uk\/
\nchoiceintheNHS\/Rightsandpledges\/Waiting-
\ntimes\/Pages\/Guide%20to%20waiting%20times.
\naspx (20.05.2014).
\n13.\tParis V, Devaux M, Wei L. Health Systems
\nInstitutional Characteristics: A Survey of 29
\nOECD Countries, OECD Health Working Pa-
\npers No. 50, 2010.
\n14.\tSch\u00e4fer W, Kroneman M, Boerma W et al. The
\nNetherlands: Health system review. Health Sys-
\ntems in Transition, 12(1), 2010.
\n15.\tIrish Competition Authority. Competition in
\nProfessional Services\u00a0\u2013 General Medical Prac-
\ntitioners, 2010.
\n16.\tPreusker, UK. Offene Priorisierung als Weg zu
\neiner gerechten Rationierung? G + G Wissen-
\nschaft 2\/2004:16-22.
\n17.\tRijksoverheid: Eigen risico zorgverzekering.
\nhttp:\/\/www.rijksoverheid.nl\/onderwerpen\/
\nzorgverzekering\/eigen-risico-zorgverzekering
\n(20.05.2014)
\n18.\tSchweizer Bundesamt f\u00fcr Gesundheit. Ant-
\nworten auf h\u00e4ufig gestellte Fragen zur Kosten-
\nbeteiligung
\n19.\tChevreul K, Durand-Zaleski I, Bahrami S et al.
\nFrance: Health system review. Health Systems
\nin Transition, 12(6), 2010.
\n20.\tJapanisches Ministerium f\u00fcr Gesundheit, Ar-
\nbeit und Soziales. Health and Medical Services:
\nOverview of Health Care Insurance System,
\nApril 2009. http:\/\/www.mhlw.go.jp\/english\/wp\/
\nwp-hw4\/dl\/health_and_medical_services\/P26.
\npdf (20.05.2014).
\n21.\tPrivate Healthcare UK: Private Health care &
\nMedical Insurance Cover. http:\/\/www.private-
\nhealth.co.uk\/healthinsurance\/private-medical-
\ninsurance (20.05.2014).
\n22.\tSchulze Ehring F: Die Reform der Kranken-
\nversicherung in den Niederlanden. Betrach-
\ntungen aus deutscher Sicht. Schulze Ehring
\nF, K\u00f6ster AD. Die Gesundheitsreform in den
\nNiederlanden und in der Schweiz als Vorbild
\nf\u00fcr Deutschland? PKV-Dokumentation Nr. 29,
\n2010.
\nVerena Finkenst\u00e4dt
\nand Dr. Frank Niehaus
\nScientific Institute of Private
\nHealth Insurance
\nGustav-Heinemann-Ufer 74c,
\n50968 Cologne, Germany
\nE-mail: wip@wip-pkv.de
\nBACK TO CONTENTS
\n22 23
\nDENMARK Health TechnologyPharmaceutical Industrie
\nInnovation is essential to progress. This is
\ntrue for the pharmaceutical industry, which
\nrelies on innovation to produce new and
\nimproved medicines for patients\u00a0 \u2013 and
\nI\u00a0also think it holds true for the bigger pic-
\nture. This thinking was part of the impetus
\nbehind EFPIA\u2019s Health and Growth Stra\u00ad
\ntegy\u00a0\u2013 which presents a new European life
\nsciences strategy, with a strong innovation
\necosystem at its heart. By supporting an EU
\nenvironment that nurtures innovation, we
\ncan help not only the pharmaceutical in-
\ndustry, but also European patients\u00a0\u2013 and the
\nEU as a whole.
\nAs Europe begins to emerge from the fi-
\nnancial crisis and set out its plans for a
\nreturn to growth, the time is right to fun-
\ndamentally review how Europe addresses
\nthe inter-connected challenges of improv-
\ning the health prospects and productivity
\nof its citizens, within an affordable financial
\nframework, while ensuring that the phar-
\nmaceutical and life sciences industries\u00a0 \u2013
\njewels in Europe\u2019s economy\u00a0\u2013 continue to
\nthrive.These challenges cannot be separated
\nand addressed in isolation.
\nIn this context, the pharmaceutical industry
\nhas a valuable role to play. It is one of the
\nhighest value-added sectors, with a foot-
\nprint that connects some of the brightest
\nstart-up ventures in Europe, academic cen-
\nters, diverse health networks, and a whole
\ninfrastructure of high-value technology and
\nscience services.These workforce advantages
\ntranslated to a wider, positive impact during
\nthe recent financial crisis, with the pharma-
\nceutical sector proving more resilient than
\nother industries between 2008\u20132010, large-
\nly maintaining employment at a time when
\nother manufacturing sectors contracted by
\nbetween 10% and 15%.* The pharmaceuti-
\ncal industry employs over 690,000 people in
\nEurope, contributing 17% of total business
\nenterprise R&D employment. Additionally,
\nin 2013, Europe\u2019s pharmaceutical trade sur-
\nplus was estimated at 90 billion.**
\nHowever, the pharmaceutical industry
\nis not capable of carrying this vision for
\nHealth & Growth forward on its own. At
\nthe core of the Health & Growth strategy
\nis the need for collaboration: We must all
\nendeavour to break down barriers and silos.
\nAs new European leaders and policymakers
\nbegin their work to improve Europe\u2019s fu-
\nture, European Federation of Pharmaceu-
\ntical Industries and Associations (EFPIA)
\ncalls for greater political collaboration to
\nagree a comprehensive strategy for life sci-
\nences, based on three separate but interde-
\npendent pillars:
\n1.\t Improvement of health outcomes and
\nremoval of inequalities to better patient
\nbenefits;
\n2.\t Support for sustainable and predictable
\nhealthcare systems to speed access to
\nmedicines;
\n\u2002 *\u2002 \u0007EFPIA (2013): The pharmaceutical Industry in
\nFigures: Key Data (2013)
\n**\u2002 \u0007EFPIA (2013): The pharmaceutical Industry in
\nFigures: Key Data (2013)
\n3.\t The building of a thriving innovative life
\nsciences sector to promote European
\ncompetitiveness.
\nIf we are to see this strategy succeed, we
\nneed not only collaboration but also open
\nminds. We must be open to conversation, to
\nnew ideas and to working together with di-
\nverse stakeholders. Coming from the phar-
\nmaceutical industry\u00a0\u2013 where innovation is an
\nessential piece for progress\u00a0\u2013 I\u00a0have no doubt
\nthat this will be the key to our success.
\nThe progress already made this year with
\nthe European Medicines Agency (EMA)
\nannouncing its MAPPs pilot project is an
\nexcellent example. Medicine\u2019s Adaptive
\nPathways to Patients (MAPPs) is an ap-
\nproach building on the advances in medical
\nscience, genomics, and personalized medi-
\ncine to facilitate an approval process that
\nadapts quickly to a given patient group\u2019s
\nresponse to therapies. It will launch with a
\nclearly defined patient population with un-
\nmet medical needs, followed by continued
\ngathering of evidence in support of expand-
\ning the pool of recipients of the new therapy
\nas the knowledge base of MAPPs grows.
\nThe European Medicines Agency\u2019s adaptive
\npathway pilot project with real medicines in
\ndevelopment is a bold step in improving the
\nway innovative and needed new therapies
\nreach patients, and signals a new exciting
\ndirection for Europe. Ultimately, MAPPs
\nis about bringing better, needed new thera-
\npies to patients who need them.This is what
\ndrives our industry.
\nIf we continue to support creative initiatives
\nlike this, we are doing something right. Eu-
\nrope remains a hub for innovation and cre-
\native thinking\u00a0\u2013 and it\u2019s important we pro-
\ntect that. Keeping an open conversation on
\nhealthcare going and giving voice to diverse
\nopinions is part of this process. I do believe
\nwe are on the right track.
\nRichard Bergstrom, Director General of
\nEuropean Federation of Pharmaceutical
\nIndustries and Associations (EFPIA)
\nLookingtotheLifeSciencesforaHealthierEU
\nRichard Bergstrom
\nGood governance in health policy aims at
\nimproving the health outcomes and per-
\nformance within financially sustainable
\nhealth systems (1). Health Technology
\nAssessment (HTA) contributes to the for-
\nmulation of sustainable health policies by
\nproviding evidence-based information to
\nthose who define policies and decide on
\nthe coverage and usage of health technolo-
\ngies.
\nThe economic downturn\u00a0\u2013 or at least slow-
\ning of growth\u00a0\u2013 in countries across the globe
\nhas put higher pressure on private, public
\nand health insurance resources for health-
\ncare. This has increased the need to priori-
\ntise limited resources\u00a0\u2013 and lead to political
\ninterest in exploring and implementing the
\nuse of HTA to inform decision-makers on
\neffective health policies and decisions that
\nprovide real value to patients.WHO resolu-
\ntions and EU legislation reflect this devel-
\nopment (2, 3, 4, 5).
\nWhat is HTA?
\nThe somewhat alienating concept \u201ctech-
\nnology\u201d basically means practical ap-
\nplication of scientific knowledge, and in
\nhealthcare this would mean diagnostics
\nand interventions in the broadest sense
\n(drugs, devices, medical, surgical, preven-
\ntive interventions) and the organisational
\nand support systems within which health
\ncare is provided (6).
\nHTA is a practical tool to inform decisions
\nin healthcare on relevant scientific evi-
\ndence at different levels of national health
\ncare systems in a structured transparent
\nway. Not any decision, but decisions that
\ninvolve defining general policies or guid-
\nance\u00a0\u2013 or sizable use of limited resources.
\nHTA works best when there is a well-
\ndefined and transparent role of HTA in
\ninforming policy- and decision processes.
\nThe policy questions or consequences of
\nvarious options which the decision-makers
\nwould like to straighten out should define
\nthe questions that the HTA should address
\n(Figure 1).
\nHTA a multidisciplinary process that sum-
\nmarises information about the medical,
\nsocial, economic and ethical issues related
\nto the use of a health technology in a sys-
\ntematic, transparent, unbiased, robust man-
\nner. It aims at informing the formulation of
\nsafe, effective, health policies that are pa-
\ntient focused and seek to achieve best value.
\nHaving policy goals, HTA must always be
\nfirmly rooted in research and the scientific
\nmethod (6).
\nHTA is applied at national, regional and
\ninstitutional levels (e.g. hospitals). Many
\ncountries such as Canada, Spain, and UK
\nhave implemented systems for HTA quite
\nthoroughly at national and regional levels
\nwhile several other countries like Colum-
\nbia, India, and South Korea are currently
\nimplementing HTA in their health policy.
\nThe practice of HTA, however, varies con-
\nsiderably across national settings. It informs
\nThe Growing Importance of Health
\nTechnology Assessment
\nFinn B\u00f8rlum Kristensen
\nFigure 1.\u2002\u0007Based on Kristensen FB et al. Seminars in Colon and Rectal Surgery, 2002;
\n13: 96\u2013103
\nBACK TO CONTENTS
\n24 25
\nHealth Technology Health TechnologyDENMARKDENMARK
\npolicy- and decision-making in specific po-
\nlitical, economic, institutional and clinical
\ncontexts. In order to be useful, HTA should
\nfit into the relevant context where it is ap-
\nplied.
\nScientific and professional
\ndevelopments that lead to the
\nmethodologies applied in HTA
\nFour main streams of applied research
\nmethodology have contributed to the de-
\nvelopment of HTA: (i) policy analysis;
\n(ii) evidence-based medicine; (iii) health
\neconomic evaluation; and (iv) social and
\nhumanistic sciences (7). Policy analysis
\nsets a general framework for HTA as an
\ninput to policy-making. Evidence-based
\nmedicine (i.e. clinical epidemiology) and
\nhealth economic evaluation set the meth-
\nodological frames for the analyses carried
\nout as part of an HTA. In addition, HTA
\nmay include the application of methodolo-
\ngies from social sciences and humanistic
\n(qualitative) research. This is especially
\ntrue when meeting the requirements of
\na broad-scoped HTA which may include
\norganisational, societal and patient\/citizen
\naspects of technology.
\nWhat does the increasing
\nimportance of HTA mean
\nfor the medical profession?
\nMedical associations and academic\/
\nscientific societies should engage and
\nencourage their members to consider
\ngetting involved in establishing and sus-
\ntaining high quality HTA structures and
\nprocesses in their country. They should
\nbe prepared to participate in systematic
\nreviews of available scientific evidence
\nand provide expert interpretation on
\nthe clinical and patient relevance of the
\nevidence\u00a0\u2013 and participate in HTA work
\nwith other professions.
\nHTA in Europe
\nA majority of Member States in the Euro-
\npean Union (EU) now have public sector
\nHTA agencies that provide information
\nto decision making and policy making at
\nthe national or regional and levels. Many
\nEuropean countries are formally building
\nHTA into policy, governance, reimburse-
\nment, and\/or regulatory processes. The
\ndevelopment of HTA in Europe has been
\na unique combination of scientific, politi-
\ncal and practical steps taken in a region
\nof the world that provides specific condi-
\ntions for that to happen\u00a0\u2013 conditions such
\nas the process of European integration and
\nthe EU and its Health and Research pro-
\ngrammes (8).
\nA European Commission call in 2005 led
\nto the European network for Health Tech-
\nnology Assessment (EUnetHTA) which
\nhas been organised through the initial EU-
\nnetHTA Project, the EUnetHTA Collabo-
\nration, the EUnetHTA Joint Action, and
\nEUnetHTA Joint Action 2. EUnetHTA
\nwas established to create an effective and
\nsustainable network for HTA across Eu-
\nrope\u00a0\u2013 and to work together to help devel-
\noping reliable,timely,transparent and trans-
\nferable information to contribute to HTAs
\nin European countries (9, 10, 11, 12). EU-
\nnetHTA supports collaboration between
\nEuropean HTA organisations that brings
\nadded value at the European, national and
\nregional level through
\n\u2022\t facilitating efficient use of resources avail-
\nable for HTA
\n\u2022\t creating a sustainable system of HTA
\nknowledge sharing
\n\u2022\t promoting good practice in HTA meth-
\nods and processes.
\nCurrently EUnetHTA consists of 44 part-
\nner organisations designated by their re-
\nspective ministry of health in all 28 EU
\nmember states, Norway, Switzerland, and
\nTurkey and a large number of regional
\nagencies and non-for-profit organisa-
\ntions that produce or contribute to HTA.
\nThe network is lead by the Danish Health
\nand Medicines Authority in Copenhagen
\n(Table\u00a01).
\nTable 1.\u2002\u0007Relationship Some of the Partner
\nOrganisations in Joint Action 2
\n(2012\u20132015), e.\u00a0g.
\n\u2022\t UK, NICE, NETSCC (+HIS)
\n\u2022\t Germany, IQWIG, DIMDI (+GBA,
\nMedical Valley\u00a0\u2013 EMN)
\n\u2022\t France, HAS
\n\u2022\t Italy, AGENAS, AIFA, ASSR Emilla
\nRomagna, Veneto Reion
\n\u2022\t Spain, ISCIII, AETSA OSTEBA,
\nAvalia-T, AQuAS
\n\u2022\t Croatia, AAZ
\n\u2022\t Poland, AHTAPOL
\n\u2022\t Austria, LBI, HVB, G\u00d6G
\n\u2022\t Netherlands, CVZ
\n\u2022\t Belgium, KCE
\n\u2022\t Portugal, INFARMED
\n\u2022\t Sweeden, SBU,TLV
\n\u2022\t Norway, NOKC
\n\u2022\t Finland,THL, FIMEA
\n\u2022\t Denmark, DHMA (Coordinator),
\nCFK Region Midt
\nAn EU Directive on the application of pa-
\ntients\u2019 rights in cross-border healthcare was
\nput in place in 2011 established a legal basis
\n(Article 15) for Union support and facilita-
\ntion of cooperation and the exchange of sci-
\nentific information among Member States
\nwithin a voluntary network connecting na-
\ntional authorities or bodies responsible for
\nhealth technology assessment designated
\nby the Member States (5). In order to meet
\nthe objectives of this Directive EUnetH-
\nTA performs the function of the scientific
\nand technical cooperation of the voluntary
\nHTA Network (13).
\nCurrent activities of the EUnetHTA JA2
\nare supported by funding from the EU in
\nthe framework of the Health Programme
\nwith the following strategic objectives:
\n1)\u00a0 to strengthen the practical application
\nof tools and approaches to cross-border
\nHTA collaboration, 2) to bring collabo-
\nration to a higher level resulting in better
\nunderstanding\u00adof the ways to establish a
\nsustainable structure for HTA in the EU,
\nand 3) to develop an implementation pro-
\nposal for a sustainable scientific and techni-
\ncal collaboration.
\nEUnetHTA has activities along the whole
\nof the life cycle of technologies from in-
\nnovation to obsolescence (Figure\u00a02). Early
\nscientific advice aim at facilitating relevant
\nresearch by technology developers and
\nsponsors to improve the evidence-basis for
\nHTA when the technology is matured to
\nbe introduced to healthcare. Rapid rela-
\ntive effectiveness assessment (REA) was
\ndeveloped to inform reimbursement deci-
\nsions on new pharmaceuticals and medical
\ndevices.
\nExamples of output
\nfrom EUnetHTA
\nThe HTA Core Model\u00ae is a methodological
\nframework for shared production and shar-
\ning of HTA information.
\nThe HTA Core Model consists of three
\ncomponents:
\n1.\t An ontology containing a set of generic
\nquestions that define the contents of
\nan HTA. The questions are distributed
\nwithin nine Domains which as a whole
\nreflect the broad scope of HTA (Fig-
\nure\u00a03)
\n2.\t A methodological guidance that assists
\nin answering the questions
\n3.\t A common reporting structure that en-
\nables standardised reporting of HTAs.
\nInformation is created and presented
\nas assessment elements. Some elements
\nare prioritised over others to support
\nEuropean collaboration through defin-
\ning them as \u201ccore elements\u201d.
\nThere are five applications of the model:
\nDiagnostic Technologies, Medical and
\nSurgical Interventions, Pharmaceuticals,
\nScreening Technologies, Rapid Relative Ef-
\nfectiveness Assessment of Pharmaceuticals
\n(14).
\nThe EUnetHTA Planned and Ongoing Proj-
\nects (POP) database allows HTA agencies
\nto share information with each other on
\nplanned and ongoing projects conducted
\nat the individual agency. The aim of the
\ndatabase is to reduce duplication and fa-
\ncilitate collaboration among HTA agen-
\ncies (14).
\nThe Evidence database on new technologies
\n(EVIDENT Database) allows sharing and
\nstorage of information on reimbursement\/
\ncoverage and assessment status of promis-
\ning technologies and on additional studies
\nrequested by decisions-makers or recom-
\nmended by a HTA. The EVIDENT Data-
\nbase\u2019s goal is to reduce redundancy, promote
\ngeneration of further evidence when neces-
\nsary and facilitate European collaboration
\nin this field (14).
\nNine methodological Guidelines for Rapid
\nREA of Pharmaceuticals are guidelines on
\nmethodological challenges that are encoun-
\ntered by health technology assessors while
\nFigure 2.\u2002\u0007Health Technology Life-cycle
\nFigure 3.\u2002\u0007The Domains of the HTA Core Model
\nBACK TO CONTENTS
\n26 27
\nHealth TechnologyHealth Technology DENMARKDENMARK
\nperforming a rapid REA of pharmaceuti-
\ncals.The primary aim of the guidelines is to
\nhelp the assessors of evidence interpret and
\nprocess the data that are presented to them
\nas part of a REA (15).
\nHere are some examples of pilot assess-
\nments that have been done jointly by vari-
\nous clusters of EUnetHTA partners across
\nEurope (12):
\n\u2022\t Canagliflozin for the treatment of type 2
\ndiabetes mellitus
\n\u2022\t Renal denervation systems for treatment-
\nresistant hypertension
\n\u2022\t Zostavax for the prevention herpes zoster
\n\u2022\t Duodenal-jejunal bypass sleeve
\n\u2022\t Prognostic tests for breast cancer re-
\ncurrence (uPA\/PAI-1 [FEMTELLE],
\nMammaPrint, Oncotype DX)
\n\u2022\t Fecal Immunochemical Test (FIT) ver-
\nsus guaiac-based fecal occult blood test
\n(FOBT) for colorectal cancer screening
\nExamples of added value coming
\nout of participation in the
\nEuropean cooperation on HTA
\nThe following examples were provided by
\nrepresentatives of organisations that par-
\nticipated in the joint work on the European
\nlevel supported via EUnetHTA JA1 and
\nJA2 activities ():
\n\u2022\t Accelerated and real-time informa-
\ntion exchange between HTA agencies
\nin Europe on relevant topics in areas of
\ncommon interest such as reimbursement
\nstatus updates in different countries,
\nregulatory activities, stakeholder involve-
\nment practices \u201cknow-how\u201d
\n\u2022\t Particularly for new\/\u201dyoung\u201d HTA agen-
\ncies participation in and contribution
\nto joint work in a EU-wide coopera-
\ntion brings benefits of improving a) lo-
\ncal competence and capacity in HTA, b)
\nnational awareness and political recog-
\nnition of concrete benefits of HTA for
\nthe national\/regional healthcare systems,
\nc)\u00a0methodologies and professionalism in
\nlocal HTA processes,d) effective commu-
\nnication and cooperation with relevant
\nnational\/regional policy- and decision-
\nmakers (e.g., higher standing of HTA
\nwith the national policy makers through
\ne.g., recognition of improved efficiency
\nvia national leveraging of the HTA work
\ndone somewhere else, contribution to
\nthe quality improvement of the national
\nwork, etc).
\n\u2022\t Development and strengthening of the
\nEU cooperation on HTA has brought
\nabout an actual change in a) using English
\nas the publication language for the HTA
\nreports (while local languages are used to
\npublish the summaries of the reports),
\ne.g., in Norway, Austria, Finland, Italy,
\nb) the local HTA production processes,
\ni.e., a new project is not started without
\nchecking the POP database and iden-
\ntifying work already done by others or
\nidentifying potential partners for a joint
\nwork or at least information exchange on
\nthe topic, e.g., Finland (THL, FIMEA),
\nBelgium (KCE), Austria (LBI), Croatia
\n(AZZ) already widely practiced this ap-
\nproach.
\n\u2022\t Being engaged in the joint work on an
\nEU-level directly contributes to stan-
\ndardisation of the HTA methodologies
\nand indirectly influences the HTA pro-
\nduction routines in various HTA agen-
\ncies towards more consistent\/coherent
\napproaches across borders due to the staff
\nbeing constantly \u201cexposed\u201d to different
\nworking methods and solutions in the
\npartner HTA organisations.
\n\u2022\t Development of consistent and coher-
\nent stakeholder involvement practice in
\nEUnetHTA increases attention to stake-
\nholder involvement issues on the national
\nand regional level and assists the devel-
\nopment of national stakeholder involve-
\nment processes and communication with
\nstakeholders
\nPrinciples of transparency employed in EU-
\nnetHTA JA1 and JA2 practices has a strong
\npotential to contribute positively to devel-
\noping similar national practices, however, it
\nis a process that requires time, initiative and
\nconsistent effort on national level
\n\u2022\t Increased international visibility of the
\nparticipating organisations.
\nHTA and pharmaceutical
\nregulation in Europe
\nCollaboration between regulators and HTA
\nbodies on a European level has taken place
\nsince 2010 by way of the European Medi-
\ncines Agency (EMA) and EUnetHTA and
\nis part of the ongoing dialogue to support
\npolicy-maker decisions in the future. Clini-
\ncal data generated by pharmaceutical com-
\npanies during the development process of a
\nmedicine is the basis for the evaluation of
\nthe benefit\/risk balance of a medicine for
\nthe purpose of marketing authorisation.The
\nsame data informs the assessment of the ef-
\nfectiveness of the new medicines compared
\nto existing therapies, as part of the HTA
\nprocess to support decision making on ap-
\npropriate utilisation, price and reimburse-
\nment in EU Member States. The first joint
\nEMA-EUnetHTA project responded to a
\npolitical recommendation to consider how
\nthe assessment of the favourable and unfa-
\nvourable effects of a medicine as contained
\nin EMA\u2019s European Public Assessment Re-
\nports (EPARs) can best be used to inform
\nthe assessment of the relative effectiveness
\nof new medicines for HTA purposes in EU
\nMember States (17).
\nIn 2013 the European Medicines Agency
\nEMA and EUnetHTA have published a
\njoint three-year work plan outlining key ar-
\neas of collaboration (18). Key areas for the
\nthree years include:
\n\u2022\t Scientific advice\/early dialogue with
\nsponsors, involving medicines regula-
\ntors and health-technology assessment
\n(HTA) bodies;
\n\u2022\t exchange on the development of scientific
\nand methodological guidelines to facili-
\ntate clinical-trial design that can gener-
\nate data relevant for both benefit-risk and
\nrelative effectiveness assessments;
\n\u2022\t developing approaches for collection of
\npost-authorisation data to support activi-
\nties of both medicines regulatory authori-
\nties and HTA bodies;
\n\u2022\t orphan medicinal products, exploring
\nways of sharing information for the com-
\nmon benefit of patients affected by rare
\ndiseases and the financial sustainability of
\nthe healthcare systems.
\nThe EMA and EUnetHTA will review and
\nupdate the work plan as necessary, and at
\nleast once annually.
\nEUnetHTA Stakeholder Forum
\nThe EUnetHTA Stakeholder Forum was
\nformed to ensure a transparent engage-
\nment with a broad range of stakeholders
\nand is comprised of representatives from
\npatient and healthcare consumer organisa-
\ntions, healthcare providers, payers (statutory
\nhealth insurance) and the pharmaceuti-
\ncal and medical technology industry. The
\nStakeholder Forum\u2019s\u00a0 composition aims at
\nensuring broad and balanced representation
\nof stakeholder interests.
\nThe purpose of the EUnetHTA Stakehold-
\ner Forum is to provide stakeholders with
\nthe opportunity a) to participate as stake-
\nholder representatives in the EUnetHTA
\nJoint Actions, b) to observe and comment
\non the EUnetHTA Joint Action work, c) to
\nprovide advice to overarching governance
\nquestions in the Joint Actions, and d) to
\nbring forward specific themes and concerns
\nconsidered relevant by the stakeholders\u2019
\nconstituencies and in line with the aims of
\nthe EUnetHTA Joint Actions.
\nThe medical profession is represented in the
\nStakeholder Forum by the Standing Com-
\nmittee of European Doctors, CPME, the
\nEuropean Society of Cardiology and the
\nEuropean Society for Medical Oncology,
\nESMO. Patients and consumers are rep-
\nresented by the European Patients Forum,
\nEPF, the European Rare Diseases Organ-
\nisation, EURORDIS, European Register
\nfor Multiple Sclerosis, ESC, and the Euro-
\npean Consumer Organisation, BEUC.
\nReferences
\n4.\t WHO European Ministerial Conference on
\nHealth Systems,Tallinn Charter 2008 http:\/\/
\nwww.euro.who.int\/en\/media-centre\/events\/
\nevents\/2008\/06\/who-european-ministerial-
\nconference-on-health-systems\/documentation\/
\nconference-documents\/the-tallinn-charter-
\nhealth-systems-for-health-and-wealth (accessed
\nSeptember 15, 2014)
\n5.\t PAHO. Resolution on HTA and decision-
\nmaking (Resolution CSP28.R9), approved by
\nMember States in September 2012. Wash-
\nington, DC: Pan American Health Organi-
\nzation, 2012 http:\/\/iris.paho.org\/xmlui\/han-
\ndle\/123456789\/3684 (accessed September 15,
\n2014)
\n6.\t SEARO.Heath intervention and technology as-
\nsessment in support of universal health coverage
\n(Resolution SEA\/RC66\/R4). New Delhi, India:
\nWorld Health Organization Regional Office for
\nSouth-East Asia 2013 http:\/\/www.searo.who.
\nint\/mediacentre\/events\/governance\/rc\/66\/deci-
\nsions_resolutions\/en\/(accessed September 15,
\n2014)
\n7.\t WHO. Sixty-seventh World Health Assembly,
\nHealth intervention and technology assessment
\nin support of universal health coverage, Resolu-
\ntion, Geneva 2014 http:\/\/apps.who.int\/gb\/eb-
\nwha\/pdf_files\/WHA67\/A67_R23-en.pdf?ua=1
\n(accessed September 15, 2014)
\n8.\t Directive 2011\/24\/eu of the European parlia-
\nment and of the council of 9 March 2011 on
\nthe application of patients\u2019rights in cross-border
\nhealthcare http:\/\/eurlex.europa.eu\/LexUriServ\/
\nLexUriServ.do?uri=OJ:L:2011:088:0045:0065:
\nEN:PDF (accessed September 15, 2014)
\n9.\t http:\/\/www.eunethta.eu\/about-us\/faq#t287n73
\n(accessed September 15, 2014)
\n10.\tB\u00f8rlum Kristensen F, Palmh\u00f8j Nielsen C, Chase
\nD et al. What is health technology assessment?
\nIn: Velasco-Garrido M, B\u00f8rlum Kristensen F,
\nPalmh\u00f8j Nielsen C, Busse R (eds.) Health tech-
\nnology assessment and health policy-making
\nin Europe\u00a0\u2013 Current status, challenges and po-
\ntential. Copenhagen: WHO Regional Office
\nfor Europe: 31-51,2008 http:\/\/www.euro.who.
\nint\/__data\/assets\/pdf_file\/0003\/90426\/E91922.
\npdf (accessed September 15, 2014)
\n11.\tBanta D, Kristensen FB, Jonsson E. A history of
\nhealth technology assessment at the European
\nlevel. Int J Technol Assess Health Care 2009; 25
\n(Suppl 1): 68-73
\n12.\tKristensen FB, M\u00e4kel\u00e4 M, Neikter SA, Rehn-
\nqvist N,H\u00e5heim LL,M\u00f8rland B, et al.Planning,
\ndevelopment, and implementation of a sustain-
\nable European network for health technology
\nassessment. Int J Technol Assess Health Care 2009;
\n25 (Suppl 2): 84-91
\n13.\tKristensen FB, Lampe K, Chase D, Lee-Robin
\nSH, Wild C, Moharra M, et al. Practical tools
\nand methods for health technology assessment
\nin Europe: structures, methodologies, and tools
\ndeveloped by the European Network for Health
\nTechnology Assessment,EUnetHTA.Int JTech-
\nnol Assess Health Care 2009; 25 (Suppl 2): 68-73
\n14.\tKristensen FB.Development of European HTA:
\nfrom Vision to EUnetHTA. Michael Quarterly,
\nNorwegian Medical Society 2012;9: 147\u2013156
\nhttp:\/\/www.dnms.no\/index.php?seks_id=1493
\n47&treeRoot=147800&element=Subsek3&a=1
\n(accessed September 15, 2014)
\n15.\twww.eunethta.eu (accessed September 15,2014)
\n16.\thttp:\/\/ec.europa.eu\/health\/technology_assess-
\nment\/policy\/network\/index_en.htm (accessed
\nSeptember 15, 2014)
\n17.\thttp:\/\/www.eunethta.eu\/outputs (accessed Sep-
\ntember 15, 2014)
\n18.\thttp:\/\/www.eunethta.eu\/eunethta-guidelines
\n(accessed September 15, 2014)
\n19.\thttp:\/\/www.eunethta.eu\/sites\/5026.fedimbo.
\nbelgium.be\/files\/EUnetHTA%20JA2_Plenar-
\nyAssembly%202014_SummaryReport_FINAL.
\npdf (accessed September 15, 2014)
\n20.\tBerntgen M,\u00a0Gourvil A,\u00a0Pavlovic M,\u00a0Goettsch
\nW,\u00a0Eichler HG,\u00a0Kristensen FB. Improving the
\nContribution of Regulatory Assessment Re-
\nports to Health Technology Assessments-A
\nCollaboration between the European Medicines
\nAgency and the European network for Health
\nTechnology Assessment. Value Health. 2014
\nJul;17(5):634-41
\n21.\thttp:\/\/www.ema.europa.eu\/docs\/en_GB\/docu-
\nment_library\/Other\/2013\/11\/WC500154588.
\npdf (accessed September 15, 2014)
\n22.\thttp:\/\/www.eunethta.eu\/eunethta-stakeholder-
\nforum (accessed September 15, 2014)
\nProfessor Finn B\u00f8rlum Kristensen, MD, PhD
\nEUnetHTA Secretariat
\nDanish Health and Medicines Authority
\nFaculty of Health Sciences,
\nUniversity of Southern Denmark
\nAxel Heides Gade 1
\nDK-2300 Copenhagen S
\nTel: +45 7222 7400
\nDir: +45 7222 7727
\nMob: +45 20759647
\nE-mail: fbk@sst.dk
\nBACK TO CONTENTS
\n28 29
\nGERMANY\/LATVIAGERMANY\/LATVIA Medical EthicsMedical Ethics
\nBeneficial medical treatment is based on a
\ntrustful therapeutical relationship between
\ndoctor and patient. This does not just hap-
\npen by itself, but must be developed with
\ncompetence and maintained with care.
\nThrough the ages, the way doctors and
\npatients meet and interact has undergone
\nsubstantial changes, with every era posing
\nspecific challenges.
\nThe Patient:
\nhelp-seeking sufferer or
\ncritical consumer?
\nThe traditional view is strongly paternalistic.
\nBound to the Hippocratic oath, the fatherly
\nphysician is commited to the patient\u2019s well
\nbeing, his own best possible skills, personal
\nintegrity and privacy. \u201cSalus aegroti supre-
\nma lex\u201d (the well-being of the patient is the
\nsupreme law) and \u201cprimum nihil nocere\u201d
\n(first of all do not harm) are the principle
\nprofessional rules. As a benevolent father-
\nfigure, it is the doctor who decides.
\nEnlightment and The French Revolution
\nbrought about a fundamentally egalitarian
\napproach. Questioning authoritative rule
\neventually leads to the, nowadays, widely
\naccepted concepts of \u201cinformed consent\u201d
\nand \u201cshared decision making\u201d, promoting
\npatient competence and autonomy. Nego-
\ntiating disagreements becomes possible, the
\nprevention of abuse and exploitation of the
\nsubordinate easier. Instead of command and
\nobedience, two individuals with equal rights
\nmake a contract.And finally,it is the patient
\nwho decides.
\nSounds good, but where does this leave us?
\nThe egalitarian model is easily applied to
\nbuyer and seller at the marketplace, where
\nthe buyer looks for a certain product or ser-
\nvice and makes an informed decision after
\nhaving checked price and quality. But is a
\npatient\u2019s need for aid when in distress and
\ncrisis the same thing as buying a new vacu-
\num cleaner, a favourable mobile phone tarif
\nor an attractive spa package?
\nThe more fit a patient is, the more he is able
\nto act like a competent consumer. By means
\nof the internet he is sometimes better in-
\nformed about specific details than his doc-
\ntor. The greater a patient\u2019s distress however,
\nand the younger, older or more sick he is,
\nthe less important autonomous negotiating
\nmight be for him.
\nBetween doctor and patient, duties and
\nresponsibilities are shared in a very asym-
\nmetrical manner. Unlike the doctor, whose
\nhealth remains in a comfortable and safe
\nposition, the patient, may be in a situation
\nof life and death, his physical integrity in
\nquestion as well as having responsibilities
\nfor loved ones. So in everyday medical prac-
\ntice, a third option must often be consid-
\nered: The patient wants the doctor to decide
\nfor him.
\nThis doesn\u2019t make things easier, however.
\nThe doctor: trusted medic
\nor top salesman?
\nMedical doctors still hold a high social
\nstatus in public opinion polls and achieve
\nremarkable income levels. Enormous tech-
\nnical progress has added to the reputation
\nof the profession. Consequently, doctors
\nare confronted with high expectations by
\nsociety as a whole and by the individual
\npatient.
\nBut something has gone wrong. Numer-
\nous publications highlight serious deficits
\nin medical care, pointing to an increasing
\nmutual alienation between doctors and
\npatients. A gap of mistrust seems to have
\nopened. Patients have become cautious be-
\ncause they know or have heard of doctors
\nmotivated by pressure from their admin-
\nistrations and lured by bonus payments to
\nprescribe more expensive drugs, more lucra-
\ntive diagnostic interventions and higher-
\npriced surgical procedures; all potentially
\nharmful. Alternative medicine may seem
\nless of a hazard.
\nAt the same time, patients seem to be fight-
\ning back. We are seeing a surge in malprac-
\ntice and negligence suits, and many colleg-
\nues feel the pressure of receiving bad patient
\nratings in online portals.
\nTo heal the breach of trust,doctors must ac-
\ncount for the current state of medicine and
\nLost in Translation?
\nThe doctor-patient-relationship revisited
\nGunta Ancane Arturs AncansBernhard Palmowski
\ndecide which kind of medical care they ac-
\ntually prefer.
\nMedicine: human science
\nor technical engineering?
\nToday, academic medicine is going through
\na dramatic structural change which is char-
\nacterized by the rule of economy, bureau-
\ncracy and technology. Bernard Lown, re-
\nnowned cardiologist,compellingly describes
\nthe far-reaching consequences for everyday
\nmedical practice in his book \u201cThe lost art
\nof healing\u201d (1). We are confronted with a
\nradical erosion of human medicine in its
\noriginal sense. What is lost, is the specifi-
\ncally human element.
\nIt seems as if the trustful and sustainable
\ndoctor-patient-relationship has become a
\nside issue. In this way medicine is losing its
\nsoul and becoming a technical engineering
\ncraft. In addition, clinical procedures are
\noften Tayloristically elaborate, not only in
\noperating theaters, but wherever they are
\nperformed.
\nSuch a development is not without con-
\nsequences for the status of a profession in
\nsociety. By means of historical examples,
\nRichard Sennett describes the social decline
\nof once highly respected professions (as was
\nthe case with the potter profession in an-
\ncient Greece), which is caused by increasing
\ndominance of purely technical processes us-
\ning mainly manual labor (2).
\nIn this respect, it is highly alarming that
\npersonal and \u201ctalking medicine\u201d is increas-
\ningly outsourced to non-medical profes-
\nsions (pedagogues, psychologists, social
\nworkers, etc.). Alongside, and to the detri-
\nment of,Cardiology,Oncology or Diabetol-
\nogy we see the establishing of non-medical
\nPsycho-Cardiology, Psycho-Oncology or
\nPsycho-Diabetology. Instead of the present
\ntraditional family doctor, we might soon see
\na non-medical family therapist taking over
\nthe verbal and general counselling care.
\nThis split is something patients definitely do
\nnot want. It\u2019s simply of no use to a suffering
\npatient to have on the one side the medical
\nequivalent of a plumber or clockmaker to
\nrepair the broken engine and on the other
\nside a friendly talking psycho-conversation-
\npartner, who doesn\u2019t know any more about
\nthe subject matter at stake than the patient
\nhimself. After a myocardial infarction, with
\nthe diagnosis of breast cancer, or with a
\nthreatening somatoform symptom, a pa-
\ntient has a justified wish to be cared for by
\na doctor, who is both medically competent
\nand compassionate. It is an appallingly dis-
\ntressing experience for a patient, in a short
\nsession, to be fully informed, according to
\nall legal standards, about the diagnosis of,
\nfor example, malignant lymphoma by the
\nresponsible oncologist and then to be sent
\nafterwards to an appointment with a psy-
\ncho-oncologist to talk over the emotional
\nelements.
\nThe consequence of this is that frustrated
\npatients turn away from scientific medi-
\ncine, and unhappy doctors seek jobs outside
\nmedical care in research, counseling, jour-
\nnalism or administration.
\nPatients and doctors\u00a0\u2013
\nstrangers or friends?
\nIt makes a big difference if doctor and pa-
\ntient meet for the first time in an emergency
\nroom, strangers to one another, than if they
\nhad already had a couple of appointments in
\nthe assessment of rectal hemorrhage, if they
\ncollaborate on a regular basis in the treat-
\nment of rheumatic arthritis, or if they are
\neven engaged in a psychotherapy meeting
\nonce a week.
\nWhatever the setting, they face the de-
\nmanding task of establishing a trustful and
\nsustainable relationship. Coming from two
\nvery different worlds, the patient with his
\nsuffering, the medical problem and his psy-
\ncho-social history and the doctor with his
\nmedical expertise and the promise to help,
\nthey have to get acquainted with one anoth-
\ner in order to accomplish the common goal
\nof relief, or hopefully even healing.
\nNumerous challenges have to be met. The
\naverage conversation time in a personal
\ncontact between patient and doctor is said
\nto be less than ten minutes. After fifteen
\nseconds the patient\u2019s speech is interrupted,
\neither by the doctor\u2019s questions,or having to
\ncheck the computer monitor, or other tasks
\nsuch as filling in forms (3). Only half of the
\ninformation conveyed by the doctor is prop-
\nerly understood by the patient and half of
\nthis again forgotten after half an hour. It is
\nperfectly clear that medicine by the minute
\nleaves no room for sufficient understanding,
\nlet alone exchange.
\nThis is in strong contrast to the require-
\nments of adequate medical care and effi-
\ncient treatment.
\nThe psychosomatic approach
\nAbout ten percent of the urban population
\nsuffer from psychosomatic disorders, mostly
\nsomatoform disorders with functional so-
\nmatic syndromes accounting for the ma-
\njority (4). The prevalence in family doctor\u2019s
\npractices goes up to some thirty or forty
\npercent and reaches up to sixty percent in
\nsecondary care, e. g. specialised neurologi-
\ncal or gynecological units (5). The clinical
\nspectrum ranges from chronic pain syn-
\ndromes such as headache and back-pain, or
\nsyndromes with compromised organ func-
\ntion such as vertigo, tinnitus, arrythmias,
\nhyperventilation, irritable bowel or sexual
\ndysfunction, to more generalised pictures
\nsuch as agitation or burn-out (6). Psychoco-
\nmatic medicine considers the crucial role of
\nemotional factors in pathogenesis here.
\nIf speaking with a patient is considered im-
\nportant, then listening is indispensable. Be-
\ning in tune with the patient,applying the art
\nof careful active listening, means listening
\nwith the \u201cthird ear\u201d.This enables the doctor
\nBACK TO CONTENTS
\n30 31
\nUNATED STATES OF AMERICA Environmental HealthGERMANY\/LATVIAMedical Ethics
\nto understand subliminal, hidden messages
\nand to discover those problems the patient
\nis not yet able to communicate in an open
\nand direct manner. As Balint put it, if the
\npatient could clearly name his problem, he
\nwould not have to present a symptom (7).
\nPatients with psychosomatic disorders are
\nespecially difficult to deal with. Whereas
\n\u201cordinary\u201d patients might be expectant and
\nvulnerable, psychosomatic patients in par-
\nticular are additionally prone to feeling dis-
\nappointed, insulted, hurt and abandoned by
\ntheir doctor. Often limited in their abilities
\nto adequately express their fears and wishes,
\nthey make their medical counterpart offer
\nhelp by proposing medical actions in the
\nform of prescribing drugs, suggesting addi-
\ntional diagnostic procedures or even recom-
\nmending surgical interventions.
\nDoctors do so especially when confronted
\nwith affect-laden signals from their pa-
\ntients, for example, when confronted with
\nstatements like, \u201cDoctor, I can\u2019t stand this
\nback pain anymore\u201d, \u201cmy head is burn-
\ning like fire\u201d, or, \u201cthis tears my heart into
\npieces\u201d. Overstrained and overwhelmed by
\nthe patient\u2019s relational attitude it seems a
\nway out is to at least present a medical \u201cgift\u201d
\n(8). \u201cUt aliquid fiat\u201d (to do something) may
\nbe one of the most frequent indications in
\nmedicine. As one collegue put it, \u201csending
\nthat patient to another CT-scan bought
\nme one month of peace and quiet\u201d. This
\nexample shows that doctors, in their des-
\nperation, sometimes reject their patients
\nby sending them to unnecessary examina-
\ntions or referring them to another colleague.
\nIf in the back of the patients mind is the
\nnotion that evidence based medicine can-
\nnot understand their suffering and is even
\nrejecting them, then alternative medicines
\ngain appeal, which is a dangerous trend if
\nleft unchecked.
\nIn order to offer these patients adequate
\ncare, skills and knowledge in understand-
\ning and handling patients, emotionally dif-
\nficult for the doctor, are necessary. Doctors\u2019
\nwidespread wish to offer comprehensive
\nhelp, including somatic and psycho-social
\nsupport, is specifically realized in Psycho-
\nsomatic Medicine. Apart from specialist
\ntraining, there are several opportunities.
\nBalint-groups and courses in primary psy-
\nchosomatic care are especially helpful for
\nevery physician responsible for medical
\ncare, whether it be conservative medicine or
\nsurgery.
\nAs Edward Weiss wrote in 1943, the crucial
\npoint in psychosomatics is \u201cnot to study the
\nsoma less; it only means to study the psyche
\nmore\u201d (9).
\nReferences
\n1.\t Lown B. The Lost Art of Healing. Houghton
\nMifflin. 1996
\n2.\t Sennett R.The Craftsman.Yale University Press.
\n2009
\n3.\t B\u00e4r T. Die spontane Gespr\u00e4chszeit von Pa-
\ntienten zu Beginn des Arztgespr\u00e4chs in der
\nhaus\u00e4rztlichen Praxis. Dissertation, Charit\u00e9
\n2009
\n4.\t Schepank H: Epidemiology of Psychogenic
\nDisorders: The Mannheim Study \u00b7 Results of a
\nField Survey in the Federal Republic of Germa-
\nny.Heidelberg,New York,London,Paris,Tokyo:
\nSpringer 1987.
\n5.\t Nimnuan C, Hotopf M, Wessely S. Medically
\nunexplained symptoms. An epidemiological
\nstudy in seven specialities. Journal of Psychoso-
\nmatic Research, 2001, Volume 51, Issue 1, 361-
\n367
\n6.\t Henningsen P, Zipfel S, Herzog W. Manage-
\nment of functional somatic syndromes. Lancet.
\n2007 Mar 17;369(9565):946-55.
\n7.\t Balint, M.The doctor, his patient and the illness.
\nLondon, Edinburgh Churchill Livingstone.
\n1957.
\n8.\t Ring A, Dowrick C, Humphris G, Salmon P.
\nDo patients with unexplained physical symp-
\ntoms pressurise general practitioners for so-
\nmatic treatment? A qualitative study. BMJ
\n2004;328:1057
\n9.\t Weiss E. Psychosomatic Aspects of Allergic
\nDisorders. Bull N Y Acad Med. 1947 Nov;
\n3(11): 604\u2013630.
\nProf. Dr. med. Gunta Ancane,
\nRiga Stradi\u0146\u0161 University, Department of
\nPsychosomatic medicine and psychotherapy;
\nDr. med. Bernhard Palmowski,
\nAkademie f\u00fcr Psychosomatische Medizin und
\nPsychotherapie Berlin;
\nDr. Arturs Ancans,
\nRiga Stradi\u0146\u0161 University, Department of
\nPsychosomatic medicine and psychotherapy
\nChronic Kidney Disease (CKD) is a grow-
\ning public health issue around the globe,
\nespecially as CKD leads to end-stage renal
\ndisease (ESRD) which is both very diffi-
\ncult and costly to treat [1,2]. In the West,
\nCKD has been predominantly tied to an-
\nalgesic use and the increasing prevalence of
\ndiabetes and hypertension. However, less
\nattention has been given to environmental
\nexposures as factors in the development of
\nCKD, which may play a larger role in the
\ndeveloping world [3].
\nMany parts of the developing world such as
\nSri Lanka [1], Central America [4], India
\n[5] and Egypt [6] are experiencing epidem-
\nics of CKD of unknown origin (CKDu).
\nThis article presents an overview of the epi-
\ndemiological and postulated etiologies for
\nthe under-recognized epidemic of CKD in
\nCentral America and Sri Lanka, two of the
\nmajor regions of activity.
\nCentral America
\nFor the past two decades in Central Amer-
\nica, many young men of working age have
\nfallen victim to a form of chronic kidney
\ndisease of unknown origin-in fact a silent
\nepidemic has taken hold [4,7, 8, 9, 10, 11].
\nCKDu in this context has been given the
\nname \u2018Mesoamerican Nephropathy,\u2019 or
\nMeN.
\nWhile exact figures are unavailable, the
\nlikely death toll is at least 20,000 [4]. El
\nSalvador, surprisingly, has the highest
\noverall mortality from kidney disease in
\nthe world, and CKD is the second lead-
\ning cause of death among men of working
\nage in that country [10, 12]. Nicaragua and
\nHonduras are also in the top ten coun-
\ntries in the world with the highest overall
\nmortality from kidney disease [12]. While
\ndata on incidence is lacking, studies have
\nrevealed a markedly elevated prevalence
\ndespite poor survival after diagnosis (renal
\nreplacement therapies are inaccessible and
\nprohibitively expensive for the majority of
\nvictims), indicating that the epidemic is
\nprogressing rapidly [4].
\nEarly unpublished studies and mortality
\ndata from this region indicated that men
\nworking along the Pacific coast were experi-
\nencing a non-proteinuric chronic renal dis-
\nease to a much greater extent than workers
\nin other parts of their respective countries
\n[7, 8]. For example, the mortality rate for
\nmales in the coastal departments of Le\u00f3n
\nand Chinandega in Nicaragua are three
\ntimes higher than the department at the
\nnext highest elevation and five times higher
\nthan the national average [4].
\nDespite the important public health im-
\nplications of such an epidemic, there have
\nbeen relatively few studies published on
\nthe epidemic of CKD in Central America
\n[4]. Most of these studies have been cross-
\nsectional prevalence studies: measuring se-
\nrum creatinine to determine renal function
\nand\/or administering questionnaires to
\nascertain medical, occupational, and envi-
\nronmental exposures [13, 14, 15, 16, 17].
\nWhile cross-sectional studies have limita-
\ntions, such as recall bias and the inability
\nto determine causality or incidence, the
\nstudies that have been conducted all con-
\nfirm that an epidemic of CKD is underway
\namong residents of the Central American
\nPacific coastline, especially among young
\nmen working in agriculture, such as in sug-
\narcane production [4].
\nTorres et al. conducted one of the largest of
\nthese cross-sectional studies [14]. They ex-
\namined men and women aged 20\u201360 years
\nin five villages in Northwest Nicaragua,
\nwhich varied by industry and elevation.
\nOverall, 14% of men and 3% of women
\nexhibited decreased kidney function (es-
\ntimated glomerular filtration rate [eGFR]
\n<60ml\/min per 1.73m2). In the United\nStates, on the other hand, the prevalence of\neGFR <60 in both men and women aged\n20-59 years is approximately 1% [19].Tor-\nres et al. also found villages at lower eleva-\ntions (e.g. 100-300m vs. 200-675m) and\nwhere the industry was mining or agricul-\nture (e.g. banana or sugarcane) were most\nimpacted.\nThe \u201cusual suspects\u201d for CKD-pre-existing\ndiabetes and hypertension-are largely ab-\nsent in this epidemic [4, 15, 17]. The cross-\nsectional studies, through medical record\nreview, clinician interviews, biological sam-\npling, and questionnaires, have uniformly\nconcluded that the epidemic of MeN can-\nnot be attributed to these factors [4, 14, 20,\n21, 22, 23]. There is also little evidence to\nimplicate nephrotoxic metals, such as cad-\nmium or lead [4].\nThere are a myriad of environmental, oc-\ncupational, and behavioral factors to which\nthe affected population may be highly ex-\nposed and which can cause renal damage,\nhowever these are not known to be associ-\nated with CKD in particular or to such an\nextent [4].These factors are: strenuous labor\nin hot conditions leading to chronic de-\nhydration, medications (e.g. non-steroidal\nanti-inflammatories, analgesics, or amino-\nglycosides), infection (e.g. leptospirosis),\narsenic, and agrochemicals (e.g. pesticides).\nOne theory postulates that an initial injury\ndamages the kidneys, but one or more ad-\nditional factors trigger the progression to\nCKD [24]. Thus MeN may result from a\n\u201cmultifactorial synergistic mechanism\u201d [4].\nEvidence that initial kidney damage may\nbe occurring at an early age comes from a\npilot study, which found a similar pattern of\nelevated biomarkers of tubular kidney dam-\nage among adolescents without prior work\nChronic Kidney Disease of Unknown Origin\nin Central America and Sri Lanka\nBACK TO CONTENTS\n32 33\nEnvironmental Health Environmental HealthUNATED STATES OF AMERICAUNATED STATES OF AMERICA\nhistory in areas with high adult CKD mor-\ntality [23].\nElucidating the cause(s) of the MeN epi-\ndemic will require investigating many po-\ntential risk factors as well as considering\na \u201cpreviously undescribed mechanism ca-\npable of causing CKD\u201d [4]. As discussed\nbelow, both substantial public health and\nclinical efforts will be needed to tackle\nthis problem now, even without conclusive\nevidence regarding the causes of the epi-\ndemic.\nSri Lanka\nSince the early 1990s, many studies have\ndocumented an increasing prevalence of\nChronic Kidney Disease of unknown eti-\nology (CKDu) in Sri Lanka [2]. CKDu\nis defined as chronic kidney disease, usu-\nally diagnosed based on evidence of mi-\ncroalbuminuria, that is present without\nprior history of diabetes, hypertension,\nor other renal disease [3]. Epidemiologic\ndata has helped trace most of these cases\nto a region known as the North Central\nProvince, a relatively dry region in the\ninterior of the country with a heavy reli-\nance on irrigation systems for agriculture\n[2]. In this region, the point prevalence\nof CKDu has been estimated at 2-3%, a\nfigure which is likely underreported [25].\nOther reports have estimated a prevalence\nof 5.1% based on microalbuminuria [1].\nWidely quoted figures in the lay press state\nthe death toll as high as 20,000, more 200-\n450,000 currently affected [26]. Patients\ntypically affected included young males,\ngenerally from farming communities with\nlow-socioeconomic status. The affected\npopulation has be found to have a higher\nprevalence of microalbuminuria, as well as\npathologic findings including tubular atro-\nphy, mononuclear interstitial cell infiltra-\ntion and tubular fibrosis [27,28]. Disease\nprogression is greater in men than women,\nwith disparities in prevalence widening in\nstage 3 and 4 CKDu [3]. Numerous fac-\ntors have been proposed to account for the\ndevelopment of CKDu in this population,\nincluding herbal medications, snakebites,\ngenetic predisposition, and more common\ncauses of CKD such as diabetes mellitus\nand hypertension. However, the majority\nof the evidence in Sri Lanka points to en-\nvironmental exposures as a major contrib-\nuting factor to the increased prevalence of\nCKDu [29, 30].\nPotential environmental exposures in this\ncommunity are varied, and include heavy\nmetals, pesticides, contaminated well wa-\nter as well as food-borne mycotoxins and\nair pollution [3]. Due to the agrarian na-\nture of the North Central Province, most\nstudies focused on potential heavy metal\nand pesticide exposure from soil, well wa-\nter, irrigation channels, and locally grown\nfoods. This was supported by early studies\nshowing that microalbuminuria in the lo-\ncal population was associated with drink-\ning well water from agricultural fields.\nMany studies pointed to cadmium, and to\na lesser extent arsenic, as the likely cause of\nCKDu due to their nephrotoxic properties\nand elevated readings in well water [27].\nA recent case-control study analyzed urine,\nhair and serum for presence of heavy met-\nals such as cadmium, lead and arsenic as\nwell as numerous common pesticides. Sta-\ntistically significant elevations in cadmium\nlevels were found in the urine and nails of\ncases versus controls. In fact, urine cad-\nmium levels corresponded with severity of\nCKDu on a dose-response basis. Arsenic\nlevels were also significantly elevated in the\nurine and nails of cases compared to con-\ntrols. Finally, various pesticides were found\nin cases at levels well above reference levels\n[3]. Results regarding the source of these\nexposures were mixed. While initial stud-\nies found elevated cadmium levels in well\nwater, more recent studies have shown\ncadmium levels to be within normal limits\n[3,27]. However, elevated levels of cadmi-\num and arsenic were found in local foods,\nprimarily vegetables and fish, as well as the\nsoil [3,30]. It is postulated that these heavy\nmetals are primarily entering the food\nchain from unregulated use of pesticides\n(and possibly fertilizers).\nAs discussed above, evidence of CKDu in\nother regions such as Central America and\nthe Balkans is leading to greater awareness\nof the role local environmental factors play\nin development of kidney disease [20, 31].\nWhile the case in Sri Lanka is different\nin that heavy metals seem to be playing a\nmore significant role in the development\nof CKDu, there are some commonalities.\nStudies have found evidence that, as in\nCentral America, agricultural work in the\nhot climate of Sri Lanka leads to dehydra-\ntion, which may be exacerbating the toxic\neffects of heavy metals and agrochemicals\n[14, 27]. It is possible that increasing hydra-\ntion and improving access to clean drinking\nwater may be able to prevent or slow the\nprogression of CKDu in both Sri Lanka\nand Central America [3, 27].\nIn those already afflicted with CKDu, stud-\nies have found that the presence of comor-\nbidities hastens disease progression, espe-\ncially in men. A prospective cohort study\nfrom the North Central Province found that\ncomorbid hypertension was significantly as-\nsociated with disease progression, especially\nin men [32]. It is possible that treatment of\nhypertension and other comorbidities may\nslow progression, however this is yet to be\nshown.\nWhile much of the research to date has\npointed to environmental heavy metal expo-\nsure as,at the very least,a major factor in the\ndevelopment of CKDu, there are still many\nquestions remaining. It is widely speculated\nthat most heavy metal exposure comes from\nagrochemical use, but the exact nature of\nthe exposure has not been definitely proven.\nIt is also unclear what role genetics, comor-\nbidities and other environmental factors are\nplaying in the development and progression\nof CKDu. Recent studies have shown that\nfactors as variable as mycotoxin exposure,\nthe mineral content of drinking water and\ngenetic predisposition to the development\nof CKDu may play a significant a role in\nthe development of CKDu, showing that\nthere is much more to be learned about this\ndisease process and that little has been de-\nfinitively proven [2, 33, 34].\nWhat is Being Done from a\nPublic Health Standpoint?\nPublic health responses cannot wait until\nthe mysteries are conclusively solved. The\ngovernments of El Salvador and Sri Lanka\nhave taken steps to address the issue.For ex-\nample,the Sri Lankan government has been\nworking with WHO and in-country part-\nners to improve surveillance and care for the\naffected population [35]. The Sri Lankan\ngovernment is also considering measures\nto reduce environmental exposure to ag-\nrochemicals. The Ministry of Health of El\nSalvador successfully spearheaded the effort\nto have MeN prioritized as a major health\nconcern by the Pan American Health Or-\nganization and the Council of Ministries\nof Central America [4]. In October 2013,\nPAHO passed a resolution formally rec-\nognizing MeN as a serious threat to public\nhealth and called on member states to con-\nduct research on the disease and strengthen\noccupational and environmental health pro-\ngrams.\nProminent researchers into the epidemic\nof MeN\/CKDu have called for the follow-\ning actions to halt its progression:\n\u2003 1)\u2002\u0007improve surveillance systems to deter-\nmine incidence and causative factors\n\u2003 2)\u2002\u0007develop and implement preventive\nstrategies for putative causes\n\u2003 3)\u2002\u0007increase compliance and enforcement\nof existing laws regulating agrochemi-\ncal use\n\u2003 4)\u2002\u0007strengthen healthcare systems to im-\nprove delivery of primary care and re-\nnal replacement therapies and\n\u2003 5)\u2002\u0007develop evidence-based CKD guide-\nlines and education tailored to each\ncountry [4, 36].\nWhat can be Done from\na Clinical Standpoint?\nClinicians in these regions should be aware\nof the heightened prevalence of chronic kid-\nney disease, especially among young males\nworking in agriculture. Though proposed\netiologies vary by country,physicians should\nstill note the patient\u2019s occupation, risk fac-\ntors (level of exertion in hot conditions,\nhydration status, exposure to heavy met-\nals and agrochemicals, etc.). Patients that\nmeet multiple criteria could then be fur-\nther evaluated for the presence of albumin\nor protein in the urine with urine dipstick.\nPatients found to be at risk for development\nof CKD may then need to be counseled on\nthe hazards posed by their occupations and\nreferred for further care as necessary.\nAcknowledgements: Assistance provided\nby Dr. Peter Orris, Chief, Occupational and\nEnvironmental Medicine with this report\nwas greatly appreciated.\nReferences\n1.\t Athuraliya, N. T. C., Abeysekera, T. D. J.,\nAmerasinghe, P. H., Kumarasiri, R., Bandara,\nP., Karunaratne, U., \u2026 Jones, A. L. (2011).\nUncertain etiologies of proteinuric-chronic\nkidney disease in rural Sri Lanka. Kidney In-\nternational, 80(11), 1212\u20131221. doi:10.1038\/\nki.2011.258\n2.\t Jayasekara, J.M.K.B., Dissanayake D.M., Adhi-\nkari, S.B., Bandara, P. (2013). Geographical\ndistribution of chronic kidney disease of un-\nknown origin in North Central Region of Sri\nLanka.Ceylon Medical Journal,58(1),6-10.doi:\n10.4038\/cmj.v58i1.5356\n3.\t Jayatilake, N., Mendis, S., Maheepala, P., Me-\nhta, F.R. (2013). Chronic kidney disease of\nuncertain aetiology: prevalence and causative\nfactors in a developing country. Biomed Cen-\ntral Nephrology, 14:180, doi:10.1186\/1471-\n2369-14-180\n4.\t Ramirez-Rubio, O., McClean, M. D., Amador,\nJ. J., & Brooks, D. R. (2013). An epidemic of\nchronic kidney disease in Central America: an\noverview. Journal of Epidemiology and Com-\nmunity Health, 67(1), 1\u20133. doi:10.1136\/jech-\n2012-201141\n5.\t Machiraju,R.Y.,Gowrishankar,S.,Edwards,K.,\nAttaluri, S., Miller, F., Grollman, A., & Dick-\nman, K. (2009). Epidemiology of Udhanam\nEndemic Nephropathy. Journal of American\nSociety of Nephrology, 20.\n6.\t Kamel, E., & El-Minshawy, O. (2010). Envi-\nronmental factors incriminated in the develop-\nment of end stage renal disease in El-Minia\nGovernate, Upper Egypt. International Journal\nof Urology and Nephrology, 2, 431\u20137.\n7.\t Cuadra, S. J., Hogstedt, C., & Wesseling, C.\n(2006). Chronic Kidney Disease: assessment of\ncurrent knowledge and feasibility for regional\nresearch collaboration in Central America (No.\n2). SALTRA. Retrieved from http:\/\/www.\nsaltra.una.ac.cr\/images\/SALTRA\/Documen-\ntacion\/SerieSaludTrabajo\/seriesaludytrabajo2.\npdf\n8.\t Brooks, D. (2009). Final Scoping Study Re-\nport: Epidemiology of Chronic Kidney Dis-\nease in Nicaragua. Boston University School\nof Public Health. Retrieved from http:\/\/www.\ncao-ombudsman.org\/cases\/document-links\/\ndocuments\/03H_BU_FINAL_report_scopes-\ntudyCRI_18.Dec.2009.pdf\n9.\t Trabanino, R. G., Aguilar, R., Silva, C. R., Mer-\ncado,M.O.,& Merino,R.L.(2002).[End-stage\nrenal disease among patients in a referral hos-\npital in El Salvador]. Revista panamericana de\nsalud p\u00fablica = Pan American journal of public\nhealth, 12(3), 202\u2013206.\n10.\tMinistry of Public Health and Social Assistance,\nEl Salvador. (2009). De que se mueren y enfer-\nman los salvadorenos? Memoria de Labores\n2009-2010, 24\u201330.\n11.\tCerdas, M. (2005). Chronic kidney disease\nin Costa Rica. Kidney International. Sup-\nplement, (97), S31\u201333. doi:10.1111\/j.1523-\n1755.2005.09705.x\n12.\tWHO. (2008). Global burden of disease. 2008.\nDisease and injury country estimates. World\nHealth Organization. Retrieved from http:\/\/\nwww.who.int\/healthinfo\/global_burden_dis-\nease\/estimates_country\/en\/index.html\n13.\tLaux, T. S., Bert, P. J., Barreto Ruiz, G. M.,\nGonz\u00e1lez, M., Unruh, M., Aragon, A., & Torres\nLacourt,C.(2012).Nicaragua revisited: evidence\nof lower prevalence of chronic kidney disease in\na high-altitude, coffee-growing village. Journal\nof Nephrology, 25(4), 533\u2013540. doi:10.5301\/\njn.5000028\n14.\tTorres, C., Arag\u00f3n, A., Gonz\u00e1lez, M., L\u00f3pez,\nI., Jakobsson, K., Elinder, C.-G., \u0085 Wesseling,\nC. (2010). Decreased kidney function of un-\nknown cause in Nicaragua: a community-based\nBACK TO CONTENTS\n34 35\nEnvironmental Health UNATED STATES OF AMERICA\nsurvey. American Journal of Kidney Diseases:\nThe Official Journal of the National Kidney\nFoundation, 55(3), 485\u2013496. doi:10.1053\/j.\najkd.2009.12.012\n15.\tO\u2019Donnell, J. K., Tobey, M., Weiner, D. E.,\nStevens, L. A., Johnson, S., Stringham, P., \u2026\nBrooks, D. R. (2011). Prevalence of and risk\nfactors for chronic kidney disease in rural Nica-\nragua. Nephrology, Dialysis, Transplantation:\nOfficial Publication of the European Dialysis\nand Transplant Association\u00a0 \u2013 European Renal\nAssociation, 26(9), 2798\u20132805. doi:10.1093\/\nndt\/gfq385\n16.\tGracia-Trabanino, R., Dom\u00ednguez, J., Jans\u00e0,\nJ. M., & Oliver, A. (2005). [Proteinuria and\nchronic renal failure in the coast of El Salvador:\ndetection with low cost methods and associated\nfactors]. Nefrolog\u00eda: publicaci\u00f3n oficial de la So-\nciedad Espa\u00f1ola Nefrologia, 25(1), 31\u201338.\n17.\tOrantes, C. M., Herrera, R., Almaguer, M.,\nBrizuela, E. G., Hern\u00e1ndez, C. E., Bayarre, H.,\u0085\nCastro, B. E. (2011). Chronic kidney disease and\nassociated risk factors in the Bajo Lempa region\nof El Salvador: Nefrolempa study, 2009. ME-\nDICC Review, 13(4), 14\u201322.\n18.\tSanoff, S. L., Callejas, L., Alonso, C. D., Hu,\nY., Colindres, R. E., Chin, H., \u2026 Hogan, S. L.\n(2010). Positive association of renal insufficiency\nwith agriculture employment and unregu-\nlated alcohol consumption in Nicaragua. Renal\nFailure, 32(7), 766\u2013777. doi:10.3109\/088602\n2X.2010.494333\n19.\tLevey, A. S., Stevens, L. A., Schmid, C. H.,\nZhang, Y. L., Castro, A. F., 3rd, Feldman, H. I.,\n\u2026 CKD-EPI (Chronic Kidney Disease Epide-\nmiology Collaboration). (2009). A new equation\nto estimate glomerular filtration rate. Annals of\nInternal Medicine, 150(9), 604\u2013612.\n20.\tPeraza, S., Wesseling, C., Aragon, A., Leiva, R.,\nGarc\u00eda-Trabanino, R. A., Torres, C., \u0085 Hogstedt,\nC. (2012). Decreased kidney function among\nagricultural workers in El Salvador. American\nJournal of Kidney Diseases: The Official Jour-\nnal of the National Kidney Foundation, 59(4),\n531\u2013540. doi:10.1053\/j.ajkd.2011.11.039\n21.\tAschengrau, A., Brooks, D., McSorley, E., Rief-\nkohl, A., Applebaum, K., Amador, J., & Ram-\nirez-Rubio,O.(2012).Cohort pilot study report:\nevaluation of the potential for an epidemiologic\nstudy of the association between work practices\nand exposure and chronic kidney disease at the\nIngenio San Antonio (Chichigalpa, Nicara-\ngua). Boston, MA: Boston University School of\nPublic Health. Retrieved from http:\/\/www.cao-\nombudsman.org\/cases\/document-links\/docu-\nments\/BU_CohortPilotStudyReport_Jan2012_\nENGLISH.pdf\n22.\tMcClean, M., Amador, J., Laws, R., Kaufman,\nJ., Weiner, D., Sanchez Rodriguez, J., \u2026 Brooks,\nD. (2012). Biological Sampling Report: Investi-\ngating biomarkers of kidney injury and chronic\nkidney disease among workers in Western Nica-\nragua. Boston, MA: Boston University School\nof Public Health. Retrieved from http:\/\/www.\ncao-ombudsman.org\/cases\/document-links\/\ndocuments\/Biological_Sampling_Report_\nApril_2012.pdf\n23.\tRamirez-Rubio, O., Brooks, D., Amador, J.,\nKaufman, J., Weiner, D., Parikh, C., \u2026 Laws, R.\n(2012). Biomarkers of early kidney damage in\nNicaraguan adolescents September-November\n2011. Boston, MA: Boston University School\nof Public Health. Retrieved from http:\/\/www.\ncao-ombudsman.org\/cases\/document-links\/\ndocuments,\n24.\tAdolescentReportJune252012.pdf\n25.\tBrooks, D. R., Ramirez-Rubio, O., & Amador,\nJ. J. (2012). CKD in Central America: a hot\nissue. American Journal of Kidney Diseases:\nThe Official Journal of the National Kidney\nFoundation, 59(4), 481\u2013484. doi:10.1053\/j.\najkd.2012.01.005\n26.\tChandrajith, R., et. al. (2011) Chronic kidney\ndisease of uncertain etiology (CKDue): geo-\ngraphic distribution and environmental implica-\ntions. Environmental Geochemistry and Health,\n33(3),267-278.doi:10.1007\/s10653-010-9339-1\n27.\tChatterjee, R. (2012, September 18). Sri lanka\nkidney disease blamed on farm chemicals. Brit-\nish Broadcasting Company\n28.\tWanagusuriya, K.P., Peiris-John, R.J., Wickre-\nmasinghe, R. (2011). Chronic kidney disease of\nuncertain aetiology in Sri Lanka: is cadmium a\nlikely cause? Biomed Central Nephrology,12:32,\ndoi: 10.1186\/1471-2369-12-32\n29.\tWijetunge, S., Ratnatunga, N.V., Abeysekara,\nD.T., Wazil, A.W., Selvarajah, M., Ratnatunga,\nC.M. (2013). Retrospective analysis of renal his-\ntology in asymptomatic patients with probable\nchronic kidney disease of unknown aetiology\nin\u00a0 Sri Lanka. Ceylon Medical Journal, 58(4),\n142-147. doi: 10.4038\/cmj.v58i4.6304.\n30.\tWanagusuriya, K.P., Peiris-John, R.J., Wick-\nremasinghe, R., Hittarage, A. (2007). Chronic\nrenal failure in North Central Province of Sri\nLanka: an environmentally induced disease.\nTransactions of the Royal Society of Tropical\nMedicine and Hygiene, 101(10), 1013-1017.\n31.\tBandara, J.M., Senevirathna, D.M., Dasanay-\nake, D.M., Herath,V., Abeysekara,T., Rajapak-\nsha, K.H. (2008). Chronic renal failure among\nfarm families in cascade irrigation systems in\nSri Lanka associated with elevated dietary\ncadmium levels in rice and freshwater fish\n(Tilapia). Environmental Geochemistry and\nHealth, 30(5), 465-478. doi: 10.1007\/s10653-\n007-9129-6\n32.\tStefanovich, V., Polenakovic, M. (2009). Fifty\nyears of research in Balkan endemic nephropa-\nthy: where are we now? Nephron. Clinical Prac-\ntice, 112(2), 51-56, doi: 10.1159\/000213081\n33.\tSenevirathna, L. et. al. (2012). Risk factors as-\nsociated with disease progression and mortality\nin chronic kidney disease of uncertain etiology:\na cohort study in Medawachchiya, Sri Lanka.\nEnvironmental Health and Preventive Medi-\ncine, 17(3), 191-198. doi: 10.1007\/s12199-011-\n0237-7\n34.\tNanayakkara, S., et. al. (2013). An Integrative\nStudy of the Genetic, Social and Environmental\nDeterminants of Chronic Kidney Disease Char-\nacterized by Tubulointerstitial Damages in the\nNorth Central Region of Sri Lanka. Journal of\nOccupational Health (Japan), advance publica-\ntion.\n35.\tRedmon, J. H., Elledge, M. F., Womack, D.\nS., Wickremashinghe, R., Wanigasuriya, K. P.,\nPeiris-John, R. J., ... & Levine, K. E. (2014).\nAdditional perspectives on chronic kidney\ndisease of unknown aetiology (CKDu) in Sri\nLanka-lessons learned from the WHO CKDu\npopulation prevalence study.\u00a0 BMC nephrol-\nogy,\u00a015(1), 125.\n36.\tWHO, country office for Sri Lanka. (n.d.).\nChronic kidney disease of unknown aetiology\n(CKDu): a new threat to health (newsletter).\nRetrieved from http:\/\/www.searo.who.int\/Link-\nFiles\/News_Letters_CKDu.pdf\n37.\tThe epidemic of chronic kidney disease in\nCentral America. Pedro Ordunez, Carla Sae-\nnz, Ram\u00f3n Martinez, Evelina Chapman, Lu-\ndovic Reveiz, Francisco Becerra The Lancet\nGlobal Health\u00a0 - 1 August 2014 (Vol. 2, Issue\n8, Pages e440-e441). DOI: 10.1016\/S2214-\n109X(14)70217-7.\nSumeet Batra MD, and Ana Nobis MD,\nMPH, University of Illinois Hospital\nand Health Sciences System, Occupational\nand Environmental Medicine 835 S.\nWolcott St, MC684, Chicago, Il 60615\nOver the last five years, a new genera-\ntion of trade agreement negotiations\nhas emerged with the purported goal\nof increasing economic growth [2]. The\nTrans Pacific Partnership (TPP), Trans-\natlantic Trade & Investment Partnership\n(TTIP), Comprehensive Economic and\nTrade Agreement (CETA) and Trade\nin Services Agreement (TiSA) negotia-\ntions seek to further trade liberalization\nwhile establishing a new global gover-\nnance framework for trade beyond exist-\ning World Trade Organization structures.\nThese deals have the potential to (re)\nshape public health and health care glob-\nally [1] with significant implications for\nefforts to address health inequities and\nthe social determinants of health [4-8],\nwhich are both emerging priorities of the\nWorld Medical Association [97].\nMore than fifty countries, representing\nmore than half of the global GDP, are\ncurrently engaged in this new generation\nof trade negotiations. The effects of these\nagreements, however, are not likely to be\nlimited to countries currently participating\nin negotiations. Many non-participating\ncountries have sought or are seeking to\njoin negotiations. Moreover, the U.S.Trade\nRepresentative has repeatedly signaled that\nthese agreements are being negotiated as a\n\u201ctemplate\u201d for all future trade agreements\n[2], suggesting that these negotiations may\nhave truly global ramifications.\nAnnounced in 2008 and launched in 2010,\nTPP negotiations currently include twelve\nparties: Australia, New Zealand, Singapore,\nBrunei, Malaysia, Japan, Peru, Chile, Mexi-\nco, the United States and Canada.The TPP\nmandate is broad with twenty-nine plus\nchapters across economic sectors.\nLaunched in 2013, TTIP negotiations cur-\nrently include the European Union and\nUnited States. Similar to the TPP, the TTIP\nhas a broad mandate with implications across\neconomic sectors. Although models and es-\ntimates vary, the TTIP has been projected\nto result in up to a 0.5 percent increase in\nthe European GDP with similar projections\navailable for the US economy. In the case\nof the TTIP, up to 80% of these gains are\nprojected to be attributable to reductions in\nnon-tariff trade barriers, suggesting that the\nbulk of projected benefits would be a result of\n\u201cregulatory harmonisation\u201d[9].\nSimilar in character and scope to the TPP\nandTTIP,CETA negotiations included only\nBeyond Chlor H\u00fchner & N\u00fcrnberger Bratw\u00fcrste:\nThe Case for Physician & Organized Medical Advocacy\nto Promote Health in Trade Agreement Negotiations\nMedical Advocacy\nBACK TO CONTENTS\n36 37\nthe European Union and Canada. CETA\nnegotiations concluded in 2014, and the deal\nis currently awaiting ratification [10].\nThe Trade in Services Agreement (TiSA)\nnegotiations include twenty-three parties:\nAustralia, Canada, Chile,Taiwan, Colombia,\nCosta Rica, the EU, Hong Kong, Iceland,\nIsrael, Japan, Korea, Liechtenstein, Mexico,\nNew Zealand, Norway, Pakistan, Panama,\nParaguay, Peru, Switzerland, Turkey and the\nU.S. While the scope of TiSA negotiations\nmay be somewhat different as compared to\nTPP, TTIP & CETA, TiSA negotiations\nhave enormous potential to affect health\ncare services.Leaked documents suggest that\nTiSA may seek to realize the \u201cuntapped po-\ntential\u201d for the \u201cglobalization of healthcare\nservices\u201d [11]. However, very limited infor-\nmation is available about the status, scope\nand direction of TiSA negotiations.\nTransparency\nPublic access to negotiating drafts and\nnegotiators has been limited. There are no\npublicly available draft texts and restrict-\ned stakeholder access during negotiating\nrounds. Civil society has been forced to rely\non leaked documents unofficial leaked doc-\numents and rumors. This lack of transpar-\nency hinders civil society engagement and\npublic scrutiny.\nInvestor-State Dispute\nSettlement\nInvestor State Dispute Settlement (ISDS)\nprovisions could have profound, cross-\ncutting implications for health, health care\nand the social determinants of health. ISDS\nprovides a mechanism for investors to bring\nclaims against governments and seek com-\npensation for damages and potential loss of\nprofit.Thus, ISDS allows multinational cor-\nporations to challenge laws and regulations\nthat threaten their interests outside of exist-\ning legal systems of accountability.\nISDS provisions smaller scale trade agree-\nments over the last few decades have been\nused to challenge evidence-based public\nhealth laws, such as tobacco control mea-\nsures in Uruguay [12]. According to United\nNations Conference on Trade and Devel-\nopment (UNCTAD) data, there have been\nmore than 500 ISDS cases brought against\ngovernments under existing agreements. Of\nthese cases, approximately 57% have either\nbeen settled outside of court (at the expense\nof the state) or adjudicated in favor of the\ninvestor [13]. This demonstrates the power\nthat ISDS as a mechanism has to advance\ncorporate interests over health. In addi-\ntion, there is some evidence to suggest that\nthe availability of ISDS may deter govern-\nment from enacting laws and regulations\nthat may be challenged by investors [3]. By\nlimiting the ability of governments to adopt\nand implement policies to protect and ad-\nvance health, ISDS may have harmful in-\ntersectoral impacts that result in numerous\npublic health consequences, in areas such as\ntobacco control, alcohol control, regulation\nof obesogenic food and beverages, access to\nmedicines, health care services, the health\nprofessional workforce, environmental pro-\ntection and climate change regulation and\noccupational and environmental health\n[14,77].\nNoncommunicable Diseases:\nTobacco,Alcohol&NutritionPolicy\nPrevention and control of noncommuni-\ncable diseases (NCDs) has been recognized\nas a global health priority by the World\nHealth Organization [26], and trade agree-\nments are \u201can upstream driver\u201d of NCDs\n[15]. As a result of both ISDS-driven le-\ngal challenges and indirect regulatory chill,\nISDS provisions may used to undermine\nthe development of evidence-based NCD\ninterventions including tobacco, alcohol\nand obesogenic product control efforts.\nThe potential implications of the TPP,\nTTIP and CETA on tobacco regulation\nhas been one of the most well-publicized\ndimensions of negotiations. ISDS mecha-\nnisms in a smaller scale trade agreement\nhave already been used to challenge to-\nbacco control measures in Uruguay. Pos-\nsible avenues for industry to challenge\ntobacco control measures include enforce-\nment of trademark protections, stakeholder\nprovisions to expand industry influence in\npolicy-making, cross-border services provi-\nsions to protect advertising and licensing,\nand technical barriers to trade provisions\n[16-20,66]. If tobacco is not excluded, these\nagreements could sabotage existing tobacco\ncontrol efforts under the World Health Or-\nganization\u2019s Framework Convention on To-\nbacco Control (FCTC) [12,21,62-63]. De-\nspite evidence that 4% of the global burden\nof disease is attributable to alcohol [22-23],\nalcohol control measures may be similarly\ntargeted for challenge under ISDS provi-\nsions [24-25].\nNutrition policy may be affected by this\nnew generation of trade deals [14, 27].\nTariff reduction, intellectual property and\nforeign investment liberalization provisions\nin the setting of ISDS may threaten exist-\ning NCD control efforts [28-29]. Experi-\nence with prior bilateral and regional trade\nagreements suggests that trade liberaliza-\ntion increases the sale of unhealthy trans-\nnational products and advertising of these\nproducts resulting in significant changes in\nconsumption patterns [15, 30].\nHealth Care Services &\nHealth Workforce\nTPP, TTIP, CETA and TiSA may have\nthe potential to affect the availability, ac-\ncessibility and regulation of health care\nservices. TiSA in particular is anticipated\nto contain significant provisions which seek\nto redesign the health care services land-\nscape [31]. Of particular concern are provi-\nsions which could facilitate commercializa-\ntion of health systems as well as promote\nhealth tourism, \u201chealth exporting\u201d and\/or\n\u201chealth \u00adoffshoring\u201d [31-35]. ISDS may also\nhave implications for health insurance and\nhealth care services markets. Under existing\nISDS provisions, there have been at least\ntwo cases where legislative barriers to the\nexpansion of private provision of services\nand\/or coverage have been challenged. The\nUS experience suggests that commercializa-\ntion of health care coverage and services is\nassociated with reduced coverage and access\nto health care services and increased costs.\nThus, such commercialization could be in-\nconsistent with current efforts to achieve\nuniversal health coverage [36]. Whether\nand how health care services might be \u201cex-\ncluded\u201d from each potential agreement has\nbeen subject to significant controversy and\nspeculation [77].\nAs the World Health Organization and\nGlobal Health Workforce Alliance is seek-\ning to develop a Global Strategy on Human\nResources for Health [89], trade agree-\nments may also unanticipated and unin-\ntended consequences on the supply and\ndistribution of the health care workforce. In\nsome countries, higher education including\nmedical education may be subject to com-\nmercialization [86-88] and reduced public\nfinancing which may have negative impli-\ncations for accessibility and affordability.\nLeaked TiSA documents suggest that the\nagreement may promote significant \u201chealth\nexporting\u201d and expanding health insurance\nportability across national borders [84]\nwhich may affect the supply and move-\nment of health professionals globally. Trade\nagreement negotiations may also implicate\nehealth including telemedicine and access\nto medical knowledge. However, assessing\nthe potential implications of negotiations is\nchallenging and speculative without access\nto texts.\nAccess to Medicines\nThe World Trade Organization (WTO)\nAgreement onTrade-Related Aspects of In-\ntellectual Property Rights (TRIPS) sought\nto codify common principles, standards and\nrules for the global protection of intellec-\ntual property. TRIPS included safeguards\nand flexibilities, clarified by the Ministerial\nDeclaration on TRIPS and Public Health\n(\u201cDoha Declaration\u201d) in 2001, to ensure\nthat the protection of intellectual property\nunder the agreement can and should not\ncompromise public health [37-38].\nDespite reassurances and efforts to protect\naccess to medicines [55], leaked texts and\ndetails of potential intellectual property\nprovisions paint a troubling picture for ac-\ncess to medicines [81]. There are several\npossible trade agreement provisions that\ncould exceed those protections afforded\nunder TRIPS and ultimately reduce the\naffordability and accessibility of medica-\ntions including (but not limited to) [39-44,\n50,65,81,96]:\n\u2022\t Evergreening, or prolonged patent pro-\ntection for minor modifications of exist-\ning drugs;\n\u2022\t Patent linkage or other patent term ex-\ntensions that may serve to as a barrier to\ngeneric entry into the market;\n\u2022\t Extended data and\/or market exclusivity\nand transition periods for products in-\ncluding biologics;\n\u2022\t Restrictions on TRIPS safeguards and\nflexibilities including compulsory licens-\ning and parallel imports;\n\u2022\t Limits on clinical trial data transparency\nthrough trade secret or other intellectual\nproperty protections.\nTrade agreements may also challenge thera-\npeutic reference pricing and other features\nof effective pharmaceutical benefits pro-\ngrams including Australia\u2019s Pharmaceutical\nBenefits Scheme [45-46,77], New Zea-\nland\u2019s Pharmaceutical Management Agen-\ncy (PHARMAC) Program [44,47], the\nUnited Kingdom\u2019s National Health Service\n[48,64], Canada\u2019s Health Canada program\n[67] among others.\nISDS further complicates potential impli-\ncations of trade agreement negotiations on\naccess to medicines. Under NAFTA, Eli\nLilly has brought a claim in excess of $500\nmillion against Canada over its invalida-\ntion of the company\u2019s patents on Strattera\nand Zyprexa [49]. Similar claims to enforce\nmore stringent intellectual property protec-\ntions could have devastating implications\nfor access to medicines.\nThe patenting of diagnostic, therapeutic\nand surgical techniques may also warrant\nattention in trade agreement negotiations.\nConsistent with existing World Medical\nAssociation policy opposing the patenting\nof such techniques [51], it is critical that\nan exception, similar to 35 USC 287(c), be\nincorporated into any agreement to pre-\nvent potential liability for patent infringe-\nment for health professionals performing\nprocedures and providing care for patients\n[52-53].\nEnvironmental Protection\n& Climate Change\nMillions of deaths globally each year are\nattributable to sequelae of air pollution\nand reliance on fossil fuels\u00a0 \u2013 it is esti-\nmated that one in eight deaths globally\nis due to air pollution [98]. Without sus-\ntained global mitigation and adaptation,\nclimate change could result in worsening\noutbreaks of deadly infectious diseases,\nexacerbation of food insecurity, increased\nnatural disasters and conflict\u00a0 \u2013 all with\nsignificant health implications [57]. In\nthis context, trade agreement negotia-\ntions may have negative implications for\nenvironmental protection and efforts to\naddress climate change [55-56,64]. Thus,\nas momentum grows in advance of Con-\nference of Parties 21 (COP21) negotia-\ntions in Paris, trade policy may simultane-\nously undermine commitments under the\nUnited Nations Framework Convention\non Climate Change (UNFCCC) by em-\npowering corporate interests to directly\nand\/or indirectly challenge domestic poli-\ncies to curb greenhouse gas emissions. In\nMedical AdvocacyMedical Advocacy\nBACK TO CONTENTS\n38 39\naddition, ISDS provisions may be used to\nexpand environmentally harmful practices\nsuch as fracking under these agreements\nwith well-documented devastating envi-\nronmental consequences [90].\nRegulatory harmonization and \u201cdown-\nward\u201d regulatory pressure could weaken\nsanitary and phytosanitary (SPS) measures\n[58-59]. These measures include criti-\ncal public health protections such as food\nsafety and plant and animal health. Across\nEurope, concern about food safety and\nregulation has sparked significant contro-\nversy and garnered substantial media at-\ntention. However, it is difficult to project\noverall potential health impact of such\nprovisions [77].\nLabor standards, labor rights and occupa-\ntional health and safety may also be on the\nproverbial negotiating table [85]. Under\nexisting trade agreements, social protection\nfor workers and collective bargaining rights\nhave been curtailed in favor of trade liberal-\nization [60-61,64]. If a similar approach to\nlabor is incorporated into this new genera-\ntion of agreements, there is a risk of exac-\nerbating social inequality and undermining\nefforts to address the social determinants of\nhealth.\nA Call to Action for\nPhysicians and Organized\nMedicine on Trade+Health\nSeveral World Medical Association nation-\nal member associations and other medical\ngroups have responded to the potential\nthreat posed by these trade agreement ne-\ngotiations. In 2014, the German Medical\nAssociation General Assembly adopted a\nresolution urging adherence to democratic\nprinciples including transparency as well\nas protection of patient safety and the ex-\nemption of health care services from any\nagreement [69]. The Standing Committee\nof European Doctors (CPME) has issued\nstatements urging transparency in TTIP\nnegotiations [70] and called for \u201cexemption\nfor the provision of healthcare services from\nthe scope of application of the TTIP\u201d [71].\nThe British Medical Association has ex-\npressed concern about the potential effects\nthe TTIP may have on the privatization of\nthe NHS and other European health care\nsystems [73-74].\nThe Australian Medical Association Fed-\neral Council has approved a resolution\nrecognizing that international trade agree-\nments have the potential to undermine\nthe Australian Pharmaceutical Benefits\nScheme and hinder government\u2019s ability\nto protect public health [72]. With respect\nto the TPP, the AMA has also expressed\nconcern about the secrecy of negotiations,\nnoting that the agreement would advance\ncommercial interests at the expense of\npatients, and the government\u2019s ability to\nimprove public health [72]. The CEO of\nthe Public Health Association of Austra-\nlia highlights some key concerns around\nthe effects of the provisions included in\nthe TPP, stating that organisations seek-\ning effective public health policies such\nas nutrition labeling will be burdened\nby more hurdles [79]. The New Zealand\nMedical Association supports the call for\nan independent assessment into the TPP,\nciting alcohol, tobacco regulation and af-\nfordable access to medicine. The NZMA\nChair stated that \u201cWe need to have a clear\nunderstanding of the possible effects of the\nTPPA on current and future policy set-\ntings and directions\u00a0\u2013 before we are com-\nmitted to such a deal\u201d [83]. The Japanese\nMedical Association President Yokokura\nhas publicly expressed concern about the\npotential negative implications of the TPP\non Japan\u2019s universal health insurance pro-\ngram and pharmaceutical pricing [99].The\nAmerican Medical Association maintains\npolicy on international trade agreements\n[94] and has expressed support for exemp-\ntion of tobacco products and alcoholic\nbeverages in the context of ongoing TPP\nnegotiations [95].\nLast year, the International Federation of\nMedical Students\u2019 Associations (IFMSA)\nalso adopted a comprehensive trade and\nhealth policy statement urging that trade\nagreements, \u201c...should not prioritize multi-\nnational corporate profits over patients and\nconsumes around the world\u201d [80]. IFMSA\nand its 126 national member organizations\nhave been active in advocacy to promote\nhealth in trade agreement negotiations\n[81,92-93].\nWhile current efforts by WMA national\nmember associations and similar groups\nwithin the organized medicine community\nto promote health in trade policy are en-\ncouraging,the stakes of current negotiations\nare high and a more coordinated advocacy\nresponse may be warranted. Although trade\npolicy has not traditionally been an advo-\ncacy priority for global organized medicine,\nthis new generation of trade agreement ne-\ngotiations including the TPP,TTIP, CETA\nand TiSA pose numerous unprecedented\ndirect and indirect challenges for health\nand health care\u00a0\u2013 challenges that may pro-\nfoundly affect our patients and the practice\nof medicine.\nThe World Medical Association (WMA)\nStatement on Patient Advocacy and Confi-\ndentiality stipulates that medical practitio-\nners have a duty that includes \u201c..advocating\nfor patients, both as a group (such as advo-\ncating on public health issues) and as indi-\nviduals\u201d [75]. Moreover, the WMA State-\nment on Social Determinants of Health \u201c[t]\nhere is a growing movement, globally, that\nseeks to address gross inequalities in health\nand length of life through action on the so-\ncial determinants of health...Doctors should\nbe well informed participants in this debate\u201d\n[76]. Given the threat of trade agreements\nto health and health care and the value of a\nhealth in all policies approach, the medical\ncommunity\u00a0\u2013 both physicians and organiza-\ntions like the WMA\u00a0\u2013 have a professional\nobligation to engage and advocate in trade\nagreement negotiations and policies to pro-\ntect and advance health.\nReferences\n1.\t Jarman, H. Public health and the transatlantic\ntrade and investment partnership. Eur J Public\nHealth (2014) 24(2). Available at http:\/\/eurpub.\noxfordjournals.org\/content\/24\/2\/181.short\n2.\t Ferguesson I, McMinimy M & Williams B.\nThe Trans-Pacific Partnership (TPP) Negotia-\ntions and Issues for Congress. 2015. Available at\nhttp:\/\/fas.org\/sgp\/crs\/row\/R42694.pdf\n3.\t Freeman J et al. Call for transparency in\nnew generation of trade deals. Lancet 2015;\n385(9968):604-605. 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Available at http:\/\/www.foeeurope.org\/\nsites\/default\/files\/publications\/foee_ttip-isds-\nfracking-060314.pdf\n91.\tRaptopoulou K. Legal Implications for the\nNHS of the Transatlantic Trade and Investment\nPartnership. Available at http:\/\/www.uniteth-\neunion.org\/uploaded\/documents\/FINAL%20\nLegal%20implications%20of%20TTIP%20\nfor%20the%20NHS%2012%20Feb%20\n201511-21864.pdf\n92.\tMannering B. Put NZ\u2019s health before in-\nterests of big pharma. New Zealand Her-\nald. 2012: 6 Dec. Available at http:\/\/www.\nnzherald.co.nz\/business\/news\/article.cfm?c_\nid=3&objectid=10852419\n93.\tOnarheim K et al.Stepping out of the silos: inte-\ngrating global health into trade negotiations.The\nLancet Global Health Blog. 2014. Available at\nhttp:\/\/globalhealth.thelancet.com\/2014\/06\/06\/\nstepping-out-silos-integrating-global-health-\ntrade-negotiations\n94.\tAmerican Medical Association. D-505.998\nInternational Trade Agreements [Policy].\nReaffirmed 2007. Available at https:\/\/www.\nama-assn.org\/ssl3\/ecomm\/PolicyFinderForm.\npl?site=www.ama-assn.org&uri=\/resources\/\nhtml\/PolicyFinder\/policyfiles\/DIR\/D-505.998.\nHTM\n95.\tAmerican Medical Association. Letter to the\nU.S. Trade Representative Regarding the Ex-\nclusiovn of Tobacco and Alcohol and Their\nProducts from Negotiations on the Trans Pa-\ncific Partnership Trade Agreement. 2011. Avail-\nable at http:\/\/www.citizen.org\/documents\/ama-\ncomment-on-tpp-8-sept-2011.pdf\n96.\tUNITAID. The Trans-Pacific Partnership\nAgreement: Implications for Access to Medi-\ncines and Public Health. 2014. Available at\nhttp:\/\/www.unitaid.eu\/en\/rss-unitaid\/1339-\nthe-trans-pacific-partnership-agreement-impli-\ncations-for-access-to-medicines-and-public-\nhealth\n97.\tMarmot M. Speech to the World Medical As-\nsociation World Medical Assembly at the time\nof the Presidential Election. 2014. 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JMAJ 2012;\n55(5):353-356.\nElizabeth Wiley, MD, JD, MPH, Resident,\nUniversity of Maryland, Past President,\nAmerican Medical Student Association\n(2012\u20132013), Supervising Council,\nInternational Federation of Medical\nStudents\u2019 Associations, Socio Medical\nAffairs Officer, Junior Doctors Network,\nWorld Medical Association (USA);\nDeborah Vozzella Hall, University\nof Connecticut (USA);\nThorsten Hornung, University\nof Bonn (Germany);\nCam Stocks, Queen Mary\nUniversity of London (UK);\nKonstantinos Roditis, National\nKapodistrian University of Athens &\nJunior Doctors Network-Hellas (Greece);\nJade Lim, University of\nMelbourne (Australia);\nRenzo R. Guinto, Reimagine\nGlobal Health (Philippines);\nClaudel P\u00e9trin-Desrosiers, University\nof Montreal (Canada);\nLawrence Loh, University of Toronto,\nDalla Lana School of Public Health\n& The 53rd Week Ltd (Canada);\nXaviour Walker, Johns Hopkins Bloomberg\nSchool of Public Health (USA);\nIan Pereira, Queen\u2019s University (Canada);\nAnya Gopfert, Newcastle University (UK);\nMaria Ignacia Alvarez Argaluza,\nUniversidad Cat\u00f3lica del Norte (Chile);\nReshma Ramachandran,\nBrown University (USA);\nIvana Di Salvo, University of Pavia (Italy)\nE-mail: elizabeth.wiley.md@gmail.com\nMedical AdvocacyMedical Advocacy\nBACK TO CONTENTS\nIV\n\n<\/p>\n"},"caption":{"rendered":"

wmj201501 COUNTRY vol. 61 MedicalWorld Journal Official Journal of The World Medical Association, Inc. ISSN 2256-0580 Nr. 1, April 2015 Contents New Trade Agreements and what They May Mean for Public Health and Health Care . . . . . 1 Report on \u201cEthical Guidelines and Practices for U.S. Military Medical Professionals\u201d . . . […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":727,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/wmj201501.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3674"}],"collection":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/comments?post=3674"}]}}