WMJ 01 2015

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 “Ethical Guidelines and Practices for U.S. Military Medical Professionals” . . . . . 3
Self-care – the CPME Statement: Quality and Safety, and Transparency! . . . . . . . . . . . . . . . . 6
Healthcare in Camp Liberty, Baghdad, Iraq . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
The Evolution of Research Ethics in South Africa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Nuclear War: A Greater Threat than Ebola . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Rationing and Differences in Care in Health Systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Looking to the Life Sciences for a Healthier EU. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
The Growing Importance of Health Technology Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Lost in Translation?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
The doctor-patient-relationship revisited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Chronic Kidney Disease of Unknown Origin in Central America and Sri Lanka . . . . . . . . . . 31
Beyond Chlor Hühner & Nürnberger Bratwürste:The Case for Physician & Organized
Medical Advocacy to Promote Health in Trade Agreement Negotiations . . . . . . . . . . . . . . . . 35
1
Editorial
Editor in Chief
Dr. Pēteris Apinis, Latvian Medical Association, Skolas iela 3, Riga, Latvia
Phone +371 67 220 661
peteris@arstubiedriba.lv, editorin-chief@wma.net
Co-Editor
Prof. Dr. med. Elmar Doppelfeld, Deutscher Ärzte-Verlag, Dieselstr. 2, D-50859 Köln, Germany
Assistant Editor
Inese Sviestiņa, wmj-editor@wma.net
Journal design and
cover design by
Pēteris Gricenko
Layout and Artwork
The Latvian Medical Publisher, “Medicīnas apgāds”, President Dr. Maija Šetlere, Katrīnas street 2, Riga, Latvia
Publisher
The Latvian Medical Association, “Latvijas Ārstu biedrība”,
Skolas street 3, Riga, Latvia.
ISSN: 2256-0580
Dr. Xavier DEAU
WMA President
Conseil National de l’Ordre des
Médecins (CNOM)
180, Blvd. Haussmann
75389 Paris Cedex 08
France
Dr. Donchun SHIN
WMA Chairperson of the Finance
and Planning Committee
Korean Medical Association
46-gil Ichon-ro
Yongsan-gu, Seoul 140-721
Korea
Prof. Dr. Frank Ulrich
MONTGOMERY
WMA Vice-Chairperson of Council
Bundesärztekammer
Herbert-Lewin-Platz 1 (Wegelystrasse)
10623 Berlin
Germany
Dr. Margaret MUNGHERERA
WMA Immediate Past-President
Uganda Medical Association
Plot 8, 41-43 circular rd., P.O.
Box 29874
Kampala
Uganda
Dr. Joseph HEYMAN
WMA Chairperson
of the Associate Members
163 Middle Street
West Newbury, Massachusetts 01985
United States
Dr. Masami ISHII
WMA Treasurer
Japan Medical Assn
2-28-16 Honkomagome
Bunkyo-ku
Tokyo 113-8621
Japan
Sir Michael MARMOT
WMA President-Elect
British Medical Association
BMA House,Tavistock Square
London WC1H 9JP
United Kingdom
Dr. Heikki PÄLVE
WMA Chairperson of the Medical
Ethics Committee
Finnish Medical Association
P.O. Box 49
00501 Helsinki
Finland
Dr. Miguel Roberto JORGE
WMA Chairperson of the Socio-
Medical Affairs Committee
Brazilian Medical Association
Rua-Sao Carlos do Pinhal 324,
CEP-01333-903 Sao Paulo-SP
Brazil
Dr. Ardis D. HOVEN
WMA Chairperson of Council
American Medical Association
AMA Plaza, 330 N. Wabash,
Suite 39300
60611-5885 Chikago, Illinois
United States
Dr. Otmar KLOIBER
Secretary General
World Medical Association
13 chemin du Levant
01212 Ferney-Voltaire
France
World Medical Association Officers, Chairpersons and Officials
Official Journal of The World Medical Association
Opinions expressed in this journal – especially those in authored contributions – do not necessarily reflect WMA policy or positions
www.wma.net
In a concise article [1] in this journal, Elizabeth Wiley and her co-
authors analyse the current discussions and negotiations surround-
ing upcoming trade agreements, which, if they come into effect, will
be huge and unprecedented in terms of their in-depth regulation
and the combined economic power behind them. The trade agree-
ments discussed, TTP (Trans Pacific Partnership), TTIP (Trans-
atlantic Trade & Investment Partnership), CETA (Comprehensive
Economic and Trade Agreement) and TiSA (Trade in Services
Agreement), essentially include most industrialized nations.
The authors outline the possible effects on health and health care,
from public health legislation to the structure of health systems,and
explain why the upcoming agreements could have negative effects
for public health and health care systems within the countries con-
cerned, but also in so-called third countries, which at first glance
have nothing to do with these agreements.
The World Medical Association has never had a position on trade
agreements in general, but Wiley et al. demonstrate the relation of
these upcoming trade agreements to our WMA policies, such as the
WMA Statement on Patient Advocacy and Confidentiality [2], the
WMA Statement on Social Determinants of Health [3] and the
WMA Statement on Patenting Medical Procedures [4].They argue
that it is time to bring health into the arena.
The Good,…
First of all, our world is undeniably networked and our economies
are globally connected. This has enabled economic growth to take
place globally and given some regions stability, peace and consider-
able prosperity.
Secondly, the medical profession has always been internationally
orientated. Diseases don’t recognise political borders boundaries
and are not confined by customs areas. International exchange and
cooperation is crucial for medicine. Both physicians and patients
migrate:, and cross-boarder services are a reality.
Thirdly, whoever has experienced life as an expatriate knows that
there is more red tape than this world needs. Those who want to
conduct cross-border business will find that protectionism and
out-dated or simply meaningless regulation can be prohibitive, if
not disastrous. Getting rid of unjustified regulation is not only
beneficial for migrants or those carrying out business across bor-
ders, it will also help those within countries who may likewise be
inhibited by it.
The Bad,…
The upcoming trade agreements have been feted as generators of
jobs and enhancers of business. But the euphoria of recent years has
passed.The last (2010–2014) European Union (EU) Commissioner
for Trade,Karel de Gucht,speculated about an increase in EU GDP
of O.5 percent [5] and 400,000 new jobs. However, the tone has
recently become more cautious. The suggested potentially positive
effects of TTIP now sound more like “maybes” and the glorious
numbers have also disappeared from the EU website [6].
The creation of TTIP is one of the best kept secrets of our time.
Very few officials at the EU Commission in Brussels deal with the
US delegation.The documents are not publically available, and only
under immense public pressure has the EU Commission begun
to reveal its strategy in a piecemeal approach. A few MEPs have
“on-screen access only” to the documents. However, the majority of
MEPs and national governments are not properly informed. Why
the secrecy? This leads us to question who this protective shield is
being built to defend against? Why are industry leaders involved
in negotiations but not the Members of the European Parliament?
Not even the members of the committees concerned are able to ac-
cess printed copies, let alone the national governments of Member
States. Are these shields meant to defend against the nations who
are not sitting around the table? Groups like Health Action Inter-
national, Oxfam and Médecins Sans Frontiers (MSF) warn against
TTP [7] and TTIP [8], seeing in them a danger to poorer nations’
access to medicines.
Or has this veil of secrecy been created to defend against the elec-
torate? Do we the people not have a right to know? Is it us mem-
bers of civil society who some politicians believe could endanger
this huge step forward, as the rhetoric of our leaders constantly
suggests?
In its title, “Beyond Chlor Hühner and Nürnberger Bratwurst”, the
article by Wiley et al. already distances itself from the panicked re-
porting of the European and especially the German press,which for
more than a year seized on issues such as US food industry practices
New Trade Agreements and what They May Mean
for Public Health and Health Care
BACK TO CONTENTS
2 3
U.S. military health care professionals serve
in a variety of settings, more diverse than
is typically found in the civilian environ-
ment. In all settings, military and civilian,
health care professionals face innumerable
conflicts in the practice of their vocation. At
times,health care professionals who practice
in these settings may face ethical challenges
in honoring the ethical standards of their
profession and obeying military orders or
policies. Tensions can arise if the demands
of the mission or line command are at odds
or in tension with the duties to attend to the
health of those needing care.
In particular, military personnel serving in
combat zones might be confronted with nu-
merous ethical and moral challenges. Most
of these can be resolved with effective com-
munication, training, leadership, clear rules
of engagement, and unit cohesion and sup-
port. However, the very act of experiencing,
witnessing, or participating in troubling
events can undermine a Service member’s
humanity. An act of serious transgression
that leads to serious inner conflict because
the experience is at odds with core ethi-
cal and moral beliefs is called moral injury,
which can be long lasting and painful.
In January 29, 2013 the Acting Under Sec-
retary of Defense for Personnel and Readi-
ness requested the Defense Health Board
(DHB) review the unique challenges faced
by military medical professionals in their
dual-hatted positions as a military officer
and a medical provider.Two questions were
asked:
• How can military medical professionals
most appropriately balance their obliga-
tions to their patients against their obli-
gations as military officers to help com-
manders maintain military readiness?
• How much latitude should military
medical professionals be given to refuse
participation in medical procedures or
request excusal from military operations
with which they have ethical reservations
or disagreement?
The DHB tasked its Medical Ethics Sub-
committee to conduct its review of military
medical professional practice policies and
guidelines. The Subcommittee reviewed
current civilian and military health care
medical professional practice policies and
guidelines as well as medical ethics, educa-
tion and training in the Department of De-
fense (DoD) and in civilian institutions.The
Subcommittee members also held panel
discussions with the subject matter experts
and DoD personnel, including Active Duty,
National Guard, Reserve, and retired mili-
tary health care medical professionals and
line officers as well as healthcare profession-
als in civilian institutions. Included among
the civilian organizations were the World
Medical Association, American Medical
Association, American Nurses Association,
American Psychiatric Association and the
American Psychological Association.
On February 11, 2015 the DHB unani-
mously approved the report “Ethical
Guidelines and Practices for U.S. Military
Medical Professionals”. It is an effort that is
notable for being well done. It is character-
ized by thoroughness and a sensitivity to the
issues described.
The Subcommittee developed its own prin-
ciples to guide its review and deliberation:
Context: Military health care professionals
face unique challenges resulting from their
dual role as medical providers and military
personnel. Throughout their careers, these
professionals may be required to plan and
participate in health care support for com-
bat operations, humanitarian assistance, di-
saster response and other activities, which
may be conducted in austere environments
with limited resources. As health care pro-
viders, military medical professionals have
ethical responsibilities to their patients,
which arise from a variety of legal, moral,
and professional codes as well as personal
moral and religious beliefs of both the care-
giver and the patient. However, military
health care professionals must weigh and
prioritize these ethical responsibilities with
their role as military officers.
Overarching Principle: DoD has a duty
to provide military health care professionals
with the resources, tools, and knowledge to
determine the best course of action when con-
fronted with ethical dilemmas and a practice
environment in which they feel safe in rais-
ing ethical concerns and confident they will
receive support in seeking a fair and just reso-
lution to those concerns. In addition, DoD
also has an obligation to assist professionals
in developing the resiliency to cope with and
recover from the moral injury resulting from
confronting intractable ethical dilemmas.
The Guiding Principles provided herein
guided the DHB and the Medical Ethics
UNATED STATES OF AMERICA Medical EthicsEditorial
of disinfecting chicken with a chlorine solution and the fear that
traditional food could be pushed from the market by low ­quality
imitations. However, the authors distance themselves from this
populist type of criticism of the trade agreements only to tell us that
it could actually be far worse!
Indeed, as the real implications of the trade agreements slowly be-
come apparent, the populist fears of chlorinated chicken and fake
Bratwurst look pale and rather unimportant in comparison. It is
public health at large and the values on which health care systems
are based, solidarity, equality and justice, which are under attack.
From what has so far leaked through the veil of secrecy, it seems
that the only common denominator in these negotiations is a spirit
of mammon.
National politicians don’t get tired of reassuring us that health care
systems and their social fabric will not be touched. Most impres-
sively, Japan’s premier Shinzo Abe told us at the WMA Council
Meeting in Tokyo last April that the universal health care system
of Japan will be maintained and even suggested holding it up as an
ideal to be exported.Likewise, European politicians repeatedly state
that our social systems will not be touched [9].
Really? Even if no elements of the trade agreements would directly
affect the structure of our health care systems, the indirect effects
would still be very real.The loss of jobs, the tearing down of protec-
tive regulation, the commoditization of health care, and the take-
over of public institutions by for-profit companies – all of this could
threaten the health care sector. However, as far as we know, health
care is not even excluded. And why should it be [10]? In most of
our economies, health care systems are one of, if not the biggest,
identifiable sectors of the economy.
And the Ugly
While the potential effects on public health, social structures and
health care systems are bad, there are aspects that may even be far
worse:The trade agreements foresee dispute settlement systems that
allow companies not only to litigate other companies, but also states
which are party to the agreements, in secret private courts. They
will, in fact, constitute a private system without any controls that
could ultimately not only undermine systems of justice, but may
lead governments and lawmakers to pre-emptively stall any public
health act that would run the risk of being sued by such a private
court, regardless of how important and relevant such acts may be.
The development of public health would be seriously inhibited.This
might be beneficial for industries producing or marketing unhealthy
products, however these agreements would place public health in
invisible shackles.
Of course, since the negotiations are conducted in secret and we
don’t know what is in the agreements, it can be claimed that all
these fears merely represent worst case scenarios. This is correct.
However, the burden of proof lies with those who are maintaining
this secrecy. Only they have the means to produce evidence that
positive aspects will prevail and that harmful effects are defini-
tively ruled out.
Regardless of the outcome of the trade agreements, if they continue
in this way they will not be beacons of justice and democracy.
References
1. E. Wiley et al. Beyond Chlor Hühner & Nürnberger Brat-
würste:
The Case for Physician & Organized Medicine Ad-
vocacy to Promote Health in Trade Agreement Negotiations.
World Medical Journal 2015
2. World Medical Association. Statement on Patient Advocacy
and Confidentiality. 1993, 2006. Available at http://www.wma.
net/en/30publications/10policies/a11/
3. World Medical Association. Statement on Social Deter-
minantsof Health. 2011. Available at https://www.wma.net/
en/30publications/10policies/s2/

4. World Medical Association. WMA Statement on Patenting
Medical Procedures, 2009. Available at https://www.wma.net/
en/30publications/10policies/m30/
5. J. Crisp. De Gucht rejects claims Commission misrepresented
benefits of TTIP. EurActiv.com, 09.09.2014 Available at http://
www.euractiv.com/sections/trade-industry/de-gucht-rejects-
claims-commission-misrepresented-benefits-ttip-308292
6. E.Bonse.EU kippt TTIP-Versprechen.02.04.2015 Available at
http://www.taz.de/1/archiv/?dig=2015/04/02/a0104
7. N.N. Trans-Pacific Partnership Agreement  – Trading Away
Health. 18.08.2013. Available at http://www.msfaccess.org/
spotlight-on/trans-pacific-partnership-agreement
8. HAI and Oxfam. Joint Agency Briefing Paper – Trading away
access to medicines  – Revisited. 29.09.2014. Available under
https://www.oxfam.org/en/research/trading-away-access-med-
icines
9. F. Bermingham. EU Trade Commissioner Karel De Gucht
Confirms NHS Exemption from TTIP. International Business
times. 14.07.2014 Available at http://www.ibtimes.co.uk/eu-
trade-commissioner-karel-de-gucht-confirms-nhs-exemption-
ttip-1456538
10. F. Bermingham. TTIP: Government Will Not Exclude NHS
From Free Trade Agreement. International Business times.
01.09.2014 Available at http://www.ibtimes.co.uk/ttip-govern-
ment-will-not-exclude-nhs-free-trade-agreement-1463454
Otmar Kloiber and Liene Puke
Cecil B. Wilson
Report on “Ethical Guidelines and Practices
for U.S. Military Medical Professionals”
BACK TO CONTENTS
4 5
UNATED STATES OF AMERICA UNATED STATES OF AMERICAMedical Ethics Medical Ethics
Subcommittee in its review of the dual loy-
alties of military health care professionals:
I.These must take into consideration:
  a. The spectrum of health care profes-
sional ethical codes, laws and licensing
requirements;
  b. Military professional ethics and codes;
  c. Medical education and continuing
medical education both within and
outside of DoD;
  d. The spectrum of experiences of both
civilian and military health care pro-
fessionals;
  a. The need for military health care pro-
fessionals to explore and address their
own and their patient’s religious be-
liefs, ethics, and medical preferences;
and
  f. Recommendations of those within and
outside of DoD.
II. Provide guidance regarding how to best
educate and train military health care pro-
fessionals to recognize and determine the
best course of action when ethical dilemmas
arise.
III. Acknowledge the moral injury that may
occur as a result of encountering an ethi-
cal dilemma and incorporate practices that
enhance resiliency and assist professionals
in coping with and recovering from these
injuries.
IV.Provide guidance to ensure a support in-
frastructure and environment is established
and maintained to provide military health
care professionals a safe avenue to raise eth-
ical concerns and seek timely assistance in
determining the best courses of action.
Defense Health Board –
Federal Advisory Committee
to the Secretary of Defense
The Defense Health Board (DHB) is a
Federal Advisory Committee to the Secre-
tary of Defense that provides independent
advice/recommendations on matters relat-
ing to operational programs, health policy
development, health research programs,
and requirements for the treatment and
prevention of disease and injury, promotion
of health and the delivery of health care to
Department of Defense (DoD) beneficia-
ries.
Mission
The mission of the DHB is to provide in-
dependent authoritative advice to maximize
the health, safety, and effectiveness of the
United States Armed Forces.
Ethical Guidelines and
Practices for U.S. Military
Medical Professionals
February 11, 2015
Recommendation 1: Department of De-
fense (DoD) should further develop and ex-
pand the infrastructure needed to promote
DoD-wide medical ethics knowledge and
an ethical culture among military health
care professionals, to include: a code of eth-
ics; education and training programs; con-
sultative and online services; ethics experts;
and an office dedicated to ethics leadership,
policy, and oversight.To achieve these goals,
DoD should form a tri-Service working
group with appropriate representation to
formulate policy recommendations on med-
ical ethics.This should include development
of a DoD Instruction to guide development
of the infrastructure needed to support the
ethical conduct of health care professionals.
In addition, this working group should con-
sider the best ways to implement the rec-
ommendations in this report.
Recommendation 2: Throughout its poli-
cies, guidance, and instructions, DoD must
ensure that the military health care profes-
sional’s first ethical obligation is to the pa-
tient.
Recommendation 3: DoD leadership, par-
ticularly the line commands, should excuse
health care professionals from performing
medical procedures that violate their pro-
fessional code of ethics, State medical board
standards of conduct, or the core tenets of
their religious or moral beliefs. However,
to maintain morale and discipline, this ex-
cusal should not result in an individual be-
ing relieved from participating in hardship
duty. Additionally, health care professionals
should not be excused from militaryopera-
tions for which they have ethical reserva-
tions when their primary role is to care for
the military members participating in those
operations.
Recommendation 4: DoD should formu-
late an overarching code of military medical
ethics based on accepted codes from various
health care professions to serve as a guide-
post to promote ethical leadership and set a
standard for the cultural ethos of the MHS.
To inform this process, the ethics codes of
relevant health care professional organiza-
tions should be reviewed regularly and up-
dates should be made to the military medi-
cal ethics code as appropriate.
Recommendation 5: To provide formal
ethics guidance, direction, and support to
the MHS and its components, DoD and
the Military Departments should:
 a) Publish directives/instructions re-
garding the organization, composi-
tion, training and operation of medi-
cal ethics committees and medical
ethics consultation services within the
MHS. DoD should review best prac-
tices at leading civilian institutions in
formulating this guidance.
 b) Ensure military treatment facili-
ties have access to consistent, high-
quality, ethical consultation services,
including designation of a respon-
sible medical ethics expert for each
location. For those facilities/locations
without onsite medical ethics support,
DoD should ensure remote consulta-
tion is available.
  c) Provide a “reach back” mechanism for
deployed health care professionals to
contact an appropriately qualified in-
dividual to assist in resolving an ethi-
cal concern that has not been resolved
through their chain of command.
  d) Develop a small cadre of clinicians
with graduate level training in bioeth-
ics to serve as senior military medical
ethics consultants.
  e) Ensure that health care professionals
are knowledgeable about their rights
and available procedures for obtaining
ethics consultation, expressing dissent
or requesting recusal from certain ob-
jectionable procedures or activities.
  f) Review compliance with ethics direc-
tives and instructions as part of recur-
ring health service inspections.
Recommendation 6: DoD should develop
clear guidance on what private health infor-
mation can be communicated by health care
professionals to leadership, and the justifi-
cations for exceptions to the rule for reasons
of military necessity.
Recommendation 7: DoD should pro-
vide military health care professionals with
privileges similar to those of Chaplains and
Judge Advocates regarding their indepen-
dence and obligation to protect privacy and
confidentiality while meeting the require-
ments of line commanders.
Recommendation 8: DoD should provide
specific education and training for health
care professionals designated to serve as
medical mentors or health care providers in
foreign health care facilities or in support
of humanitarian assistance or disaster relief
operations. Such education and training
should cover cultural differences, potential
ethical issues, rules of engagement, and ac-
tions that might be taken to avert, report,
and address unethical,criminal,or negligent
behavior or practices.
Recommendation 9:DoD should create an
online medical ethics portal.At a minimum,
it should include links to relevant policies,
guidance, laws, education, training, profes-
sional codes, and military consultants in
medical ethics.
Recommendation 10: DoD should include
in professional military education courses
information on the legal and ethical limita-
tions on health care professionals regarding
patient care actions they may or may not
take in supporting military operations and
patient information they may and may not
communicate to line leadership.
Recommendation 11: DoD should ensure
that systems and processes are in place for
debriefing health care professionals to help
them transition home following deploy-
ment. Debriefing should occur as a team
when possible. Not only could this help
mitigate potential moral injury in health
care professionals, but it may also provide
lessons learned and case studies for inclu-
sion in ongoing training programs.
Recommendation 12: To create an envi-
ronment that promotes ethical conduct and
minimizes conflicts of dual loyalty, DoD
leadership should emphasize that senior
military health care professionals are full
members of the Commander’s staff as an
advisor on medical ethics as it relates to
military readiness.
Recommendation 13: To minimize isola-
tion of health care professionals, the Mili-
tary Departments should make every effort
to ensure personnel who are deploying to
the same location train together as a team
prior to deployment. Establishing relation-
ships prior to deployment may enable better
communication and trust among line com-
mand and health care professionals in the
deployed setting.
Recommendation 14: DoD should issue a
directive or instruction designating mini-
mum requirements for basic and continuing
education and training in military medical
ethics for all health care professionals in
all components and indicate the appropri-
ate times in career progression that these
should occur.
Recommendation 15: To enhance ethics
training for military health care profession-
als and the line command, DoD should:
  a) Ensure pre-deployment and periodic
field training includes challenging
medical ethics scenarios and remind-
ers of available resources and contact
information to prepare both health
care professionals and line personnel.
Curricula should include simulations
and case studies in addition to didac-
tics.
  b) Provide a mechanism to ensure sce-
narios and training curricula are
continually updated to reflect spe-
cific challenges and lessons learned
through debriefing from real-world
deployments and garrison opera-
tions.
  c) Ensure key personnel returning from
deployment who have faced signifi-
cant challenges provide feedback to
assist personnel preparing for deploy-
ment
Recommendation 16: To enhance health
care practices in the military operational
environment, DoD should:
a) Update the Joint Knowledge Online
Medical Ethics and Detainee Health
Care Operations courses to improve the
efficiency with which the information is
communicated and maintain currency of
the material.
b) Create a medical ethics course to cover
key principles, ethical codes, and case
studies applicable to both garrison and
deployed environments, in addition to
providing resources and appropriate
steps to take when assistance is needed
in esolving complex ethical issues. This
course should be required for all health
care professionals.
Cecil B. Wilson, MD, MACP
Past President World Medical Association
BACK TO CONTENTS
6 7
Introduction
Self-care is gaining more and more atten-
tion in the European healthcare field these
days and has become a central element in
the strategy of many national health au-
thorities, EU bodies, as well as for the Eu-
ropean Council and WHO/Europe.
CPME (“Comité permanent des médecins
européens”), the umbrella organization of
European Doctors, has also recently issued
a “Statement on Self-Care”, with a view to
the future of self-care policy in the Euro-
pean Union, and is actively participating in
a EU tender on this topic.
But first, what is self-care in the meaning of
all these political discussions?
Self-care is considered as the ability of
patients to take measures to manage, es-
tablish and maintain their own health, or,
as the UK Department of Health put it in
2005 [1], self-care is “the actions people take
for themselves, their children and their fami-
lies to prevent and care for minor ailments and
long-term conditions and maintain health and
well-being after an acute illness or discharge
from hospital”.
Self-care policy also refers to self-medi-
cation, but self-medication is no longer at
its core – patient empowerment and health
literacy are nowadays considered as the key
aspects that determine self-care.
This definition points to the fact that self-
care has to do with 2 quite different topics:
• on the one hand, self-care deals with the
so-called “minor self-limiting ailments”
which, in the meaning of self-care,
should not request a medical consulta-
tion,
• and on the other hand, self-care deals
with two major elements of the future of
the health system in our countries, which
are prevention and chronic diseases.
Behind the rising political activities about
self-care, there is not only the idea of pa-
tient empowerment, but also obvious finan-
cial and economic interests: self-care should
reduce costs of healthcare by reducing the
need for medical intervention, in a time of
scarce financial resources – an effect that re-
mains to be proven in a significant manner,
as the latest studies are mostly inconclusive
in this respect. And self-care is of course
also a huge business for the pharmaceuti-
cal industry, bringing direct access to the
patients-consumers.
All in all, this introduction shows that self-
care can affect the very core of our health-
care systems – the finances and, most of all,
the relationship Doctors have with the pa-
tients. In other words, transparency, ethics,
quality and safety are all involved.
This is definitely a discussion – one more! –
where we should be active to defend our
understanding of medicine!
Quality and safety
I don’t think that Doctors have a problem
accepting that in many different situa-
tions patients can manage their own health
themselves  – either it is about minor ail-
ments that seldom require a real medical
intervention (headache,common cold,indi-
gestion, backache or whatever) or it is about
a chronic disease which the patient knows
very well and is able to manage in normal
circumstances.
But our professional experience also tells
us how difficult it is to spot a not-so-minor
pathology in the bulk of the everyday con-
sultation: we know all too well how dan-
gerous it may be to trivialize a symptom
which this time should not be overlooked!
Patients should definitely be protected from
the consequences of undue trivialization of
a symptom, and this concern must make us
cautious about promotion of self-care. At
the same time as patients read on the inter-
net or talk with their Doctor about self-care
possibilities, they should also learn about
the limits: which is the acceptable dura-
tion of symptoms? Wwhat to expect from
an available treatment? wWhat to do if the
expected results don’t show?
This is all about patient empowerment
(once again!). Clearly, empowerment also
means responsibiliy, for the patiet, and the
means to take on this responsibility – in our
view, self-care cannot be supported with-
out making sure that quality and safety are
guaranteed in this situation just as they are
for patients consulting a Doctor.
Another element which should be men-
tioned in the discussion about quality
and safety in self-care is the influence of
the pharmaceutical industry, which sees
huge profit possibilities in addressing di-
SWISSSWISS Self-careSelf-care
Self-care – the CPME Statement:
Quality and Safety, andTransparency!
Jacques de Haller
rectly the patients and selling the so-called
“OTC” (“Over-The-Counter”) medica-
tions. Advertisement and sponsoring of
internet home-pages, or in the field of
chronic disease the sponsoring of patient
groups, must be completely transparent
and in lie, to avoid unbalanced influence on
the decisions being made by patients about
their treatment.This is clearly also a matter
of quality and safety!
These short reflexions on quality and safey,
in consideration to self-cae, mean in fact
that although we definitely, as Doctors,
aren’ot opposed to self-care and thereby to
patient empowerment, we cannot support
without precaution measures that can put a
patient at risk or make him/her a victim of
marketing campaigns.
In other words, self-care is only to be seen
as a positive development if the quality of
the treatment and the safety of the patients
are at the center of attention.This means ef-
ficient regulations to keep marketing in line,
and the necessity for all involved healthcare
professionals to commit to sufficient and
adequate patient information.
The CPME Statement
on Self-Care
Acknowledging the importance of the on-
going discussions on self-care for the medi-
cal profession in Europe, last January the
CPME Executive Committe, adopte athe
“Statement o sSelf-care”.
The CPME document reaffirms that the
health education of society should always
be based on evidence, ann begins with an
important preliminary declaration remind-
ing that “It is the responsibility of doctors in
every EU member state to offer an appropriate
diagnosis to the patient, based on qualifications
and skills which in all cases include a degree in
medicine. Medicine is among the most difficult
sciences because of the knowledge required as
well as the complexity of its practice. CPME
is against any attempts to change the role of the
doctor to the detriment of patient safety. The
medical profession must be involved in the de-
velopment of the EU policy on self-care”.
The Statement also stresses the fact that tea
EU self-care policy must include a strategy
on health literacy for the patiet, as well as
concrete recommendations for health pro-
fessionals on patient empowerment. These
two supporting components of self-care
must be deployed in full cooperation with
member states and competent national au-
thorities to ensure the legitimacy of tea EU
policy on self-care (cf. “CPME joint state-
ment: Making Health Literacy a Priority”,
April 2013 [2]).
The CPME Statemenn continues with the
following 10 recommendations:
• Self-care is an area of health and social
care and it refers to the capacity of peo-
ple/patients to take care of themselves.
CPME therefore believes that people/
patients are at the core of self-care actions
and must not be defined as consumers.
• Patient empowerment and health literacy
are two areas where the EU is lagging be-
hind in terms of data and action so they
need to be a priority of self-care policy (cf.
“CPME joint statement: Making Health
Literacy a Priority”, April 2013 [3]).
CPME encourages doctors to support
patient empowerment and health literacy
as well as enhance collaboration between
health and social care.The patient-doctor
relation is one way of effective promotion
of self- care. Empowered patients should
be able to rely on the fact that physicians
provide assistance, advice and informa-
tion about self-care, including self-med-
icaion [4].
• The principle that treatment requires
prior diagnosis is central in medicine, and
a reliable diagnosis should be the prereq-
uisite of any treatment, also in the field of
self-medication.
• Self-medication should not result in in-
appropriate medication since it may re-
sult in delayed diagnosis and/or severe
complications. All necessary measures
need to be taken to avoid such situations.
Great attention must be given to avoid
situations of a risky self-diagnosis which
may become an issue of patient safety.
• In the frame of self-care as in any thera-
peutic situation, circumstances where
non-medical healthcare professionals can
take therapeutic decisions without con-
sulting a doctor must be strictly defined
and limited. For reasons of patient safety,
these situations must be defined together
with the medical profession.
• Self-medication with non-prescription
drugs is primarily suited for minor ail-
ments, diseases of short duration that are
easy to recognize by patients, pharmacists
and/or a non-specialist/healthcare pro-
fessional. Patients should be made aware
of the need to consult a physician in situ-
ations where self-care needs to be com-
plemented by medical treatment.
• CPME believes that in order to identify
the areas where self-care can and should
be promoted, necessary evidence needs
to be collected from member states and
other scientific reliable data sources, to
provide a common understanding of
which minor or acute ailments or long-
term conditions are manageable through
self-care.
• It is required that the safety and effi-
ciency of self-medication drugs be suf-
ficienly documented and that the use of
these medicines is evidence based. Public
authorities should closely monitor the
development in sale and use of non-pre-
scription drugsaalso the sale of pharma-
ceuticals outside the pharmacies. When
buying non-prescription drugs, it must
be ensured that the patient receives suf-
ficient information on its efficacy and on
the correct use of the medicinal product,
the risks and possible side effects, and the
possible misuse of the product.
• Public authorities must provide objective
information on medicinal products and
their use. Competent authorities, experts
that are independent and transparent and
the representatives of professional associ-
BACK TO CONTENTS
8 9
IRAQIRAQ Camp HealthcareCamp Healthcare
Healthcare in Camp Liberty, Baghdad,Iraq
Hassan Jazayeri
Sept. 1, 2013 – Dyalya Province – Camp Ashraf. An emergency room nurse and six patients killed after Iraqi security forces attacked the clinic.
Dr. Ahmadi hours after the incident at the scene of the crime (right). UN observer is recording the evidences and eye-witness accounts (left).
A blatant violation of the Geneva Conventions (1949) and their additional Protocols forming the core of the international humanitarian law.
ations are to define the future EU policy
through just and unbiased evidence.
• Self-care should not become the field of
commercial advertising and product pro-
motion. Measures must be implemented
to avoid his, as well as any type of conflict
of interest and the damaging consequenc-
es which can result from the proximity of
commercial actors to patients.
Self-care needs a
constructive approach!
We, Doctors, can gladly share the view that
self-care is a step towards patients recov-
ering more autonomy  – and autonomous,
empowered patients are an essential facet of
the health of the population.
This, however, cannot be without informed
patients. Medicine has been developed to
the point where it can immensely help the
population live a better life, whereas, com-
plex as it is, it needs people – Doctors! –
wnks due to sufficient knowlednks due to
their education, are able to use it efficiently
and safely. The possibilities of medicine be-
ing what they are nowadays, self-care may
not be o be seen as a “cheap medicine”, and
may not put patients at risk.
In this meaning, it should be our contribu-
tion to the development and implementa-
tion of self-care to be committed to the best
patient information, particularly in our pro-
fessional daily life.
Self-care and empowered patients is good
for them, and is also good for us, Doctors,
as it contributes to alleviate the shortage
in health professionals. But it requires the
willingness of the Doctors to inform their
patients whenever they need it.
And honestly, my own old GP experience
is that treating autonomous and informed
patients is so much more fun!
References
1. Self Care – A Real Choice, Self Care Support –
A Real Option. London: Department of Health,
2005
2. http://cpme.dyndns.org:591/adopted/2014/
Health.Literacy.Consensus.Paper.FINAL.pdf
3. Ibid.
4. http://cpme.dyndns.org:591/adopted/2012/
CPME_AD_Brd_24112012_145_Final_EN-
tion
Dr. Jacques de Haller,
Vice-President of CPME,
former President of the Swiss
Medical Association
12, chemin de Seppey – 1085  VULLIENS
Tél.: +41 79 458 35 14
E-mail: mail@jdehaller.ch
A large number of Iranian refugees, members
of PMOI, an opposition to the Iranian regime,
are forced to live in Camp Liberty, a desolate
abandoned US military base with dilapi-
dated infrastructure in the vicinity of Bagh-
dad Airport. This camp falls short under the
internationally accepted humanitarian and
human rights standard. Prior to their eviction
to Camp Liberty, these refugees were all liv-
ing in “Camp Ashraf ”, a modern highly self-
contained camp, owned and managed by them
in Diyala Province.
In 2004 and following the occupation of Iraq,
residents of Ashraf were recognized as “pro-
tected person” under the Fourth Geneva Con-
vention by the U.S. government. Since then
U.S. Army had the responsibility to safeguard
and protect the camp. In 2009 U.S. handed
over the protection and control of Camp
Ashraf to the Iraqi government under then
Prime Minister al-Maliki against the will
and wishes of the residents. Ever since Iraqi
forces under the command of PM al-Maliki
committed six bloody incursions against the
unarmed civilian residents of the camp at
the behest of the Iranian regime as a result of
which 116 have been killed and over 1,370
others were injured and maimed. An all-out
siege and blockade of medical and logistical
needs of the camp has cost the lives of 24 pa-
tients who died till March 2015. The aim was
an Iranian dictated agenda to force the camp
residents, who had left their homeland in op-
position to the current theocracy to surrender
to the wills of the perpetrators.
Current healthcare condition in this camp is
better fully understood in a greater context of
the political turmoil in the country and how
it has affected the rule of law and logically our
core values and commitments to healthcare and
medical ethics.
Turmoil in Iraq
The current situation in Iraq is character-
ized by a large-scale political and security
crisis with momentous local, national and
regional implications. Iraq belongs to cat-
egory 3 (most severe) of ECHO’s Cri-
sis Index. The Iranian regime and its ally,
Nourial-Maliki,provoked widespread anger
among the Sunni community and the dis-
turbing trend facilitated the rise and expan-
sion of extremism, particularly through the
Islamic State (ISIS).
The Washington Post of 27 December 2014
reported that since last June, “Iran has sent
more than 1,000 military advisers” and
“elite units to Iraq and has conducted air-
strikes and spent more than $1 billion on
military aid”. The Post added that “Iraq’s
Shiite-led government is increasingly reli-
ant on the powerful militias and a massive
Shiite volunteer force, which together may
now equal the size of Iraq’s security forces.”
Pro-Iranian regime militias have vast re-
gions of Iraq under their control and are a
mirror-image of ISIS – or in the words of
some Iraqi Kurdish officials are worse than
ISIS – and are carrying out crimes against
humanity. Amnesty International report of
14 October 2014 “Absolute Impunity” and
Human Rights Watch report of 29 January
2015 “Tyranny’s False Comfort” are testi-
mony to this fact.
Current turmoil in this country has brought
lawlessness, terrorism, corruption and the
systematic abuse of human rights each as a
daily feature of life here. The World Bank
lists Iraq as having one of the worst quali-
ties of governance in the world. Transpar-
ency International lists Iraq as one of the
world’s most corrupt countries. Interpol has
already suspended its activities in protest to
the level of corruption in the government
and specially the lack of impartiality of the
Judiciary branch.
The unleashed Iranian backed fundamental-
ist terrorist and militia groups in Iraq both
pose a major threat to the civilian popula-
tion in general and to the safety and protec-
tion of Camp Liberty residents in particular.
Clinical Approach
One of the most striking aspects of former
Prime Minister of Iraq, Al-Maliki’s level
of dependence on Iran had been his acts
in violation of IHL and IHRL in connec-
tion with the Iranian regime’s opposition in
camps Ashraf and Liberty.
Of course, it was expected that the new
prime minister would take serious measures
to distance his administration from previ-
ous policies.However,to date PM al-Abadi
has not taken any positive measures to end
the unlawful siege and medical blockade
on Camp Liberty and has guaranteed nei-
ther the security of the residents nor their
property rights. Instead, the restrictions
on the Camp Liberty residents have in-
tensified in recent months. Meanwhile no
measures have been taken to prosecute and
punish the perpetrators of the past 6 incur-
sions and rocket attacks in camps Ashraf
and Liberty.To rub salt into the wound, the
commanders and perpetrators of these acts
retain control and management of Camp
Liberty.
Respecting the rights of these refugees is a
clear indicator of adherence to the rule of
law and respect for international treaties
BACK TO CONTENTS
10 11
IRAQIRAQ Camp HealthcareCamp Healthcare
Orthopedy, 254
MRI, 146
General Surgery, 100
Internal Medicine, 81
Ophtalmology, 56
ENT, 52
Neurology, 34
Cardiology, 34
Rheumatology, 28
Urology, 29 EMG, 28
Neurosurgery, 21
Gynecology, 16
Oncology,
2
CT-Scan, 11
Dermatology, 5
Ultrasound, 3
Plastic Surgery, 3
Psychology, 1
Maxillofacial Surgey, 2
Thoracic Surgery, 1
By the end of 2014 a total of 907 patients had received referrals to make secondary and tertiary
appointments outside the camp
Camp Liberty Iraqi infirmary – The only sub-standard trivial primary care offered for the camp’s
population
and laws. Violating those rights raises se-
rious questions about the intentions of the
new government.
This has been also noted many times by the
United Nations Office of the High Com-
missioner for Human Rights. The latest
one is a communication by three UN spe-
cial rapporteurs, Chair-Rapporteur of the
Working Group on Arbitrary Detention;
Independent Expert on the promotion of
a democratic and equitable international
order and Special Rapporteur on extra-
judicial, summary or arbitrary executions
to the Government of Iraq about inves-
tigations on the killings of the residents
of Ashraf and Liberty in 2009, 2011 and
2013.
This document addressing the Govern-
ment of Iraq was made public and posted
on the OHCHR website on February
26, 2015. It reads in part as, “Without
prejudging the accuracy of the information
made available to us, we reiterate our con-
cern that investigations into the attacks of
1 September 2013 appear to fall short of
basic standards and principles of indepen-
dence and impartiality, and have remained
inconclusive. Our serious concern extends to
the five previous attacks against that com-
munity, none of which has been properly
investigated, and for which no one has been
brought to account. We are further concerned
that the whereabouts of the seven persons
abducted during the 1 September 2013 at-
tack remain unknown.
The past 6 attacks against that community,
the lack of proper investigations and of effec-
tive measures to protect its members, heightens
our concern about its vulnerability to further
attacks, especially in the context of the recent
upsurge in fighting in the country including in
areas close to the camp.
We thus respectfully urge your Excellency’s
Government to step up its efforts to investi-
gate all past attacks, to bring to justice anyone
found to have been responsible for these acts,
and to take effective measures to ensure the
safety of the residents of Camp Hurriya and
ensure that they are treated in accordance with
international human rights standards. Under
international law, Iraq has the legal obliga-
tion to ensure the right to life to all persons
living in the country and to effectively pun-
ish those responsible for violations of this right.
Severe crimes of the nature of those referred
above, and the impunity that has accompanied
them, entail violations of numerous interna-
tional treaty provisions.”
WMA’s Firm Response
In a letter delivered on 10 November
2014 to the Prime Minister of Iraq, the
President of the WMA Dr. Xavier Deau,
strongly voiced medical profession’s objec-
tion against recurrent violations of medi-
cal ethics and the right to health in Camp
Liberty: “According to testimonies and re-
ports from human rights organisations the
basic rights of the 2700 residents  – such as
access to physicians and medicine, the confi-
dentiality of physician-patient relationship
or the right of patients to have interpreter
and accompanying nurses when needed – are
frequently violated.‘Furthermore, numerous
reported cases relate to situations where hos-
pitalisation of patients and purchase of medi-
cine have been prevented. Other examples
include cancellation of medical appointments,
delayed transfers of patients to hospital, or
denial of permission to travel outside the
Camp to receive treatment. These on-going
obstructions have resulted in the rapid dete-
rioration of the health conditions of several
patients of the Camp Liberty and even in the
death of some.”
This resolute approach by WMA’s presi-
dent provoked a strong international re-
sponse from other international or regional
health bodies just to name a few: Interna-
tional Council of Nurses ICN), Standing
Committee of European Doctor (CPME),
European Union of Medical Specialist
(UEMS), European Association of Salaried
Doctor (FEMS), European Association of Se-
nior Hospital Physicians (AEMH), Working
Group of Practitioners and Specialists in Free
Practic- (EANA), European Public Health
Associatio (EUPHA…. Also numerous key
prominent national medical associations
responded to the call of the president by
actively participating in this campaign
including British Medical Association,
American Medical Association, Canadian
Medical Association, Belgian Medical
Trade Unions Association, German Mar-
burger Bund, Indian Medical Association,
etc.
Year 2009: a turning point
It is noteworthy to emphasize that the pub-
lic health standards of these residents were
at the highest attainable quality of health-
care offered in Iraq before 2009 which was
managed through integrated efforts of a 40
strong member medical team consisting of
11 doctors and specialists, all exiled refu-
gees residing in the camp. The camp resi-
dents used to enjoy free access to medical
services and facilities and they managed a
privately owned hospital inside their for-
mer camp (Camp Ashraf), self-contained
and fully equipped, including a newly pur-
chased spiral CT-Scan to that date to cover
primary and secondary health service, as
well as medical referral services and en-
sured availability of life-saving emergency
services.
In 2009 an all-out logistical and medi-
cal blockade of the camp was initiated by
Iraqi Army forces (IAF) under the com-
mand ofAal-Maeiki who started imple-
menting an Iranian agenda. In 2012 the
residents were evicted from Camp Ashraf
to Camp Liberty and the Government of
Iraq blocked the transfer of the resident’s
medical resources (equipment and sup-
plies) to Camp Liberty leaving the resi-
dents’ doctors with no resources and ca-
pabilities to diagnose and treat or conduct
surgery inside the Camp. Thus the camp
healthcare system became totally depen-
dent on what was offered by the very same
government that had planned and perpe-
trated the attacks and incursions on their
camps.
The current system is nothing but a sub-
standard trivial primary care in a tiny Iraqi
infirmary.
In this infirmary only a general practitioner
(GP) diagnoses the patients daily. There is
not enough medicine.There is no emergen-
cy medicine and facilities and the GP’s job
is just to refer the patients outside the camp.
He only issues referral papers for incoming
patients.
The outcome of this Medical Blockade, tak-
ing into account the span of almost 6 years,
can be outlined into the following facts and
figures:
• 24 patients died due to lack of free access
to vital medical services;
• By the end of 2014 the restricted access to
secondary and tertiary care services out-
side the camp had piled up a total number
of 907 patients who had already received
official referral forms from the GP at the
Iraqi clinic inside the camp for an ap-
pointment with a specialist in Baghdad
hospitals;
• The blockade also applies to the entrance
of pesticides, bactericides and chemi-
cal disinfectants which has added to the
Camp’s already existing hygiene deficien-
cies.
Dr. Deau elucidates this situation in his
letter to the Prime Minister as follows:
“We are extremely concerned by this situa-
tion that reveal flagrant violations of medical
ethics principles and human rights standards.
The right of everyone to the enjoyment of the
highest attainable standard of physical and
mental health is a fundamental element of
human rights enshrined in article 14 of the
International Covenant on Economic, Social
and Cultural rights that Iraq has ratified in
1971.”
BACK TO CONTENTS
12 13
Medical EthicsSOUTH AFRICAIRAQCamp Healthcare
The history of health research dates as far
back as the 1800’s [1] in South Africa,
when Cape Town, Grahamstown, Dur-
ban, Pietermaritzburg and Kimberley were
large thriving towns in with many doctors
in practice. They formed their own asso-
ciations as branches of the British Medical
Association. By the 1920’s, these branches
had spread throughout South Africa and
in 1927, they joined to form a national
association, the Medical Association of
South Africa (MASA). The MASA later
joined the WMA when it was established.
The MASA was replaced by the South
African Medical Association (SAMA) on
the 21st
May 1998.The SAMA as we know
it today is the result of the unification of
the fragmented pre-democracy medical
groups [2]. Although medical research had
been conducted in South Africa since the
1800’s, and despite oversight mechanisms
being set up at individual institutional
levels, there was no national guideline or
policy until 1979. Even this document was
limited in scope in that it applied only to
researchers affiliated with the MRC,either
as recipients of funding from the MRC or
as researchers within its institutes, units or
groups. Despite there being no safeguards
for participants in research at a national
level for many decades, doctors involved in
research were bound by the World Medi-
cal Associations guidelines and declara-
tions.
Following the publication of a paper by
Beecher [3] on unethical research be-
ing conducted by leading and respect-
able scientists in the United States, the
Committee for Research on Human Sub-
jects (Medical), the first Research Eth-
ics Committee (REC) in South Africa
(SA), was established at the University
of the Witwatersrand, Johannesburg in
1966. From the seventies, tertiary institu-
tions at which health research was con-
ducted established local RECs. In 1979,
the Medical Research Council (MRC),
SA produced the first set of guidelines
at a national level  [4]. The protections
espoused in those guidelines applied to
any research being funded by the MRC
or conducted by researchers affiliated to
the MRC. These guidelines have under-
gone several revisions. While an impor-
tant milestone in the participant protec-
tions endeavours in South Africa, the
MRC guidelines did not have regulatory
authority for non MRC associated re-
search. Furthermore, there was no uni-
formity of functioning between the local
institutional RECs that had been set up.
Standards of review ranged from excep-
tionally high at some RECs to very poor
at others and some RECs even served
as mere “rubber-stamping” committees.
Hence, ethics “shopping” was not uncom-
mon in the country. The promulgation of
the National Heath Act (No 61 of 2003)
brought about far-reaching changes, with
research participant protections and the
functioning of RECs now being regulated
by the country’s statutory laws which re-
quire the registration and audit of RECs
by the National Health Research Ethics
Council, a statutory body established to
determine the standards for participant
protections in health research.
The importance of the principles in the
Declaration of Helsinki in shaping South
Africa’s ethico-regulatory framework in
health research must be highlighted. The
Declaration has greatly influenced our
national guidelines [5] from both the Na-
tional Health Research Ethics Council
and the Health Professions Council as
well. A breach of ethics in health research
could result in sanctions by both these
bodies.
References
1. Thirty years of the MRC  – a history.
(Undated). Accessed 20/08/2013 at
http://www.mrc.ac.za/history/history.
pdf
2. SAMA’s History. (Undated). Accessed
21/08/2013 at https://www.samedical.
org/history.html
3. Beecher HK. Ethics and Clinical Re-
search, New England Journal of Medi-
cine. (1966): 274; 1354-60.
4. Cleaton-Jones PC. Research Ethics in
South Africa: Putting the Mpumalanga
Case into Context. In Ethical Issues in
International Biomedical Research. eds
Lavery J, Grady C, Wahl ER, Emanuel
EJ. Oxford University Press. Oxford.
(2007): 240-245.
5. Ethics in Health Research: Principles,
Structures and Processes. Department
of Health South Africa.(2004) Accessed
on 22/08/2013 at http://www.nhrec.
org.za/wp-content/uploads/2011/eth-
ics.pdf
Ames Dhai
President SAMA
The Evolution of Research Ethics
in South Africa
Ames Dhai
Current Crisis
Recurrent violations of medical ethics and
the right to health in Camp Liberty are
quite coincidental to the current turmoil
and level of the corruption in the country,
discussed above. The most recent case of a
BPH (benign prostatic hyperplasia) patient,
Mr. Safar Zakery, has been quite alarming
and should not be regarded as an isolated
incident in this new line of violations of our
medical ethics.
Mr. Zakery, 61, is a hygiene worker who left
the camp on 16 March 2015 for routine sew-
age disposal where in a scripted scenario his
tanker was struck by an Iraqi Police Hum-
vee but they arrested Mr. Zakery instead
of the guilty Humvee driver! Ever since he
is being kept in an arbitrary detention in
Ameriah police station in Baghdad under
phony charges. He was not released on bail
inconsistent to routine misdemeanor court
procedures.Mr.Zakery was denied access to
receive proper healthcare and even to attend
his BPH surgery appointment scheduled on
April 5, 2015, after a long-awaited duration
for admission to the hospital. This condi-
tion has already jeopardized Zakery’s health
with the risk of further complications and
complete urinary retention.
In their letter to Iraqi Prime Minister
Haider al-Abadi our colleagues at Canadian
Medical Association expressed our deepest
concern of medical profession regarding the
unlawful detention of Mr. Safar Zakery as a
clear breach of principles of medical ethics
and human rights standards:
“…We find it especially alarming that Mr. Za-
kery has been denied access to proper healthcare,
including attending his surgery appointment
scheduled on April 5, 2015. This is jeopardiz-
ing Mr. Zakery’s health with the risk of further
complications.
We would like to emphasize that it is categori-
cally illegal under existing international law
and conventions to jeopardize the life, safety,
and well-being of Protected Persons under the
Fourth Geneva Convention, to which Iraq is
signatory.
We take this opportunity to call on you to secure
the immediate release of Mr. Zakery and his
immediate return to Camp Liberty to ensure
recommencement of his medical therapy.
Mr. Zakery is a victim of extrajudicial punish-
ment by the Government of Iraq…” [11]
Ongoing battle for
medical ethics and human
rights standards
The current turmoil has transformed Iraq
into a formidable global threat, in the same
line Camp Liberty has also become the
front line of our medical profession in an
international thrive for recognition of stan-
dards of medical ethics for dignified treat-
ment and care.These breaches should never
be regarded as separate, isolated cases of lo-
cal or, at the best, regional importance. The
trend of participation by national medical
associations is a certain proof of the impor-
tance in a path that others are also invited
to join effort. Every national medical asso-
ciation can take its share by writing to the
Prime Minister of Iraq by reminding him of
his core commitments and by requesting for
medical accountability.
a. Requesting immediate release of Mr.
Safar Zakery and his return to Camp
Liberty to ensure recommencement of
his medical therapy.
b. Requesting medical accountability on
this case or similar previous cases.
c. Reminding Iraqi authorities that under
international law and conventions it is
illegal to jeopardize the life, safety and
well-being of Protected Persons under
the Fourth Geneva Convention and
“a Person of Concern to UNHCR”.
d. To ensure the residents of Camp Lib-
erty full access to adequate health care
facilities and to respect their dignity,
safety and protection under interna-
tional law.
References
1. Parts of this topic is cited from European Iraqi
Freedom Association (EIFA)Iraq Report –
February, 2015
2. European Commission’s Directorate General
for Humanitarian Aid and Civil Protection –
ECHO
http://reliefweb.int/report/iraq/humanitarian-
implementation-plan-hip-iraq-crisis-echo-me-
bud201491000-last-update-2
3. Assessment Report by ECHO-ECHO/IRQ/
BUD/2015/91000 – Last update: 03/11/2014
4. http://www.washingtonpost.com/world/
national-security/the-us-and-iran-are-
aligned-in-iraq-against-the-islamic-state–for-
now/2014/12/27/353a748c-8d0d-11e4-a085-
34e9b9f09a58_story.html
5. http://www.amnesty.org.uk/sites/default/files/
absolute_impunity_iraq_report.pdf
6. http://www.hrw.org/world-report/2015/essays/
tyranny-false-comfort
7. http://dinarvets.com/forums/index.php?/topic/
138165-international-police-interpol-suspend-
its-activities-in-iraq-and-continuity-in-
kurdistan/http://kurdistanskyscrapers.com/
topic/8373851/1/
8. A/HRC/28/85 Communications report of
Special Procedures of the United Nations
9. https://www.wma.net/en/40news/20archives/
2014/2014_30/index.html
10. https://www.wma.net/en/20activities/
20humanrights/20distress/Letter-to-the-
attention-of-Honorable-Dr_-Haider-al-
Abadi—11-Nov_-2014.pdf
11. Canadian Medical Association- letter of
concern to Prime Minister of Iraq – April 9,
2015
Hassan Jazayeri M.D.,
Camp Liberty
E-mail: jazayeri.hassan@gmail.com
BACK TO CONTENTS
14 15
Prevention of Nuclear WarPrevention of Nuclear War
At the recent World Medical Associa-
tion meeting in Durban, there was much
appropriate concern focused on the Eb-
ola outbreak in West Africa. Ebola, like
AIDS, malaria, tuberculosis and many
other public health problems affect our
patients daily and demand our attention.
But, we also need to consider another,
even greater, threat to public health: the
danger of nuclear war. It has been nearly
70 years since a nuclear weapon was ex-
ploded over a populated area. But the
devastation that will follow any future use
of nuclear weapons, and the high likeli-
hood that these weapons will be used
again, require that we address this prob-
lem now in the hope of preventing this
future catastrophe.
Our concern with nuclear weapons flows
in part from our understanding that the
medical community cannot provide sig-
nificant relief even to the victims of a sin-
gle nuclear bomb detonated on a city. In
a 2012 statement at the United Nations,
the ICRC reaffirmed its belief that the
world lacks any “adequate international
response capacity to assist the victims if a
nuclear weapon were to be detonated” [1].
Based on this understanding the medical
community must prevent what we cannot
cure.
Today, it is not the detonation of a sin-
gle nuclear weapon that we must fear.
Although the Cold War ended some 25
years ago, there are still more than 17,000
nuclear weapons in the world, most of
these weapons are many times more pow-
erful than the bombs that destroyed Hi-
roshima and Nagasaki [2, 3]. During the
Cold War, there was widespread attention
to this existential threat to human sur-
vival; today the nuclear threat is largely
ignored.
How Great is the Danger?
A large-scale nuclear war would threaten
the survival of our species. A conflict be-
tween the US and Russia would cause
worldwide climate disruption. Even if they
used only those weapons they will still
possess when the New START treaty is
fully implemented in 2017, the firestorms
caused by the detonation of these weapons
over urban targets would loft 150 million
tons of soot into the atmosphere, dropping
temperatures an average of 8 degreesC
across the globe [4]. In the interior regions
of North America and Eurasia, tempera-
tures would drop 20 to 30 degrees Celsius,
producing conditions not seen on Earth
since the coldest point of the last Ice Age
[5]. In many regions, agricultural would
stop, ecosystems would collapse, and the
vast majority of the human race would
starve to death.
Since the end of the Cold War we have
been assured that we do not need to worry
about nuclear war between the US and Rus-
sia.Events in Ukraine have shown,however,
that conflict between the nuclear super-
powers is still possible. Even if the US and
Russia do not engage in a deliberate use of
nuclear weapons,there remains the very real
danger that an accident or computer failure
could trigger an unintended use of nuclear
weapons.There have been many near misses
during the nuclear weapons era, including
at least one well after the end of the Cold
War. On many occasions we have been ex-
traordinarily lucky. The hope that we will
continue to be lucky is simply not an ac-
ceptable public health policy.
Even a very limited use of nuclear weap-
ons would cause a worldwide catastrophe.
A 2006 paper by Alan Robock and his
colleagues examined the impact of a lim-
ited nuclear war between India and Paki-
stan. The scenario in this study assumed
that each side used fifty Hiroshima-sized
bombs, which is less than half of their cur-
rent nuclear arsenals and less than 0.03
percent of the world’s nuclear weapons [6].
The direct effects in South Asia would be
catastrophic: more than 20 million people
dead in less than a week from the explo-
sions, fires, and immediate radiation ef-
fects.
The global climate impact would not be as
severe as that caused by a large scale war
between the US and Russia, but it would
still cause a catastrophic decline in food
production. In this scenario, five million
tons of soot would be lifted into the up-
per atmosphere. Temperatures would drop
an average of 1.3 degrees Celsius across the
planet, enough to shorten the growing sea-
son and decrease precipitation in many key
food producing areas.. In the US, corn pro-
duction would decline 12 percent for a full
decade [7]. In China, rice production would
decline 17 percent, corn production16 per-
cent, and winter wheat 31 percent, all for a
full decade [8].
A decrease in food production of this mag-
nitude would have profound effects on hu-
man health. Current world grain reserves
amount to only some 70 days of consump-
tion [9]. Even at current levels of food pro-
duction there are some 825 million people
who suffer significant malnutrition [10],
and 300 million people who receive ad-
equate nutrition today but live in countries
that are highly dependent on food imports
[11, 12]. With the large decrease in food
production that would follow a limited
nuclear war, all of these people would be at
risk of starvation in a global “nuclear fam-
ine” which would affect people thousands
of miles from the site of the actual conflict.
Nuclear War: A Greater Threat than Ebola
In addition, the very severe shortfalls in
Chinese food production would put an-
other 1.3 billion people at risk. Worldwide,
more than 2 billion people would face se-
vere food insecurity and possible starva-
tion [13].
What Can the Medical
Community Do?
It turns out that the medical community
can do a great deal.
For more than 50 years, members of the
medical community have worked to educate
the public and world leaders about the ac-
tual consequences of nuclear war in the be-
lief that such knowledge would affect public
policy. In 1962, the American organization
Physicians for Social Responsibility (PSR)
published a series of articles in a special is-
sue of the New England Journal of Medicine
explaining the expected consequences of
a nuclear war [14-18]. In an accompany-
ing editorial, Joseph Garland wrote that
“the most important function of the physi-
cian, however, relates to prevention…. The
employment of every reasonable means to
prevent such a catastrophe becomes the
concern of everyone, and not least the phy-
sician” [19].
These articles and other advocacy work by
physicians and other health professionals
helped create the climate which lead the
next year to the Limited Test Ban Treaty,
banning above ground nuclear tests.
The ability of the medical community to af-
fect nuclear policy was even clearer during
the very dangerous escalation in Cold War
tensions in the early 1980s.Starting in 1983
JAMA, published a special issue each Au-
gust on the anniversary of the Hiroshima
bombing dedicated to the danger posed by
nuclear weapons. PSR conducted public
symposia with medical schools in major cit-
ies across the United States, describing the
then-available data about the medical effects
of nuclear war. PSR’s sister organizations in
the International Physicians for the Preven-
tion of Nuclear War (IPPNW) conducted
similar educational efforts.In recognition of
the importance of this work IPPNW was
awarded the 1985 Nobel Peace Prize for
“spreading authoritative information and…
creating an awareness of the catastrophic
consequences of atomic warfare… [T]his in
turn contributes to an increase in the pres-
sure of public opposition to the prolifera-
tion of atomic weapons” [20].
These educational activities had a pro-
found impact on public policy. PSR was
able to brief President Reagan at the White
House and a delegation from IPPNW met
with President Gorbachev in the Kremlin.
Speaking of the impact of that briefing,
Gorbachev said,
The International Physicians for the Preven-
tion of Nuclear War has come to exercise a
tremendous influence on world public opin-
ion within quite a short period of time. Their
work commands great respect. For what they
say and what they do is prompted by accurate
knowledge and a passionate desire to warn
humanity about the danger looming over it.
In light of their arguments and the strictly
scientific data which they possess, there seems
to be no room left for politicking. And no seri-
ous politician has the right to disregard their
conclusions [21].
In response to these briefings, and to the
growing public concern about nuclear
weapons, the US and the Soviet Union ne-
gotiated a series of agreements which halted
and reversed the arms race, significantly re-
ducing the danger of nuclear war.
Unfortunately, with the end of the Cold
War, the medical community, like the
broader public, became less concerned
about the ongoing danger of nuclear war,
and an historic opportunity to eliminate
these weapons was lost.
In recent years there has been some in-
creased attention to the message first put
forward by the medical community more
than 50 years ago. Inspired in significant
measure by the new data on limited nuclear
war, the International Committee of the
Red Cross and the Red Cross/Red Crescent
Movement have passed two resolutions cit-
ing the overwhelming humanitarian catas-
trophe that would result from nuclear war,
calling for the abolition of nuclear weapons,
and urging all national Red Cross and Red
Crescent Societies to conduct educational
campaigns about the humanitarian conse-
quences of nuclear war [22, 23].
In January of 2012 more than 30 deans of
US medical schools and schools of public
health issued a statement calling “on our
colleagues in the medical and public health
communities to educate their colleagues,
patients and communities about the enor-
mous danger we face as long as these weap-
ons exist” [24].
This renewed attention to the medical con-
sequences of nuclear war is beginning to af-
fect public policy.There have been two large
governmental conferences on the humani-
tarian consequences of nuclear war and the
implications for nuclear weapons policy.
The first, in March of 2013 was attended
by representatives of 126 governments.
146 nations attended a follow up meeting
in February of 2014, and a third meeting is
scheduled for December.
Unfortunately, the medical community as
a whole has been less vocal in addressing
this pre-eminent threat to human survival.
Medical schools, medical associations, and
most medical journals have ignored this
issue. In a 2010 editorial in the Lancet,
David Wolfe and Richard Horton chided
the medical community for this failure:
“Indeed, it is over a decade ago now since
The Lancet published anything remotely
relevant to nuclear weapons as a threat to
health. Such complacency has been a seri-
ous error. Now is the moment for physi-
cians and scientists to build new opportu-
nities for political progress to defuse the
BACK TO CONTENTS
16 17
GERMANY Health SystemsPrevention of Nuclear War
danger of a new more regionally focused
nuclear arms race” [25].
This complacency is indeed a serious error.
The danger of nuclear war remains the most
significant threat to human survival. The
literature on the global impact of limited
nuclear war has been developing over the
last 5 years, and many outside the medical
community have taken seriously our warn-
ing and are beginning to act on it. It is time
for the medical community to again provide
leadership on the most important public
health issue of our era. Our success in help-
ing to stop the forward momentum of the
arms race in the 1980s shows clearly the
impact that we can have. We need to edu-
cate our patients again about the existential
threat they face and to help them become
active in the growing international move-
ment to eliminate that threat.
At the Durban meeting, a resolution was
introduced by the Junior Doctors Network
updating WMA statement, on nuclear
weapons and calling on national medical as-
sociations to undertake educational activi-
ties and to urge their governments to work
to “ban and eliminate” nuclear weapons.
National medical associations should sup-
port this new statement at the International
Council meeting in Oslo in April, and they
should begin now the critically important
educational and advocacy work called for in
the statement.
References
1. ICRC statement to the United Nations, 2012
http://www.icrc.org/eng/resources/documents/
statement/2012/united-nations-weapons-state-
ment-2012-10-16.htm Accessed April 20, 2014.
2. Kristenson H, Norris R, Slowing nuclear weap-
on reductions and endless nuclear weapon mod-
ernizations, Bulletin of the Atomic Scientists 2014
70: 94.
3. Ploughshares Foundation, World Nuclear Forc-
es Report, http://www.ploughshares.org/world-
nuclear-stockpile-report?gclid=CjwKEAjw9L
KeBRDurOugs43jnlgSJACUXqHxfiJvtPwK-
PHcXWZi-N3zEqreXkbz6YxDqZ7y2VSu-
eRoCTZrw_wcB.
4. Robock, Alan, Luke Oman, and Georgiy L.
Stenchikov, 2007: Nuclear winter revisited with
a modern climate model and current nuclear ar-
senals: Still catastrophic consequences. J. Geo-
phys. Res., 112, D13107, doi:2006JD008235.
5. Toon O, Robock A, Turco R, 2008: Environ-
mental consequences of nuclear war. Physics To-
day, 61, No. 12, 37-42.
6. Robock A, Oman L, Stenchikov G, Toon O,
Bardeen C, and Turco R, 2007, Climatic conse-
quences of regional nuclear conflicts.Atm. Chem.
Phys., 7: 2003-12.
7. Ozdogan M, Robock A, and Kucharik C, 2012:
Impacts of Nuclear Conflict in South Asia on
Crop Production in the Midwestern United
States. Climatic Change 116, 373-387.
8. Xia L,Robock,A,Mills M,Stenke A,Helfand I,
“Global famine after a regional nuclear war”sub-
mitted to Earth’s Future October 2013.
9. www.usda.gov/oce/commodity/wasde/latest.pdf
Accessed April 20 2014
10. www.fao.org/publications/sofi/en/Accessed April
20, 2014
11. www.iucn.org/themes/wani/eatlas/html/gm19.
html
12. www.ers.usda.gov/publications/gfa16/GFA-
16CountryTablesNAfrca.xls.
13. Helfand I.Nuclear Famine:Two Billion at Risk?
http://www.ippnw.org/nuclear-famine.html.
Accessed April 20, 2014.
14. Nathan DG,Geiger HJ,Sidel VW,Lown B.The
medical consequences of thermonuclear war: in-
troduction. N Engl J Med. 1962;266:1149-1155.
15. Ervin FR, Glazier JB, Aronow S, et al. The
medical consequences of thermonuclear war, I:
human and ecologic effects in Massachusetts of
an assumed thermonuclear attack on the United
States. N Engl J Med. 1962;266:1127-1137.
16. Sidel VW, Geiger HJ, Lown B. The medical
consequences of thermonuclear war, II: the phy-
sician’s role in the post attack period. N Engl J
Med. 1962;266:1137-1145.
17. Aronow S. The medical consequences of ther-
monuclear war, III: a glossary of radiation ter-
minology. N Engl J Med. 1962;266:1145-1149.
18. Leiderman PH, Mendelson JH. The medical
consequences of thermonuclear war, IV: some
psychiatric and social aspects of the defense-
shelter program. N Engl J Med. 1962;266:1149-
1155.
19. Garland J. Earthquake, wind and fire [editorial].
N Engl J Med. 1962;266:1174.
20. Nobel Peace Prize Committee. Citation to the
International Physicians for the Prevention of
Nuclear War; October 11, 1985. Available at:
http://www.ippnw.org/nobel-peace-prize.html.
Accessed April 20, 2014
21. Gorbachev M. Perestroika, Harper & Row 1987.
Page 154.
22. http://www.icrc.org/eng/resources/documents/
resolution/council-delegates-resolution-1-2011.
htm Accessed April 20, 2014
23. http://www.icrc.org/eng/resources/documents/
red-cross-crescent-movement/council-dele-
gates-2013/11-18-council-delegates-2013-adopt-
ed-resolutions.htm Accessed April 20,2014
24. www.psr.org/nuclear-weapons/rxforsurvival.pdf.
Accessed April 20 2014.
25. Wolfe D, Horton R. Lancet, 2010, Vol. 375 No.
9710, 173-174
Ira Helfand, MD,
is co-president of International Physicians
for the Prevention of Nuclear War and
past president of IPPNW’s US affiliate
Physicians for Social Responsibility. He
practices medicine at Family Care Medical
Center in Springfield, Massachusetts.
Antti Junkari, BM,
is the European Student Representative
of IPPNW, and a member of IPPNW’s
Finnish affiliate, Physicians for Social
Responsibility/Finland. He is a PhD student
at the University of Eastern Finland.
Ogebe Onazi, MD,
is deputy chair
of the Board of International Physicians
for the Prevention of Nuclear War.
He practices medicine at the General
Hospital, Angware, Jos East LG,
Plateau State, Nigeria.
Introduction
The health policies of all OECD countries
are shaped by a similar guiding principle:
each state would like to guarantee its citi-
zens the necessary state-of-the-art medi-
cal care, regardless of ability to pay. To
achieve this goal, almost all countries have
developed universal healthcare coverage fi-
nanced by taxes or contributions to cover
the risk of illness [1]. General features in-
clude, among other things, state regulation
of prices and standard service catalogues.
In a global comparison, Germany has a
special position with its dual health system
of statutory (GKV [statutory health insur-
ance]) and private health insurance (PKV
[private health insurance]). It is the only
country where two parallel health insur-
ance systems exist for major parts of the
population.
However, the share of the population
with health insurance coverage is an im-
perfect indicator of accessibility, since the
range of services covered and the degree
of cost-sharing applied to those services
vary across countries (e.g. waiting times,
exclusion of services or co-payments). In
an international comparative study, the
“Wissenschaftliche Institut der PKV
(WIP)” [Scientific Institute of Private
Health Insurance] has examined the ex-
tent of rationing and differences in care in
health systems. Furthermore, it is analysed
whether single-payer healthcare systems
can provide protection from inequalities in
care within the population, and which role
voluntary private health insurance plays in
OECD countries.
Reasons for rationing
Due to collective tax or contribution fi-
nancing, the traditional mechanisms of
demand, supply and pricing are eliminated
in the healthcare systems of OECD coun-
tries. In order to understand why this is the
case, the characteristics of a perfect market
with free pricing functions are explained in
Figure 1.
Supply
Demand
QuantityQG
Price
PG
Figure 1. Schematic representation of a
perfect market
One function of a price in a market is to
allocate and ration scarce resources. Gener-
ally, as prices increase, the supply of a com-
modity/service increases, as represented by
the green line. With a higher price, suppli-
ers produce more of the commodity/ser-
vice and more suppliers enter the market.
Conversely, demand drops with increasing
prices (blue line), as the consumers want
to purchase less of a commodity/service or
relinquish demand entirely.If there is an ex-
cess of supply,the suppliers have to drop the
price in order to be able to sell their goods
and services; if there is an excess of demand
the commodity/service becomes scarce and
suppliers can increase the price. The price
mechanism balances supply and demand.
The equilibrium price PG
clears the market,
i.e. the quantity of a product offered is equal
to the quantity of the product in demand.
Healthcare markets do not function like a
perfect economic market. Not all consum-
ers or patients are willing or able to acquire
healthcare services at the price PG
.Typically,
neither the public nor social policy toler-
ate that patients cannot financially afford
healthcare services. In most developed coun-
tries, there is a social consensus according
to which healthcare should be accessible to
an individual regardless of his or her abil-
ity to pay. As such, the healthcare market
is regulated in almost all countries. In sys-
tems financed through general taxation or
by contributions, the price does not play a
Rationing and Differences in Care
in Health Systems
Frank NiehausVerena Finkenstädt
BACK TO CONTENTS
18 19
GERMANYGERMANYHealth Systems Health Systems
key role in allocation of resources, but rather
the community of the insured citizens or tax
payers bear the costs of healthcare (either in
whole or in part). Therefore, the patients are
allowed to request services at a price below
the market price or without charge. In addi-
tion, there usually exists a fixed price system
for service providers in the healthcare system,
i.e. prices cannot be freely chosen by the ser-
vice provider, but rather are determined by
statutes, regulations and other binding rules.
Supply
Demand
QuantityQdemand
Price
Pfixed
Qsupplied
Figure 2. Schematic representation of a
market in the case of price limits
As a result of these regulations, the price is
below the equilibrium price for those who
supply and those in demand (patients).This
is represented schematically in Figure 2.
For the sake of simplicity, the same price is
represented for both suppliers and patients.
As mentioned above, the relevant price for
patients is often significantly lower or even
at zero due to tax-funding or contributions.
Thus, the patients are not prevented from
demanding the services, and the demand
exceeds the supply provided by the health-
care system. If there is no price mechanism,
supply and demand must be balanced in an-
other way. Rationing is therefore unavoid-
able in collectively financed health systems.
Extent of rationing
across countries
The extent of explicit rationing is best
shown using objectively observable indi-
cators. These include waiting times, lim-
ited choice of doctor, restricted services and
obligatory co-payments.
Waiting times
In order to counter the excess of demand
for healthcare services, many countries use
waiting times [2] [3] [4]. Waiting times
arise if the capacity is not sufficient to sat-
isfy the current demand. Through rationing
in the form of waiting lists,access to health-
care services is made more difficult for pa-
tients, and some patients are prevented
entirely from receiving treatment. Waiting
times are, however, also deliberately used
as an instrument to control demand on the
part of patients.
From an economic point of view, waiting
times represent a cost for the patients wait-
ing. By associating this “price” to waiting
times and treatment, the demand can be re-
duced. Instead of selling services or medical
goods to those who pay the most,those who
are prepared to wait the longest are the ones
to receive the healthcare service.
In Germany, there are no excessive waiting
times [5]. The average waiting time for an
appointment with a specialist amounts to
only 16 days for the statutorily insured [6].
Regarding waiting times for planned sur-
gery or appointments with a specialist, an
international survey by the Commonwealth
Fund states that Germany performs best
[7]. In Canada, on the other hand, a quar-
ter of all those surveyed had to wait longer
than 4 months for planned surgery. In Swe-
den,Norway,the UK and Australia,it is still
around one fifth (see Figure 3).
A look at the official statistics of OECD
countries also reveals the extent of waiting
times in other health systems: in the Eng-
lish National Health Service (NHS),almost
4.8 million people were on waiting lists for
medical treatment or diagnosis at the be-
ginning of 2014. The average time from a
GP referral up to a meeting with a special-
ist amounts to five weeks [8]. In Sweden,
C
anada
N
etherlands
U
SA
Switzerland
France
N
ew
Zealand
A
ustralia
G
reatBritain
N
orway
Sweden
G
erm
any
0
30
25
20
15
10
5
5
777
8
18
2121
22
25
0
Figure 3. Proportion of patients surveyed who had to wait 4 months or longer for elective
surgery in % (Source: Authors’ own representation according to the Common-
wealth Fund, 2010)
about 21,000 patients were waiting for
more than 90 days in March 2014, which
is the maximum guaranteed waiting time
in this country [9]. Patients in neighbour-
ing Scandinavian countries must have more
patience. For example, waiting times for a
new hip in Denmark vary from one to 16
weeks, or from one to 27 weeks for a menis-
cus operation [10]. The situation is similar
in the Netherlands: in March 2014,patients
in Amsterdam did not receive a prosthetic
hip until after 29 weeks [11].
Connection between the source
of financing and waiting times
It is conspicuous that in tax-funded health-
care systems, waiting times are particularly
common and longer than in systems fi-
nanced by contributions. Typically, waiting
times are also statistically covered in tax-
funded systems and are often used specifi-
cally as steering instruments [2].
Figure 4 makes the connection clear. Here,
the countries are arranged according to the
proportion of their healthcare system which
is financed through taxation. The left-hand
side shows the systems financed mostly
through taxation such as Sweden, the UK,
Australia and Denmark; the right-hand.
side represents the systems which are pre-
dominantly financed by contributions, such
as Germany, the Netherlands or France.
The colour-coding of country names in red
or green symbolises whether the health-
care system has official statistics on waiting
times and/or waiting lists.This figure clearly
shows that all systems financed predomi-
nantly through taxation show at least one
kind of official information regarding wait-
ing times, whereas systems financed by con-
tributions do not generally do this. Poland,
Estonia and the Netherlands are exceptions
to this.
Waiting times as a
steering instrument
The UK example shows that in tax-funded
healthcare systems, waiting times can also
be utilized as a steering instrument. The
NHS England website expressly states that
patients can compare waiting times of hos-
pitals in order to choose the hospital with
the shortest waiting times for their treat-
ment [12]. Here, waiting times function as
a price. The patient must decide whether to
accept the long waiting time or rather to
make use of another hospital.
Limited freedom of
choice for patients
A further rationing instrument used mainly
in tax-funded health systems is to limit pa-
tients’ freedom of choice. For example, in
Denmark,Finland,Spain and Portugal,nei-
ther the GP nor the specialist can be chosen
by the patient. In the Spanish public system
in particular, there is almost no freedom of
choice for patients. Here, patients may gen-
erally only visit a GP located nearby, and
patients are assigned to a particular special-
ist or hospital. The choice of GP is also re-
stricted in a similar manner in the UK and
the Netherlands [13].
In many European countries, it is com-
mon to limit direct access to specialist care
through the GP as “gatekeeper”.This means
that the patient may not choose a special-
ist without a referral from the GP. He or
she is therefore dependent on the opinion
of the GP. In these systems the GP is usu-
ally required to take cost considerations into
account when referring patients, and is thus
encouraged to ration. Such systems exist,
inter alia, in Spain and Italy [13].
Limited coverage
The most direct way of rationing is not to
provide services in the public healthcare
system at all. This can be done by using
positive or negative lists, or whole blocks of
services are not covered in the system. For
example, physio- and psychotherapy are not
covered in the Netherlands. [14]. Dental
prosthesis is not covered in Australia, Can-
ada, Denmark, Ireland, Italy, Luxembourg,
the Netherlands and Switzerland [13].
Positive and negative lists as well as other
instruments are the international rationing
Official statistics on waiting times and lists
Sweden
UnitedKingdom
Slovenia
Australia(2010)
CzechRepublic
Netherlands
Slovakia
Germany
Japan(2010)
Estonia
Belgium
Poland
Hungary
Luxemburg
Korea
Israel
Switzerland
Greece
Austria
Iceland
Finland
Norway
NewZeland
Spain
Portugal
Canada
Italy
Ireland
France
Denmark
Social insurance contributions (%)
Taxes (%)
Figure 4. Comparison of waiting times and source of financing of the healthcare system
(Source: Authors’ own representation; OECD Health Data, 2013)
BACK TO CONTENTS
20 21
GERMANY GERMANY Health SystemsHealth Systems
standard in the supply of medicines [13].
In Ireland, 70 % of patients fund their GP
privately, because they exceed the income
threshold for reimbursement [15].
In Germany, a statutory entitlement to
healthcare services applies nationwide.
This differs completely from Sweden, for
example. Here, the county councils decide
whether the costs for medical services will
be covered [16]. Thus, the decision whether
someone will receive a new hip depends on
the place of residence.
Co-payments
Another rationing instrument applied in
each country are co-payments. In Germany,
in the case of hospital stays, 10 euro must
be paid by the patient per calendar day for a
maximum of 28 days. In addition, there are
rules and regulations on co-payments for,
inter alia, medicines, remedies and medical
aids. In the Netherlands, by contrast, the
statutory health insurance includes a pa-
tient deductible of 360 euro per year for all
insured persons over the age of 18. Only the
costs for the GP and obstetrics are exempt
from this [14] [17]. There is also a patient
deductible in Switzerland (the so-called
franchise) for health insurance. The fran-
chise amounts to around 250 euro per year,
converted from francs. Besides this, a fur-
ther 10 % of the remaining invoice amount
must be covered by the insured party them-
selves [18]. In the French and Japanese
health system, obligatory co-payments are
also relatively high [19] [20]. In Japan, a
contribution of 30 % can be a financial bur-
den, in particular for cost-intensive inpa-
tient treatment.
Even if many OECD countries have imple-
mented rules and regulations to protect par-
ticular population groups from excessive fi-
nancial demands arising from co-payments,
the steering effect of co-payments still ap-
plies to the remaining parts of the popula-
tion.
Voluntary private
health insurance as a
reaction to rationing
Taking out voluntary private health insur-
ance represents an indicator for significant
rationing in basic statutory care. Depending
on the type of “gap” in the public system,
matching private insurances develop to fill
it. As a result, there is a market for volun-
tary private health insurance in almost all
OECD countries.
Duplicate insurance ensures a claim to
services which the patient already officially
has in the statutory system, but cannot be
enforced in practice. It is used above all
to avoid waiting times and limitations of
free choice in the public health system and
are widespread in, for example, the UK,
Ireland and Denmark. The supplemen-
tary insurance reimburses services that
are not covered in the public system at all.
This system has an effect in the Nether-
lands, for example, as the services covered
by statutory health insurance only include
basic medical treatment. Services that
go beyond this, such as physiotherapy or
orthodontic treatment, can be covered by
supplementary private health insurance.
The complementary insurance completes
the insurance cover of the public system by
reimbursing obligatory co-payments. For
example, around 94 % of French people
possess such complementary insurance in
order to cover the high-cost sharing in the
public system [1].
Differences in care as a
consequence of rationing
Rationing measures in healthcare lead to eva-
sive reactions,as patients are not willing to set-
tle for the rationed services offered by the pub-
lic system and acquire the desired services at
home or abroad.In the UK,for example,there
exists a well-structured private health sector
in parallel to the tax-funded public sector.
This is partly established within the National
Health Service (e.g. private departments in
public hospitals) or also outside it (e.g. in pri-
vate clinics or private medical practices).Thus,
British patients can be treated in the private
sector in order to avoid waiting times and
cover the costs either by using private health
insurance or paying for the treatment them-
selves [21]. In the Netherlands, various types
of service are excluded from reimbursement,
such as dental treatment or physiotherapy for
adults. In order to supplement the range of
services according to individual needs, a large
range of supplementary insurances are on
offer. Around 86 % of people in the Nether-
lands have supplementary insurance for dental
and orthodontic care, and 71 % have supple-
mentary insurance for physiotherapy [22].
The options to purchase a desired service
outside the collectively financed health
system are generally distributed unevenly
across the population. The requirements
for access depend firstly on the socio-eco-
nomic situation of the patient. Only those
who possess the required financial resources
can purchase the services. That means that
they either have the possibility to finance
Table 1. Relationship between voluntary private health insurance and rationing in the pub-
lic health system Source: Authors’ own representation
Type of private
health insurance
Form of rationing, which promotes the type of private health
insurance
Duplicate Waiting times, gatekeeping and low quality in public health system
Supplementary
Limitation of services in public health system, e.g. no assumption of
costs for dental treatment, medicine, rehabilitation, alternative medi-
cine, single room or treatment by the head physician at the hospital
Complementary
Obligatory co-payments, i.e. the public health system only takes on
services on a pro-rata basis
the private health services themselves or
they can afford to take out voluntary private
health insurance, which reimburses these
services. However, there are other people
who remain relegated to the (limited) level
of care of the public system because they
lack financial means. As a result, patients
with comparable indications are treated
completely differently in societies that have
a single-payer healthcare system.
The existence of voluntary private health in-
surance cannot entirely remove inequalities
in care, but can reduce it markedly. This be-
comes clear in comparison with a situation
in which the only option is self-payment: in
this case, a patient might have to forgo ex-
pensive treatment because it exceeds his or
her budget. However, if healthcare provision
is covered by insurance, he or she might be
in a position to afford the insurance cover,
since the costs of insurance premiums re-
main well below the costs of any potential
treatment. If, for example, dental prosthesis
is not included in the service catalogue of a
country’s public health system, people who
would not be able to afford expensive dental
treatment, may well cover this risk by taking
out supplementary insurance. In this way,
the existence of private dental insurance re-
duces the inequalities in care in relation to a
situation in which a patient must pay out of
pocket for the treatment. More people can
afford supplemental care through the exis-
tence of private insurance and are not ex-
posed to high costs if they require treatment.
Conclusion
In conclusion, it becomes clear that medical
services are rationed in all the countries sur-
veyed, by means of waiting times, gatekeep-
ing, limited coverage and/or co-payments.
This fact is due to the elimination of market
mechanisms, including free pricing. As a re-
sult of tax-funding and (compulsory) contri-
butions in healthcare systems, the price does
not take on the function of allocation and
rationing, which it has in a perfect market.
In single-payer health systems, barriers to
access (e.g. waiting times) lead to differ-
ences in care within the population. Here,
patients have an incentive to purchase the
services on the private market. Public sys-
tems thus fall short of the target of ensuring
equal access to care. Because they involve
rationing,they help contribute to the spread
of private markets. As only certain parts of
the population can afford private health
services, this promotes the so-called “two-
tier healthcare”. Voluntary private health
insurance, however, can help reduce these
inequalities.
References
1. OECD Health Data: Social protection, OECD
Health Statistics 2012 (database).
2. Hurst J, Siciliani L. Tackling Excessive Waiting
Times for Elective Surgery: A Comparison of
Policies in Twelve OECD Countries OECD
Health Working Papers No. 6, 2003.
3. Siciliani L, Hurst J. Explaining Waiting Times
Variations for Elective Surgery across OECD
Countries. OECD Health Working Papers No.
7, 2004.
4. Schoen C, Osborn R, Squires D et al.: How
Health Insurance Design Affects Access to Care
and Costs, by Income, in Eleven Countries.
Health Affairs 2010, 29(12):2323-2334.
5. Kassenärztliche Bundesvereinigung: Versi-
chertenbefragung der Kassenärztlichen Bundes-
vereinigung 2011. Ergebnisse einer repräsenta-
tiven Bevölkerungsumfrage – September 2011,
Mannheim.
6. Roll K, Stargardt T, Schreyögg J: Effect of type
of insurance on waiting time for outpatient care.
Hamburg Centre for Health Economics, Re-
search Paper 2011/03.
7. Commonwealth Fund: 2010 Commonwealth
Fund International Health Policy Survey, on-
line unter: http://www.commonwealthfund.org/
Surveys/2010/Nov/2010-International-Survey.
aspx (20.05.2014).
8. NHS England. Consultant-led Referral to
Treatment Waiting Times Data 2013-14  –
Referral to Treatment (RTT) Waiting Times,
England. http://www.england.nhs.uk/statistics/
statistical-work-areas/rtt-waiting-times/rtt-
data-2013-14 (20.05.2014).
9. Sveriges Kommuner och Landsting. Planerad
specialiserad vård  – Besök, mars 2014. http://
www.vantetider.se/Kontaktkort/Sveriges/Spe-
cialiseradBesok (20.05.2014).
10. Sundhedsstyrelsen. Ventetider for udvalgte be-
handlinger og operationer, maj 2014. http://
www.esundhed.dk/sundhedskvalitet/NIV/NIV/
Sider/Venteinfo.aspx (20.05.2014).
11. Rijksinstituut voor Volksgezondheid en Milieu –
Nationale Atlas Volksgezondheid. Wachtlijsten
ziekenhuiszorg. http://www.zorgatlas.nl/thema-
s/wachtlijsten (20.05.2014).
12. National Health Service. NHS waiting times –
Comparing waiting times. http://www.nhs.uk/
choiceintheNHS/Rightsandpledges/Waiting-
times/Pages/Guide%20to%20waiting%20times.
aspx (20.05.2014).
13. Paris V, Devaux M, Wei L. Health Systems
Institutional Characteristics: A Survey of 29
OECD Countries, OECD Health Working Pa-
pers No. 50, 2010.
14. Schäfer W, Kroneman M, Boerma W et al. The
Netherlands: Health system review. Health Sys-
tems in Transition, 12(1), 2010.
15. Irish Competition Authority. Competition in
Professional Services – General Medical Prac-
titioners, 2010.
16. Preusker, UK. Offene Priorisierung als Weg zu
einer gerechten Rationierung? G + G Wissen-
schaft 2/2004:16-22.
17. Rijksoverheid: Eigen risico zorgverzekering.
http://www.rijksoverheid.nl/onderwerpen/
zorgverzekering/eigen-risico-zorgverzekering
(20.05.2014)
18. Schweizer Bundesamt für Gesundheit. Ant-
worten auf häufig gestellte Fragen zur Kosten-
beteiligung
19. Chevreul K, Durand-Zaleski I, Bahrami S et al.
France: Health system review. Health Systems
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beit und Soziales. Health and Medical Services:
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wp-hw4/dl/health_and_medical_services/P26.
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22. Schulze Ehring F: Die Reform der Kranken-
versicherung in den Niederlanden. Betrach-
tungen aus deutscher Sicht. Schulze Ehring
F, Köster AD. Die Gesundheitsreform in den
Niederlanden und in der Schweiz als Vorbild
für Deutschland? PKV-Dokumentation Nr. 29,
2010.
Verena Finkenstädt
and Dr. Frank Niehaus
Scientific Institute of Private
Health Insurance
Gustav-Heinemann-Ufer 74c,
50968 Cologne, Germany
E-mail: wip@wip-pkv.de
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22 23
DENMARK Health TechnologyPharmaceutical Industrie
Innovation is essential to progress. This is
true for the pharmaceutical industry, which
relies on innovation to produce new and
improved medicines for patients  – and
I also think it holds true for the bigger pic-
ture. This thinking was part of the impetus
behind EFPIA’s Health and Growth Stra­
tegy – which presents a new European life
sciences strategy, with a strong innovation
ecosystem at its heart. By supporting an EU
environment that nurtures innovation, we
can help not only the pharmaceutical in-
dustry, but also European patients – and the
EU as a whole.
As Europe begins to emerge from the fi-
nancial crisis and set out its plans for a
return to growth, the time is right to fun-
damentally review how Europe addresses
the inter-connected challenges of improv-
ing the health prospects and productivity
of its citizens, within an affordable financial
framework, while ensuring that the phar-
maceutical and life sciences industries  –
jewels in Europe’s economy – continue to
thrive.These challenges cannot be separated
and addressed in isolation.
In this context, the pharmaceutical industry
has a valuable role to play. It is one of the
highest value-added sectors, with a foot-
print that connects some of the brightest
start-up ventures in Europe, academic cen-
ters, diverse health networks, and a whole
infrastructure of high-value technology and
science services.These workforce advantages
translated to a wider, positive impact during
the recent financial crisis, with the pharma-
ceutical sector proving more resilient than
other industries between 2008–2010, large-
ly maintaining employment at a time when
other manufacturing sectors contracted by
between 10% and 15%.* The pharmaceuti-
cal industry employs over 690,000 people in
Europe, contributing 17% of total business
enterprise R&D employment. Additionally,
in 2013, Europe’s pharmaceutical trade sur-
plus was estimated at 90 billion.**
However, the pharmaceutical industry
is not capable of carrying this vision for
Health & Growth forward on its own. At
the core of the Health & Growth strategy
is the need for collaboration: We must all
endeavour to break down barriers and silos.
As new European leaders and policymakers
begin their work to improve Europe’s fu-
ture, European Federation of Pharmaceu-
tical Industries and Associations (EFPIA)
calls for greater political collaboration to
agree a comprehensive strategy for life sci-
ences, based on three separate but interde-
pendent pillars:
1. Improvement of health outcomes and
removal of inequalities to better patient
benefits;
2. Support for sustainable and predictable
healthcare systems to speed access to
medicines;
  *  EFPIA (2013): The pharmaceutical Industry in
Figures: Key Data (2013)
**  EFPIA (2013): The pharmaceutical Industry in
Figures: Key Data (2013)
3. The building of a thriving innovative life
sciences sector to promote European
competitiveness.
If we are to see this strategy succeed, we
need not only collaboration but also open
minds. We must be open to conversation, to
new ideas and to working together with di-
verse stakeholders. Coming from the phar-
maceutical industry – where innovation is an
essential piece for progress – I have no doubt
that this will be the key to our success.
The progress already made this year with
the European Medicines Agency (EMA)
announcing its MAPPs pilot project is an
excellent example. Medicine’s Adaptive
Pathways to Patients (MAPPs) is an ap-
proach building on the advances in medical
science, genomics, and personalized medi-
cine to facilitate an approval process that
adapts quickly to a given patient group’s
response to therapies. It will launch with a
clearly defined patient population with un-
met medical needs, followed by continued
gathering of evidence in support of expand-
ing the pool of recipients of the new therapy
as the knowledge base of MAPPs grows.
The European Medicines Agency’s adaptive
pathway pilot project with real medicines in
development is a bold step in improving the
way innovative and needed new therapies
reach patients, and signals a new exciting
direction for Europe. Ultimately, MAPPs
is about bringing better, needed new thera-
pies to patients who need them.This is what
drives our industry.
If we continue to support creative initiatives
like this, we are doing something right. Eu-
rope remains a hub for innovation and cre-
ative thinking – and it’s important we pro-
tect that. Keeping an open conversation on
healthcare going and giving voice to diverse
opinions is part of this process. I do believe
we are on the right track.
Richard Bergstrom, Director General of
European Federation of Pharmaceutical
Industries and Associations (EFPIA)
LookingtotheLifeSciencesforaHealthierEU
Richard Bergstrom
Good governance in health policy aims at
improving the health outcomes and per-
formance within financially sustainable
health systems (1). Health Technology
Assessment (HTA) contributes to the for-
mulation of sustainable health policies by
providing evidence-based information to
those who define policies and decide on
the coverage and usage of health technolo-
gies.
The economic downturn – or at least slow-
ing of growth – in countries across the globe
has put higher pressure on private, public
and health insurance resources for health-
care. This has increased the need to priori-
tise limited resources – and lead to political
interest in exploring and implementing the
use of HTA to inform decision-makers on
effective health policies and decisions that
provide real value to patients.WHO resolu-
tions and EU legislation reflect this devel-
opment (2, 3, 4, 5).
What is HTA?
The somewhat alienating concept “tech-
nology” basically means practical ap-
plication of scientific knowledge, and in
healthcare this would mean diagnostics
and interventions in the broadest sense
(drugs, devices, medical, surgical, preven-
tive interventions) and the organisational
and support systems within which health
care is provided (6).
HTA is a practical tool to inform decisions
in healthcare on relevant scientific evi-
dence at different levels of national health
care systems in a structured transparent
way. Not any decision, but decisions that
involve defining general policies or guid-
ance – or sizable use of limited resources.
HTA works best when there is a well-
defined and transparent role of HTA in
informing policy- and decision processes.
The policy questions or consequences of
various options which the decision-makers
would like to straighten out should define
the questions that the HTA should address
(Figure 1).
HTA a multidisciplinary process that sum-
marises information about the medical,
social, economic and ethical issues related
to the use of a health technology in a sys-
tematic, transparent, unbiased, robust man-
ner. It aims at informing the formulation of
safe, effective, health policies that are pa-
tient focused and seek to achieve best value.
Having policy goals, HTA must always be
firmly rooted in research and the scientific
method (6).
HTA is applied at national, regional and
institutional levels (e.g. hospitals). Many
countries such as Canada, Spain, and UK
have implemented systems for HTA quite
thoroughly at national and regional levels
while several other countries like Colum-
bia, India, and South Korea are currently
implementing HTA in their health policy.
The practice of HTA, however, varies con-
siderably across national settings. It informs
The Growing Importance of Health
Technology Assessment
Finn Børlum Kristensen
Figure 1. Based on Kristensen FB et al. Seminars in Colon and Rectal Surgery, 2002;
13: 96–103
BACK TO CONTENTS
24 25
Health Technology Health TechnologyDENMARKDENMARK
policy- and decision-making in specific po-
litical, economic, institutional and clinical
contexts. In order to be useful, HTA should
fit into the relevant context where it is ap-
plied.
Scientific and professional
developments that lead to the
methodologies applied in HTA
Four main streams of applied research
methodology have contributed to the de-
velopment of HTA: (i) policy analysis;
(ii) evidence-based medicine; (iii) health
economic evaluation; and (iv) social and
humanistic sciences (7). Policy analysis
sets a general framework for HTA as an
input to policy-making. Evidence-based
medicine (i.e. clinical epidemiology) and
health economic evaluation set the meth-
odological frames for the analyses carried
out as part of an HTA. In addition, HTA
may include the application of methodolo-
gies from social sciences and humanistic
(qualitative) research. This is especially
true when meeting the requirements of
a broad-scoped HTA which may include
organisational, societal and patient/citizen
aspects of technology.
What does the increasing
importance of HTA mean
for the medical profession?
Medical associations and academic/
scientific societies should engage and
encourage their members to consider
getting involved in establishing and sus-
taining high quality HTA structures and
processes in their country. They should
be prepared to participate in systematic
reviews of available scientific evidence
and provide expert interpretation on
the clinical and patient relevance of the
evidence – and participate in HTA work
with other professions.
HTA in Europe
A majority of Member States in the Euro-
pean Union (EU) now have public sector
HTA agencies that provide information
to decision making and policy making at
the national or regional and levels. Many
European countries are formally building
HTA into policy, governance, reimburse-
ment, and/or regulatory processes. The
development of HTA in Europe has been
a unique combination of scientific, politi-
cal and practical steps taken in a region
of the world that provides specific condi-
tions for that to happen – conditions such
as the process of European integration and
the EU and its Health and Research pro-
grammes (8).
A European Commission call in 2005 led
to the European network for Health Tech-
nology Assessment (EUnetHTA) which
has been organised through the initial EU-
netHTA Project, the EUnetHTA Collabo-
ration, the EUnetHTA Joint Action, and
EUnetHTA Joint Action 2. EUnetHTA
was established to create an effective and
sustainable network for HTA across Eu-
rope – and to work together to help devel-
oping reliable,timely,transparent and trans-
ferable information to contribute to HTAs
in European countries (9, 10, 11, 12). EU-
netHTA supports collaboration between
European HTA organisations that brings
added value at the European, national and
regional level through
• facilitating efficient use of resources avail-
able for HTA
• creating a sustainable system of HTA
knowledge sharing
• promoting good practice in HTA meth-
ods and processes.
Currently EUnetHTA consists of 44 part-
ner organisations designated by their re-
spective ministry of health in all 28 EU
member states, Norway, Switzerland, and
Turkey and a large number of regional
agencies and non-for-profit organisa-
tions that produce or contribute to HTA.
The network is lead by the Danish Health
and Medicines Authority in Copenhagen
(Table 1).
Table 1. Relationship Some of the Partner
Organisations in Joint Action 2
(2012–2015), e. g.
• UK, NICE, NETSCC (+HIS)
• Germany, IQWIG, DIMDI (+GBA,
Medical Valley – EMN)
• France, HAS
• Italy, AGENAS, AIFA, ASSR Emilla
Romagna, Veneto Reion
• Spain, ISCIII, AETSA OSTEBA,
Avalia-T, AQuAS
• Croatia, AAZ
• Poland, AHTAPOL
• Austria, LBI, HVB, GÖG
• Netherlands, CVZ
• Belgium, KCE
• Portugal, INFARMED
• Sweeden, SBU,TLV
• Norway, NOKC
• Finland,THL, FIMEA
• Denmark, DHMA (Coordinator),
CFK Region Midt
An EU Directive on the application of pa-
tients’ rights in cross-border healthcare was
put in place in 2011 established a legal basis
(Article 15) for Union support and facilita-
tion of cooperation and the exchange of sci-
entific information among Member States
within a voluntary network connecting na-
tional authorities or bodies responsible for
health technology assessment designated
by the Member States (5). In order to meet
the objectives of this Directive EUnetH-
TA performs the function of the scientific
and technical cooperation of the voluntary
HTA Network (13).
Current activities of the EUnetHTA JA2
are supported by funding from the EU in
the framework of the Health Programme
with the following strategic objectives:
1)  to strengthen the practical application
of tools and approaches to cross-border
HTA collaboration, 2) to bring collabo-
ration to a higher level resulting in better
understanding­of the ways to establish a
sustainable structure for HTA in the EU,
and 3) to develop an implementation pro-
posal for a sustainable scientific and techni-
cal collaboration.
EUnetHTA has activities along the whole
of the life cycle of technologies from in-
novation to obsolescence (Figure 2). Early
scientific advice aim at facilitating relevant
research by technology developers and
sponsors to improve the evidence-basis for
HTA when the technology is matured to
be introduced to healthcare. Rapid rela-
tive effectiveness assessment (REA) was
developed to inform reimbursement deci-
sions on new pharmaceuticals and medical
devices.
Examples of output
from EUnetHTA
The HTA Core Model® is a methodological
framework for shared production and shar-
ing of HTA information.
The HTA Core Model consists of three
components:
1. An ontology containing a set of generic
questions that define the contents of
an HTA. The questions are distributed
within nine Domains which as a whole
reflect the broad scope of HTA (Fig-
ure 3)
2. A methodological guidance that assists
in answering the questions
3. A common reporting structure that en-
ables standardised reporting of HTAs.
Information is created and presented
as assessment elements. Some elements
are prioritised over others to support
European collaboration through defin-
ing them as “core elements”.
There are five applications of the model:
Diagnostic Technologies, Medical and
Surgical Interventions, Pharmaceuticals,
Screening Technologies, Rapid Relative Ef-
fectiveness Assessment of Pharmaceuticals
(14).
The EUnetHTA Planned and Ongoing Proj-
ects (POP) database allows HTA agencies
to share information with each other on
planned and ongoing projects conducted
at the individual agency. The aim of the
database is to reduce duplication and fa-
cilitate collaboration among HTA agen-
cies (14).
The Evidence database on new technologies
(EVIDENT Database) allows sharing and
storage of information on reimbursement/
coverage and assessment status of promis-
ing technologies and on additional studies
requested by decisions-makers or recom-
mended by a HTA. The EVIDENT Data-
base’s goal is to reduce redundancy, promote
generation of further evidence when neces-
sary and facilitate European collaboration
in this field (14).
Nine methodological Guidelines for Rapid
REA of Pharmaceuticals are guidelines on
methodological challenges that are encoun-
tered by health technology assessors while
Figure 2. Health Technology Life-cycle
Figure 3. The Domains of the HTA Core Model
BACK TO CONTENTS
26 27
Health TechnologyHealth Technology DENMARKDENMARK
performing a rapid REA of pharmaceuti-
cals.The primary aim of the guidelines is to
help the assessors of evidence interpret and
process the data that are presented to them
as part of a REA (15).
Here are some examples of pilot assess-
ments that have been done jointly by vari-
ous clusters of EUnetHTA partners across
Europe (12):
• Canagliflozin for the treatment of type 2
diabetes mellitus
• Renal denervation systems for treatment-
resistant hypertension
• Zostavax for the prevention herpes zoster
• Duodenal-jejunal bypass sleeve
• Prognostic tests for breast cancer re-
currence (uPA/PAI-1 [FEMTELLE],
MammaPrint, Oncotype DX)
• Fecal Immunochemical Test (FIT) ver-
sus guaiac-based fecal occult blood test
(FOBT) for colorectal cancer screening
Examples of added value coming
out of participation in the
European cooperation on HTA
The following examples were provided by
representatives of organisations that par-
ticipated in the joint work on the European
level supported via EUnetHTA JA1 and
JA2 activities ():
• Accelerated and real-time informa-
tion exchange between HTA agencies
in Europe on relevant topics in areas of
common interest such as reimbursement
status updates in different countries,
regulatory activities, stakeholder involve-
ment practices “know-how”
• Particularly for new/”young” HTA agen-
cies participation in and contribution
to joint work in a EU-wide coopera-
tion brings benefits of improving a) lo-
cal competence and capacity in HTA, b)
national awareness and political recog-
nition of concrete benefits of HTA for
the national/regional healthcare systems,
c) methodologies and professionalism in
local HTA processes,d) effective commu-
nication and cooperation with relevant
national/regional policy- and decision-
makers (e.g., higher standing of HTA
with the national policy makers through
e.g., recognition of improved efficiency
via national leveraging of the HTA work
done somewhere else, contribution to
the quality improvement of the national
work, etc).
• Development and strengthening of the
EU cooperation on HTA has brought
about an actual change in a) using English
as the publication language for the HTA
reports (while local languages are used to
publish the summaries of the reports),
e.g., in Norway, Austria, Finland, Italy,
b) the local HTA production processes,
i.e., a new project is not started without
checking the POP database and iden-
tifying work already done by others or
identifying potential partners for a joint
work or at least information exchange on
the topic, e.g., Finland (THL, FIMEA),
Belgium (KCE), Austria (LBI), Croatia
(AZZ) already widely practiced this ap-
proach.
• Being engaged in the joint work on an
EU-level directly contributes to stan-
dardisation of the HTA methodologies
and indirectly influences the HTA pro-
duction routines in various HTA agen-
cies towards more consistent/coherent
approaches across borders due to the staff
being constantly “exposed” to different
working methods and solutions in the
partner HTA organisations.
• Development of consistent and coher-
ent stakeholder involvement practice in
EUnetHTA increases attention to stake-
holder involvement issues on the national
and regional level and assists the devel-
opment of national stakeholder involve-
ment processes and communication with
stakeholders
Principles of transparency employed in EU-
netHTA JA1 and JA2 practices has a strong
potential to contribute positively to devel-
oping similar national practices, however, it
is a process that requires time, initiative and
consistent effort on national level
• Increased international visibility of the
participating organisations.
HTA and pharmaceutical
regulation in Europe
Collaboration between regulators and HTA
bodies on a European level has taken place
since 2010 by way of the European Medi-
cines Agency (EMA) and EUnetHTA and
is part of the ongoing dialogue to support
policy-maker decisions in the future. Clini-
cal data generated by pharmaceutical com-
panies during the development process of a
medicine is the basis for the evaluation of
the benefit/risk balance of a medicine for
the purpose of marketing authorisation.The
same data informs the assessment of the ef-
fectiveness of the new medicines compared
to existing therapies, as part of the HTA
process to support decision making on ap-
propriate utilisation, price and reimburse-
ment in EU Member States. The first joint
EMA-EUnetHTA project responded to a
political recommendation to consider how
the assessment of the favourable and unfa-
vourable effects of a medicine as contained
in EMA’s European Public Assessment Re-
ports (EPARs) can best be used to inform
the assessment of the relative effectiveness
of new medicines for HTA purposes in EU
Member States (17).
In 2013 the European Medicines Agency
EMA and EUnetHTA have published a
joint three-year work plan outlining key ar-
eas of collaboration (18). Key areas for the
three years include:
• Scientific advice/early dialogue with
sponsors, involving medicines regula-
tors and health-technology assessment
(HTA) bodies;
• exchange on the development of scientific
and methodological guidelines to facili-
tate clinical-trial design that can gener-
ate data relevant for both benefit-risk and
relative effectiveness assessments;
• developing approaches for collection of
post-authorisation data to support activi-
ties of both medicines regulatory authori-
ties and HTA bodies;
• orphan medicinal products, exploring
ways of sharing information for the com-
mon benefit of patients affected by rare
diseases and the financial sustainability of
the healthcare systems.
The EMA and EUnetHTA will review and
update the work plan as necessary, and at
least once annually.
EUnetHTA Stakeholder Forum
The EUnetHTA Stakeholder Forum was
formed to ensure a transparent engage-
ment with a broad range of stakeholders
and is comprised of representatives from
patient and healthcare consumer organisa-
tions, healthcare providers, payers (statutory
health insurance) and the pharmaceuti-
cal and medical technology industry. The
Stakeholder Forum’s  composition aims at
ensuring broad and balanced representation
of stakeholder interests.
The purpose of the EUnetHTA Stakehold-
er Forum is to provide stakeholders with
the opportunity a) to participate as stake-
holder representatives in the EUnetHTA
Joint Actions, b) to observe and comment
on the EUnetHTA Joint Action work, c) to
provide advice to overarching governance
questions in the Joint Actions, and d) to
bring forward specific themes and concerns
considered relevant by the stakeholders’
constituencies and in line with the aims of
the EUnetHTA Joint Actions.
The medical profession is represented in the
Stakeholder Forum by the Standing Com-
mittee of European Doctors, CPME, the
European Society of Cardiology and the
European Society for Medical Oncology,
ESMO. Patients and consumers are rep-
resented by the European Patients Forum,
EPF, the European Rare Diseases Organ-
isation, EURORDIS, European Register
for Multiple Sclerosis, ESC, and the Euro-
pean Consumer Organisation, BEUC.
References
4. WHO European Ministerial Conference on
Health Systems,Tallinn Charter 2008 http://
www.euro.who.int/en/media-centre/events/
events/2008/06/who-european-ministerial-
conference-on-health-systems/documentation/
conference-documents/the-tallinn-charter-
health-systems-for-health-and-wealth (accessed
September 15, 2014)
5. PAHO. Resolution on HTA and decision-
making (Resolution CSP28.R9), approved by
Member States in September 2012. Wash-
ington, DC: Pan American Health Organi-
zation, 2012 http://iris.paho.org/xmlui/han-
dle/123456789/3684 (accessed September 15,
2014)
6. SEARO.Heath intervention and technology as-
sessment in support of universal health coverage
(Resolution SEA/RC66/R4). New Delhi, India:
World Health Organization Regional Office for
South-East Asia 2013 http://www.searo.who.
int/mediacentre/events/governance/rc/66/deci-
sions_resolutions/en/(accessed September 15,
2014)
7. WHO. Sixty-seventh World Health Assembly,
Health intervention and technology assessment
in support of universal health coverage, Resolu-
tion, Geneva 2014 http://apps.who.int/gb/eb-
wha/pdf_files/WHA67/A67_R23-en.pdf?ua=1
(accessed September 15, 2014)
8. Directive 2011/24/eu of the European parlia-
ment and of the council of 9 March 2011 on
the application of patients’rights in cross-border
healthcare http://eurlex.europa.eu/LexUriServ/
LexUriServ.do?uri=OJ:L:2011:088:0045:0065:
EN:PDF (accessed September 15, 2014)
9. http://www.eunethta.eu/about-us/faq#t287n73
(accessed September 15, 2014)
10. Børlum Kristensen F, Palmhøj Nielsen C, Chase
D et al. What is health technology assessment?
In: Velasco-Garrido M, Børlum Kristensen F,
Palmhøj Nielsen C, Busse R (eds.) Health tech-
nology assessment and health policy-making
in Europe – Current status, challenges and po-
tential. Copenhagen: WHO Regional Office
for Europe: 31-51,2008 http://www.euro.who.
int/__data/assets/pdf_file/0003/90426/E91922.
pdf (accessed September 15, 2014)
11. Banta D, Kristensen FB, Jonsson E. A history of
health technology assessment at the European
level. Int J Technol Assess Health Care 2009; 25
(Suppl 1): 68-73
12. Kristensen FB, Mäkelä M, Neikter SA, Rehn-
qvist N,Håheim LL,Mørland B, et al.Planning,
development, and implementation of a sustain-
able European network for health technology
assessment. Int J Technol Assess Health Care 2009;
25 (Suppl 2): 84-91
13. Kristensen FB, Lampe K, Chase D, Lee-Robin
SH, Wild C, Moharra M, et al. Practical tools
and methods for health technology assessment
in Europe: structures, methodologies, and tools
developed by the European Network for Health
Technology Assessment,EUnetHTA.Int JTech-
nol Assess Health Care 2009; 25 (Suppl 2): 68-73
14. Kristensen FB.Development of European HTA:
from Vision to EUnetHTA. Michael Quarterly,
Norwegian Medical Society 2012;9: 147–156
http://www.dnms.no/index.php?seks_id=1493
47&treeRoot=147800&element=Subsek3&a=1
(accessed September 15, 2014)
15. www.eunethta.eu (accessed September 15,2014)
16. http://ec.europa.eu/health/technology_assess-
ment/policy/network/index_en.htm (accessed
September 15, 2014)
17. http://www.eunethta.eu/outputs (accessed Sep-
tember 15, 2014)
18. http://www.eunethta.eu/eunethta-guidelines
(accessed September 15, 2014)
19. http://www.eunethta.eu/sites/5026.fedimbo.
belgium.be/files/EUnetHTA%20JA2_Plenar-
yAssembly%202014_SummaryReport_FINAL.
pdf (accessed September 15, 2014)
20. Berntgen M, Gourvil A, Pavlovic M, Goettsch
W, Eichler HG, Kristensen FB. Improving the
Contribution of Regulatory Assessment Re-
ports to Health Technology Assessments-A
Collaboration between the European Medicines
Agency and the European network for Health
Technology Assessment. Value Health. 2014
Jul;17(5):634-41
21. http://www.ema.europa.eu/docs/en_GB/docu-
ment_library/Other/2013/11/WC500154588.
pdf (accessed September 15, 2014)
22. http://www.eunethta.eu/eunethta-stakeholder-
forum (accessed September 15, 2014)
Professor Finn Børlum Kristensen, MD, PhD
EUnetHTA Secretariat
Danish Health and Medicines Authority
Faculty of Health Sciences,
University of Southern Denmark
Axel Heides Gade 1
DK-2300 Copenhagen S
Tel: +45 7222 7400
Dir: +45 7222 7727
Mob: +45 20759647
E-mail: fbk@sst.dk
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28 29
GERMANY/LATVIAGERMANY/LATVIA Medical EthicsMedical Ethics
Beneficial medical treatment is based on a
trustful therapeutical relationship between
doctor and patient. This does not just hap-
pen by itself, but must be developed with
competence and maintained with care.
Through the ages, the way doctors and
patients meet and interact has undergone
substantial changes, with every era posing
specific challenges.
The Patient:
help-seeking sufferer or
critical consumer?
The traditional view is strongly paternalistic.
Bound to the Hippocratic oath, the fatherly
physician is commited to the patient’s well
being, his own best possible skills, personal
integrity and privacy. “Salus aegroti supre-
ma lex” (the well-being of the patient is the
supreme law) and “primum nihil nocere”
(first of all do not harm) are the principle
professional rules. As a benevolent father-
figure, it is the doctor who decides.
Enlightment and The French Revolution
brought about a fundamentally egalitarian
approach. Questioning authoritative rule
eventually leads to the, nowadays, widely
accepted concepts of “informed consent”
and “shared decision making”, promoting
patient competence and autonomy. Nego-
tiating disagreements becomes possible, the
prevention of abuse and exploitation of the
subordinate easier. Instead of command and
obedience, two individuals with equal rights
make a contract.And finally,it is the patient
who decides.
Sounds good, but where does this leave us?
The egalitarian model is easily applied to
buyer and seller at the marketplace, where
the buyer looks for a certain product or ser-
vice and makes an informed decision after
having checked price and quality. But is a
patient’s need for aid when in distress and
crisis the same thing as buying a new vacu-
um cleaner, a favourable mobile phone tarif
or an attractive spa package?
The more fit a patient is, the more he is able
to act like a competent consumer. By means
of the internet he is sometimes better in-
formed about specific details than his doc-
tor. The greater a patient’s distress however,
and the younger, older or more sick he is,
the less important autonomous negotiating
might be for him.
Between doctor and patient, duties and
responsibilities are shared in a very asym-
metrical manner. Unlike the doctor, whose
health remains in a comfortable and safe
position, the patient, may be in a situation
of life and death, his physical integrity in
question as well as having responsibilities
for loved ones. So in everyday medical prac-
tice, a third option must often be consid-
ered: The patient wants the doctor to decide
for him.
This doesn’t make things easier, however.
The doctor: trusted medic
or top salesman?
Medical doctors still hold a high social
status in public opinion polls and achieve
remarkable income levels. Enormous tech-
nical progress has added to the reputation
of the profession. Consequently, doctors
are confronted with high expectations by
society as a whole and by the individual
patient.
But something has gone wrong. Numer-
ous publications highlight serious deficits
in medical care, pointing to an increasing
mutual alienation between doctors and
patients. A gap of mistrust seems to have
opened. Patients have become cautious be-
cause they know or have heard of doctors
motivated by pressure from their admin-
istrations and lured by bonus payments to
prescribe more expensive drugs, more lucra-
tive diagnostic interventions and higher-
priced surgical procedures; all potentially
harmful. Alternative medicine may seem
less of a hazard.
At the same time, patients seem to be fight-
ing back. We are seeing a surge in malprac-
tice and negligence suits, and many colleg-
ues feel the pressure of receiving bad patient
ratings in online portals.
To heal the breach of trust,doctors must ac-
count for the current state of medicine and
Lost in Translation?
The doctor-patient-relationship revisited
Gunta Ancane Arturs AncansBernhard Palmowski
decide which kind of medical care they ac-
tually prefer.
Medicine: human science
or technical engineering?
Today, academic medicine is going through
a dramatic structural change which is char-
acterized by the rule of economy, bureau-
cracy and technology. Bernard Lown, re-
nowned cardiologist,compellingly describes
the far-reaching consequences for everyday
medical practice in his book “The lost art
of healing” (1). We are confronted with a
radical erosion of human medicine in its
original sense. What is lost, is the specifi-
cally human element.
It seems as if the trustful and sustainable
doctor-patient-relationship has become a
side issue. In this way medicine is losing its
soul and becoming a technical engineering
craft. In addition, clinical procedures are
often Tayloristically elaborate, not only in
operating theaters, but wherever they are
performed.
Such a development is not without con-
sequences for the status of a profession in
society. By means of historical examples,
Richard Sennett describes the social decline
of once highly respected professions (as was
the case with the potter profession in an-
cient Greece), which is caused by increasing
dominance of purely technical processes us-
ing mainly manual labor (2).
In this respect, it is highly alarming that
personal and “talking medicine” is increas-
ingly outsourced to non-medical profes-
sions (pedagogues, psychologists, social
workers, etc.). Alongside, and to the detri-
ment of,Cardiology,Oncology or Diabetol-
ogy we see the establishing of non-medical
Psycho-Cardiology, Psycho-Oncology or
Psycho-Diabetology. Instead of the present
traditional family doctor, we might soon see
a non-medical family therapist taking over
the verbal and general counselling care.
This split is something patients definitely do
not want. It’s simply of no use to a suffering
patient to have on the one side the medical
equivalent of a plumber or clockmaker to
repair the broken engine and on the other
side a friendly talking psycho-conversation-
partner, who doesn’t know any more about
the subject matter at stake than the patient
himself. After a myocardial infarction, with
the diagnosis of breast cancer, or with a
threatening somatoform symptom, a pa-
tient has a justified wish to be cared for by
a doctor, who is both medically competent
and compassionate. It is an appallingly dis-
tressing experience for a patient, in a short
session, to be fully informed, according to
all legal standards, about the diagnosis of,
for example, malignant lymphoma by the
responsible oncologist and then to be sent
afterwards to an appointment with a psy-
cho-oncologist to talk over the emotional
elements.
The consequence of this is that frustrated
patients turn away from scientific medi-
cine, and unhappy doctors seek jobs outside
medical care in research, counseling, jour-
nalism or administration.
Patients and doctors –
strangers or friends?
It makes a big difference if doctor and pa-
tient meet for the first time in an emergency
room, strangers to one another, than if they
had already had a couple of appointments in
the assessment of rectal hemorrhage, if they
collaborate on a regular basis in the treat-
ment of rheumatic arthritis, or if they are
even engaged in a psychotherapy meeting
once a week.
Whatever the setting, they face the de-
manding task of establishing a trustful and
sustainable relationship. Coming from two
very different worlds, the patient with his
suffering, the medical problem and his psy-
cho-social history and the doctor with his
medical expertise and the promise to help,
they have to get acquainted with one anoth-
er in order to accomplish the common goal
of relief, or hopefully even healing.
Numerous challenges have to be met. The
average conversation time in a personal
contact between patient and doctor is said
to be less than ten minutes. After fifteen
seconds the patient’s speech is interrupted,
either by the doctor’s questions,or having to
check the computer monitor, or other tasks
such as filling in forms (3). Only half of the
information conveyed by the doctor is prop-
erly understood by the patient and half of
this again forgotten after half an hour. It is
perfectly clear that medicine by the minute
leaves no room for sufficient understanding,
let alone exchange.
This is in strong contrast to the require-
ments of adequate medical care and effi-
cient treatment.
The psychosomatic approach
About ten percent of the urban population
suffer from psychosomatic disorders, mostly
somatoform disorders with functional so-
matic syndromes accounting for the ma-
jority (4). The prevalence in family doctor’s
practices goes up to some thirty or forty
percent and reaches up to sixty percent in
secondary care, e. g. specialised neurologi-
cal or gynecological units (5). The clinical
spectrum ranges from chronic pain syn-
dromes such as headache and back-pain, or
syndromes with compromised organ func-
tion such as vertigo, tinnitus, arrythmias,
hyperventilation, irritable bowel or sexual
dysfunction, to more generalised pictures
such as agitation or burn-out (6). Psychoco-
matic medicine considers the crucial role of
emotional factors in pathogenesis here.
If speaking with a patient is considered im-
portant, then listening is indispensable. Be-
ing in tune with the patient,applying the art
of careful active listening, means listening
with the “third ear”.This enables the doctor
BACK TO CONTENTS
30 31
UNATED STATES OF AMERICA Environmental HealthGERMANY/LATVIAMedical Ethics
to understand subliminal, hidden messages
and to discover those problems the patient
is not yet able to communicate in an open
and direct manner. As Balint put it, if the
patient could clearly name his problem, he
would not have to present a symptom (7).
Patients with psychosomatic disorders are
especially difficult to deal with. Whereas
“ordinary” patients might be expectant and
vulnerable, psychosomatic patients in par-
ticular are additionally prone to feeling dis-
appointed, insulted, hurt and abandoned by
their doctor. Often limited in their abilities
to adequately express their fears and wishes,
they make their medical counterpart offer
help by proposing medical actions in the
form of prescribing drugs, suggesting addi-
tional diagnostic procedures or even recom-
mending surgical interventions.
Doctors do so especially when confronted
with affect-laden signals from their pa-
tients, for example, when confronted with
statements like, “Doctor, I can’t stand this
back pain anymore”, “my head is burn-
ing like fire”, or, “this tears my heart into
pieces”. Overstrained and overwhelmed by
the patient’s relational attitude it seems a
way out is to at least present a medical “gift”
(8). “Ut aliquid fiat” (to do something) may
be one of the most frequent indications in
medicine. As one collegue put it, “sending
that patient to another CT-scan bought
me one month of peace and quiet”. This
example shows that doctors, in their des-
peration, sometimes reject their patients
by sending them to unnecessary examina-
tions or referring them to another colleague.
If in the back of the patients mind is the
notion that evidence based medicine can-
not understand their suffering and is even
rejecting them, then alternative medicines
gain appeal, which is a dangerous trend if
left unchecked.
In order to offer these patients adequate
care, skills and knowledge in understand-
ing and handling patients, emotionally dif-
ficult for the doctor, are necessary. Doctors’
widespread wish to offer comprehensive
help, including somatic and psycho-social
support, is specifically realized in Psycho-
somatic Medicine. Apart from specialist
training, there are several opportunities.
Balint-groups and courses in primary psy-
chosomatic care are especially helpful for
every physician responsible for medical
care, whether it be conservative medicine or
surgery.
As Edward Weiss wrote in 1943, the crucial
point in psychosomatics is “not to study the
soma less; it only means to study the psyche
more” (9).
References
1. Lown B. The Lost Art of Healing. Houghton
Mifflin. 1996
2. Sennett R.The Craftsman.Yale University Press.
2009
3. Bär T. Die spontane Gesprächszeit von Pa-
tienten zu Beginn des Arztgesprächs in der
hausärztlichen Praxis. Dissertation, Charité
2009
4. Schepank H: Epidemiology of Psychogenic
Disorders: The Mannheim Study · Results of a
Field Survey in the Federal Republic of Germa-
ny.Heidelberg,New York,London,Paris,Tokyo:
Springer 1987.
5. Nimnuan C, Hotopf M, Wessely S. Medically
unexplained symptoms. An epidemiological
study in seven specialities. Journal of Psychoso-
matic Research, 2001, Volume 51, Issue 1, 361-
367
6. Henningsen P, Zipfel S, Herzog W. Manage-
ment of functional somatic syndromes. Lancet.
2007 Mar 17;369(9565):946-55.
7. Balint, M.The doctor, his patient and the illness.
London, Edinburgh Churchill Livingstone.
1957.
8. Ring A, Dowrick C, Humphris G, Salmon P.
Do patients with unexplained physical symp-
toms pressurise general practitioners for so-
matic treatment? A qualitative study. BMJ
2004;328:1057
9. Weiss E. Psychosomatic Aspects of Allergic
Disorders. Bull N Y Acad Med. 1947 Nov;
3(11): 604–630.
Prof. Dr. med. Gunta Ancane,
Riga Stradiņš University, Department of
Psychosomatic medicine and psychotherapy;
Dr. med. Bernhard Palmowski,
Akademie für Psychosomatische Medizin und
Psychotherapie Berlin;
Dr. Arturs Ancans,
Riga Stradiņš University, Department of
Psychosomatic medicine and psychotherapy
Chronic Kidney Disease (CKD) is a grow-
ing public health issue around the globe,
especially as CKD leads to end-stage renal
disease (ESRD) which is both very diffi-
cult and costly to treat [1,2]. In the West,
CKD has been predominantly tied to an-
algesic use and the increasing prevalence of
diabetes and hypertension. However, less
attention has been given to environmental
exposures as factors in the development of
CKD, which may play a larger role in the
developing world [3].
Many parts of the developing world such as
Sri Lanka [1], Central America [4], India
[5] and Egypt [6] are experiencing epidem-
ics of CKD of unknown origin (CKDu).
This article presents an overview of the epi-
demiological and postulated etiologies for
the under-recognized epidemic of CKD in
Central America and Sri Lanka, two of the
major regions of activity.
Central America
For the past two decades in Central Amer-
ica, many young men of working age have
fallen victim to a form of chronic kidney
disease of unknown origin-in fact a silent
epidemic has taken hold [4,7, 8, 9, 10, 11].
CKDu in this context has been given the
name ‘Mesoamerican Nephropathy,’ or
MeN.
While exact figures are unavailable, the
likely death toll is at least 20,000 [4]. El
Salvador, surprisingly, has the highest
overall mortality from kidney disease in
the world, and CKD is the second lead-
ing cause of death among men of working
age in that country [10, 12]. Nicaragua and
Honduras are also in the top ten coun-
tries in the world with the highest overall
mortality from kidney disease [12]. While
data on incidence is lacking, studies have
revealed a markedly elevated prevalence
despite poor survival after diagnosis (renal
replacement therapies are inaccessible and
prohibitively expensive for the majority of
victims), indicating that the epidemic is
progressing rapidly [4].
Early unpublished studies and mortality
data from this region indicated that men
working along the Pacific coast were experi-
encing a non-proteinuric chronic renal dis-
ease to a much greater extent than workers
in other parts of their respective countries
[7, 8]. For example, the mortality rate for
males in the coastal departments of León
and Chinandega in Nicaragua are three
times higher than the department at the
next highest elevation and five times higher
than the national average [4].
Despite the important public health im-
plications of such an epidemic, there have
been relatively few studies published on
the epidemic of CKD in Central America
[4]. Most of these studies have been cross-
sectional prevalence studies: measuring se-
rum creatinine to determine renal function
and/or administering questionnaires to
ascertain medical, occupational, and envi-
ronmental exposures [13, 14, 15, 16, 17].
While cross-sectional studies have limita-
tions, such as recall bias and the inability
to determine causality or incidence, the
studies that have been conducted all con-
firm that an epidemic of CKD is underway
among residents of the Central American
Pacific coastline, especially among young
men working in agriculture, such as in sug-
arcane production [4].
Torres et al. conducted one of the largest of
these cross-sectional studies [14]. They ex-
amined men and women aged 20–60 years
in five villages in Northwest Nicaragua,
which varied by industry and elevation.
Overall, 14% of men and 3% of women
exhibited decreased kidney function (es-
timated glomerular filtration rate [eGFR]
<60ml/min per 1.73m2). In the United States, on the other hand, the prevalence of eGFR <60 in both men and women aged 20-59 years is approximately 1% [19].Tor- res et al. also found villages at lower eleva- tions (e.g. 100-300m vs. 200-675m) and where the industry was mining or agricul- ture (e.g. banana or sugarcane) were most impacted. The “usual suspects” for CKD-pre-existing diabetes and hypertension-are largely ab- sent in this epidemic [4, 15, 17]. The cross- sectional studies, through medical record review, clinician interviews, biological sam- pling, and questionnaires, have uniformly concluded that the epidemic of MeN can- not be attributed to these factors [4, 14, 20, 21, 22, 23]. There is also little evidence to implicate nephrotoxic metals, such as cad- mium or lead [4]. There are a myriad of environmental, oc- cupational, and behavioral factors to which the affected population may be highly ex- posed and which can cause renal damage, however these are not known to be associ- ated with CKD in particular or to such an extent [4].These factors are: strenuous labor in hot conditions leading to chronic de- hydration, medications (e.g. non-steroidal anti-inflammatories, analgesics, or amino- glycosides), infection (e.g. leptospirosis), arsenic, and agrochemicals (e.g. pesticides). One theory postulates that an initial injury damages the kidneys, but one or more ad- ditional factors trigger the progression to CKD [24]. Thus MeN may result from a “multifactorial synergistic mechanism” [4]. Evidence that initial kidney damage may be occurring at an early age comes from a pilot study, which found a similar pattern of elevated biomarkers of tubular kidney dam- age among adolescents without prior work Chronic Kidney Disease of Unknown Origin in Central America and Sri Lanka BACK TO CONTENTS 32 33 Environmental Health Environmental HealthUNATED STATES OF AMERICAUNATED STATES OF AMERICA history in areas with high adult CKD mor- tality [23]. Elucidating the cause(s) of the MeN epi- demic will require investigating many po- tential risk factors as well as considering a “previously undescribed mechanism ca- pable of causing CKD” [4]. As discussed below, both substantial public health and clinical efforts will be needed to tackle this problem now, even without conclusive evidence regarding the causes of the epi- demic. Sri Lanka Since the early 1990s, many studies have documented an increasing prevalence of Chronic Kidney Disease of unknown eti- ology (CKDu) in Sri Lanka [2]. CKDu is defined as chronic kidney disease, usu- ally diagnosed based on evidence of mi- croalbuminuria, that is present without prior history of diabetes, hypertension, or other renal disease [3]. Epidemiologic data has helped trace most of these cases to a region known as the North Central Province, a relatively dry region in the interior of the country with a heavy reli- ance on irrigation systems for agriculture [2]. In this region, the point prevalence of CKDu has been estimated at 2-3%, a figure which is likely underreported [25]. Other reports have estimated a prevalence of 5.1% based on microalbuminuria [1]. Widely quoted figures in the lay press state the death toll as high as 20,000, more 200- 450,000 currently affected [26]. Patients typically affected included young males, generally from farming communities with low-socioeconomic status. The affected population has be found to have a higher prevalence of microalbuminuria, as well as pathologic findings including tubular atro- phy, mononuclear interstitial cell infiltra- tion and tubular fibrosis [27,28]. Disease progression is greater in men than women, with disparities in prevalence widening in stage 3 and 4 CKDu [3]. Numerous fac- tors have been proposed to account for the development of CKDu in this population, including herbal medications, snakebites, genetic predisposition, and more common causes of CKD such as diabetes mellitus and hypertension. However, the majority of the evidence in Sri Lanka points to en- vironmental exposures as a major contrib- uting factor to the increased prevalence of CKDu [29, 30]. Potential environmental exposures in this community are varied, and include heavy metals, pesticides, contaminated well wa- ter as well as food-borne mycotoxins and air pollution [3]. Due to the agrarian na- ture of the North Central Province, most studies focused on potential heavy metal and pesticide exposure from soil, well wa- ter, irrigation channels, and locally grown foods. This was supported by early studies showing that microalbuminuria in the lo- cal population was associated with drink- ing well water from agricultural fields. Many studies pointed to cadmium, and to a lesser extent arsenic, as the likely cause of CKDu due to their nephrotoxic properties and elevated readings in well water [27]. A recent case-control study analyzed urine, hair and serum for presence of heavy met- als such as cadmium, lead and arsenic as well as numerous common pesticides. Sta- tistically significant elevations in cadmium levels were found in the urine and nails of cases versus controls. In fact, urine cad- mium levels corresponded with severity of CKDu on a dose-response basis. Arsenic levels were also significantly elevated in the urine and nails of cases compared to con- trols. Finally, various pesticides were found in cases at levels well above reference levels [3]. Results regarding the source of these exposures were mixed. While initial stud- ies found elevated cadmium levels in well water, more recent studies have shown cadmium levels to be within normal limits [3,27]. However, elevated levels of cadmi- um and arsenic were found in local foods, primarily vegetables and fish, as well as the soil [3,30]. It is postulated that these heavy metals are primarily entering the food chain from unregulated use of pesticides (and possibly fertilizers). As discussed above, evidence of CKDu in other regions such as Central America and the Balkans is leading to greater awareness of the role local environmental factors play in development of kidney disease [20, 31]. While the case in Sri Lanka is different in that heavy metals seem to be playing a more significant role in the development of CKDu, there are some commonalities. Studies have found evidence that, as in Central America, agricultural work in the hot climate of Sri Lanka leads to dehydra- tion, which may be exacerbating the toxic effects of heavy metals and agrochemicals [14, 27]. It is possible that increasing hydra- tion and improving access to clean drinking water may be able to prevent or slow the progression of CKDu in both Sri Lanka and Central America [3, 27]. In those already afflicted with CKDu, stud- ies have found that the presence of comor- bidities hastens disease progression, espe- cially in men. A prospective cohort study from the North Central Province found that comorbid hypertension was significantly as- sociated with disease progression, especially in men [32]. It is possible that treatment of hypertension and other comorbidities may slow progression, however this is yet to be shown. While much of the research to date has pointed to environmental heavy metal expo- sure as,at the very least,a major factor in the development of CKDu, there are still many questions remaining. It is widely speculated that most heavy metal exposure comes from agrochemical use, but the exact nature of the exposure has not been definitely proven. It is also unclear what role genetics, comor- bidities and other environmental factors are playing in the development and progression of CKDu. Recent studies have shown that factors as variable as mycotoxin exposure, the mineral content of drinking water and genetic predisposition to the development of CKDu may play a significant a role in the development of CKDu, showing that there is much more to be learned about this disease process and that little has been de- finitively proven [2, 33, 34]. What is Being Done from a Public Health Standpoint? Public health responses cannot wait until the mysteries are conclusively solved. The governments of El Salvador and Sri Lanka have taken steps to address the issue.For ex- ample,the Sri Lankan government has been working with WHO and in-country part- ners to improve surveillance and care for the affected population [35]. The Sri Lankan government is also considering measures to reduce environmental exposure to ag- rochemicals. The Ministry of Health of El Salvador successfully spearheaded the effort to have MeN prioritized as a major health concern by the Pan American Health Or- ganization and the Council of Ministries of Central America [4]. In October 2013, PAHO passed a resolution formally rec- ognizing MeN as a serious threat to public health and called on member states to con- duct research on the disease and strengthen occupational and environmental health pro- grams. Prominent researchers into the epidemic of MeN/CKDu have called for the follow- ing actions to halt its progression:   1) improve surveillance systems to deter- mine incidence and causative factors   2) develop and implement preventive strategies for putative causes   3) increase compliance and enforcement of existing laws regulating agrochemi- cal use   4) strengthen healthcare systems to im- prove delivery of primary care and re- nal replacement therapies and   5) develop evidence-based CKD guide- lines and education tailored to each country [4, 36]. What can be Done from a Clinical Standpoint? Clinicians in these regions should be aware of the heightened prevalence of chronic kid- ney disease, especially among young males working in agriculture. Though proposed etiologies vary by country,physicians should still note the patient’s occupation, risk fac- tors (level of exertion in hot conditions, hydration status, exposure to heavy met- als and agrochemicals, etc.). Patients that meet multiple criteria could then be fur- ther evaluated for the presence of albumin or protein in the urine with urine dipstick. Patients found to be at risk for development of CKD may then need to be counseled on the hazards posed by their occupations and referred for further care as necessary. Acknowledgements: Assistance provided by Dr. Peter Orris, Chief, Occupational and Environmental Medicine with this report was greatly appreciated. References 1. Athuraliya, N. T. C., Abeysekera, T. D. J., Amerasinghe, P. H., Kumarasiri, R., Bandara, P., Karunaratne, U., … Jones, A. L. (2011). Uncertain etiologies of proteinuric-chronic kidney disease in rural Sri Lanka. Kidney In- ternational, 80(11), 1212–1221. doi:10.1038/ ki.2011.258 2. Jayasekara, J.M.K.B., Dissanayake D.M., Adhi- kari, S.B., Bandara, P. (2013). Geographical distribution of chronic kidney disease of un- known origin in North Central Region of Sri Lanka.Ceylon Medical Journal,58(1),6-10.doi: 10.4038/cmj.v58i1.5356 3. Jayatilake, N., Mendis, S., Maheepala, P., Me- hta, F.R. (2013). Chronic kidney disease of uncertain aetiology: prevalence and causative factors in a developing country. Biomed Cen- tral Nephrology, 14:180, doi:10.1186/1471- 2369-14-180 4. Ramirez-Rubio, O., McClean, M. D., Amador, J. J., & Brooks, D. R. (2013). An epidemic of chronic kidney disease in Central America: an overview. Journal of Epidemiology and Com- munity Health, 67(1), 1–3. doi:10.1136/jech- 2012-201141 5. Machiraju,R.Y.,Gowrishankar,S.,Edwards,K., Attaluri, S., Miller, F., Grollman, A., & Dick- man, K. (2009). Epidemiology of Udhanam Endemic Nephropathy. Journal of American Society of Nephrology, 20. 6. Kamel, E., & El-Minshawy, O. (2010). Envi- ronmental factors incriminated in the develop- ment of end stage renal disease in El-Minia Governate, Upper Egypt. International Journal of Urology and Nephrology, 2, 431–7. 7. Cuadra, S. J., Hogstedt, C., & Wesseling, C. (2006). Chronic Kidney Disease: assessment of current knowledge and feasibility for regional research collaboration in Central America (No. 2). SALTRA. Retrieved from http://www. saltra.una.ac.cr/images/SALTRA/Documen- tacion/SerieSaludTrabajo/seriesaludytrabajo2. pdf 8. Brooks, D. (2009). Final Scoping Study Re- port: Epidemiology of Chronic Kidney Dis- ease in Nicaragua. Boston University School of Public Health. Retrieved from http://www. cao-ombudsman.org/cases/document-links/ documents/03H_BU_FINAL_report_scopes- tudyCRI_18.Dec.2009.pdf 9. Trabanino, R. G., Aguilar, R., Silva, C. R., Mer- cado,M.O.,& Merino,R.L.(2002).[End-stage renal disease among patients in a referral hos- pital in El Salvador]. Revista panamericana de salud pública = Pan American journal of public health, 12(3), 202–206. 10. Ministry of Public Health and Social Assistance, El Salvador. (2009). De que se mueren y enfer- man los salvadorenos? Memoria de Labores 2009-2010, 24–30. 11. Cerdas, M. (2005). Chronic kidney disease in Costa Rica. Kidney International. Sup- plement, (97), S31–33. doi:10.1111/j.1523- 1755.2005.09705.x 12. WHO. (2008). Global burden of disease. 2008. Disease and injury country estimates. World Health Organization. Retrieved from http:// www.who.int/healthinfo/global_burden_dis- ease/estimates_country/en/index.html 13. Laux, T. S., Bert, P. J., Barreto Ruiz, G. M., González, M., Unruh, M., Aragon, A., & Torres Lacourt,C.(2012).Nicaragua revisited: evidence of lower prevalence of chronic kidney disease in a high-altitude, coffee-growing village. Journal of Nephrology, 25(4), 533–540. doi:10.5301/ jn.5000028 14. Torres, C., Aragón, A., González, M., López, I., Jakobsson, K., Elinder, C.-G., … Wesseling, C. (2010). Decreased kidney function of un- known cause in Nicaragua: a community-based BACK TO CONTENTS 34 35 Environmental Health UNATED STATES OF AMERICA survey. American Journal of Kidney Diseases: The Official Journal of the National Kidney Foundation, 55(3), 485–496. doi:10.1053/j. ajkd.2009.12.012 15. O’Donnell, J. K., Tobey, M., Weiner, D. E., Stevens, L. A., Johnson, S., Stringham, P., … Brooks, D. R. (2011). Prevalence of and risk factors for chronic kidney disease in rural Nica- ragua. Nephrology, Dialysis, Transplantation: Official Publication of the European Dialysis and Transplant Association  – European Renal Association, 26(9), 2798–2805. doi:10.1093/ ndt/gfq385 16. Gracia-Trabanino, R., Domínguez, J., Jansà, J. M., & Oliver, A. (2005). [Proteinuria and chronic renal failure in the coast of El Salvador: detection with low cost methods and associated factors]. 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A., Torres, C., … Hogstedt, C. (2012). Decreased kidney function among agricultural workers in El Salvador. American Journal of Kidney Diseases: The Official Jour- nal of the National Kidney Foundation, 59(4), 531–540. doi:10.1053/j.ajkd.2011.11.039 21. Aschengrau, A., Brooks, D., McSorley, E., Rief- kohl, A., Applebaum, K., Amador, J., & Ram- irez-Rubio,O.(2012).Cohort pilot study report: evaluation of the potential for an epidemiologic study of the association between work practices and exposure and chronic kidney disease at the Ingenio San Antonio (Chichigalpa, Nicara- gua). Boston, MA: Boston University School of Public Health. Retrieved from http://www.cao- ombudsman.org/cases/document-links/docu- ments/BU_CohortPilotStudyReport_Jan2012_ ENGLISH.pdf 22. McClean, M., Amador, J., Laws, R., Kaufman, J., Weiner, D., Sanchez Rodriguez, J., … Brooks, D. (2012). Biological Sampling Report: Investi- gating biomarkers of kidney injury and chronic kidney disease among workers in Western Nica- ragua. Boston, MA: Boston University School of Public Health. Retrieved from http://www. cao-ombudsman.org/cases/document-links/ documents/Biological_Sampling_Report_ April_2012.pdf 23. Ramirez-Rubio, O., Brooks, D., Amador, J., Kaufman, J., Weiner, D., Parikh, C., … Laws, R. (2012). Biomarkers of early kidney damage in Nicaraguan adolescents September-November 2011. Boston, MA: Boston University School of Public Health. Retrieved from http://www. cao-ombudsman.org/cases/document-links/ documents, 24. AdolescentReportJune252012.pdf 25. Brooks, D. R., Ramirez-Rubio, O., & Amador, J. J. (2012). CKD in Central America: a hot issue. American Journal of Kidney Diseases: The Official Journal of the National Kidney Foundation, 59(4), 481–484. doi:10.1053/j. ajkd.2012.01.005 26. Chandrajith, R., et. al. (2011) Chronic kidney disease of uncertain etiology (CKDue): geo- graphic distribution and environmental implica- tions. Environmental Geochemistry and Health, 33(3),267-278.doi:10.1007/s10653-010-9339-1 27. Chatterjee, R. (2012, September 18). Sri lanka kidney disease blamed on farm chemicals. Brit- ish Broadcasting Company 28. Wanagusuriya, K.P., Peiris-John, R.J., Wickre- masinghe, R. (2011). Chronic kidney disease of uncertain aetiology in Sri Lanka: is cadmium a likely cause? Biomed Central Nephrology,12:32, doi: 10.1186/1471-2369-12-32 29. Wijetunge, S., Ratnatunga, N.V., Abeysekara, D.T., Wazil, A.W., Selvarajah, M., Ratnatunga, C.M. (2013). Retrospective analysis of renal his- tology in asymptomatic patients with probable chronic kidney disease of unknown aetiology in  Sri Lanka. Ceylon Medical Journal, 58(4), 142-147. doi: 10.4038/cmj.v58i4.6304. 30. Wanagusuriya, K.P., Peiris-John, R.J., Wick- remasinghe, R., Hittarage, A. (2007). Chronic renal failure in North Central Province of Sri Lanka: an environmentally induced disease. Transactions of the Royal Society of Tropical Medicine and Hygiene, 101(10), 1013-1017. 31. Bandara, J.M., Senevirathna, D.M., Dasanay- ake, D.M., Herath,V., Abeysekara,T., Rajapak- sha, K.H. (2008). Chronic renal failure among farm families in cascade irrigation systems in Sri Lanka associated with elevated dietary cadmium levels in rice and freshwater fish (Tilapia). Environmental Geochemistry and Health, 30(5), 465-478. doi: 10.1007/s10653- 007-9129-6 32. Stefanovich, V., Polenakovic, M. (2009). Fifty years of research in Balkan endemic nephropa- thy: where are we now? Nephron. Clinical Prac- tice, 112(2), 51-56, doi: 10.1159/000213081 33. Senevirathna, L. et. al. (2012). Risk factors as- sociated with disease progression and mortality in chronic kidney disease of uncertain etiology: a cohort study in Medawachchiya, Sri Lanka. Environmental Health and Preventive Medi- cine, 17(3), 191-198. doi: 10.1007/s12199-011- 0237-7 34. Nanayakkara, S., et. al. (2013). An Integrative Study of the Genetic, Social and Environmental Determinants of Chronic Kidney Disease Char- acterized by Tubulointerstitial Damages in the North Central Region of Sri Lanka. Journal of Occupational Health (Japan), advance publica- tion. 35. Redmon, J. H., Elledge, M. F., Womack, D. S., Wickremashinghe, R., Wanigasuriya, K. P., Peiris-John, R. J., ... & Levine, K. E. (2014). Additional perspectives on chronic kidney disease of unknown aetiology (CKDu) in Sri Lanka-lessons learned from the WHO CKDu population prevalence study.  BMC nephrol- ogy, 15(1), 125. 36. WHO, country office for Sri Lanka. (n.d.). Chronic kidney disease of unknown aetiology (CKDu): a new threat to health (newsletter). Retrieved from http://www.searo.who.int/Link- Files/News_Letters_CKDu.pdf 37. The epidemic of chronic kidney disease in Central America. Pedro Ordunez, Carla Sae- nz, Ramón Martinez, Evelina Chapman, Lu- dovic Reveiz, Francisco Becerra The Lancet Global Health  - 1 August 2014 (Vol. 2, Issue 8, Pages e440-e441). DOI: 10.1016/S2214- 109X(14)70217-7. Sumeet Batra MD, and Ana Nobis MD, MPH, University of Illinois Hospital and Health Sciences System, Occupational and Environmental Medicine 835 S. Wolcott St, MC684, Chicago, Il 60615 Over the last five years, a new genera- tion of trade agreement negotiations has emerged with the purported goal of increasing economic growth [2]. The Trans Pacific Partnership (TPP), Trans- atlantic Trade & Investment Partnership (TTIP), Comprehensive Economic and Trade Agreement (CETA) and Trade in Services Agreement (TiSA) negotia- tions seek to further trade liberalization while establishing a new global gover- nance framework for trade beyond exist- ing World Trade Organization structures. These deals have the potential to (re) shape public health and health care glob- ally [1] with significant implications for efforts to address health inequities and the social determinants of health [4-8], which are both emerging priorities of the World Medical Association [97]. More than fifty countries, representing more than half of the global GDP, are currently engaged in this new generation of trade negotiations. The effects of these agreements, however, are not likely to be limited to countries currently participating in negotiations. Many non-participating countries have sought or are seeking to join negotiations. Moreover, the U.S.Trade Representative has repeatedly signaled that these agreements are being negotiated as a “template” for all future trade agreements [2], suggesting that these negotiations may have truly global ramifications. Announced in 2008 and launched in 2010, TPP negotiations currently include twelve parties: Australia, New Zealand, Singapore, Brunei, Malaysia, Japan, Peru, Chile, Mexi- co, the United States and Canada.The TPP mandate is broad with twenty-nine plus chapters across economic sectors. Launched in 2013, TTIP negotiations cur- rently include the European Union and United States. Similar to the TPP, the TTIP has a broad mandate with implications across economic sectors. Although models and es- timates vary, the TTIP has been projected to result in up to a 0.5 percent increase in the European GDP with similar projections available for the US economy. In the case of the TTIP, up to 80% of these gains are projected to be attributable to reductions in non-tariff trade barriers, suggesting that the bulk of projected benefits would be a result of “regulatory harmonisation”[9]. Similar in character and scope to the TPP andTTIP,CETA negotiations included only Beyond Chlor Hühner & Nürnberger Bratwürste: The Case for Physician & Organized Medical Advocacy to Promote Health in Trade Agreement Negotiations Medical Advocacy BACK TO CONTENTS 36 37 the European Union and Canada. CETA negotiations concluded in 2014, and the deal is currently awaiting ratification [10]. The Trade in Services Agreement (TiSA) negotiations include twenty-three parties: Australia, Canada, Chile,Taiwan, Colombia, Costa Rica, the EU, Hong Kong, Iceland, Israel, Japan, Korea, Liechtenstein, Mexico, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Switzerland, Turkey and the U.S. While the scope of TiSA negotiations may be somewhat different as compared to TPP, TTIP & CETA, TiSA negotiations have enormous potential to affect health care services.Leaked documents suggest that TiSA may seek to realize the “untapped po- tential” for the “globalization of healthcare services” [11]. However, very limited infor- mation is available about the status, scope and direction of TiSA negotiations. Transparency Public access to negotiating drafts and negotiators has been limited. There are no publicly available draft texts and restrict- ed stakeholder access during negotiating rounds. Civil society has been forced to rely on leaked documents unofficial leaked doc- uments and rumors. This lack of transpar- ency hinders civil society engagement and public scrutiny. Investor-State Dispute Settlement Investor State Dispute Settlement (ISDS) provisions could have profound, cross- cutting implications for health, health care and the social determinants of health. ISDS provides a mechanism for investors to bring claims against governments and seek com- pensation for damages and potential loss of profit.Thus, ISDS allows multinational cor- porations to challenge laws and regulations that threaten their interests outside of exist- ing legal systems of accountability. ISDS provisions smaller scale trade agree- ments over the last few decades have been used to challenge evidence-based public health laws, such as tobacco control mea- sures in Uruguay [12]. According to United Nations Conference on Trade and Devel- opment (UNCTAD) data, there have been more than 500 ISDS cases brought against governments under existing agreements. Of these cases, approximately 57% have either been settled outside of court (at the expense of the state) or adjudicated in favor of the investor [13]. This demonstrates the power that ISDS as a mechanism has to advance corporate interests over health. In addi- tion, there is some evidence to suggest that the availability of ISDS may deter govern- ment from enacting laws and regulations that may be challenged by investors [3]. By limiting the ability of governments to adopt and implement policies to protect and ad- vance health, ISDS may have harmful in- tersectoral impacts that result in numerous public health consequences, in areas such as tobacco control, alcohol control, regulation of obesogenic food and beverages, access to medicines, health care services, the health professional workforce, environmental pro- tection and climate change regulation and occupational and environmental health [14,77]. Noncommunicable Diseases: Tobacco,Alcohol&NutritionPolicy Prevention and control of noncommuni- cable diseases (NCDs) has been recognized as a global health priority by the World Health Organization [26], and trade agree- ments are “an upstream driver” of NCDs [15]. As a result of both ISDS-driven le- gal challenges and indirect regulatory chill, ISDS provisions may used to undermine the development of evidence-based NCD interventions including tobacco, alcohol and obesogenic product control efforts. The potential implications of the TPP, TTIP and CETA on tobacco regulation has been one of the most well-publicized dimensions of negotiations. ISDS mecha- nisms in a smaller scale trade agreement have already been used to challenge to- bacco control measures in Uruguay. Pos- sible avenues for industry to challenge tobacco control measures include enforce- ment of trademark protections, stakeholder provisions to expand industry influence in policy-making, cross-border services provi- sions to protect advertising and licensing, and technical barriers to trade provisions [16-20,66]. If tobacco is not excluded, these agreements could sabotage existing tobacco control efforts under the World Health Or- ganization’s Framework Convention on To- bacco Control (FCTC) [12,21,62-63]. De- spite evidence that 4% of the global burden of disease is attributable to alcohol [22-23], alcohol control measures may be similarly targeted for challenge under ISDS provi- sions [24-25]. Nutrition policy may be affected by this new generation of trade deals [14, 27]. Tariff reduction, intellectual property and foreign investment liberalization provisions in the setting of ISDS may threaten exist- ing NCD control efforts [28-29]. Experi- ence with prior bilateral and regional trade agreements suggests that trade liberaliza- tion increases the sale of unhealthy trans- national products and advertising of these products resulting in significant changes in consumption patterns [15, 30]. Health Care Services & Health Workforce TPP, TTIP, CETA and TiSA may have the potential to affect the availability, ac- cessibility and regulation of health care services. TiSA in particular is anticipated to contain significant provisions which seek to redesign the health care services land- scape [31]. Of particular concern are provi- sions which could facilitate commercializa- tion of health systems as well as promote health tourism, “health exporting” and/or “health ­offshoring” [31-35]. ISDS may also have implications for health insurance and health care services markets. Under existing ISDS provisions, there have been at least two cases where legislative barriers to the expansion of private provision of services and/or coverage have been challenged. The US experience suggests that commercializa- tion of health care coverage and services is associated with reduced coverage and access to health care services and increased costs. Thus, such commercialization could be in- consistent with current efforts to achieve universal health coverage [36]. Whether and how health care services might be “ex- cluded” from each potential agreement has been subject to significant controversy and speculation [77]. As the World Health Organization and Global Health Workforce Alliance is seek- ing to develop a Global Strategy on Human Resources for Health [89], trade agree- ments may also unanticipated and unin- tended consequences on the supply and distribution of the health care workforce. In some countries, higher education including medical education may be subject to com- mercialization [86-88] and reduced public financing which may have negative impli- cations for accessibility and affordability. Leaked TiSA documents suggest that the agreement may promote significant “health exporting” and expanding health insurance portability across national borders [84] which may affect the supply and move- ment of health professionals globally. Trade agreement negotiations may also implicate ehealth including telemedicine and access to medical knowledge. However, assessing the potential implications of negotiations is challenging and speculative without access to texts. Access to Medicines The World Trade Organization (WTO) Agreement onTrade-Related Aspects of In- tellectual Property Rights (TRIPS) sought to codify common principles, standards and rules for the global protection of intellec- tual property. TRIPS included safeguards and flexibilities, clarified by the Ministerial Declaration on TRIPS and Public Health (“Doha Declaration”) in 2001, to ensure that the protection of intellectual property under the agreement can and should not compromise public health [37-38]. Despite reassurances and efforts to protect access to medicines [55], leaked texts and details of potential intellectual property provisions paint a troubling picture for ac- cess to medicines [81]. There are several possible trade agreement provisions that could exceed those protections afforded under TRIPS and ultimately reduce the affordability and accessibility of medica- tions including (but not limited to) [39-44, 50,65,81,96]: • Evergreening, or prolonged patent pro- tection for minor modifications of exist- ing drugs; • Patent linkage or other patent term ex- tensions that may serve to as a barrier to generic entry into the market; • Extended data and/or market exclusivity and transition periods for products in- cluding biologics; • Restrictions on TRIPS safeguards and flexibilities including compulsory licens- ing and parallel imports; • Limits on clinical trial data transparency through trade secret or other intellectual property protections. Trade agreements may also challenge thera- peutic reference pricing and other features of effective pharmaceutical benefits pro- grams including Australia’s Pharmaceutical Benefits Scheme [45-46,77], New Zea- land’s Pharmaceutical Management Agen- cy (PHARMAC) Program [44,47], the United Kingdom’s National Health Service [48,64], Canada’s Health Canada program [67] among others. ISDS further complicates potential impli- cations of trade agreement negotiations on access to medicines. Under NAFTA, Eli Lilly has brought a claim in excess of $500 million against Canada over its invalida- tion of the company’s patents on Strattera and Zyprexa [49]. Similar claims to enforce more stringent intellectual property protec- tions could have devastating implications for access to medicines. The patenting of diagnostic, therapeutic and surgical techniques may also warrant attention in trade agreement negotiations. Consistent with existing World Medical Association policy opposing the patenting of such techniques [51], it is critical that an exception, similar to 35 USC 287(c), be incorporated into any agreement to pre- vent potential liability for patent infringe- ment for health professionals performing procedures and providing care for patients [52-53]. Environmental Protection & Climate Change Millions of deaths globally each year are attributable to sequelae of air pollution and reliance on fossil fuels  – it is esti- mated that one in eight deaths globally is due to air pollution [98]. Without sus- tained global mitigation and adaptation, climate change could result in worsening outbreaks of deadly infectious diseases, exacerbation of food insecurity, increased natural disasters and conflict  – all with significant health implications [57]. In this context, trade agreement negotia- tions may have negative implications for environmental protection and efforts to address climate change [55-56,64]. Thus, as momentum grows in advance of Con- ference of Parties 21 (COP21) negotia- tions in Paris, trade policy may simultane- ously undermine commitments under the United Nations Framework Convention on Climate Change (UNFCCC) by em- powering corporate interests to directly and/or indirectly challenge domestic poli- cies to curb greenhouse gas emissions. In Medical AdvocacyMedical Advocacy BACK TO CONTENTS 38 39 addition, ISDS provisions may be used to expand environmentally harmful practices such as fracking under these agreements with well-documented devastating envi- ronmental consequences [90]. Regulatory harmonization and “down- ward” regulatory pressure could weaken sanitary and phytosanitary (SPS) measures [58-59]. These measures include criti- cal public health protections such as food safety and plant and animal health. Across Europe, concern about food safety and regulation has sparked significant contro- versy and garnered substantial media at- tention. However, it is difficult to project overall potential health impact of such provisions [77]. Labor standards, labor rights and occupa- tional health and safety may also be on the proverbial negotiating table [85]. Under existing trade agreements, social protection for workers and collective bargaining rights have been curtailed in favor of trade liberal- ization [60-61,64]. If a similar approach to labor is incorporated into this new genera- tion of agreements, there is a risk of exac- erbating social inequality and undermining efforts to address the social determinants of health. A Call to Action for Physicians and Organized Medicine on Trade+Health Several World Medical Association nation- al member associations and other medical groups have responded to the potential threat posed by these trade agreement ne- gotiations. In 2014, the German Medical Association General Assembly adopted a resolution urging adherence to democratic principles including transparency as well as protection of patient safety and the ex- emption of health care services from any agreement [69]. The Standing Committee of European Doctors (CPME) has issued statements urging transparency in TTIP negotiations [70] and called for “exemption for the provision of healthcare services from the scope of application of the TTIP” [71]. The British Medical Association has ex- pressed concern about the potential effects the TTIP may have on the privatization of the NHS and other European health care systems [73-74]. The Australian Medical Association Fed- eral Council has approved a resolution recognizing that international trade agree- ments have the potential to undermine the Australian Pharmaceutical Benefits Scheme and hinder government’s ability to protect public health [72]. With respect to the TPP, the AMA has also expressed concern about the secrecy of negotiations, noting that the agreement would advance commercial interests at the expense of patients, and the government’s ability to improve public health [72]. The CEO of the Public Health Association of Austra- lia highlights some key concerns around the effects of the provisions included in the TPP, stating that organisations seek- ing effective public health policies such as nutrition labeling will be burdened by more hurdles [79]. The New Zealand Medical Association supports the call for an independent assessment into the TPP, citing alcohol, tobacco regulation and af- fordable access to medicine. The NZMA Chair stated that “We need to have a clear understanding of the possible effects of the TPPA on current and future policy set- tings and directions – before we are com- mitted to such a deal” [83]. The Japanese Medical Association President Yokokura has publicly expressed concern about the potential negative implications of the TPP on Japan’s universal health insurance pro- gram and pharmaceutical pricing [99].The American Medical Association maintains policy on international trade agreements [94] and has expressed support for exemp- tion of tobacco products and alcoholic beverages in the context of ongoing TPP negotiations [95]. Last year, the International Federation of Medical Students’ Associations (IFMSA) also adopted a comprehensive trade and health policy statement urging that trade agreements, “...should not prioritize multi- national corporate profits over patients and consumes around the world” [80]. IFMSA and its 126 national member organizations have been active in advocacy to promote health in trade agreement negotiations [81,92-93]. While current efforts by WMA national member associations and similar groups within the organized medicine community to promote health in trade policy are en- couraging,the stakes of current negotiations are high and a more coordinated advocacy response may be warranted. Although trade policy has not traditionally been an advo- cacy priority for global organized medicine, this new generation of trade agreement ne- gotiations including the TPP,TTIP, CETA and TiSA pose numerous unprecedented direct and indirect challenges for health and health care – challenges that may pro- foundly affect our patients and the practice of medicine. The World Medical Association (WMA) Statement on Patient Advocacy and Confi- dentiality stipulates that medical practitio- ners have a duty that includes “..advocating for patients, both as a group (such as advo- cating on public health issues) and as indi- viduals” [75]. 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World Health Organization. 7 million pre- mature deaths linked annually to air pollution. 2014. Available at http://www.who.int/media- centre/news/releases/2014/air-pollution/en/ 99. Yokokura Y. Policy Address. JMAJ 2012; 55(5):353-356. Elizabeth Wiley, MD, JD, MPH, Resident, University of Maryland, Past President, American Medical Student Association (2012–2013), Supervising Council, International Federation of Medical Students’ Associations, Socio Medical Affairs Officer, Junior Doctors Network, World Medical Association (USA); Deborah Vozzella Hall, University of Connecticut (USA); Thorsten Hornung, University of Bonn (Germany); Cam Stocks, Queen Mary University of London (UK); Konstantinos Roditis, National Kapodistrian University of Athens & Junior Doctors Network-Hellas (Greece); Jade Lim, University of Melbourne (Australia); Renzo R. Guinto, Reimagine Global Health (Philippines); Claudel Pétrin-Desrosiers, University of Montreal (Canada); Lawrence Loh, University of Toronto, Dalla Lana School of Public Health & The 53rd Week Ltd (Canada); Xaviour Walker, Johns Hopkins Bloomberg School of Public Health (USA); Ian Pereira, Queen’s University (Canada); Anya Gopfert, Newcastle University (UK); Maria Ignacia Alvarez Argaluza, Universidad Católica del Norte (Chile); Reshma Ramachandran, Brown University (USA); Ivana Di Salvo, University of Pavia (Italy) E-mail: elizabeth.wiley.md@gmail.com Medical AdvocacyMedical Advocacy BACK TO CONTENTS IV