WMJ 02 2013

COUNTRY
• 194th
WMA Council Session – Bali
• Protective Provisions for Research Participants
vol. 59
MedicalWorld
Journal
Official Journal of the World Medical Association, INC
G20438
Nr. 2, April 2013
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
Velta Pozņaka
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 iela 2, Riga, Latvia
Cover painting:
English physician vaccinating his son/sculpture
by Edward Jenner/vintage illustration from
Meyers Konversations-Lexik on 1897
Publisher
The World Medical Association, Inc. BP 63
01212 Ferney-Voltaire Cedex, France
Publishing House
Publishing House
Deutscher-Ärzte Verlag GmbH,
Dieselstr. 2, P.O.Box 40 02 65
50832 Cologne/Germany
Phone (0 22 34) 70 11-0
Fax (0 22 34) 70 11-2 55
Producer
Alexander Krauth
Business Managers J. Führer, N. Froitzheim
50859 Köln, Dieselstr. 2, Germany
IBAN: DE83370100500019250506
BIC: PBNKDEFF
Bank: Deutsche Apotheker- und Ärztebank,
IBAN: DE28300606010101107410
BIC: DAAEDEDD
50670 Cologne, No. 01 011 07410
Advertising rates available on request
The magazine is published bi-mounthly.
Subscriptions will be accepted by
Deutscher Ärzte-Verlag or
the World Medical Association
Subscription fee € 22,80 per annum (incl. 7%
MwSt.). For members of the World Medical
Association and for Associate members the
subscription fee is settled by the membership
or associate payment. Details of Associate
Membership may be found at the World
Medical Association website
www.wma.net
Printed by
Deutscher Ärzte-Verlag
Cologne, Germany
ISSN: 0049-8122
Dr. Cecil B. WILSON
WMA President
American Medical Association
515 North State Street
60654 Chicago, Illinois
United States
Dr. Leonid EIDELMAN
WMA Chairperson of the Finance
and Planning Committee
Israel Medical Asociation
2 Twin Towers, 35 Jabotinsky St.
P.O.Box 3566, Ramat-Gan 52136
Israel
Dr. Masami ISHII
WMA Vice-Chairman of Council
Japan Medical Assn
2-28-16 Honkomagome
Bunkyo-ku
Tokyo 113-8621
Japan
Dr. José Luiz
GOMES DO AMARAL
WMA Immediate Past-President
Associaçao Médica Brasileira
Rua Sao Carlos do Pinhal 324
Bela Vista, CEP 01333-903
Sao Paulo, SP Brazil
Sir Michael MARMOT
WMA Chairperson of the Socio-
Medical-Affairs Committee
British Medical Association
BMA House,Tavistock Square
London WC1H 9JP
United Kingdom
Dr. Guy DUMONT
WMA Chairperson of the Associate
Members
14 rue des Tiennes
1380 Lasne
Belgium
Dr. Margaret MUNGHERERA
WMA President-Elect
Uganda Medical Association
Plot 8, 41-43 circular rd., P.O. Box
29874
Kampala
Uganda
Dr. Heikki PÄLVE
WMA Chairperson of the Medical
Ethics Committee
Finnish Medical Association
P.O. Box 49
00501 Helsinki
Finland
Dr.Frank Ulrich MONTGOMERY
WMA Treasurer
Herbert-Lewin-Platz 1
(Wegelystrasse)
10623 Berlin
Germany
Dr. Mukesh HAIKERWAL
WMA Chairperson of Council
58 Victoria Street
Williamstown, VIC 3016
Australia
Dr. Otmar KLOIBER
WMA Secretary General
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
41
WMA news
It has been a great privilege for me over
the past five months to represent the
World Medical Association as your presi-
dent.
I have found the responsibility sobering,
the experience fascinating and the oppor-
tunity personally rewarding.
In my inaugural address at the General As-
sembly last October in Bangkok I shared
with you the message that I would carry
in my travels around the world on behalf
of the WMA.
That message consisted of three parts:
1. The moral imperative of ethics in medi-
cine
2. The challenge of noncommunicable dis-
eases and their Siamese twins, the social
determinants of health
3. The threat of climate change
That message has gone with me as I have traveled to four continents,
To twelve countries and
Fifteen cities within those countries for a total of
Sixteen meetings and conferences in the past five months.
The countries visited include the US, Canada, Taiwan, South Af-
rica, Israel, Egypt, Singapore, China, Japan, Nepal, England and
Latvia.
I would be remiss if I did not express my appreciation to the medi-
cal associations and others in each of those countries, many of
which are here in this room today, for their warm hospitality to
me and their expressions of support for the World Medical As-
sociation.
Thank you all.
Posted on the web last week is a list of all the events in which I have
participated with a brief description of each.
In addition, following the meeting in Bangkok I started a presi-
dent’s blog titled “Around the World with WMA President Cecil
Wilson, MD”. The blog site is accessible from the WMA home
page at www.wma.net. These blogs total 38 to date, almost two a
week.
In them I have chronicled each of the events in which I have par-
ticipated.
They have also dealt with other issues of
importance to the WMA.
Each event in which I have participated
has warranted at least one blog and there
are some for which I wrote two – “two blog
meetings” – if you will.
I will not describe each visit today in detail,
but I would like to highlight some of the
themes that were a part of the meetings and
were only some among the many issues that
caught my attention.
I will conclude with some observations
about the WMA based on my experience in
this office to date.
The themes include:
• NCDs and the social determinants of
health,
• Violence in the health sector,
• Revision of the Declaration of Helsinki,
• Medical students and junior doctors
• Leadership training for physicians.
First, the social determinants of health.
Two weeks ago at a conference in London organized by our Chair of
the Socio-Medical Committee, Sir Michael Marmot, a new report
was presented, “Working for Health Equity: The Role of Health
Professionals in the Social Determinants of Health.
This report from the University College of London, Institute of
Health Equity addresses what medical professionals can do to ad-
dress this problem.
Twenty-one national professional organizations participated in the
report.
Proof that when Sir Michael calls, people say yes.
I provided an international perspective based on WMA policy.
And Dr. Anna Reid, President of the Canadian Medical Associa-
tion reported on a simultaneously released Canadian study based
on a survey of Canadian physicians titled “Physicians and Health
Equity Opportunities in Practice”.
At the Taiwan Health Forum held in Taipei in November Dr.Wen-
Ta Chiu, Minister of Health emphasized the importance of the so-
cial determinants of health.
Dr. Chiu is credited with leadership in passing a bike helmet law in
Taiwan a number of years ago.
President’s Report
World Medical Association Cecil B. Wilson, MD, MACP April 4, 2013 Bali, Indonesia
Cecil B. Wilson
42
WMA news
During the time since passage of the law the number of people in
Taiwan has increased, the number of motor bikes has increased ex-
ponentially and likewise the number of accidents.
However the number of deaths has decreased or at least remained
relatively stable.
Since head injuries are the primary cause of deaths from bike acci-
dents, this social determinant of health has been addressed in large
part by the helmet law.
Estimates are this law saves approximately 4000 lives a year in Tai-
wan.
At the annual scientific conference in Beijing in January Dr. Chen
Zhu, President of the Chinese Medical Association and Minister of
Health for China reported on the status of health system reform in
China and the influence of social determinants of health.
Dr. Zhu commented positively on my remarks to the conference
about the importance of governments recognizing that all policy
has health effects – that we should think not just about one min-
ister of health but all ministers should be considered health min-
isters.
At the All Nepal Medical Conference in Kathmandu in March, Dr.
Ram Baran Yadav, President of Nepal and a physician, described
the threat of earthquakes in Nepal where buildings lack structural
integrity.
He highlighted the increasing burden of communicable disease
with its strains on the health care infrastructure.
He reported on the high incidence of accidents in a developing
country with roads in a poor state of repair, the absence of street
lights and only a few traffic lights in Kathmandu a city of roughly
three million people where vehicles, bikes and pedestrians all share
the same roadways.
All social determinants of health.
Next is the issue of violence in the health sector:
Last October Chair of Council Dr. Mukesh Haikerwal, Dr. Dana
Hanson, former WMA president and I attended the third inter-
national conference on violence in the health sector in Vancouver,
Canada.
Dr. Haikerwal gave the opening keynote speech.
The evidence that this is a major problem of epidemic proportions
was illustrated by the attendance of 482 health care workers from 43
countries who presented 189 papers documenting violence against
health professionals in their countries.
An additional aspect of this problem is the increase in violence
against health care professionals and facilities in areas of armed
combat.
The WMA is working with the ICRC/Red Crescent Society on
the Health Care in Danger Initiative seeking to develop ways to
decrease the danger of violence in these circumstances.
Vivienne Nathanson of the British Medical Association and I were
in Cairo, Egypt in December participating in one of the regional
conferences to seek advice from those actually working in the field.
The meeting included 70 physicians from areas of armed conflict in
Egypt, Libya, Syria, Yemen, Kenya, Pakistan and Afghanistan.
These true heroes of medicine described in dispassionate profes-
sional detail the work they are doing and measures that can help
decrease danger based on their experience.
In February I spoke to the Syrian American Medical Society
(SAMS) Conference in Clearwater, Florida in the US and de-
scribed the WMA’s work with the ICRC and our publically call-
ing on President Assad of Syria to protect health care workers and
facilities.
SAMS is involved in a major effort to provide medical relief to
wounded Syrian citizens in Turkey, in border refugee camps and
inside Syria.
Of their 10 chapters nationwide, over 100 volunteer physicians to
date have traveled across the Turkish border to reach field hospi-
tals.
Once there, these doctors treat hundreds of casualties while under
the constant threat of attacks by Syrian military artillery and air-
strikes.
SAMS has established eleven hospitals in Syria, supported twenty-
five already existing medical facilities, and has appropriated over
$2 million to specific relief projects since April 2012.
In the area of ethics, it was my privilege to attend and present open-
ing remarks at the two expert conferences our workgroup on the
Declaration of Helsinki has held since we met in Bangkok.
I was impressed by the quality of the conferences and the input
received.
I believe the work group was similarly impressed and apprecia-
tive.
I was also impressed by the hospitality and arrangements of our host
countries – the South African Medical Association hosting the con-
ference in Cape Town, South Africa in December and the Japanese
Medical Association (JMA) serving as host for the conference in
Tokyo in February.
Thank you both.
Some of you may know, others not, that at the conference in Tokyo
I gave my opening remarks in Japanese.
Dr. Yoshitake Yokokura, JMA President, and Dr. Massami Ishii,
vice chair of the WMA Council were kind in complimenting me
on my efforts.
In fact when I asked Dr. Yokokura how I had done he said “per-
fect!”
Yokokura san, Ishii san, thank you very much for your most gener-
ous assessment of my performance.
Doomo Arrigato Gozaimasu.
Now to medical students.
The WMA is a strong supporter of medical students through the In-
ternational Federation of Medical Student Associations (IFMSA).
43
WMA news
In March I gave the opening speech to their annual meeting held in
Baltimore, Maryland in the United States.
I focused on optimism about the future of the profession tempered
by an understanding of the major challenges we face.
During the conference I led a president’s session on conflicts of
interest physicians face particularly in their interaction with com-
mercial interests.
I also spoke to the alumni section and Junior Doctors group on
worldwide health care systems and the future of medicine.
The group meeting in Baltimore, the medical student association, is
most favorably impressed with the support of the WMA and eager
to continue a positive relationship.
Next is leadership training:
The INSEAD/WMA sponsored weeklong leadership-training
course was held this year in January in Singapore.
Our Secretary General Otmar Kloiber, Dr. Yank Coble, former
WMA President, Leah Wapner, Secretary General Israeli Medical
Association and I participated in the course along with the faculty
of INSEAD.
32 medical association leaders from 20 countries were enrolled in
this course, which began initially in 2006.
A superb faculty and an enthusiastic, engaged group of physician
leaders highlighted the week.
This effort to provide leadership training for physicians is truly a star
in the WMA crown.
Over the years I have had the opportunity to attend similar
courses in premier institutions in my country – Kellogg Business
School in Chicago, Harvard Kennedy School of Government in
Massachusetts and Stanford University School of Business in
California.
I can say based on my experiences, and in comparison, that the
WMA course in Singapore is the gold standard.
I would recommend WMA member associations take advantage
of this outstanding opportunity for their rising leaders to receive
training.
Let me conclude with some thoughts based on my initial experi-
ences as your president.
The WMA has a powerful positive message to share with the
world.
It is a message based being a voice for ethics, good health policy and
seeking to support physicians to achieve the best of health care for
patients around the world.
We are speaking out on matters of importance.
We are pointing out violations of health related human rights – vio-
lations against health care workers and patients.
We are fortunate to have a professional, creative, energetic staff led
by our Secretary General Otmar Kloiber.
My thanks to them for what they do and for their support of my ef-
forts over the past months, especially facilitating work on the presi-
dent’s blog.
Nigel Duncan, our communications director, is working diligently
and creatively moving into social media to expand communication
of our message to the world.
Those around the world who know of the WMA’s work and interact
with us appear to hold the WMA in high regard.
For those around the world who do not know the WMA, just our
name the World Medical Association suggests to them an organiza-
tion of importance.
After all, we are not just another medical association.
We are The World Medical Association.
That being said, organizations thrive and endure if they continue
to grow.
Our resources are limited and as everyone in this room knows,come
primarily from dues income.
Therefore it is important in preserving those resources that our
member organizations, which provide the dues income, are aware of
the importance of the WMA.
And it is incumbent on us as leaders to keep our associations aware
so that they continue to support the WMA.
The achievements of the WMA, which are considerable, are ac-
complished with extremely limited resources for an organization so
important to world medicine.
It is a credit to our staff that they are able to achieve so much given
the limited resources.
Going forward I believe the existing dues income structure is in-
adequate to support the significant role the WMA should play in
representing the medical profession on the world stage.
I understand that we have struggled for a number of years with how
to increase income while remaining true to the ethical principles
that are the foundation of this association.
However,I believe it is important for us to continue to look for ways
to expand the power of our voice by increasing our interaction with
other international organizations – and by finding more resources
(translation – more money).
Thank you for the opportunity to share this report with you.
44
WMA news
Honorable Governor of Bali,
Chairman of the World Medical Association,
Chairman of the Indonesian Medical Asso-
ciation,
Head of the Agency for Development of Hu-
man Resources for Health
Ministry of Health, Indonesia
Head of the Provincial Health Services of
Bali,
Members of the World Medical Association
Council,
Distinguished Guests,
Ladies and Gentlemen.
It is a great pleasure for me be here with
you at the opening of this important 194th
World Medical Association Council Ses-
sion. Let me extend my warm welcome
to all participants who have travelled here
from the four corners of the world to join this meeting today.
I am impressed that your organization includes representation
from north and south, from east and west and, happily, reflecting
the make up of the modern medical profession, I see both men
and women.
I would like to thank the World Medical Association for orga-
nizing this council session in Bali. Although some of you may
have visited here before, I am sure you will agree this is always
a good place to revive the body and renew the soul. I have never
heard anyone complain when they had reason to come back to
this beautiful island.Let me also extend thanks to the Organizing
Committee and the partners who have worked so hard to make
this event a success.
The values and practices which were identified as important in
1947 when your organization was founded are just as crucial to-
day as they were then. Innovation in medicine enables doctors to
extend life and cure more patients than ever before. If, however,
this is done without reference to the highest professional and
ethical standards we are all placed at risk – patients, practitio-
ners, the health systems within which we practice. Doctors looses
touch with their limitations, patients become merely “objects of
concern”, and health services loose the
human touch.
As we gather here today,what are some of
the most significant changes in our field?
Diseases like leprosy used to need life-
long treatment, while today they can be
cured in a year. Many cancers are also
curable,while a decade ago the number of
people with even a five year survival rate
was limited. Now we find “cancer survi-
vors” leading full, independent, normal
lives. Advances in diagnostic technology,
likewise, contribute to improved health
outcomes and make outreach of diagno-
sis to new patients possible. Disease can
be identified and treated far earlier than
was possible formerly and telemedicine
can make diagnosis and consultation possible for patients who
without such technology would have been altogether unreached
and unserved.
These rapid advances of technology in medical care combined
with revolutions in communications and information present us
with both opportunity and challenge. Health outcomes can with-
out doubt be improved but almost without exception these in-
novations are costly and beyond the reach of many, perhaps most,
of our people.To meet this challenge some governments have de-
veloped national health financing schemes which increase acces-
sibility of service while distributing health costs more equitably.
Such health insurance systems have generally proved extremely
effective.
While changes have been taking place relative to medical tech-
nology there have also been epidemiological changes across the
globe. Many communicable diseases have become curable result-
ing in steadily increasing life expectancy. At the same time there
has also been an increase in prevalence of non communicable
diseases many of which are particularly dependent on advanced
technology for diagnosis and treatment. This, in turn, has con-
tributed to increasing health care costs, leading many countries to
Opening Speech by H. E. Dr. Nafsiah Mboi, Md, Pediatrician,
MPH Minister of Health of the Republic of Indonesia at the 194th
World Medical Association Council Session
Nafsiah Mboi
45
WMA news
more careful evaluation of the effectiveness, structure, and equita-
bility of their health expenditures.
In fact, in most situations technological advances account for the
bulk of health care costs, now. Responsible management of health
care systems requires good cost benefit analysis to assure that ben-
efits to health outcomes justify the costs. Calculations are compli-
cated, nonetheless, it is clear that correct and equitable use of new
technologies has contributed to reductions in mortality, increases
in longevity, improvements in quality of life, and reductions in
productivity losses resulting from ill health.
The objectives of the World Medical Association are attuned to
assisting physicians in learning to be sensitive, skilled, and con-
sistent in making such decisions. This commitment is reflected
in your programs to “achieve the highest international standards
related to Medical Education, Medical Science, Medical Art,
Medical Ethics, and Health Care for all people in the world.”
I take this opportunity to call upon the WMA to encourage phy-
sicians around the globe, including those in Indonesia, to remain
faithful to the highest professional standards of service to their
patients as they evaluate and utilize technology. At the same time
I would underscore that no cost benefit analysis of treatment is
complete without due attention to the issue of equity in the provi-
sion of health services.
I would like to comment on the issue of Human Resources for
Health or HRH. In Indonesia, one of the main challenges to im-
proving our health services has been related to the inadequate sup-
ply and uneven distribution of trained health care personnel to
meet the needs of our widely scattered people. The Government
of Indonesia has used various approaches to increase the number
of health workers, improved the range and quality of their skills,
and to achieve their more equitable distribution across the country.
In the early 2000s management of health services was decentral-
ization in Indonesia. While in some parts of the country the im-
portance of Human Resources for Health was well recognized by
local government, in other areas it was not regarded as a priority
issue. Local budget allocations were uneven in this field, and in
some cases were extremely low.
In 2008, to increase the availability of specialist care in more
remote areas, the Ministry of Health established a scholarship
program to support education of medical specialists. Upon grad-
uation, scholarship awardees have a service obligation (twice as
long as their residential education) in areas lacking appropriate
specialists. At the end of 2012, a total of 4,311 doctors had been
granted the scholarships. 320 had already graduated. Although
this program has gotten off to a good start, there is concern that
this approach may only meet the needs temporarily,because at the
end of their term of service, if they wish, these specialists will be
free to move to other posts.
Before closing, let me comment briefly on the importance of the
work of WMA. I believe that collaboration among WMA mem-
bers is important, especially working together and information
sharing to tackle common health problems of developing coun-
tries, such as malnutrition, and infant and maternal mortality.
Additionally, many of us experience a “brain drain” with various
faces – the movement of doctors from short assignments in rural
areas to settle in the city, from the public service to the private
sector, and from their low paying home country to higher paying
service abroad. Finally, as provision of health care is increasingly
driven by market forces and international boundaries become
more opened, physicians in some countries find themselves at a
disadvantage competing with externally funded health care pro-
viders and facilities which are part of the evolving global health
care market.
This is a comparatively new issue and one I believe is of consider-
able long term importance. I urge the World Medical Association
to engage itself and its members in exploring this important issue.
The global market is here to stay and will undoubtedly expand
but it is important that as medical practitioners and health care
providers we not jump into the world market and sell our souls to
the highest bidder.
I would argue that we are a service-based profession and should
fight hard to remain so. We should not loose our identity in the
search for a bigger profit. Likewise, the countries that are most
likely to be targets of new international medical enterprise need
advice and support in considering how to respond to this new
challenge.This is a challenge calling for national and international
reflection and cooperation if we are to protect our profession and
the rights and the well being of our patients. I believe that only
with collaboration between developed and developing countries,
between “sending” and “receiving” countries, between techni-
cal and ethical specialists will we be able to influence the global
health market and better serve the global family.
We need doctors whose of obsession is the best interest of the
patient, still inspired by the principle “primum non nocere” that is
to say “first, do no harm”. As it is mentioned the Hippocratic Oath:
“I will use treatment to help the sick according to my ability and
judgment, but will never use it to injure or wrong them.”
Now, with rising education the world around and information
technology available to all, patients are no longer passive. Doctors
46
WMA news
have to be prepared to answer difficult questions from the pa-
tients, often to work more with them, not just issue instructions!.
Improvement in the quality of doctors – their technical knowl-
edge and skills as well as professionalism, commitment to ser-
vice, and perhaps strengthening of human skills – should begin
in medical education. Teachers in medical school are role models
for doctors and, in their knowledge and manner they train their
students. I thank you WMA, therefore, for your attention to the
important field of medical education.
In closing, let me repeat my thanks to the WMA for organiz-
ing this meeting and for bringing it to Indonesia. We are pleased
to host your gathering and have high hopes for your discussions.
May you have fruitful deliberations and a pleasant stay in this
island paradise called Bali.
Finally, asking the Grace of God The Almighty, on our delibera-
tions, I declare the 194th
World Medical Association Council Ses-
sion officially open.
The 194th
Council Session,held at the Laguna
Resort and Spa, Nusa Dua, Bali, Indonesia
(April 4–6) was opened wiseth a speech of
welcome from Indonesia’s Minister of Health
Madame Nafsiah Mboi,a paediatrician.
Council
Following the speech, which was warmly
received, the Council went into formal ses-
sion and Dr. Mukesh Haikerwal (Australia)
was re-elected Chair, Dr. Masai Ishii (Ja-
pan) was re-elected Vice-Chair and Prof.
Frank-Ulrich Montgomery (Germany) was
re-elected Treasurer.All three were re-elect-
ed unopposed.
Dr.Wilson then gave his Presidential report
on his activities since his inauguration in
Bangkok in October 2013. He said he had
travelled to four continents with his three-
fold message on ethics in medicine,the chal-
lenge of non-communicable diseases and
the social determinants of health, and on
climate change. He had attended 16 meet-
ings in 12 countries and 15 cities. He spoke
about his twice-weekly President’s blog on
the WMA website which had detailed these
trips. He said the WMA had a powerful
positive message to share with the world. It
was a message based on a voice for ethics,
good health policy and seeking to support
physicians to achieve the best of health care
for patients around the world. The WMA
was speaking out on matters of importance,
pointing out violations of health-related
human rights, violations against health care
workers and patients. But the organisation’s
achievements were accomplished with ex-
tremely limited resources and he thought
it was very important for the WMA to in-
crease its inter-action with other organisa-
tions and to find more resources.
Dr. Otmar Kloiber, Secretary General, in
his oral report elaborated on the secretar-
iat’s activities as set out in his written re-
port (see page 54). He detailed the actions
taken in support of the 2012–15 strategic
plan and the 20 strategic initiatives set out
in the plan. He spoke about partnerships
and collaboration with other organisation,
as well as the activities of the Junior Doc-
tors Network, the Business Development
Group and the potential for the growth of
the organisation.
Dr. Haikerwal reported on his many visits
around the globe during his chairmanship
and praised the work of the WMA secre-
tariat.
The Council then heard arguments why two
emergency Resolutions should be discussed
at the meeting as matters of urgency.
The first was a Resolution proposed by
the American Medical Association on the
Criminalisation of Medical Practice. It was
argued that three developments had made
this a matter of urgency – the case of Pro-
fessor Cyril Karabus, who had faced man-
slaughter charges in the United Arab Emir-
ates, reports that more than 400 physicians
were under arrest in Syria for giving care to
wounded combatants and state legislatures
in the USA that were proposing to force
doctors to do procedures without medical
indications.
The second Resolution, proposed by the
South African Medical Association, re-
lated specifically to the case of Professor
Karabus who had been acquitted of all
charges against him concerning the death
of a child under his care, but faced an ap-
peal against the acquittal by the prosecut-
ing authorities.The South Africans wanted
the WMA to send a strong message to the
government in the UAE that this was not
acceptable.
The Council decided that both Resolutions
were urgent and should be debated, as well
as a third motion on Patient Safety and
Standardisation in Medical Practice pre-
sented jointly by the Conseil National de
l’Ordre des Médecins France, the Consejo
General de Colegios Médicos de España
and the German Medical Association.
194th
WMA Council Session.
General Report
Bali, Indonesia (April 4–6, 2013)
47
WMA news
Socio Medical Affairs Committee
Sir Michael Marmot (British Medical As-
sociation) was re-elected unopposed as
Chair of the Socio-Medical Affairs Com-
mittee.
Professor Karabus
The emergency Resolution on the case of
Professor Karabus was formally proposed
to thecCommittee by the South African
Medical Association. The Resolution ex-
pressed concern that Professor Karabus re-
mained on bail in the United Arab Emir-
ates despite being absolved of all charges
against him. It stated that he was being
treated in a manner which failed to meet
international fair trial standards and that
he should be allowed to return home im-
mediately. But the South African delegates
argued for stronger measures than those
outlined in the Resolutio, such as sanctions
against the UAE. When the committee
voted for the Resolution to be sent to the
Council, the South Africans declined to
support it.
Later in the meeting the South Afri-
can Medical Association returned with
an amended Resolution, adding that the
Council should publish an advisory notice
in the World Medical Journal and on the
WMA website to note the working condi-
tions in the United Arab Emirates and en-
courage NMAs to publish similar advisories
in their publications.
This was agreed on and thecCommittee rec-
ommended the Resolution to the Council.
Chair’s Report
In his opening words, Sir Michael Marmot
reported on the development of the post-
48
WMA news
2015 Millennium Development Goals
agenda. He said the British Prime Minis-
ter was co-chairing the global planning ac-
tivities. Sir Michael said he had made the
case that the health-related MDGs should
include health equity that covered not only
averages for countries, but the unequal dis-
tribution of health and disease within coun-
tries. The United Nations Development
Programme was the lead UN agency. Sir
Michael said he had made the case to the
UNDP that their policies and activities re-
lated to the development were,in fact,social
determinants of health. A similar approach
had been made to UNICEF. He also wel-
comed the recent four-year plan of activi-
ties adopted by the Canadian Medical As-
sociation, which included actions on social
determinants of health and health equity,
as a good example of concrete action that
medical associations could do in the area of
social determinants.
Violence Against Women and Girls
The British Medical Association reported
that it would submit written proposals to
the committee on implementing the WMA
Resolution on Violence against Women.
Sir Michael said it was important for the
WMA to take a strong stand on this issue
following a number of high profile cases
of violence against women and girls. The
BMA said its proposals could include on-
line learning courses for doctors on the topi,
and developing co-operation with relevant
partner, such as the International Federa-
tion of Gynaecology and Obstetrics.
Health Databases
Dr. Jon Snaedal (Iceland), Chair of the
Workgroup on Health Databases, present-
ed a proposed Declaration to the commit-
tee on The Ethical Considerations Regard-
ing Health Databases. He said this was not
a final document but only information and
he invited thecCommittee members to send
their comments to the group. The aim was
to present the final text to the committee
at the General Assembly meeting in Brazil
in October. It was agreed to refer the paper
to the Medical Ethics Committee for con-
sideration.
Right to Reparation of Victims of Torture
The committee considered a proposed
Statement from the Danish Medical As-
sociation on The Right to Reparation of
Victims of Torture. The paper noted with
grave concern the continued use of torture
throughout the world and said doctors had
a critical role to play in the reparation pro-
cess of victims of torture. During a brief
debate it was argued that the definition of
reparation needed further consideration.
The committee decided to recommend to
the Council that the document be circu-
lated to NMAs for comment.
Standardisation in Medical Practice and Pa-
tient Safety
A proposed Resolution on Standardisa-
tion in Medical Practice and Patient Safety
was put forward jointly by the Conseil Na-
tional de l’Ordre des Médecins France, the
Consejo General de Colegios Médicos de
España and the German Medical Associa-
tion. It was explained that the Resolution
was tabled to enable the WMA to react to
plans currently under way in the European
Union to allow the European Community
of Standardisation to set standards in med-
ical practice in the fields of aesthetic sur-
gery services. This would cover procedures
as well as post-graduate education and
would open the door to similar efforts in
other medical fields. The concern was that
this move might be followed in other parts
of the world. The three NMAs proposing
the Resolution wanted to send a clear mes-
sage that allowing industrial standardisa-
tion bodies that did not have the required
professional, medical, ethical or technical
competenc, to set standards in medical
practice could have negative implications
for patient safety.
Following a debate, it was decided to defer
further consideration and amend the Reso-
lution to make it shorter and punchier.
When the shortened amended Resolution
was later presented, the committee agreed it
should be sent to the Council for approval
and then forwarded to the Assembly for
adoption.
Human Papillomavirus Vaccination
The American Medical Association report-
ed that it had set up an internal working
group with a view to developing a policy on
HPV which would be submitted at the next
Council meeting in October.
Fungal Disease Diagnosis and Management
The Brazilian Medical Association pro-
duced a proposed Statement on Fungal
Disease Diagnosis and Management giv-
ing guidance to NMAs and physicians on
how they should be involved in providing
diagnostic tests and prescribing antifungal
therapy most effectively.
After a brief debate it was agreed to rec-
ommend that work should continue on the
document and afterwards to be circulated to
NMAs for comment.
Criminalisation of Medical Practice
An emergency Resolution on the Criminal-
isation of Medical Practice was presented
by the American Medical Association. This
urged that NMAs should oppose criminal-
izing medical judgment. But the following
concern by some delegates that the Reso-
lution might give the impression doctors
should be above the law, an amended para-
graph was proposed making it clear that
doctors who committed criminal acts unre-
lated to patient care must remain as liable
to sanctions as all other members of society.
This provoked a lengthy debate about crim-
inal intent and how incompetent doctors
who committed errors should be dealt with.
49
WMA news
The committee eventually recommended
that the amended Resolution should be
sent to the Council for approval and then
forwarded to the Assembly for adoption as
policy.
Classification of 2003 Policies
Under the rules stating that policies that
are 10 years old should come up for revi-
sion, it was decided that the Statement on
the Ethical Guidelines for Recruitment of
Physicians and the Resolution on the Non-
Commercialization of Human Reproduc-
tive Material should undergo major revision.
The committee agreed that the Resolu-
tion on SARS (Severe Acute Respiratory
Syndrome) be rescindet and NMAs be in-
vited to come forward with a new policy on
chronic respiratory diseases.
Health and the Environment
Dr. D.C.Shin (Korea) reported on a meet-
ing of the Association’s environment cau-
cus that had taken place earlier in the da,
where participants had discussed the global
mercury treaty recently signe, as well as the
outcome of the Doha United Nations sum-
mit on climate change. The caucus had also
discussed the results of a WMA survey of
the NMA activity in the field of environ-
ment. It was agreed to recommend that the
work of the caucus should continue.
WMA Advocacy
Paul-Emile Cloutier (Canada), Chair of the
Advocacy Advisory Group, reported on the
activities of the group and said that it was
proposing to develop an advocacy plan in
relation to the Declaration of Helsinki.This
would emphasise the WMA’s ownership of
the document.
He said that as part of developing tools for
the benefit of NMAs, the group was willing
to organise an advocacy training session at a
future Assembly meeting.
Collaboration between the Stakeholders and
the Pharmaceutical Industry
The Secretary General informed thecCom-
mittee about a collaborative project between
the stakeholders and the pharmaceutical in-
dustry on the ways of dealing with common
issues relating to sponsorship of research,
support and gifts. This was a draft Joint
Framework on Collaboration between the
pharmaceutical industry, healthcare pro-
fessionals, medical institutions and patient
organizations. The plan was for the docu-
ment to be published later in the year on
a common website, although a common
policy was not the intention. Dr. Kloiber
emphasised that this did not constitute
a new policy since the Framework docu-
mentdcontained common existing policies
of all participants. This could then be used
as a toolkit for others wanting to develop
the policy.
After a brief debate the committee agreed
that the item be referred to the Council for
further consideration.
Council
Professor Karabus
The Council reconvened to consider the
amended Resolution on Professor Karabus
and it was agreed on (see page 59).
Medical Ethics Committee
Dr. Heikki Palve (Finnish Medical Asso-
ciation) was elected unopposed as Chair of
the Medical Ethics Committee, succeeding
Dr. Torunn Janbu (Norway) who stepped
down after three years.
Declaration of Helsinki
Dr. Ramin Parsa-Parsi (Germany), Chair of
the Workgroup revising the Declaration of
Helsinki, reported that considerable prog-
ress had been made, with essential input on
the part of the expert conferences held in
South Africa and Japan. The Cape Town
conference was attended by 76 delegates
from 22 countries, while in Tokyo 135 del-
egates from 23 countries participated.
Professor Urban Wiesing, adviser to the
Workgroup, reported on the key issues dis-
cussed at these meetings – the structure of
the Declaration, vulnerable groups, post-
study arrangements, research ethics com-
mittees, compensation, bio-banks and the
frequency of revisions. He said that a gen-
eral consensus had been reached, except on
the final two points.
Dr. Parsa-Parsi presented a preliminary
draft revision which he hoped the com-
mittee would recommend to be posted on
the WMA website for a two-month con-
sultation with NMAs and the public. This
would last from mid-April to mid-June. At
the end of this period, in August, a meet-
ing would be held in Washingtontto assess
all the comments and a further revised ver-
sion of the Declaration would be presented
to the committee at its meeting in Brazil in
October. If approved, the document would
be forwarded to the Council with a view
to submitting to the General Assembly in
Brazil for adoption.
Dr. Jeff Blackmer (Canada) presented the
revised document, explaining paragraph by
paragraph the proposed changed.
After further debate and unsuccessful moves
to amend the draft document, the commit-
tee agreed to recommend to the Council
that the document should be posted on the
WMA website for public consultation and
comments from NMAs.
Person Centered Medicine
ThecCommittee considered a proposed
revision of the WMA Statement on Per-
son Centered Medicine. Dr. Jon Snaedal
(Iceland) said the paper was intended for
50
WMA news
physicians to have some kind of definition
of the core issue and to support the WMA
in the initiative it had been working on
for the last five years. The committee rec-
ommended that a Workgroup be set up to
complete this work.
Euthanasia
The committee considered a minor revision
to update the WMA Resolution on Eu-
thanasia. This prompted Dr. Van der Gaag
(Royal Dutch Medical Association) to say
that he coult support neither the revision
nor the Resolution. He said that since 2002
the Netherlands had been one of the few
countries where euthanasia and physician-
assisted suicide had been regulated by law
under strict conditions. Therefore his Asso-
ciation could not and would not support the
Resolution in its present form. It would not
tell the doctors in his country that it consid-
ered euthanasia to be unethica, nor would it
condemn doctors who performed euthana-
sia. He called on the Council to reconsider
the revision of the Resolution and work on
rephrasing it respecting the different views
on this subject.
The committee Chair said that should they
wish the Royal Dutch Medical Association
could submit a new policy proposal. How-
ever, the committee agreed to approve the
minor revision.
Use of the Death Penalty
The committee considered a proposal for
the WMA to support the United Nations
General Assembly Resolution calling for a
moratorium on the use of the death penalty.
This led to an extensive debate about wheth-
er the WMA should take a position on the
death penalty, with delegates expressing op-
posing views. It was argued that this should
be a matter for individual physicians and
that by supporting a moratorium it might
be demonstrated that the WMA was siding
with those physicians and NMAs who were
opposed to the death penalty.
However, at the conclusion of the debate
the committee voted overwhelmingly to
recommend to the Council that the WMA
should support a moratorium.
Women’s Right to Health Care
The South African Medical Association
presented a proposed revision to the WMA
Resolution on Women’s Rights to Health-
care and how that related to Mothed-to-
ChildnTransmission of HIn. It was agreed
to recommend to the Council that this
should be circulated to NMAs for com-
ment.
Human Rights
Clarisse Delorme, WMA advocacy adviser,
highlighted some of the Association’s ac-
tivities on human rights in recent months,
including its work on palliative care with
Human Rights Watch and the Healthcare
in Danger initiative of the International
Committee of the Red Cross.
She said that in March representatives
of ten Medical Associations from Arabic
countries had met in Amman to discuss the
provision of health care in detention places.
The regional conference had been orga-
nized by the ICR, in collaboration with the
WMA.The meeting focused on the specific
health needs of prisoner, as well as the role
of NMAs and the WMA in co-operating to
improve the situation in prisons.
The Secretary General, who attended the
conference, reported in more detail on the
discussionk that had taken place during the
event.He emphasized the positive outcome,
notably the strong interest expressed by Ar-
abic medical associations about the WMA
and their possible willingness to join the
Association.
European Union Clinical Trials Directive
Professor André Herchuelz (Association
Belge des Syndicats Médicaux) reported
on current developments in the EU with
regard to the revision of the Clinical Trials
Directive and its implications for the Dec-
laration of Helsinki. Dr. Kloiber responded
by referring to the WMA’s activities on this
issue. He said he was in contact with the
competent EU Committee Rapporteur.
Financeand Planning
Committee
Dr. Leonid Eidelman (Israel) was re-elect-
ed unopposed as Chair of the Finance and
Planning Committee.
Membership Dues Payments
The committee received a report on Mem-
bership Dues Payments for 2013 and an
oral report from Mr Adi Hällmayr, Finan-
cial Advisor, on Dues Arrears.
Financial Statement
Mr. Hällmayr provided a detailed explana-
tion of the pre-audited interim Financial
Statement for 2012. ThecCommittee was
pleased with the favourable financial situa-
tion and recommended that the Statement
be approved.
Business Development
An oral report was given by Mr. Tony
Bourne (British Medical Association),
Chair of Business Development Group,
about the work of the group. He spoke
about the WMA roundtable initiative and
plans for the year ahead. Twelve organisa-
tions had expressed an interest in being
involved in the roundtable. These organisa-
tions would now be approached and it was
hoped to hold the first introductory meet-
ing later in the year.
He also spoke of potential new initiatives
being considere, which would be self-
financing and enable the WMA capacity
building.
51
WMA news
WMA Meetings
There was a discussion about the dates for
the Council meeting in Tokyo in the Spring
of 2014, about holding the 2015 Spring
meeting in St. Petersburg and about the
meetings in 2016 being held in Buenos Ai-
res in April 2016 and in Taipei, Taiwan in
October 2016.
The committee recommended that further
consideration be given to these venues.
The South African Medical Association
proposed the theme of the scientific session
at the General Assembly in Durban, South
Africa, 8–11 October 2014 be the subject
of ‘Universal Access to Healthcare after
MDGs’.
50th
Anniversary of the Declaration of Hel-
sinki
The Committee received an oral report
from the Workgroup on the 50th
Anniver-
sary of the Declaration of Helsinki in 2014.
Dr. Eidelman reported that the main event
would be held in Helsinki in November
2014, possibly at the place where the origi-
52
WMA news
nal Declaration was adopted 50 years ago.
The Workgroup was encouraging NMAs
to organise events on regional and national
level. Moreover, a book was being written
about the Declaration for publication in
2014.
Disaster Preparedness and Medical Response
The Committee received an oral report of
the Workgroup on Disaster Preparedness
and Medical Response. On behalf of Dr.
Miguel Jorge, the Chair of the Workgroup,
Dr. Nivio Moreira (Brazil) summarised the
result of a survey of NMAs about their di-
saster preparedness and medical responses.
Of those that replied, most had experi-
enced disasters in recent years and almost
all had plans to cope with them. Most of
the NMAs had been involved in assisting
people affected by disasters. Few offered
general training courses for physicians on
disaster issues and few also offered some
basic medical guidance to the general pub-
lic on how to behave when facing a disaster.
But most had systems for mobilizing physi-
cians and other health care personnel in the
event of a disaster.
The Workgroup recommended that the
survey should be updated in two or three
years and the findings should be posted on
the WMA website and be shared among
NMAs.
The committee recommended that the
Council approve the Workgroup’s recom-
mendations.
Associate Membership
It was reported that the total number of
Associate Members whose annual sub-
scriptions had been paid was 832. In ad-
dition members of the International Fed-
eration of Medical Student Associations
would be granted Associate Membership
on graduation as physicians for a period of
five years and no membership fee would be
charged.
Past Presidents Network
Dr. Dana Hanson (Canada), Past President
of the WMA, reported on the proposal and
terms of reference foraPast Presidents and
Chairs of Council Network. He said this
largely virtual network would be very useful
for the WMA to tap into the expertise of
the past officers in any projects that would
be of assistance.
The committee recommended that the
Council approve the establishment and the
terms of reference for the Network.
Junior Doctors Network
An oral report on the activities of the Junior
Doctors Network was given by the Chair of
the Network, Thorsten Hornung (Germa-
ny).He reminded the meeting that the Net-
work was a forum for experience-sharing
and discussion among younger members
of the Association. The Network had been
liaising with other junior doctor groups
around the world. Its projects included a
white paper on physicians’ wellbeing to be
presented in Brazil, a policy paper on the
ethical aspects of global health education
and an environmental scan of post-graduate
medical education examining conditions
for junior doctors in training in countries
around the world. A questionnaire was be-
ing prepared.
He said that the Network was currently dis-
cussing the definition of a junior doctor and
at the moment was considering basing this
on a number of years after graduation, such
as eight to 10 years.
Cooperative Relations
Dr. Kloiber reminded the committee that
the Council had approved three academic
organisations to be the WMA Cooperating
Centers from 2013–2015 – the Center for
the Study of International Medical Policies
and Practices, George-Mason-University,
Fairfax, Virginia, on microbial resistance
and the development of public health
policy; the Center for Global Health and
Medical Diplomacy, University of North
Florida, on MedicallLeadership and Medi-
cal Diplomacy; and the Institute of Eth-
ics and History of Medicin,: University of
Tübingen. He proposed a further Center,
the Institut de droit de la santé, Université
de Neuchâtel, Switzerland. The committee
recommended this to the Council.
Death of Dr. Perelman
Dr. Leonid Mikhailov (Russia) informed
the committee of the recent death of
Dr. Perelman, former President of the Rus-
sian Medical Society and a prominent tho-
racic surgeon.
Council
The Council then reconvened.
Dr. Ketan Desai
Dr. Ajay Kumar (India) said the Indian
Medical Association had submitted an ap-
plication to the Council for Dr.Ketan Desai
to be installed as President of the WMA.
He reminded the meeting that in 2009
Dr. Ketan Desai was elected President Elect
of the WMA. But in 2010 he was arrested
in India on charges that he had used his
office as President of the Medical Council
of India for personal gain. As a result the
WMA Assembly decided to suspend his
Presidency indefinitely. Dr. Desai said that
the charges facing Dr.Ketan Desai had now
been dropped and he should be allowed to
be reinstalled as the WMA President.
Dr. Haikerwal replied that the relevant pa-
pers would be studied and the application
would be considered.
The Council later requested the execu-
tive committee and Chair to ensure that
due diligence takes place before pro-
ceeding.
53
WMA news
The Council then considered reports from
three Committees, approving the follow-
ing
From the Medical Ethics Committed:
• a public consultation process on the re-
vised draft of the Declaration of Helsinki
and a further meeting in Washington to
review the comments received;
• a new Workgroup on person centred
medicine to complete work on a revised
Statement;
• a minor revision to the Resolution on Eu-
thanasia;
• a circulation to NMAs of the proposed
revision of the Resolution on Women’s
Right to Healthcare and how that re-
lates to Mother and Child HIV Infec-
tion;
• a Statement supporting the UN mora-
torium on the use of the death penalty
which should be forwarded to the Gen-
eral Assembly for adoption.
From the Finance and Planning Commit-
ted:
• the interim 2012 Financial Statement;
• referring future meeting venues and dates
to the executivec Committee for further
consideration;
• an on-going survey relating to NMA di-
saster preparedness and medical response;
• the establishment of Past Presidents and
Chairs of the Council Network;
• the renewals and appointments of the
WMA Cooperating Centers.
From the Socio-Medical Affairs Commit-
ted:
• the referral to the Medical Ethics Com-
mittee of the proposed Declaration
on Ethical Considerations Regarding
Health Databases;
• the circulation to NMAs of the proposed
Statement on the Right to Reparation of
Victims of Torture;
• the Resolution on Standardisation in
Medical Practice and Patient Safety (see
page 59);
• the circulation to NMAs of a revised pa-
per on fungal disease diagnosis and man-
agement.
The Council heard oral reports on outreach
activities.
The Editor-in-Chief of the World Medical
Journal,Dr.Pēteris Apinis,said he was plan-
ning to produce six issues in 2013. He said
the content of the Journal must be created
by physicians from all over the world and
articles were mainly related to four issues:
news of the WMA and national medical as-
sociations, medical ethics, self- governance
and public health.The aim was to include at
least one contribution from each continent
in every Journal. The concept of the WMJ
was based on the assumption that, although
all people were different,they all had a lot in
common. The problems and situations they
had to deal with were the same, especially
in the domain of medical ethics and public
health.
During further debate, the Council raised
no objection to continuing the collaborative
project between the stakeholders and the
pharmaceutical industry, as reported earlier
by the Secretary General.
World Health Assembly
Clarisse Delorme reported on issues due to
be discussed at this year’s World Health As-
sembly. One related the targets and moni-
toring framework concerning non-commu-
nicable diseases. She said that one positive
move had been the inclusion of a mental
health action plan in the discussions. Other
issues were health workforce, Millennium
Development Goals and social determi-
nants of health.
Criminalisation of Medical Practice
A further debate took place in the Coun-
cil on the Resolution on Criminalisation of
Medical Practice, when amendments were
proposed to deal with the issue of criminal
intent and negligence. The Council eventu-
ally agreed to approve the Resolution for
forwarding it to the General Assembly for
consideration (see page 58). In the vote Can-
ada, Finland and France abstained.
The meeting ended with thanks to the In-
donesian Medical Association for hosting
the event.
Mr. Nigel Duncan,
Public Relations Consultant, WMA
54
WMA news
Secretary General’s Report
Policy & Advocacy
Non-Communicable Diseases
NCDs have emerged as one of the most
important topics on the public health
agenda. The WHO is developing a
2013–2020 Global Action Plan for the
Prevention and Control of NCDs. The
WMA’s main criticism of the new plan
and the monitoring framework is that it
focuses only on adults and adolescents.
Yet it is during childhood when many
lifelong habits are developed and which
are difficult to change later in life. Many
countries emphasized at the last WHO
Executive Board meeting the importance
of health care system strengthening, uni-
versal access and the link to social deter-
minants of health as the right approach in
the fight of NCDS. A revised draft of the
2013–2020 Action Plan was opened for
comment in February and was discussed
in March with NGOs. The WMA will advocate for a holistic
health care approach, avoiding a silo-style disease-specific ap-
proach and considering the social determinants of health.
Together with our partners at the WHPA, the WMA participated
in the development of the NCD toolkit to assess the risk level in
lifestyle behaviours and bio measures in the form of NCD indica-
tors. We are also setting up an independent project together with
Sir Michael Marmot (British Medical Association) and his team
to develop a common set of Social Determinants of Health and
NCD indicators.
Multi Drug Resistant Tuberculosis Project
In March, the WMA launched the revised MDR-TB online
course.We now have a complete set of TB and MDR-TB courses
as online versions, printed formats and CDs.The printed courses
have been translated into Azeri, Chinese, French, Georgian, Rus-
sian Spanish and other languages may follow. All courses can be
accessed free of charge via the WMA webpage. The printed TB
refresher course and the new MDR-TB course were nominated
by the United States Center for Disease Control (CDC) as an
educational highlight and received an award. The WMA is col-
laborating with the WHO to develop the MDR-TB course as
an application for tablet computers, especially for low-cost 10-
inch devices running on Android, which are increasingly used in
low-income countries.The app will be accessible from the Google
and iPhone app webpage and, once downloaded, will be self-
contained and able to run offline without an internet connection.
Tobacco Project
The WMA is involved in the implemen-
tation process of the WHO Framework
Convention on Tobacco Control that con-
demns tobacco as an addictive substance,
imposes bans on advertising and promo-
tion of tobacco, and reaffirms the right
of all people to the highest standard of
health.The WMA will cooperate with the
public private partnership “QuitNowTXT
program” to develop an evidence-based
diffusion of health information for to-
bacco cessation via mobile phones to reach
people at risk from preventable NCDs.
Alcohol
In May 2010, the World Health Assem-
bly endorsed the Global Strategy to Re-
duce the Harmful Use of Alcohol. The Strategy provides a port-
folio of policy options and interventions for implementation at a
national level with the goal of reducing the harmful use of alco-
hol worldwide.The successful implementation of the strategy re-
quires concerted action by countries, effective global governance,
and appropriate engagement of all relevant stakeholders, includ-
ing health actors. In line with the WMA Statement on Reducing
the Global Impact of Alcohol on Health and Society, the WMA
Secretariat monitors progress to ensure that medical associations
at the national and global levels continue to be engaged in imple-
mentation.
Counterfeit Medical Products
The WMA and the members of the World Health Professions
Alliance WHPA stepped up their activities on counterfeit medi-
cal issues and developed an Anti-Counterfeit campaign with an
educational grant from Pfizer Inc. and Eli Lilly. The basis of the
campaign is the ‘Be Aware’ toolkit for health professionals and
patients to increase awareness of this topic and provide practi-
cal advice for actions to take in case of a suspected counterfeit
medical product.The WHPA organised several regional WHPA
Counterfeit Medical Products workshops to implement the
toolkit.
Otmar Kloiber
55
WMA news
Climate change
The WMA continues to be involved in the UN Climate Change
negotiations. Due to its UN observer status to the Convention,
the WMA Secretariat can facilitate the participation of medi-
cal associations interested in the various official meetings taking
place in this framework. The WMA takes part in an informal
consultation group set up by the WHO, which brings together
civil society actors working on health and environmental issues.
The goal of the group is to facilitate the exchange of information
with regard to the UN meetings and coordinate potential joint
approaches. In this context, the WMA signed the Doha Dec-
laration on Climate, Health and Wellbeing that was adopted by
health and medical associations from around the world on the
occasion of the Climate Change Summit in Doha (COP 18 –
December 2012). The Declaration calls for the protection and
promotion of health to be made the one of the central priorities
of global and national policy responses to climate change.
Mercury
The WMA has been a member of the UNEP Global Mercury Part-
nership (Mercury product) since December 2008 in order to con-
tribute to the partnership goal of protecting human health and the
global environment from the release of mercury and its compounds.
This engagement is based on the WMA Statement on Reducing the
Global Burden of Mercury (Seoul,2008).Since June 2010,Dr.Peter
Orris has been attending the successive negotiating sessions of the
UNEP (UN Environment Programme) for a legally binding instru-
ment on mercury, and brought forward the WMA’s recommenda-
tions from its 2008 Resolution on Mercury.The Mercury Treaty was
finally adopted in January 2013 in Geneva.The Treaty sets a phase-
out date of 2020 for most mercury containing products – including
thermometers and blood pressure devices, and calls for the phase-
down of dental amalgam.This aspect of the treaty is a major victory
for all who have worked for mercury-free health care.
Chemicals
In December 2009, the WMA joined the Strategic Approach to
International Chemicals Management (SAICM) of the Chemicals
Branch of the United Nations Environment Programme (UNEP),
which aims to develop a strategy for strengthening the engagement
of the health sector in the implementation of the Strategic Approach.
In consultation with the WHO, Prof. Shin (Korean Medical As-
sociation) has represented the WMA at several SAICM meetings,
bringing forward the WMA Statement on Environmental Degra-
dation and Sound Management of Chemicals (adopted in October
2010 in Vancouver). In September 2012, the WMA, together with
the World Federation of Public Health Associations, the Govern-
ment of Slovenia and the WHO,organised a side event on the topic
in the context of the third session of the International Conference
on Chemicals Management, held in Nairobi in September 2012.
Social Determinants of Health
The Rio Political Declaration on Social Determinants of Health
produced at the World Conference on Social Determinants of
Health in Rio, Brazil, in October 2011, identifies five action areas
for health to engage in to address the social determinants of health.
One of these action areas emphasizes the role of the health sector
in reducing health inequities. Within this framework, the WMA
and the International Federation of Medical Students Associations
(IFMSA) organised in May 2012 a side-event during the World
Health Assembly in Geneva, with the support of the UK delega-
tion. Participants discussed concrete ways for the health sector to
implement the Rio Declaration and engage in reducing health in-
equities.The issue of medical education and training of health pro-
fessionals regarding SDH was raised several times and there was a
general agreement that efforts should focus on this matter.
Millennium Development Goals
As the 2015 target date for the MDGs approaches, there is lively
debate on the contents and form of the post-2015 agenda. This
debate raises important questions about how progress in improv-
ing human health should be reflected in any future set of goals,
targets and indicators. At the start of the 2013 UN General As-
sembly there will be a high level summit to review progress and
map out a forward-looking agenda. In preparation, the UN De-
velopment Group (chaired by the United Nations Development
Programme – UNDP) is leading a series of national and global
thematic discussion on key issues: inequalities, population, health,
education, economic growth and employment, conflict and fra-
gility, governance, environmental sustainability, and food security
and nutrition. The aim is to involve a broad range of stakehold-
ers to discuss the options for a post-2015 framework.The WMA
submitted a proposal and will continue to advocate that health
and health care systems are important drivers for the economies
and for securing social stability and development.
Health Systems
General
Immunization rates against influenza among our profession re-
main worryingly low. Therefore we developed an advocacy and
awareness campaign with support from IFPMA on immunisa-
tion for influenza. The campaign started with a survey of the
56
WMA news
activity level of our nation members on influenza immunisation
and, in a second step, we will develop material for our members
and individual physicians emphasizing the emotional benefits
of receiving immunisation. As part of this campaign, this year’s
WMA luncheon during the World Health Assembly will be on
‘Immunisation with a focus on influenza’. This event will give us
the possibility to highlight our new WMA policy on Immunisa-
tion as well.
Person Centered Medicine
Together with the World Psychiatric Association (WPA), the
World Organization of Family Doctors, the World Health Orga-
nization, the International Association of Patient Organizations
and many other partners, the WMA will hold for the fifth time
the Conference on Person Centered Medicine in Geneva in May
2013.The concept of person centered cedicine embodies the prin-
ciples of patient-centered medicine, but goes far beyond this and
better reflects the entire spectrum of medicine where we as physi-
cians not only deal with the “patient-hood” of person, but respect
the individual with his or her entire personality and in the context
of his or her personal life.
Health Workforce
Third Global Forum on Human Resources for Health (GHWA).
Human resources for health (HRH) challenges are in many coun-
tries the single largest impediment to scaling up access to health
services and to achieving the health-related Millennium Develop-
ment Goals (MDGs) and universal health coverage. Along with
the revised strategy of GHWA the theme for the forum will be
“Human Resources for Health: Foundation for Universal Health
Coverage and the Post-2015 Development Agenda” and will
be held in November in Brazil. Participation is only possible by
invitation. WMA advocates that the voice of physicians will be
reflected in the program and as a result Dr. Julia Tainijoki-Seyer
was invited to take part in the forum working group to define the
program. The WHO has developed the Guidelines on Reten-
tion Strategies for Health Professionals in Rural Areas, with the
WMA taking part in the drafting process.The guidelines are based
on three pillars: educational and regulatory incentives, monetary
incentives and management, and environment and social support.
Workplace Violence in the Health Sector
The 3rd
Conference on Workplace Violence in the Health Sector
took place in October 2012 in Vancouver.The WMA was a mem-
ber of the planning committee. Dr. Mukesh Haikerwal, Chair of
Council, opened the conference with a keynote speech. It was a
good opportunity to present the WMA policy on Violence in the
Health Sector that was adopted in Bangkok last October, and to
bring forward more strongly the physicians’ perspective in the de-
bate.The next Conference is scheduled for October 2014 in the US.
Education & Research
The World Federation for Medical Education (WFME) has
started a discussion process on the future role of the physician.
Beginning with an expert panel in March that included represen-
tatives from academia, the WHO, the WMA and international
and regional organizations for medical education, the WFME
rolled out a debate.The WMA participated as a member of steer-
ing groups in two projects commissioned by the European Union
on the Mobility and Migration of Health Professionals. One
project was led by the European Health Care Management As-
sociation, and the other by the Research Institute of the German
Hartmann Bund, a private physicians’ organization. The general
objective of the research projects is to assess the current trends
of mobility and migration of health professionals to, from, and
within the European Union, including their reasons for moving.
Patient Safety
The WHO stepped up its commitment to patient safety and de-
fined it as a major global priority in health care. To deliver safe
health care, clinicians require training in the discipline of patient
safety, which includes an understanding of the nature of medi-
cal error, how clinicians themselves can work in ways that reduce
the risk of harm to patients, techniques for learning from errors
and how clinicians can harness quality improvement methods to
improve patient safety in their own organizations. The WHO
revised the existing Patient Safety Curriculum Guide for medi-
cal schools and transformed it into a Multi-professional Patient
Safety Curriculum Guide. The WMA was a member of the re-
viewing committee for the multi-professional guidelines.
Caring Physicians of the World Leadership Course
The CPW Project began with the Caring Physicians of the World
book, published in English in October 2005 and in Spanish in
March 2007, which is now available in html and pdf. Some hard-
copies (English and Spanish) are still available at the WMA of-
fice upon request. Please visit the WMA website (http://www.
wma.net/en/30publications/60cpwbook/index.html) to access to the
electronic versions and to order the hardcopies. The CPW Proj-
ect was extended to include a leadership course organized by the
INSEAD Business School in Fontainebleau, France in Decem-
ber 2007. The fifth course was held at the INSEAD campus in
Singapore in January 2013.The courses were made possible by an
unrestricted educational grant provided by Bayer HealthCare and
57
WMA news
Pfizer, Inc. This work, including the preparation and evaluation
of the course, is supported by the WMA cooperating center, the
Center for Global Health and Medical Diplomacy at the Univer-
sity of North Florida.
Health Politics
The WMA has intervened three times on health politics matters
at the request of member associations:
In Slovakia,the government declared a state of emergency in hos-
pitals in order to stop protests and industrial action by physicians
fighting for better working conditions and against the privatisa-
tion of public hospitals. In consultation with the Slovak Medi-
cal Association, the WMA wrote to the Prime Minister and the
President of the Republic to call for proper working conditions
and fair payment.
In Poland, physicians were made liable for managing the reim-
bursement entitlements of the insured. Everyone in Poland is
insured under a state insurance scheme which gives various en-
titlements for reimbursement. These different entitlements were
at least in part non-transparent to the physicians, who should not
be held liable for wrongly assigning reimbursement statuses for
drugs on prescription.Together with the Polish Chamber of Phy-
sicians and Dentist, the WMA protested against this measure,
which was later revoked.
At the end of 2011, the Turkish Government removed key func-
tions, such as the supervision of physicians and the regulation of
post-graduate education, from the Turkish Medical Association
and other self-governing institutions. Together with the Turkish
Medical Association, the WMA staged public events in Ankara
and Istanbul in April 2012 to fight for retaining these critical
rights of physician self-governance.
Human Rights
Zimbabwe
In November 2012, the International Rehabilitation Council for
Torture Victims drew our attention to the case of its member
centre – the Counselling Services Unit, Zimbabwe – which faces
ongoing legal harassment of its staff, with three staff arrested
and in detention. The WMA wrote a letter to the authorities of
Zimbabwe, expressing its concerns regarding the procedures fall-
ing short of international standards for fair trial, as well as the
violation of the confidentiality principle towards patients by the
security forces during the raid. The staff was finally granted bail.
Turkey
On 12 September 2012, around 60 prisoners began a hunger
strike in seven prisons across Turkey as a protest against the au-
thorities’ longstanding refusal to allow Kurdistan Workers’ Party
(PKK) leader Abdullah Öcalan to meet with his lawyers and to
demand the provision of education in the Kurdish language.
According to Amnesty, prison doctors were routinely refusing
to conduct medical examinations of the hunger strikers. In No-
vember, the Turkish Medical Association drew the attention of
the WMA to the gravity of the situation. The WMA wrote a
letter to the Turkish authorities to support TMA’s call to form
boards composed of independent and experienced physicians to
visit hunger strikers and check their health status. The WMA
also asked for an assurance that no punitive measures were taken
against prisoners on hunger strike and that the absolute prohibi-
tion of torture and other forms of ill treatment was upheld.Under
increasing national and international pressure, the Turkish au-
thorities took measures to improve the situation of the prisoners.
United Arab Emirates
WMA secretariat has sent letters to the United Arab Emirates’
authorities expressing its concerns about the arrest of Professor
Cyril Karabus. He was arrested whilst transiting through Dubai
from UK to South Africa and was held responsible for the death
of a child (member of the royal family) in 2002 when he worked
there of WMA on the precarious health situation of Prof. Kara-
bus. A range of questions – regarding the legal proceeding and
guarantees for a fair trial – were also asked to the Minister of
Justice.
Protection of health professionals in areas of armed-conflicts
Last January, the WMA joined a group of 18 NGOs, initiated by
the Safeguarding Health in Conflict coalition to co-sign a letter
to WHO Director General Margaret Chan expressing alarm at
the recent spate of attacks on health workers in Pakistan.
ICRC Campaign “Health Care in Danger”
The framework of the International Committee of the Red Cross
4-year campaign “Healthcare in Danger”,in which the WMA is a
partner, was launched during the summer 2011. A series of work-
shops took place on specific themes, each designed to come up
with practical measures to enhance the protection of health-care
providers and beneficiaries in armed conflicts and other emergen-
cies.The WMA participated in the workshop entitled “The secu-
rity and delivery of effective and impartial health care in armed
58
WMA news
conflict and other situations of violence” that took place in Lon-
don in April 2012. It was organised by the ICRC, the British Red
Cross Society, the British Medical Association and the WMA.
Cooperation with International Rehabilitation Council for Torture
Victims
As an elected member of the Executive Committee of the IRCT,
Clarisse Delorme attended the Executive Committee and Coun-
cil meetings that took place last November in Budapest. A new
round of elections took place. Ms Delorme was re-elected as
an independent expert for a new mandate of three years in the
Council and the Executive Committee.
Ethics
Declaration of Helsinki
InOctober2011,theCounciloftheWorldMedicalAssociationdecid-
edtoembarkonanewprocessofrevisingtheDeclarationofHelsinki.
A workgroup was subsequently formed with the mandate to present
a revised wording of the Declaration to the Ethics Committee.The
revision process was accompanied by a series of expert conferences.
The WMA and the University of Tübingen organised a satel-
lite meeting during the 11th
World Congress of Bioethics in
Rotterdam in June 2012 during which international speakers
from a wide range of scientific disciplines were invited to pres-
ent their views on the future of the Declaration. In addition, a
call for comments was sent out to all WMA members, and se-
lected international organisations were invited to submit their
suggestions for topics requiring revision. In December 2012
the WMA together with the South African Medical Associa-
tion staged the first open expert conference on the revision of
the Declaration of Helsinki in Cape Town South Africa. A sec-
ond conference was held in Tokyo in February. A public con-
sultation on the revision process is envisioned for spring 2013.
World Health Professions Alliance
Health Improvement Card
Together with other members of the WHPA, the WMA launched
the WHPA NCD campaign in May 2011. At the core of the
campaign is the WHPA Health Improvement Card, a simple,
universal educational tool that will allow everyone to assess and
record his or her lifestyle/behavioural and biometric risk fac-
tors. The objective of the project is to develop a tool that can be
used in all health care settings throughout the world that 1) in-
creases awareness of the individual responsibility of each person
for their health, and 2) serves as an advocacy tool for improved
health care systems. The NCD health Improvement Card is
translated into French, Spanish and Portuguese. An online ver-
sion of the toolkit is now available on the WHPA webpage. 2012
saw the second phase start with a pilot study in South Africa.
Counterfeit Medical Products
For the past four years, the WMA together with the other health
professionals of WHPA have engaged in an anti-counterfeit
medical products campaign to protect public health. This year
the WHPA’s activity is to involve national members and national
student organisation through an offer of small grants of $2500–
6000. Each grant application required at least two national asso-
ciations of different health professions in the same country. In the
first round of applications the following were selected as recipi-
ents: Ethiopia, Lesotho, Rwanda and the Philippines.The second
round of selection is still taking place.
Dr. Otmar Kloiber,
Secretary General
Preamble
Doctors who commit criminal acts which are not part of patient
care must remain as liable to sanctions as all other members of so-
ciety. Serious abuses of medical practice must be subject to sanc-
tions, usually through professional regulatory processes.
Numerous attempts are made by governments to control physi-
cians’ practice of medicine at local, regional and national levels
worldwide. Physicians have seen attempts to:
• Prevent medically indicated procedures;
• Mandate medical procedures that are not indicated; and
• Mandate certain drug prescribing practices.
WMA Council Resolution on Criminalisation of Medical Practice
Adopted by the 194th
WMA Council Session, Bali, April 2013
59
WMA news
The World Medical Association is extremely concerned that
Professor Cyril Karabus, a retired paediatric oncologist remains
remanded on bail in the UAE despite a long and slow judicial
process, which has absolved him of all the charges against him.
The WMA notes that the expert medical panel, appointed by the
court to advise it whether there was any evidence against Professor
Karabus, has advised the judge that Professor Karabus has no case
to answer. Consequently the judge dismissed all charges and a rul-
ing of not guilty was given.It also notes with concern that the pros-
ecutors have indicated they will appeal the courts ruling meaning
that Professor Karabus needs to remain in the UAE indefinitely.
Given the findings of the medical panel, the WMA believes that
Professor Karabus is being treated in a manner, which fails to
meet international fair trial standards and should be allowed to
return home immediately.
In light of the above experience, the WMA will publish an ad-
visory notice in the WMJ and on the WMA website to advise
doctors thinking of working in the UAE to note the working con-
ditions and the legal risks of employment there. The WMA will
encourage member NMAs to publish similar advisory notices in
their national publications.
Ensuring patient safety and quality of care is at the core of medi-
cal practice. For patients, a high level of performance can be a
matter of life or death. Therefore, guidance and standardisation
in healthcare must be based on solid medical evidence and has
to take ethical considerations into account. Currently, trends in
the European Union can be observed to introduce standards in
clinical, medical care developed by non-medical standardisation
bodies, which neither have the necessary professional ethical and
technical competencies nor a public mandate.
The WMA has major concerns about such tendencies which are
likely to reduce the quality of care offered, and calls upon govern-
ments and other institutions not to leave standardisation of medi-
cal care up to non-medical self-selected bodies.
WMA Council Resolution on Standardisation in Medical
Practice and Patient Safety
Adopted by the 194th
WMA Council Session, Bali, April 2013
Criminal penalties have been imposed on physicians for vari-
ous aspects of medical practice, including medical errors, despite
the availability of adequate non-criminal redress. Criminalizing
medical decision making is a disservice to patients. In times of
war and civil strife, there have also been attempts to criminalize
compassionate medical care to those injured as a result of these
conflicts.
Recommendations
Therefore, the WMA recommends that its members:
• Oppose government intrusions into the practice of medicine
and in healthcare decision making, including the government’s
ability to define appropriate medical practice through imposi-
tion of criminal penalties.
• Oppose criminalizing medical judgment.
• Oppose criminalizing healthcare decisions, including physician
variance from guidelines and standards.
• Oppose criminalizing medical care provided to patients injured
in civil conflicts.
• Implement action plans to alert opinion leaders, elected offi-
cials and the media about the detrimental effects on healthcare
that result from criminalizing healthcare decision making.
• Support the principles set forth in the WMA’s Declaration of
Madrid on Professional Autonomy and Self-Regulation.
• Support the guidance set forth in the WMA’s Regulations in
Times of Armed Conflict and Other Situations of Violence.
WMA Council Resolution on Professor Karabus
Adopted by the 194th
WMA Council Session, Bali, April 2013
60
Prison Health
Past Practices and Controversies
This second section examines specific hun-
ger strikes from the recent past, to discuss
the pitfalls and stumbling points encoun-
tered by both custodial and medical au-
thorities. As will been seen, a conflictual
situation develops mainly because the non-
medical, custodial authorities decide to
stop the protest by ordering the physician
intervene. In some cases this may be out of
genuine concern that the fasting prisoner(s)
may come to harm. In our experience,
however, it more often is simply to ensure
taking all precautions so that no prisoner
“kills him/herself.”As a determined hunger
striker is hardly likely to simply accept an
“order” from the physician to resume eat-
ing, the doctor is then instructed to feed
the fasting prisoner against his/her will, i.e.
force-feed.
The examples chosen are from different
countries, different contexts. What is im-
portant is the phenomenon that each ex-
ample illustrates. This is neither intended
to be an analysis in any way of the underly-
ing political situation, nor to justify either
side in positions taken regarding the rea-
son for the hunger strikes. The aim is to
show how these hunger strikes have been
handled, or (mostly) mishandled, and to
review briefly the decisions taken and why
they were taken. Hence it is not important
to identify the specific case and country,
with the obvious exceptions of the well-
publicized cases of Guantánamo Bay and
Northern Ireland (N.I.). All examples are
based on personal field experience or that
of close colleagues.
Ethical Background:
the Evolution of
“WMA Malta”
The Northern Ireland hunger strikes in
1980 and 1981 took place in the context
of “the Troubles” in Ulster, at a time when
there were mass arrests of I.R.A. militants
and accusations of brutality and worsened
by the public order forces. Some years be-
fore, to avoid any medical involvement in
interrogations and other such activities
the British Medical Association had ap-
proached the WMA, so a clear position be
taken regarding medical participation in
such non-medical activities. (At one point,
the British authorities had suggested that
physicians sit in on interrogations to see
there was “fair play”…). The WMA issued
its declaration of Tokyo in 1975 against the
participation of doctors in any form of tor-
ture. In this Declaration, one of the Articles
(originally “5”, now in the revised 2006 ver-
sion, “6”) mentioned hunger strikers, stipu-
lating:
“Where a prisoner refuses nourishment and is
considered by the physician as capable of form-
ing an unimpaired and rational judgment
concerning the consequences of such a voluntary
refusal of nourishment, he or she shall not be
fed artificially. The decision as to the capacity
of the prisoner to form such a judgment should
be confirmed by at least one other independent
physician. The consequences of the refusal of
nourishment shall be explained by the physician
to the prisoner.”
Few doctors know why this clause is includ-
ed in what is essentially a declaration on
non-physician participation in torture. The
reason1
relates to situations that may occur
where torture is taking place. If a prisoner
being tortured decides to protest against
his plight by refusing to eat, the physician
should not be obliged to administer nour-
ishment against the prisoner’s will, and
thereby effectively revive him for more tor-
ture. This was the reason for the inclusion
of this article in the Tokyo declaration. The
wording “artificially fed”, instead of “forci-
bly fed”was an imprecise choice of wording,
as “artificially” clearly does not convey that
it was feeding against the prisoner’s will
that was prescribed. It also implied not to
resuscitate an unconscious prisoner, victim
of torture, even without force being used, so
as to send him back for more.
During the hunger strikes in N.I. in 1980
and 1981, force-feeding was not performed.
The UK doctors never envisaged the pos-
sibility “that there be any circumstances
where the due process of law would require
a physician to force-feed anybody against
1 Reyes H., Luebeck; op. cit.
Physicians and Hunger Strikes in Prison: Confrontation,
Manipulation, Medicalization and Medical Ethics (part 2) (part 1 vol. 59 N 1)
Hernán Reyes George J. AnnasScott Allen
61
Prison Health
their will.”1
A clear position for the uphold-
ing of patient autonomy was taken by the
U.K. during the hunger strikes in Northern
Ireland. Respecting autonomy came with a
price.Ten deaths resulted before the prison-
ers broke off their strike, and the authori-
ties quietly gave in to some of the prisoners’
demands.
After these dramatic events in Ulster, it
was awhile before there were any such de-
termined protests leading to loss of life.
Many hunger strikes took place during the
next 15 years, in the Middle East, in Latin
America and elsewhere, but never led to
any showdowns as in Northern Ireland.
Protest fasting in most of these contexts,
without wanting to minimize neither the
prisoners’ sincerity nor their grievances,
never went “down to the wire”. In South
Africa, however, in the 1980s, there were
“more serious” hunger strikes. This led the
South African doctors to seek further guid-
ance from the WMA, about hunger strikes
per se, and as a result, a new declaration, ex-
clusively on hunger strikes in custody, was
drafted and passed by the World Medi-
cal Assembly in Malta in 1991 (hereafter
“Malta 1991”).This new document defined
the different forms of fasting, the role of
the doctor in monitoring the patient, and
mentioned the effects of “terminal” hunger
strikes.
While “Malta 1991” mentioned artificial
feeding, still it did not explicitly forbid
force-feeding. At the time, forcible treat-
ment was not an issue, and hence was not
considered as a problem. After the deadly
mistake,occurring during a hunger strike in
the Middle East in the early 1980s, which
resulted in the death of two prisoners who
were forcibly fed – liquid nutrients being
erroneously introduced into the windpipe
rather than the oesophagus – force-feeding,
already rare, had practically disappeared.
1 Written statement to the author by a former sen-
ior medical officer who was involved at the time
in the Irish hunger strikes.
The hunger strikes in Turkey in the late 90s
led to an unprecedented number of deaths.
At least 60–70 prisoners, and also many
family members fasting outside the prison,
died.The deaths from fasting occurred after
periods of time well beyond the “72 days”,
which implied they had not been “totally
fasting”, and so died from prolonged, not
acute, malnutrition. This was a completely
different situation from that of the 1981
Irish Hunger Strikes. The Turkish hunger
strikes and the way they were ultimately
“managed” by the authorities and by the
prisoners are a complex issue, well beyond
any detailed discussion here. The point to
be stressed is that there was no question of
any forcible feeding, the confrontation be-
ing of a very different complexity. It was
the Turkish strikes that triggered the revi-
sion of “Malta 1991”2
at the WMA. Ini-
tially, the new draft was intended to refer
essentially to the confrontation in Turkey.
However, as the revision was taking place
and being debated within the WMA, the
equally serious situation at Guantánamo
Bay was taken into consideration. The use
of systematic force-feeding at Guantánamo
Bay led to a review of the ethical issues in-
volved,and to reaffirming patient autonomy
over just beneficence at any cost. This was
the main reason for the WMA considerably
strengthening the condemnation of force-
feeding, distinguishing it this time clearly
from voluntary artificial feeding3
. The new
“Malta 2006” was revised and passed by the
World Medical Assembly in South Africa
in 2006.
The Controversy Around
Force-feeding
The situation at Guantánamo Bay (Gtmo)
has been widely documented in the press
2 Reyes, H. Force-Feeding and Coercion: No Physi-
cian Complicity. In: Virtual Mentor, American
Medical Association Journal of Ethics, October
2007, Vol. 9, No 10, pp 703-708.
3 WMJ; op. cit.; Glossary
since 2001, and there is now a large amount
of information accessible to the public.
Force-feeding at Gtmo is now well docu-
mented in many articles in prestigious
journals, and on countless websites4
. Force-
feeding was implemented there by physi-
cians, and may still be at the time of this
publication. This constitutes a violation of
the principles set down by “Malta 2006”,
and constitutes an example of medical
complicity in what the WMA has defined
as inhuman and degrading treatment. The
WMA’s firm position against force-feeding
is explained in detail in the Background
paper5
accompanying the revised 2006 ver-
sion of “Malta”. Article 13 of “Malta 2006”
states:
“Forcible feeding is never ethically accept-
able.Even if intended to benefit,feeding ac-
companied by threats, coercion, force or use
of physical restraints is a form of inhuman
and degrading treatment. …”
Physicians now should unequivocally know
that it is their ethical duty not to participate
in, nor condone, any such coercive proce-
dures. Guantánamo Bay is a typical exam-
ple of “medicalization” being implemented
as the “solution” to a problem the custodial
authorities – in this case the military —
cannot accept. The term used, “asymmetric
warfare”6
brings to light a fundamental con-
tradiction in the response to hunger strikes
in the Guantánamo context. On the one
hand,medical intervention by force-feeding
is “justified”as necessary to provide humane
medical treatment to prisoners, to save their
lives. On the other hand, hunger strikes
being described as a new type of “warfare”
cannot have a “medical” solution. It is ei-
ther suppression, by any and all means pos-
sible, of an act of warfare, or it is providing
4 http://www.nytimes.com/2006/02/22/interna-
tional/middleeast/22gitmo.html?scp=1&sq=Force-
Feeding%20at%20Guant%E1namo%20Is%20
Now%20Acknowledged&st=cse
5 WMJ; op. cit.
6 Annas G.J., op. cit.
62
Prison Health
humane treatment – one cannot have it
both ways!
Two arguments for feeding hunger strik-
ers even against their will have been given
by the military authorities responsible for
Gtmo. The first argument is that force-
feeding has had to be implemented to “save
lives”. This statement is fallacious, as the
feeding was being administered very early
on, after a maximum of 10-15 days of to-
tal fasting. As has been shown, at this stage
there is no risk of dying from fasting.When
pressed with this reasoning, the custodial
authorities have switched their argument
to being “not to save lives, but to save their
health”. This is again a fallacious argument,
vaguely disguising the real intent, which is
to break the protest, indeed to suppress the
“asymetrical warfare”.
There have been rare cases of hunger strikers
dying very early on in their protest fasting.
One of the ten 1981 N.I. hunger strikers,
Martin Hurson, died after 46 days, from a
complication that apparently did not allow
him to ingest water. A recent 2012 case of a
California prisoner on hunger strike, dying
after one week”1
is still being medically in-
vestigated, but the death was most certainly
not due to the fasting alone.
The second argument issued by the mili-
tary authorities for intervention has been
that the vast majority of internees at Gtmo
“accept” in fact being thus fed, meaning
they do not struggle and fight against in-
sertion of the naso-gastric tube, “because
they do not want to die”. If this were to
be the case, i.e. voluntary acceptance of
the feeding, it would not constitute force-
feeding, but artificial feeding. The latter, as
has been stated, is not a transgression of
ethics as by definition it implies voluntary
acceptance of medical intervention from
the hunger striker.
1 http://rt.com/usa/news/california-hunger-strike-
gomez-187/
This argumentation nonetheless warrants
further scrutiny. One of the higher authori-
ties in the military command has stated
that at Gtmo they have been “strapping
some of the detainees (sic) into restraint
chairs to force-feed them and isolate them
from one another after finding that some
were deliberately vomiting or siphoning
out the liquid they had been fed”2
. This is
also the reason naso-gastric tubes have not
been left in place, as they can indeed be
used to empty the nutrients introduced into
the stomach by a hunger striker not want-
ing to receive food. The point is obvious:
the fact that restraint is “necessary” proves
that the administration of nutrients is not
accepted voluntarily, and hence constitutes
force-feeding.
This being said, one must look beyond this
first stage,as force-feeding has been the sys-
tematic policy at Gtmo3
for many years now,
and not merely an exceptional intervention.
The military authority quoted earlier ad-
mitted that “…commanders (had) decided
to try to make life less comfortable for the
hunger strikers, and that the measures were
seen as successful. … Pretty soon it wasn’t
convenient, and they [the hunger strikers]
decided it wasn’t worth it,” … “A lot of the
detainees said: ‘I don’t want to put up with
this. [resisting force and the restraint chair]
This is too much of a hassle.”
It is thus deliberately misleading to ascer-
tain that the feeding implemented at Gtmo
is not coercive because a hunger striker
gives up protesting and struggling. Know-
ing that he cannot prevail against the physi-
cians charged with feeding him, a hunger
striker may even renounce resisting at all.
Seeing fellow hunger strikers being forced
to submit to the naso-gastric feeding and
2 http://www.nytimes.com/2006/02/22/interna-
tional/middleeast/22gitmo.html?scp=1&sq=Force-
Feeding%20at%20Guant%E1namo%20Is%20
Now%20Acknowledged&st=cse op. cit.
3 Annas G.J; op. cit. and others
the restraint chair may be enough to dis-
courage any resistance.
In this respect, “Malta 2006” specifically
states, in the same Article 13:
”Equally unacceptable is the forced feeding of
some detainees in order to intimidate or coerce
other hunger strikers to stop fasting.”
The whole discussion around the policy of
force-feeding hunger striking internees at
Gtmo thus centers on this flouting of the
clear prohibition for physicians to partici-
pate in inhuman and degrading treatment.
Much has been debated regarding the is-
sue of whether force-feeding qualifies as a
form of torture.The WMA does not use the
term torture, but declare force-feeding as
“inhuman and degrading treatment”, mak-
ing it a violation of Common Article 3 of
the Geneva Conventions of 1949, which
condemn “cruel, humiliating and degrad-
ing treatments”. Repeated force-feedings
can only make the situation more degrading
and inhuman. However, legally speaking, as
there is no clear intent “to inflict pain”, the
juridical definition or torture according to
the UN 1984 Convention against Torture
would arguably not be met. The distinc-
tion here between “inhuman and degrading
treatment” and “torture” is not the point –
force-feeding is a violation of medical ethics
under any circumstances.
Indeed, in many non-military settings, the
force-feeding is not only legally permissible,
it is actually ordered by the courts. Court
orders do not invalidate the professional
obligation of the physician to act within the
bounds of medical ethics. While such con-
flicts are notoriously challenging for indi-
vidual physicians, violations of professional
ethics greatly undermine the integrity and
autonomy of the medical profession and
may have profound consequences on the fu-
ture efficacy of the profession. As a practical
matter, they have the immediate impact of
damaging the ability of professional col-
leagues and future physicians to establish
63
Prison Health
trust with fellow prisoner patients; and as
we have said, without trust, medicine can-
not be practiced.
In Guantánamo Bay, restraint chairs ac-
companied by threats and muscular
interventions,were used, and any recalci-
trant to the feeding thus made to comply.
This situation of coercion, the force-feed-
ing, was maintained for weeks, months and
more on fasting detainees.The WMA Dec-
laration of Malta qualifies “force-feeding”
unequivocally as “a form of cruel, inhuman
treatment” – but this refers to a “one-shot”
force-feeding.The WMA never envisaged a
situation whereby repeated force-feedings
would be applied to the same individu-
als over such long periods of time. There is
no historical precedent for hunger strikes
lasting over five years and “managed” with
inhumane and unethical practices in this
coercive way1
. There may be one exception
to this, Irom Chanu Sharmila of India who
has been on a hunger strike for more than
a decade. It could arguably be necessary to
now submit to the WMA the question of
how long-term and repeated force-feedings
should be qualified.
Lessons from Guantánamo
At Gtmo force-feeding was accordingly
made mandatory. It was the Secretary of
Defence who specifically decided that the
decision was a military one, to be made by
the non-medical camp commander,but that
would be implemented by physicians2 3
.
1 Polgreen, L. In India, 11-Year Hunger Strike over
Military Violence is Waged in Shadows. In: New
York Times, September 11, 2011, 5. Annas G.J.
personal communication.
2 Annas, G.J. Military Medical Ethics – Physician
first, last, always. In: N Engl J Med 2008; 359;
1087-90
3 Rubenstein, L.S., Annas, G,J, Medical Ethics at
Guantánamo Bay Detention Centre and in the US
Military: a time for Reform In: Lancet 2009, 374;
353-55
“The use of physicians to aggressively break
a prison hunger strike raises complex medi-
cal ethical and legal issues that have been the
subject of international debate for decades.”4
It is a perverse medicalization of the issue,
imposing a medical act on an unwilling pa-
tient, thus taking the physician away from
the role of medical intermediary. The issue
became so politicized that the most senior
physician in the Pentagon at the time con-
tradicted his base commander on the issue
of the hunger strikers being suicidal5
and
suggesting that the case of hunger strikers
at Guantánamo was like the Terri Schiavo
case6
.“There is a moral question. Do you al-
low a person to commit suicide? Or do you
take steps to protect their health and pre-
serve their life?7
” The order was then given
specifically requiring military physicians to
perform an act in direct violation of medi-
cal ethics.
Another recent case in Switzerland illus-
trates this point. The heated arguments
between the judiciary, adamant to “break”
a well-known hunger striker by having the
doctors force-feed him, and the physicians,
refusing to comply citing the support of
their Medical Association, even though
the decision to force-feed was (surprising-
ly) sustained by the Swiss Federal Tribunal
(the equivalent in the US to the Supreme
Court) led to a stand-off. In the end, the
physicians stood their ground and firmly
refused to give in to any judicial authority
that flouted medical ethics, be it the high-
est Tribunal in the land.8
They were right
in doing so, and the judiciary was wrong
4 Annas G.J. op. cit. Footnote 10
5 Wei M., Brendel J.W., op. cit.
6 Media Roundtable with Department of Defense
Assistant Secretary for Health Affairs William
Winkenwerder, News Transcript, June 7, 2006
available at: http://www.defenselink.mil/tran-
scripts/transcript.aspx?transcriptID=33
7 Annas G.J., op. cit.
8 Editorial by Dr. Jacques de Haller, President of
the Swiss Medical Association (FMH); Bulletin
des Médecins Suisses, September 2010, N° 39.
to try to get physicians to violate medical
ethics, including the clear directives on
hunger strikes of the World Medical As-
sociation9
.
It is this abuse of the medical role of prison
authorities and even the judiciary that has
led to serious confrontations. Unfortunate-
ly, the spotlight has been turned more and
more onto the extreme violation of medical
ethics in the case of hunger strikes – force-
feeding – neglecting almost totally the real
role of physicians. This real role of doctors
has been discussed earlier and it will be fur-
ther addressed later on.
The US military authorities do not dis-
pute that force-feeding violates medical
ethics, but insist that physicians follow
orders because force-feeding is necessary
for national security reasons. National se-
curity, not the prevention of “self-harm”, is
the real issue. Physicians at Gtmo, mainly
Navy reservists, have complied with or-
ders, although it is possible that any physi-
cian not willing to do so may have been
directed elsewhere. In Switzerland, eighty
prominent physicians signed a petition re-
sisting such “orders”from the highest court
in the land, the Federal Tribunal10
, and the
order was revoked.
The Conflict that Needn’t Be
Guantánamo Bay has been merely the
most visible example of “medicalization” of
the controversy around hunger strikes, in
the media spotlight because of the char-
acteristics of the place and its inmates.
Such “medicalization” occurs, however,
to a lesser degree, in prisons everywhere.
The custodial authorities’ first and utmost
priority is maintaining security and “peace
and quiet”. A prisoner who protests by
fasting, by definition will do it “noisily”, to
attract as much attention as s/he can, and
9 “Malta 2006”, op. cit.
10 de Haller J., op. cit.
64
Prison Health
get as much support as possible from all
sides. A hunger striker is seen therefore as
a trouble-maker, a “hostage taker” as has
been mentioned.The tendency to “have the
doctor” solve the problem is not limited to
Gtmo.
Hunger strikes elsewhere have had similar,
though mostly attenuated, complications.
A case in point was a collective hunger
strike in a Latin American country, where
an ICRC physician played a key role in
finding a solution. By speaking to the pris-
oners both collectively and individually, it
became clear that none of them wanted to
die, but all wanted their protest to continue
and make as much “noise” as possible. The
doctor could thus persuade the hunger
strikers to accept intravenous lines and the
administration of vitamins and nutrients.
The prisoners continued proclaiming they
were still “on hunger strike”. The physician
played his role of intermediary discreetly,
refusing to comment publicly on whether
the hunger strike was “really genuine”.
Had he made any public statements, this
would have been seen by the hunger strik-
ers as a betrayal of trust, possibly leading
to a breakdown in the process of recon-
ciliation. It was finally a representative of
the Church who brought about a peaceful
resolution.
Other recent examples in the Middle East
have proven again that if the physician
plays his or her role of discreet, trusted
medical intermediary, there will be no
need for any force to be considered. The
hunger striker not wanting to die may be
persuaded to accept medical help in ex-
change for some face-saving “concession”
for example. Or he may accept transferral
to hospital so as to be able to “blame the
prison doctor” for having to refrain from
pursuing the protest fast.The prison doctor
must be ready to shoulder this blame, hav-
ing the interest of the patient as a priority.
Furthermore, it will allow for smoothing
the conflictual situation between the cus-
todial authorities and the protestors.
Thus, there need be no conflict once all par-
ties agree that a solution has to be found so
as not to endanger anyone’s life.
Allowing the Prisoner
One Last Chance
The debate on respecting autonomy, and
not imposing treatment on hunger strik-
ers is most often a moot point. The hunger
strikers at Guantánamo Bay were force-
fed early, and it will never be known how
many of them could have been coaxed out
of their collective strike had the doctors
been able to have an independent role of
medical intermediary. Some well meaning
voices have intransigently supported re-
spect at all times of, for example, any writ-
ten instructions, calling the (exceptional)
hunger striker who goes “all the way”, to
be respected.
This is certainly the policy that was applied
to the Northern Ireland hunger strikers.
However, a recent personal example will
illustrate exactly the contrary, and still be
in accordance with the guidance in “Malta
2006”.
In a hunger strike in Transcaucasia, the
prison doctor took it upon himself to resus-
citate a vociferous political hunger striker
who had reached the confusional phase late
in total fasting. This was, in fact, contrary
to the hunger striker’s written instructions.
On the face of it, this case would seem to be
a violation of medical ethics by the prison
doctor.
Some time later, this same prisoner pro-
tested about the prison doctor’s actions
to one of the authors of this paper. When
questioned as to why he had gone against
the hunger striker’s written decision not to
be resuscitated, the local doctor explained
that he came from the same region as the
hunger striker. “In his heart”, he said, he
knew the patient would not want to die, so
he intervened once the prisoner was no lon-
ger alert and aware of what was happening.
This prison doctor did well in doing so. As
the hunger striker confessed to the author,
he was actually delighted to find himself
alive and well – but he did not want either
the authorities or the prison doctor to know
this! This example may be uncommon, but
it is not atypical of the ambivalence there is
in many cases.
Prisoners begin a hunger strike often not
really knowing what they get into. As shall
be discussed further on, some will “paint
themselves into a corner”at some point, and
may not know how to back off. It is here the
doctor can play an important role. Force-
feeding will not be an issue, since this type
of hunger striker does not want to harm
himself. In the privacy of the medical con-
sultation, away from any outside peer pres-
sure, the physician often easily convinces
the hesitating protester to accept artificial
feeding. As to the ethical guidelines, it is
important to understand that “Malta 2006”
specifically allows such leeway to the treat-
ing physician who knows the patient, and
should thus have the final word in deciding
what is best1
. Article 10 reads:
“If no discussion with the individual is pos-
sible and no advance instructions exist, phy-
sicians have to act in what they judge to be
the person’s best interests. This means consid-
ering the hunger strikers’ previously expressed
wishes, their personal and cultural values as
well as their physical health. In the absence of
any evidence of hunger strikers’ former wish-
es, physicians should decide whether or not to
provide feeding, without interference from
third parties.”
The prison doctor who thus ignored the
Transcaucasian hunger strikers’ written in-
structions thus took the risk of erring by
going against the expressed will of the pris-
oner – but in fact he ended up taking the
right decision. The physician retained the
proper authority to exercise judgment, in
1 WMJ; op cit. 10. Artificial feeding, force-feeding
and resuscitation; p. 40
65
Prison Health
good faith, in assessing the patients’will in a
difficult clinical situation.
“Malta 2006” allows for error. If the Trans-
caucasian prisoner had torn away his in-
travenous lines and naso-gastric tube upon
revival, then the prison doctor would have
been justified in not interfering a second
time.This will be discussed in the final point
before reaching a conclusion.
Volunteer or Volunteered ?
The common denominator to all problem-
atic hunger strikes is the clash between
medical and non-medical authorities.How-
ever, this should not distract the physician
from other possible conflicts which will di-
rectly influence the ethical management of
the hunger strikers.
A prisoner who decides to protest by fast-
ing must do so voluntarily. As it has been
mentioned, some voices object to anything
being truly voluntary in a custodial setting,
referring to the overall control exerted by
the custodial authorities. Different pressure
on the hunger striker has also been exert-
ed, which in some contexts can be potent
enough to force the hunger striker to pursue
the protest that the individual would have
broken off.It is here that the physician has a
duty to identify such a case.
By making sure every hunger striker is seen
and interviewed in the privacy of the medi-
cal consultation, the physician has a good
chance of establishing sufficient trust to be
able to know what the situation is. All too
often, when many prisoners are all on strike
together, they are kept in an open ward to-
gether. In such conditions it is easy for a
“leader”, identifiable or not, to exert pres-
sure on the others to pursue a hunger strike
all may not be in agreement with. To avoid
this type of peer coercion, the physician
must insist on seeing each hunger striker
individually. If the hunger strikers initially
refuse (possibly again because of peer pres-
sure), the excuse of doing a “medical ex-
amination in private” usually gets them to
consent.
Concerns about how to examine “hundreds
of prisoners” individually should not be a
major issue, as “mass hunger strikes” usu-
ally fade out after a few weeks, reducing the
number down to the real and problematic
cases. As will be developed in the recom-
mendations and in contexts where this is
feasible, hunger strikers should be kept in
separate rooms – but not in isolation. To
absolutely separate them and leave them
incommunicado will be in most cases seen
as a repressive measure,required by the phy-
sician to boot, and will not encourage the
prisoners to trust the doctor.
Experience from many contexts has shown
that many hunger strikers will, in the pri-
vacy of the consultation, even plead with
the physician to help in getting away from
peer coercion, or from a threatening leader-
ship. If the physician can convey the mes-
sage that s/he is there not to stop the strike,
but to help the individual hunger striker,
more than half the battle is won. It is then
a question of finding a solution. This may
entail transfer to the medical ward, for “fur-
ther exams”, or for “treatment of a medical
condition”. A form of “reverse medicaliza-
tion” can be evoked here, the physician tak-
ing upon him/herself to give the individual
a way out. This may be so as to merely “not
lose face”, important in many contexts. Or
it may be to extract from reprisals a hun-
ger striker who has “volunteered” to protest
way beyond the length of time he may have
envisaged initially.The result – medical care
being provided – is the same as for the food
refuser, but in the refuser’s case it is clear
from the start that the fasting is limited and
to be under full medical control. It cannot
be stressed sufficiently here the need for the
physician to be able to convey to the hunger
strikers that s/he is “on their side”, meaning
to provide care and empathy and whatever
assistance is needed, and not as an agent of
the custodial authorities.
Manipulators and Manipulated
The imposition on medical staff by judges,
tribunals or other custodial authorities of
orders to perform the task of force-feeding
“recalcitrant” hunger strikers, knowing full
well or ignoring that this is contrary to
the doctors’ ethical principles, is a form of
manipulation. Physicians should never let
themselves be manipulated this way, what-
ever the authority evokes, be it judicial or
military. Even in situations of “dual loyal-
ties”, whereby physicians owe loyalty to, for
example, the Prison Service, or the Armed
Forces, the bottom line must always be re-
spect for their ethical principles1
.Physicians
are first and foremost responsible to their
patients2 3
, and they have the full support
of the World Medical Association behind
them in this.
There is a different form of manipulation
that physicians also should avoid.Individual
or groups of hunger strikers may also seek
to “use” the doctor. Recent cases of what
one may call “problematic hunger strikes”,
i.e. going beyond a mere couple of weeks,
in politically charged contexts, have given
rise to such behaviour.A hunger striker may
tell the physician in confidence that for sure
he neither does want to die nor endanger
his health. While accepting assistance in
the form of an intravenous line or possibly
even nutritional intake in the discretion of
the medical consultation, the hunger striker
tries to manipulate the doctor, for example,
insisting he makes a public statement to the
press, or blatantly lies to his superiors in the
prison.This is unacceptable when it is obvi-
ously a form of manipulation of the physi-
cian, trying to get him to collaborate with
the protest. The physician has to remain on
neutral ground, and thus retain credibility
1 Reyes, H. Medical ethics subject to national law:
Should doctors always comply? In: Medische Neu-
traliteit; Jaargang 51, 8 November 1996 MC NR
45; pp. 1456/1459
2 Annas G.J. op. cit.
3 Allen S., Reyes H.; op. cit.
66
Prison Health
on all sides. While there is not need to be
specific, towards the press for example, on
“what type of treatment” is being given,
the physician should not lie about it. To his
immediate superiors he should explain his
situation of intermediary, and not let them
manipulate the situation either.
In another highly publicized hunger strike
in Europe, a determined prisoner, who to-
tally fasting lost more than 20 kilos but
who knew exactly what he was doing, man-
aged to manipulate into believing he was
steadfast in his resolve not only the custo-
dial authorities, but also the medical staff.
The custodial authorities, in this case both
prison and judicial, ordered the prisoner to
be force-fed. The physicians refused, evok-
ing the ethical principles in “Malta 2006”.
The nurses, however, took pity on the “poor
old man”1
and persuaded him (sic) to accept
a naso-gastric tube. The hunger striker as-
certained that if he were attached, he would
yank it out. However, he then proceeded to
help the nurses attach him.
This case was widely commented on and
even went visually into the media. It is now
clear that the prisoner had no intention of
starving himself to death, but manipulated
the authorities into ordering him force-fed;
manipulated the medical staff into attach-
ing him down, while accepting in fact the
naso-gastric feeding; and even manipulated
an outside higher authority into believing
he had been force-fed. Once he obtained
what he wanted, he quickly stopped fasting
and walked out of custody a free man.
It is most important for physicians to main-
tain the high moral ground here, and refuse
manipulation from any side. In the above-
mentioned case most of them refused to
have anything to do with the prisoner, but
some – and the nursing staff – were tricked
into playing his game.It is essential the phy-
sician not let him/herself be manipulated by
1 An authentic quote to the author from the inter-
viewed medical staff…
any side.Only this way a constructive medi-
cal role will be possible and hopefully calm
down the situation and avoid coming to an
impasse.
Painting Hunger Strikers
Out of Their Corner
It was mentioned in the introduction to this
paper that the hunger striker was some-
times “forgotten” in the heated controver-
sies between the custodial authorities and
the medical profession. Such confronta-
tions, and their often very public “ventila-
tion” in the media, put the hunger striker
“on the spot”, or more to the point, “in the
spotlight”. A lone hunger striker may all of
a sudden find he has become a “star”, talked
about, held up as a “victim” or “martyr” as
the case may be. From a hostage taker hold-
ing himself hostage, he effectively becomes
a real one of the situation. Any “support”
from outside or from the same media, may
have the contra-productive effect of “paint-
ing the hunger striker into a corner”. Find-
ing oneself with the “star” or “martyr” status
makes it very difficult to back out of a more
and more difficult situation. Abandoning
the hunger strike becomes impossible, even
in exchange for lesser concessions that glad-
ly might have been accepted initially. The
hunger striker may fear the taunts from the
prison guards if he now backs down; or the
shaming of his family; or the reproaches of
his fellow inmates who will fell “let down”…
The hunger striker may thus feel obliged to
fast beyond whatever limit he initially may
have had in mind.
When the individual hunger striker, or
group of resolute hunger strikers, gets into
such a “showdown” position with the au-
thorities,pushed by their new notoriety into
radical positions they may have not initially
intended to take, it may seem too late to
find a useful alternative to impasse. How-
ever, even in the most politicised situations,
letting the situation deteriorate and become
confrontational is not inevitable.
The physician still can play a crucial role in
finding a way out. It is important for the
physician not to medicalize just any form
of fasting during the first 72 hours, other-
wise the precious time will be wasted on
futile cases. The custodial authorities may
certainly consult the doctor about a spe-
cific prisoner – to know whether there is
a medical condition that would put him in
danger very early on. As mentioned above,
it is to be avoided to have the physician rush
to each hunger striker’s bedside before 72
hours. After this period of time, the physi-
cian can plan how to manage each situation,
and first and foremost reaffirm a relation-
ship of trust as soon as s/he can. The phy-
sician should proceed without fanfare, and
most of all without pressure from any side,
either from the custodial authorities or from
the prisoner(s).
The Ultimate Goal:
Preserving Human Dignity
A final point need be made here. It should
be sufficiently clear that hunger strikers very
rarely go to a final fatal conclusion. Those
that do often fall into the “painted into the
corner” category, i.e. a situation of impasse,
created by those who have left the situa-
tion get out of hand. The Northern Ireland
strikes were an exception, and no one can
accuse the physicians of not having done all
they possibly could to defuse a highly po-
liticized situation. That hunger strike, like
those embarked on by Mahatma Ghandi,
had there been no concessions in his case,
ended in fatalities. Such rare terminations
of the ultimate way for prisoners to protest
are rare, and it has been shown that they
can be avoided in the majority of cases.
However, force-feeding is not a solution,
as it imposes refused medical treatment on
the individual, from a non-medical author-
ity, making the physician an accomplice of
wrong-doing, if inhuman and degrading
treatment. As already said, “Malta 2006”
clearly states that force-feeding is never
justified. A competent hunger striker can-
67
Prison Health
not be coerced, even were it to save his or
her life.
Article 11 of “Malta 2006” states:
“If, after resuscitation and having regained
their mental faculties, hunger strikers continue
to reiterate their intention to fast, that decision
should be respected. It is ethical to allow a de-
termined hunger striker to die in dignity rather
than submit that person to repeated interven-
tions against his or her will.”
This clause applies to cases where a prisoner
may have been forced to sign such instruc-
tions under duress, in a repressive or dicta-
torial prison system for example. However,
in a more normal situation, it also applies
to those cases, such as the above mentioned
Caucasian one, where the prison doctor has
given a terminal hunger striker “one last
chance”. As has been said, this is admis-
sible if the doctor who has been following
the patient, and knows him, has the firm
conviction there is good reason to believe
the hunger striker really does not want to
die. If the physician has in good faith mis-
judged the situation, he cannot be accused
of unethical behaviour. What would not
be admissible, it would be the physician’s
complicity with the coercive custodial au-
thorities to play the game of allowing de-
liberate deterioration of the hunger striker’s
mental state through total fasting. In such a
case, once the hunger striker was in a con-
fused state and no longer able to make an
informed decision, s/he would be in fact
“force-fed, evoking the lack of resistance
to such feeding. To thus justify “artificial”
feeding (sic!), and then start over all again
once the prisoner was resuscitated, is totally
unacceptable.This type of situation actually
occurred in the 1970s, in a North African
country, several hunger striking prison-
ers submitted to what was assimilated to
a “yo-yo” situation, which ended up last-
ing for some two years. “Malta” specifically
says that a truly determined hunger striker
should be allowed, if all ethical attempts to
reverse his or her decision have failed, “to
die in dignity.”
Way Forward: How to
Extricate Physicians
(and their ethics) from the
Imbroglio and Possibly
Contribute to a Solution
How can the confrontational situations
mentioned above be avoided? The authors
of this paper are convinced the “Way For-
ward” that has been mentioned, specifically
involving physicians, will work for the great
majority of hunger strikers. It may not in
the most extreme situations, but such cases
are truly exceptional.
All physicians want to preserve life. They
should do so respecting the dignity and
rights of their patients,and respect for med-
ical ethics will automatically follow.
Our analysis leads us to conclude there are
many ways that physicians can act, consis-
tent with medical ethics, to develop a true
doctor-patient relationship with hunger-
strikers. It is also critical that the custo-
dial authorities do not act to undermine
the fragile trust between the doctor and
the patient for in doing so, they deprive
themselves of the easiest solutions to the
conflict. Positive and trusting therapeu-
tic relationships will ultimately result in a
reasonable outcome for all involved in the
vast majority of cases. It must be recalled
that hunger strikes, if they are to work, can
only do so over a span of time. The key to
finding a way out of the imbroglio is for
the custodial authorities to realize that
a hunger strike is not an emergency, let
alone a medical emergency. If the physi-
cians have done their job of excluding any
potential cases with concurrent medical
problems, there is no need for panic. There
is at least a full month before reaching the
stage when medical symptoms may begin
to cloud the issue. These full four weeks
are unfortunately seldom used to look for
a solution. Instead, the custodial authori-
ties tend to crack down from a viewpoint
of mere “principle” (“Nobody kills himself
in my prison!”) that is when the spotlights
turn on and confrontations begin.
Rigid standard operating procedures
(SOP’s) which decree that hunger strikers
shall be force-fed already during the sec-
ond or third week of fasting supposedly “to
save their lives” are unethical nonsense and
precisely what is to be avoided. A healthy
young adult with no concurrent medical
problems can usually go for a month tak-
ing only sufficient amounts of water, and
have no serious health issue. The timeframe
presented in this paper clearly shows that
no serious medical complications of fasting
will occur during this first month, leaving
ample time for the physician to play a more
useful role than merely monitoring blood
tests, weights and blood pressures.
Paramount during this period is the mean-
ingful discussion between the physician
and the hunger striker. This whole concept
of a constructive way forward is based on
the physician-patient relationship. The pro-
posed solutions and suggestions that follow
have all to be seen from this perspective.
To be continued…
Dr. Hernán Reyes,
MD, Medical coordinator for the
International Committee of the Red Cross,
specializing in medical and ethical aspects
of Human Rights, Prison Health, and in
the field of MDR TB in prisons. Observer
for the ICRC on issues of medical ethics.
Prof. George J. Annas,
Chair of the Department of Health
Law, Bioethics & Human Rights of
Boston University School of Public
Health; Prof. Boston University School
of Medicine, and School of Law.
Scott A. Allen, MD, FACP, School of
Medicine,University of California, Riverside
E-mail: manzikert@gmail.com
68
Council of Europe
The Council of Europe, which, as an inde-
pendent institution, may not be confused
with the European Union, was established
in 1949 for the promotion of human rights
and democracy on the basis of its Conven-
tion for the Protection of Human Rights
and Fundamental Freedoms of 4 No-
vember 1950 [1]. This Intergovernmental
Body, composed of 47 Member States and
5 Observer States (Canada, the Holy See,
Japan, Mexico and the USA) and repre-
senting about 800 million of citizens aims
at harmonizing the European legislation
by using Conventions and Additional
Protocols to these Conventions. Conven-
tions and Protocols are treaties, and it is
up to the decision of the Member States
to incorportae them into their national law
by signature and ratification. The develop-
ment of modern biomedicine, in particu-
lar the in-vitro-fertilisation of man, gave
a reason to the Council to pay more at-
tention to the application of biology and
medicine on man. To achieve the aim a
Standing Committee, the Steering Com-
mittee on Bioethics (CDBI), was estab-
lished which is the author of all provisions
in that field. It was clear from the begin-
ning that the common good of protection
of human dignity, autonomy, beneficence
and justice should be in the focus.
Classification of
Provisions and Reasons
for Legal Instruments
Provisions for the protection of research
participants are commonly classified as le-
gal instruments and other provisions, of-
ten addressed as “soft law”. There are few
legal instruments. Meanwhile there are
recognised treaties like the Oviedo Con-
vention (Council of Europe, 1997) and its
additional Protocol concerning biomedical
research, as well as Directive 2001/20/EC
(2001) [2] of the European Union.The Di-
rective is applicable only to drug research.
Most States regulate biomedical research,
at least drug research, by national law. It
seems that there is a big number of “other
provisions”. The most important texts, at
least in the view of the author, are the Dec-
laration of Helsinki [3], the International
Guidelines of CIOMS [4] and the UNES-
CO Universal Declaration on Bioethics on
Human Rights [5]. The national codes of
deontology, e.g. for physicians, and other
professional codes are to be mentioned as
parts of “soft law”. Soft law may be incor-
porated into national binding law by the
decision of the State. At least in the past,
soft law played an important role in the
protection of research participants. There-
fore a question may arise about the need
of its replacing by legally binding instru-
ments. In this context the relation between
ethics and law may be reflected upon. In
modern states ethical principles are more
and more adopted by legislation with the
purpose to find regulations acceptable to
all citizens. Free and informed consent can
be considered important, e.g.,based on the
doctrine of autonomy, in Germany pre-
dominantly linked to Immanuel Kant, the
German law system requires this consent
since 1887 for medical interventions and
since 1900 for participation in research.
In the past decades, particularly since the
end of the Second World War, protection
of human rights and fundamental freedoms
is mainly a responsibility of the States and
it has been accepted and laid down in sev-
eral International Conventions. In line with
these internationally based provisions the
States are asked to regulate the respective
fields concerning these rights by the instru-
ments under their supervision and respon-
sibility. Soft law has no sufficient protective
force in these fields. Law is a necessary in-
strument for the harmonization of interests,
even contradictory ones, of different groups
of society. No group should be entitled to
impose its specific positions, even with the
best intention, on other groups. Legal in-
struments, usually a result of compromise,
are binding for all groups concerned. They
give the frame for the application of soft
law, a frame which might be used, but never
broken.
System of Protective
Provisions of the
Council of Europe
The system of protective provisions of the
Council of Europe in the field of biomedi-
cal research is composed by legally binding
instruments and other provisions (see Box)
Protective Provisions for Research
Participants1
1 Presented at the Expert Conference on the Revision of the Declaration of Helsinki, 28 February – 1 March 2013,Tokyo
Elmar Doppelfeld
Clinical Research
69
Clinical Research
These protective provisions address re-
searchers of all disciplines and are not re-
stricted to one group, e.g. physicians. The
Oviedo Convention [6] contains the basic
principles for the application of biology
and medicine on human beings covering
the whole field of health. A specific chap-
ter on biomedical research entails the basic
principles which apply, in the context with
other provisions of the Convention, for the
protection of research participants. These
principles became legally binding in the 29
Member States of the Council which rati-
fied this treaty. The Convention gives the
framework for the elaboration of a specific
protocol concerning biomedical research
[7], in fact, a treaty that enters into legal
force by ratification.
Moreover, the Committee of Ministers
adopted a recommendation for research
using biological material of human origin
[8].This recommendation, even not a le-
gal instrument, influences the practice of
scientific use of those materials, as well as
are the first steps to regulate this field. The
recommendation, currently under revision,
outlines important provisions for biobanks.
The provisions need to be implemented in
actual protection of research participants.
Due to the important role of Research Eth-
ics Committees (RECs) the Steering Com-
mittee adopted guidelines for Committee
members [9] that may help with capacity
building.
Fundamental Principles
of Protection
Research involving human beings is carried
out for the potential benefit of the person
concerned or for the benefit of others or to
enhance knowledge. The relation between
the rights of the individual and the inter-
ests of society must be clarified.The Oviedo
Convention (Article 2) states that the in-
terests and the welfare of the human being
“shall prevail over the sole interest of society
or science”. This provision underlines the
primacy of the human being without mak-
ing it an absolute priority. The word “sole”
indicates that individual rights and interests
of society may be balanced to develop syn-
ergy.
Freedom of research is a basic provision
also for scientific projects in the field of
biology and medicine. The Convention
supports this freedom (Article 15), but
emphasizes clearly that this freedom is
subject to the protective prescriptions of
the Convention and of other legal provi-
sions ensuring the protection of the hu-
man being. This article clearly stipulates
that research must not be carried out
without limitations.
It is generally accepted that the quality of
a scientific project is one of the main pro-
visions to justify ethically the exposure
of human beings to research related risks.
Article 8 of the Research Protocol provides
for scientific justification, general criteria of
scientific quality and relevant professional
standards. Moreover, supervision of an ap-
propriately qualified researcher is required.
The Article is a rare example of legal defini-
tion of the quality of research.
Risk and Benefit
The legal wording of this principle is as
follows: “No risks and burdens to the par-
ticipant disproportionate to its potential
benefits” – the well known postulate of a
proportion between risk and benefit. This
proportion is adapted to specific kinds of
research. In research without a potential
direct benefit for the participant, e.g. re-
search on healthy volunteers, no more than
acceptable risk and acceptable burden is al-
lowed. It is the obligation of the competent
ethic committee to assess the acceptance.
In research with a potential direct benefit
for the participant, e.g. patients suffering
from a specific disease for which a drug
treatment is tested, risk and burden may
not be disproportionate to the expected
benefit
The risk/benefit relation plays a specific role
in research on persons not able to consent,
e.g. minors, victims of traffic accidents or
patients suffering from dementia.
If research is carried out with the expec-
tation of a potential direct benefit for
the participants, the above mentioned
proportion of risk, burden and benefit
may take place. If such a potential direct
benefit is not expected, research on per-
sons not able to consent may be carried
out in compliance with other provisions
only if the project does not entail more
than minimal risk and minimal burden.
Introduced in 1997 by the Oviedo Con-
vention these limitations of “minimal risk
and minimal burden” (both must be met)
have been later incorporated in national
or soft law. (Main sources: Articles 16,17,
Oviedo Convention; Article 6, Research
Protocol)
Free and Informed Consent
Free and informed consent is the absolute
precondition for participation in a research
project. A valid consent can be given only
Legally binding instruments
• Convention for the Protection of
Human Rights and Dignity of the
Human Being with regard to the Ap-
plication of Biology and Medicine:
Convention on Human Rights and
Biomedicine (Oviedo Convention)
• Additional Protocol to the Conven-
tion on Human Rights and Bio-
medicine concerning Biomedical
Research
Other provisions
• Recommendation Rec(2006) 4 of the
Committee of Ministers to member
states on research on biological ma-
terials of human origin
• Guide for Members of Research
Ethics Committees
70
on the basis of full information on the
project given to the invited participant in
a wording understandable for him or her.
Consent may be given freely without any
undue influence or coercion. Consent may
be refused or withdrawn in the course of
the research project. No discrimination, in
particular no withdrawal of healthcare, may
occur as a consequence of such a refusal or
withdrawal. It is one of the main respon-
sibilities of ethics committees to supervise
the conditions for free and informed con-
sent.
Protection of Persons
Undergoing Research
A precondition for involving persons in
medical research is the lack of alternatives
of comparable effectiveness to research on
humans. The risk/benefit proportion has
been assessed as acceptable.The approval by
a competent body has been given after an
independent examination of the scientific
merit, including assessment of the impor-
tance of the aim of the research, and after
multidisciplinary review of the ethical ac-
ceptability. The ethical review has to pre-
cede any approval of a competent body as
provided by national law. In addition to the
information on the research project partici-
pants shall be informed on their rights and
the safeguards prescribed by law for their
protection
Free and informed consent or, in case of
research on persons not able to consent,
authorization by the legal representative
must be given expressly and specifically;
and it must be documented. Consent and
authorization may be refused or withdrawn
at any time. It is clear that “specific con-
sent” only applies to specific research proj-
ects. This provision is applied to research
using human materials to “open consent”
(Recommendation [8]). Article 16 of the
Oviedo Convention contains the protec-
tive provisions that recur in other relevant
provisions.
Research on Persons
Unable to Consent
Research on persons unable to consent is a
world wide ethical and legal problem, spe-
cifically in research without a potential di-
rect benefit for the person. The provisions
of the Council introduce a proposal for a
solution, accepted in many States. Scientific
quality must be ensured, research on the
envisaged group of persons has to be justi-
fied.Research which could be performed on
persons able to consent is excluded. If there
is an expected benefit for participants, the
risk may be assessed in view of this benefit.
Research without such a potential direct
benefit may only be performed if protective
provisions prescribed by law are applicable.
Only minimal risk and minimal burden are
acceptable1
.
The authorization by the legal representa-
tive according to national law is needed
to include into research persons unable to
consent. The representative receives full
information on the research projects. The
represented person participates in the au-
thorization procedure proportionally to his/
her maturity and understanding.Any objec-
tion has to be respected.The best interest of
the represented person is the decision line.
Refusal or withdrawal of the authorisation
is possible at any time without any form
of discrimination against the represented
1 Minimal risk and minimal burden are rather new
terms. Thereis a legal definiton in Article 17 of
the Research Protocol.:”Article 17 – Research
with minimal risk and minimal burden
• For the purposes of this Protocol it is deemed
that the research bears a minimal risk if, hav-
ing regard to the nature and scale of the inter-
vention, it is to be expected that it will result,
at the most, in a very slight and temporary
negative impact on the health of the person
concerned.
• It is deemed that it bears a minimal burden if
it is to be expected that the discomfort will be,
at the most, temporary and very slight for the
person concerned. In assessing the burden for
an individual,a person enjoying the special con-
fidence of the person concerned shall assess the
burden where appropriate.”
person. The legal representative should not
have any financial or other interest. (Sourc-
es: Article 17, Oviedo Convention; Chap-
ter V, Research Protocol).
Research in Specific Situations
The provisions of the Council of Europe
are extended to research fields that are not
covered by other texts, at least not in detail.
a) Research during pregnancy or breast-
feeding
Research without a potential direct benefit
for the pregnant woman, or for her embryo,
foetus or child after birth, are only admit-
ted if there is expected a contribution to the
benefit of that group and if comparable re-
search cannot be carried out on women who
are not pregnant.Minimal risk and minimal
burden are the absolute limitations.
b) Research on persons deprived of liberty
For safeguarding human rights in research
on this group protective provisions by law
are required. Research without a poten-
tial direct benefit may be only carried out
if comparable research on persons not de-
prived of liberty is not possible and if a
contribution to the benefit of that group is
expected. Again minimal risk and minimal
burden are the limiting conditions.
For research with a potential direct benefit
on pregnant women and on persons de-
prived of liberty the relevant provisions of
the legal instruments apply.
c) Research in clinical emergency situations
Again for safeguarding human rights in this
very specific field of research, which is un-
til now rarely regulated, the permission and
the determination of protective additional
conditions by law are required.These provi-
sions should define research in emergency
as a situation when a person is not in a state
Clinical Research
71
to give consent, and when because of the
urgency of the situation, it is impossible to
obtain in a sufficiently timely manner the
authorisation from the legal representative
or an authority or a person or a body to be
called upon to give authorization and when
research of comparable effectiveness cannot
be carried out on persons in non-emergency
situations.
Moreover, specific provisions are compul-
sory. The project has been approved as “re-
search in emergency situations”by the com-
petent body. This approval may be given in
line with the relevant articles of the research
protocol, e.g. only after assessment of the
scientific quality and after ethical review.
Expressed objections, if known, shall be re-
spected. For research with a potential direct
benefit the risk/benefit assessment takes
place. A research project without a potential
direct benefit for the participant is limited
by minimal risk and minimal burden. In-
formation to the person involved or to the
legal representative is given as soon as it is
possible to ask for consent or authorization
for continued participation. This procedure
is considered as postponed consent/autho-
rization and not as a waiver of consent/au-
thorization. (Source: Chapter VI, Research
Protocol).
Responsibility of Ethics
Committees
The world wide accepted principle of inde-
pendent examination of research projects
by Research Ethics Committees (REC) is
codified. Every research project should be
submitted for independent examination
of its ethical acceptability to a REC. In
transnational projects this examination is
required in each State in which the project
or parts of it are performed. Depending on
national law the scope of the examination
may be restricted to ethical acceptability
or extended including the scientific quality
and conformity with law. The protection of
dignity, rights, safety and well-being of re-
search participants are listed as purpose of
the examination.The composition of RECs
is mostly regulated by national law. How-
ever, the appropriate range of expertise and
experience adequately reflecting profession-
al and lay views are the basic principles.The
independence of the REC must be guaran-
teed. The harmonization of information for
RECs plays a major role in enabling these
committees to decide on a similar basis.The
items for this information are listed in the
Appendix to the Research Protocol. And
as already stated above: any approval of a
research project by an authority, if required
by national law, is appropriate only after the
examination by a REC! (Sources: Article
16, Oviedo Convention; Chapter III, Re-
search Protocol).
Safety, Supervision
and Duty of Care
In research risk and burden should be mi-
nimised in proportion to the scientific aims.
Minimisation may not be confused with
minimal risk and minimal burden men-
tioned above, which are absolute limita-
tions. A qualified clinical professional shall
be in supervision. The assessment of health
status prior to inclusion in research with
particular considerations on participants in
the reproductive stage of life may be done
on the basis of patients’ files or by a spe-
cific assessment. Necessary preventive, di-
agnostic or therapeutic procedures may not
be delayed or abandoned in favour of the
research project. Control groups shall be
assured of proven methods of prevention,
diagnosis or treatment. The use of placebo
is accepted when no methods of proven
effectiveness are known or if withdrawal
or withholding of such methods does not
present an unacceptable risk or burden.
A re-examination of a project is justified
in the light of scientific developments or
events arising in the course of the research.
A decision to discontinue or to change the
research project may be the result of this
re-examination. In line with this procedure
it may be necessary to inform the research
participants or their representatives of the
developments or events.An additional con-
sent or authorisation for participation can
be proven as appropriate. The information
of the competent body of the reasons for
any premature termination of a research
project serves as a help to prevent similar
projects if appropriate. (Source: Chapter
VII, Research Protocol).
If results of the research can be of rel-
evance to the current or future health or
quality of life of research participants, this
information must be offered to them.“That
shall be done within a framework of health
care or counselling. In communication of
such information, due care must be taken
in order to protect confidentiality and to
respect any wish of a participant not to
receive such information”. (Article 27, Re-
search Protocol).
Confidentiality and
Right to Information
Data collected during biomedical research
should be protected as confidential data.
Legal provisions to prohibit inappropriate
disclosure of information submitted to an
Ethics Committee should be introduced to
prevent any misuse of this information.
The right to information for research par-
ticipants is often questioned by researchers
and physicians in view of “the best for the
person concerned”. However, the provisions
of the Council of Europe underline the
right to know any information on health
collected in the research project and the
right not to know (Article 10, Oviedo Con-
vention).This states clearly that researchers,
including physicians, are obliged to inform
the person concerned and to respect any
wish not to be informed. The right not to
know may only be suspended by law. Per-
sonal information outside the health field
may be given in conformity with the na-
tional law on data protection.
Clinical Research
72
Primary Care TANZANIA
Background: The worldwide prevalence of
hypertension in established market economy
countries was estimated to be 37.4% for males
and 37.2% for females. The prevalence of hy-
pertension in Tanzania ranged between 30
and 57% (<20% aware of their hypertension, <10% compliant). The purpose of our study is to identify the frequency of hypertension in our sample population, looking at gender differ- ences, rate of previous diagnosis, compliance to medication in relation to socio-economic sta- tus, and diet. Methods: A cross-sectional population based survey to calculate the frequency of hyperten- sion in a primary care clinic. Results: Satisfactory data was available on 198 patients (98.0%), 160 (85.0%) were fe- males. The mean age of the population was 37.8years. Frequency of patients suffering from hypertension was 44.9% (89 patients), confi- dence intervals 95% (CI 95%) 38.0–51.9%. 19 patients (9.6%, CI 95% 3.8–15.4%) were diagnosed with malignant hypertension. 62 patients (69.7%, CI 95% 60.1–74.2%) were incidence cases while 27 patients (30.3%, CI 95% 20.8–39.9%) were prevalence. Only 6 persons (22.2%) were compliant to the pre- viously prescribed medication and only 2 of Frequency of Hypertension in a Primary Care Setting in Buza,Tanzania To improve transparency of research a re- port or a summary should be submitted to the Ethics Committee or to the competent body after termination of the project. Con- clusions of the research should be avail- able to the participants within a reasonable time on request. Unfortunately it was not possible to introduce a stringent provision concerning publication of the results. As a compromise appropriate measures of the researcher to make public the results of the research in a reasonable time has been ac- cepted (Source: Chapter VIII, Research Protocol). The protective provisions of the Council of Europe seem to be very detailed. However, it was aimed at addressing all the ethical and legal problems known at the moment of their adoption.The provisions enter more and more into legal force binding all re- searchers, including physicians.They are the legal framework to follow soft law which, as such,does not permit to neglect any of these provisions. References 1. Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950, Council of Europe, CETS N: 005 2. DIRECTIVE 2011/20/EC OF THE EU- ROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001on the approxima- tion of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, Official Journal of the European Communities, 1.5.2001, L 121/34 3. DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Hu- man Subjects, 2008, wma@wma.net 4. Council for International Organizations of Medical Sciences (CIOMS), International Eth- ical Guidelines for Biomedical Research Involv- ing Human Subjects, Geneva 2002 5. Universal Declaration on Bioethics an Human Rights, UNESCO, 2005 6. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedi- cine, Oviedo, 4.IV.1997, European Treaty Serie, N. 164 7. Additional Protocol to the Convention on Hu- man Rights and Biomedicine concerning Bio- medical Research, Strasbourg, 25.I.2005, Coun- cil of Europe Treaty Serie, N. 195 8. Recommendation Rec(2006)4 of the Commit- tee of Ministers to member states on research on biological materials of human origin (Adopted by the Committee of Ministers on 15 March 2006). Strasbourg, www.Health and Bioethics – Council of Europe 9. Guide for Members of Research Ethics Com- mittees (Adopted by the Steering Committee on Bioethics on 3 December 2010), Strasbourg, www.Health and Bioethics – Council of Eu- rope Prof. Elmar Doppelfeld, MD Chair of the Working Group “Biomedical Research”, Committee on Bioethics (DH-BIO),Chair (2005–2007) of the “Steering Committee on Bioethics (CDBI)” Council of Europe Chair (1994–2012) of the Permanent Working Party of Research Ethics Committees in Germany E-mail: elmar-doppelfeld@t-online.de Daphne Gatt Nigel CamilleriSteven Micallef Eynaud 73 Primary CareTANZANIA these (7.4%) had their blood pressure controlled (blood pressure <140/90 mmHg). Conclusion: Prevalence of hypertension (44.9%) in the population was significantly higher than that calculated for the market economy countries (37.3%). However, it fell within the range of previous reported stud- ies (30–57%). No significant differences were found between males and females, though a statistical link was found to lowest and highest socio-economic states and diet. Awareness and management of hypertension is a much needed public health service in Tanza- nia and one that is cheap, easy and would result in greatly improved quality of life. Background Hypertension (HT) is defined by the World Health Organisation as a persistent raised arterial blood pressure (BP) of over 140/90 mm Hg. HT is the main risk factor for con- gestive heart failure and is of great social and economic importance because of its high prevalence, mortality and impact on young, economically active individuals [1]. A systematic review calculated the preva- lence of HT in established market economy countries to be 37.4% in males and 37.2% in females. The prevalence of HT varied greatly around the world, with the lowest prevalence being in rural India (3.4% in men and 6.8% in women) and the high- est prevalence in Poland (68.9% in men and 72.5% in women). Control of HT (BP <140/90 mmHg while on antihypertensive medication) varied from 5.4% in Korea to 58% in Barbados [2]. A study that focused on the prevalence of HT in the United States, Canada and 6 European countries found it to be 28% in the North American countries and 44% in the European countries[3]. In a self re- ported study carried out in the US, overall two-thirds of the population were aware of their diagnosis (69%) and a majority of these (53% to 79%) were taking prescribed medication [4]. Another study analysing compliance rates in three Central European countries reported 53.5% as compliant and 46.5% as non-compliant [5]. The causes of heart failure in Africans re- main largely non-ischemic. Hypertensive heart disease complications occur more frequently in Africans than in Europeans and North Americans, and the majority of affected patients are younger. [6] It is a growing problem in African communities of low socio-economic demographics. [7] Tanzania is an East African country with a population of 38,329,000, and an estimated growth rate of 2%. Population distribution is extremely uneven, varying from 1 person per sq km to 134 per sq km, with over 80% of the population being rural. GDP per capita stands at $1,416. [8] Whilst infec- tious disease continues to pose a relentless threat to life throughout impoverished re- gions on the continent, numerous studies carried out in Africa have brought to light the emerging problem of non-communi- cable disease, in particular cardiovascular disease. [9] Another study carried out in Tanzania re- ported the prevalence of HT as 30% in men and 26.8% in women in Ilala (urban area), and 32% in men and 31.5% in women in Shari (rural area). In both areas, just under 20% of hypertensive subjects were aware of their diagnosis,approximately 10% reported receiving treatment, and less than 1% had a controlled BP. [10] A different study fo- cused on gender-related differences in car- diovascular disease risk factors and their correlates in an urban area in Tanzania. They reported a higher prevalence of HT (57%) and severe HT (30%) in the popu- lation. Women had more than three-fold greater odds of having metabolic syndrome compared to male counterparts. In contrast, female participants had 50% lower odds of having hypertension, compared to men. [11] A similar trend was noticed in other East African countries. A study in Addis Ababa, Ethiopia found the prevalence to be 31.5% among males and 28.9% among females. [12] A study in Nakuru, Kenya found the overall prevalence of HT to be 50.1%. [13] In Mozambique, the prevalence of HT was found to be 35.7% among men and 31.2% among women. Of those receiving anti- hypertensive treatment, only 42.9% of the women and 28.7% of the men were well controlled. [14] Other studies carried out on the African continent showed a varying prevalence of HT. Studies carried out in Algeria (North Africa) showed that the prevalence of HT ranged between 32.7% and 44%. Of those treated, only 25% were well controlled. [15] In South Africa, a study concluded that HT was independently related to age, obesity and urbanization. Only 16% of those on treatment were controlled. [16] In central Ghana (West Africa), the overall preva- lence of HT was found to be 28.7% in men andwomen, and was higher in semi-urban villages (32.9%) than in rural villages (24%). [17] The location for our study was Buza, a slum in the outskirts of Dar es Salaam. This area is among those of the lowest socioeconomic status’ (SES) in the region. The aim of this study was to identify the frequency of hy- pertension in our sample population, look- ing specifically at gender differences, the rate of previous diagnosis, compliance to medication in relation to socio-economic status, and diet. To date we believe it is the first study of this kind to be done in the area. Methods Study design: The study design was a cross-sectional population based survey to calculate the frequency of hypertension in a primary care medical clinic. 74 The setting was an urban suburb of an over- all low socio-economic area, named Buza, Dar Es Salam,Tanzania. The Inclusion criteria included any adult (n=202) of ages 18 and older, any gender or social class who attended this clinic for any medical reason or even for a basic medi- cal check–up between the 19th July and 6th august 2010. Thus the cohort of people in- cluded in our study ranged from being very unwell and requiring referralor admission to hospital, to those who had simply just heard of this new clinic were passing by and asked for a medical review. This reduced any pos- sible selection and observation bias. Exclusion criteria: All patients under the age of 18 years were excluded from our study for statistical pur- poses. This is not to say that those with a higher risk of suffering from hypertension who were under 18 years of age did not have their blood pressure checked. Analysis: Every person attending the clinic had their blood pressure assessed by one of the staff working at reception. If the patient was found to be hypertensive this would be re- corded in the patient’s case notes (repeated twice or more), and then reviewed, treated and followed up by the doctors working in the clinic. Every patient attending the clinic had a full history taken by a doctor. Those previously diagnosed with hypertension, were asked whether they were prescribed and taking any anti-hypertensives or dietary precau- tions. Their blood pressure was monitored on subsequent follow-ups and recorded. Data Protection: All patients reviewed at this clinic gave in- formed consent for their blood pressure to be checked.Any person who refused to have this parameter assessed was not negatively or positively affected by the treatment re- ceived here. All data collected was anony- mous and confidential. Statistics: All data collected were input into Microsoft Excel and analysed using SPSS. P values were calculated using Fisher’s Exact test. Confidence intervals were calculated using standard formulae for rates.Gender and age specific direct standardisation of data was carried out. Results: The cohort consisted of 202 people. Satis- factory data was available on 198 patients (98.0%),160 (85.0%) of whom were females and 38 (15%) were males.The mean age for the population studied was 37.8years. The ages ranged from 18 to 88 years. Prevalence: The frequency of patients in our population suffering from hypertension (blood pres- sure  = or >140/or 90 mmHg) was 44.9%
(89 patients), confidence intervals 95% (CI
95%) 38.0–51.9%. Of these 20 (52.6% of
the male cohort) CI 95% 36.8–68.5% were
males and 69 (43.1%, CI 95% 35.5–50.8)
persons of our cohort were females. There
was no statistical significance between the
two gender groups (P=0.365).
19 (9.6%, CI 95% 3.8–15.4%) patients were
diagnosed with malignant hypertension,
25 (12.6%, CI 95% 6.1–19.1%) patients
suffered from stage 2 hypertension (BP
>160/>100mm) and 31 (15.7%, CI 95%
8.6–22.8%) of these patients were diag-
nosed with stage 1 HT (BP >140–159/90–
99). For more details, see table: 1
62 patients (69.7%, CI 95% 60.1–74.2%)
were incidence cases as they received the
diagnosis of hypertension for the first time
in their lives.
27 patients (30.3%, CI 95% 20.8–39.9%)
from the cohort had previously received a
diagnosis for hypertension. Of these pa-
tients, only 6 (22.2%) were compliant to
the prescribed medication and, following
a blood pressure examination in this clinic,
it was noticed that only two persons (7.4%)
had their blood pressure controlled. (mean-
ing blood pressure <140/90 mmHg). Outcome of patients receiving treatment in the Buza clinic: Of the 89 patients diagnosed with hyper- tension, 83 (93.3%) patients received some form of treatment. 20 (22.1%) patients re- ceived advice on how to live a healthy life- style.This included diet and exercise. 63 (87.9%) patients who attended the clinic were treated for hypertension with medica- tion. Of these, 22 (34.9%) patients did not Table 1. Sample population of varying grades of severity of hypertension n= Percentage % Blood pressure within normal range 68 34.3 (Cl 95% 25.1–43.7) Pre-hypertensive 120–139/80–89 43 21.7 (Cl 95% 16.6–29.3) Stage 1 hypertension 140–159 of >90–99 31 15.7 (Cl 95% 8.6–22.8)
Stage 1 hypertension >160 or >100 25 12.6 (Cl 95% 6.1–19.1)
Malignant hypertension >180/110 19 9.6 (Cl 95% 3.8–15.4)
Blood pressure >130/80 and suffering from DM, Kid-
ney disease or CVS disease
6 3.0 (Cl 95% 0.6–6.3)
Isolated hypertension >140 but <90 6 3.0 (Cl 95% 0.6–6.3) Total 198 100 Primary Care TANZANIA 75 turn up for their follow up appointment so were never reviewed at the clinic again. Of those who did turn up for their follow up reviews,26 (41.3%) were found to have con- trolled blood pressure. Another 10 (15.9%) patients who attended the clinic attained partial control of their hypertension, whilst 3 (4.8%) other patients who had some im- provement in their blood pressure recorded and were still referred on to a specialist, for further advice. Only 2 (3.2%) patients had no improvement in blood pressure recorded by the end of the study period and these too were referred for specialist advice. Age: When looking at the changes in frequency of hypertension with age, statistical signifi- cance P<0.001 is found in females. From the results one notices a stark increase in frequency of hypertension from the 35–44 year age group (33.3%) to the 45–54 year age group (65.5%) and keeps increasing gradually after that. This sudden change in not observed within the male cohort of the study (P0.149), in- stead a constant but gradual increase with age is noticed. In this cohort the males over 75 years (n=2) were all hypertensive. Then again one must take into account the small sample size for men. Socio-economic status: This study looked further into whether there was a significant link between socio eco- nomic status and hypertension. Though the P value for a difference in socio-economic status and hypertension was not statistically significant (P=0.156), the difference in fre- quency for those placed in social class one [hypertensive: 6 (35.3%), non-hypertensive: 11 (64.7%)] and five [(Hypertensive: 5 (33.3%) non-hypertensive: 10 (66.7%)] was remarkable.The difference seen in the other social classes is not as remarkable, further details may be found in table 3. Non medical treatment of hypertension, 22.0% Blood pressure controlled by medication, 43.0% Partial control of blood pressure, 15.9% Partial control of BP, referred to specialist, 4.3% No improvement in BP, referred to specialist, 3.2% Lost to follow up, 28.0% Figure 1. Outcome of patients who received treatment in clinic Table 2. BP = N (BP within normal range), HT (hypertensive) Hypertension by gender and age Age Total <25 25–34 35–44 45–54 55–64 64–74 75+ Males BP = N 3 6 1 3 3 2 0 18 60.0% 85.7% 50.0% 60.0% 37.5% 22.2% 0% 47.4% HT 2 1 1 2 5 7 2 20 40.0% 14.3% 50.0% 40.0% 62.5% 77.8% 100.0% 52.6% Total 5 7 2 5 8 9 2 38 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% Females BP = N 12 34 24 10 5 4 2 91 85.7% 75.6% 66.7% 34.5% 31.3% 30.8% 28.6% 56.9% HT 2 11 12 19 11 9 5 69 14.3% 24.4% 33.3% 65.5% 68.8% 69.2% 71.4% 43.1% Total 14 45 36 29 16 13 7 160 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% Table 3. BP = N (BP within normal range), HT (Hypertensive) Hypertension according to socio-economic status Socio economic status Total 1 (very poor) 2 (poor) 3 (avarage) 4 (above avarage) 5 (rich) BP = N 6 68 22 8 5 109 35.3% 58.6% 61.1% 57.1% 33.3% 55.1% HT 11 48 14 6 10 89 64.7% 41.4% 38.9% 42.9% 66.7% 44.9% Primary CareTANZANIA 76 Discussion The prevalence of HT (44.9%) in the popu- lation from Buza included in this study was significantly higher than that calculated for the market economy countries (37.3%) [2]. However, the prevalence of HT in our target population was found to be within the range of previous reported studies (30– 57%) carried out in Tanzania, [10], [11]. Once again similar results are reported in other East African countries (28% to 50%) [8], [11], [13] and to other African coun- tries (28.7% to 44%) [6], [7], [9]. One rea- son for such differences could be explained by some studies reporting examined results whereas others use patient reported BP re- sults. There is no real statistical significance be- tween males and females. Statistical signifi- cance was found when using age standard- ization for females (P<0.001). It was also observed that between the 35–44 and 45– 54 year age group the prevalence in women doubled from 33% to 66%. One can hy- pothesise that most probably almost 100% of the women in menopause were suffering from HT. This is further substantiated by the increase in frequency of HT with age. In males this was not statistically significant (P=0.149) though this could be due to the small male sample. As found in other stud- ies carried out around the world, therate of HT in males increases proportionally with age. [18] The results in our study highlight another risk factor associated with HT  – low so- cioeconomic status (SES). [19] However, results from our study have taken this asso- ciation a step further and reported another peak in HT with the high SES group. In Buza being of higher SES means having a staple diet of things such as fried chicken and chips, thus bringing to light the prob- able association of HT to diet.This was also found in other studies. [20] Less than a third of our patients were aware that they were suffering from high blood pressure, as found in a parallel study (20%) carried out in other cities in Tanzania. [10] This is markedly lower than awareness re- ported by studies carried out in the US (69%) and Europe (53%) [4],[5].This high- lights another important fact that awareness and availability of clinics to manage HT may help increase compliance. Another im- portant finding in our study highlights the fact that over 9% of the target population had malignant hypertension,a life threaten- ing condition which people were living with undiagnosed and, thus, untreated. The compliance rate in our study was found to be slightly higher (22.2%) to that carried out in another study in Africa (10%) [10]. We believe that this may simply be due to smaller sample size (n=198) than the other study (n=1600). Another important finding consistent with previous studies is that less than 8% of the cohort in Buza had their HT treated ad- equately (BP <140/90) [14], [15], [16]. The results of this study show that a clinic open for only 3 weeks was able to get the BP of 41.4% within normal range and improve the BP for 16% of patients, meaning that such a life threatening disease can be eas- ily and cheaply managed by increasing the availability of such clinics. Strengths and limitations of the study The results from our study report only ex- amined BP as opposed to self-reported, thus reducing a recall bias. The population sample in this study did not only include patients who were ill but also those who at- tended the clinic for a check up, thus reduc- ing a selection bias. All patients had their BP checked at least twice, and most were reviewed for follow up more than once. Limitations of this study include a relatively small sample size, thus representativeness of the target population is questioned and patients were only followed up for a short while, so a longer longitudinal study is rec- ommended. Conclusion The prevalence of HT is expected to rise substantially in sub-Saharan Africa, so the authors call for population-based studies and registries of the epidemiology of HT Poland, 2005 India, 2005 Mozambique, 2009 Nakuru, Kenya, 2010 Addis Ababa, Ethiopia, 2009 Shara, Tanzania, 2000 Iliala, Tanzania, 2000 Buza, Tanzania, 2010 Market economy countries, 2005 0 604020 80 Males % Females % Figure 2. International prevalence of hypertension Primary Care TANZANIA 77 in the African population. The provision of awareness campaigns and more clinics available for assessment and management of HT in the health services in Tanzania is strongly recommended. As reported in this study this cheap provision of service yield quick positive results, thus improving the overall quality of life of the people living in Tanzania. Other studies carried out worldwide found that more than half of respondents took action following the receipt of advice. [17] Thus the authors believe that this simple measure will have a highly positive effect on the people living in this country. Conflict of Interest: The authors declare they have no conflict of interest and this data has not been submit- ted for publication anywhere else. Authors contribution: All authors have contributed equally to the work in this study and agree with the publi- cation of this document. Dr. Daphne Gatt: contributed to the litera- ture search, writing up of the background and managed the overall work of the manu- script. Dr. Steve ME: contributed to the literature search, writing up of discussion and refer- ences. Dr. Nigel Camilleri: Came up with the re- search question, was involved in the writing up of the methodology and results and su- pervised the work. Acknowledgements We would like to thank Dr. Neville Calleja for his constant support and advice provid- ing a public health perspective to the study and with carrying out the statistics needed for this study. References 1. Chockalingam AA, Norman RC, Fodor JG. Worldwide epidemic of hypertension.Can Jour Cardiol. 2006 May; 22(7): 553–555. 2. earney PM, Whelton M, Reynolds K, et al. Worldwide prevalence of hypertension: a sys- tematic review. J Hypertens. 2004 Jan;22(1):21-4. 3. Wolf-Maier K, Cooper RS, Banegas JR, et al. Hypertension prevalence and blood pres- sure levels in 6 European countries, Canada, and the United States. JAMA. 2003 May 14;289(18):2420-2. 4. Valderrama AL, Tong X, Ayala C, Keenan NL. et al. Prevalence of self-reported hypertension, advice received from health care profession- als, and actions taken to reduce blood pressure among US adults, HealthStyles, 2008. J ClinHy- pertens (Greenwich). 2010 Oct;12(10):784-92. 5. George J. Fodora, Marian Kotreca, KingaBac- skaia, et al Is interview a reliable method to ver- ify the compliance with antihypertensive ther- apy? An international central-European study. Journal of Hypertension 2005, 23:1261–1266. 6. Gombet T, Steichen O, Plouin PF. Hypertensive disease in subjects born in sub-Saharan Africa or in Europe referred to a hypertension unit: a cross-sectional study. Bull AcadNatl Med. 2007 Nov;191(8):1745-54. 7. Bunker CH, Okoro FI, Markovic N, et al. Rela- tionship of hypertension to socioeconomic sta- tus in a west African population. Ethn Health. 1996 Mar;1(1):33-45. 8. The Tanzania Demographic and Health Survey (TDHS) 2004-05. June 2005. 9. Unwin N, Agyemang C, Allotey P, et al. Tack- ling Africa’s chronic disease burden: from the lo- cal to the global. Global Health. 2010 Apr 19;6:5. 10. Edwards R, Unwin N, Mugusi F, et al. Hy- pertension prevalence and care in an urban and rural area of Tanzania. J Hypertens. 2000 Feb;18(2):145-52. 11. Njelekela MA, Mpembeni R, Muhihi A, et al.Gender-related differences in the prevalence of cardiovascular disease risk factors and their correlates in urban Tanzania. BMC Cardiovasc Disord. 2009 Jul 17;9:30 12. Tesfaye F, Byass P, Wall S. Population based prevalence of high blood pressure among adults in Addis Ababa: uncovering a silent epidemic. BMC CardiovascDisord. 2009 Aug 23;9:39. 13. Mathenge W, Foster A, Kuper H. Urbanization, ethnicity and cardiovascular risk in a population in transition in Nakuru, Kenya: a population- based survey. BMC Public Health. 2010 Sep 22;10:569. 14. Damasceno A, Azevedo A, Silva-Matos C, et al. Hypertension Prevalence, Awareness, Treat- ment, and Control in Mozambique. Urban/ Rural Gap During Epidemiological Transition. Hypertension. 2009;54:77. 15. Temmar M, Labat C, Benkhedda S, et al. Prevalence and determinants of hyperten- sion in the Algerian Sahara. J Hypertens. 2007 Nov;25(11):2218-26. 16. Steyn K, Fourie J, Lombard C, Katzenellenbo- gen J, et al. Hypertension in the black commu- nity of the Cape Peninsula, South Africa. East Afr Med J. 1996 Nov;73(11):758-63. 17. Francesco PC, Frank B, Sally LE, et al. Preva- lence, Detection, Management, and Control of Hypertension in Ashanti, West Africa. Hyper- tension.2004;43:1017. 18. Joan H. Skurnick, MordechayAladjem, Abra- ham Aviv. Sex Differences in Pulse Pressure Trends with Age Are Cross-Cultural. Hyperten- sion. 2010;55:40-47 19. Grotto I, Huerta M, Sharabi Y. Hypertension and socioeconomic status.CurrOpinCardiol. 2008 Jul;23(4):335-9. 20. John P. Forman, Meir J. Stampfer, Gary C. Curhan. Diet and lifestyle risk factors associated with incident hypertension in women.JAMA. 2009 July 22; 302(4): 401–411. Steven Micallef Eynaud, Mater Dei Hospital Tal-Qroqq, Msida, Malta Nigel Camilleri UON, University of Newcastle Corresponding author: Dr. Daphne Gatt MD Mater Dei Hospital Tal-Qroqq, Msida, Malta 32, Triq il-Konventwali Qawra SPB1133 Malta, Europe E-mail: daphnegatt@gmail.com Primary CareTANZANIA 78 Environment and Health European coal-fired power plants are caus- ing 18,200 premature deaths and serious illnesses that cost the population up to €43 billion each year, say health experts in a new report entitled The Unpaid Health Bill— How coal power plants make us sick. The Health and Environment Alliance (HEAL) also expresses concerns that dirty emissions from coal are contributing to cli- mate change, which itself will create more costly public health problems-especially amongst the most vulnerable groups-the young and elderly. Despite this double threat, the use of coal as an energy source is now on the rise in Europe. Coal use is projected to rise worldwide throughout 2013 which is, ironically, the EU’s designated Year of Air. Health experts at HEAL are now urging governments to put a stop to building new coal plants in Europe and abandon coal altogether by 2040. If the share of coal in power gen- eration is not brought down over the next decades, Europe will put in jeopardy its cli- mate target for 2050. In October 2011, over 500 health and secu- rity experts, including medical associations, leading medical research institutes and pub- lic health organisations, called on govern- ments to ban the building of new coal-fired power plants without Carbon Capture and Storage (CCS) technology,and to phase out the operation of existing coal-fired plants, starting with lignite plants due to their most harmful effects on health. Last year at the UN climate talks, medical organisations petitioned negotiators at the international climate talks in Doha, Qatar (http://dohadeclaration.weebly.com/index. html) to recognise that worldwide millions of deaths each year have been linked to air pollution that occurs as a result of burning coal. The World Medical Association was among the top medical group signatories to the so-called Doha Declaration on Climate, Health and Wellbeing. Dr. Cecil Wilson, President of the WMA, said he was ex- tremely worried about the slow progress in international negotiations and called on the world’s leaders to recognise the impact on health from climate change. As the “first ever economic assessment of the health costs associated with air pollu- tion from coal power plants in Europe”, this report highlights evidence on how exposure to air pollutants affects the lungs, heart and nervous system. Effects include chronic respiratory diseases, such as chronic bron- chitis, emphysema and lung cancer; and cardiovascular diseases, such as myocardial infarctions, congestive heart failure, isch- emic heart disease and heart arrhythmias. Acute effects include respiratory symptoms, such as chest tightness and coughing, as well as exacerbated asthma attacks. Children, older people and patients with an underlying condition are more susceptible to these effects. Children are particularly sus- ceptible to air pollutants,in part because they breathe more air in relation to their body weight and spend more time outside,but also due to the immaturity of their immune and enzyme systems and their still-developing airways. In addition, coal power plants are the largest source for mercury emissions in Europe, a heavy metal that is well known to affect brain development in children. A re- cent study put the price tag of this mercury exposure at about €9 billion per year. The report draws on the work of medi- cal and health groups in the US, Australia and elsewhere around the world.The inten- tion is that the report will stimulate further engagement of doctors and other health groups around the issue of coal and health, especially in countries where coal burning is a major contributor to poor air quality. In coming months, the Standing Committee of European Doctors (CPME), which has 27 members representing medical doctors in EU countries,will be raising awareness of the risks of coal burning as part of its work underlining the importance of cleaner air. Medical professionals are powerful advo- cates for better policy to protect health. Medical doctor and German Member of the European Parliament, Peter Liese has already indicated his support for the report. He says he recognises coal as both an im- mediate and a long-term threat to public health because of its contribution to climate change. HEAL will be running a Health and Coal educational and advocacy campaign throughout Europe, with national launches planned in Germany and Poland in close collaboration with medical experts, asthma groups and local experts. Expertise and tes- timonies from doctors and others in the health community are key to our success, and we invite you to join the collective ef- forts to prevent chronic disease and suffer- ing from coal power pollution. This article is adapted from one which appeared on the blog of the Collabora- tive on Health and Environment (CHE) http://ourhealthandenvironment.wordpress. com/2013/03/07/778/ HEAL’s vision is a healthy planet for healthier people in Europe and beyond. We show how environmental action can bring down rates of asthma,obesity,diabetes,can- cer and infertility working closely with our members in more than 26 countries. Génon Jensen Executive Director, Health and Environment Alliance (HEAL) , Coordinator of CHE’s Climate Change and Health Working Group. Revealed: Coal’s Unpaid Health Bill 79 Regional and NMA news The Human Factors in Crisis and Disas- ters Thematic Conference to be held in Melbourne, Australia from 30 September to 2 October 2013 will focus on issues of great relevance to us all. Disasters and crises impact globally and lo- cally, affecting diverse human populations, and the resources that sustain them. Disas- ters by their very nature may overwhelm communities and their capacity to respond, with mass death and damage, as we have seen across the world with tsunamis, earth- quakes, hurricanes and cyclones, floods and famine, fire and pollution as after the vol- canic eruption. The mass natural disasters of recent times have also lead to population displacement, huge economic loss and bur- den. Disasters of disease, such as pandem- ics of influenza and virulent infections are also a challenge and threat, requiring global collaborations. Disasters that are human caused, particularly those of violence, lead to profound human damage – not only by death, fear and threat, but also in the ongo- ing vulnerabilities and further violence that may be generated. This conference will present global themes and the human factors and resources that are challenges worldwide. Dr. Judy Kurian- sky will present on these themes from the global perspective looking at the United Nations and the multiple global agencies that work together to mitigate disasters and their impact; for instance the collaboration following the Japanese earthquake, tsunami and nuclear incident; and the Haiti hurri- cane. Vulnerable groups require specific focus and particularly children, as she will dis- cuss, as will others, including Professor Brett McDermott and also those dealing with children who are war affected refugees, displaced and dislocated from family and home. Threats and disasters, including nu- clear accidents such as Chernobyl, hazards of Fukushima, collective trauma and the diverse crisis they bring; as do disaster trau- mas and mental health consequences; are all considered. Institutional aid and collabora- tions, through to the needs of the elderly, disabled and vulnerable, all come into these challenging fields.There is the need for rec- ognition of practical needs such as clean water, food, shelter and support for human engagement, families and communities that help the healing processes. Dealing with the threat and consequence of mass violence is a challenge in all societies, whether they are ‘home-grown’ or associ- ated with potential external attack, such as terrorism. Professor Lars Weisaeth, from Norway will lead this component of the conference, building on his diverse experi- ence in Europe and beyond. He will dis- cuss the bombing and subsequent shooting of young people in Norway and its mental health and social implications then and into the future. Others will present on the short and long term consequences of terrorism, especially how this relates to mental health and social well-being. War and conflict also have both short and long term consequenc- es particularly for those displaced from home and community, from families and place. Refugees, veterans and others face ongoing threat, uncertainties and loss, with little support. As well as their resilience and survival strength they continue to have pro- found vulnerabilities. Even in the face of human induced death, the ‘good’ in people remains a powerful fac- tor that supports people and gives them the courage and hope that helps people to go forward into the future. Many forms of care and support are needed in crises and disaster. Medical experts from around the world will make a major contri- bution at this meting, led by Dr. Mukesh Haikerwal, Chair of the Council of the World Medical Association and his col- leagues from USA, Japan and elsewhere, including Australia. How we all work to- gether to address the effect of disasters and crisis,our health and mental health,requires a recognition and linkage across disciplines and expertise. Systems of response facilitat- ing such linkages are critical and require global policy and adaptation to national requirements. Professor Chris Bagley, who leads Australian disaster health response will present on Australian systems in the All Hazard Framework of National Col- laboration. His colleagues will also con- tribute, addressing the defence component of response, and health and mental health programs to mitigate impact. IT systems and resources contribute in ma- jor and rapidly developing ways, from pre- vention through to longer term recovery, from warning to psychological first aid and resilience. Glenn Wightwick will lead this component with colleagues addressing the multiple chances and opportunities that can assist in such crises and their consequences. From climate change to conflict, from tsu- nami to terrorism, from global epidemics to nuclear hazard, crises and disasters are relevant to us all. They can bring death and destruction, love and loss, courage and fear. Like so many aspects of life, we do best when we invest in the future, as well as look after the present, and accept the past, as it has been what we know and will use for the future preparation and planning, but learn- ing while we do so. The human factors that flow throughout this important meeting recognize the suffering that may occur, but focuses on the courage, strength, resilience, compassion, connectedness and care. The healing and hope that will help us go for- ward, to the future. Professor Beverley Raphael Professor of Psychiatry and Addiction Medicine, Australian National University and Professor of Population Mental Health and Disasters, University of Western Sydney Mass Catastrophe: dealing with crises and disasters now and in the future 80 The New Zealand Medical Association is saddened to learn of the death of Dr. Peter Foley, Chair of the NZMA for an historic two terms from 2007 until 2011. Following in his father’s footsteps,Dr. Foley practised as a GP in Napier for over 25 years, after graduating from Otago Univer- sity in 1981. He became president of the NZMA’s Hawke’s Bay division in 1999,was an inaugural member of the NZMA’s Gen- eral Practice Council (GPC) in 1998, and then served two terms as Chair of the GPC before moving to chair the wider organisa- tion. He was also the initial Chair of the General Practice Leaders Forum (GPLF). Dr. Foley’s particular contribution was in General Practice. He was at the fore- front of the General Practice effort to seek meaningful engagement with the Govern- ment and its agencies during the debate over General Practice fees. The efforts of the initial GPLF team, led by Dr. Foley, resulted in effect involvement for General Practice in the contracting process, and in a successful outcome – an achievement that was recognised when he was awarded the NZMA’s highest honour, the Chairman’s Award, in 2006 and an NZMA Fellowship in 2011. Further recognition followed – last year Dr.  Foley received the Member NZ Order of Merit for his services to health, which was presented in a special ceremony last month by Governor-General Sir Jerry Mateparae. After ending his term with the NZMA, Dr. Foley continued his active role in the health sector with roles as Chief Medical Officer for primary care in the Hawkes Bay and Deputy Chair for the Health Quality and Safety Commission. He also headed the independent panel that reviewed health services in Queenstown and the surround- ing area. “Pete recognised that our health system requires the profession’s strong guidance and in striving to do this he researched the issues, engaged in consultation and worked towards achieving consensus,” says Dr. Ockelford. “In his time as GPC Chair and NZMA Chair, he cultivated strong re- lationships within the medical profession, the Government and wider health sector. He was always a loyal NZMA member, and held a strong belief in the NZMA’s ability to make a difference, and have significant influence. He consistently promoted the hallmarks of the NZMA – its pan-profes- sionalism, its ability to represent all sectors of the profession and its willingness to en- gage with all sectors within health. In Memoriam In Memoriam Dr. Peter Foley It has been a joy to have known,worked and relaxed with Pete over at least ten years. Pete was well known, highly respected around and warmly welcomed around the World in the World Medical Association family and in CMAAO (Confederation of Medical Associations of Asia & Oceania). Over the years we met across the World and in Australia and in his beloved New Zea- land of which he would wax lyrical about without drawing breath! He taught us as Chair of the GP Council and later of the NZ Medical Association the skills energy and tenacity not to mention charm needed to work with and influence governments and lead the profession whilst achieving results and not compromising his patients, profession or himself. Pete was a passionate advocate for General Practice and quality health care and for the rights of all to that health care he personally provided to the people of Napier. Interna- tionally he was equally forthright for the rights of physicians and the key role they play in the health of individuals and na- tions and the need to maintain high moral, ethical and professional standards set by the profession. Tireless, diligent and dedicated to his pro- fession though he was, he would always remember the support and love and devo- tion for those at home who supported him in his endeavours on the road or “up in the air” of whom he spoke with great passion and pride. The world has benefited from having Peter Foley as a champion for its health, I and numerous of his friends and colleagues are the richer for having had him in our lives. Farewell my dear friend! Keep smiling at us from where you rest – in peace. Dr. Mukesh Haikerwal AO Chair of Council, WMA Australian Medical Association The IRCT and Restart Center are holding a global conference on the right to rehabilitation for torture victims. The conference takes place on 27–28 June 2013 in Beirut, Lebanon. We hope that you will be able to participate in this exciting global event which will provide a platform for discussion between key stakeholders in the torture reha- bilitation movement on the right to rehabilitation for torture victims. The conference will explore in detail the way rehabilitation is pro- vided to torture victims and it will consider how States can be en- couraged to strengthen their implementation efforts in providing holistic and victim-centred rehabilitation services and the neces- sary funding to torture victims.The four interlinked themes of the conference will provide a platform to share good practice examples in models for the delivery and funding of rehabilitation and explore ways in which rehabilitation services and other key stakeholders can assess and evaluate the services provided in their national con- text. Linked to this is a need to focus on the immediate situation in the MENA region which faces particular challenges with regard to the provision of rehabilitation services to torture victims. The conference will draw on the experience from rehabilitation centres worldwide as well as representatives from academia, governments, inter-governmental organisations and civil society. Registration is free but required – please fill in the online registra- tion form at www.irct.org/conference2013. Please note places are limited. The conference programme and information on the venue and nearby accommodation are available on the website. For more details, please contact Rachel Towers (rto@irct.org) or Dalal Khawaja (dalal@restartcenter.com). Global Conference on the Right to Rehabilitation for Torture Victims Congress Topics: Person-centered medical education, Person- centered interdisciplinary training in medicine and healthcare, Patients and family education, Stakeholders in health education, Students-centered health education, Art in health education. Clinical topics: Primary care, Pediatrics, Geriatric medicine, Mental health, Internal medicine, Cardiovascular Cancer, Cir- culatory disorders, Respiratory disorders, Obesity, Diabetes, Pain management and palliative medicine. Public health topics: Prevention, Health promotion, Services, Policies. Congress Participants: physicians, nurses psychologists, social workers, pharmacists, dentists, policy makers and other health professionals (including students), educators and other interested scholars, representatives of patients and their families, advocates, industry, person-centered public health. Presentation Formats: lectures, symposia, workshops, brief oral presentations and poster presentations. Deadlines: For abstracts: July 1st , 2013; For early registration: September 1st , 2013. Congress Committee: Juan E.Mezzich (president),Jon Snaedal, Chris van Weel,Michel Botbol,Ihsan Salloum,Tesfamicael Ghe- brehiwet, Veljko Đorđević, Marijana Braš, Lovorka Brajković. Technical secretariat: Penta Ltd, PCO, Address: I. Kršnjavoga 25, 10 000 Zagreb, Croatia. Phone: (+385 1) 462 8615, Fax: (385 1) 4555 3284, Web: www.penta-zagreb.hr, E-mail: ana.jurasic@penta-zagreb.hr Zagreb – the capital of Croatia, is deeply rooted in rich Central European culture. In it lives the legacy of Prof. Andrija Štampar, the president of the first WHO World Health Assembly and a pioneer of person-centered public health. Zagreb is waiting for you with its thousand fascinating faces, ready to make you feel at home. For more information, as well as for registration and abstract forms, please visit the Congress website: www.ICPCMzagreb2013.com 1st International Congress of the International College of Person-centered Medicine Whole Person in Health Education and Training. November 7–10, 2013 Westin Hotel, Zagreb Croatia IV Contents A two-month public consultation on the World Medical Association’s Declaration of Helsinki on medical research involving hu- man subjects began today (Monday) with the posting of a revised version of the Dec- laration on the WMA website. The public and the WMA’s 102 national medical association members are being in- vited to comment on the proposed changes which have been drawn up following an 18-month process of deliberation. A WMA workgroup has held comprehensive discus- sions and three expert conferences to help it draft the changes. In an explanatory note on the WMA web- site, the workgroup states that the proposed changes provide for more protection for vulnerable groups and all participants by including the issue of compensation, more precise and specific requirements for post- study arrangements and a more systematic approach to the use of placebos. In addition the workgroup states that the revised text maintains the unique character and length of the Declaration. It also provides better readability by reorganising and restructur- ing the document with sub headings. For details of the major changes, people should refer to the WMA website. All experts and stakeholders have been in- vited to submit comments to the WMA secretariat no later than 15 June 2013. The workgroup will then produce a fi- nal revised draft to be considered by the WMA’s ethics committee and Council at their meetings in Fortaleza, Brazil in Oc- tober 2013 when a decision will be taken whether to forward the document to the WMA Assembly at the same meeting for adoption. Thedocumentforpublicconsultationmaybe downloaded here http://ndcommunications. hosted.phplist.com/lists/lt.php?id=N0RSBgZP AAQMGVUGBg%3D%3D www wma.net Public Consultation Opens on WMA Helsinki Declaration President’s Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Opening Speech by H. E. Dr. Nafsiah Mboi . . . . . . . . . . . 44 194th WMA Council Session. General Report . . . . . . . . . . 46 Secretary General’s Report . . . . . . . . . . . . . . . . . . . . . . . . . 54 WMA Council Resolution on Criminalisation of Medical Practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 WMA Council Resolution on Standardisation in Medical Practice and Patient Safety . . . . . . . . . . . . . . . . 59 WMA Council Resolution on Professor Karabus . . . . . . . . 59 Physicians and Hunger Strikes in Prison: Confrontation, Manipulation, Medicalization and Medical Ethics . . . . . . . . 60 Protective Provisions for Research Participants . . . . . . . . . 68 Frequency of Hypertension in a Primary Care Setting in Buza,Tanzania . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 Revealed: Coal’s Unpaid Health Bill . . . . . . . . . . . . . . . . . 78 Mass Catastrophe: dealing with crises and disasters now and in the future . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 In Memoriam Dr. Peter Foley . . . . . . . . . . . . . . . . . . . . . . 80