wmj201502

COUNTRY
vol. 61
MedicalWorld
Journal
Official Journal of The World Medical Association, Inc.
ISSN 2256-0580
Nr. 2, July 2015
Contents
The General Assembly in Moscow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
200th
WMA Council Session, Oslo, April 2015. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
WMA Council Resolution on Trade Agreements and Public Health . . . . . . . . . . . . . . . . . . . . 52
World Health Assembly Week . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Global Epidemics. Industrialised Nations Must Develop Global Strategies
to Counter Epidemics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
WMA Roles for Climate Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
The Art and Heart of Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
One Health: A Concept for the 21st
Century . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Pros and Cons of the Over-the-counter Sales of Antimicrobials . . . . . . . . . . . . . . . . . . . . . . . . 64
Medicines Shortages: Global Problems
Need Global Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Do Ethics Need to Be Adapted to mHealth?
A Plea for Developing a Consistent Framework . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Health Apps – Sound and Trustworthy?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Interview with Vytenis Andriukaitis, EU Commissioner for Health and Food Safety . . . . . . 78
Position of Israeli Medical Association in Forced Feeding Issue . . . . . . . . . . . . . . . . . . . . . . . . 82
41
WMA News
Editor in Chief
Dr. Pēteris Apinis, Latvian Medical Association, Skolas street 3, Riga, Latvia
Phone +371 67 220 661
peteris@arstubiedriba.lv, editorin-chief@wma.net
Co-Editor
Prof. Dr. med. Elmar Doppelfeld, Deutscher Ärzte-Verlag, Dieselstr. 2, D-50859 Köln, Germany
Assistant Editor
Inese Sviestiņa, wmj-editor@wma.net
Journal design and cover design by
Pēteris Gricenko
Layout and Artwork
Latvian Medical Publisher “Medicīnas apgāds”, President Dr. Maija Šetlere, Katrīnas street 2, Riga, Latvia
Publisher
Latvian Medical Association “Latvijas Ārstu biedrība”, Skolas street 3, Riga, Latvia.
ISSN: 2256-0580
Dr. Xavier DEAU
WMA President
Conseil National de l’Ordre des
Médecins (CNOM)
180, Blvd. Haussmann
75389 Paris Cedex 08
France
Dr. Donchun SHIN
WMA Chairperson of the Finance
and Planning Committee
Korean Medical Association
46-gil Ichon-ro
Yongsan-gu, Seoul 140-721
Korea
Prof. Dr. Frank Ulrich
MONTGOMERY
WMA Vice-Chairperson of Council
Bundesärztekammer
Herbert-Lewin-Platz 1 (Wegelystrasse)
10623 Berlin
Germany
Dr. Margaret MUNGHERERA
WMA Immediate Past-President
Uganda Medical Association
Plot 8, 41-43 circular rd., P.O.
Box 29874
Kampala
Uganda
Dr. Joseph HEYMAN
WMA Chairperson
of the Associate Members 163
Middle Street
West Newbury, Massachusetts 01985
United States
Dr. Masami ISHII
WMA Treasurer
Japan Medical Assn
2-28-16 Honkomagome
Bunkyo-ku
Tokyo 113-8621
Japan
Sir Michael MARMOT
WMA President-Elect
British Medical Association
BMA House,Tavistock Square
London WC1H 9JP
United Kingdom
Dr. Heikki PÄLVE
WMA Chairperson of the Medical
Ethics Committee
Finnish Medical Association
P.O. Box 49
00501 Helsinki
Finland
Dr. Miguel Roberto JORGE
WMA Chairperson of the Socio-
Medical Affairs Committee
Brazilian Medical Association
Rua-Sao Carlos do Pinhal 324,
CEP-01333-903 Sao Paulo-SP
Brazil
Dr. Ardis D. HOVEN
WMA Chairperson of Council
American Medical Association
AMA Plaza, 330 N. Wabash,
Suite 39300
60611-5885 Chikago, Illinois
United States
Dr. Otmar KLOIBER
Secretary General
World Medical Association
13 chemin du Levant
01212 Ferney-Voltaire
France
World Medical Association Officers, Chairpersons and Officials
Official Journal of The World Medical Association
Opinions expressed in this journal – especially those in authored contributions – do not necessarily reflect WMA policy or positions
www.wma.net
The General Assembly in Moscow
October 14–17, 2015
An Invitation
The World Medical Association was founded in the wake of World
War II.After a two-year preparation period,27 medical associations
met in Paris in September 1947 to found a new association. Since
then, medical ethics and socio-medical affairs have been at the core
or our work and we are proud to have shaped major international
medical guidelines and regulations over the past seven decades.
Of course, physicians have had many other interest groups both
before and since, but the WMA became, and still is, an advocacy
group striving to make the best health care possible for all,including
through health education, prevention, rehabilitation and palliative
therapy, aside from curative care and public health.
Over past years, aspects of human rights and social determinants
have become more prominent and important for the work of the
association.The spectrum we deal with stretches from equitable ac-
cess to treatment through to issues of human rights violations in
medicine right up to the challenge of preserving medical neutrality.
We are now working more closely than ever on human rights issues
with partners like the International Committee of the Red Cross,
Amnesty International and Physicians for Human Rights, to name
just a few.
We support member associations in making their case for the ethi-
cal practice of our profession, we call upon governments to allow
physicians to perform properly and we advise on how to stay within
the rules. We are searching deeper for the causes behind the causes
of diseases, and we often find very simple mechanisms that deter-
mine our health and our chances of dealing with disease.
The WMA has become a strong voice for physicians and their pa-
tients worldwide and we need to stay that way: able to raise ques-
tions, willing to find answers, and able to speak out. We invite our
members – Constituent and Associate Members – to join us in
Moscow from 14–17 October for the Council Session and the 2015
General Assembly. Please register on our website now. We need ev-
ery single one of you!
https://www.wma.net/en/50events/10statutorymeetings/13ga_2015/
index.html
Dr. Otmar Kloiber
WMA Secretary General
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WMA News WMA News
Emergency Resolution
A proposal was put forward by the British Medical Association that
the meeting should consider an urgent Resolution about the several
trade agreements being negotiated throughout the world and their
impact on the provision of health. The Council accepted this as an
urgent matter which should be discussed in committee.The Council
then adjourned for the committee meetings.
Finance and Planning Committee
Dr. Dongchun Shin (Korean Medical Association) was elected un-
opposed as Chair of the Committee. The Committee received a re-
port on membership dues payments and on the Financial Statement
for 2014.The Committee approved the document as an interim fi-
nancial statement. A debate took place on a new dues structure.
Alcohol Session
The Committee meeting then adjourned to hear two invited speak-
ers talking about the alcohol policy in Norway. Mr Øystein Bakke,
Senior Adviser, FORUT, Campaign for Development and Solidar-
ity and Secretary of the Global Alcohol Policy Alliance,spoke about
Norway’s 40 years of experience with a ban on alcohol advertising.
He said that increasing amounts of evidence showed that alcohol ad-
vertising and other marketing efforts had an impact on consumption.
Marketing was a dominant feature of the global alcohol trade, and
drinks companies spent massively towards “investments in the brands”.
Advertising and marketing had the strongest impact on young people,
speeding up onset of drinking and increasing the amount consumed by
those who already drank.The alcohol industry looked for new markets
as the traditional markets of the West were becoming less profitable.In
these emerging markets in Africa and Asia, marketing was effective in
recruiting new consumers from the non-drinking population.
The alcohol industry’s response to calls for marketing regulations
was “self-regulation”. This approach to alcohol marketing had gen-
erally been deemed ineffective by several studies, but the alcohol
producers and their so called “social aspects organizations” still re-
ferred to this as the best way forward.
He said that, marketing restrictions existed in many countries
around the world and not only in Norway. Almost 50 countries had
a total ban on alcohol advertising on national television in 2012,
while another 50 had some sort of partial restriction on TV adver-
tising. That added up to about half the world’s countries. Advertis-
ing bans were effective measures,particularly in reducing the impact
on underage and young consumers.
The second speaker,Lilly Sofie Ottesen,Deputy Director General of
the Unit for Alcohol and Illicit Drugs Policy at Norway’s ­Ministry
of Health and Care Services Department of Public Health, spoke
about 40 years’ experience of the alcohol ban in Norway. She said
the ban, which was introduced in 1975, was very strict and probably
the most comprehensive in Europe. It covered all the media and
all expressions associated with alcoholic beverages. Phrases such as
‘happy hour’ and ‘a cold one’ were even covered, as well as the mere
use of a neutral picture of a beverage and alcohol sponsorships such
as beer brands on football shirts and on boards at sport venues.
The aim of the ban was twofold – to reduce directly the demand and
thereby the consumption and harm of alcohol, and secondly to re-
inforce the effect of other alcohol policy measures and to contribute
to the support for the alcohol policy as a whole.
Addressing the question of whether the ban was working,Ms  Ottesen­
replied that it was. Alcohol consumption in Norway was low com-
pared to the rest of Europe and there was evidence to back up the
assumption that the ban reinforced other alcohol measures. Public
support for the ban had grown in recent years. There had been chal-
lenges to the ban from the alcohol industry,but there was now a broad
political consensus that Norway should keep the ban.
She concluded: ‘We believe that it is important to maintain a strict
and media neutral advertising ban. We do not see any threats to
the ban as such, but as there will always be changes in society, com-
munications and industry, and we must make sure that the ban and
its exceptions adapts to these changes. This, along with an efficient
control and sanction system, is important to safeguard the support
for the ban also in the years to come.’
Finance and Planning Committee (resumed)
WMA Strategic Plan
The Secretary General spoke about the WMA’s strategic alliances
and highlighted a number of activities implemented according to its
strategic plan. These included organising another Regulation Con-
ference with the World Health Professions Alliance in May 2016.
There would be a Global One Health Conference with the World
Veterinarian Association on 21–22 May in Madrid with an agenda
concerning issues relating to both professions. There would be a
UNESCO Bioethics Conference from October 20–22 in Naples at
which the WMA would be organising two sessions and the WMA
was now participating in the World Federation of Medical Educa-
tion as a voting member.
Business Development
A report was given on the Business Development Group’s work
and the issue of finding external sources of funding. The Group had
worked on the first principle that the core work of the WMA had to
be funded by membership subscriptions. The question was whether
other activities, such as educational activities, should be funded in
some way by external sources. The meeting agreed that the Group
should prepare a paper on the issue and come back to the Committee.
The 200th
WMA Council meeting, was held at the Hotel Bristol in Oslo,
Norway. The meeting was opened by the Secretary General Dr. Otmar
Kloiber, who began by reminding delegates that this was a confidential
meeting and that tweeting should not take place. There were no apolo-
gies for absence. He welcomed three new members of Council, Dr. Heidi
Stensmyren from Sweden, Prof. Rutger Jan Van Der Gaag from the
Netherlands and Dr. Carlos Jorge Janez from Argentina. He also wel-
comed delegates from more than 35 national medical associations, Past
Presidents, observers and guests and in particular the return of one of the
WMA’s founding members, the Italian Medical Association.
Council
Elections and Appointments
The Council began with an election for Chair of Council.Two nomi-
nations were received – from the sitting Chair Dr. Mukesh Haik-
erwal (Australian Medical Association) and from Dr. Ardis Hoven
(American Medical Association). Both candidates briefly addressed
the meeting. Dr.  Haikerwal, a former President of the Australian
Medical Association, spoke about his achievements as a leader of the
medical profession throughout his career and talked about his vision
for the future of the WMA to build on his work of the past four years.
Dr. Hoven, Immediate Past President of the American Medical As-
sociation, spoke of the great opportunity the WMA had to influence
medical practice and global health, and the complex and far reaching
challenges facing the Association – shrinking resources, complicated
and difficult practice environments, shifting government regulations
and dangerous working conditions. The WMA’s current work spoke
to its impact and credibility. She said she valued consensus and the
WMA’s diversity and she would work to increase the Association’s
visibility and strengthen its voice. In the vote, Dr. Hoven was elected
and immediately took the Chair,thanking the Council for its support
and in particular thanking Dr. Haikerwal for his work as Chair.
Prof. Dr.  Frank Ulrich Montgomery (German Medical Associa-
tion) was elected unopposed as Vice-Chair to succeed Dr. Masami
Ishii and Dr. Ishii (Japan Medical Association) was elected unop-
posed as Treasurer to succeed Dr. Montgomery.
The Council approved the membership of the Council committees
and approved the names of their advisers.
President’s Report
The President Dr. Xavier Deau gave an interim report on his activities
since his inauguration in Durban last year.He referred to the work on
the Health Care in Danger project and the H20 Health Summit in
Melbourne,where it was concluded that health was a wise investment
and an economic driver in society for the creation of employment.
He also spoke about WMA’s role on the issue of climate change, the
importance of the issue of the Social Determinants of Health and the
successful revision of the Declaration of Helsinki.
Secretary General’s Report
Dr. Kloiber had presented a lengthy written report to Council about
the secretariat’s activities. In his oral report he highlighted two
­issues to illustrate the WMA’s influence and impact.
The Association had received an invitation from the United States
Defence Health Board to advise the US Defence Secretary and the
US military on issues relating to health and the military. The WMA
was invited to take part in a session on medical ethics. Past Presi-
dent Dr. Cecil Wilson represented the WMA at this meeting and the
Board came out with 16 recommendations. Dr. Kloiber then quoted
from a letter from the Vice Chair of the US Senate Committee on
Intelligence, Senator Dianne Feinstein, to the US Defence Secretary
referring to the WMA’s Declaration of Malta on the issue of ending
the forced feeding of detainees at Guantanamo Bay.
The second development illustrating the WMA’s impact related to
the issue of scheduling the drug Ketamine some weeks ago by the
United Nations Commission on Narcotic Drugs. The WMA had
asked its members to argue against this scheduling as many people
would have suffered from the absence of the drug. Eventually it was
decided to postpone the decision for a year and Dr. Kloiber thanked
those NMAs who had lobbied on this issue.
Dr. Margaret Mungherera, the Immediate Past President, said that
the largest threat to global health were the African health systems,
but there was not enough attention being paid to this. She said the
WMA needed to keep this issue on the agenda. The WMA had
done a lot of work to reduce the deafening silence of NMAs in
­Africa on this issue, but it had a moral authority to do more and
could not afford to sit back.
Chair’s Report
In his report, Dr. Haikerwal reported on the WMA’s increased foot-
print on the global health map.He referred to the first “H20+”Health
Summit in Melbourne, adjacent to the G20 World Leader’s Summit.
He said ethical guidance and ensuring access to health and healthcare
remained core and key. He and the WMA’s leaders continued to re-
mind people that health was a core component of a successful fair and
just society,that health was a wise investment and that health brought
human, political and economic dividends. Physicians were part of the
solution in health and healthcare research planning implementation.
200th
WMA Council Session, Oslo, April 2015
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Future Meetings
The Committee considered the planning and arrangements for fu-
ture WMA statutory meetings. The Taiwan Medical Association
suggested that at the Assembly meeting in Taipei in October 2016
the scientific session should be on ‘Healthcare System Sustainabil-
ity’ with two sessions, the first on ‘Health System Performance’ and
the second session on ‘eHealth’.This was agreed.
The Secretary General reported that as in previous years, a WMA
luncheon in Geneva would again be held during the WHO World
Health Assembly period.The main theme this year would be public
health issues, including health and investments. Dr. Haikerwal re-
ported that a second H20+ Health Summit was also being planned
following the success of the Melbourne meeting.
Associate Members
The Committee received an oral report from the Chair of the As-
sociate Members, Dr. Joe Heyman. He informed the Committee
of his plans to draw more commitment from individual associate
members by promoting membership through introducing life mem-
bership. An international conference call was planned for May and
he also spoke about holding regional, on-site meetings when statu-
tory meetings were held and linking up with the Junior Doctors
Network and the Past Presidents and Chairs of Council Network.
Junior Doctors Network
The Chair of the Junior Doctors Network,Dr. Ahmet Murt,gave an
oral report on the JDN’s activities. Among the current topics it was
working on were physicians’ wellbeing, medical work force, medical
education, Ebola and social media.
Past Presidents and Chairs of Council Network
Delegates received a written report on the activities of the Past Presi-
dents and Chairs of Council Network. Dr. Cecil Wilson had repre-
sented the WMA at the U.S. Defence Health Board Subcommittee
Meeting in February, Prof. Dr. José Luiz Gomes do Amaral had given
expert advice on the possible scheduling of Ketamine as a narcotic drug
and Dr. Dana Hanson was presenting a paper entitled,“Global Physi-
cian Resilience: The Role of Social Context to the European Associa-
tion for Physician Health”in Barcelona in April. Dr. Jon Snaedal gave
an oral report and said the activities of the Network were increasing.
World Medical Journal
The WMJ Editor, Dr. Peteris Apinis, in his oral report, said the
transition producing a digital edition of the Journal had been com-
plicated. Four issues had been scheduled for this year and the first
digital edition would be published within days.
Public Relations
The WMA’s Public Relations Consultant, Mr. Nigel Duncan, spoke
about the importance of social media and the advantages this pre-
sented for the WMA. He said there was a need for some guidelines
and rules for a more efficient and productive use of social media.
IFMSA Memorandum of Understanding
Dr.  Kloiber reported on a new Memorandum of Understanding
with the International Federation of Medical Students Associa-
tions. Dr. Agostinho de Sousa, President of IFMSA, explained that
IFMSA had been cooperating with the WMA since the 1960s,
and that the official MoU would facilitate future collaboration. The
Committee agreed to recommend to the Council to accept the new
Memorandum of Understanding.
Internship and Secondment
The Committee received an oral report from the Secretary General
on internships and secondment to the WMA. He reported that two
bioethics students from the University of Pennsylvania and medical
students from the IFMSA had been interning at the WMA Secre-
tariat in Ferney Voltaire annually. He asked NMAs to consider sec-
ondment for intensive contact with the WMA for mutual benefit.
Violence Against Doctors
The meeting heard a report from the Indian Medical Association
about increasing incidents of assaults on doctors by patients in India.
Dr. Kloiber­agreed that this was a very pressing issue that had arisen in
countries around the globe. He had received reports in recent months
from every continent,from Asia,Eastern Europe and from Latin Amer-
ica.The WMA had recently issued a press release about the case of a sur-
geon murdered in a Boston hospital in the USA.There had also been a
recent case in Germany.He added that this was a second line of violence
in addition to the violence taking place in areas of armed conflict,about
which the WMA was working with the International Committee of the
Red Cross. He told the meeting that the WMA would need to step up
its work on violence against doctors not connected with armed conflict.
Socio-Medical Affairs Committee
Elections
The proceedings began with a contested election for Chair of the
Committee, following the decision of President Elect Sir Michael
Marmot to stand down. Two candidates were nominated, Prof.
Miguel Roberto Jorge (Brazilian Medical Association) and Dr. An-
dré Bernard (Canadian Medical Association).After both candidates
addressed the meeting,the Committee elected Prof.Jorge,Associate
Professor of Psychiatry and Chair of the Research Ethics Commit-
tee, at the Federal University of São Paulo.
Oral Report
Dr. Kloiber noted the increasing number of items on the SMAC
agenda, reflecting the increased involvement of the WMA in socio-
medical issues.He again highlighted the key importance of address-
ing violence against health care personnel and facilities that occurred
not only in situations of armed conflict, but also in civil situations.
There were some instances, such as in Mexico, where violence was
reaching armed conflict in a war on drug gangs between the state
and the people, and doctors were being taken hostage and killed.
He mentioned the WMA’s commitments in this area, in particular
within the Health Care in Danger Project, initiated by the ICRC.
He called on national medical associations to cooperate with the
Secretariat in sharing information on situations in their countries
and to become further engaged in addressing this issue.
Health and the Environment
Dr. Shin, Chair of the Environmental Caucus, reported on the ac-
tivities of the Caucus that had met the previous day. The meeting
had focused on the forthcoming United Nations Climate Change
Conference in Paris in early December 2015.The expected outcome
of the event was to reach a new universal agreement on climate
aiming at keeping global warming under 2°C. So far the draft ne-
gotiating text included a plan to completely phase out fossil fuel
emissions. The text also for the first time included language on the
health benefits of climate action.
Participants in the Caucus had discussed ways of influencing the
process and have doctors’ voices heard at the national and interna-
tional level. Dr. Deau had presented a plan for the WMA in col-
laboration with the Société Française de Santé Publique (French
Society of Public Health) and the European Public Health Asso-
ciation to target the French negotiating team, which would have a
major role in the negotiations as it was the host country of the event.
Health Care in Danger
Prof. Vivienne Nathanson, Chair of the Work Group on Health
Care in Danger, reported on the activities of the Group, which had
met the previous day. She said Dr. B. Eshaya-Chauvin (ICRC) had
updated the Group on the latest developments on the ICRC proj-
ect. He said the project had been extended by two years.The Group
discussed ways of translating into action the recommendations
emerging from the project.Two actions were identified: that NMAs
make contact with Red Crescent societies at the national level and
that the WMA website include a defined area featuring activities
developed by NMAs in this area.
The Group had examined a proposed revision of current WMA policy
on Ethical Issues Concerning Patients with Mental Illness adopted in
2006.This revision would reflect doctors’concerns about recent policy
developments in this area and reaffirm medical ethics principles in
relation to patients in psychiatric centres. It was proposed that the
revised version be submitted to the Committee for consideration.
Finally Prof. Nathanson referred to the draft toolkit the British
Medical Association had developed for doctors going into situa-
tions of armed conflict for the first time. It was proposed that the
document, which would be an online publication only, be submitted
to the Committee for consideration
Violence Against Women and Girls
Sir Michael Marmot reminded the Committee of the very success-
ful WMA luncheon held in Geneva in May 2014 alongside the
World Health Assembly that was dedicated to violence against
women. He said that one in three women globally would experience
physical or sexual violence. This was a huge public health issue. It
was now proposed that the British Medical Association would host
a discussion meeting of interested NMAs in London about how the
WMA could continue working on this subject.
Social Determinants of Health
A report on the successful BMA symposium that was held in March
organised jointly by the British Medical Association, the Canadian
Medical Association and the Institute of Health Equity was given
by Sir Michael Marmot. He updated the Committee on his plans
for following up the conference. The first aim would be to continue
strengthening global networks and building a social movement. The
next would be to increase the visibility of the WMA Statement on
Social Determinants of Health and build on the best evidence to pro-
duce a report.The third aim would be to develop educational tools for
physicians to learn what they could do to tackle the Social Determi-
nants of Health through online courses and training workshops.
Role of Physicians in Preventing theTrafficking with Minors and Illegal
Adoptions
It was reported that experts on the topic had been consulted over
recent months. However, having not received enough material or
responses, it had so far not been possible to submit a paper to the
Work Group. It was hoped that the Work Group would be in a
position to submit a draft policy in October 2015.
It was decided to postpone further discussion until the next com-
mittee meeting in Moscow.
Proposed Statement on Physicians’ Well-Being
A new draft Statement on Physicians’ Well-Being was presented
to the Committee by the Work Group. There was a brief debate
about the need for doctors with disabilities to be enabled to return
to work by making the necessary adaptions to the workplace. It was
also argued that the paper should contain a more expanded section
on physicians at risk from alcohol abuse. It was agreed to recom-
mend to Council that the paper should be recirculated to NMAs
for comments.
Revision of the WFME Standards for Post-Graduate Education and
Continuing Professional Development
A report was received on the activities of the Work Group on
Medical Education. The Group had made comments on revising
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46 47
WMA News WMA News
the World Federation of Medical Education Standards for Post-
Graduate Education. The revision was considered thorough and
comprehensive.
Dr. Kloiber reported that he has been consulted by the WFME in a
personal capacity on the revision of standards for Continuing Pro-
fessional Development. He thanked those members that had sent
comments on the proposed revision and he expected there would
also be an open consultation with the opportunity for NMAs to
submit further comments.
Statement on Providing Health Support to Street Children
New guidelines for National Medical Associations on providing
health support to street children were set out in a revised Statement
on Providing Health Support to Street Children.
The reworded Statement was introduced by the Conseil de l’Ordre
National des Medecins. Delegates were told that the issue effect-
ed a large number of countries in all continents. It was difficult to
quantify this phenomenon but it was a reality in large cities w­hich
­children sought out after leaving their villages and towns. Many
children were dumped in ships and sent across the sea to find a bet-
ter future.They often travelled in groups and many died on the way.
So how could doctors help them? A specific response was required.
It was argued that the WMA had a duty to support local organisa-
tions working with these children and a duty to sensitise govern-
ments. It was urgent to work together with people working in the
field and on the streets.
The Committee agreed that the proposed Statement should go to
Council to be approved and forwarded to the General Assembly for
approval and adoption.
Proposed revision of WMA Statement on Child Abuse and Neglect
It was decided that this proposed document should be withdrawn.
Statement on Chemical Weapons
The Committee considered the proposed revision of the WMA
Statement on Chemical Weapons which deals with the appropriate
use of riot control agents. It was proposed that the title of the paper
be changed to Statement on Riot Control Agents.
This was approved and it was decided to send the document to
Council for forwarding to the General Assembly for approval and
adoption.
Proposed Declaration on Alcohol
The Australian Medical Association introduced a draft Declaration
on Alcohol which recommends priority legal and regulatory mea-
sures as well as social policy interventions to address alcohol-related
harm.The document was welcomed by a succession of speakers and
after a brief debate it was agreed that with two minor amendments
it should be sent to Council for forwarding to the General Assem-
bly for approval and adoption.
Mobile Health
A proposed new Statement on Mobile Health was presented to the
Committee by the German Medical Association. Delegates were
told that National Medical Associations had commented on the pa-
per and many of their suggestions had been included.
Speakers welcomed the document on what they said was a very
important issue. There was one suggestion that the Statement
should include more about secrecy and confidentiality. This led to
a debate during which many speakers argued that the guidelines
should remain as broad and as general as possible. The meeting
decided to reorder the wording of the document and the Commit-
tee agreed that the proposed Statement, as amended, be approved
by the Council and be forwarded to the General Assembly for
approval and adoption.
World Day for Eliminating Violence Against Health Professionals
The Turkish Medical Association introduced a revised Statement
on a World Day for Eliminating Violence against Health Profes-
sionals. This would be in memory of all those health professionals
who had died in the course of duty, including the young Turkish
surgeon Dr. Ersin Arslan who was stabbed by a relative of his pa-
tient while on duty in his hospital three years ago.
Several speakers questioned whether there was a need to adopt new
policy and it was suggested that this proposal should be referred to
the WMA Advocacy Group. Other speakers supported the idea for
a special day. It was reported that the Conseil de l’Ordre National
des Medecins had set up an observatory to monitor physician safety
and a form had been devised for physicians to report physical and
verbal attacks. In 2014 they had noted a major increase in incidents
of violence. In France it was not as usual for physicians to report
such attacks and therefore the known figures should be multiplied
to get a correct picture of what was going on.
Speakers also said that one of the reasons for violence was the lack
of resources for hospitals and doctors when it came to working
conditions, and the public sometimes reacted violently as a con-
sequence. Doctors felt helpless when confronted with this type of
problem and often resorted to defensive medicine. It was said that
in Mexico over four years more than 60 physicians had died at the
hands of the drug trafficking industry. The Committee agreed that
the proposed Statement be forwarded to the Advocacy Group for
considering possible action.
Nuclear Weapons
The Committee considered the proposed Statement on Nuclear
Weapons requesting all National Medical Associations to join the
WMA in urging their respective governments to work to ban and
eliminate nuclear weapons.
Members of the Committee welcomed the Statement and recom-
mended that it be sent to Council for forwarding to the General
Assembly for approval and adoption.
Statement on Destruction of Smallpox Virus Stockpiles
The Junior Doctors Network re-presented a revised proposed State-
ment on Destruction of Smallpox Virus Stockpiles. The JDN sug-
gested setting up a Work Group to work on bringing forward a fur-
ther paper at the next Committee meeting. This prompted a debate
on the complexity of the issue. Several speakers said that although
they supported the Statement they would prefer to wait for a pending
report on the issue from the World Health Organisation scientists.
At the end of the debate the Committee decided that the Statement
should be postponed to the next Council meeting, so that members
could review the WHO report when it was published.
Corporal Punishment of Children
A proposal was made to endorse a statement by international health
organizations in support of Prohibition and Elimination of all
Corporal Punishment of Children. The Committee considered the
Statement and recommended Council that the Statement should be
endorsed by the General Assembly.
Guidelines on Mass Media Appearances by Physicians
The Korean Medical Association introduced a draft Statement con-
taining guidelines for physicians appearing in the media. Delegates
were told that some physicians misused appearances on the mass media
for marketing purposes misleading patients’trust in physicians. Speak-
ers generally supported the document but said there needed to be some
clarification about whether it related to all media appearances or only
appearances related to marketing products. The Committee recom-
mended that the guidelines be circulated among NMAs for comment.
Statement on Transgender People
The German Medical Association brought forward a proposed
Statement on Transgender People as a new item of business. This
referred to the crucial role played by physicians in advising and con-
sulting with transgender people and their families about desired
treatments. It was meant to serve as a guideline for patient-phy-
sician relations and to foster better training to enable physicians to
increase their knowledge and sensitivity toward transgender people
and the unique health issues they faced.
Speakers welcomed the paper,although one delegate expressed some
concern that WMA policy might enter into conflict with national
legislation. However another speaker referred to the saying ‘Ethics
trumps national law’. The issue of medical ethics and intersexual-
ity was also raised and it was agreed that this was a separate topic
and that a specific paper should be drafted on this. The Committee
recommended that the Statement be circulated among constituent
members for comments.
Statement on Vitamin D Insufficiency
A proposed Statement on Vitamin D Insufficiency was introduced
by the Czech Medical Association. Delegates were told this was an
important global health issue with an estimated one third of the
population having insufficient vitamin D concentrations. It was ar-
gued that Vitamin D should now be considered essential for overall
health and well-being and that attention should be focused on ad-
equate action in populations at risk, such as young children, older
people and pregnant women. The Committee recommended that
the Statement be circulated among NMAs for comments.
Ageing
The Brazilian Medical Association proposed that a new policy on
ageing should be drafted. In the last hundred years life expectancy
had increased by more than 30 years worldwide. By 2050 the pro-
portion of those over 60years old was likely to increase from 11.9
per cent to more than 21 per cent, a total of over two billion people
of whom 83 per cent were living in developing countries. There
would be a consequential increase in diseases such as NCDs, car-
diovascular disease,cancer,diabetes and chronic respiratory diseases.
These diseases could be controlled but doctors were not sufficiently
prepared for these challenges. It was time to begin considering
guidelines on this issue.Committee members heard about the expe-
rience of several countries and supported the proposal for a policy.
The Committee recommended that a Work Group be set up with
the mandate to produce a draft policy on ageing.
Classification of 2005 Policies
The Committee considered the potential revision of SMAC policies
for which it had been 10 years since adoption or revision.
It recommended that the following policies be rescinded and ar-
chived:
• the Council Resolution on Chronic Non-Communicable Disease
• the Council Resolution on the Healthcare Skills
• the Council Resolution on the Genocide in Darfur
It recommended that the following policies undergo a major revi-
sion:
• the Council Resolution on Implementation of the WHO Frame-
work Convention for Tobacco Control
• the Statement on Boxing
• the Statement on Body Searches of Prisoners
• the Statement on Female Genital Mutilation
It recommended that following policies be reaffirmed:
• the Declaration of Hong Kong on the Abuse of the Elderly
• the Statement on Drug Substitution
• the Statement on Medical Liability Reform
Advocacy
Dr. André Bernard, Chair of the Advocacy Advisory Committee,
reported on the activities of the Committee, including the use of
social media and the need to develop guidelines on how social
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­media and particularly twitter might fit into WMA’s proceedings.
He said a task group would be set up to draft some guidelines
and bring them back to the next meeting of the Advocacy Com-
mittee. He also referred to the need to follow up the advocacy
training session held at the Assembly in Durban and said that the
Committee would explore how to advance the various initiatives
discussed.
Finally he said the Committee was considering how advocacy fit-
ted with the Association’s policy making process. There was a need
to have clear messaging and to consider what levers for advocacy
communication were available for each piece of work produced by
the WMA.
Resolution on Trade Agreements and Public Health
The British Medical Association submitted a proposed urgent
Resolution on Trade Agreements and Public Health. It was re-
ported that there were a large number of trade agreements moving
towards finality. It was very difficult for individual NMAs to have
a significant impact on these agreements because of the secrecy
surrounding the negotiations. But it was possible to get concerns
heard if it was handled collectively. The key issue was that the
WMA wanted to protect the ability of governments to make deci-
sions about promoting health and well-being and health equity in
each country. It did not want to have those policies damaged or
stopped because it was felt by some companies that their trading
rights had been infringed and to use the new trade agreements to
either stop the policy changes or even worse to make governments
pay for damage to their trade. This could be policies as simple as
plain packaging of cigarettes or something more complicated such
as bringing in a new form of competition within the provision of
health care.
What was needed was a process within the negotiations which said
that these services introduced by governments for the public would
be protected.
Speakers agreed that this was a particularly hot topic in Europe
and in Asia. Health care was being endangered by these nego-
tiations. It was also said that the Trans-Atlantic Trade and In-
vestment Partnership might lead to the commercialization of
education, particularly medical education. It was argued that
Government medical services should not be hindered by a trade
agreement. Following agreement on an amendment to the Reso-
lution on securing services in the public interest, the Committee
agreed to recommend that the proposed Resolution, as amended,
be ­adopted by the Council.
Medical Ethics Committee
Dr.  Heikki Pälve (Finnish Medical Association) was re-elected
Chair of the Committee.
The Secretary General highlighted four current international topics
of discussion within the committee’s remit:
• The potential of health databases and biobanks for improving
treatment, while at the same time facing the risk of undue com-
mercial exploitation
• Reproductive health (surrogacy, and social freezing)
• End of life (physician assisted suicide and euthanasia)
• Medical confidentiality and reporting of medical findings follow-
ing the recent German air crash
• Conscientious objection
On the issue of medical confidentiality, Dr. Kloiber said this had
become an issue following the recent German air crash when the
question arose about the pilot’s medical fitness.This raised the issue
of the obligation on physicians for mandatory reporting of medical
fitness. So far the medical associations had reacted very appropri-
ately, pointing out the value of medical confidentiality and the po-
tential damage that could be done by lifting medical confidentiality
and secrecy. Delegates were told that in South Africa and Holland
physicians were either legally obliged to or allowed to release infor-
mation about a patient if it was in the public interest. However in
Australia, on the issue of the mandatory reporting for physicians
who were unwell, it was unclear whether this was for all physicians
when they were unwell or only when they were a danger. Although
this was supposed to be a national law, certain states had not ad-
opted that policy and doctors were going to these states to get their
treatment.
Person Centred Medicine
The Committee received an oral report about the activities of the
Work Group on Person Centred Medicine which had begun its
work in 2012. It was reported that a white paper would be de-
veloped for the next meeting in October explaining the different
existing concepts and their challenges. The language had evolved
over the different definitions of person centred medicine.The white
paper would address the difficulty in balancing the patient focus
of medicine and public health and the physicians’ perspective. A
WMA policy would be developed out of this white paper.
This led to a brief debate in which speakers elaborated on the defi-
nition of person centred medicine and the reason why the name
patient centred medicine was an incomplete term.
Health Databases and Biobanks
The activities of the Work Group on Health Databases and Bio-
banks were outlined to the Committee in an oral report. It had pro-
duced a draft policy paper and an open public consultation had been
started, which would run until 5 June 2015. The Work Group in-
vited all constituent members to contact experts in their country to
comment on the draft paper or to send the WMA Secretariat sug-
gestions of who to contact for this process. A small drafting group
would incorporate the comments received at a drafting meeting in
Berlin later this year. The Work Group then proposed to hold an
open meeting with additional experts at the beginning of Septem-
ber 2015. The Danish Medical Association had offered to host this
meeting in Copenhagen and the Work Group would report back at
the next Council meeting in October.
Speakers emphasised that this was an ever changing topic and
even when a paper was produced it would only be a work in prog-
ress. The topic was a core issue for the profession of patient con-
fidentiality.
Inclusion of Medical Ethics and Human Rights in the Curriculum of
Medical Schools
A report was given to the Committee on a major revision of the
WMA Resolution on the Inclusion of Medical Ethics and Hu-
man Rights in the Curriculum of Medical Schools World-Wide.
The aim was that the teaching of medical ethics and human rights
at every medical school should be obligatory. It was also recom-
mended that medical schools should ensure they had sufficient fac-
ulty skilled at teaching ethical enquiry and human rights to make
courses sustainable. The revised draft argued that there was a clear
need for physicians in training to understand the social and envi-
ronmental context within which they would practice. Failures of
individual physicians to recognize the ethical obligations they owed
their patients and communities damaged the reputation of doctors
throughout a country, and could have a global impact. The Com-
mittee recommended that the proposed revision be circulated to
NMAs for comment.
Declaration of Geneva
The German Medical Association put forward a proposal that it
should form an informal workgroup to explore the potential revi-
sion of the Declaration of Geneva. The Declaration was due to be
revised in 2016 and the German Medical Association said it would
like to express its support for re-exploring this crucial document
from a 21st
century perspective.This would be to ensure an appropri-
ate level of careful preparedness for when the official revision pro-
cess began.The informal work group would create an initial draft to
serve as a basis for the final revision next year.
Some speakers agreed with this approach and said the Declara-
tion needed a thorough revision. This led to a lengthy debate dur-
ing which many other speakers questioned whether such a working
group would be set up to revise the Declaration or simply to review
whether the Declaration should be revised. Several speakers were
doubtful whether the Declaration needed revising at all, although
there was general agreement that any work group set up should be a
formal and not an informal group.
The Committee concluded by recommending to the Council that a
formal WMA Work Group be set up to review the Declaration of
Geneva and come back to the Committee with recommendations.
Classification of 2005 Policies
The Committee considered the status of several policies which were
adopted or last revised 10 years ago. It was proposed that the State-
ment on Physician-Assisted Suicide, rather than being automati-
cally reaffirmed, should undergo a major revision. The Canadian
Medical Association volunteered to do this. This prompted a brief
debate when it was pointed out that in responses from NMAs, the
majority opinion was that this policy should not be revised. On a
vote, the Committee recommended that the Statement on Physi-
cian-Assisted Suicide and three other policies be reaffirmed:
• The Declaration of Lisbon on the Rights of the Patient
• The Declaration on Euthanasia
• The Resolution on Academic Sanctions or Boycotts
It recommended that the Statement on Non-discrimination in Pro-
fessional Membership and Activities of Physicians be reaffirmed
with a minor revision by the Secretariat and be submitted to the
Committee and Council at the next meeting.
Human Rights
Clarisse Delorme, the WMA’s Advocacy Advisor, reported on the
WMA’s work on human rights in Turkey, Saudi Arabia and else-
where. She highlighted that the WHO and PAHO were developing
a training curriculum for health professionals about care for women
subjected to intimate partner violence and sexual violence. As a first
step,a survey had been prepared with the aim of identifying the needs
of health professionals in providing adequate care for women sub-
jected to violence and she asked members to respond to the survey.
Council
On the final day of the conference, the Council meeting reconvened
to hear reports back from the three Committee meetings.
Medical Ethics
Health Databases and Biobanks
The Council approved the Committee’s recommendation to hold an
open meeting as part of the public consultation on the Health Data-
bases and Biobanks draft document. The meeting, at the beginning
of September 2015, would include outside experts.
Physician-Assisted Suicide
A lengthy debate took place on the recommendation from the Com-
mittee to reaffirm the Statement on Physician-Assisted Suicide.
Some speakers spoke strongly in favour of reviewing this policy in
view of changing public opinion. It was argued that very few of the
111 national medical associations consulted on the issue had argued
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for reaffirmation and that the WMA should not attempt to hush up
debate. Delegates were reminded that there was already legislation
on physician-assisted suicide in several countries. Other speakers,
however, said it was not the WMA’s role to follow public opinion
and argued that discussion on this policy should not be re-opened.
After further debate the Council voted to accept the recommenda-
tion of the Committee that the Statement on Physician-Assisted
Suicide be reaffirmed and invited any NMA who wished a review
to produce a paper.
Classification of 2005 Policies
The Council also approved the reaffirmation of the Declaration of
Lisbon on the Rights of the Patient, the Declaration on Eutha-
nasia and the Resolution on Academic Sanctions or Boycotts. It
agreed that the Statement on Non-discrimination in Professional
Membership and Activities of Physicians should undergo a minor
revision by the Secretariat and be submitted to the Committee and
Council at the next meeting.
Declaration of Geneva
The Council approved the Committee’s recommendation to set up a
Work Group to review the Declaration of Geneva.
Person Centered Medicine
The proposal for a white paper on person-centred medicine to be de-
veloped for the next meeting in October was agreed by the Council.
Inclusion of Medical Ethics and Human Rights in the Curriculum of
Medical Schools
The Council approved the Committee’s recommendation that the
WMA Resolution on the Inclusion of Medical Ethics and Human
Rights in the Curriculum of Medical Schools World-Wide be cir-
culated to NMAs for comment.
Finance and planning committee
Dues Structure
The Council agreed that a recommendation should be sent to the
General Assembly for setting a budget based on a new dues struc-
ture.
Future Meetings
It was agreed to recommend to the Assembly that Zambia be the
venue for the April 2017 Council meeting. Following the success-
ful H20 meeting in Melbourne last year, the Council agreed that a
further meeting, H20+ Health Summit, be held in Istanbul,Turkey.
Financial Statement
The Financial Statement for 2014 was approved.
Business Development Group
The report of the Group was approved.
IFMSA Memorandum of Understanding
The Council approved a new Memorandum of Understanding be-
tween the WMA and the International Federation of Medical Stu-
dents Associations.
Socio medical affairs committee
Social Determinants of Health
Sir Michael Marmot welcomed the offer from the Zambian Medi-
cal for Zambia to become part of the global movement in support
of the Social Determinants of Health. He said that to become an
active partner needed the support of the NMA, a university and the
government.
Proposed Declaration on Alcohol
The Council considered the proposed Declaration on Alcohol which
had been brought forward by the Australian Medical Association. It
was proposed that there should be an amendment to the document’s
wording on reducing the impact of harmful alcohol consumption in
at risk populations,such as children and young people,alcohol depen-
dents, pregnant and breast-feeding women, ‘and minority groups’. It
was proposed that the words ‘and minority groups’be deleted because
in some countries minority groups did not see themselves at risk.This
led to a lengthy debate and opposition from the Australian Medi-
cal Association on the grounds that it was imperative to highlight
Australia’s indigenous population. Two further amendments were
proposed, one to reword the statement to read ‘and some minority
groups’ and the other to ‘vulnerable groups’. Other speakers argued
that the document should not list particular groups, which led to a
lively debate.The meeting eventually decided to amend the document
to read ‘Reduce the impact of harmful alcohol consumption in at risk
populations’ and the Council approved the Declaration as amended
for forwarding to the General Assembly for approval and adoption.
Proposed Statement on Physicians’ Well-Being
The Council agreed that the proposed Statement on Physicians’
Well-Being be recirculated to NMAs for comments.
Statement on Providing Health Support to Street Children
The Council agreed that the proposed Statement on Providing
Health Support to Street Children should be forwarded to the
General Assembly for approval and adoption.
Statement on Riot Control Agents.
The Council agreed to send the renamed Statement on Riot Con-
trol Agents to the General Assembly for approval and adoption.
Mobile Health
The Council approved the proposed Statement on Mobile Health
and agreed that it be forwarded to the General Assembly for
­approval and adoption.
World Day for Eliminating Violence Against Health Professionals
The Council agreed that the proposed Statement on a World Day
for Eliminating Violence Against Health Professionals be forward-
ed to the Advocacy Group for considering possible action.
Nuclear Weapons
The proposed Statement on Nuclear Weapons was accepted and the
Council agreed that it should be sent to the General Assembly for
approval and adoption.
Ageing
The Council agreed that a Work Group be set up with the mandate
to produce a draft policy on ageing.
Reclassification of Policies
The Council agreed that several 10-year-old SMAC policies should
be reclassified as recommended by the Committee.
Resolution on Trade Agreements and Public Health
The Council approved the emergency Resolution on Trade Agree-
ments and Public Health without debate.
World Health Assembly
Delegates heard a report on likely items to be discussed at the World
Health Assembly agenda in May. This included the Millennium
Development Goals, air pollution, anti-microbial resistance and the
­Social Determinants of Health.Side events included a WHPA Lead-
ership Forum,the WHPA luncheon celebrating collaborative practice
and the WMA luncheon on the topic of investments and their effects
in health and healthcare.The Junior Doctors Network would also be
having a side event with the International Committee of the Red
Cross on the roles of education and training for preparing students
and junior doctors for their possible roles for health care in danger.
Social Determinants of Health
The Council decided to upgrade the WMA Statement on the Social
Determinants of Health. It was decided that the Statement should
be named the Declaration of Oslo. The Council agreed to recom-
mend this change to the General Assembly for adoption.
World Veterinary Association
The meeting concluded with an address from Dr. René Carlson,
President of the World Veterinary Association. Dr. Carlson, a gen-
eral private practitioner, said she wanted to share two very impor-
tant messages with the WMA. The first was the common ground
on which the two organisations could collaborate. These included
zoonotic diseases, such as rabies. Rabies still killed around 60,000
humans every year primarily through exposure to unvaccinated and
infected dogs.It killed more people every year than Ebola had killed
over several decades. Yet rabies was almost one hundred per cent
preventable. If the WMA and WVA worked together to strengthen
health care systems, and advocate to the appropriate government
agencies to establish policies that would protect their own citizens’
lives, they could have a large impact on improving human and ani-
mal health just by eliminating dog-mediated human rabies.
A second area of collaboration was animal welfare, which directly
affected human well-being in many cases. Healthy and well-cared
for animals produced a safer, more nutritious, more abundant, and
more economically profitable and affordable food supply.
A third area was good quality education which improved the
­knowledge and core competencies of veterinarians around the world
as it did for physicians, and which benefited the global public good.
Finally was pharmaceutical stewardship. According to the World
Health Organization, antimicrobial resistance was the next major
global public health threat. Physicians and veterinarians must be
part of the solution and must work together to move toward keeping
people and animals healthy in the first place, rather than depending
on medicines to treat the consequences of poor management and
illness, especially with excessive use of antimicrobials.
Her second message was that the WMA and the WVA were hosting
the Global Conference on One Health in Madrid shortly, along with
the Spanish Medical and Veterinary Associations.This meeting could
be a real turning point and was receiving a lot of attention world-
wide.This was their opportunity to move past the usual rhetoric and
continuing justification that One Health issues were important from
both their perspectives. But they must define how they could truly
bridge the gap between the two professions to strengthen collabora-
tion as these diseases became more prominent in the future.
Dr. Carlson concluded: ‘The continuing good collaboration between
our two organizations is both important and beneficial in many ways.
People are intricately interconnected to animals as fellow members of
the animal kingdom.We know why we should work together,so now
how do we work together to more effectively protect and improve
the health of humans, animals, and our planet? That is the question
we want to answer next month in Madrid. For that to happen, it is
important that both physicians and veterinarians attend that meeting.
’If we continue to work jointly on many of these common issues, we
will become a working model for national and regional collabora-
tion between our two professions leading to a much greater impact
on improving human, animal, and environmental health’.
Mr. Nigel Duncan,
Public Relations Consultant, WMA
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Preamble
Trade agreements are sequelae of globaliza-
tion and seek to promote trade liberaliza-
tion. They can have a significant impact on
the social determinants of health and thus
on public health and the delivery of health
care.
Trade agreements are designed to produce
economic benefits. Negotiations should
take account of their potential broad impact
especially on health and ensure that health
is not damaged by the pursuit of potential
economic gain.
Trade agreements may have the ability to
promote the health and wellbeing of all
people, including by improving economic
structures, if they are well constructed and
protect the ability of governments to legis-
late,regulate and plan for health promotion,
health care delivery and health equity, with-
out interference.
Background
There have been many trade agreements
negotiated in the past. New agreements
under negotiation include the Trans Pa-
cific Partnership (TPP), [1] Trans At-
lantic Trade and Investment Partner-
ship (TTIP)[2], the Trade in Services
Agreement (TiSA) and the Compre-
hensive Economic and Trade Agreement
(CETA [3].
These negotiations seek to establish a global
governance framework for trade and are un-
precedented in their size, scope and secrecy.
A lack of transparency and the selective
sharing of information with a limited set of
stakeholders are anti-democratic.
Investor-state dispute settlement (ISDS)
provides a mechanism for investors to bring
claims against governments and seek com-
pensation, operating outside existing sys-
tems of accountability and transparency.
ISDS in smaller scale trade agreements has
been used to challenge evidence-based pub-
lic health laws including tobacco plain pack-
aging. Inclusion of a broad ISDS mecha-
nism could threaten public health actions
designed to effect tobacco control, alcohol
control, regulation of obesogenic foods and
beverages, access to medicines, health care
services, environmental protection/climate
change and occupational/environmental
health improvements. This especially in na-
tions with limited access to resources.
Access to affordable medicines is critical to
controlling the global burdens of communi-
cable and non-communicable diseases. The
World Trade Organization’s Agreement
on Trade-Related Aspects of Intellectual
Property Rights (TRIPS) established a set
of common international rules governing
the protection of intellectual property in-
cluding the patenting of pharmaceuticals.
TRIPS safeguards and flexibilities includ-
ing compulsory licensing seek to ensure that
patent protection does not supersede public
health. [4].
TiSA may impact on eHealth provision by
changing rules in licensing and telecoms.Its
impact on the delivery of eHealth could be
substantial and damage the delivery of com-
prehensive, effective, cost-effective efficient
health care.
The WMA Statement on Patenting Medi-
cal Procedures states that patenting of diag-
nostic, therapeutic and surgical techniques
is unethical and “poses serious risks to the
effective practice of medicine by potentially
limiting the availability of new procedures
to patients.”
The WMA Statement on Medical Work-
force states that the WMA has recognized
the need for investment in medical educa-
tion and has called on governments to “…
allocate sufficient financial resources for the
education, training, development, recruit-
ment and retention of physicians to meet
the medical needs of the entire popula-
tion…”
The WMA Declaration of Delhi on Health
and Climate Change states that global cli-
mate change has had and will continue to
have serious consequences for health and
demands comprehensive action.
Recommendations
Therefore the WMA calls on national gov-
ernments and national member associations
to: Advocate for trade agreements that pro-
tect, promote and prioritize public health
over commercial interests and ensure wide
exclusions to secure services in the pub-
lic interest, especially those impacting on
individual and public health. This should
include new modalities of health care pro-
vision including eHealth, Tele-Health,
mHealth and uHealth.
Ensure trade agreements do not interfere
with governments’ ability to regulate health
and health care, or to guarantee a right to
health for all. Government action to protect
and promote health should not be subject to
challenge through an investor-state dispute
settlement (ISDS) or similar mechanism.
Oppose any trade agreement provisions
which would compromise access to health
WMA Council Resolution on Trade Agreements and Public Health
Adopted by the 200th
WMA Council Session, Oslo, April 2015
care services or medicines including but not
limited to:
• Patenting (or patent enforcement) of diag-
nostic,therapeutic and surgical techniques;
• “Evergreening”, or patent protection for
minor modifications of existing drugs;
• Patent linkage or other patent term ad-
justments that serve as a barrier to generic
entry into the market;
• Data exclusivity for biologics;
• Any effort to undermine TRIPS safe-
guards or restrict TRIPS flexibilities in-
cluding compulsory licensing;
• Limits on clinical trial data transparency.
Oppose any trade agreement provision
which would reduce public support for or
facilitate commercialization of medical ed-
ucation.
Ensure trade agreements promote environ-
mental protection and support efforts to
reduce activities that cause climate change.
Call for transparency and openness in
all trade agreement negotiations includ-
ing public access to negotiating texts and
meaningful opportunities for stakeholder
engagement.
References
1. TPP negotiations currently include twelve par-
ties: the United States, Canada, Mexico, Peru,
Chile, Australia, New Zealand, Brunei, Singa-
pore, Malaysia, Japan and Vietnam.
2. TTIP negotiations currently include the Euro-
pean Union and the United States.
3. CETA negotiations currently include the Euro-
pean Union and Canada.
4. See World Trade Organization, Declaration on
TRIPS and Public Health (“Doha Declaration”)
(2001).
The Sixty-eighth session of the World
Health Assembly, the supreme decision-
making body of the World Health Organ-
isation, was held in Geneva May 18–26.
As usual it attracted to the city an array
of world leaders, health ministers, chief
medical officers, global leaders from the
health professions and countless lobby-
ists. More than 3000 delegates from the
WHO’s 194 Member States, including
a large proportion of the world’s health
minis­ters, ­attended the Assembly. This
year, the WMA leaders who were present
were ably assisted by a particularly active
group from the Junior Doctors Network
(JDN), as well as by representatives from
the International Federation of Medi-
cal Students Associations (IFMSA), with
whom the WMA has recently signed a
Memorandum of Understanding.
During the Assembly delegates discussed
a host of topics, including antimicrobial
resistance, Ebola, epilepsy, the Interna-
tional Health Regulations, malaria, nu-
trition, polio, public health, innovation,
intellectual property, counterfeit medical
products, surgical care and anaesthesia.
They also reviewed progress reports on a
wide range of issues such as adolescent
health, immunization, noncommunica-
ble diseases, women and health, and the
WHO’s response to severe, large-scale
emergencies. This year, for the first time,
the WHO provided a live feed from the
Assembly to allow people to follow its
proceedings remotely. Although the offi-
cial Assembly dominated the week, it was
the many side events and unofficial meet-
ings held simultaneously that proved just
as beneficial.
During the weekend before the Assembly
opened, the World Health Professions
Alliance held a successful Leadership
Forum, bringing together representatives
from the nursing, pharmaceutical, physi-
cal therapy, dental and medical associa-
tions. The Forum held two sessions, one
devoted to discussing human resources as
a health component in all WHO policies
and the other concerning issues around
ageing populations and the ageing health
workforce.
Participants discussed the fact that health
workforce implications were often largely
ignored when public health goals were set,
as was the case when targets were set for
both the Millennium Development Goals
and the Sustainable Development Goals.
On the issue of ageing populations, the Fo-
rum considered the challenges that would
be faced as the number of citizens over 65
increased to almost 30 per cent by 2060,
while those over 80 would nearly triple.
During this time, health and health care
services would need to adapt to a growing
demand.
At the same time as the WHPA Forum
was meeting, the WMA’s Junior Doc-
tors Network was gathering to prepare
its activities for the week. It organized a
two-day workshop at the WMA office in
Ferney-Voltaire which was attended by
more than twenty JDN members from
four continents. The focus of the work-
shop was on preparing JDN delegates for
the Assembly.
JDN members met with Dr. Xavier Deau,
WMA President, and Dr. Otmar Kloiber,
WMA Secretary General. Highlights in-
cluded discussions on the International
Recruitment of Healthcare Personnel, in-
fluenza preparedness with Dr.  Julia Seyer
from the WMA, Emergency and Disaster
Risk Reduction, Air Pollution and Climate
Change, advocacy at the WMA and trade
and health.
World Health Assembly Week
Geneva, May 18–26, 2015
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54 55
WMA News WMA News
Dr.  Caline Mattar, Chair of the JDN’s
Pre-WHA Organizing Committee, pro-
vided attendees with an introduction to
the WHA and what to expect for the
week to come. In addition, JDN mem-
bers joined the International Federation
of Medical Students’ Associations’ Pre-
WHA workshop at the Graduate Institute
in Geneva for a successful panel discussion
and collaborative issue-based small group
sessions on human resources for health,
climate change and antimicrobial resis-
tance.These sessions prepared participants
for the Assembly and provided the oppor-
tunity to learn more about WHA agenda
items.
Representatives from both the JDN and
IFMSA helped to prepare the various in-
terventions to be made by the WMA and
the WHPA to the Assembly during the
week.
On the Monday morning, while thousands
of delegations gathered for the opening
of the Assembly, leaders of the World
Health Professions Alliance were meet-
ing a group of African journalists to brief
them on the events of the coming week.
Organised by the World Health Editors
Network and its founder Franklin Apfel,
the gathering allowed the Presidents and
CEOs of the five WHPA professions to
talk to the African media about their pri-
orities at the ­Assembly and their respective
roles. Among the priorities mentioned by
the WHPA leaders were childhood obe-
sity, antimicrobial resistance, the social
determinants of health and the problem of
counterfeit medicines.
This was followed by a meeting between
the WHPA leaders and representatives
from the World Health Students Alli-
ance and the International Federation of
Medical Students Associations. This was
a useful opportunity for student bodies to
explain to the leaders of the global health
professions the role and workings of their
organizations.
Meanwhile, at the UN Palais des Nations
the World Health Assembly was getting
under way with an opening address from
Angela Merkel, Chancellor of the Federal
Republic of Germany. She said that the
WHO was the only international organiza-
tion that had universal political legitimacy
on global health issues, but said she would
like to see a new plan to deal with “catas-
trophes”like the recent Ebola outbreak.The
outbreak had highlighted the critical need
for urgent, collaborative action in emergen-
cies, and the importance of having efficient
structures in place.
She said that under Germany’s presidency,
the G7 would focus on fighting antimi-
crobial resistance and neglected tropical
diseases. She emphasized the need for all
countries to have strong health systems and
highlighted the key role of health in sus-
tainable development.
In the afternoon, WHO Director-­
General Dr. Margaret Chan spoke about
the WHO’s response to the Ebola out-
break and criticism that it should have re-
acted earlier. She admitted that the world
was ill prepared to respond to the out-
break, but promised that the WHO would
learn from what happened and would not
be overwhelmed again. She outlined new
plans to create a single new WHO pro-
gramme for health emergencies, uniting
outbreak and emergency resources across
the three levels of the Organization. She
said she had heard what the world expect-
ed from the WHO and she promised it
would deliver.
The new programme would set up a new
global health emergency workforce, as well
as strengthening its own core and surge ca-
pacity of trained emergency response staff.
Dr.  Chan reiterated Chancellor Merkel’s
points about the importance of building
resilient health systems and defeating an-
timicrobial resistance, citing the “spectre
of a post-antibiotic era in which common
infections will once again kill,” and urging
­delegates to adopt the draft global action
plan on antimicrobial resistance on this
year’s Assembly agenda.
She also noted the need to ensure that
the International Health Regulations, the
world’s legal instruments for outbreak pre-
paredness and response, were effective. She
urged the delegates to ready themselves for
the post-2015 development agenda and to
ensure that health received the attention,
and the resources it needed
At lunchtime on the Monday the WHPA
held its annual reception at the InterCon-
tinental Hotel when it presented the first
of what will become an annual award for
collaborative practice. This is a new award
which aims to recognise an outstanding in-
terprofessional team which has improved
patients’ health and promoted a collabora-
tive approach to healthcare.
The winner of the award was the Thai
Health Professional Alliance Against To-
bacco (THPAAT). The award was present-
ed by Dr.  Carmen Peña, President of the
World Dental Federation. She reminded
the audience that the WHPA spoke for
more than 26 million healthcare profession-
als through more than 600 national associa-
tions of healthcare professionals.
She went on: “WHPA works to improve
global health and the quality of patient
care and facilitates collaboration among the
health professions and major stakehold-
ers. For several years, our motto has been
“Teaming up for better health” and clearly,
this is the vision that guided our activities:
we believe that healthcare professionals’im-
pact is bigger when we are working in syn-
ergy.”
In 2013 the WHPA adopted its joint state-
ment on Interprofessional Collaborative
Practice, defining collaborative practice as
when multiple health workers from dif-
ferent professional backgrounds worked
together with patients, families, carers and
communities to deliver the highest quality
of care across settings.
Dr. Peña said that the Thai Health Profes-
sional Alliance Against Tobacco brought
together more than 21 different associa-
tions, most being healthcare professionals
bodies. It had initiated many projects cov-
ering different areas such as public promo-
tion of smoking-free environment, educa-
tion, and national health policy. It was also
the pioneer in starting educational centres
on tobacco hazard in 12 provinces of Thai-
land.
The WHPA award was received by Prof.
Dr.  Somsri Pausawasdi, President of the
THPAAT and CEO of the Medical Asso-
ciation of Thailand. She said that THPAAT
was established in 2005 under the vision of
the Medical Association of Thailand and a
time when the King of Thailand, Bhumibol
Adulyadej, had expressed his wish to reduce
the growing problems of cigarettes addic-
tion in Thailand. The Medical Association
of Thailand had responded to the King’s
wish and to the WHO campaign by initiat-
ing the THPAAT with the goal of recruit-
ing a mixture of health professionals for an
antismoking campaign.
She went on: “It was clear that the best
way to accomplish our goals was to create
a collaborative interprofessionals team and
thus the Medical Association collaborated
with the Thai Health Foundation and re-
cruited four more organizations including
the Pharmacy Council,the Nurses’Associa-
tion, the Dental Association, and the Public
Health association to join the team. Over
the years, our network has expanded and
we currently comprise 21 different health
professional bodies under the support of the
Thai government.The goals of our team are
to promote a reduction in tobacco use and
enforce the smoking free society as national
health policy.”
She said the Alliance’s activities included
the aim of improving the awareness of
tobacco hazards to all levels of education,
creating a national network of 321 smok-
ing cessation clinics in the network hos-
pitals in over 77 provinces throughout the
nation and conducting research in 85 proj-
ects.
Dr. Somsri Pausawasdi continued stating:
“The ultimate goal of our campaign is to
create a tobacco-free environment for the
nation. We now have smoking-free envi-
ronment in 47 universities, all hospitals
and most of the pharmacy in the nation.
We have implemented a larger graphic
health warning on cigarette packages from
55% to 85% of the cover and actively in-
volved in the national policy on tobacco
control.
Finally, we have joined together with other
organizations and many foundations to
initiate “the National Alliance for To-
bacco Free Thailand-NATFT” in 2013 to
push forward the act of legislation on to-
bacco control for our nation. Currently, the
NATFT has more than 1,400 members
and 729 organizations. We are working to-
wards the United Nations policy on non-
communicable diseases (NCD) to decrease
the tobacco consumption rate to 15% by
the year 2025.
We do hope that our experience can inspire
some tobacco control initiatives in many
countries,and together we create a healthier
world for us and for our next generations
to come.”
The following day it was the turn of the
WMA to host its annual luncheon semi-
nar at the Pavillon Gallatin, Chateau de
­Penthes. This year the theme was “Health
Support to Street Children” and the speak-
er was WMA President Dr. Xavier Deau.
He began by saying that the United Na-
tions had estimated there could be around
150 million street children throughout the
world. This was “a worldwide and grow-
ing phenomenon”. He said physicians were
often the first point of contact for these
children and should use their trusted posi-
tions and skills to reintegrate these children
back into society. He also said that national
medical associations had an important role
to play in educating their members about
what they could do to help.
Dr.  Deau quoted WMA policy deriving
from the Declaration of Ottawa on Child
Health adopted in 1998. This stated that
children needed to grow up in a place where
they could thrive, spiritually, emotionally,
physically and intellectually. This required
a safe and secure environment, the oppor-
tunity for growth and development, health
services when needed and monitoring and
research for evidence-based continual im-
provement.
He said that assisting street children re-
quired a method, such as a multi profes-
sional team including health professionals,
social workers, drivers, teachers and police.
There had to be a medical and psycho-social
approach and co-operation with local and
governmental authorities.
He said that although there was no official
definition of street children, all such child­
ren faced common issues  – they suffered
from a lack of cultural identity, they lived
in the streets, they were no longer part of
any social or family environment, they were
organised in small societies and they hardly
survived.
Finally, Dr. Deau said that at the WMA’s
General Assembly in Moscow delegates
would consider a new Statement for adop-
tion, calling for all street children to be
provided with care and where necessary
returned to a living environment. He said
that remaining indifferent towards street
children was not an option.
During the Assembly,the JDN and ­IFMSA
delivered a number of interventions they
had drafted on behalf of the WMA and/
or World Health Professions Alliance.
These were based on the WMA policy and
BACK TO CONTENTS
56 57
WMA News GERMANY Epidemiology
in collaboration with the WMA staff and
leadership and included interventions on
antimicrobial drug resistance, polio, non-
communicable diseases, climate change and
Ebola.
On the Global Action Plan on Antimicro-
bial Drug Resistance the WMA said that
antimicrobial resistance was a threat to all
countries without regard for geographical
boundaries. A commitment was needed
from both member states and the WHO
to ensure financial sustainability to imple-
ment interventions in LMICs. The WMA’s
intervention emphasized that the Global
Action Plan could not be separated from
strengthening healthcare systems, building
on lessons learned from the Ebola epidemic.
A focus on access to primary care, availabil-
ity of diagnostic labs including rapid diag-
nostic methods and surveillance systems
was needed to fight the spread of resistant
pathogens. The Assembly went on to agree
on resolutions to improve access to afford-
able vaccines.
On polio eradication, the WMA said, it
had condemned in the strongest terms the
recent killing of five health care workers in
Pakistan while providing polio immuniza-
tion to the citizens of Pakistan. This trag-
edy had underscored the urgent need to
ensure the protection of health care work-
ers in conflict areas. It urged the WHO
and member states to ensure adequate se-
curity for the healthcare workers to enable
effective implementation of immunization
protocols, to develop systems sensitive sur-
veillance and immediate notification to the
WHO of any detected poliovirus transmis-
sion and to implement adequate immuni-
zation training for health professionals.The
WMA also wanted to see an increase in
effective public awareness and education to
prevent and dispel myths.
The IFMSA spoke about the need to
tackle, prevent and control the global
burden of noncommunicable diseases
(NCDs), and reduce the worldwide mor-
bidity and mortality related to cardiovas-
cular diseases, cancers, chronic respiratory
diseases and diabetes, as well as reduce the
four shared risk factors. It strongly recom-
mended that interventions aimed at re-
ducing the burden of NCDs must include
addressing risk factors during childhood
and adolescence.
The IFMSA also spoke on the issue of
health in the post-2015 development agen-
da asking the WHO to focus its attention
on supporting the development of realistic
targets and clear indicators, which would
remain a main topic of discussions in the
following months. However, it referred to
the absence of several important health
­areas, such as recognizing primary health
coverage and the importance of health lite­
racy, patient centered care and patient em-
powerment.
On the issue of the International Recruit-
ment of Health Personnel, the IFMSA
raised a concern that the current Code was
mainly focused on regulating the migra-
tion of health personnel. It was important
that member states tackled fundamental
factors that caused the migration, such as
poor or unsafe practice environments, poor
education and excessive workload. Medical
students were facing mental and physical
strain, harming their practice, decreasing
patient safety and exponentially increas-
ing the costs of healthcare systems, and
sometimes even leading to suicide. Health
workers and students must be protected
from violence, discrimination and exploi-
tation in the workplace, and be allowed to
operate within a positive practice environ-
ment that guaranteed occupational safety
and health.
The Assembly passed several landmark
resolutions on air pollution, on epilepsy and
the next steps in finalizing the framework of
engagement with non state actors.
Among the many side events attended by
WMA representatives and JDN delegates
was one which the JDN co-hosted with the
International Committee of the Red Cross
on the Healthcare in Danger. This focused
on the role of education and training in ad-
dressing healthcare in danger and featured
a panel discussion including Dr.  Ahmed
Berzig (Head of Health Unit, ICRC),
Prof. David Gordon (President, WFME),
Dr.  Bruce Eshaya-Chauvin (Medical Ad-
viser,Healthcare in Danger) and Dr. ­Ahmet
Murt (Chair, JDN).
At the end of the Assembly, IFMSA Presi-
dent Agostinho Sousa said: “The voices of
medical students, and of youth more gener-
ally,have been recognized several times dur-
ing this World Health Assembly. Addresses
by Dr.  Margaret Chan, Director General
of the World Health Organisation, and
references made by numerous Ministers of
Health or their representatives, have shown
the crucial role that future health profes-
sionals play in shaping the global health
agenda.”
The Assembly ended with thousands of
delegates returning to their countries, feel-
ing they had spent a worthwhile 10 days in
Geneva.
Among the JDN representatives who spoke
at the Assembly were:
Dr. Ahmet Murt (JDN Chair) speaking at
the Assembly
Dr. Thorsten Hornung (JDN)
Dr. Kostas Roditis (JDN)
Dr. Mike Kalmusz-Elias (JDN)
Mr. Nigel Duncan,
Public Relations Consultant,
WMA
In March 2014, the Ebola virus was iden-
tified as the force behind a wave of illness
in Guinea. According to the latest figures
from the WHO, there have been nearly
27,000 cases of Ebola reported in West
Africa and 11,120 deaths. The approach
taken in response to previous outbreaks of
the Ebola virus (i.e. quarantining patients
and monitoring their immediate social cir-
cles) proved to be inadequate in this case
due to the mobility of the population and
the prolonged duration of the disease. As
a result, major cities in West Africa had to
contend with large numbers of victims for
the first time.
One particular problem facing the affect-
ed countries was the lack of appropriately
trained professionals needed to contain the
virus. In Germany, the German Medical
Association teamed up with the Federal
Ministry of Health and the German Red
Cross, as well as the national professional
associations of physicians, to promote vol-
unteer efforts in the affected regions. On an
international level, the World Medical As-
sociation and the Standing Committee of
European Physicians (CPME) called for
concrete measures to contain the virus. The
necessary structures must be developed on
a national and international level in order
to combat epidemics more efficiently in the
future. Providing protection for physicians
before,during and after they engage in relief
efforts is a key component of this.This pro-
tection must include, for example, guaran-
teed repatriation for physicians in the case
of infection, access to comprehensive medi-
cal and psychological care upon their return,
as well as sufficient life insurance.
In hindsight, we must concede that govern-
ments, the scientific community and relief
organisations underestimated the severity
of the Ebola crisis in West Africa for far
too long. Although the situation appears
to be largely under control and the Ebola
epidemic is now only a passing reference in
the media, we cannot fall back into the old
habit of ignoring and avoiding the problem.
The Ebola outbreak continues to demand
the full attention of the international com-
munity.
At the same time, it demonstrates by exam-
ple that in a globalised world,epidemics not
only have the potential to wipe out entire
populations, but also that they do not stop
at national borders, nor are they confined
to certain continents. We must work to de-
velop effective global strategies to ensure
that viruses can be contained early going
forward. These strategies must incorporate
elements of prevention, as well as rapid re-
sponse facilities.
The Ebola outbreak made it clear that vac-
cines, a sensible tool for combating epidem-
ics,were initially not developed by the phar-
maceutical industry because the market was
not deemed profitable enough. Although
there are promising trials in progress, there
is still no approved vaccine available. The
World Medical Association and the CPME
have demanded that adequate funding fi-
nally be made available for immunization
programmes and for vaccine research and
development. The Declaration of Helsinki
can and must serve as the basis for these de-
velopments. But this call from the Europe-
an and global medical communities should
not be limited to research focused on Ebola
vaccines. As a matter of principle, if there is
a lack of incentives for conducting research
and if the development of diagnostic tests,
therapies and vaccines is not being pursued
rigorously, governments are called upon to
take effective measures in this regard, start-
ing with providing access to adequate finan-
cial resources.
Above and beyond research into vaccines,
the international community and, in partic-
ular,the industrialised world are called upon
to provide the resources needed to develop
the appropriate infrastructure to ensure
the early containment of epidemics. The
­German government recently announced
that it will earmark 200 million euros in
funding to support the development of
healthcare systems in the countries affected
by this crisis. The administration also plans
to organise a team of physicians and other
medical personnel that could be deployed
anywhere in the world within three to
five days, and to provide additional medi-
cal supplies, like field hospitals and mobile
laboratories. However, a breakthrough will
only be possible if the G7 countries agree to
coordinate their activities effectively on an
international level and to commit sufficient
financial resources. It is therefore a welcome
sign that neglected diseases and diseases
associated with poverty, as well as Ebola,
were addressed at this year’s G7 summit in
­Germany.
Frank Ulrich Montgomery
Global Epidemics. Industrialised Nations Must Develop Global
Strategies to Counter Epidemics
BACK TO CONTENTS
58 59
Climate changesClimate changes
The 21st
Conference of the Parties
(COP21) to the UN Framework Conven-
tion on Climate Change (UNFCC) will
be held in Paris for two weeks from No-
vember 30 to December 11, 2015. COP21
is practically the last opportunity to reach
an agreement on a plan where all nations
would participate to achieve substantive
reduction in greenhouse gas emissions to
limit global warming within 2 °C. That is
why some are even calling it the “historic
two weeks.”
Due to the earth’s feed-back mechanism,
any change, once gaining enough mo-
mentum in a certain direction, becomes
extremely difficult to reverse. Even if all
emission of greenhouse gas is stopped now,
it would still be difficult to completely pre-
vent global warming. The goal of limiting
global warming to 2 °C is the minimum
measure necessary to prevent the worst
case scenario.
Health needs to be given the greatest pri-
ority in efforts to minimize climate change.
Climate change causes change in tempera-
West Africa’s Ebola epidemic demon-
strated the consequences of uncontrolled
outbreaks of infectious disease. For this
reason, this year’s 118th
German Medi-
cal Assembly in Frankfurt deliberated
the most pressing issues relating to civil
protection under the heading “Medicine
in times of global epidemics”. The discus-
sion was initiated by presentations meant
to shed light on the domestic and inter-
national aspects of battling global epidem-
ics. Dr.  Tankred Stöbe, chairman of the
board of the German chapter of Médecins
Sans Frontières (Doctors Without Bor-
ders), drew attention to the preconditions
and challenges of establishing a preventive
medical infrastructure in regions affected
by epidemics. He reported on practical
measures taken to stem the disease, which
included educating the population and in-
creasing public awareness about infectious
disease and safe burials, as well as efforts to
strengthen countries affected by epidem-
ics. From the perspective of an interna-
tional non-governmental organisation, it
is also essential to address what is needed
to protect and safeguard medical and non-
medical personnel and their employment
rights during their deployment abroad.
Following this talk, Prof. Dr.  René
­Gottschalk, Director of the Public Health
Office of the city of Frankfurt/Main, dis-
cussed the domestic and European aspects
of the fight against global epidemics. Prof.
Dr.  Gottschalk addressed options for re-
gional, national and European crisis inter-
vention, as well as the limits of each. He
also presented early warning and response
systems for monitoring and controlling
the spread of communicable diseases and
options for improving risk and crisis com-
munication.
The level of engagement with which the
parliament of the German medical profes-
sion dealt with this issue and formulated
political demands through a very lively
discussion is noteworthy. In the battle
against global epidemics like Ebola, the
118th
German Medical Assembly called
for Germany, Europe and the international
community to promote the research of in-
fectious disease and the development and
implementation of diagnostic tests, thera-
pies and vaccines. One resolution of the
Medical Assembly expressed that “govern-
ment funding must be made available for
the development and provision of pharma-
ceuticals and vaccines to curb epidemics
and to finance comprehensive vaccination
programmes”. The parliament of physi-
cians also called upon drug manufacturers
to conduct targeted research, even at low
profit margins, in order to develop the per-
tinent drugs and vaccines.
Financial resources to combat epidemics
and to rebuild healthcare systems and pub-
lic life in the wake of an epidemic should
be allocated to the affected countries in
the form of a fund, according to the Medi-
cal Assembly. This fund should be financed
by the United Nations, the World Bank,
the International Monetary Fund and the
­European Union, among others.The Medi-
cal Assembly also demanded essential pro-
tection for medical and non-medical per-
sonnel during their deployment abroad, as
well as approved leaves of absence and job
security for physicians who volunteer to
participate in aid missions.
The Medical Assembly also called upon the
German federal government to establish a
state-funded and organised medical relief
organisation to provide emergency medical
relief with specially trained health profes-
sionals in crisis areas. This would make it
possible for doctors and other health profes-
sionals to be deployed faster by simplifying
the process of obtaining approved leaves of
absence from their employers and provid-
ing social protection.The Ebola epidemic in
West Africa demonstrated that the systems
in place for gathering the appropriate medi-
cal personnel to engage in crisis situations
were inadequate. According to the Medical
Assembly, a state-organised medical relief
organisation must be created to work with
non-governmental organisations to facilitate
prompt delivery of healthcare in crisis areas.
Prof. Dr. Frank Ulrich Montgomery,
President of the German
Medical Association,
Vice-Chairperson of the WMA Council
E-mail: international@baek.de
ture, wind, and precipitation with profound
effects on all natural systems.These, in turn,
have effects on the health, safety, and liveli-
hoods of people-especially the poor.
We have already seen previews of the
health impact that lies ahead if extreme
weather events continue to increase. Heat
waves like the one that hit Chicago in
1995, killing some 750 people and hospi-
talized thousands, and the 2003 European
heat wave, killing 21,000 to 35,000 people
in five countries, are becoming more com-
mon.
But even more subtle, gradual climatic
change can still harm human health. El-
evated carbon dioxide levels promote the
growth and sporulation of some soil fungi,
and diesel particles help deliver these aero-
allergens deeper into our alveoli and present
them to immune cells along the way.
Mosquitoes, which can carry many diseases,
are very sensitive to temperature changes.
Warming of their environment  – even
within its viable range – boosts their rates
of reproduction and prolongs their breeding
season, and shortens the maturation period
for the microbes they disperse. Extremely
wet weather may bring its own share of
ills. Floods are frequently followed by dis-
ease clusters. Major coastal storms can also
trigger harmful algal blooms (“red tides”),
which can be toxic, help to create hypoxic
“dead zones” in gulfs and bays, and harbor
pathogens.
These are only a few examples of what is in
store. The impact of climate change comes
in many shapes and sizes from not only
damage from increase in harmful substances
or chemicals in the air but also the increase
in prevalence of various contagious diseases,
which are all major public health challenges.
In particular, the detrimental effects of cli-
mate change on health are far more serious
among the more vulnerable population such
as children, the elderly and people in less
developed countries.
WMA has continuously expressed its con-
cern over the health impact by climate
change, and has worked to raise awareness
regarding the benefits of putting health in
the center of the climate change agenda.
As a way to tackle the issue in the WMA,
the Environment Caucus was organized.
It aims to exchange opinions among WMA
members and related bodies regarding
WMA future activities related with health
and environment.
The main activity of the Environmental
Caucus is sharing global trends and con-
ference information regarding environ-
ment and identifying common topics of
interest and to discuss follow-up measures.
It encourages free exchange of opinions
by adopting an informal setting. Major
themes discussed at the Environmental
Caucus with regards to the direction of
future WMA activities include the role of
physicians and of constituent members in
greenhouse gas reduction, promoting re-
search on the health co-benefits of coun-
tering climate change and expansion of
green hospitals and clinics.
At the last meeting of the Environmental
Caucus held in Oslo, Norway, during the
200th
Council Session of WMA, partici-
pants all agreed on the importance of form-
ing a coordinated voice representing the
entire medical community in anticipation
of COP 21 and shared ideas about what we
can do.
The discussion can be summarized into the
following approaches:
1. Recognition of co-benefits of dealing
with health issues in climate action
2. Getting involved in liaising with each
government’s negotiation representa-
tives
3. Active media coverages and journal ex-
poses
4. Collaboration with other professional
organizations and NGOs on joint ini-
tiatives on the issue
5. Promoting awareness of members on
green policies for daily operation of
health facilities.
As described by LANCET, climate change
is “the greatest global health challenge of
the 21st
century.” This is a battle cry for all
physicians to take on a more active role in
tacking climate change, and for us to feel a
greater sense of responsibility starting from
our everyday lives and also at a national level
through each NMA, and at an international
level through the WMA.
Much is at stake as COP21 approaches,and
hopes are high that we will be able to de-
liver our voices effectively so that COP21
will find a meaningful framework to pre-
vent and resolve health problems caused by
climate change.
Dong Chun Shin, MD, PhD,
Chair, Environment Caucus, WMA
Chair, Finance and Planning
Committee, WMA
Prof., Dept. of Preventive Medicine
Yonsei Univ. College of Medicine
E-mail: dshin5@yuhs.ac; intl@kma.org
Dong Chun Shin
WMA Roles for Climate Action
BACK TO CONTENTS
60 61
UNITED KINGDOMUNITED KINGDOM Medical EthicsMedical Ethics
The Art of the conversation between a
physician and their‘patien; is at the heart
of medical practice [1]. It is a dialogue be-
tween a person seeking help and a physi-
cian who possesses the relevant medical
knowledge­and skills This patient/physician
relationship is founded both on service and
on trust within which two way communi-
cation is key. The physician’s professional
service to their patient must be conducted
within a professional code of ethics which
has become enshrined within the World
Medical Associations International Code
of Medical Ethics 1949 et seq.
This statement includes the requirement
that “a physician shall be dedicated to pro-
viding competent medical service in full
professional and moral independence with
compassion and respect for human dignity’.
Trust
Trust can only be assured if the patient be-
lieves that the physician respects them as in-
dividuals,will act only in their best interests,
avoid ‘harms’where possible,be truthful and
be treated equally with others according to
their needs.
The physician also has a duty of care to their
patients and should keep their medical re-
cords secret within applicable national laws.
These ethical principles need to become
‘internalized’ as the individual physician’s
‘professional’ conscience and act as a com-
pass through the complex scientific, medical,
psychological, social, cultural and spiritual
scene. These principles relate both to the in-
dividual health care professional as a basis for
the ‘trust’ given by the patient as a person to
them and to society in general where they
form part of the essential ‘contract’ between
the health care professions and society allow-
ing the physician to work as an independent
clinician whose primary duty is to their pa-
tient. Only in this ‘trusting’culture will a ‘pa-
tient’s inner worries and secrets be gradually
shared with their physician”.
A person’s narrative
A patient’s own story is the key to the phy-
sician finding out what may be right and
what may be wrong during a professional
consultation. A narrative approach encom-
passes an open awareness of health and dis-
ease within a storied structure from which
the meaning and purpose in both an illness
and the experience of recovery emerge. Di-
agnostic ‘labels’ become secondary to the
life of the individual person. A story is re-
counted in a complicated narrative of illness
told in words,silences,gestures,physical ob-
servations,overlain not only by the objective
findings but also with the fears, hopes and
implications associated with it [2].
The narration is a therapeutic central act be-
cause to find the words to contain the disorder
and its attendant worries gives shape to and
control over the uncertainties of the illness.
As the physician listens to the patient, he or
she follows the narrative thread of the story in
all its existential, cultural, familial, biological,
social, psychological and spiritual dimensions.
The act of listening, so essential to the
process, enlists the physician’s interior re-
sources – memories, association, curiosities,
creativity, interpretive powers and allusions
to other stories by the person and others to
identify meaning. Only then the physician
can hear and confront the person’s narrative
questions wWhat is wrong with me? Why
is this happening to me? And what will be
the result?” [3]
Listening to stories of illness and recognizing
that there are often no clear answers to pa-
tients’ narrative questions demand the cour-
age and generosity to tolerate and to bear
witness to unfair losses and random tragedies
[4]. Accomplishing such acts of witnessing
allows the physician to proceed to his or her
more recognizably clinical narrative tasks: to
establish a therapeutic alliance, to generate
and proceed through a differential diagnosis,
to interpret physical findings and laboratory
reports correctly, to experience and convey
empathy for the patient’s experience [5],and,
as a result of all these, to engage the patient
for effective care.
If the physician cannot perform these narra-
tive tasks,the patient might not tell the whole
story, might not ask the most frightening
questions, and might not feel heard [6].
The resultant diagnostic workup might be
unfocused and therefore more expensive
than need be,the correct diagnosis might be
missed,the clinical care might be marked by
noncompliance and the search for another
opinion, and the therapeutic relationship
might be shallow and ineffective. The nar-
rative is absorbing. It engages the listening
physician and invites an interpretation. It
gives him or her the experience of “living
through”, not simply “knowledge abou” the
characters and events in the story.
James Appleyard
The Art and Heart of Medicine
The erosion of
humanistic medicine
Where this professional space is taken over
by an authoritarian organization not only is
this patient/physician relationship seriously
damaged but also the independent spirit of
enquiry that drives advances in medicine is
distorted [7]. As the cost of health care has
escalated, additional pressures on this ‘pro-
fessional’space by Healthcare providers, In-
surance Companies and Governments are
occurring which are distorting the patient/
physician discourse [8].
During the professional consultation, elicit-
ing a ‘history’ from a patient is one of the
least perfected and most neglected clinical
skills despite a wealth of research and time
spent in undergraduate training [9]. Yet for
the great majority of’patient’ the narrative
history is the most important and most
revealing part of any personal health data
base. Too often a computer generated form
is completed with the minimum of narra-
tive followed by a cursory clinical examina-
tion and a huge array of expensive investiga-
tions from which a diagnosis is expected to
emerge. It is important to realize that not
only is the patient presenting with symp-
toms of a possible illness but experiencing
the effect of all of their life’s events in their
biological,social,mental,psychological,cul-
tural and spiritual dimensions.
A person centered approach
Those starting out on a medical career may
need a format to act as guidance. The per-
son centered Integrated Diagnostic model
is being developed and refined to meet this
need. It proposes the whole person in con-
text as the Centre and goal of clinical care
and public health [10]. This encourages a
more flexible and conversational style.
It is only through this open style interactive
conversation and questioning the physician
sorts, extracts, subtracts and adds informa-
tion into a meaningful format. As rapport
is established elements of the patient’s tem-
perament and personality become more
apparent and the patient’s reaction to each
question can be noted.
Very often the physician will have a very
good idea of the likely diagnosis of the pa-
tient’s problem within the first two minutes
through his or her experienced pattern rec-
ognition of the common disease processes.
The physician will search for additional
clues – information that will aid in the solu-
tion of the person’s problem. There is then
a tendency to move to gather more specific
information to exclude other possibilities
and confirm the presumptive diagnosis.The
danger is that at this stage other pertinent
information may not be given by the patient
or sought by the physician. Some physicians
may avoid eliciting multiple concerns due to
the fear of extending the encounter when
time is limited.
However, unexpressed patient concerns
may lead to a prolonged investigation of a
concern hypothesized to be the “chief com-
plaint” but which in reality was the second
most important problem. Repeated invita-
tions to express additional concerns early in
the consultation may enhance the efficiency
of the interview by decreasing late-arising
concerns,allowing the physician and patient
to prioritize problems at the outset, to make
the best use of their time and minimize im-
plicit assumptions of what the patient wants
to discuss. Patients may defer emotionally
laden topics until the trustworthiness of the
physician is better known or until the physi-
cian brings up the topic [11].
The tendency of even experienced family
physicians not to seek the patient’s com-
plete agenda is similar to the finding of
Beckman and Frankel 15 years ago. Despite
concern that a patient-centered approach
will take more time, the study further re-
inforces that exploring all of the patient’s
concerns does not decrease efficiency. Using
a simple opening empathic enquiry, such as
“What concerns do you have?,” then asking
“Anything else?”repeatedly until a complete
agenda has been identified appears to take
6 seconds longer than interviews in which
the patient’s agenda is interrupted. Agenda
setting is a teachable and learnable skill that
deserves emphasis and reinforcement.
A few verbal affective remarks can be ef-
fective and this is not necessarily time con-
suming [12]: In one study it took only 38
seconds to make a difference! The affective
statements that caused this reduction were
related to emphasizing being there for the
person – the sense of a physician’s duty of
care  – providing reassurance of continuing
medical support. These points have been
defined as fundamental for effective patient-
physician communication.Whilst one of the
most difficult tasks for physicians is to convey
bad news, physicians who are emotionally
supportive can influence patients’ emotional
functioning with little effort and time [13].
Affective communication may have the
power to elicit beneficial effects in clinical
encounters as it enables patients to adjust
better to the emotional and cognitive im-
pact of medical information [14]. Indirect
effects might also be present. When pa-
tients remember more about treatment
procedures and their consequences, this
may affect adherence to treatment or medi-
cation regimen. A few affective statements
can have a large impact on patients’ anxiety,
uncertainty and recall. Affective communi-
cation allows physicians to temper patients’
emotional responses and improve their abil-
ity to remember medical information.
Conclusion
A person-centered approach involves a re-
newal of our ethical commitment both to
each person as a patient and to society as
a whole within a wide biomedical, psycho-
logical, social, cultural and spiritual frame-
work. It attends to both ill health and posi-
tive health and focusds on the diagnostic
BACK TO CONTENTS
62 63
UNITED STATES OF AMERICAUNITED STATES OF AMERICA One Health conceptOne Health concept
One Health is a new term, but an ancient
concept that recognizes the inherent links
between human, animal, and environmen-
tal health. Humans and animals cannot be
healthy if the environment in which they
live is sick.The One Health concept seeks to
increase communication and collaboration
between human, animal, and environmental
health professionals.
The One Health concept is important for
many reasons. Zoonotic disease risks from
wildlife, livestock, and pets cannot be ad-
equately addressed without meaningful
collaboration and cooperation between vet-
erinarians and physicians. Microbes do not
necessarily recognize the differences between
species and could infect across them if given
the right conditions. Indeed, approximately
75 percent of emerging infectious diseases
and approximately 60 percent of all human
pathogens are zoonotic in origin [1].
Some of the greatest discoveries in the histo-
ry of medicine and public health were made
at the intersection between human and ani-
mal health. For example, Dr. Edward Jenner,
an apprentice surgeon, learned from dairy-
maids that they were immune from smallpox
because they had had cowpox. He applied
this concept to the practice of variolation
and developed the word “vaccination” from
the Latin word “vacca”meaning cow [2].Ap-
proximately two centuries later, Dr. Jenner’s
vaccine was used to eradicate smallpox from
global human populations [3].
Drs. Louis Pasteur and Robert Koch, a
French chemist who studied chicken cholera
and a German physician who studied anthrax,
respectively, independently developed the
germ theory of disease. Dr. Pasteur discov-
ered the theory of immunity and developed
the world’s first rabies vaccine, and Dr. Koch
developed “Koch’s Postulates” for establish-
ing the infectious causations of disease [4, 5].
Drs. Theobald Smith and Frederick
L.  ­Kilbourne, a physician and veterinarian
team, respectively, discovered that an arthro-
pod, in this case a tick, could transmit cattle
fever from animal to animal [6].This monu-
mental discovery stage for the widespread
recognition that other arthropods could
serve as vectors for zoonotic diseases, such as
mosquitoes transmitting yellow fever.
As the twentieth century progressed, sci-
entific knowledge exploded, and medicine
became increasingly specialized. Collabo-
ration between medicine and veterinary
medicine waned, but the challenges of the
­communication between the patient and
physician. There is shared understanding
and decision making with prevention and
health promotion as shared commitments
and the promotion of partnerships at all
levels.
References
1. Mezzich J.E. (2011) Building Peron Centered
medicine through dialogue and partnerships.
International Journal of Person Centered medi-
cine,(), 10–13
2. Genette G. (1980) Narrative Discourse: An Essay
in Method. Lewin J., trans. Ithaca, NY: Cornell
University Pres
3. Greenhalgh T. Hurwitz. B. (1999)”Narrative
based medicine: Why study narrative” BMJ
318,:48–50)DeSalvo L. (1999) Writing as a Way
of Healing: How Telling Our Stories Transforms
Our Lives. San Francisco, Calif: Harpe
4. Laine C., Davidoff F. (1996) Patient-centered
medicine: a professional evolution. JAMA;
27:,152-156
5. Charon R. (2001) Narrative medicine: form,
function,and ethics.Ann Intern Med;134,:83-87.
6. Acare G., Pulmarski B., Acare (2015). Lost in
translation WMJ 61, 28-30
7. Lown B. (1996) The Lost Art of Healing.
Houghton
8. Cutler P. (1998) From data to diagnosis. 3rd
En.
Lippincott Williams and Wilkins
9. Salloum I,M, Mezzich J.E. (2011) Conceptual
appraisal of the person centered Integrative Di-
agnostic Model. International Journal of Person
Centered medicine 11, 39-42
10. Epstein R.M., Morse D.S., Frankel R.M., Fra-
rey L., Anderson K., Beckman H.B. (1998)
Awkward moments in patient-physician
communication about HIV risk. Ann Intern
Med.12:,435-442
11. Marvel M.K, Epstein R. M., Flowers K.. Beck-
man H. B, (1999) Soliciting the Patient’s Agen-
da Have We Improved? JAMA 281:283-287
12. van Osc, M., Sep M., van Vliet,L. M., van
Dulme, S., Bensin, J. M. (2014)
13. Reducing patients’ anxiety and uncertainty, and
improving recall in bad news consultations.The im-
pact of affective communication. In press
14. Street R. L. J., Makoul G., Neeraj K. A., Epstein
R.M. (2009). How does communication heal?
Pathways linking clinician-patient communica-
tion to health outcomes. Patient education and
counseling, 74, 295-301
James Appleyard MD FRCP,
President, International College of Person
centered medicine Thimble Hall, Blean
Common Kent CT2 9JJ UK
E-mail: jimappleyard2510@aol.com
twenty-first century demand that these two
disciplines re-establish ties and begin work-
ing collaboratively again. Increasing global
populations, widespread deforestation and
environmental destruction, intensive agri-
culture, global trade and travel, and likely
climate change will adversely impact life
on the planet [7]. Zoonotic diseases such as
HIV/AIDS,West Nile virus,SARS,MERS,
and Ebola that cross species barriers require
increased communication and collaboration
between the health professions.Occasional-
ly, animals become infected before humans
and should serve as important sentinels for
looming epidemics in human populations.
For people who live with chronic immuno-
suppression such as organ transplant recipi-
ents or people taking immunosuppressive
medications, the risk of zoonotic disease
transmission becomes much greater than
for the general population. Grant and Olsen
found that assessing zoonotic disease risks in
this vulnerable population often gets ignored
because physicians are not familiar with the
diseases while veterinarians defer to physi-
cians for human health care [8]. Physicians
rarely ask their patients about pet ownership
or animal exposures,yet pet-associated infec-
tions are common and can be deadly [9].
Beyond zoonoses, comparative medicine is
the study of disease processes such as asth-
ma, diabetes, and cancer across species. Dis-
coveries in veterinary medicine can benefit
human medicine and vice versa.As with hu-
mans, an increase in canine and feline obe-
sity has led to an increase in diabetes [10].
Studying disease similarities and differences
between species could shed important new
information on disease progression, treat-
ment,and control.In another example,a ca-
nine vaccine for oral melanoma was the first
therapeutic vaccine approved for the use in
either animals or humans [11]. An impor-
tant benefit to studying diseases in animals
is that they do not experience the placebo
effect, so improvements resulting from nov-
el treatments demonstrate actual benefits
that warrant further study in humans.
Animals have served as sentinels for toxic
environmental contamination. In the mid-
1950’s, dancing cats of Minamata Bay,
­Japan were exhibiting mercury poisoning
from industrial pollution [12]. Humans
began suffering from mercury poisoning
as well [13]. Pets and other small animals
can develop symptoms of lead poisoning
from very small doses and should serve as
sentinels for potential human cases if they
become sick [14, 15].
Physicians and veterinarians have much to
learn and benefit from each other. Recently,
the World Medical Association and the
World Veterinary Association held a joint
global conference on One Health. Informa-
tion was shared, and collegial relationships
formed. These two professions are comple-
mentary and synergistic, and ideally, if they
re-forge old ties, they will make great new
discoveries that will benefit the health of all
species as the twenty-first century progresses.
References
1. Taylor LH, Latham SM, Woolhouse ME. “Risk
Factors for Human Disease Emergence.” Philos
Trans R Soc Lond B Biol Sci July 29, 2001.
http://rstb.royalsocietypublishing.org/con-
tent/356/1411/983
2. Riedel S.“Edward Jenner and the history of small-
pox and vaccination.” BUMC Proceedings. 2005;
18: 21–25. http://www.ncbi.nlm.nih.gov/pmc/
articles/PMC1200696/
3. Deria A, Jezek Z, Markvart K, et al. “The world’s
last endemic case of smallpox: surveillance and con-
tainment measures.” Bull World Health Organi-
zation.1980; 58: 279-283.http://www.ncbi.nlm.
nih.gov/pmc/articles/PMC2395794/
4. Smith K.A. “Louis Pasteur, the Father of Immu-
nology?” Frontiers in Immunology. 2012; 3: 68.
http://www.ncbi.nlm.nih.gov/pmc/articles/
PMC3342039/
5. Committee to Update Science, Medicine, and
Animals, National Research Council. “Science,
Medicine, and Animals.” 2004. National Acad-
emies Press. Washington DC. Page 7. http://
www.ncbi.nlm.nih.gov/books/NBK24656/pdf/
Bookshelf_NBK24656.pdf
6. Assadian O, Stanek G. “Theobald Smith—
the discoverer of ticks as vectors of disease.”
Wien Klin Wochenschr. 2002 114 (13-14):
479-81. http://www.ncbi.nlm.nih.gov/pub-
med/12422586
7. Morse SS. “Factors in the Emergence of Infec-
tious Diseases.” Emerging Infectious Diseases.
1995; 1: 7-15. http://wwwnc.cdc.gov/eid/arti-
cle/1/1/95-0102_article
8. Grant S, Olsen CW. “Preventing Zoonotic Dis-
eases in Immunocompromised Persons: The Role of
Physicians and Veterinarians.” Emerging Infec-
tious Diseases. 1999; 5: 159-163. http://wwwnc.
cdc.gov/eid/article/5/1/99-0121_article
9. Rabinowitz PM, Gordon Z, Odofin L. “Pet-
Related Infections.” 2007; 76: 1314-1322. http://
www.aafp.org/afp/2007/1101/p1314.html
10. Hoenig M. “Comparative Aspects of Human,
Canine, and Feline Obesity and Factors Pre-
dicting Progression to Diabetes.” Vet Sci. 2014;
1: 121-135. http://www.mdpi.com/2306-
7381/1/2/121
11. Heflin M. “Canine Melanoma Vaccine Gets Con-
ditional OK.” Veterinary Practice News. May
2007. http://www.veterinarypracticenews.com/
April-2009/Canine-Melanoma-Vaccine-Gets-
Conditional-OK/
12. Aronson S. “The Dancing Cats of Minamata
Bay.” Medicine and Health Rhode Island.
2005; 88.7: 209. http://search.proquest.com/
docview/195779436/fulltext/2FCF9AF281834
074PQ/1?accountid=13314
13. Eto K, Marumoto M, Takeya M. “The pathol-
ogy of methylmercury poisoning (Minamata dis-
ease).” Neuropathology 2010; 30: 471-479.
http://onlinelibrary.wiley.com/store/10.1111/
j.1440-1789.2010.01119.x/asset/j.1440-
1789.2010.01119.x.pdf?v=1&t=iao5jp4n&s=b
f561531ab8e6609a20ea4d31ebeb4a45513790a
14. Newman AA. “For Small Animals, a Fleck
is a Lot.” New York Times. December 22,
2007. http://www.nytimes.com/2007/12/22/
business/22petside.html
15. Morgan RV. “Lead poisoning in small companion
animals: an update (1987–1992).”Vet Hum Toxi-
cology 1994; 36: 18-22.
Laura H. Kahn, MD, MPH, MPP,
Research Scholar,
Program on Science and Global Security,
Woodrow Wilson School of Public
and International Affairs,
Princeton University
E-mail: lkahn@princeton.edu
The author would like to acknowledge
her One Health Initiative colleagues:
Bruce Kaplan, DVM
Tom Monath, MD
Jack Woodall, PhD
Lisa Conti, DVM, MPH
Laura H. Kahn
One Health: A Concept for the 21st
Century
BACK TO CONTENTS
64 65
SPAINSPAIN Antimicrobials useAntimicrobials use
Most antimicrobial use is probably
­inappropriate. It has been estimated that
up to 50% of human antibiotic use and up
to 80% of veterinary antibiotic use could be
eliminated without serious consequences
[1]. The inappropriate use of these drugs in-
creases the risk of selection of resistant bacte-
ria and may contribute to antibiotic resistance
[2]. Antibiotic resistance has become a global
health problem and is responsible for signifi-
cant morbidity and mortality and, therefore,
restriction of antibiotic use and marketing
regulations are among many important strate-
gies to control this problem [3,4].
The sale of antibiotics and other antimicro-
bial medicines without prescription remains
widespread, with many countries lacking
standard treatment guidelines; thereby in-
creasing the potential for overuse of antimi-
crobial medicines by the public and medical
professionals [5]. In general, governments
support policies on the prudent use of
­antimicrobials in order to control resistance
and recommend control measures to sup-
port careful use by encouraging doctors and
pharmacists to promote the appropriate use
of antimicrobials.However,implementation
has generally been weak in many countries,
and the prevalence of bacterial resistance
continues to increase since antimicrobial
resistant bacteria are common in commu-
nities where over-the-counter policy is still
available.
Prevalence
The prevalence of over-the-counter sale
of antibiotics varies across countries, be-
ing common outside Northern Europe
and North America [5]. The percentage of
non-prescription access to antimicrobials
is often underestimated, and also depends
on the methodology used to estimate it. In
2013, the European Commission published
a questionnaire-based study (Eurobarom-
eter), carried out in 28 European countries,
including 27,680 respondents,in which 35%
admitted having taken at least one dose of
antibiotic in the previous 12 months [6].The
large majority of those who had used antibi-
otics during the time covered by the survey
had got them from a healthcare provider,but
3% of users reported to have obtained them
without prescription and 2% more stated
that they used the leftovers from a previous
course. However, when more reliable meth-
ods are used the results are much higher.
One of the most reliable ways to estimate
how frequent the sale of antibiotics is in-
cludes simulated-client-method pharmacy
studies in which actors simulating certain
infectious diseases manage to obtain anti-
biotics at community pharmacies. Table 1
describes the 30 studies published so far and
applying this methodology.
In 2007 in Spain, making use of a mystery
shopper who presented at community phar-
macies requesting an antibiotic for one of
three different clinical scenarios, our group
observed that these drugs were sold in
45.6% of the pharmacies without a medi-
cal prescription [7]. This percentage was
slightly higher at 54.1% when the study was
repeated in 2014 using the same methodol-
ogy [8]. However, according to the Euroba-
rometer, the percentage of Spanish people
who admitted having bought an antimicro-
bial at the pharmacy was only 4% [6].
By contrast with Northern Europe and
North America, non-prescription access
to antimicrobials is common in the rest of
the world [5], as shown in Table 1. In a nice
study carried out in a Finnish community
living in Spain, Väänänen et al. found that
antibiotics, which are considered as pre-
scription-only medicines in Finland, were
purchased by 41% of the immigrants who
admitted having taken an antibiotic in the
previous 6 months [9].
Drawbacks of the over-the-
counter sale of antimicrobials
The link between the over-the-counter sale
of antibiotics and antibiotic overconsump-
tion is clearly established. Southern Euro-
pean countries usually rank at the top in
Carl Llor
Pros and Cons of the Over-the-counter
Sales of Antimicrobials
Ana Moragas
Table 1.  Frequency of the sale of antimicrobials based on simulated client method surveys
Author, year Country Type URTI OM Sin.
Sore
throat
LRTI
or flu
Dia. UTI STI
Specific anti-
microbials
Vari-
ousa
EUROPE
Contopoulos-Ioannidis DG,
2000
Greece D 78%
Plachouras D, 2008 Greece D 53–100%b
Marković-Peković V, 2010 Bosnia&Herzegovina D 58%
Simó S, 2006c
Spain I 12%
Llor C, 2007 Spain D 35% 16% 80%
Gastelorrutia, 2009 Spain D 17%
Simó S, 2012c
Spain I 6%
Guinovart M, 2014 Spain D 48% 33% 81%
AMERICA
Gellert GA, 1994 Mexico I 100%
Bartoloni A, 1992 Bolivia D, Id
24% 91% 24% 40–92%e
58% 67%f
Volpato DE, 2002 Brazil I 74%
Vacca CP, 2007 Colombia D 80%
AFRICA
Nyazema N, 2004 Zimbabwe D 9% 8–65%g
MIDDLE EAST
Amidi S, 1975 Iran D 60% 40%
Tomson G, 1985 Yemen I 9%
Al-Faham Z, 2009 Syria I 97%
Dameh H, 2005 United Arab Emirates D 69%
Al-Ghamdi MS, 1999 Saudi Arabia D 82%
Bin Abdulhak AA, 2010 Saudi Arabia I 51% 40% 90% 73% 90% 75%
ASIA
Wolffers I, 1983 Sri Lanka D 100%
Tomson G, 1985 Sri Lanka I 41%
Tomson G, 1985 Bangladesh I 68%
Hadi U, 2006 Indonesia D 74%
Puspitasari HP, 2010 Indonesia D 91%
Quagliarello AB, 1999 Vietnam D 99% 75%
Chalker J, 1999 Vietnam D 98%
Wachter DA, 1996 Nepal D, Ih
97% 38%
Thajlikitkul V, 1986 Thailand D
50–
100%
Chalker J, 1999 Thailand I 76%
Apisarnthanarak A, 2006 Thailand I 80% 74% 65% 76% 100%
Type=type of simulated patient (D, direct: the patient him-/herself; I, indirect: simulating having a relative or friend with an infectious disease); URTI=upper respira-
tory tract infection (including rinorrhoea, sneezing, with or without fever); OM=otitis media; Sin.=sinusitis; LRTI=lower respiratory tract infection; Dia.=diarrhoea;
UTI=urinary tract infection; STI=sexually transmitted infection
a
Various infectious diseases considered; b
Mistery shoppers requested ciprofloxacin (53% of success) and amoxicillin/clavulanate (100% of success); c
Related to a
9-month old baby with an upper respiratory tract infection and fever; d
The indirect simulated patients corresponded to children; e
40% in case of a 6-month old child
and 92% when an adult with this infection was simulated; f
Case of male urethral discharge; g
8% in the case of a male urethritis and 65% when a vaginal discharge was
simulated; h
The direct simulated patient corresponded to the case of UTI; the indirect case corresponded to his 5-year son with diarrhoea
BACK TO CONTENTS
66 67
SPAINSPAINAntimicrobials use Antimicrobials use
terms of the consumption of antibiotics,
as described in the last report issued by the
European Surveillance of Antimicrobial
Consumption Network (ESAC-Net) [10].
Indeed, over-the-counter sale of antibiot-
ics is reportedly common in countries such
as Italy, Greece, and Spain [5]. In a study
on pharmaceutical surveillance in Spain,
Campos et al. observed that about 30% of
the outpatient antimicrobials purchased
was not identified by reimbursement data,
largely because over-the-counter sales were
not tracked [11].
Self-medication with antimicrobials is also
widespread, occurring among the population
in the same countries where over-the-coun-
ter sale is available [12]. Antibiotics available
at home have been found to be an important
risk factor for this practice [13], and leftover
medication may later be considered for self-
medication,leading to inappropriate usage of
these drugs. In a study carried out in 2006,
the prevalence of anti­biotic storage in Span-
ish households was 37% [14]. This in-home
antibiotic storage might also increase the risk
of self-prescription of antibiotics to families
and friends. In a population survey con-
ducted in 19 ­European countries, covering
15,548 respondents, Grigoryan et al. found
that the main reason for self-medication
was a previous medical prescription of the
same medication [15]. Thus, the over-the-
counter sale of antibiotics both encourages
self-medication and the storage of leftover
antimicrobials, creating a vicious circle that
increases the consumption of antimicrobials
(Figure 1).
Public awareness of the issue is low, with
many people still believing that antibiot-
ics are effective against viral infections. Ac-
cording to the last Eurobarometer available,
carried out in November 2013, 84% of re-
spondents were aware that the overuse of
antibiotics makes them ineffective. When
asked questions about antibiotics and how
they work, 49% of Europeans replied that
antibiotics kill viruses and 52% correctly re-
plied that antibiotics are not effective against
colds and influenza. A north-south gradient
was also observed, with better knowledge of
how antibiotics work in northern countries
and, conversely, citizens living in southern
countries were less knowledgeable about this
subject [6].Since 2008,the European Union,
through the European Centre for Disease
Prevention and Control, has encouraged
public information campaigns on prudent
antibiotic use in its member countries, by
promoting the European ­Antibiotic Aware-
ness Day on the 18 November [16]. Never-
theless, concerns have been raised that such
campaigns are not having their anticipated
effect [17]. In addition, the recent Euroba-
rometer stated that 60% of respondents had
taken at least one course of antibiotics in the
previous year for flu, acute bronchitis, colds,
or sore throat [6].
Another factor is patients’ non-adherence
to antibiotic therapy. Our group observed
an intentional non-adherence to antibiotic
regimens of 35% for respiratory tract in-
fections with the use of Medication Event
Monitoring System or MEMS contain-
ers [18], resulting in the presence of some
leftover drugs that might be used on future
occasions by the members of the house-
hold. Although a relationship between in-
tentional non-compliance and the storage
of antibiotics has not been proven, the fact
that approximately one third of individuals
store antibiotics in their households and a
similar percentage intentionally do not take
them as requested makes this association
very likely.
Over-the-counter sale of antimicrobials of-
ten leads to a wrong choice of these drugs.
For instance, in our study carried out in
2007, fluoroquinolones, which are consid-
ered as critically important antimicrobials
by the World Health Organization as also
are third- and fourth-generation cephalo-
sporins and macrolides) [19], accounted for
40% of the antibiotics sold for urinary tract
infections [7]. Similarly, essential antitu-
berculosis drugs are available without pre-
scription in many areas, with streptomycin,
rifampicin and isoniazid being sold for indi-
cations other than tuberculosis as over-the-
counter antimicrobials [20,21]. This easy
access and inappropriate use of these drugs
clearly constitute risk factors for further de-
velopment of multidrug resistant tuberculo-
sis, which is nowadays challenging due to
the associated high morbidity and mortality
[22]. Over-the-counter sale without a pre-
scription may also lead to the use of insuf-
ficient dosages, with lower doses dispensed
being more common when the antibiotic is
sold at the pharmacies compared to other
healthcare facilities [23].
Safety issues associated with non-prescrip-
tion use also include adverse drug reactions
and masking of underlying infectious pro-
cesses (Table 2). Antimicrobials frequently
cause side effects, despite most being mild;
however, side effects accounted for nearly
one fifth of all visits to the emergency room
for adverse drug events in a US study [24].
Linked to this, low-quality and counterfeit
antimicrobials have been more frequently
reported among antimicrobials sold without
a medical prescription, mainly in develop-
ing countries, resulting in a possible direct
harm and treatment failure [25]. Another
concern of the non-prescription status is
the possibility of drug interactions, particu-
larly in children, elderly patients and preg-
nant women.In another study carried out in
Taiwan, patients with detectable ­antibiotic
concentrations in urine were nearly twice as
likely to have a missed diagnosis of a true
bacterial infection compared to the patients
without any antimicrobial detected [26].
Proper diagnosis of an infectious disease
can also be challenging in a pharmacy. Di-
agnosis is even often difficult in the primary
care clinic and to distinguish between bac-
terial and viral aetiology is even more so,
mainly in respiratory tract infections.
Another inconvenience is the pressure of
the population on both the pharmacist and
the physician. In the first case this pressure
is related to the selling of the antimicrobial
and in the second, to obtaining the pre-
scription of the drug sold by the pharmacist
to thereby be partially or totally reimbursed
for the cost of the antimicrobial.
Advantages of over-the-
counter sale of antimicrobials
Accessibility to over-the-counter antimi-
crobials has also some advantages. Some of
these are for the patient,others for the physi-
cian, the pharmacist, the pharmaceutical in-
dustry itself and others for the government.
The individuals would have a greater choice
of access to healthcare both in the way it is
delivered and at a time and place convenient
to them. For instance, patients with recur-
rent urinary tract infections, who clearly
know their symptoms, can be benefitted
from an over-the-counter policy. Physicians
may gain from having fewer consultations
for minor ailments; pharmacists would have
a further opportunity to use their profes-
sional knowledge and develop their rangeof
services tothe public. In our study, however,
the pharmacists who refused to sell antibi-
otics without a prescription gave responses
related to health or resistance issues in only
30% of the cases and pharmacists only asked
about possible allergies, or potential preg-
nancy and side effects in less than half of the
subjects to whom antibiotics were sold [7].
Education is therefore particularly impor-
tant in the over-the-counter sale of anti-
microbials; when patients choose self-care,
there is often no possibility to obtain advice
from a physician, and thus the responsibil-
ity of providing appropriate information
falls on pharmacists. It should not be for-
gotten that one of the greatest beneficiaries
of the non-prescription use of antimicrobi-
als is the pharmaceutical industry, which
sees a new marketing opportunity with this
policy. Furthermore, the government could
be relieved of some costs of antimicrobials
obtained on National Health Service pre-
scriptions. In addition, non-prescription
status of antimicrobials might be an impor-
tant mechanism of access to antimicrobials
in countries with low resources. Further-
more, in these low-income settings, a high
demand for antibiotics without a prescrip-
tion might be expected from customers who
cannot afford to consult a doctor.
Conclusions
Antimicrobial resistance is a global issue
[27]. According to the current UK Health
Chief Officer, we are losing the battle
against infectious diseases since bacteria are
fighting back and are becoming resistant to
modern medicine so that, in short, antibiot-
ics will no longer work [28]. This reinforces
the need to prescribe antimicrobial agents
only when there is good evidence that the
benefits outweigh the risks. Barring the dis-
pensing of antibiotics without a prescrip-
tion constitutes one of the most valuable
strategies to accomplish this objective. The
over-the-counter sale of antimicrobials has
pros and cons but, in any case, this policy
requires that pharmacists have a key role as
healthcare agents and it must be forbidden
to pharmacists who are not familiar with
the management of some mild infectious
diseases, mainly in non-low-income coun-
tries. Notwithstanding, critically important
antimicrobials should never be purchased
without a medical prescription anywhere.
References
1. Wise R., Hart T., Cars O., Streulens M.; Hel-
muth R., Huovinen P., et al. (1998) Antimicro-
bial resistance. Is a major threat to public health?
BMJ, 317,609–10.
2. Goossens H.,Ferech M.,Vander Stichele R,.El-
seviers M.; ESAC Project Group. (2005) Out-
patient antibiotic use in Europe and association
Table 2.  Drawbacks of the over-the-counter sale of antimicrobials
• Self-medication with antimicrobials
• Storage of antimicrobials in households
• Inappropriate use of antimicrobials
• Potential side effects
• Masking of underlying clinical syndrome
• No questioning by pharmacists regarding allergies, pregnancy and side effects
• Contraindicated antimicrobials
• Inadequate dose regimens
• Low-quality medication
• Pressure of having an antimicrobial prescribed
Figure 1. Relationship between over-the-counter sale of antimicrobials, storage and self-
medication
BACK TO CONTENTS
68 69
Medicines shortagesSPAINAntimicrobials use
with resistance: a cross-national database study.
Lancet,;365, 579–87.
3. Butler C.C., Rollnick S., Pill R., Maggs-Rap-
port F., Stott N. (1998) Understanding the cul-
ture of prescribing: qualitative study of general
practitioners’ and patients’ perceptions of antibi-
otics for sore throats. BMJ, 317, 637–42.
4. Carbon C., Bax R.P. (1998) Regulating the
use of antibiotics in the community. BMJ, 317,
663–65.
5. Morgan D.J., Okeke I.N., Laxminarayan R.,
Perencevich E.N., Weisenberg S. (2011) Non-
prescription antimicrobial use worldwide: a sys-
tematic review. The Lancet Infectious Diseases.,11,
692–701.
6. European Commission. Special Eurobarometer
407 ‘Antimicrobial resistance’. (2013) Available
from: http://ec.europa.eu/public_opinion/ar-
chives/ebs/ebs_407_en.pdf
7. Llor C., Cots J.M. (2009) The sale of antibiotics
without prescription in pharmacies in Catalonia,
Spain. Clinical Infectious Diseases.,48, 1345–49.
8. Guinovart M.C., FIgueras A., Llop J.C., Llor
C. Obtaining antibiotics without prescription in
Spain in 2014: even easier now than 6 years ago.
(2015) Journal of Antimicrobial Chemotherapy,70,
1270–71.
9. Väänänen M.H., Pietilä K., Airaksinen M. Self-
medication with antibiotics–does it really hap-
pen in Europe? (2006) Health Policy, 77,166–71.
10. European Centre for Disease and Prevention
Control. Summary of the latest data on antibi-
otic consumption in the European Union, No-
vember 2014. Available at: http://ecdc.europa.
eu/en/eaad/Documents/antibiotic-consumptio-
ESAC-Net-2014-EAAD.pdf
11. Campos J., Ferech M., Lázaro E., de Abajo F.,
Oteo J., Stephens P., Goossens H. Surveillance
of outpatient antibiotic consumption in Spain
according to sales data and reimbursement data.
(2007) Journal of Antimicrobial Chemotherapy, 60,
698–701.
12. Grigoryan L., Haaijer-Ruskamp F.M., Burger-
hof J.G.M., et al. Self-medication with antimi-
crobial drugs in Europe. (2006) Emerging Infec-
tious Diseases,12, 452–59.
13. McNulty C.A., Boyle P., Nichols T., Clappison
D.P., Davey P. Antimicrobial drugs in the home,
United Kingdom. (2006) Emerging Infectious
Diseases12, 1523–26.
14. González J.,Orero A.,Prieto J.Almacenamiento
de antibióticos en los hogares españoles. (2006)
Revista Espanola de Quimioter, 19, 275–85.
15. Grigoryan L.,Burgerhof J.G.,Haaijer-Ruskamp
F.M., Degener J.E., Deschepper R., Monnet
D.L., et al., on behalf of the SAR group. Is self-
medication with antibiotics in Europe driven by
prescribed use? (2007) Journal of Antimicrobial
Chemotherapy 59,152–56.
16. Earnshaw S., Mancarella G., Mendez A., To-
dorova B., Magiorakos A.P., Possenti E., et al.,
on behalf of the European Antibiotic Awareness
Day Technical Advisory Committee; on behalf
of the European Antibiotic Awareness Day Col-
laborative Group. European Antibiotic Aware-
ness Day: a five-year perspective of Europe-wide
actions to promote prudent use of antibiotics.
(2014) Eurosurveillance,19, 20928.
17. Stockley J.M. European Antibiotic Awareness
Day 2010: why doesn’t promoting antibiotic
awareness always work? (2010) Journal of Infec-
tion,61, 361–63.
18. Llor C., Hernández S., Bayona C., Moragas A.,
Sierra N., Hernández M., et al. A study of ad-
herence to antibiotic treatment in ambulatory
respiratory infections. (2013) International Jour-
nal of Infectious Diseases,17, e168–72.
19. World Health Organization Advisory Group
on Integrated Surveillance of Antimicro-
bial Resistance (AGISAR). Critical impor-
tant antimicrobials for human medicine.
(2012) World Health Organization. Avail-
able at: http://apps.who.int/iris/20.bitstre
am/10665/77376/1/9789241504485_eng.pdf
20. Kobaidze K., Salakaia A., Blumberg H.M.
Over-the-counter availability of antituberculosis
drugs in Tbilisi, Georgia in the setting of a high
prevalence of MDR-TB. (2009) Interdisciplinary
Perspective of Infectious Diseases, 513609.
21. Lambert M.L., Delgado R., Michaux G., Volz
A., Van der Stuyft P. Tuberculosis control and
the private health sector in Bolivia: a survey of
pharmacies. (2004) The International Journal of
Tuberculosis and Lung Diseases,8, 1325–29.
22. Gandhi N.R., Nunn P., Dheda K., Schaaf H.S.,
Zignol M., van Soolingen D., et al. Multidrug-
resistant and extensively drug-resistant tubercu-
losis: a threat to global control of tuberculosis.
(2010) The Lancet, 375, 1830–43.
23. Mukonzo J.K., Namuwenge P.M., Okure G.,
Mwesige B.,Namusisi O.K.,Mukanga D. Over-
the-counter suboptimal dispensing of antibiot-
ics in Uganda.(2013) Journal of Multidisciplinary
Healthcare;6, 303–10.
24. Shehab N., Patel P.R., Srinivasan A., Budnitz
D.S. Emergency department visits for antibi-
otic-associated adverse events. (2008) Clinical
Infectious Diseases, 47, 735–43.
25. Taylor R.B., Shakoor O., Behrens R.H. Drug
quality, a contributor to drug resistance? (1995)
The Lancet, 346, 122.
26. Liu Y.C.,Huang W.K.,Huang T.S.,Kunin C.M.
Inappropriate use of antibiotics and the risk for
delayed admission and masked diagnosis of in-
fectious diseases: a lesson from Taiwan. (2001)
Archives of Internal Medicine, 161, 2366–70.
27. Okeke I.N., Edelman R. Dissemination of
antibiotic-resistant bacteria across geographic
borders. (2001) Clinical Infectious Diseases, 33,
364–69.
28. Davies S.C., Grant J., Catchpole M. (2013) The
Drugs Don’t Work. A Global Threat. London: Pen-
guin Specials
Carl Llor, Primary care physician,
Primary Healthcare Centre,
Via Roma, Barcelona
Ana Moragas, Primary care physicians,
Primary Healthcare Centre,
Jaume I, Tarragona, Spain
E-mail: carles.llor@gmail.com
Is there a health system in the world at this
moment not suffering from the impacts of
medicines shortages? With strong docu-
mentation of the problem in such coun-
tries as the USA [1], Australia [2], South
Africa  [3], Canada [4] and elsewhere, to
the understanding of the pan-European
dimensions of the problem was recently
added the publication of the report by the
European Association of Hospital Phar-
macists “Medicines Shortages in European
Hospitals” (November 2014) [5].
Distributed across Europe by the net-
work of 34 EAHP national country asso-
ciations [6], over 600 hospital pharmacists
from 36 countries responded to a call for
information about the problems being
faced in practice as a result of medicines
shortages. A definitive answer was re-
turned: 86% responded in the affirmative
that, yes, medicines shortages are a current
problem in the hospital the responding
pharmacist works in, in terms of delivering
the best care to patients and/or operating
the hospital pharmacy. Indeed, no country
surveyed responded with less than 60%
agreement that medicines shortages are a
current problem. 88% of the respondents
experience medicines shortages at least
monthly, with 66% expressing it as a daily
or weekly problem.
But what kinds of problem are being cre-
ated? The report sheds some further light on
the nature of the negative impacts entailed
for pharmacists, but above all, patients,
when a medicine prescribed for the patient
simply becomes unavailable.
For pharmacists,enormous amounts of time
can suddenly be absorbed into the pressing
task of finding a new source of supply for
the medicine. In the European context, this
might often be from other countries, with
all the delay, and potential knock-on im-
pacts for supply in the source country that
can be involved [5]. EAHP’s 2014 report
finds that 55% of hospital pharmacists in
Europe say that up to 5 hours of staff time
a week is being diverted from other tasks in
order to deal with shortage problems, with
a further 32% indicating that more than 5
hours a week is consumed with managing
the situations caused by shortages. Indeed,
some respondents reported the need to em-
ploy full time equivalents dedicated solely
to locating new sources for out-of-stock
medicines.
However, if the medicines shortages prob-
lem was simply a question of inefficiency it
would not excite the attention and momen-
tum that the matter has been gaining at the
international level [8]. The most telling and
pressing impact is for patients. Here again,
EAHP’s 2014 report provides some addi-
tional insight.
Over 75% of the respondents to the survey
either agreed or strongly agreed with the
statement “medicines shortages in my hos-
pital are having a negative impact on patient
care”. Many respondents then went on to
provide examples including:
• The aggravation caused to patients, main-
ly elderly, when explaining the required
changes or delays to their treatment;
• The distress caused by delays or interrup-
tions to chemotherapy treatments;
• The confusion experienced by prescrib-
ers and nurses when out-of-stock but
familiar medicines must be replaced by
available alternatives, and the potential
increase in medication error risk;
• Heightened risk of hospital acquired in-
fection as a result of antibiotic shortage;
• Deterioration in patients’ condition due
to shortage of the most efficacious medi-
cines;
• Raised risk levels from the required use
of unlicensed alternatives to a medicine in
shortage; and,
• Additional hospital admissions as a result
of some shortages (e.g. cardiology medi-
cines).
As suggested by the title, however, simply
drawing attention to the problems caused
by medicines shortages is not enough. Ef-
fort, energy and awareness must be drawn
to potential solutions. With the causes of
shortages acknowledged to be so multi-fac-
eted, as well as situation and region-specific,
it need barely to be mentioned that it is a
list of mitigating policy actions that are re-
quired, rather than any single answer.
The reflections of the International Phar-
maceutical Federation (FIP) and, indeed,
the regulatory action advocated for by
our colleagues at the American Society
of Health System Pharmacists (ASHP)
have certainly informed the outlook of the
­European Association of Hospital Pharma-
cists on the matter of potential solutions to
the medicines shortages problem.
In 2013 FIP brought together pharmacy
professionals from across the globe in an in-
ternational summit on medicines shortages
Richard Price
Medicines Shortages: Global Problems
Need Global Solutions
BACK TO CONTENTS
70 71
Medicines shortages Medicines shortages
held in Toronto, Canada [8]. At the end of
two days of deliberations they made a series
of principal recommendations for tackling
the problem, including:
• Improved publicly available information
on shortages;
• A globally agreed list of critical/vulner-
able products;
• Improved procurement processes to as-
sure continuity of supply; and,
• Improved regulatory cooperation be-
tween countries on the matter.
Meanwhile, in the United States, some
case study examples of what can be
achieved, at least as interim steps, have
been provided via the FDA Innovation
Act (FDASIA) of 2012 [9]. This legisla-
tion not only clarified the statutory remit
of the USA’s medicines agency to be in-
volved in resolving medicine shortages
problem, but also addressed problems in
relation to the legal responsibilities of
manufacturers to report likely disrup-
tions to supply at an early stage in order
to enable better contingency planning.
Some early monitoring results from the
University of Utah has suggested such ac-
tion, whilst by no means eliminating the
problem, it has proven effective in so far
as reducing the difficulties [10].
Drawing inspiration, EAHP’s 2014 report
on medicines shortages in European hospi-
tals ends with a set of policy calls to political
decision makers:
• Improved collection and sharing of in-
formation about medicines shortages
in Europe, by both national medicines
agencies and the European Medicines
Agency;
• Clarification and enforcement of legal re-
sponsibilities on manufacturers of medi-
cines to report disruptions to supply;
• An inquiry at the European level into the
primary factors causing medicines short-
ages;
• Criteria for a fair distribution of supply in
cases of shortage, based on primary con-
sideration of patient need.
EAHP is now working with counterpart
healthcare professional and patient organ-
isations at the European level to promote
this much needed policy agenda [11] and
hope that in time a positive European ex-
ample of response to the shortages prob-
lem may yet be provided to our colleagues
elsewhere in the world. That work, how-
ever, remains ongoing. A new European
Commission settling into its 5 year term
of office could provide the opportunity re-
quired [12].
References
1. McLaughlin M., et al. Empty Shelves, Full of
Frustration: Consequences of Drug Shortages
and the Need for Action. (2013) Hospital Phar-
macy, 48(8). 617-618
2. Quilty S. Medicines shortages in Australia – the
reality. (2014). The Australasian Medical Journal,
7(6), 240-242
3. Bateman C. Drug stock-outs: Inept supply-
chain management and corruption. (2013)
SAMJ: South African Medical Journal, 103, 600-
602.
4. Barthelemy I., Lebel D., Bussieres J-F. Drug
shortages in health care institutions: perspec-
tives in early 2013. (2013) Canadian Journal of
Hospital Pharmacy, 66(1), 39–40
5. European Association of Hospital Pharmacists.
Medicines shortages in European hospitals. (2014)
Available: http://www.eahp.eu/press-room/
patients-suffering-medicines-shortages-all-eu-
ropean-countries. Accessed 17 June 2015.
6. European Association of Hospital Pharmacists.
EAHP Members. (2015) Available at: http://
www.eahp.eu/about-us/members. Accessed 17
June 2015.
7. Gray A., & Manasse H. R. (2012). Shortages
of medicines: a complex global challenge. Bul-
letin of the World Health Organization, 90(3),
158–158A.
8. Besancon L., Chaar B. Report of the interna-
tional summit on medicines shortage. (2013)
International Pharmaceutical Federation (FIP),
Toronto. Available at: http://www.fip.org/files/
fip/publications/FIP_Summit_On_Medicines_
Shortage.pdf. Accessed 17 June 2015.
9. Fact Sheet: Drug Products in Shortage in the Unit-
ed States.(2015) [ONLINE] Available at: http://
www.fda.gov/RegulatoryInformation/Legisla-
tion/FederalFoodDrugandCosmeticActFD-
CAct/SignificantAmendmentstotheFDCAct/
FDASIA/ucm313121.htm. Accessed 17 June
2015.
10. Are Shortages Going Down Or Not? Interpreting
Data From The FDA And The University Of Utah
Drug Information Service. [ONLINE] Available
at: http://healthaffairs.org/blog/2015/04/08/
are-shortages-going-down-or-not-interpreting-
data-from-the-fda-and-the-university-of-utah-
drug-information-service/Accessed 17 June
2015.
11. Houÿez F., et al. Common position between
patients’, consumers, and healthcare profession-
als’ organisations involved in the activities of the
European Medicines Agency on Supply Short-
ages of Medicines. (2013) [cited 21.03.2014.];
Available from: http://download.eurordis.org.
s3.amazonaws.com/documents/pdf/common-
position-supply-shortages-final-10-2013.pdf.
12. European Commission (2014, Sep 10) The
Juncker Commission: A strong and experienced
team standing for change, http://europa.eu/rapid/
press-release_IP-14-984_en.htm Accessed 17
June 2015.
Richard Price,
Policy and Advocacy
Officer at the European Association of
Hospital Pharmacists (EAHP)
E-mail: richard.price@eahp.eu
Which type of medicine do you most commonly experience to be in short supply?
According to the respondents they most commonly experience originator (patented) products to be in
short supply. 51.8% (n=221) reported them as the most common category of shortage.
Generic products (including branded generics) were affected to a lesser degree, with 36.5% (n=156) of
hospital pharmacists starting that they are the most affected category in theri experience.
11.7% (n=50) of respondents considered that unlicensed medicines are the most common type of
medicines in short supply.
Generic
36.5%
Unlicensed
medicines
11.7%
Originator
51.8%
The countries with highest recordes prevalence of originator (patented) shortages are Belgium
(78.3%, n=69), Spain (64.5%, n=62), Austria (73.3%, n=15) and Slovakia (78.6%, n=14). The pharmaceu-
tical markets of Bulgaria, Ireland, Switzerland, Italy, Norway, France, and Poland also expressed that
patented products were the most common category of shortages.
Figure 2.  Nature of the shortages reported from all of the respnseces. N=427
In which area of medicine does your hospital experience shortage most commonly?
The areas in which shortages of medicines are most commonly reported are:
• antimicrobial agents
• oncology medicines
• emergency medicines
• cardiovascular medicines
• anaesthetic agents
It is interesting to note that at least 19 (4.5%) reports were received for the lowest affected category:
transplant medicines. This indicates the many categories of medicine are affected by shortage.
57%
55%
30% 30%
26%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
Antimicrobilalagents(Antibiotics/
Antivirals/Antifungals)
Oncology
Emergency
Cardiovascularmedicines
Anaestheticagents
Endocrinemedicines
Preventivemedicines
(e.g.vaccines)
Haematologymedicines
Other
Paediatricmedicines
Respiratory
Topicaltreatments
Gastrointestinal
Orphan
Renal
Urology
Transplant
Figure 3. Category of shorages reported overall.The categories with the highest responds
include antimirobials (56.7%), oncology (54.5%), emergency medicines (30.4%)
and cardiovascular medicines (30.4%). n=418
Approximately how often does your hospital pharmacy experience shortages?
Most hospital pharmacists responded that they are affected by shortages on a weekly basis.
Hospital pharmacists are affected by shortages on a daily basis, with 21.1% (n=111) replying that they
experience a shortage of a medicine every day.
The situation for the majority of those who replied was that they experience shortages at least weekly,
45.2% (n=238) selecting this response.
21.2% (n=112) replied that they are affected by shortages on a monthly basis with 12.4% (n=65) stating
that they are affected occasionally.
This resulted in a combined 87.6% (n=112) of the respondents replying by saying that they are affected
by medicines shortages at least monthly.y
Monthly
21.2%
Occasionally
12.4%
Daily
21.2%
Weekly
45.2%
Figure 1.
BACK TO CONTENTS
72 73
GERMANYGERMANY Mobile HealthMobile Health
The rapid advancement of technology does
not stop at mobile devices: For most people,
these sophisticated gadgets have become
an integral part of their daily life. Smart
phones and tablets as well as various wear-
able devices, e.g. smart watches, perform
their duties in an unobtrusive way but still
provide users with impressive functional-
ities that would have been unthinkable of
only a few years ago: the sensor technology
included in most of these devices can record
data relating to many different aspects of
the user’s life and these data can easily be
stored and evaluated either on the devices
themselves or be sent to some remote loca-
tion for further processing and storage.
At first gaining great popularity with busi-
nesspeople as well as private users who feel
they can rarely do without their constant
mobile companions, the devices have also
become accepted in other sectors, including
the medical field. Part of this stems from
the fact that economists as well as politi-
cians have come to realize that mobile de-
vices along with the (public) health related
apps running on them offer great potential
for the medical field, not only by improv-
ing the quality of care for patients, but also
from an economic point of view. Their uses
in the medical context are manifold. For
example, they are regarded as invaluable
for prevention, e.g. for monitoring chronic
conditions such as high blood pressure or
diabetes [1, 2] and improving adherence to
therapies. For patients, the main aspect is
the added comfort of such mobile solutions
compared to conventional methods, while
from a professional point of view, better ad-
herence to a prescribed regimen as well as
meticulous monitoring may serve to prevent
long-term damages that might be caused as
a result of a more careless approach. Never-
theless, despite the perceived benefits mo-
bile technologies can offer in healthcare, the
highly sensitive nature of this field of appli-
cation raises a number of ethical questions
that need to be answered [3].
People who use health related apps for re­
creational purposes, training or other health
related tasks are usually confident that those
who provide the apps (vendors as well as
developers) follow the unwritten rules with
respect to how personal data should be han-
dled or not.They are not necessarily ignorant
or careless, but often, they like to think that
datasets recorded by the mHealth applica-
tions they use are deleted as soon as they are
no longer needed or that only they them-
selves can gain access to their data because
they do not suspect anything else. However,
there are divergent interests involved that
may lead some providers of mHealth apps to
collect data and use them for purposes that
the users are not aware of (and would never
or only hesitatingly acquiesce to if they were
told), e.g. marketing. The consequences of
this “misinterpretation” of the other party’s
goals are not trivial.This is not about wheth-
er people should clap hand in the British
House of Parliament or not – it is about seri-
ous issues regarding autonomy, participation,
personal health, economy and public inter-
ests. Different interests and different notions
about “what should be done” cause tensions
and conflicts of goals and norms. Conflicts
like these are well known to medicine at
large, but mHealth in its ubiquity, availabil-
ity and accessibility may provoke a new and
enhanced debate about some ethical aspects
that are already being discussed in medicine
in general.
The power of mHealth apps to medicalise
[4] the behaviour of individuals causes us
to start a debate about ethics in mHealth.
­Users often make excessive use of mobile
technologies when it comes to monitoring
their health because they have been told this
may help to reduce their risk for disease.
Also, they believe that being well informed
may also serve to mitigate potential risks.
At the same time apps have already proven
to be effective tools for boosting adherence
to therapies (for example, via text messag-
ing reminders) or for disease management
[5]. However, these developments go hand
in hand with technical challenges and ethi-
cal concerns: Above all, the medicalisation
of apps results in limited consumer choices.
This refers as much to using the apps them-
selves as to targeted advertising users may
receive which is specifically adapted to their
“health”-related data or their health pro-
file. Consumers may be led to think that
they need certain apps or commercialized
products for their well-being. Having these
radical examples in mind, we believe that it
is essential to transparently describe what
people using mobile devices for mHealth
can expect from mHealth providers. Thus,
mHealth ethics is not so much about find-
ing out which rules people want mHealth
providers to follow, but about which rules
mHealth providers promise to follow in the
future.
Our objective in this article is to provide
some starting points for the clearly need-
ed discussion about ethics in mHealth.
Therefore, after an introductory definition
of what constitutes “mHealth”, we outline
how the fundamental principles of medical
ethics as they are described in several stan-
dard codices can be transformed in order to
make them applicable to mHealth.In a nut-
shell, we propose mHealth specific ethical
principles to be developed that – while they
are still based on established principles and
guidelines – also take the specific require-
ments of mHealth under consideration.
Do Ethics Need to Be Adapted to mHealth?
A Plea for Developing a Consistent Framework
What Constitutes mHealth?
As specified by the WHO’s Global Obser-
vatory for eHealth (GOe), mHealth, also
known as mobile health, can be seen as the
“medical and public health practice support-
ed by mobile devices, such as mobile phones,
patient monitoring devices, personal digital
assistants (PDAs), and other wireless devic-
es.”[6].However,considering the rapid tech-
nological evolution that of course does not
stop at mobile devices,this definition (dating
back to 2011) falls short of what is possible
nowadays. Even sensors commonly found in
mobile devices but developed with entirely
different fields of application in mind are of-
ten used for medical and health related pur-
poses.Apart from applications making use of
sensor based data, there are also those that
aim at providing users with health related
information, while even others target bio-
medical research or can be used for (preven-
tive) healthcare. Often, it is impossible (and
not even desirable) to clearly distinguish
between these areas, since they all make use
of monitoring, recording as well as surveil-
lance functionalities and there are many
overlaps. A “definition” guideline has been
provided, for example, by the FDA in their
“Guidance for Industry and Food and Drug
Administration Staff  – Priority Review of
Premarket Submissions for Devices” [7] re-
vised on February 9, 2015. Also, the manner
in which mHealth is being used means that
the ­access to health related services is no lon-
ger restricted to time or location, i.e. getting
to a doctor’s office or a hospital at a specific
time. Instead, by using mHealth technolo-
gies, ­users can gain access to an impressive
number of health related services whenever
they need them [5].
Evaluating Existing Biomedical
Principles and Codes
Due to the vast number of imaginable areas
of application for mHealth solutions, start-
ing with their use in private settings in the
patient’s home and further extending to re-
mote monitoring of various data as well as
large scale collection of health related data
for biomedical research (the so called “big
data” approaches [8, 9]), many different lev-
els of medical ethics are affected and must be
considered.
For example, as soon as data originally re-
corded in a care context is (additionally)
evaluated in a research project, research eth-
ics need to be included in the equation. On
the other hand, if mobile devices are em-
ployed to record physiological parameters
(independent of whether this patient care or
research in mind), patient autonomy as well
as the patient’s right “not to know” must be
respected. Also, sometimes, the target ori-
ented approach commonly used in medicine,
namely, research vs. treating patients, stands
in the way of applying the value-rational
principles of medical ethics as would be
­appropriate. And lastly, the use of mHealth
may also influence the relationship between
patients and their physicians. A striking ex-
ample is the reference to the traditional issue
of confidentiality: mHealth app users might
use them to communicate their disease spe-
cific parameters with their physician, either
actively, for example, via text messaging or
passively by having their data monitored.This
communication can only be frank, trustful,
true and free of manipulation if confidential-
ity, as a crucial element of patient-physician
relationships, is guaranteed. For both sides,
confidentiality is of utmost importance and
this also holds true for third parties because
this is essential for guaranteeing mutual re-
spect,full disclosure of symptoms to the phy-
sician and privacy, including protection from
stigmatization.
Considering the different spheres of pa-
tient’s life which apps can monitor and
record, it becomes clear that at least in the
medical field, the health related use of apps
needs some ethical guidance. Referring to
classical elements of medical ethics this
means that, for example, the four principles
of “autonomy”, “nonmaleficence”, “benefi-
cence”, and “justice” mentioned in the so-
called “Georgetown mantra” [10] as well as
similar aspects mentioned in other docu-
ments and normative analyses have to be an
essential part of all further work.
Codes of ethics that are already available
and deal with issues related to the conse-
quences of using technologies, public health
[11], research [10, 12], or telemedicine [13]
as well as the general use of internet based
services [14] or other subject areas such as
medical informatics [15] also need to be
scrutinized with respect to their applicabil-
ity to the mHealth sector.
However, such an analysis reveals that there
are certain dimensions that might be in con-
flict with each other. For example, while a
user may simply want to have his or her data
monitored to stay healthy and continue to be
able to participate in public, mHealth pro-
viders may rather have the collection of data
for research or marketing purposes in mind
and may also want to influence the behavior
of consumer in one or the other direction.
Here, specifically the above mentioned tra-
ditional concepts like autonomy, confiden-
tiality, beneficence and maleficience are at
stake.At the same time and on another level,
a consumer using mHealth may have the im-
pression that the promise of confidentiality
commonly applied in medical contexts also
extends toward mHealth settings in gen-
eral and, thus, his or her health related data
are also protected similarly. However, many
mHealth providers have a more or less legiti-
mate interest to simply make use of the data
they obtain. Additionally, the interest in data
does not stop with researchers. Public health
officials, a “medical police”, insurances or
employers might also have interest in these
data to increase their chances on the market
by choosing the clients or employers with the
best risk profile. Transparency usually has a
good reputation, but from a patient perspec-
tive, mHealth transparency interpreted in
this manner may go too far.
As a first approach,we would therefore sug-
gest to follow the classical codes of medical
BACK TO CONTENTS
74 75
Health AppsGERMANYGERMANYMobile Health
ethics and codes for e-health and telemedi-
cine in order to examine the dimensions of
normative conflicts involved. From this ba-
sis, we propose to develop a specific WHO
mHealth code of ethics along the following
lines:
1. Above all, patient interests need to be
addressed and questions of autonomy
have to be integrated in such a mHealth
code as well.This would involve
— respecting the right to self-determina-
tion with respect to active or passive
participation where use or application
of mHealth are concerned,
— voluntary participation and the right to
withdraw at any time,
— providing comprehensive and target-
group as well as situation specific in-
formation to allow for an informed
decision,
— promotion of health awareness for
(self-) confident decision making in
health contexts.
2. Furthermore, the mHealth code of eth-
ics needs to address possible settings
where mHealth apps can be beneficial,
their inclusive or exclusive character and
their accessibility for people potentially
benefitting from their use. This would
for example mean that
— the primary benefits for the affected
persons must be obvious or deducible,
— objectives of the mHealth app must be
achieved based on valid data,
— decision processes must be transparent
and need to include all stakeholders
concerned (affected persons) in order
to justify an intervention in a compre-
hensible manner.
3. Additionally,
— mHealth interventions must be avail-
able to everyone, regardless of social
status, income, education, political ori-
entation, religious faith, inclinations
and ideals,gender,age,ethnic group but
also when it comes to technical affinity,
health competence, mental or physical
impairments. Neither discrimination
nor stigmatization may be caused by
the intervention.
— mHealth interventions should aim at
eliminating existing inequalities. For
this, the fair distribution of potential
benefits and potential harm within the
target group is a prerequisite.
4. It is often forgotten that mHealth apps
differ from other apps in the very aspect
that they address the fundamental issue
of health. Therefore, mHealth providers
should – in line with the medical tra-
dition – promise not to cause harm to
their users. For example,
— the mHealth intervention shall not in
any way have a negative impact on its
user or on the receiving party. Specifi-
cally, this applies to the physical and
mental wellbeing of each individual, a
group of individuals or the individual’s
environment.
— The risks of an intervention must be
commensurate with its expected ben-
efits. This requires carefully weighing
up the risks and benefits based on valid
and reliable information.
— The right to privacy, which aside from
confidentiality also includes protecting
personal integrity, must be protected in
order to prevent any harm.
5. Finally, when using mHealth tools for
research purposes, one should be care-
ful to respect the existing principles for
good scientific practice, specifically
— that research using mHealth appli-
cations needs to generate valid and
reliable data and that the commonly
known principles of good scientific
practice as well as the biomedical prin-
ciples of research must be observed.
Conclusion
The presented catalogue of principles is
supposed to offer a first glimpse of a pos-
sible code promising certain behaviors (on
the part of mHealth providers) to users of
mHealth apps. Users seek health, provid-
ers may seek data as well as novel revenue
generating areas of application and, thus,
they may follow public, individual or eco-
nomic interests. Maintaining the overview
of all aspects that need to be respected by
stakeholders involved in mHealth is not an
easy task as the aforementioned consider-
ations reveal. Although several codes re-
garding eHealth exist, we think that, due to
its ubiquity, the requirements to be met for
mHealth are even more challenging. Hav-
ing a unified “code of ethics” specifically
targeting mHealth would simplify the ten-
sion caused by the mismatch between users’
expectations and the morals of providers
and it might improve compliance with the
required principles.
References
1. Eng D.S.,Lee J.M.The promise and peril of mo-
bile health applications for diabetes and endo-
crinology. (2013) Pediatric Diabetes,2013,14(4,)
231–238.
2. Fangerau H., Martin M. (2014) Blutdruck
messen: Die ‚Technikalisierung‘ der Kreislauf-
diagnostik. Technomuseum (Hrsg): “Herzblut.
Geschichte und Zukunft der Medizintechnik”,
Theiss/WBG, Darmstadt, S. 74-93
3. Albrecht U.V., Pramann O. (2014) Ethical and
Legal Implications on Apps in Clinical Trials.
(2014) Biomed Tech 59 (s1,) pp. 674-675 DOI
10.1515/bmt-2014-4290
4. Conrad P. (2007) The Medicalization of Society.
On the Transformation of Human Conditions into
Treatable Disorders. Baltimore
5. Boulos M.N., Brewer A.C., Karimkhani C.,
Buller D.B., Dellavalle R.P. Mobile medical and
health apps: state of the art, concerns, regulatory
control and certification.(2014) Online Journal of
Public Health Informatics.5(3),229. doi:10.5210/
ojphi.v5i3.4814.
6. World Health Organization. (2011) mHealth –
New horizons for health through mobile technolo-
gies. Global Observatory for eHealth series. V.3, 6
7. FDA. Mobile Medical Applications. Guidance
for Industry and Food and Drug Administration
Staff. http://www.fda.gov/downloads/Medi-
calDevices/…/UCM263366.pdf. (Last access:
18.06.2015)
8. Sungmee Park, Jayaraman S. A transdiscipli-
nary approach to wearables, big data and qual-
ity of life. (2014) Conference Proceedings of the
IEEE Engineering in Medicine and Biology Soci-
ety.4,155-58.
9. Hsieh J.C., Li AH, Yang C.C. Mobile, cloud,
and big data computing: contributions, chal-
lenges, and new directions in telecardiology.
(2013) International Journal of Environmental
Research and Public Health, Nov.10(11),6131-53.
10. Beauchamp T.L., Childress J.F. (2009) Principles
of Biomedical Ethics. Oxford University Press.
11. Public Health Leadership Society. (2002) Prin-
ciples of the Ethical Practice of Public Health.
http://phls.org/CMSuploads/Principles-of-the-
Ethical-Practice-of-PH-Version-2.2-68496.pdf
12. World Medical Association.(2014) World Med-
ical Association Declaration of Helsinki. Ethical
Principles for Medical Research Involving Hu-
man Subjects. JAMA. 2013; 310(20):2191-2194.
doi:10.1001/jama.2013.281053
13. Iserson K.V.Telemedicine: a proposal for an eth-
ical code. (2000) Cambridge Quarterly of Health-
care Ethics.9, 404–406
14. Rippen H., Risk A. e-Health Code of Eth-
ics. (2000) Journal of Medical Internet Research.
2(2):e9 URL: http://www.jmir.org/2000/2/e9
DOI: 10.2196/jmir.2.2.e9 PMID: 11720928
PMCID: PMC1761853
15. International Medical Informatics Association.
IMIA Code of Ethics for Health Information Pro-
fessionals. http://www.imia-medinfo.org/new2/
node/39
Dr. med. Urs-Vito Albrecht, MPH,
Hannover Medical School,
Peter L. Reichertz
Institute for Medical Informatics, Germany
E-mail: albrecht.urs-vito@mh-hannover.de
Prof. Dr. med. Heiner Fangerau,
Institute of the History,
Philosophy and Ethics
of Medicine at Cologne
University of Cologne, Germany
E-mail: heiner.fangerau@uni-koeln.de
A gold rush mood is prevailing among all
stakeholders who are active in healthcare
and everybody is clamoring for “their” app:
Healthy users want to track their fitness and
to obtain health related information and pa-
tients hope to get a comfortable means to
manage their condition or to get into con-
tact with their doctors. For manufacturers,
apps and mobile technology in general stand
for an additional chance for selling “health”,
either under a new guise, or ideally based on
entirely new and exciting ideas. The market
is diverse and it is hard to maintain an over-
view – for those interested in health related
mobile offers, the situation is often confus-
ing. The most difficult part in determining
whether an offer is acceptable or not is rat-
ing the quality of health apps. Most users –
patients and healthcare professionals alike –
are simply not familiar with the strategies
needed for carrying out such an assessment
on their own. Although various tools exist
that could help them in this process (e.g. [1,
2]), many of these are still under develop-
ment or users are simply not aware of their
existence. What are the dangers users may
be confronted with in this context? This ar-
ticle is meant to shed some light on the cur-
rent situation and to provide some remedies.
The App Market, Health
Apps and Medical Apps
The smartphone and app hype really started
in 2008 when 500 apps were made available
on one app store [3].In May 2015,the num-
ber of offered apps had already grown to the
formidable number of 3,730,000 [4] for four
mobile platforms in five app stores.The con-
tinuing growth of the app market in general
also applies to apps for health and fitness
and, in fact, some analysts predict that this
part of the app market will have the largest
percentage change [5]. Recent estimates are
that there are about 100 000 mHealth apps
[6] with an estimated growth of about 1 000
apps per month [7]. An exact number for
mHealth apps cannot be determined since
the app stores only offer very basic rules for
assigning apps to one category or another.
Rather, this is left to the manufacturers, who
will often choose a category that promises
better sales. To clarify the classification and
to give users a better understanding, we rec-
ommend the following to clearly differenti-
ate between health apps and medical apps
[8]. While, following the WHO’s definition
of health as “a state of complete physical,
mental and social well-being and not merely
the absence of disease or infirmity” [9]  –
the term “health apps” encompasses a wide
range of health related apps, “medical apps”
are primarily intended for diagnosing, treat-
ing or preventing illnesses or injuries.
Risks and Limitations
The relevance of this categorization becomes
apparent when one considers the potential
risks and ramifications that may arise in the
intended field of application. For medical
apps, the inherent risks of causing harm are
considerably greater, since their focus is pri-
marily on diagnosing or treating patients –
supported by the app and the mobile devices
they run on – whose health is already com-
promised in some way. However, the desired
success may either fail to materialize or, in a
worst-case scenario, it may come to an exac-
erbation or additional health problems. Of
course, this outcome is highly undesirable,
Urs-Vito Albrecht
Health Apps – Sound and Trustworthy?
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76 77
Health Apps Health AppsGERMANYGERMANY
not only for the patients themselves but of-
ten also for the medical staff, their employ-
ers, as well as the manufacturers. There exist
many possible sources of risks and the fol-
lowing paragraphs will mention the most
obvious ones – the list is by no means ex-
haustive. Roughly speaking, two areas where
problems can arise can be discerned:
1. “The app does not do what is supposed
to do!” This sentence and other simi-
lar utterances, often voiced by discon-
tented users, for example in user com-
ments that they leave on the stores, is
often caused not only by shortfalls in
performance that may for example be
caused by technical limitations of the
devices used to run the app, but also by
programming errors, deficiencies of the
content or simply bad usability.
2. “The app does more than it should!”
This is often caused by non-obvious
“features” of an app, for example when
data protection and data security or
the user’s right to self-determination
are compromised. This may be caused
either with or without intent, e.g. by
failing to observe due security measures
when dealing with this highly sensitive
type of data,lack of providing users with
adequate information regarding data
handling or even worse, secret and illicit
data transmission and evaluation.
The App as a Medical Device
Although many aspects of the app business
give the impression of a “wild west” scenario,
at least some apps, namely, those where the
manufacturers have specified that they are a
“medical device”, have to conform to the of-
ficial regulatory requirements that apply to
such products. However, whether these re-
quirements apply also depends on whether
the manufacturer has assigned a medical pur-
pose to his product, in this case the app. Go-
ing through the processes is often time-con-
suming and costly.Thus, although some apps
can be medical products and would therefore
have to comply with regulations for such
products,manufacturers often avoid or ignore
this due to the considerable hurdles raised by
the necessary regulatory processes. Currently,
compared to the number of available apps,
only a relatively small number of apps have so
far gained approval by a federal authority (e.g.
by the Food and Drug Administration in the
USA) or passed an assessment following the
federal laws of other states (e.g. conformity
assessment for European countries). The im-
possibility of closer scrutiny of all apps by the
authorities, which would be appropriate, can
also easily be explained by the sheer number
of apps and additionally contributes to the
uncertainties in this area, although the intent
of regulation is to protect patients as well as
users of these products. An exhaustive over-
view of the subject of “apps and regulations”
can be found in [10].
Private Certification
For many apps, regulations simply do not
apply, while for others, manufacturers ig-
nore the regulatory processes either due to
a lack of knowledge about the requirements
or intentionally. Unfortunately, this means
that in order to obtain some sort of qual-
ity seal for their product, the manufacturers
have to resort to using the services offered
by a number of private contractors. These
seals can also be used for advertising pur-
poses. Of course, this comes with a price
and such services are offered both nationally
as well as on an international level. Still, the
reliability of these offers is highly variable,
as was recently underlined by the deficien-
cies found in the recently halted certifica-
tion processes offered by Happtique [11].
Appraising the
Trustworthiness of Apps
Ultimately,the decision on whether to use an
app or to refrain from using it remains with
the users.They carry the prime responsibility
and can also be held accountable – at least
in a professional context – when using apps
[12]. Users of health apps are in a difficult
situation: they have to decide for themselves
whether they place their trust in an app.This
is a difficult and error prone decision mak-
ing process.The probability for errors can be
reduced if users can base their decision on
readily available and valid information, but
such information is often hard to come by.
AvailableInformationIsnotAlways
Reliable and Reliable Information
Is Only Rarely Available
Users often rely on comments made by other
users on the distribution platforms.Such com-
ments can be easily created and publicized.
The more “stars” and positive comments an
app has received, the greater its attractiveness
for users as well as for the search algorithms
of the stores. However, these comments and
ratings are not subject to any review and do
not follow any standards. They can be freely
assigned and given pseudonymously. Their
quality is often questionable, but still they
are generally the main source of information
for those interested. Other information can
usually only be found via time-consuming
searches: blogs, evaluations done by (private)
initiatives or databases containing specific in-
formation provided by the manufacturers that
are often not widely known. If available, peer
reviews of apps or corresponding scientific
studies provide more reliable information,but
finding this information often requires con-
siderable effort on the users’part.
Which Information Is Important
for Making a Decision?
For users, the situation is quite chaotic due to
the vast number of available apps. Identify-
ing apps that match the desired use and are
trustworthy is like a mixture between finding
a needle in the haystack and playing Wheel of
Fortune. The emphasis of available informa-
tion is often on marketing aspects and infor-
mation that can support the claimed credibil-
ity and trustworthiness can rarely be found.
Alternative sources of information need to be
identified and are often only available some
time after an app has been published. Certifi-
cations are also rare and they often suffer from
questionable credibility. There are even fewer
apps conforming to regulatory standards.
What can be done to make things work?
Sensitizing Users as well as
Manufacturers Combined with
Standardized Information
Users need reliable applications, especially
where either their own health or that of
the patients they treat is concerned. This
is not only an ethical imperative, but also a
strict requirement from a legal point of view
(buzzword: “medical device”). Imprudent
use of apps can cause serious harm. There
is no alternative to requiring manufacturers
to actively provide reliable and trustworthy
apps and corresponding information. Ex-
erting pressure will work best if sales are af-
fected. In order to enable users to use their
power in this context, they need tools that
can support them in their decision whether
to purchase an app or not.Information to be
used towards this end may be gained from
a number of different sources. For example,
it may be based on standardized reporting
mechanisms, such as an app synopsis [4,
10] which covers all important aspects and
provides the crucial information in a single
location.Information covered by the synop-
sis contains not only the background of the
manufacturer or distributor of an app and
his associates as well as the experts involved
in the development, but also the rationale
behind the app, i.e. its intended purpose(s)
and target audience. It also makes provi-
sions for aspects such as functionality and
reliability of the app as well as data acquisi-
tion, data transmission and storage and, of
course, also calls for information on how
data protection and privacy are handled. A
more exhaustive description of the app syn-
opsis can be found in [8, 13, 14].
Transparency as an Added Value
The situation in the market can be improved
as soon as manufacturers acknowledge that
providing transparent information about their
product can significantly contribute towards
an app’s perceived quality. Users will appreci-
ate the added value they receive via this trans-
parent reporting. For manufacturers, it is an
easy task to compile the information point by
point and to publish it,for example on the app
stores,since they already possess the necessary
knowledge. Thus, users have a fair chance to
inform themselves about an app even before
they download it. For users, this is only fair
since they are also affected by the potential
consequences of using the app.This can serve
both as an important confidence building
measure as well as towards improving sales.
Still, just providing this information does
not suffice as in addition users must be made
aware of the inherent risks of apps that are to
be used in a health context and they must also
learn to ask the right questions. Educating
­users towards this goal is imperative.
Conclusion
One objective of the article was to present
aspects relevant for assessing the trustwor-
thiness of a health related app, while also
sensitizing readers to what needs to be in-
cluded even during the development phase
of a trustworthy app. Only based on trust-
worthy apps will it be possible to fully re-
alize the potential apps offer for healthcare
without risking to lose the trust users place
in them  – only an app that can be used
without any problems will be a success.
References
1. Bonacina S.,Marceglia S.,Pinciroli F.A pictorial
schema for a comprehensive user-oriented iden-
tification of medical Apps. (2014) Methods of In-
formation in Medicine;53, 208–24. doi:10.3414/
ME13-01-0093.
2. Lewis T.L. A systematic self-certification mod-
el for mobile medical apps. (2013) Journal of
Medical Internet Research;15:e89. doi:10.2196/
jmir.2446.
3. Engadget. Jobs: App Store launching with 500
iPhone applications, 25% free. (2008) http://
www.engadget.com/2008/07/10/jobs-app-
store-launching-with-500-iphone-applications-
25-free/(accessed June 17, 2015).
4. Statista. Number of apps available in leading app
stores as of May 2015. (2015) http://www.statista.
com/statistics/276623/number-of-apps-available-
in-leading-app-stores/(accessed June 17, 2015).
5. Research2Guidance. Mobile Health Market Re-
port 2013-2017. Available from http://www.re-
search2guidance.com/shop/index.php/mhealth-
report-2 (accessed June 17, 2015).
6. Research2Guidance. mHealth App Devel-
oper Economics 2014. Available from http://
mhealtheconomics.com/mhealth-developer-
economics-report/(accessed June 17, 2015).
7. Becker S., Miron-Shatz T., Schumacher N.,
Krocza J., Diamantidis C., Albrecht UV.
mHealth 2.0: Experiences, Possibilities, and
Perspectives. (2014) Journal of Medical Internet
Research, 2:e24.
8. Albrecht U.V., Pramann O., von Jan U. Synopsis
for Health Apps – Transparency for Trust and
Decision Making. (2014) In: Househ M, Bory-
cki E, Kushniruk A (Hrsg): Social Media and
Mobile Technologies for Healthcare. (pp. 94-
108) Medical Information Science Reference (an
imprint of IGI Global), Hershey PA, USA.
9. WHO. Preamble to the constitution of the
World Health Organization as adopted by the
International Health Conference, New York,
19-22 June, 1946; signed on 22 July 1946 by the
representatives of 61 states (official records of
the World Health Organization, No. 2, p. 100)
and entered into force on 7 April 1948
10. Pramann O.,Albrecht UV.: Medical Apps – Alles
was recht ist: Ein rechtlicher Überblick über den
Einsatz von Apps und Mobilgeräten im Kinikbe-
trieb. (2013) E-HEALTH-COM, 1, 22-27.
11. Dolan P.L. Health app certification program
halted. (2013) Irving, TX: MultiView, Inc;.
URL: http://exclusive.multibriefs.com/content/
health-app-certification-program-halted [ac-
cessed 2014-02-15]
12. Pramann O., Albrecht UV.: Medical-Apps im
Krankenhaus – Sicherheit, Verantwortung, Haf-
tung. (2013) Krankenhausjustitiar 04, 16-17.
13. Albrecht UV.: Transparency of Health-Apps for
Trust and Decision Making (2013) Journal of
Medical Internet Research 15(12): e277.
14. Albrecht UV., Pramann O., U von J. Medical
Apps  – The Road To Trust. (2015) European
Journal for Biomedical Informatics,11:en7–12.
Dr. med. Urs-Vito Albrecht,
MPH, Deputy Director,
Peter L. Reichertz Institute for Medical
Informatics, Hannover Medical School,
Germany
E-mail: albrecht.urs-vito@mh-hannover.de
http://www.plrimedapplab.de
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78 79
LATVIALATVIA NMA NewsNMA News
Q. The half-year of the Latvian Presidency
of the Council of the European Union has
cometoanend. Astohealthcare,wehaveor-
ganised a number of European-level confer-
ences on the topics of healthy lifestyles and
nutritionforchildren,tuberculosis,eHealth,
popular sports, healthcare financing as well
as addressed a number of other important
issues. How do you evaluate Latvia’s per-
formance in its half a year of presidency?
I would like to congratulate Latvia for
succeeding in delivering results on a set
of priority issues during its Presidency of
the Council of the EU. Latvia took up the
Presidency at a very important moment and
contributed to the discussions on the future
directions for health policy at EU level. In
addition, the European conferences organ-
ised under Latvian leadership helped make
progress in reducing the risks associated
with poor nutrition and lack of exercise.The
Latvian Presidency has put the spotlight on
tuberculosis – and led discussions towards
the adoption of the Riga Declaration which
will be guiding action to address this im-
portant – and often neglected – disease in
the European Union. The Presidency has
further explored how eHealth could benefit
both citizens and health systems, and con-
tributed to the discussions on how to create
efficient, equitable health systems.
Q. Currently there is a tendency all across
Europe that patients obtain information
about diseases and health from the Inter-
net or magazines. Over 80% of Internet
portals and social sites which are dedicated
to health topics are financed by businesses:
drugs, dietary supplements or a special
method. More often than not, it is difficult
for patients to discriminate between the
truth about health and surreptitious adver-
tising. As to Latvia, there is even a publi-
cation, the magazine Ko Ārsti Tev Nestāsta
(What Doctors Don’t Tell You), advertis-
ing dietary supplements, Ayurveda, unjus-
tified diets, and at the same time discour-
aging patients from seeing an oncologist
or gynaecologist. How to deliver correct
information to the patient? Is the Euro-
pean Commission going to set up a health
information site for Europe containing ev-
idence-based information, similar to Med-
linePlus in the USA? What is your opinion
on pan-European level information cam-
paigns on healthcare topics?
The European Commission has a dedicated
website on health and healthcare topics [1]
and several specialised EU agencies offer
health-specific information to the citizens
[2]. The Commission has also supported a
number of recent and ongoing health cam-
paigns, carried out by the EU in collabora-
tion with Member States and neighbouring
countries, for example, awareness raising
campaigns about tobacco, the initiative
European Action Against Cancer, healthy
workplaces campaigns and European Anti-
biotic Awareness Day, to name a few. With
Member States facing common challenges
such as a rise in chronic diseases, and in-
creasing antimicrobial resistance, I find
these types of pan-EU initiatives extremely
valuable.
One of my priorities is to increase the avail-
ability of scientifically sound, comparable
and high quality health information to
identify the key challenges in health. Policy
makers need this type of reliable health in-
formation, based on good indicators, sound
data and regular analysis.The overall aim of
EU health information policy is to support
evidence-based development, implementa-
tion and evaluation of actions for health at
EU-level and in Member States.
Q. Right now, there is quite an opposi-
tion to vaccination in Latvia. The situa-
tion is pretty similar in other European
countries. There are excellent lecturers,
nice-looking books and You Tube files
discouraging people from vaccination and
explaining about the dangers of vaccina-
tion. What could the European Commis-
sion do in order to present information on
the need of immunization in an equally
attractive manner from the visual and in-
formative aspect? Maybe it is the time to
have a common immunization calendar in
Europe? This issue is more and more topi-
cal due to the increasing labour mobil-
ity in Europe. Children are moving along
with their parents. Each single country in
Europe has its own vaccination calendar,
which is the reason why many children do
not get adequate vaccination and immu-
nization. Shouldn’t such vaccinations as
against diphtheria, poliomyelitis, tetanus
and some more be declared as mandatory,
to be administered according to strictly
defined time schedule, whereas the rest
(rotavirus, German measles, pneumo-
cocci) could be left on the national level?
Isn’t it high time that we have a mandatory
requirement to vaccinate all immigrants
from third countries because their earlier
vaccination is unreliable?
Interview with Vytenis Andriukaitis, EU
Commissioner for Health and Food Safety
By Dr.Peteris Apinis. June, 2015
Vytenis Andriukaitis
Vaccination is one of the most effective
means of preventing diseases. I am keen
to support Member States in securing ef-
ficient vaccination programmes, and to
foster co-operation at European level in
this area, while bearing in mind that in the
EU vaccination is a responsibility of the
individual Member States. As such, the
way national immunisation programmes
are organised differs considerably between
countries. National immunisation strate-
gies range from voluntary vaccinations to
almost complete mandatory vaccination
programmes.
The Commission provides support to
Member States on vaccination, e.g. in the
field of seasonal influenza and childhood
vaccination. The Commission is working
with Member States within the Health Se-
curity Committee to be better prepared to
address vaccine shortages as well as scepti-
cism about vaccines; to prevent cases like
the recent tragic death of an unvaccinated
child in Spain. Last year’s Council conclu-
sions on vaccination provide an opportunity
to co-operate further in this area, and en-
courage Member States to share best prac-
tices on their vaccination policies.
When it comes to vaccination of immi-
grants from third countries, this is also the
responsibility of individual Member States.
The Commission, together with ECDC, is
developing screening guidance that includes
the issue of vaccination of migrants to sup-
port EU countries. We have also financed
the project “Promote Vaccinations among
Migrant Populations in Europe” under our
health programme, which has resulted in
recommendations for policy-makers on the
immunisation of migrants and educational
material for health professionals and mi-
grants.
Q. In Europe, the manufacturing and
distribution of dietary supplements is
becoming increasingly widespread. Con-
trary to drugs, the supervision of manu-
facturing, distribution and advertising
of dietary supplements is much more
lenient. As a rule, dietary supplements
contain chemically active substances: vi-
tamins, ferments and minerals, and their
abuse may cause health problems. Is the
Commission for Health going to intro-
duce somewhat more stringent restric-
tions to the distribution and advertising
of dietary supplements?
EU rules are in place to ensure that food
supplements placed on the EU market are
safe. The list of vitamins and minerals that
may be used in food supplements is har-
monised at EU level; however, maximum
levels of such substances are not harmon-
ised and may be set by Member States in
accordance with the rules of the Treaty. Bo-
tanicals are covered by the general frame-
work on food safety together with appli-
cable national rules. The Commission does
not envisage at this stage any measures to
restrict the marketing of such foods.
Q. Today, health of and polypragmasia
in senior citizens is becoming an ever in-
creasing problem all across Europe. On
average, each senior citizen in Europe
consumes 6.4 various drugs daily. Doesn’t
the pharmaceutical business have a too
heavy influence on the healthcare system?
Demographic and epidemiologic trends,to-
gether with a range of other factors as phar-
maceutical markets’ own dynamics, changes
in medical practice and pharmaceutical
policies influence pharmaceutical spend-
ing, which is an important component of
healthcare expenditure in Member States.
In addition, changes in the therapeutic
mix of medicines used that occur with new
treatments can also influence the share of
the overall pharmaceutical bill accounted
for by hospitals. The use of multiple medi-
cations in elderly increases the possibility of
adverse reactions to drugs, increases the risk
of hospitalisation, of medical errors caused
by these medicines and may question the
quality of healthcare in general. This is an
area of Member States competence; how-
ever, the Commission supports Member
States to exchange experience and in par-
ticular on developing of tools and method-
ologies to assess the quality of care.
Q. More often than not, the pharmaceuti-
cal business in Europe would not supply
all countries with drugs on equal terms,
and the prices vary significantly across the
countries. If there were a common phar-
maceutical policy for Europe, what would
the effect be like?
At EU level, prices of medicines are un-
der the responsibility of Member States.
The only field of EU regulatory interven-
tion is the so-called “transparency directive”
(Directive 89/105/EEC) which lays down
procedural rules for regulating prices of
medicines and their inclusion in the scope
of health insurance systems. I am keen to
foster discussions and support co-operation
between Member States in this area so as
to make medicines more affordable and
accessible to patients. I am encouraged by
recent developments including the Coun-
cil conclusions whereby Member States
have agreed to exchange information about
the prices of innovative medicines; about
on-going discussions on this issue, as well
as emerging pilot project amongst some
Member States.
Other challenges of pharmaceutical policy
in Member States that also gained atten-
tion lately at EU level relate to the optimal
use of current regulatory framework, the
early dialogue with all relevant stakehold-
ers and the bilateral agreements between
member states. Such issues also relate to
the efficiency of pharmaceutical spending,
i.e. the capacity to get the most value from
today’s expenditure while keeping appro-
priate incentives for future innovation,
­associated with challenges for affordabil-
ity in some countries. It is agreed in the
Council that further cooperation between
Member States is needed in such areas and
the Commission is ready to further coop-
erate based on an integrated approach and
a long term agenda.
Q. Today the biggest issue concerning
children all over Europe is sedentary
lifestyle and obesity. Every fifth child in
­Europe is overweight. Unfortunately, in
Latvia the national Ministry for Educa-
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80 III
tion resists to introduce the third sports
class per week.Could the European Com-
mission be more active in making the
national governments to introduce daily
sports classes for children?
I regret to report that the figures are even
worse. One out of three children in Europe
in 2010 was overweight or obese. This is
a major increase compared to 2008 when
one out of four children was overweight or
obese.
Member States play the key role in provid-
ing education for school children in relation
to nutrition, physical activity, overweight
and obesity – and this is something most
are addressing.
I am ready to use all the tools at my dis-
posal to support them in their efforts to
promote healthy lifestyles.The Commission
is working with Member States in this re-
gard within the High Level Group on Nu-
trition and Physical Activity. In 2014 this
group ­adopted an Action Plan on Child-
hood Obesity with the aim to prevent the
increase in obesity in children by 2020.
A Joint Action on Nutrition and Physical
Activity will start after the summer period
to further support Member States in the
implementation of this Action Plan.
Q. In Latvia, the attitude of the Minis-
try of Education to children’s health is
quite an issue. Since 2002, health educa-
tion is no longer in the school curricula.
The situation (i.e., no health education
for children) is similar in many countries
in Eastern Europe. Could the Commis-
sioner make some pressure on national
governments with regard to educating
children in the basics of health?
Again, the competence in the field of edu-
cation lies with the 28 EU Member States.
However, under the EU Strategy on Nu-
trition, Overweight, and Obesity-related
Health Issues for example, the Commis-
sion closely cooperates with the national
governments to promote healthy lifestyles
in children. The High Level Group on
Nutrition and Physical Activity brings to-
gether governmental experts that promote
and exchange best practices in this area.The
promotion of healthier environments, espe-
cially at schools and pre-schools, is one of
the key areas of the 2014 Action Plan on
Childhood Obesity.
Q. In the past two years, the Latvian
Medical Association managed to intro-
duce two important regulations in legal
acts. The first is that smoking in the pres-
ence of minors should be treated as child
abuse. This means that in Latvia an adult
must not smoke in the presence of a child,
be it at home, in the street or at a bus stop.
The other amendment to the law stipu-
lates that a person has the statutory right
to clean smoke-free air, and this right
has a priority over other persons’ right to
smoke. Thereby, smoking in the presence
of another person is impermissible, un-
less the latter has given permission. Apart
from that, in Latvia it is absolutely pro-
hibited to smoke at sports and cultural fa-
cilities,in the premises of central and local
government institutions, in cafes, restau-
rants, work places, on loggias, balconies,
common staircases and elsewhere where
it can harm other people’s health. How
would you evaluate our achievement and
how could we attain this in entire Europe?
I am very pleased to hear about Latvia’s
efforts towards achieving a smoke-free
environment and, in particular, to protect
children. Furthermore, strengthening the
right of the individual person wishing to
be protected against tobacco smoke is an
important step in that direction. While the
legislative competence in this area lies pri-
marily with the Member States, the Euro-
pean Commission is indeed committed to
continue working with Member States in
their implementation and enforcement of
the Council recommendation on smoke-
free environments (2009/C 296/02). We
regularly discuss the state-of-play and
progress in this area with representatives of
the Member States’ competent authorities.
We know from past experience that good
examples from one country often motivate
others to follow.
Q. In terms of percentage of GDP, ­Latvia
has the lowest healthcare financing in
Europe, it is less than 3%. Could the
European Union make a pressure on na-
tional governments that the accessibility
to healthcare services for population is
a priority and thus healthcare financing
throughout Europe should be at least
4.5% of GDP?
The Commission acknowledges that
healthcare systems need to be reformed
to provide accessible and quality health-
care through efficient structures. Sustain-
ability challenges of healthcare systems
in the EU are addressed and monitored
within the process of the European
­Semester.
Under the 2014 European Semester Latvia
received for the first time a country-specific
recommendation (CSR) calling for the
reform of its health system with concrete,
targeted areas including the quality and ac-
cessibility. Since then, the Latvian govern-
ment increased the health budget by € 31.2
million in 2015 compared with 2014 and
approved a € 30.6 million increase each year
until 2017. But even with this additional
funding, still below 3% of GDP, the finan-
cial burden on patients in Latvia remains
very high and accessibility is still a prob-
lem. Therefore, in 2015 the Commission­
once again proposed the same health CSR
to Latvia, and we will closely monitor its
implementation.
The Commission provides help and sup-
port, which is what countries that are fac-
ing difficulties need. For example, Member
States can make use of the European Stra-
tegic and Investment Funds (ESIF) for
health investments. I welcome the com-
mitment made by the Latvian authorities
to use ESIF for better access to healthcare,
especially for those socially and territori-
ally excluded. For the years 2014–2020 the
health infrastructure allocation for Latvia
exceeds €152 million and further alloca-
tions have been programmed for measures
such as health promotion and prevention,
enhancing qualifications of the medical
staff and health.
Q. Shouldn’t public health issues override
the national level? For example, isn’t it the
time for the European Union to declare
thatithasacommonpolicyastopesticides
and other substances which inhibit the de-
velopment of hormonal system? Isn’t it the
time to have a common European strategy
in place for reducing the consumption of
alcoholic beverages and tobacco products,
and for prohibiting trans fatty acids?
The overriding principle of EU health pol-
icy is that human health is well protected
and accounted for in the development of all
EU policies and activities. All EU policies
are required by the EU treaty to follow this
“Health in all Policies” (HIAP) approach.
Taking some of your specific examples:
Endocrine disruptors are already regulated
in some sectors. Currently, the European
Commission is carrying out an impact as-
sessment to analyse different options for
defining the criteria for the identification
of endocrine disruptors in the context of
the plant protection products and biocidal
products regulations. The decision at EU
level concerning the criteria will be made
once the impact assessment is concluded.
On alcohol, whereas the main responsibility
for public health interventions lies with Mem-
ber States, the Commission will continue­
to support them in reducing alcohol related
harm. This will be done based on the objec-
tives of the 2006 Strategy and by making use
of existing structures like the Committee on
National Alcohol Policy and Action. In line
with the Commission’s “health in all policies”
approach, we will further consider how to en-
shrine alcohol harm into a holistic approach
to reduce the burden of chronic diseases.
Q. Would you agree that the vast dif-
ference as to the availability of medical
services is actually a shame for Europe?
Maybe it is the time we start considering
a common European health strategy, uni-
fied health tax,unified standards for emer-
gency medical care and first aid?
At present there is no unified health sys-
tems policy in the EU: it is for Member
States to decide which services to provide
to their citizens and how this should be
funded. However, the EU does have a role
in supporting Member States and we are
actively working on ways to try to help
them increase availability of services. The
cross-border healthcare Directive makes
it easier for patients to access services in
other Member States. We are in the pro-
cess of setting up European Reference
Networks which will bring together cen-
tres of expertise for conditions or treat-
ments where expertise is rare: these will act
as a resource for all Member States. We are
working together to deliver the consider-
able potential benefits of Health Technol-
ogy Assessments and eHealth. And we are
increasingly looking at the question of how
collaboration in border areas can improve
the delivery of health services.
References
1. See link: http://ec.europa.eu/health/index_
en.htm
2. e.g. the European Centre for Disease Prevention
and Control (ECDC) (http://ecdc.europa.eu/
en/Pages/home.aspx), the European Medicines
Agency (http://www.ema.europa.eu/ema/), the
European Agency for Health and Safety at
Work (https://osha.europa.eu/), and the Euro-
pean Monitoring Centre for Drugs and Drug
Addiction (http://www.emcdda.europa.eu/).
Hunger strikes have been used as a means of
non-violent resistance by political prisoners
throughout history in an effort to achieve
specific objectives.
Famous examples include Mahatma
­Gandhi, British and American suffragettes,
and the Irish Republican hunger strike of
1981. In Israel, Palestinian detainees and
prisoners have used the hunger strike as a
tool for soliciting acquiescence to their de-
mands. Over one thousand hunger strikes
have occurred in Israel to this point. In
general, these hunger strikes began in the
facilities of the Israeli Prison Services (IPS),
and, when the prisoners’ medical condition
deteriorated,this stage was followed by hos-
pitalization in public hospitals. The hunger
strikes lasted everywhere from several days
to weeks and months, during which most,
though not all, prisoners drank and agreed
periodically to undergo tests, and take vita-
mins and carbohydrates intravenously. Each
time,the duration and extent of cooperation
with IPS and/or hospital physicians varied.
No detainee or prisoner in Israel has ever
died during a hunger strike.
In the early months of 2014, the Israeli
Medical Association (IMA) became aware
of legislation being prepared in Israel that
would allow the forced feeding of prisoners.
The IMA immediately requested a meeting
with the Ministry of Health and the Min-
istry of Justice, in which we expressed, in no
uncertain terms, our complete opposition to
such a bill and the fact that we would in-
struct our physicians not to comply with it.
We followed this with a letter to then Jus-
tice Minister, Tzippi Livni, explaining our
strong ethical positon.
Our objections notwithstanding, the Min-
istry of Justice continued work on the bill
and brought it before our Parliament (the
Knesset). We sent a letter to the Knesset
members before the bill was considered in
the Ministerial Committee for Legislation,
but unfortunately it passed this commit-
tee. Although we urged those Ministers
Position of Israeli Medical Association in
Forced Feeding Issue
ISRAELLATVIA NMA NewsNMA News
BACK TO CONTENTS
who opposed the bill in the Committee to
­appeal the decision, the bill continued to a
first review in the Knesset plenum, where
it passed.
Seeing that the bill was progressing, and
against the backdrop of a mass hunger strike
in the Israeli prisons in June 2014, the IMA
and its Ethics Bureau convened an emer-
gency consensus conference, under the title
“Treatment of prisoners/detainees on hunger
strikes – the medical challenge.” Participat-
ing in the conference were representatives of
the IMA scientific associations, members of
the IMA ethics bureau,representatives of the
Ministry of Health,the National Council for
Bioethics, IPS physicians, representatives
of the International Committee of the Red
Cross and others.
At this conference, IMA officials made it
clear that the law does not change a doctor’s
ethical obligations not to coerce feeding on
a competent individual. At the end of the
conference, all parties agreed on a list of
principles which can be viewed on the IMA
website [1].
Recently,Gilad Erdan,the new Israeli Min-
ister for Interior Security, announced plans
to renew the proposed legislation regard-
ing forced feeding of hunger strikers. The
proposal will be put for discussion in the
­Knesset Committee for Internal Affairs and
then for final voting.
The proposal enables obtaining legal per-
mission for the provision of medical care
and/or nutrients (including force-feeding
through a tube) despite the active opposi-
tion of the prisoner.
In our view,the proposed law is both unethi-
cal and unrealistic and does not help solve
the problem.It creates an illusion that forced
feeding will prevent medical harm to the
patient, whereas the opposite may in fact be
true.We cannot approve a law that puts phy-
sicians at the forefront of a policy – both as
a group and as individuals – which is against
their professional and ethical obligations.
The fundamental change underlying this
proposal is in contradiction with and con-
trary to the accepted medical ethics in Israel
and throughout the world, including the
IMA’s ethical Code and the WMA’s Dec-
laration of Tokyo and Declaration of Malta,
which recognize it as a form of inhuman
and degrading treatment.
The IMA is strongly opposed to the in-
tended force feeding law. Our opposition
was expressed to the government offices
and representatives of the attorney general
at every possible opportunity. We are pre-
pared to continue to protect the doctors at
all levels, including in the public sphere and
parliamentary level, in order to thwart the
legislative process.
We know our hospital doctors will be pre-
sented with ethical dilemmas and be placed
in an impossible position professionally.
Therefore, we have established a hotline for
these physicians to call with any questions
they may have, as well as professional and
ethical guidelines that we released in a hand-
book following last year’s mass hunger strikes.
Our concern is that the proposed law will
move quickly through the legislative process
and we are taking measures to ensure that
it does not materialize. The IMA took out
paid announcements in major Israeli news-
papers (in addition to regular press coverage
on the matter) explaining our opposition to
the proposed law.
The World Medical Association (WMA)
has also been a steadfast partner in our
struggle against this unethical bill. On
June 22, Drs. Deau and Hoven sent a let-
ter to Prime Minister Benjamin Netanyahu
explaining the WMA’s position and its sup-
port of the IMA,and the inevitable interna-
tional condemnation that would follow the
passage of such a law.
In its letter, the WMA stated the following:
“Over the past four decades there have been
clear directives developed on what physi-
cians can do, and from what they must
refrain. Clearly torture, inhuman and de-
grading treatments are nothing with which
a doctor should be involved in any way.
Force-feeding is violent, very painful and
absolutely in opposition to the principle of
individual autonomy. It is a degrading, in-
humane treatment, amounting to torture.
But worse: It can be dangerous and is the
most unsuitable approach to save lives.
The evidence from many cases around the
world that our colleagues have been work-
ing on over the past four decades shows that
the best results are obtained when the pa-
tient/physician relationship is maintained,
even under the difficult circumstance of a
hunger strike. This includes patient confi-
dentiality, proper medical care and advice
by the physician, but also respecting the free
will of the patient. Force-feeding is com-
pletely incompatible with this and destroys
any patient/physician trust.”
We are determined to prevent force feeding
in Israel and we will continue to support our
physicians and remind them of their ethical
obligations.
References
1. http://www.ima.org.il/ENG/ViewCategory.
aspx?CategoryId=4497
2. http://www.ima.org.il/Ima/FormStorage/
Type8/IMAHungerEN.pdf
Dr. Leonid Eidelman, President, IMA
Malke Borow, Director, Division
of Law and Policy, IMA
E-mail: malkeb@ima.org.il
Leonid Eidelman Malke Borow