wmj21

No. 1, February 2009
Editor in Chief
Dr. Pēteris Apinis
Latvian Medical Association
Skolas iela 3, Riga, Latvia
Phone +371 67 220 661
peteris@nma.lv
editorin-chief@wma.net
Co-Editor
Dr. Alan J. Rowe
Haughley Grange, Stowmarket
Suffolk IP143QT, UK
Co-Editor
Prof. Dr. med. Elmar Doppelfeld
Deutscher Ärzte-Verlag
Dieselstr. 2, D-50859 Köln, Germany
Assistant Editor Velta Pozņaka
wmj-editor@wma.net
Journal design and
cover design by Jānis Pavlovskis
Layout and Artwork
The Latvian Medical Publisher “Medicīnas
apgāds”, President Dr. Maija Šetlere,
Hospitāļu iela 55, Riga, Latvia
Cover painting : A Skin-Slice with Love
Painter: Mr. LI Shih-Chiao, 1956
Oil on canvas 116.5*91cm
Authorized by: A Skin-Slice with Love
Foundation
The painting represents a scene of skin-slice
surgery caried out by Dr. David Landsborough
in 1928. A child patient suffered from skin
necrosis due to an incident. In order to avoid
amputation operation, Mrs. Landsborough
donated her skin voluntarily to save the child.
Background: Sea Erosion Trenches
Author: Lin Yu-Wei
Authorized by: Government Information
Office, Republic of China (Taiwan).
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ISSN: 0049-8122
Dr. Yoram BLACHAR
WMA President
Israel Medical Assn
2 Twin Towers
35 Jabotinsky Street
P.O. Box 3566
Ramat-Gan 52136
Israel
Dr. Kazuo IWASA
WMA Vice-Chairman of Council
Japan Medical Assn
2-28-16 Honkomagome
Bunkyo-ku
Tokyo 113-8621
Japan
Dr. Mukesh HAIKERWAL
WMA Chairperson of the Finance
and Planning Committee
58 Victoria Street
Williamstown, VIC 3016
Australia
Dr. Dana HANSON
WMA President-Elect
Fredericton Medical Clinic
1015 Regent Street Suite # 302,
Fredericton, NB, E3B 6H5
Canada
Dr. Jörg-Dietrich HOPPE
WMA Treasurer
Bundesärztekammer
Herbert-Lewin-Platz 1
10623 Berlin
Germany
Dr. Guy DUMONT
WMA Chairperson of the Associate
Members
14 rue des Tiennes
1380 Lasne
Belgium
Dr. Jón SNÆDAL
WMA Immediate Past-President
Icelandic Medicial Assn
Hlidasmari 8
200 Kopavogur
Iceland
Dr. Eva NILSSON-
BÅGENHOLM
WMA Chairperson of the Medical
Ethics Committee
Swedish Medical Assn.
P.O. Box 5610
11486 Stockholm
Sweden
Dr. Karsten VILMAR
WMA Treasurer Emeritus
Schubertstr. 58
28209 Bremen
Germany
Dr. Edward HILL
WMA Chairperson of Council
American Medical Assn
515 North State Street
Chicago, ILL 60610
USA
Dr. José Luiz GOMES DO
AMARAL
WMA Chairperson of the Socio-
Medical-Affairs Committee
Associaçao Médica Brasileira
Rua Sao Carlos do Pinhal 324
Bela Vista, CEP 01333-903
Sao Paulo, SP
Brazil
Dr. Otmar KLOIBER
WMA Secretary General
13 chemin du Levant
France 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
1
It is well recognised that the continuing growth of both knowledge
and scientific advances and their applications in medicine, (not to
mention the new question they pose) inevitably continue to raise
both medico-social and ethical problems, These tend to be dealt
with on a “case by case” basis as many of the statements and dec-
larations of the adopted by the World Medical Association illus-
trate. While new specialties and particularly sub-specialities reflect
advances in knowledge and techniques, there are circumstances in
which a topic emerges which affects a wide number of medical spe-
cialties and other disciplines.
Such a topic is Gender Medicine which, notably in the past two de-
cades and more particularly since 2001, has brought together a wide
number of disciplines.The 21st
century has been marked not only by
the development of Departments of Gender Medicine and interna-
tional collaboration reflected in the Three World Conferences, but
also Journals of Gender Medicine and increasing trends to incorpo-
rate this in both undergraduate and postgraduate training.
While the World Medical Journal does not normally publish re-
search articles, we felt that this development merited the inclusion
in this issue of a paper which illustrates both the breadth of the
disciplines involved in Gender Medicine,and indicates some ethical
problems which may arise.
Editorial
Following nominations for Regional places on the Worid Medical
Association Council 2009-2010, in accordance with the regulations,
the following were elected automatically or unopposed:
The American Medical Association, the British Medical Asso-
ciation, Canadian Medical Association, Ethiopean Medical As-
sociation, German Medical Association, Indian Medical Asso-
ciation,Japan Medical Association,the Russian Medical Society,
the Uraguay Medical Association and in the Asian Region, fol-
lowing the withdrawal by the Indian Medical Association in favour
of the IMA, the Israel Medical Association.
Elections were necessary in the Euopean and Pacific Regions with
the following results :
EUROPE The Danish, Norwegian and Royal Dutch Medi-
cal Associations were elected, having received
28,854, 36,376 and 34,112 votes, respectively.
The Association Beige des Syndicates Medicales, the
Czech Medical Association, the Association Medi-
cale Francaise and the Consuelo General de Colegios
Medicos de Espana, received 599, 2,290, 21,668 and
5,454 respectively.
PACIFIC The Australian and Korean Medical Associations
were elected having received 18,576 and 35,200 votes,
respectively. In this Region the Indonesian and Thai-
land Medical Associations received 2.599 and 2,694
votes respectively.
Final Composition of the Council For 2009-2010
Therefore, as a result of the regional election process, conducted in
accordance with Chapter IV of the WMA Bylaws, the composition
of the Council for the 2009-2010 is:
Constituent Member Number of seat(s)
American Medical Association 3
Australian Medical Association 1
Brazilian Medical Association 2
British Medical Association 1
Canadian Medical Association 1
Danish Medical Association 1
Ethiopian Medical Association 1
German Medical Association 2
Indian Medical Association 2
Israel Medical Association 1
Japan Medical Association 3
Korean Medical Association 1
Norwegian Medical Association 1
Royal Dutch Medical Association 1
Russian Medical Society 1
Sindicato Médico del Uruguay 1
TOTAL 23
The President, President-Elect and Immediate Past-President of
the WMA are ex-officio members of Council, with no voting privi-
leges.
Elections for the following posts will be held as soon as the Council
convenes for its 182nd
Session in Tel Aviv, Israel on 13 May 2009:
Chairperson of Council; Vice-Chairperson of Council; Treasurer,
and Committee Chairpersons for the Finance and Planning Com-
mittee, Medical Ethics Committee, Socio-Medical Affairs Com-
mittee.
Result of Regional Elections, the Members of WMA Council 2009 – 2010
Pēteris Apinis, Alan J. Rowe, Elmar Doppelfeld
2
WMA news
Adopted by the 18th
WMA General Assembly, Helsinki, Finland, June
1964, and amended by the:
29th
WMA General Assembly, Tokyo, Japan, October 1975
35th
WMA General Assembly, Venice, Italy, October 1983
41st
WMA General Assembly, Hong Kong, September 1989
48th
WMA General Assembly, Somerset West, Republic of South Africa,
October 1996
52nd
WMA General Assembly, Edinburgh, Scotland, October 2000
53th
WMA General Assembly, Washington, United States, October 2002
(Note of Clarification on paragraph 29 added)
55th
WMA General Assembly, Tokyo, Japan, October 2004 (Note of
Clarification on Paragraph 30 added)
WMA General Assembly, Seoul, Korea, October 2008
A. Introduction
1. The World Medical Association (WMA) has developed the
Declaration of Helsinki as a statement of ethical principles for
medical research involving human subjects, including research
on identifiable human material and data.
The Declaration is intended to be read as a whole and each of its
constituent paragraphs should not be applied without consider-
ation of all other relevant paragraphs.
2. Although the Declaration is addressed primarily to physicians,
the WMA encourages other participants in medical research in-
volving human subjects to adopt these principles.
3. It is the duty of the physician to promote and safeguard the
health of patients, including those who are involved in medical
research. The physician’s knowledge and conscience are dedi-
cated to the fulfilment of this duty.
4. The Declaration of Geneva of the WMA binds the physician
with the words, “The health of my patient will be my first con-
sideration,” and the International Code of Medical Ethics de-
clares that, “A physician shall act in the patient’s best interest
when providing medical care.”
5. Medical progress is based on research that ultimately must in-
clude studies involving human subjects. Populations that are
underrepresented in medical research should be provided ap-
propriate access to participation in research.
6. In medical research involving human subjects, the well-being
of the individual research subject must take precedence over all
other interests.
7. The primary purpose of medical research involving human sub-
jects is to understand the causes,development and effects of dis-
eases and improve preventive, diagnostic and therapeutic inter-
ventions (methods, procedures and treatments). Even the best
current interventions must be evaluated continually through re-
search for their safety, effectiveness, efficiency, accessibility and
quality.
8. In medical practice and in medical research, most interventions
involve risks and burdens.
9. Medical research is subject to ethical standards that promote re-
spect for all human subjects and protect their health and rights.
Some research populations are particularly vulnerable and need
special protection.These include those who cannot give or refuse
consent for themselves and those who may be vulnerable to co-
ercion or undue influence.
10. Physicians should consider the ethical, legal and regulatory
norms and standards for research involving human subjects in
their own countries as well as applicable international norms
and standards. No national or international ethical, legal or
regulatory requirement should reduce or eliminate any of the
protections for research subjects set forth in this Declaration.
B. Principles for all Medical Research
11. It is the duty of physicians who participate in medical research
to protect the life, health, dignity, integrity, right to self-deter-
mination, privacy, and confidentiality of personal information of
research subjects.
12. Medical research involving human subjects must conform to
generally accepted scientific principles, be based on a thorough
knowledge of the scientific literature, other relevant sources of
information, and adequate laboratory and, as appropriate, ani-
mal experimentation. The welfare of animals used for research
must be respected.
13. Appropriate caution must be exercised in the conduct of medi-
cal research that may harm the environment.
14. The design and performance of each research study involving
human subjects must be clearly described in a research protocol.
The protocol should contain a statement of the ethical consid-
erations involved and should indicate how the principles in this
Declaration have been addressed. The protocol should include
information regarding funding, sponsors, institutional affilia-
tions, other potential conflicts of interest, incentives for subjects
and provisions for treating and/or compensating subjects who
are harmed as a consequence of participation in the research
study.The protocol should describe arrangements for post-study
Declaration of Helsinki
Ethical Principles for Medical Research
Involving Human Subjects
3
WMA news
access by study subjects to interventions identified as beneficial
in the study or access to other appropriate care or benefits.
15. The research protocol must be submitted for consideration,
comment, guidance and approval to a research ethics committee
before the study begins. This committee must be independent
of the researcher, the sponsor and any other undue influence.
It must take into consideration the laws and regulations of the
country or countries in which the research is to be performed as
well as applicable international norms and standards but these
must not be allowed to reduce or eliminate any of the protec-
tions for research subjects set forth in this Declaration. The
committee must have the right to monitor ongoing studies.The
researcher must provide monitoring information to the com-
mittee, especially information about any serious adverse events.
No change to the protocol may be made without consideration
and approval by the committee.
16. Medical research involving human subjects must be conduct-
ed only by individuals with the appropriate scientific training
and qualifications. Research on patients or healthy volunteers
requires the supervision of a competent and appropriately quali-
fied physician or other health care professional.The responsibil-
ity for the protection of research subjects must always rest with
the physician or other health care professional and never the
research subjects, even though they have given consent.
17. Medical research involving a disadvantaged or vulnerable popu-
lation or community is only justified if the research is responsive
to the health needs and priorities of this population or commu-
nity and if there is a reasonable likelihood that this population or
community stands to benefit from the results of the research.
18. Every medical research study involving human subjects must be
preceded by careful assessment of predictable risks and burdens to
the individuals and communities involved in the research in com-
parison with foreseeable benefits to them and to other individuals
or communities affected by the condition under investigation.
19. Every clinical trial must be registered in a publicly accessible
database before recruitment of the first subject.
20. Physicians may not participate in a research study involving hu-
man subjects unless they are confident that the risks involved
have been adequately assessed and can be satisfactorily man-
aged. Physicians must immediately stop a study when the risks
are found to outweigh the potential benefits or when there is
conclusive proof of positive and beneficial results.
21. Medical research involving human subjects may only be con-
ducted if the importance of the objective outweighs the inherent
risks and burdens to the research subjects.
22. Participation by competent individuals as subjects in medical
research must be voluntary. Although it may be appropriate to
consult family members or community leaders, no competent
individual may be enrolled in a research study unless he or she
freely agrees.
23. Every precaution must be taken to protect the privacy of re-
search subjects and the confidentiality of their personal infor-
mation and to minimize the impact of the study on their physi-
cal, mental and social integrity.
24. In medical research involving competent human subjects, each
potential subject must be adequately informed of the aims,
methods, sources of funding, any possible conflicts of interest,
institutional affiliations of the researcher, the anticipated ben-
efits and potential risks of the study and the discomfort it may
entail, and any other relevant aspects of the study.The potential
subject must be informed of the right to refuse to participate
in the study or to withdraw consent to participate at any time
without reprisal. Special attention should be given to the spe-
cific information needs of individual potential subjects as well
as to the methods used to deliver the information. After ensur-
ing that the potential subject has understood the information,
the physician or another appropriately qualified individual must
then seek the potential subject’s freely-given informed consent,
preferably in writing.If the consent cannot be expressed in writ-
ing, the non-written consent must be formally documented and
witnessed.
25. For medical research using identifiable human material or data,
physicians must normally seek consent for the collection, analy-
sis, storage and/or reuse.There may be situations where consent
would be impossible or impractical to obtain for such research
or would pose a threat to the validity of the research. In such
situations the research may be done only after consideration and
approval of a research ethics committee.
26. When seeking informed consent for participation in a research
study the physician should be particularly cautious if the poten-
tial subject is in a dependent relationship with the physician or
may consent under duress. In such situations the informed con-
sent should be sought by an appropriately qualified individual
who is completely independent of this relationship.
27. For a potential research subject who is incompetent, the physi-
cian must seek informed consent from the legally authorized
representative. These individuals must not be included in a re-
search study that has no likelihood of benefit for them unless it is
intended to promote the health of the population represented by
the potential subject, the research cannot instead be performed
with competent persons, and the research entails only minimal
risk and minimal burden.
4
WMA news
28. When a potential research subject who is deemed incompetent
is able to give assent to decisions about participation in research,
the physician must seek that assent in addition to the consent
of the legally authorized representative. The potential subject’s
dissent should be respected.
29. Research involving subjects who are physically or mentally inca-
pable of giving consent, for example, unconscious patients, may
be done only if the physical or mental condition that prevents
giving informed consent is a necessary characteristic of the re-
search population. In such circumstances the physician should
seek informed consent from the legally authorized representa-
tive.If no such representative is available and if the research can-
not be delayed,the study may proceed without informed consent
provided that the specific reasons for involving subjects with a
condition that renders them unable to give informed consent
have been stated in the research protocol and the study has been
approved by a research ethics committee. Consent to remain in
the research should be obtained as soon as possible from the
subject or a legally authorized representative.
30. Authors, editors and publishers all have ethical obligations with
regard to the publication of the results of research. Authors have
a duty to make publicly available the results of their research on
human subjects and are accountable for the completeness and
accuracy of their reports.They should adhere to accepted guide-
lines for ethical reporting. Negative and inconclusive as well as
positive results should be published or otherwise made publicly
available. Sources of funding, institutional affiliations and con-
flicts of interest should be declared in the publication. Reports
of research not in accordance with the principles of this Decla-
ration should not be accepted for publication.
C. Additional Principles for Medical Research
Combined With Medical Care
31. The physician may combine medical research with medical care
only to the extent that the research is justified by its potential
preventive, diagnostic or therapeutic value and if the physician
has good reason to believe that participation in the research
study will not adversely affect the health of the patients who
serve as research subjects.
32. The benefits, risks, burdens and effectiveness of a new interven-
tion must be tested against those of the best current proven in-
tervention, except in the following circumstances:
The use of placebo, or no treatment, is acceptable in studies
where no current proven intervention exists; or
Where for compelling and scientifically sound methodological
reasons the use of placebo is necessary to determine the efficacy
or safety of an intervention and the patients who receive placebo
or no treatment will not be subject to any risk of serious or ir-
reversible harm. Extreme care must be taken to avoid abuse of
this option.
33. At the conclusion of the study, patients entered into the study
are entitled to be informed about the outcome of the study and
to share any benefits that result from it, for example, access to
interventions identified as beneficial in the study or to other ap-
propriate care or benefits.
34. The physician must fully inform the patient which aspects of
the care are related to the research. The refusal of a patient to
participate in a study or the patient’s decision to withdraw from
the study must never interfere with the patient-physician rela-
tionship.
35. In the treatment of a patient, where proven interventions do not
exist or have been ineffective, the physician, after seeking ex-
pert advice, with informed consent from the patient or a legally
authorized representative, may use an unproven intervention
if in the physician’s judgement it offers hope of saving life, re-
establishing health or alleviating suffering. Where possible, this
intervention should be made the object of research, designed
to evaluate its safety and efficacy. In all cases, new information
should be recorded and, where appropriate, made publicly avail-
able.
30 years ago the World Health Organiza-
tion crafted the Alma Ata Declaration,
which has served as the core policy of the
WHO since that time. According to the
Alma Ata Declaration “Primary health care
forms an integral part both of the country’s
health system, of which it is the central function
and main focus, and of the overall social and
economic development of the community. Pri-
mary care brings health care as close as possible
to where people live and work, and constitutes
the first element of a continuing health care pro-
cess. […] Primary care should be sustained by
integrated, functional and mutually supportive
referral systems, leading to the progressive im-
provement of comprehensive health care for all,
and giving priority to those most in need.”
Although this approach enjoyed nearly uni-
versal supported in principle, in practice it
has failed the poor countries of the world.
Rather than serving as the driver of overall
The Return of Primary Care
5
WMA news
health care approaches and the core of com-
prehensive systems, all too often primary
care appears to have been assigned the sta-
tus of a general ideology and one in which
primary care was, in fact, an end in itself.
The WHO has recognized that the narrow
interpretation of the Alma Ata Declaration
has resulted in its failure. Not only has it led
to primary care becoming the substitute for
systematic development of health systems
in some countries, in other cases, it has been
used as a defense by funders to curtail im-
provements already underway.
The results are evident in many poor coun-
tries around the world, where health care
systems at best only marginally serve the
population, often providing unfocused pub-
lic health approaches and no real care for
seriously ill patients. Certainly, it can and
must be argued that the financial resourc-
es for health care are scarce and the lack
of financial resources is and remains the
number one problem. But there is also an
interdependency between the reductionist
approach to primary care and the resources
for it. Primary care in the Alma Ata Decla-
ration is not only the main building block
for any health care system, it is also intend-
ed to represent the minimum level of care
that must be delivered. Instead, it has been
mischaracterized as the maximum level con-
sidered necessary to be financed and thus
primary care in this context has become a
dead-end road, a scenario without a future.
In countries where this is the case, patients
and health professionals with the financial
means have simply left. The emigration of
thousands of professionals left the scars of
a painful brain drain epidemic on already
overburdened societies and health systems.
International programme, often construct-
ed around vertical programme to address
single diseases like HIV/AIDS, malaria,
river blindness or tuberculosis, rarely sup-
port comprehensive care approaches. Un-
fortunately patients in these poor countries
tend to have the same, or an even a broader,
spectrum of diseases than in affluent coun-
tries, yet there is no care available to them if
their health needs do not match one of the
vertical programs that may be available.
WHO has taken a big step forward to revive
primary care and to ask for the full and ac-
curate interpretation of the Alma Ata Dec-
laration. Primary care as the core building
block of a health system, as opposed to the
end goal, can then be extended step-by-step
by secondary and tertiary care, which is the
process required if the full development of
health systems is to have any chance to suc-
ceed. Health cares systems require academic
centres for basic and specialist medical edu-
cation. They need treatment facilities for
more difficult cases and severely ill patients.
The requirements will differ from country to
country and will take time to meet. But in
any system of care, there must be a perspec-
tive and an objective for treatment that goes
beyond primary care in order to provide trust,
hope and the impetus for development.
WHO is formally reaffirming its core
policy though the Alma Ata declaration –
and reading it in its full and proper context
creates a new and different story in which
primary care is returned as the starting posi-
tion and the cornerstone for strengthening
and maintaining real health care systems.
However, when listening to the politicians
at the Executive Board session of WHO,
where this policy had to be reaffirmed,
the crux of our future challenge became
evident. While WHO was attempting to
frame primary care as the core element of
comprehensive health care systems, some
of the politicians were promising to provide
comprehensive primary care.
Sources
Alma Ata declaration:
www.who.int/hpr/NPH/docs/declaration_
almaata.pdf
WHO report EB124/8 “Primary health care,
including health system strengthening”:
http://www.who.int/gb/ebwha/pdf_files/
EB124/B124_8-en.pdf
Resolution EB124/8 on Primary Care:
http://www.who.int/gb/ebwha/pdf_files/
EB124/B124_R8-en.pdf
Resolution EB124/9 on Traditional
Medicine:
http://www.who.int/gb/ebwha/pdf_files/
EB124/B124_R9-en.pdf
Otmar Kloiber, WMA Secretary General
Primary Care at the 124th
Session of
the WHO Executive Board
Between annual Word Health Assemblies the Executive Board
serves as the most influential organ of the WHO. According to
the WHO website, “The main functions of the Executive Board
are to give effect to the decisions and policies of the Health As-
sembly, to advise it and generally to facilitate its work.”
The body,composed of 34 country representatives,read among oth-
er documents the WHO report EB124/8 “Primary health care, in-
cluding health system strengthening”. In resolution (EB124/8) the
Executive Board accepted the report reaffirming WHO’s commit-
ment to primary care and connected it to health system strengthen-
ing efforts, emphasising the will for development.
In a side debate some delegates tried to introduce traditional med-
icine into the resolution.This effort failed,but a separate resolution
(EB124/9) on traditional medicine opens the door for countries to
include traditional medicine in primary care. Among other points
the resolution urges member states, “to consider, where appropriate,
including traditional medicine into their national health systems based
on national capacities, priorities, relevant legislation and circumstanc-
es, and on evidence of safety, efficacy and quality”.
While the resolution offers a chance for the proper evaluation of
traditional medicine, it may, on the other hand, open the door for
substituting traditional medicine for quality, proven medical care.
After all, the “evidence” of what constitutes efficient, effective and
safe will most likely be determined by those in power.
6
WMA news
Counterfeit medicines are drugs manufac-
tured below established standards of safety,
quality and efficacy and therefore risk causing
ill health and killing thousands of people ev-
ery year. Experts estimate that 10 per cent of
medicines around the world could be coun-
terfeit.The phenomenon has grown in recent
years due to counterfeiting methods becom-
ing more sophisticated and to the increasing
amount of merchandise crossing borders.
Health impact of counterfeit
medication
According to the WHO, a counterfeit medi-
cine is “a medicine, which is deliberately and
fraudulently mislabelled with respect to iden-
tity and/or source“. Counterfeiting can apply
to both brand name and generic products and
counterfeit medicines may include products
with the correct ingredients but fake pack-
aging, with the wrong ingredients, without
active ingredients or with insufficient active
ingredients or even poisoning ingredients.
Counterfeit medicines are a threat to the
health of individuals and the public health.
The serious harm for individuals can be gen-
erated either by excessive activity of the prin-
cipal active ingredient,by an insufficient dos-
age of active ingredient or by the toxicity of
ingredients that should not be present in the
medicine. Patients may also think they are
protected against a disease or an undesired
health event when in fact they are not.
Diluted or insufficiently-dosed medicines are
a threat to public health as they contribute
to drug resistance in populations, leading to
increased infection rates, increased need for
research and development of new drugs, and
increased health care spending. On the other
hand counterfeits interfere with the analysis of
adverse events as they give the impression that
the regular drug produced the adverse event.
They deprive the inventors and original
producers of medicines or materials from
their reward, thus inhibiting further devel-
opment. Even worse, they reduce the trust
in medication and therefore in physicians
and in consequence diminish adherence to
treatment schemes.
WMA activities on counterfeit
The World Medical Association, together
with the partner organisations of WHPA,
joined the International Medical Products
Anti-Counterfeiting Taskforce (IMPACT)
led by WHO in 2006 to combat the global
problem of counterfeit pharmaceuticals.
IMPACT brings together nearly two hun-
dred countries, as well as organizations with
expertise in enforcement, manufacturing,
and patient advocacy, and has called atten-
tion to the public health and commercial
impact of counterfeit medicines.
WHPA have developed a counterfeit medi-
cines toolkit ‘BE AWARE’to assist dentists,
nurses, pharmacists and physicians to tackle
counterfeit medicines in their daily prac-
tice. The toolkit shows some key steps that
health professionals can take to identify and
report counterfeit medicines, to help fight
such criminal practices and make treat-
ments safer (see box).
Executive board meeting of WHO
At the last Executive board meeting of the
WHO in January 2009 the report and draft
resolution on counterfeit medical products
were discussed and all member states stressed
the importance of protecting public health
against risks caused by counterfeit medica-
tions. However an intense debate started on
the definition of counterfeits versus substan-
dards of medicine. So far WHO has focused
on counterfeits while largely ignoring the
broader and more politically sensitive -cat-
egory of substandard drugs. WHO’s rec-
ommendations are subject to the whims of
member states. They find it easier to tackle
counterfeits rather than substandard drugs
because the latter are often manufactured by
taxpaying firms within their borders.
On the other hand substandard drugs are
difficult to combat.Identifying poor-quality
batches requires widespread testing, which
poor governments may be reluctant or un-
able to finance. Demanding manufacturer
compliance requires both strict legal codes,
which countries may lack, and rigorous en-
forcement, which many governments are
unable or unwilling to perform. Ultimately,
sustainable quality control requires each
company to introduce good techniques and
production ethics, which can take decades.
Nevertheless exporting countries are involved
in the production and distribution of sub-
standard medication as well. Their exported
medicines do not necessarily meet the same
standards as those for domestic products, ex-
cept when the importing countries have less
stringent requirements. No consensus was
found during the meeting and therefore the
WHO secretariat will do further reporting
in order to address the public health dimen-
sions of counterfeit and substandard medi-
cines and an additional text will be submitted
for further discussion at the World Health
Assembly in May 2009.
Further links:
http://www.whpa.org/pubs.htm
http://www.who.int/impact/FinalBrochureWHA2008a.pdf
http://www.who.int/impact/en/
Julia Seyer, WMA Medical Advisor
Counterfeit Medicines
BE AWARE toolkit:
B• e observant and use WHPA visual
inspection tool to identify counterfeit
medicines.
E• valuate your patient’s response to the
medicine use.
A• cquire as much information
W• here was the product procured
A• ctively inform your health profes-
sional colleagues if medicines have
been confirmed as counterfeit
R• emove any suspect medicines from
the pharmacy, clinic, hospital or con-
sulting room
E• ducate your colleagues, patients and
the public
7
WMA news
Introduction: December 2008 marked the
launch of Health Sciences Online (www.hso.
info) the only site with more than 50,000
courses, references, guidelines, and other
expert-reviewed, high-quality, current, cost-
free, and ad-free health sciences resources.
Free and accessible to anyone, the up-to-
date, authoritative information is aimed
primarily at physicians, other health care
practitioners, and public health providers,
enabling their training, continuing educa-
tion, and delivery of effective treatments
to patients. The information is delivered
by search technology from Vivisimo, Inc.,
which allows users to easily see comprehen-
sive search results and quickly find the an-
swers they need with an intuitively navigat-
ed graphic interface. Through integration
with Google Translator, users can search
and read materials in 22 languages.
Former CDC Director Dr. Jeff Koplan calls
Health Sciences Online (HSO) “a visionary
undertaking” and the World Bank heralds
it as “globally democratizing health science
knowledge.” HSO is expected by the World
Health Organization (WHO) “to make a
considerable contribution to the advance-
ment of e-learning worldwide.”
HSO is a portal that includes more than
50,000 world-class health-sciences re-
sources, selected by our knowledgeable
staff from already-existing, reliable, pro-
fessional sources and resource collections.
These include medical specialty societies,
accredited continuing education organiza-
tions, governments, and universities such
as Cambridge, Columbia, Harvard, Hop-
kins, McGill, MIT, Penn, Stanford, and
Yale. Founding collaborators for this site
include the World Medical Association,
CDC, World Bank, the American College
of Preventive Medicine, and the University
of British Columbia, and financial support
has come from WHO, the NATO Science
for Peace Program, the Canadian govern-
ment, the Annenberg Physician Training
Program, and many volunteers.
Background: Health sciences information
and training are vital for health and socio-
economic development, but excellent, free
learning resources are difficult to find. In
recent years, information and communica-
tion technologies, particularly the Internet,
have been central to remedying this situa-
tion. But there are still significant hurdles
to accessing online content. WHO notes
that there is an enormous need to identify
selective, current, accessible online educa-
tional and training resources to promote
appropriate care and policies.
Initiative details: A portal to a virtual learning
center with browse and search functions,pro-
viding free, online linkages to a comprehen-
sive collection of top-quality courses and ref-
erences in medicine, public health, pharmacy,
dentistry, nursing, basic sciences, and other
health sciences disciplines. These materials
are donated, and typically hosted and main-
tained by our distinguished content partners,
so materials are constantly updated.
Our Advisory Committee includes both
distinguished visionaries in health scienc-
es, and experienced practitioners in online
health sciences education:
Chris Candler, MD; Associate Dean for•
Medical Education, University of Okla-
homa College of Medicine
Stephen Carson, MFA; Senior Strategist,•
Open Courseware; MIT
Jim Curran, MD, MPH; Dean, Rollins•
School of Public Health, Emory Univer-
sity
Joan Dzenowagis,PhD; Project Manager,•
Health InterNetwork, WHO
Erica Frank, MD, MPH; HSO Founder/•
Executive Director, Advisory Committee
Chair
Sukon Kanchanaraksa, PhD; Director,•
Teaching and Learning with Technol-
ogy, Johns Hopkins Bloomberg School of
Public Health
Steven Kanter, MD; Vice Dean, School•
of Medicine, University of Pittsburgh
Jerome P. Kassirer, MD; Distinguished•
Professor, Tufts Univ. SoM, Former Ed-
itor-in-Chief, New England Journal of
Medicine
Jeff Koplan, MD, MPH; Former Direc-•
tor, CDC, EVP for Health Affairs, Em-
ory University
Edward Maibach, MPH, PhD; Professor,•
Social Marketing, George Mason Uni-
versity
Anne Margulies, BS; Executive Director,•
Open Course Ware, MIT
J.B. McGee, MD; Assistant Dean for•
Medical Education Technology, Univer-
sity of Pittsburgh School of Medicine
Pat Moholt, EdD; Executive Director,•
Global Health Care Learning, Interna-
tional and Corporate Health, NewYork-
Presbyterian
Hugh Tilson, MD, DrPH Clinical Pro-•
fessor of Epidemiology/Health Policy,
Senior Advisor to the Dean, UNC SPH
“HSO is an incredible resource for health
professionals all over the world. Open ac-
cess to health information should literally
save millions of lives and lead to important
new discoveries,”said Anne Margulies, Ad-
visory Committee member and Executive
Director of Open Course Ware at MIT.
And our reviews* have been strong, calling
HSO “the internet at its finest… a bonan-
za… a boon… an incredibly worthwhile en-
terprise… a model of what Health 2.0 and
Science 2.0 can be… one of the most altru-
istic and honorable health service resources
on the planet”. We believe that HSO has
succeeded because our vision of a democ-
ratization of health sciences knowledge has
tremendous appeal to a wide variety of sup-
porters. This ranges from an endocrinologist
who donated $50,000 because “HSO will
Health Sciences Online: the First
Authoritative, Comprehensive, Free and
Ad-Free Resource for the World’s Physicians
8
WMA news
In August 2008, the Commission on Social
Determinants of Health, chaired by Profes-
sor Sir Michael Marmot of the University
College of London, published its final report
“Closing the gap in a generation – Health eq-
uity through action on the social determinants
of health”. The report is the result of global
collaboration of policy-makers, researchers
and civil society, led by Commissioners with
extensive political, academic and advocacy
experience. The purpose of the Commission,
launched by the late WHO Director general
Dr. Lee Jong-Wook, was to provide guidance
to Member States and WHO’s programmes
by gathering evidence on social determinants
and ways to overcome inequities. In this com-
prehensive 200-page report, the Commission
addresses global health through social deter-
minants, i.e. the structural determinants and
conditions of daily life responsible for a major
part of health inequities between and within
countries, and proposes a new global agenda
for health equity. The global agenda includes
three overarching recommendations:
1. Improve daily conditions
This recommendation puts major emphasis
on early child development and education
for girls and boys, improvement of living
and working conditions and creating social
protection policy supportive of all.
2.Tackle the inequitable distribution
of power, money, and resources
This proposal places responsibility for action
on health equity – including equity between
women and men – at the highest level of gov-
ernment policy, with the support of a strong
public sector and effective governance.
3. Measure and understand the problem
and assess the impact of action
Under this recommendation, national and
global health equity surveillance systems
should be established to conduct routine mon-
itoring of health inequity and the social deter-
minants of health.This requires investment in
research,training of policy-makers and health
practitioners, and public understanding of the
social determinants of health.
Developing a health
mainstreaming strategy
The holistic approach taken in the report
places health equity at the core of the matter,
calling for global and coherent principles of
action in order to achieve the health-related
Millennium Development Goals (MDGs).
The Commission supports the implementa-
tion of “health mainstreaming”, a strategy
originally designed by the United Nations in
19851
to advance equality between women
and men worldwide. Since then, the concept
has been developed and used in other areas
of discriminations and in the environmental
field. Applied to health, such a strategy aims
to make health matters an integral dimension
of the design, implementation and evaluation
of policies and programmes in all political,
economic and societal spheres, with the ulti-
mate goal of achieving health equality. At the
national level, favouring this horizontal ap-
proach, rather than a sectoral one, leverages
the full decision-making spectrum – from de-
sign through monitoring – to assess the health
impact for the population of any decision
planned.This strategy helps raise awareness of
the intrinsic value of health, from social, eco-
nomic and human rights perspectives, and its
potential to promote social cohesion and well-
being. It can also stimulate reflections on the
overall health system and its relation to the
other national policies and structures in place.
Similar to gender-mainstreaming, the suc-
cess of a health mainstreaming strategy relies
on the political will of decision-makers, on
1 Third World Conference on Women,Nairobi,1985
Social Determinants of Health as a Driving
Force Towards Health Equity
change the world”, to an Armenian special-
ist in preventive medicine who volunteered
>1,000 hours because “HSO will finally
make top-quality information available to
all the world’s doctors”, to Senator Sam
Nunn’s Global Health and Security Initia-
tive stating that “HSO has abundant high
quality resources, so it’s not like putting in
keywords in a normal search engine – this
will create revolutions in health education,
disease surveillance, and telemedicine.”
Next steps – and how your institution can ben-
efit: Anyone can use materials from www.
hso.info, and we encourage WMAJ’s readers
and your colleagues to do so. Additionally,
HSO’s next phase is developing programs
using the gathered materials to help train
and educate medical and other clinical and
public health providers around the world.
We have already begun collaborating with
medical educators to create certificates,
continuing education, residency programs,
and even degrees, and encourage interested
collaborators to contact us.
Contact information for corresponding author:
Erica.Frank@ubc.ca
*http://www.altsearchengines.com/2008/12/26/
hope-for-the-future-health-sciences-online/
*http://sandnsurf.medbrains.net/2008/12/health-
sciences-online/
Erica Frank,
Professor of the University of British Columbia
Lack of emphasis on health professionals
as key players to achieve health equity
On the occasion of the 124th
session of
WHO Executive Board (January 2009),
the World Medical Association – on be-
half of the World Health Professions Al-
liance (WHPA) – presented a statement
on this report, with a focus on the health
workforce. In this statement, the WHPA
welcomed the recommendation directed at
national governments and donors to “in-
crease investment in medical and health
personnel”, but regrets that the report in
general does not give more attention to
health professionals as key players in ad-
dressing the social determinants of health
and the inequalities health professionals
face in their daily work. Concerning more
specifically the recommendation to ad-
dress the health human resources brain-
drain, the WHPA recalls the key message
of its Joint Health Professions Statement
on Task Shifting1
and insists on the im-
portance of developing positive practice
environments in the health sector as a re-
tention strategy.
9
the involvement of the actors concerned,and,
of course, on financial means. Although the
report of the Commission on Social Deter-
minants of Health has been applauded for
its comprehensive analysis and data, as well
as for its ambitious recommendations, it re-
mains to be seen whether the Member States
will have the political will and the means to
“lead global action on the social determi-
nants of health with the aim of achieving
health equity”2
. For now, during its last ses-
sion (January 2009) the countries members
2 Closing the gap in a generation’, intro, p.1
of the Executive Board of the World Health
Organisation were humbly invited “to note”
the report …
The report can be downloaded from WHO web-
site: http://www.who.int/social_determinants/en/
Clarisse Delorme, WMA Advocacy Advisor
Education
The Avicenna Directories – a new tool in quality assurance
of medical education
The creation of the Avicenna Directories –
the global directories of education institu-
tions for health professions – is a project in
progress.
Introduction
Early in its history, the World Health Or-
ganisation (WHO) developed a Directory
of Medical Schools, the first edition being
published in 1953 [1]. It was intended, at
that time, that the Directory of Medical
Schools would be followed by comparable
directories of schools of dentistry and of
veterinary medicine. The data were gath-
ered through questionnaires to the institu-
tions themselves. The medicine-centred ap-
proach, which would not be appropriate in
the 21st century, was clear: the introduction
stated “The physician is the key figure in any
health or medical programme”.
The WHO World Directory of Medical
Schools appeared in successive editions
until the last, seventh, edition published in
2000 [2]. Successive editions have varied in
style and content. Most have included, for
each country,a summary of salient informa-
tion about the system of medical education
and regulation of medical practice in the
country. The sixth edition (1988) included
information on admissions and on the cur-
riculum for each school,where available,but
this feature is not found in earlier or later
editions. Notably, each edition soon fell out
of date, because of the rapid evolution of
medical education, because of the inevitable
time-lag between collection of data and
publication in book form, and because of
the lack of effective mechanisms for updat-
ing information.
New Directories
In designing such an important resource,
modern electronic data collection and data
management give an opportunity for col-
lection of wide-ranging information, in
particular statistical data about institutions
and their programmes and about quality as-
surance. Web-based methods allow timely
updating and verification of such informa-
tion. Thus, directories can be created that
are more accurate, more up-to-date and
more comprehensive – both in the range of
disciplines covered, and in the amount of
information on each institution. It is also
important to extend the range of the direc-
tories beyond medicine, because the provi-
sion of health care, and the prevention of
ill-health, is the remit of the entire team of
health workers: medicine, pharmacy, public
health, dentistry and so on.
In 2007, WHO and the University of Co-
penhagen agreed that the University would
develop new global directories of higher ed-
ucation institutions for health professionals,
on the principles of:
Comprehensive coverage•
Improved high-quality detailed informa-•
tion – and
Improved usability•
Comprehensive coverage includes both the
range of health professions, as above, and
coverage of all schools that meet the fol-
lowing criteria:
Recognition by the national government•
Regular admissions of students for face to•
face education
Schools with national admission in the•
country concerned
David Gordon, Leif Christensen, Hans Karle and Theanne Walters Avicenna Directories, University of Copenhagen
10
Education
Schools with at least one campus in the•
country concerned and
Schools with administrative and legal•
structures in the country concerned.
Improved information includes information
on management, ownership, accreditation,
educational programme and admissions
for each school, and improved usability in-
cludes information that can be readily ac-
cessed, searched and downloaded.
These principles were set out in a Memo-
randum of Understanding (MoU) between
WHO and the University of Copenhagen
signed in August 2007. The MoU established
a Steering Board jointly between the Univer-
sity and WHO,to be assisted by an Advisory
Committee of interested stakeholders, and
provides that the University will be assisted
by the World Federation for Medical Edu-
cation (WFME [3]) in development of the
new directories: the Avicenna directories.
Why Avicenna?
Avicenna – Abu Ali al-Hussain Ibn Ab-
dallah Ibn Sina – was a polymath, and the
leading physician and philosopher of his age
[4]. His life (ca. 980 – 1037 CE) and career
was in and around modern-day Iran and Uz-
bekistan, but his outlook was international.
His most important medical writing was The
Canon of Medicine[5], in which he integrat-
ed his own learning with sources as disparate
as classical Greece, Galen and early Indian
medicine: the Canon was widely translated,
for example into Chinese and Latin, and re-
mained an important textbook for centuries.
Three principles in Avicenna’s career and
writing are particularly inspiring for the
Avicenna Directories: his willingness to
gather and synthesise worthwhile knowl-
edge from the entire known world; the em-
phasis on the practical application of medi-
cal principles (it was not enough to know
medicine, the need was to apply knowledge
to heal the sick); and the preservation and
dissemination of learning to take medicine
forward. These principles are as true now as
a thousand years ago – therefore the choice.
Within the detailed aims of the MoU estab-
lishing the Avicenna directories, these three
principles associated with Avicenna remain:
the collection of information from world-
wide sources; the synthesis of that data into
a useful and applicable form; and dissemi-
nation to all who need the information.
Progress since July 2007
The offices of WFME are situated within
the University of Copenhagen,and the Avi-
cenna secretariat is based with WFME. The
team that has been created is international
and includes experts in medical and social
science and in the work of standard-setting
authorities, as well as IT and database ex-
pertise. There is regular discussion with col-
leagues within the University of Copenha-
gen, with WHO, and with an international
network of interested advisors. In addition,
the Advisory Committee for the project had
its first meeting in 2008.
One early task was to place data from the
seventh edition of the WHO World Direc-
tory of Medical Schools, with updates re-
ceived by WHO to the end of 2007, on the
Avicenna website[6].These data are still be-
ing updated on request.Regulatory agencies
and other interested parties are increasingly
using the Avicenna website for this infor-
mation. One outcome is a steady stream of
enquires (between 5 – 20 each week) about
inclusion of medical schools in the data-
base, and an increasing number of hits on
the Avicenna website, currently about 2.500
each month.
Current and future issues
For the time being, the only academic dis-
cipline represented in the database on the
Avicenna website is medicine. In order to
expand the Directories, so that the other
professions are presented as soon as is prac-
ticable, discussions have begun with other
partners in the Avicenna project. Thus far,
this has included the International Phar-
maceutical Federation (FIP) and the World
Federation of Public Health Associations
(WFPHA), to plan the development of
Directories of schools of pharmacy, and of
public health, in the Avicenna project.
The MoU between WHO and the Uni-
versity sets out the need for information
to be gathered from reliable sources, using
a variety of tools, and explicitly mentions a
questionnaire based approach, as was also
the case for entries for individual medical
schools in all editions of the WHO World
Directory. The Avicenna team have no
doubt that this remains the most important
approach. It ensures that all schools in a
given academic discipline are asked iden-
tical questions and can provide their own
response: it is comprehensive and allows a
uniform and standardised approach to the
checking and validation of data. The use,
as a primary source, of information from
places other than the institution itself would
be unequal and would require inappropriate
interpretation by the Avicenna team itself.
Thedevelopmentofaquestionnairetoproduce
reliable and valid data is a considerable tech-
nical task [7, 8] and has taken many months,
with extensive consultation. A draft version
was piloted the last three months of 2008 by
20 medical schools,representing a world-wide
range of many different types of school. In the
light of these pilot responses, and comments
received, a final version of the questionnaire
for general use has been developed. The ques-
tionnaire is web-based, and will – where pos-
sible – be completed on line,and is in a format
that, once the information is validated, can be
downloaded into the Avicenna database.
The validation process will extract relevant
answers from the questionnaire response
from each school, and verify these with the
proper national validating authority.
It would logistically not be possible to sur-
vey all the medical schools in the world, or
all the schools in any discipline, at a single
time. Studies will therefore begin with
data collection from a group of countries
that represent about one quarter of all the
world’s medical schools. The remaining
medical schools will be surveyed in suc-
cessive waves. Allowing time for valida-
11
tion of information, and for transfer to the
website, a complete Avicenna Directory for
medicine is expected to be available by early
2010. The completion of Avicenna Direc-
tories for the next two subjects, pharmacy
and public health, depends on the continu-
ing development of plans with the relevant
partners, FIP and WFPHA.
Updating of information according to re-
quests will be on a continuing basis. In ad-
dition, it is planned to survey all institutions
every three years, on a rolling programme, so
that information is never long out-of-date.
It is clearly desirable for the Avicenna Direc-
tories to include relevant information at a na-
tional and regional level about the system of
education for health professionals, processes
for evaluation of educational institutions and
their programmes, the licensing framework
for these professions and so on.
Concluding remarks
The Avicenna project will create an up-to-
date, easily accessible, and comprehensive
electronic world list of education institu-
tions for the health professions.
There will be detailed information by coun-
try on each educational institution, about
the programmes of study and the resources
in each school, about quality assurance, and
contact details – useful for everyone world-
wideconcernedwitheducationforthehealth
professions,whether as a student,a teacher,a
regulator or other health authority.
http://avicenna.ku.dk
References
1 World Health Organization. World directory of
medical schools, 1st edn. Geneva: WHO, 1953.
2 World Health Organization. World directory of
medical schools, 7th edn. Geneva: WHO, 2000
3 http://www.wfme.org (accessed 4 February
2009)
4 http://en.wikipedia.org/wiki/Avicenna(accessed
4 February 2009)
5 http://en.wikipedia.org/wiki/The Canon of
Medicine (accessed 4 February 2009)
6 http://avicenna.ku.dk/ (accessed 4 February
2009)
7 A N Oppenheim, Questionnaire Design, Inter-
viewing and Attitude Measurement. London:
Pinter, 1992
8 R Sapsford & V Jupp, Data Collection and
Analysis. 2nd edn. London: Sage Publications,
2006.
Medical Ethics, Human Rights and Socio-medical affairs
Tom F , Deputy Head, Health Policy
& Economic Research, British Medical
Association
Blair’s Plan
On the eve of the 1997 election,Tony Blair,
the soon-to-be Prime Minister, famously
told voters they had ‘24 hours to save the
NHS’ (National Health Service). With La-
bour’s subsequent victory much was expect-
ed from a government that had purposefully
positioned itself as ‘the party of the NHS’.
A series of pledges and initiatives followed.
but it was with the publication of the ‘NHS
Plan’1
in 2000 that a watershed moment in
modern NHS reform came to pass which
was to set the direction of health policy for
the coming decade. At its core the NHS
Plan articulated a desire to increase capac-
ity, improve access and forge a new, more
responsive NHS. By promoting the value of
a more mixed supply side and encouraging
an increased challenge to the medical pro-
fession’s power, the NHS Plan ushered in
a period of ‘constructive discomfort’2
based
on a belief that improvements in the NHS
would require a certain amount of creative
tension in order to overcome what was re-
garded as a degree of both complacency and
inertia in the system.
In setting out a series of strategies designed
to reform the NHS – modernising its in-
frastructure, setting national standards, en-
abling ‘patient choice’, employing market
incentives and a growing role for the private
sector in delivering NHS care – the Gov-
1
DepartmentofHealth(2000)TheNHSPlan:aplan
for investment, a plan for reform, London:DH.
2
Stevens, S (2004) ‘Reform strategies for the Eng-
lish NHS’, Health Affairs, vol 23, no 3:37-44.
ernment matched these ambitions with a
five-year spending plan to bring the NHS
budget up to European levels by 2008 com-
prising year-on-year rises in UK spending
from £65.4bn in 2002 to £100.6bn in 2007,
more than 7% in real terms annually.Along-
side this health reform agenda, the United
Kingdom was also witnessing a process of
devolution, with each of its four home na-
tions slowly evidencing divergent policy
across a range of areas. The NHS was (and
remains) at the vanguard of this process.
Brown’s Vision
With a change of Prime Minster in the
summer of 2007 it was not clear whether
the direction of travel would alter, particu-
larly the recent emphasis on market-based
reform. Some commentators anticipated a
step-change given the new Prime Minister
Gordon Brown’s documented reservations
concerning the extent to which the market
could play a role in healthcare and medicine3
.
The launch of the NHS Next Stage Review
in the months after Brown took charge was
regarded as an early signal that change was
perhaps on the horizon. The 12-month re-
view, led by the eminent surgeon Professor
(now Lord) Darzi, was to take stock of the
3
Brown, G. (2004) A modern agenda for prosperity
and social reform, London: Social Market Foun-
dation.
National Health Service (England).
Next Stage Review –“high quality care for all? ”
rusher
12
Medical Ethics, Human Rights and Socio-medical affairs
reform agenda in the English NHS and pro-
pose a vision for the next 10 years.
The review’s findings were published in June
2008 in ‘High Quality Care for All’4
and the
vision it comprises is structured around four
broad themes:
‘high-quality care for patients and the•
public’ – an NHS that works in partner-
ship to prevent ill health, providing care
that is personal, effective and safe
‘quality at the heart of everything’ – high-•
quality care throughout the NHS
‘freedom to focus on quality’ – fostering•
clinical leadership and putting frontline
staff in control
‘high-quality work in the NHS’ – sup-•
porting staff through education and
training to deliver high-quality care.
A further substantive element of the report
established proposals for an NHS constitution
for England, with the aim of formally setting
out for the first time the purpose, principles
and values of the NHS as well as the rights
and responsibilities of patients,the public and
NHS staff5
.The concept of a constitution has
received cautious support from a range of
stakeholders,including the BMA6
.
Amongst other headline proposals was the
undertaking to offer extended choice in pri-
mary and community care with improved
access and a wider range of providers, pri-
marily by way of a pledge to create 150 new
GP-led health centres (or ‘polyclinics’).This
has so far proved to be perhaps the most
controversial proposal with much concern
amongst the medical profession, in partic-
ular general practitioners, that these plans
were not only ill-thought through with no
thorough assessment of any real local need
for the new centres, but that they would act
to divert resources away from existing gen-
4
Department of Health (2008) High Quality Care
for All, London:DH.
5
The ‘NHS Constitution for England’ was formally
published on 21st January 2009. see http://www.
dh.gov.uk/en/Healthcare/NHSConstitution/in-
dex.htm
6
British Medical Association (2008) An NHS
Constitution for England, London:BMA. (www.
bma.org.uk)
eral practice and primary care services, de-
stabilising local health economies and well-
established care pathways. Moreover, the
view that these plans might offer the private
sector another opportunity to increase its
role in delivering NHS care further fuelled
fears about the ongoing commercialisation
of the NHS.
The same, but different
Ultimately in looking beyond the detail con-
tained in “High Quality Care for All”, it is
clear that the mainstays of previous English
reform – improving access, patient choice, a
diversity of provision linked to market incen-
tives – will continue to feature heavily. Nev-
ertheless, the report does provide a shift in
focus and with it a change in language and
approach. Key to this new focus is the cen-
tral desire to target improvements in quality
(rather than the previous targeting of capac-
ity). Furthermore, the ‘quality agenda’ is ar-
ticulated by way of a commitment to have
future reform ‘locally-led, patient-centred
and clinically-driven’. Importantly for the
medical profession in developing this theme,
the review built on an earlier recognition
that NHS staff ‘had been ignored, that their
values had not been fully recognised, and
that they had not been given credit for im-
provements that had been made’7
.The vision
for the future is therefore one that aims to
nurture a ‘new professionalism’ with a much
greater emphasis on clinical leadership in
delivering improvements in the NHS. The
vast scope of the report does not lend itself
to a brief analysis and so what follows is an
overview of two of the fundamental elements
of the vision it espouses, the ‘quest for qual-
ity’ and ‘clinical leadership’, and some of the
questions they raise.
Darzi’s Quest
Quality
In wishing to steer the NHS away from a
centrally driven performance management
regime,Lord Darzi’s report seeks to enable a
future where all change is based on the best
7
Department of Health (2007) Our NHS, Our
Future, NHS Next Stage Review: interim report,
London:DH.
available evidence, with the aim of improv-
ing the quality of care that patients receive
always paramount. The ‘quest for quality’
he sets out is supported by a host of initia-
tives including a new set of national quality
indicators for acute services, a new quality
framework for community services and the
development of a wider range of local qual-
ity metrics. All providers working for or on
behalf of the NHS will,by 2010,be required
to publish ‘Quality Accounts’ detailing the
quality of their services based on measures
of patient safety, patient experience and the
effectiveness of care (mortality, complica-
tion or survival rates and patient-reported
outcome measures).
To further incentivise change in this area
the review also proposes payments to hos-
pitals conditional on the quality of care they
deliver. As a result, by 2010-11 a proportion
of annual hospital trust income will be de-
pendant on meeting service quality require-
ments. This will be driven by two particular
initiatives. The first will link hospital tariff
payments to patient-reported outcome
measures and indicators, such as hospital
acquired infection rates.The second will see
the introduction of a ‘best practice tariff’
through which payments for a range of pro-
cedures that are currently evidencing signif-
icant unexplained variation in practice will
be based not on average cost, but rather on
best practice (which notably in most cases
will be at a lower cost than the average).
Clearly, these initiatives require the NHS
to expand the scope and volume of data it
collects. However, the NHS’s ability to pro-
duce reliable, comparable data has histori-
cally been the subject of much criticism and
the initiatives’ success will therefore depend
heavily on a significant improvement in the
quality of data production itself, rather than
simply using existing datasets differently. In
addressing this shortcoming one cannot ig-
nore the related cost implications. A report
to the Department of Health in 2007 sug-
gested that the cost of collecting data on pa-
tient-reported outcome measures for elective
surgery ranged from £3 to £11 per patient
(Browne et al 2007). If such figures were ap-
13
Medical Ethics, Human Rights and Socio-medical affairs
plied to high-volume procedures, the total
cost would approximate to many hundreds
of thousands of pounds per procedure type.
It is noteworthy that “High Quality Care for
All”contains few details of costings for these
and the other proposals it contains.
Interestingly, as these examples demon-
strate, despite the report’s focus on localism
and its determination to avoid a culture of
imposed targets,there remains a critical role
for the centre with large elements of the
quality agenda set at the national level. Fur-
ther to this,the report also proposes that the
National Institute for Clinical Excellence
(NICE) has its remit expanded to set and
approve more national quality standards,
whilst a new ‘National Quality Board’ will
provide strategic oversight and leadership
on quality issues. It remains to be seen how
successfully these national and local level
initiatives will interface and where tensions
may arise, how the old charge of a ‘top-
down’ approach will be avoided.
Nevertheless, the focus on quality is to be
welcomed. Robust and reliable quality mea-
sures should provide a solid, evidence-based
platform for service improvement and will
hopefully provide a currency that clinicians
can both identify with and engage in when
reviewing clinical practice and looking at ser-
vice redesign. For patients, the routine pro-
duction of outcome data promises to increase
their ability to make informed choices about
their care and with the inclusion of patient
experience indicators, the NHS should be-
come ever more responsive to patients’needs.
However, whether patients can truly become
the empowered users of this information
remains open to question. Past experience
suggests that those patients who might most
benefit from a more detailed picture of the
care available to them often do not have
the necessary understanding or expertise to
make use of data to this end. Consequently,
such patients will require support in relating
to the quality markers and making informed
choices on this basis thus raising again the
issue of where the necessary resource can be
found to enable this.
Clinical Leadership
As noted above what is striking about the
outcome of the NHS Next Stage Review
is the unprecedented emphasis it places on
the role that clinicians have to play in lead-
ing change in the NHS. Where previous
reform, imposed from above, often acted
to disenfranchise NHS staff, the vision for
the future places the medical profession
(and other health professions) at the heart
of the process, seeking to engage them in
its planning, implementation and delivery.
The review contends that where change is
led by clinicians and based on evidence of
improved quality of care, staff who work in
the NHS respond better to it and patients
and the public are more likely to support it.
To enable this new approach the review
proposes a series of initiatives aimed at de-
veloping clinical leadership skills across the
medical profession. These range from re-
viewing undergraduate curricula for medi-
cal students to ensure that they reflect the
skills required for leadership; establishing
Clinical Leadership Fellowships to provide
protected time for clinicians to develop
their leadership skills; and establishing a
‘Clinical Management for Quality’ pro-
gramme for clinicians managing services,
especially clinical directors and primary care
professionals running practice-based com-
missioning groups. Much of this centres on
developing leadership at a local level but in
wishing to promote the concept of leader-
ship further an NHS Leadership Council,
chaired by the NHS Chief Executive, has
also been created that will act to nurture the
next generation of NHS leaders.
This investment in new programmes of
clinical leadership is welcome but it will be
some time before a proper assessment can
be made as to whether clinicians on the
ground identify and engage with the process
in a meaningful way.There will no doubt be
some initial scepticism amongst those who
question how meaningful the new oppor-
tunities are. The true test of success will be
how these undertakings are taken forward
at the local level where doctors and their
colleagues should undoubtedly be central to
the leadership of the organisations in which
they work.
What next?
Many concerns remain about the general
direction of travel that reform over the last
decade has taken, in particular the grow-
ing commercialisation of the NHS and
the potential for market reforms to foster
competition rather than collaboration and
engender fragmentation not integration.
There is also doubt as to whether the am-
bitious programme of reform has begun
to deliver substantial benefit to patients.8
As with recent past policy, the Next Stage
Review suffers from its own grand scale.
Whilst promising no new reorganisations
and offering the hope of stability within the
service,the vision encompasses a wide range
of significant changes – in primary care, in
community care,in acute care,in funding,in
measurement, in reporting, in training and
education. Does the ‘quality agenda’ pro-
vide enough of a cohesive focus to ensure
that such expected widespread change will
be successful? More worryingly, it is not at
all clear that many of the proposals have an
adequate evidence-base or have been suf-
ficiently tested in terms of cost or possible
unintended consequences.
Now, in early 2009, some 6 months or so
on from the launch of High Quality Care
for All, there are early signs that the NHS
in England is pursuing many of the policy
challenges it sets out. But perhaps now even
bigger challenges lie ahead. Given the cur-
rent economic climate the Treasury has al-
ready warned that overall public spending
growth will be cut from the 1.9 per cent real
terms growth rate enjoyed for 2008-09 so
that it will be reduced to just 1.2 % a year
from 2011 onwards. We might predict that
the NHS will see growth close to zero when
allocated its share of public funds.The ques-
tion is, following on from the exceptional
levels of funding the NHS has experienced
in recent years can Lord Darzi’s vision be
delivered on a shoe-string?
8
Audit Commission (2008). Is the treatment work-
ing? Progress with the NHS system reform pro-
gramme, London: Audit Commission.
14
Medical Ethics, Human Rights and Socio-medical affairs
Introduction
In recent times sex differences in cardio-
vascular disease have gained increased at-
tention. We are learning that the mortal-
ity of acute myocardial infarction in young
women is higher than in age-matched
men and stroke is increasingly frequent in
young women. Systolic heart failure has a
more severe clinical course and outcome in
men. Diastolic heart failure predominates
in women. Additional important sex differ-
ences are found in diabetes,hypertension,in
the anti-coagulation system,in cardiovascu-
lar metabolism and arrythmia. Women and
men differ in many aspects and particularly
in metabolic ones.This includes handling of
drugs and drug effects. A large number of
major studies in cardiovascular therapy in-
cluded mainly men. Therefore we have less
data on the mechanisms and side effects in
women compared with men.
Drug metabolism
FDA data shows that sex differences in
bioavailability are found in about 30 % of
all submitted drugs. Lower body mass and
higher lipid levels in total body composition
in women account for differences in drug
exposure. Dosing adapted to weight would
at least partially correct for these differences.
Weight adapted dosing recommendations
exist for digoxin, for some anti-arrhythmic
drugs, for heparin and some thrombolytic
drugs. These recommendations are, however,
not always respected [1]. Increased bleeding
in women with fixed dosage of thrombolytic
or GPIIb/3a inhibitors underscores the rele-
vance of dose-adaptation.In addition to pure
weight,the higher lipid content of the female
body is of relevance. Consequently, lipid sol-
uble substances have a greater distribution
volume in women. Gastrointestinal function
is also affected by sex hormones leading to
shorter mean transit times in women [2].
Some drug metabolising enzymes are differ-
ently expressed in women and men.The activ-
ity of gastric alcohol dehydrogenase is much
lower in women than in men. Sex differ-
ences in the expression of cytochrome P450
isoenzymes also affect metabolism of numer-
ous substances. Sex differences with clinical
relevance are mainly shown for CYP1A2,
CYP2B6, CYP2E1 und CYP3A4 (Tab. 1)
[3]. CYP2E1 metabolises anaesthetic drugs
such as halothane,isofluorane,as well as etha-
nol. Activity is about 30% lower in women
compared to men. CYP3A4 makes up for
30% of total hepatic CYP activity and con-
tributes to the metabolism of more than 50%
of drugs. It is involved in the metabolism of
endogenous and exogenous steroids, and of
drugs like erythromycin, methylprednisolone,
methadone, tacrolimus, diltiazem, nifedipin,
triacelam,cyclosprorine and verapamil.Wom-
en have a 20-50% higher activity of this en-
zyme than men. Accordingly CYP3A4 sub-
strates are metabolised faster in women [3].
Renal function in general is higher in men
than in women. This is only partially ex-
plained by differences in body weight. Ac-
cordingly, renal drug clearance in general is
lower in women than in men. In fact, digox-
in displays a 12-14% lower clearance rate in
women than in men. This difference addi-
tionally increases with age [4].
Pharmacodynamics
Digitalis
In 1997 the digitalis study group reported
the positive effects of digitalis on heart
Gender Aspects in
Cardiovascular Drug Therapy
Vera Regitz-Zagrosek, MD PhD, Sabine Oertelt-Prigione, MD; Berlin Institute of Gender
in Medicine (GiM), Charite´- Universitätsmedizin Berlin, Germany Deutsches Herzzentrum
Berlin (DHZB), Charite´- Universitätsmedizin Berlin, Germany
Table 1.
Sex differences in Cytochrome P450 Isoenzymes
Isoenzyme Sex differences Drugs with cardiovascular interaction
CYP1A2
Lower activity in females, influ-
enced by hormons
Caffeine, paracetamol
CYP2C9 No sex differences Warfarin
CYP2C19 Controversial data Omeprazole, diazepam
CYP2D6 Higher activity in males Propanolol, metoprolol
CYP2E1 Higher activity in males Halothane, isofluourane
CYP3A4 Higher activity in females
Tacrolimus, diltiazem, nifedipine, tria-
zolam, cyclosporine, verapamil
15
Medical Ethics, Human Rights and Socio-medical affairs
failure. Thereafter, these study results were
adopted as recommendations by numerous
guidelines. There was no sex specific analy-
sis. However, in 2002 a retrospective gender
specific analysis was undertaken and dem-
onstrated that digitalis is associated with
a significantly higher mortality in women
compared with men. In the original study, a
modest survival benefit could be detected in
men, while the opposite was true for wom-
en; nonetheless, as the study population
consisted of a combined study group with
a 3:1 male:female ratio the opposing effects
on survival counterbalanced each other al-
lowing for no survival difference detection
in the mixed population [5]. In the follow-
ing year it was shown that higher digitalis
serum levels were associated with increased
mortality in men [4], whereas serum levels
in the lower normal range were associated
with better survival. Similar trends were
reported in women. Lower drug elimina-
tion, higher blood levels and an increased
mortality associated with drug levels in the
upper normal range explain the unfavour-
able survival difference reported in women
(Fig. 1).
Beta blockers
Beta blockers are frequently associated with
higher drug exposure in women. The beta1
selective blocker metoprolol is primarily
metabolised by CYP2D6 which has a lower
activity in women. In addition women have
a lower distribution volume for metoprolol.
Thus, plasma concentrations are higher in
women than in men. Moreover, oral contra-
ceptives can interact with metoprolol [6]and
further increase its plasma levels.Other beta
blockers, like propanolol for example, reach
plasma levels that are up to 80% higher in
women compared to men [7]. Accordingly
women show stronger beta blocker side ef-
fects, a stronger decrease in heart rate and
systolic blood pressure. Positive effects are
similar in women and men [8, 9] (Fig. 2).
ACE inhibitors
In the early multicenter randomised trials
with Ace inhibitors (ACEI),benefit was more
frequently found in men in comparison to
women. In Consensus 1 and solvd, mortal-
ity reduction in women was below 5 % while
reaching 30-40 % in men [10]. Since mainly
men were included in these studies, the com-
bined analysis of both cohorts showed a ben-
eficial effect. Side effects in all these studies
were more frequent in women. Later, ACEI
study such as AIRE and HOPE documented
a significant benefit for women[11].This was
particularly the case for the secondary preven-
tion of cardiovascular events in high risk pa-
tients. In contrast, the recently published 2nd
Australian National Blood Pressure Study
Female, Bisoprolol
Male, Bisoprol =
Female, Placebo
Male, Placebo
0 3 6 9 12 15 18 21 24
Time (months)
Survival(%)
100
90
80
70
60
50
0
Figure 1 Digitalis therapy for heart insufficiency: survival rates in female and male study popu-
lations with digitalis and placebo [5]. Female patients on digitalis display a significantly worse
survival rate compared to the placebo group.
Figure 2 Survival rates with beta-blocker therapy for systolic insufficiency. Sex-specific survival
curves from the bisoprolol study [9]: female patients have better outcomes then male patients, ir-
respective of therapeutic regimen. Effects of the beta-blocker therapy are similar in both groups.
16
Medical Ethics, Human Rights and Socio-medical affairs
(ACEIs compared with diuretics) showed a
significant reduction of cardiovascular events
with in men on ACEIs, but not in women
[12].
Angiotensin receptor blockers,
Aldosterone antagonists and diuretics
These drugs are effective in women and
men. The large studies LIFE, ELITE,
VALHEFT, VALUE, VALIANT and OP-
TIMAAL did not show any sex differences.
20-30 % of women were generally included
in these studies [10]. Aldosterone antago-
nists are nowadays used in add-on strategies
in the treatment of heart failure showing
equal effectiveness in women and men. The
most prominent side effect of these drugs is
a painful gynecomasty that affects only men
[13]. Diuretics are more frequently used in
women even though they have more un-
wanted side effects, such as hyponatremia
and hypokalemia [11].
Acetyl salicylic acid, thrombolytics
and anticoagulation
Recently, surprising results were observed.
In a long term study with approx. 40,000
women the reduction of primary cardiovas-
cular events, i.e. myocardial infarction (MI)
or cardiovascular death, by Aspirin was not
statistically significant [14]. However, pri-
mary prevention of stroke was achieved.
This is opposite to the effects in men show-
ing inhibition of a primary MI, but not a
primary stroke by Aspirin. Reasons for
these differences are yet unclear.
A recent study (Crusade) documented that
percutaneous coronary interventions and
subsequent antithrombotic therapy lead to
bleeding more frequently in women com-
pared with men [15]. Detailed analysis
showed that the substances are more fre-
quently overdosed in women compared with
men and that particularly older women are
affected. However, even after adaptation of
dosage to body mass and serum creatinine
levels, women suffered from bleeding more
frequently than men. Thus, pharmacody-
namic as well as pharmacokinetic effects
may play a role in these substances [16].
Antiarrhythmic drugs
Women exhibit severe arrhythmia more
frequently on QT-prolonging therapy than
men [17, 18]. Women have a longer cor-
rected QT-time than men and a greater QT
prolongationondrugsthatinhibitpotassium
inward channels. This enables the genera-
tion of arrhythmia. A number of drugs have
been identified that prolong repolarisation
by blocking potassium channels. These are
more frequently associated with arrhythmia
in women than in men. The group does not
only include anti-arrhythmid drugs, but
also gastrointestinal drugs, antipsychotics,
antihistamines and antibiotics [19].
Reasons for sex differences
in drug effects
Most drug development in the cardiovascular
field is undertaken in young male mice. Rea-
sons for this include the greater lethality of
myocardial infarction or heart failure in male
mice allowing for easier detection of pharma-
ceutical effects. Young male mice often have
more severe outcome than female mice with
myocardial infarction (MI) or heart failure for
yet unknown reasons. In addition, the greater
biological variability in females due to their
cycling makes it more difficult to detect ef-
fects and more female animals are needed for
breeding than males. Lethality of male mice
after MI in general is about 60%, whereas
it’s only 20% in female mice. Consequently,
a drug that improves mortality by 30% has
a major effect in male mice. This same drug
may have no effect or a very small, non sig-
nificant effect on female mice. Unfortunately,
this substance, which is only effective in male
mice,is then frequently developed into a drug
that is used to treat women as well as men.
Similar relations are found in heart failure.
Of about 20 transgenic animal models that
exhibit heart failure, 18 exhibit a more severe
phenotype in males and only 2 a more severe
phenotype in females. Frequently male mice
are dying whereas female mice don’t exhibit a
phenotype. Again, drugs are then developed
to treat the disease of male mice and are even-
tually sold for female and male patients [11].
Measures
Are there any measures that can be under-
taken to improve this situation? The Institute
for Gender in Medicine aims at establishing
a database collecting all relevant data on sex
differences in drug therapy that will be pub-
licly accessible. This database will be based
on very systematic literature searches using
standardised text mining procedures. Fur-
ther,medical quality circles are rising that are
considering gender aspects.The Internation-
al Society of Gender Medicine is involved in
analysing sex differences in drug effects and
side effects. Most importantly a number of
Universities in Europe have started to devel-
op curricula for Gender Medicine including
Table 2.
Sex differences in cardiovascular drug therapy
Drug Sex differences Reference
Beta-blocker Higher plasma levels, in some cases higher effect
on female patients
10
ACE inhibitor
Angiotensin Receptor
Blocker
More side-effects in women 10
Digitalis Higher lethality in female patients, most likely
due to dosage
4,5
Diuretics No reliable data on sex differences 11
Acetylsalicylic Acid Sex differences in primary prevention of Myocar-
dial infarction and stroke
14
Glycoprotein IIb/IIIa
Antagonists
More bleeding in women, most likely due to
dosage
15
Antiarrhythmic Agents More severe arrhythmia with QT-prolonging
drugs
17,18,19
17
Gender differences in pharmacotherapy.This
will hopefully increase awareness of patients
and doctors and lead to better treatment of
women and men.
Acknowledgement:
We greatly appreciate the secretarial help of
Stefanie Roehner.
Grant support:
The Institute of Gender in Medicine is
supported by grants from the EU, BMBF,
DFG and Magarethe-Ammon-Stiftung.
Conflict of interest: The authors have no
conflict of interest to declare.
References
1. Gandhi M, Aweeka F, Greenblatt RM, Blaschke
TF. Sex differences in pharmacokinetics and phar-
macodynamics. Annu Rev Pharmacol Toxicol
2004;44:499-523.
2. Anderson GD. Sex and racial differences in phar-
macological response: where is the evidence? Pharma-
cogenetics, pharmacokinetics, and pharmacodynam-
ics. J Womens Health (Larchmt) 2005;14(1):19-29.
3. Franconi F, Brunelleschi S, Steardo L, Cuomo V.
Gender differences in drug responses. Pharmacol Res
2007;55(2):81-95.
4. Rathore SS, Curtis JP, Wang Y, Bristow MR,
Krumholz HM. Association of serum digoxin
concentration and outcomes in patients with heart
failure. Jama 2003;289(7):871-8.
5. Rathore SS, Wang Y, Krumholz HM. Sex-based
differences in the effect of digoxin for the treatment
of heart failure. N Engl J Med 2002;347(18):1403-
11.
6. Kendall MJ, Quarterman CP, Jack DB, Beeley L.
Metoprolol pharmacokinetics and the oral contracep-
tive pill. Br J Clin Pharmacol 1982;14(1):120-2.
7.Walle T,Walle K,Mathur RS,Palesch YY,Conradi
EC. Propranolol metabolism in normal subjects: as-
sociation with sex steroid hormones. Clin Pharmacol
Ther 1994;56(2):127-32.
8. Ghali JK, Pina IL, Gottlieb SS, Deedwania PC,
Wikstrand JC.Metoprolol CR/XL in female patients
with heart failure: analysis of the experience in Meto-
prolol Extended-Release Randomized Intervention
Trial in Heart Failure (MERIT-HF). Circulation
2002;105(13):1585-91.
9. Simon T, Mary-Krause M, Funck-Brentano C,
Jaillon P. Sex differences in the prognosis of conges-
tive heart failure: results from the Cardiac Insuf-
ficiency Bisoprolol Study (CIBIS II). Circulation
2001;103(3):375-80.
10. Regitz-Zagrosek V, Lehmkuhl E, Lehmkuhl HB,
Hetzer R.Gender aspects in heart failure.Pathophys-
iology and medical therapy. Arch Mal Coeur Vaiss
2004;97(9):899-908.
11. Regitz-Zagrosek V. Therapeutic implications of
the gender-specific aspects of cardiovascular disease.
Nat Rev Drug Discov 2006;5(5):425-38.
12.Wing LM, Reid CM, Ryan P, et al. A comparison
of outcomes with angiotensin-converting–enzyme
inhibitors and diuretics for hypertension in the el-
derly. N Engl J Med 2003;348(7):583-92.
13. Pitt B, Zannad F, Remme WJ, et al. The effect
of spironolactone on morbidity and mortality in pa-
tients with severe heart failure. Randomized Aldac-
tone Evaluation Study Investigators. N Engl J Med
1999;341(10):709-17.
14. Ridker PM, Cook NR, Lee IM, et al. A random-
ized trial of low-dose aspirin in the primary preven-
tion of cardiovascular disease in women. N Engl J
Med 2005;352(13):1293-304.
15. Alexander KP, Chen AY, Newby LK, et al. Sex
differences in major bleeding with glycoprotein IIb/
IIIa inhibitors: results from the CRUSADE (Can
Rapid risk stratification of Unstable angina patients
Suppress ADverse outcomes with Early implementa-
tion of the ACC/AHA guidelines) initiative.Circula-
tion 2006;114(13):1380-7.
16. Humphries KH, Kerr CR, Connolly SJ, et al.
New-onset atrial fibrillation: sex differences in pre-
sentation, treatment, and outcome. Circulation
2001;103(19):2365-70.
17. Drici MD, Knollmann BC, Wang WX, Woosley
RL. Cardiac actions of erythromycin: influence of fe-
male sex. Jama 1998;280(20):1774-6.
18. Makkar RR, Fromm BS, Steinman RT, Meissner
MD, Lehmann MH. Female gender as a risk factor
for torsades de pointes associated with cardiovascular
drugs. Jama 1993;270(21):2590-7.
19. Anthony M. Male/female differences in phar-
macology: safety issues with QT-prolonging drugs.
J Womens Health (Larchmt) 2005;14(1):47-52.
Medical Ethics, Human Rights and Socio-medical affairs
Louis M. Guenin is Lecturer on Ethics in Sci-
ence, Department of Microbiology and Mo-
lecular Genetics, Harvard Medical School. His
recent book The Morality of Embryo Use
(Cambridge University Press, 2008) explores
ethical and metaphysical issues pertaining to
embryonic stem cell research and the forma-
tion of consensus across diverse views. He has
served as co-chair of the Ethics Committee, In-
ternational Society for Stem Cell Research.
On occasion, discretionary actions preclude
transfer of extracorporeal embryos into the
womb. Such actions constitute an overlooked
and crucial ground for the moral justification
of embryo use in regenerative medicine.
In the first instance, we encounter the
situation, which often arises with fertility
patients, in which the one person in the
world who, together with the coprogenitor,
is empowered to decide about intrauterine
transfer of an embryo formed from her oo-
cyte decides that neither does she wish to
bear the embryo, nor does she wish to give
it to anyone else. Whereupon she and the
coprogenitor may decide to donate the em-
bryo to medical research and therapy. In
the second case, embryos may originate in
research from cells donated to medicine for
that purpose.
If progenitors,while fully-informed and act-
ing of their own volition, donate an embryo,
either before or after the embryo’s creation,
on the condition that the embryo shall be
used in medical research and therapy, and
may never be transferred into a uterus, such
embryo constitutes what I have called an
“epidosembryo.”1
I have taken this name
from the Greek epidosis for a citizen’s be-
neficence to the common weal.
As a moral justification for the use of epi-
dosembryos in accordance with donor in-
structions, I have offered the “argument
1 “Morals and Primordials,”Science 292: 1659-1660
(2001).
The following article is reprinted below in its complete form as unfortunately part of it was omitted in WMJ(54)4. ED
Building a Consensus in Regenerative
Medicine
18
Medical Ethics, Human Rights and Socio-medical affairs
from nonenablement.” 2
This proceeds as
follows. A woman does not have a duty to
undergo a transfer into her of an embryo
lying outside her. There does not obtain a
duty of intrauterine embryo transfer into
oneself. We, most of us, regard the decision
to undergo such a medical procedure as re-
served to a woman’s autonomous discretion.
A separate question is whether a woman
and the coprogenitor lie under a duty to
surrender for adoption any embryo that she
declines to bear. Imposition of such a duty
would likely present such adverse incentives
and consequences for fertility patients, in-
cluding compelled remote parenthood, that
we are hard pressed to find any moral view
that would support such imposition. For
reasons developed in the full account of this
argument, the decision whether to surren-
der an embryo for adoption also lies within
progenitor discretion.
Suppose, then, that a woman forbids intra-
uterine transfer of an embryo. She, with the
coprogenitor, donates to medicine either
an epidosembryo created during her fertil-
ity treatment, or an epidosembryo that will
be created by a scientist from their donated
cells. This decision is final. The epidosem-
bryo has left progenitor control. A distinc-
tion now obtains between the developmen-
tal potential of this epidosembryo, lying in
a petri dish where it will remain, and an
embryo that lies in a uterus, however it got
there. In consequence of the prohibition
on intrauterine transfer, the epidosembryo
will not complete gastrulation. If not ear-
lier sacrificed, the epidosembryo will begin
to disintegrate by about day 10. During its
remaining life,it cannot acquire any morally
significant property that it does not already
possess. To put the matter in language that
I owe to Richard Hare,3
no possible person
corresponds to an epidosembryo. We also
know that no embryo is sentient. It can
neither form preferences nor adopt ends.
Nothing that we might do concerning it
can cause it discomfort or frustrate it. We
2 The Morality of Embryo Use (Cambridge Univer-
sity Press, 2008).
3 Richard M. Hare, Essays on Bioethics (Oxford:
Clarendon Press, 1993).
cannot gain anything—neither for it nor for
any other being—by classifying it as a per-
son for purposes of the duty not to harm.
By forgoing its use in research, we could
only assure that the epidosembryo dies in
vain. Scientists maintain the reasonable,
though not certain, belief that embryo ex-
perimentation could contribute to the relief
of human suffering. Use of donated embry-
os remains crucial in research even as tech-
niques develop for reprogramming somatic
cells into pluripotent or specialized cells.
Embryonic stem cell research has been the
fountainhead of emerging knowledge of re-
programming, and the embryonic stem cell
remains the gold standard of pluripotency.
In this situation, the duty of mutual aid—
the duty, recognized across moral views, to
aid those in need when one may do so with-
out imposing an unreasonable burden—
bids us undertake such research. Hence not
only is it permissible to use epidosembryos
in medicine, but to do so will help to fulfill
a collective duty.
According to this argument, the permissi-
bility and virtuousness of epidosembryo use
rests on the autonomous decisions of people
from whose cells such embryos originate.
The moral analysis flows entirely from what
it is that they decide. Developmental po-
tential matters, but it is human decisions
that determine its situation-dependent ex-
tent. If it is permissible for progenitors to
donate epidosembryos,then it is permissible
for recipient scientists to use the donations
as instructed.
Some discussants seem to suppose that the
justification of embryonic stem cell research
lies in the circumstance that the embryos
donated were created with procreative in-
tent. The argument from nonenablement
does not invoke procreative intent. The
argument applies to any donated embryo,
whether left over from an attempt at preg-
nancy, or created in experiment. The use
of surplus embryos and the nonprocreative
formation of embryos by fertilization, non-
reprocloning, and parthenogenesis rest on
one and the same moral ground.
The argument from nonenablement is a
consensus argument insofar as it does not
invoke any premise peculiar to one or an-
other moral or religious view. The bounded
developmental potential of an embryo in the
dish is a biological circumstance. The duty
of beneficence and respect for the discre-
tion of persons to elect whether they shall
undergo medical procedures are common to
all leading moral and religious views. Some
form of the Golden Rule is found in virtu-
ally every major moral and religious view
since Confucius.
In this analysis, I accord a wide berth to re-
ligious views across diverse cultures, provid-
ed only that when moral verdicts are urged
on religious grounds, support for them can
be given on the basis of reasonable non-
religious premises. As we all know, many
religious believers condemn the sacrifice of
embryonic lives in aid of other lives. Hence
a further task presents itself. It remains to
be shown, if it can be, that if the argument
from nonenablement is introduced in the
course of sympathetically reinterpreting
one or more views presumptively opposed
to all embryo use, such views will issue in
approval for epidosembryo use. I illustrate
how that task may be accomplished as to
the most influential presumptively contrary
view, the magisterium of the Roman Cath-
olic Church.
In condemning all manner of embryo de-
struction, the Catholic magisterium speaks
consistently. Just as it condemns destruc-
tion of embryos as research subjects, it con-
demns the practice of assisted reproduction
because that practice brings about destruc-
tion of surplus embryos. (Other discussants
who approve in vitro fertilization as prac-
ticed, but oppose embryo use in research
fall into inconsistency: they condone de-
struction of surplus embryos as waste, but
condemn sacrifice of surplus embryos for
beneficent ends.) On what ground does
the magisterium’s condemnation of embryo
sacrifice rest?
One will often hear it asserted that an em-
bryo is a person and that killing a person
19
Medical Ethics, Human Rights and Socio-medical affairs
is murder. To say that a being is a person
is to recite the conclusion that the being
falls within the category of beings protected
by the duty not to harm. It remains to ask
what reasoning supports that conclusion.
Conceding that the Bible does not assert
personhood of an extracorporeal embryo—
in antiquity, people did not even know that
there existed oocytes, hence never thought
about embryos outside the body—the
magisterium allows that personhood of an
embryo is a philosophical question.4
Con-
cerning this, the magisterium’s argument in
chief is the following: fertilization creates a
new genome, therefore fertilization creates
a person. This argument’s premise is true—
fertilization produces a new genome—but
the conclusion doesn’t follow. To identify a
person with a genome is to practice genetic
reductionism with a vengeance. That view
contradicts the bedrock belief that a person
is a corpore et anima unus, a union of body
and soul. On pain of internal contradiction,
the argument cannot stand.
A defender of zygotic personhood might
plead that precisely because embryos cannot
form preferences, it is our obligation to act
according to their advantage, hence to clas-
sify them as persons. But we cannot foster
any advantage of epidosembryos. Entry
into the only kind of environment by which
they could attain the ability to experience
benefit has been forbidden by the only per-
sons in the world empowered to decide such
matters. It is from this recognition that the
argument from nonenablement builds a
prima facie justification within Catholicism,
as within other views,for epidosembryo use.
Is there a countervailing argument?
One argument is that if we do not know
whether an embryo is a person in God’s
eyes, we should exercise caution and act as
if it were. But from within a view hold-
ing that divine will is the arbiter of morality,
suppose that we could have a conversation
with God. We report that in 1998, we dis-
4 Sacred Congregation for the Doctrine of the
Faith, Declaration on Procured Abortion (Vatican
City: The Holy See, 1974), and Donum Vitae (Vati-
can City: The Holy See, 1987).
covered how to culture human embryonic
stem cells. We describe hopes of relieving
human suffering by using embryos that will
never enter a womb. Is it plausible that He
would tell us that He regards such embryos
as persons in the sense that He includes
them in a universe of beings that He never
wishes us to use as means? I do not know
of a tenable argument according to which
an all-merciful and omniscient God would
assert that preference. He would know that
unenabled embryos would never become
sentient if not used in research.
An objection peculiar to nonreprocloning
might be this. An oocyte is created for a
purpose, namely to issue in offspring, and
it is wrong to divert an oocyte to any other
purpose. This objection presupposes with
Aristotle that everything has a fixed pur-
pose and that we know what it is. After
Darwin, that notion has lost its grip on our
thought. We have learned from the history
of medicine how mistaken we humans have
often been in inferring purposes of various
cells and structures of the body. Our for-
bears would have said that bones are what
hold us up; today we think of the marrow
as a blood factory. We think it appropri-
ate to transfer marrow from one patient to
another. We know that many cells perform
multiple functions, and we are learning to
redirect proteins and cellular processes to
serve chosen ends. It seems arbitrary to say
that an oocyte can or should serve only one
purpose. Such a rule would seem puzzling
insofar as every human female possesses
from birth a quarter million or more oo-
cytes.
Turning to public policy, we observe that
there obtains no practical scheme by which
a government may fund use of embryonic
derivatives without complicity in their
derivation. Downstream demand induces
supply, and complicity transmits through
the channel of inducement. Our collective
deliberations would benefit from moral rea-
soning generally overlooked in the policy
arena. That is the reasoning adduced in the
argument from nonenablement beginning
with the premises that intrauterine embryo
transfer is discretionary and that when pro-
genitors forbid such transfer, developmental
potential is permissibly bounded. The key
to assuring that legislation endorses morally
permissible activity is what it says about pro-
genitors. Progenitors possess unique power:
each is the only person in the world (with
the coprogenitor) privileged to decide what
will happen to an embryo. It is because a
progenitor-donor decides that an embryo
will never enter a uterus that a donee may
experiment on it.
Hence the most compelling justification
for a donee in performing experiments, and
for a legislature in endorsing experiments,
consists in the donee’s fidelity to permis-
sible donative instructions bounding poten-
tial. This bring us to the following public
policy:
The government shall support biomedical
research using human embryos that, before
or after formation, have been donated to
medicine under donor instructions forbid-
ding intrauterine transfer.
This policy wears its moral justification on
its sleeve. That attribute avails for public
discussion. There the policy may be de-
scribed as one that assures that the scope
of the publicly-supported is congruent with
the scope of the morally permissible.
There arise various other ethical questions
about embryo use, including fair compen-
sation to oocyte contributors, and the for-
mation of hybrids and chimeras. In the
foregoing, we have canvassed a ground for
consensus on the most fundamental ques-
tion.
20
Introduction
One of the most widespread beliefs in the
medical community is that smoking is a
habit of personal choice, and quitting does
not require professional help [1]. To quit
or not is solely determined by the smoker’s
will power [1,2]. These beliefs by majority
of physicians are also shared by smokers
[3],and have evolved to form the stumbling
block in our efforts to mitigate one of the
most harmful and most preventable health
issues worldwide: cigarette smoking.
In forming these beliefs, or mis-beliefs, phy-
sicians failed to recognise two important as-
pects of evidence: (A) “Smoking is a chronic
addictive disease” [4,5], and as a highly ad-
dictive disease, medical assistance is not just
highly desirable,but absolutely necessary [2].
(B) Smokers take their physician’s advice
to heart [2,6,7]. Physicians, by wearing the
white gown with the aura of authority, have
the magic to break the inertia or the disin-
terest of smokers [8]. Doctors did not realise
that not only it is their job as care givers, but
also they had the unique magic touch in mo-
tivating smokers to quit. Asian patients visit
their doctors 14 times a year [9], providing
numerous opportunities and perfect mo-
ments for repeated interventions.
Individual physicians’ view and WMA or-
ganisational policy position
In a survey conducted by Harris International
polling agency of both physicians and smok-
ers in 16 countries [3],the majority of physi-
cians ranked smoking as the most harmful
behaviour globally, outranking obesity, inac-
tivity,or poor diet.[The 16 countries surveyed
included 11 countries from Europe (France,
Germany,Greece,Italy,Netherlands,Poland,
Spain, Sweden, Switzerland [physician sur-
vey only],Turkey,and UK),one from Central
America (Mexico),two from North America
(Canada and USA), and two from East Asia
(Japan and South Korea). Globally, a total of
3760 smokers and 2836 physicians were sur-
veyed [3]]. However, when physicians were
asked as to whether they wanted to help the
smokers to quit, the majority indicated they
had more important things to do and had no
time for smoking cessation. This contradic-
tory phenomenon was observed worldwide,
in North America, in Europe and in Asia. In
addition,this dilemma faced by the individu-
als was quite different in respect of their or-
ganisational position. As far back as in 1988,
the World Medical Association (WMA) ad-
opted a policy statement [10] urging all na-
tional medical associations to establish a pol-
icy position opposing smoking and the use
of tobacco products, and publicise the anti-
smoking policy so adopted. In other words,
physicians worldwide and their national or-
ganisations are fully aware of the harm from
consuming tobacco, but individual physi-
cians do not behave accordingly,despite their
strong belief to the contrary.Obviously,there
is a large the perceptional gap and the gap is
universally observed, and physicians are not
behaving as they should. Why? It is because
there are barriers that seem insurmountable.
What are the barriers, and can existing bar-
riers be overcome? That is the current chal-
lenge faced by physicians. The following is
a summary of the ten most prevalent barri-
ers to cessation and, by proposing solutions
to overcome them, these perceived barriers
could be solved and these seeming “barriers”
would just become myths.
Barriers to cessation
The followings are the ten barriers to cessa-
tion perceived by physicians. The proposed
solutions, when internalised by physicians,
would eliminate them:
(1) No time: The most common reason for
physicians not to engage in smoking cessa-
tion is lack of time [11,12]. Surveys found
contradictory statements by physicians: On
the one hand three quarters of physicians
indicate the most harmful behaviour was
smoking, among the four most commonly
cited behaviours: smoking, inactivity, obe-
sity and poor dietary habits. On the other
hand, 75% of physicians worldwide indicate
such feelings as “I have more important
things to do” as I do not have time for ces-
sation based on survey [3]. Smoking cessa-
tion takes time.
Solution: Not every doctor has to become
a cessation specialist. There should be ces-
sation specialists available. If the individual
doctor believes cessation is important,we all
agree that it takes very little time to refer to
the cessation team available in most hospi-
tals.This may take from 30 seconds to 5-10
minutes, and most doctors should have the
time to do this. In fact,“ask, advise and refer
(2A’s + R)”is all we need.It takes 30 seconds
Medical Ethics, Human Rights and Socio-medical affairs
Barriers to Smoking Cessation:
Are they really insurmountable?
Chi Pang Wen, MD, Dr. PH; Min Kuang Tsai, MPH (National Health Research Institutes,
Zhunan, Taiwan); Yung Tung Wu, MD, PhD (Past-President of Taiwan Medical Association)
21
Medical Ethics, Human Rights and Socio-medical affairs
to intervene. Let us tell all physicians to re-
member 2A’s + R in smoking cessation.
(2) No skills: Whether the doctors realise
or not, the reality is that smoking cessa-
tion was rarely taught in the medical school
years and the majority of physicians did not
receive much training after medical schools
[3]. Doctors are not interested in smoking
cessation and therefore not motivated to
learn as a new skill.
Solution• : As much as not every doctor
needs to become a cessation specialist,the
attitude toward smoking cessation will be
more important than the technical skill
of cessation per se. The skill to refer can
be learned relatively easy, as long as the
doctor’s attitude is positively favourable.
Whether the doctor is committed to the
importance of smoking hazards, his body
language will be fully revealed in making
the referral.
(3) No money: Smoking cessation is very
time consuming for the doctors, and yet few
health insurances would reimburse such
services, including many Asian countries.
To view smoking cessation as free services
is not placing its value in the right spot or
making it a sustaining effort
Solution• : The reward for successful cessa-
tion could be far more precious and long
lasting than financial terms. Cessation
gives the smoker a new and healthy life
for him and his family that money cannot
buy. Of the tens of thousands of patients
a doctor has treated in his long career,
few patients would remember the contri-
bution by the doctor after ten or fifteen
years. One exception is the smoker who
was talked into quitting and succeeded
in quitting. Most smokers are so grate-
ful that they will remember the turning
point when decisive action was taken by
the doctor.
(4) No interest from smokers [12,14]:
Smoking patients visit the doctors for medi-
cal complaints such as diabetes or hyperten-
sion and not for smoking. It is just natural
for patients to be more concerned with their
chief complaints than other issues.
Solution 1• : The most important reason
for smokers to quit worldwide has been
health concerns, and most smokers are
not interested in quitting because they feel
fine health-wise. The self reported health
of smokers showed that majority felt they
were in excellent health [15]. However,
this is deceptive feeling,as within the next
ten years, those who feel good or average
had doubled their mortality risks of their
non-smoking counterparts. The evidence
is against the smokers.
Solution 2• : On the website of Philip
Morris [16], the international tobac-
co giant advised smokers that tobacco
company agrees with the overwhelming
medical and scientific consensus that
cigarette smoking is “addictive”, mak-
ing it very difficult to quit and “cigarette
smoking causes lung cancer, heart disease,
emphysema and other serious diseases in
smokers. Smokers are far more likely to
develop serious diseases, like lung cancer,
than non-smokers [2]. There is no safe
cigarette.” Let smokers find out these
statements from the manufactures of
cigarettes.
Solution 3• : The advice from tobacco
manufacturer: “The best thing to do for
smokers is to quit.” (Philip Morris web-
site) Even the manufactures asked the
user not to use their products. What an
irony!
(5) No more: Doctors feel as long as they
had advised smoking patients once, that
would be sufficient and do not need more
than that. They are concerned that “nag-
ging” or repeated reminding, would scare
away patients.
Solution• : The global survey [3] revealed
that when physicians were interviewed,
75% of them indicated they discussed
smoking with their smoking patients,
but when smokers were interviewed only
20% recalled such encounters. This dis-
crepancy reflects a major communication
gap between the doctors and the smokers.
Part of the solution to bridge the gap is
for the doctors to repeat the message in
every visit, and not limited to one visit.
(6) No connection: Smoking cessation is
not connected with the chief complaints
clinics by the patients,and to bring up smok-
ing seems to be an entirely different subject.
When pressed for time, it is difficult to initi-
ate a new conversation on a different issue.
Solution• : As patients are interested in the
progress of diabetes or hypertension, they
are interested in following their blood
glucose and blood pressure. For this, the
glucose equivalent of smoking and blood
pressure equivalent of smoking will help
doctor to talk to their patients. Smoking
cessation is equivalent to a reduction of 40
mg/dl of fasting blood glucose [17] or to
a reduction of 40 mmHg of systolic blood
pressure[18] (shown in the accompanying
figures). While some medications might
be able to achieve such a significant drop
in blood sugar or blood pressure, but they
are effective only during the time when
medications are taken, and most medica-
tions have short term and long term side
effects. Smoking cessation provides a life
long reduction of these parameters.
Results showed that the addition of smok-
ing was equivalent to an increase of mortal-
ity risk approximating a 41 mg/dL increase
in blood pressure [17].
Results showed that the addition of smok-
ing was equivalent to an increase of mortal-
ity risk approximating a 40 mmHg increase
in blood pressure [18].
(7) No alternative: Cigarettes acted as the
best friend,with intimate contact 20 times a
day (one pack) 365 days a year. Such an in-
timate contact was more than any member
Figure1.Comparison of relative risks between
smokers and non-smokers by fasting blood glu-
cose for all cause mortality.
Fasting Blood Glucose (mg/dL)
RealtiveRisk
22
Medical Ethics, Human Rights and Socio-medical affairs
of his family. How could someone separate
relationship with such a best friend with-
out any alternative? For a young man to say
goodbye to his girl friend of more than ten
years will be extremely difficult. Even if he
decided to do so, he would miss her day and
night, struggling emotionally. He wished, at
any moment, to see her and make up again.
Solution• : The only way to separate with
his girl friend successfully is to cultivate
another girl friend before separation is
to take effect. The analogy in this case
for separating with cigarettes is to culti-
vate the love for physical activity: walk-
ing, running, sports, climbing or going to
the gym. In comparing and analysing the
caloric expenditure between smokers and
non-smokers, we found, as shown in the
table,that ex-smokers had twice the levels
of exercise as smokers. This implied that
either through picking up exercise the
smokers quit smoking or smokers start to
exercise after quitting.
Table 1.
Exercise levels by smoking status in Tai-
wan [19].
>750
Kcal/
Week
>1,000
Kcal/
Week
>2,000
Kcal/
Week
Non-smoker 19.6% 14.3% 4.5%
Smoker 15.1% 11.1% 4.4%
Ex-Smoker 31.8% 25.4% 11.6%
Ex-smokers doubled their activity levels
(8) No effect: Cessation treatment is not
fail-proof, having only one or two successes
in ten attempts, even with the availability of
the most recent medication like Varenicline
[20]. In other words, failure is the rule and
success from quitting attempts is an excep-
tion or a miracle.
Solution• : The success rate noted above is
defined as one year from treatment. The
rate quitting within 2-3 months of treat-
ment was nearly 60% [21]. What hap-
pened after that and why the decline? One
reason was the lack of intensive follow up
after the first few weeks when intensive
care was invariably provided. The quit-
ters were very vulnerable and should be
given all the TLC (Tender Loving Care)
from the health care team and from their
friends and families, particularly when
they were struggling to quit.
(9) No reminder: During clinical encoun-
ters with smoking patients, physicians fo-
cused on the medical problem and in many
instances failed to note the smoking status
of the patients.This is also true for inpatient
care.
Solution 1• : The entire medical group, in-
cluding the hospital administrator and
medical director, should all agree with
the importance of this issue and set up a
series of support system. For reminder, a
red tag, a computer prompt, or smoking
status being included as part of the vital
signs can all be instituted. A cessation
team should be available and referral can
be conveniently made and intensive fol-
low up will be carried out. .
Solution 2• : Tobacco company stated in
their website that “second-hand smoke
from cigarettes causes disease, including
lung cancer and heart disease, in non-
smoking adults, as well as causes condi-
tions in children such as asthma, respi-
ratory infections, cough, wheeze, otitis
media (middle ear infection) and Sud-
den Infant Death Syndrome” [22]. This
should be posted in the examining room
and in the corridor.
(10) No environmental support: With
limited legal restrictions on second hand
smoking, low cigarette price, or no reim-
bursement for cessation services, the hostile
environment will be barriers for cessation
services.
Solution:
Physicians become advocates of tobacco
control in the society and let the public
know their stance. Examples of issues
include:
Increase in cigarette price [23].
This has been proven to curb youth•
smoking. Smoking rates will de-
crease,first among the poorer smok-
ers and then followed by the rest, if
the increase is sufficiently large. For
10% increase in price, there will be
a 8% reduction in youth smoking
and 4% reduction in adult smoking
rates [24].
Experience in France showed a re-•
duction of 1.5 million smokers in 2
years after the price increase [25].
The added revenue can be tapped•
for mounting more tobacco control
programs [26].
Smoke free home when there are
small children or pregnant women at
home
This has been proven to reduce•
heart attacks and emergency visits
Free cessation services for all smokers
With tax increase, it is just natural•
to return the money to the smokers,
so that next increase will be sup-
ported by them.
Figure 2. Comparison of relative risks between smokers and non-smokers by systolic blood pressure
for all cause mortality.
23
Medical Ethics, Human Rights and Socio-medical affairs
Physicians become more involved with
national policy setting on tobacco con-
trol.
This has the policy statement of
World Medical Association.
Medical societies issue position state-
ment on smoking and smoking cessa-
tion
Hospitals become exemplary institution
in tobacco control by setting up “No
smoking policy for the hospitals” and
by voicing out loud on the hazards of
smoking and the availability of cessation
inside the hospitals. Inpatients are more
open for cessation, as they suffer from
more serious medical conditions.
Physicians who share similar concerns on
tobacco control form alliances for tobacco
control. They can make their views known
to the public, such as tax increases or reim-
bursement for cessation services.
Unless we do things differently, quickly
and effectively, this coming 21st
century
will see 1 billion deaths from tobacco [23].
Just imagine every single day, the number
people dying from tobacco is equivalent
to 5 times the number of deaths occurred
in 9/11 tragedies in 2001. In other words,
9/11 is happening every 5 hours. Among all
the care and “treatment” offered by a physi-
cian, including counselling, doing a physi-
cal, giving out prescriptions, or ordering lab
tests, there is nothing more important and
could have more health impact than help-
ing smokers quit. Most everyday interven-
tions are “band-aid relief ” for symptoms to
make patients happier, but helping smok-
ers quit is to make them “healthier”. While
making them happier is important, physi-
cians should focus on more important goal,
“Healthier”.
Conclusion
In summary, the physicians’ attitude toward
smoking is the turning point, rather than
the skill. Making smokers quit will be the
most rewarding activities for physicians.
Ask, advise and refer (2A’s + R), and it takes
only 30 seconds to intervene. Overcom-
ing 10 excuses, by changing ten No’s to ten
Yeses, will make the seemingly difficult task
one of the most valuable and meaningful
work physicians could offer the patients. In
addition, physicians need to stand up and
be visible in position against smoking.With
this,public respect toward physicians will be
greatly furthered.
References
1. Schroeder SA. What to Do With a Patient
Who Smokes. JAMA 2005;294:482-487.
2. Fiore MC, Jaen CR, Baker TB, et al. Treating
tobacco use and dependence: 2008 update. Clini-
cal Practice Guideline. Rockville MD: US De-
partment of Health and Human Services, 2008.
3. Wen CP, Tsai MK, Chiang PH, Lee MC, Tsai
SP. Comparing attitudes toward smoking between
physicians and smokers in East Asia: Analysis from
a global survey of 16 countries. Submitted 2009.
4. Kessler DA, Witt AM, Barnett PS, et al. The
Food and Drug Administration’s regulation of to-
bacco products. N Engl J Med 1996;335:988-994.
5. Davis RM, Novotny TE, Lynn WR. Center for
Health Promotion and Education: The Health
Consequences of Smoking: Nicotine Addiction: A
Report of the Surgeon General Center for Health
Promotion and Education. Office on Smoking
and Health 1988.
6. Health Education Authority of U.K.: Cochrane
Collaboration’s Tobacco Addiction Review
Group (Available from http://www.cochrane.org/
cochrane/revabstr).
7. Katz DA, Muehlenbruch DR, Brown RL, Fiore
MC, Baker TB. Effectiveness of Implimenting
the Agency for Healthcare Research and Quality
Smoking Cessation Clinical Practice Guideline:
A Randomized, Control Trial. J Natl Cancer Inst
2004;96(8):594-603.
8. Dixon DM, Sweeney KG, Gray DJP.The physi-
cian healer: ancient magic or modern science? . Br
J Gen Pract 1999;49(441):309-312.
9. Wen CP, Tsai SP, Chung W-SI. A 10-year ex-
perience of universal health insurance in Taiwan:
Assessing the health impact and disparity reduc-
tion. Ann Intern Med 2008;148:258-267.
10.The World Medical Association. Policy,World
Medical Association statement on health hazards
of tobacco products. (Available from http://www.
wma.net/e/policy/h4.htm), 2009.
11. Schroeder SA. What to do wtih a patient who
smokes. JAMA 2005;294:482-487.
12. Makni H, OLoughlin JL, Tremblay M, et al.
Smoking prevention counseling practices of Mon-
treal general practitioners.Arch Pediatr Adolesc Med
2002;156:1263-1267.
13. Schnoll RA, Engstrom PF. Tobacco Con-
trol in the Physician’s Office: A Matter of Ad-
equate Training and Resources. J Natl Cancer Inst
2004;96(8):573-575.
14. Blumentbal D. Barriers to the provision of
smoking cessation services reported by clinicians
in underserved communities.J Am Board Fam Med
2007;20:272-279.
15. Wen CP. Facilitating the critical process in
tobacco control. Tob Control 2005;14(Suppl 1):i1-
i3.
16. Philip Morris USA. Addiction. Smoking &
Health Issues.(Available from http://www.philip-
morrisusa.com/en/health_issues/addiction.asp).
17.Wen C,Cheng T,Tsai S,Hsu H,Chan H,Hsu
C. Exploring the relationships between diabetes
and smoking: with the development of «glucose
equivalent» concept for diabetes management.
Diabetes Res Clin Pract 2006;73:70-76.
18. Wen CP, Tsai MK, Chan HT, Tsai SP, Cheng
TYD, Chiang PH. Making hypertensive smokers
motivated in quitting: developing blood pressure
equivalence of smoking. J Hypertens 2008;26:672-
677.
19. Wen CP, Wai JPm, Chan HT, Chan YC,
Chiang PH, Cheng TYD. Evaluating the physi-
cal activity policy in Taiwan: comparison of the
prevalence of physical activity between Taiwan
and the U.S. (In Chinese). Taiwan J Public Health
2007;26(5):386-399.
20. Aveyard P, West R. Managing smoking cessa-
tion. BMJ 2007;335:37-41.
21. Gonzales D, Rennard SI, Nides M, et al.
Varenicline, an a4b2 nicotinic acetylcholine re-
ceptor partial agonist, vs sustained release bur-
popion nad placebo for smoking cessation. JAMA
2006;296:47-55.
22. U.S. Department of Health and Human Ser-
vices. The Health Consequences of Involuntary
Exposure to Tobacco Smoke: A Report of the
Surgeon General, U.S. Department of Health and
Human Services. There is No Risk-Free Level of
Exposure to Secondhand Smoke. (Available from
http://www.surgeongeneral.gov/library/second-
handsmoke/factsheets/factsheet7.html), 2007.
23.WHO Report of the Global Tobacco Epidem-
ic. 2008: The MPOWER package Geneva World
Health Organization,2008 (Available from http://
www.who.int/tobacco/mpower/en/).
24. Farrelly M, Baray J. Responses to increases in
cigatette prices by race/ethnicity, income, and age
groups- United States, 1976-1993. MMWR Morb
Mortal Wkly Rep 1998;47:605-609.
25. The French Cancer Plan: (Available from
http://www.canceropole-toulouse.com/en/page.
php?menu=4&ssmenu=1), 2009.
26. American Lung Association. State of tobacco
control: 2008. Few States Increase Tobacco Taxes,
A Missed Opportunity to Save Lives and Raise
Revenues. (Available from http://www.stateof-
tobaccocontrol.org/2008/2008-tobacco-control-
trends.html), 2008.
24
Epidemiological investigations in occupa-
tional health accept the ideals of free in-
quiry and pursuit of knowledge.The goal of
occupational health science, after all, is to
explain and to predict natural phenomena
of occupational exposure. However, epide-
miologists in occupational health also cher-
ish values of improving the public’s health
of workers through application of scientific
knowledge to the different hazards of the
working environment. These dual profes-
sional obligations sometimes give rise to
medical moral problems [1, 2, 3].
Many occupations are necessarily associated
with exposure of a worker to ionizing radia-
tion in the course of their activities. From
Ukrainian uranium miners and oil drillers to
interventional radiologists and airline crews,
the population associated with this exposure
is diverse and has varied specific job param-
eters. Occasionally, workers can receive a
significant radiation dose as a result of ef-
forts to mitigate an accidental occurrence,
wherein radioactive substances are acciden-
tally released into uncontrolled environ-
ments [2, 4]. These situations often create a
higher exposure than would otherwise be al-
lowable. There are also cumulative exposures
from unique activities, such as space flights,
which are treated as exceptional cases. Thus,
the permissible radiation load is different for
the general population, radiological work-
ers and extraordinary occupational activities.
The timeframes associated with allowable
exposure also vary with the population in
question allowable exposure e.g. determin-
ing permissible doses for the visual system,
for which radiogenic cataract can serve as a
dose-limiting expression of the damage.
In the effort to be illustrated in guidelines,
several determining parameters are given dif-
fering weights depending on the particular
activity. In the early hours of April 26, 1986,
Reactor Number Four of the Chernobyl
Nuclear Power Plant (ChNPP) underwent
a power excursion during a turbine rundown
experiment, resulting in a steam explosion
that spewed radioactive materials into the en-
vironment. It is estimated that at least 4% of
the fuel inventory was ejected as well as all the
noble gases and most of the volatile isotopes.
To deal with the accident,workers,conscripts,
and army reservists were assigned to clean up
and perform maintenance duties in the weeks
and months following the disaster. The so-
called “Liquidators” (those who would reme-
diate or eliminate,“ліквідувати”,the damage)
numbered more than 250,000 during the pe-
riod of activity considered in this publication
(April 26,1986 – December 31,1987).
In 1996, ten years after the event, a cohort
epidemiological study of radiation-exposed
Chernobyl Liquidators was initiated [5].The
programme is a joint effort by scientists and
ophthalmologists of Ukraine and the United
States, known as the Ukrainian/American
Chernobyl Ocular Study (UACOS) [3].Two
major objectives are to: 1) address whether or
not ocular disease such as radiation cataracts
data are compatible with a high dose thresh-
old,and 2) define the magnitude of the dose-
response association for radiogenic cataracts
among Liquidators. The first two rounds of
ophthalmologic exams of 8,607 subjects at
approximately 12 and 14 years post-radiation
exposure permit us to draw conclusions re-
garding the relative sensitivity of the human
lens to radiation injury that are pertinent to
current guidelines for ocular protection of ra-
diation exposed individuals [6].
We should indicate that development of
the National System for Ethical Review in
Ukraine was done as a part of joint efforts in
Eastern Europe and Central Asia [7].In the
case of cataracts, the considerations are not
straightforward. Irrespective of job descrip-
tion, cataracts generally appear in the last
decade(s) of individuals’ working life-time
and, more often than not, the subject is un-
aware of their presence.
Before the examination we settled legal and
ethical considerations of the epidemiologi-
cal investigation which included the secured
consent in epidemiological medical research
in the USA and in Ukraine. Confidentiality
and privacy aspects and protection of hu-
man rights in epidemiologic research were
considered.
The ophthalmic examinations were conduc-
ted in six cities – Dnipropetrosk, Donetsk,
Medical Ethics, Human Rights and Socio-medical affairs
Ocular Risk Standards and Medical Ethics.
A Development on Occupational Radiation
Exposure in an Epidemiological Study
Petro Vitte, Iurii Kundiiev, The Ukrainian Medical Association; SI “Institute for Occupational
Health of Academy of Medical Sciences of Ukraine”; Bioethics Committee of National Academy of
Sciences of Ukraine
25
Kharkiv, Kyiv, Poltava and Slavutych – lo-
cated in five Ukrainian regions (oblasts)
proximal to Chernobyl. The database col-
lection and analysis were done at the SI
“Institute for Occupational Health of AMS
of Ukraine” (responsible organization), and
the ophthalmology data quality control and
education of the ophthalmologists per-
formed in the National Medical Academy
for Post-Graduate Education. The SI “Sci-
entific Center for Radiation Medicine of
AMS of Ukraine” was responsible for the
dosimetry part of these studies.
Annual human subjects’ reviews and bio-
ethical approval were provided by the In-
stitutional Review Boards of Columbia
University, Health Sciences Division (New
York),the Institute for Occupational Health
(Kyiv) and New York University School of
Medicine (New York) from the 1992.
To complicate matters, lens changes appear
with age in a specific manner and the rate
of development (worsening) varies among
individuals. Until recently, the presence of
a potential background level of cataract was
not considered a problem because it was
believed that radiation cataracts were a de-
terministic response and therefore required
a dose threshold to be exceeded if the radia-
tion was to be considered cataractogenic.
The data indicate that radiation cataracto-
genesis has a dose threshold much lower
than the current radiation protection guide-
lines specify. For highly fractionated or
protracted exposures the ICRP assumed
the dose-effect threshold was 5 Gy for
“detectable opacities” and >8 Gy for “vi-
sual impairment” [8].The NCRP, following
UNSCEAR, indicated a cataract threshold
dose of 4 Gy for fractionated low-LET ex-
posures,therefore recommended dose limits
to the eye were 2 Gy-Equivalent in a year
or 4 Gy-Eq over a career for space activities
[9].These dose values are incompatible with
the findings of the present study, which in-
volves predominantly protracted exposures;
our formal threshold analyses are statisti-
cally inconsistent with a cumulative-dose
threshold less 700 mGy.
However, accumulated data suggest that a
real threshold does not yet exist. In allow-
ing for such a possibility,standards in special
conditions, such as the astronaut corps, were
based on the concept of “clinical relevance,”
i.e. induced lens changes might be accept-
able if an individual does not suffer from
visual decrements by their presence. This is
one more medical moral question.This posi-
tion is fraught with a host of problems, not
least of which is the variegated distribution
and pleomorphism of early lens changes.
However, perhaps the most problematic to
such considerations is a recent follow-up of
the Chernobyl Liquidators, which clearly
shows that if a threshold exists it is at least
of an order of magnitude lower than pres-
ently thought and is likely not to exist at all
(for Lens – 200 mGy). Under such circum-
stances,the potential to develop cataracts oc-
cupies the same stochastic realm as cancer.
The problem was discussed on the Na-
tional Committee of Radiation Protection
of Population of Ukraine under the “Verk-
hovna Rada” (Parliament of Ukraine) in
August 2008 and our proposal to decrease
the threshold for lens was adopted. The last
publication of the ICRP indicates that this
question must be discussed and the target
group created. The ethical issue then ap-
pears: “How many excess cataracts in a
particular age we are willing to accept?” Al-
though there are other cataract-specific as-
pects which must also be considered, philo-
sophically and ethically the acceptance of a
certain damage is the main issue.
Once decisions have been made regarding
permissible exposures, the bioethical issue
becomes one of the informed consent. How
should the actual health risk be framed, so
that the individual can make a judgment as
to whether or not the added risk to cata-
ract development is personally acceptable?
Clearly, occupational activity that leads
to compromised visual acuity could eas-
ily constitute a trigger to change an indi-
vidual’s environment in order to minimize
the exposure. However, what of clinically
detectable, but not “clinically relevant” lens
changes characterize a radiogenic damage?
What provision should be made to deal
with the individual? Is simply informing the
patient of the finding without further action
an appropriate response? Should a worker
be educated on realities of the only proven
method to deal with visually debilitating
cataracts, namely, eye surgery? Or, should a
worker quit his/her job?
These are only some of ethical issues to be
examined and although, in this case, they
apply to cataract as the medical ethical
judgment, they are similarly to a problem of
other work-related pathologies.
References:
Ethics and Epidemiology. / Eds. Steven S.1.
Coughlin & Tom L. Beauchamp./ Oxford Univ.
Press./1996. – 311 P.
Occupational Medicine: State of the Art Re-2.
views. Vol.17, No.4, October-December 2002.
ETHICS IN THE WORKPLACE. Eds. By
Linda Forst, MD, MPH and Peter Orris, MD,
MPH./Publisher HANLEY&BELFUS, Inc.,/
2002. -720 P.
Anthology of bioethics. Kundiiev Y.I., editor.3.
Kiev: BaK, 2003/ – 592 P.
Ocular Radiation Risk Assessment in Popula-4.
tions Exposed to Environmental Radiation Con-
tamination / Ed. A.K. Junk, Y.Kundiev, P.Vitte,
B.V.Worgul/ Kluwer Academic Publishers, Dor-
drecht, NATO ASI Series, 1999, vol. 50. – 225 P.
B.V. Worgul, Y.I. Kundiev, N.M. Sergienko,5.
V.V.Chumak, P.M.Vitte, C.Medvedovsky,
E.V.Bakhanova, A.K.Junk, O.Y.Kyrychenko,
N.V.Musijachenko, S.A.Shylo, O.P.Vitte, S.Xu,
X.Xue and R.E.Shore. Cataracts among Cher-
nobyl Clean-up Workers: Implications Regard-
ing Permissible Eye Exposures.// Radiation Re-
search. – 2007. – 167. – P. 233-243.
V.V.Chumak, B. V. Worgul, Y.I. Kundiev,6.
N.M. Sergienko, P.M.Vitte, C. Medvedovsky,
E.V.Bakhanova, A.K Junk, O.Y.Kyrychenko,
N.V.Musijachenko, S.V.Sholom, S.A.Shylo,
O.P.Vitte, S.Xu, X.Xue and R.E. Shore. Dosim-
etry for a Study of Low-Dose radiation Cataracts
among Chernobyl Clean-up Workers // Radia-
tion Research. – 2007. – 167. – P. 606-614.
Yurii I. Kundiiev, Peter N. Vitte, Mykola Chash-7.
chin, Tatyana Mishatkina, Bakhyt Sarymsakova.
Developing National Systems for Ethical Review
in Eastern Europe and Central Asia: Legitimacy
and Responsibility. Pharmaceutical Medicine/
Vol.22, No,5. 2008. – P. 285-287.
ICRP, 1990 Recommendations of the Interna-8.
tional Commission on Radiological Protection.
Ann. ICRP 21 (Publication 60), 1-201 (1991).
UNSCEAR, Ionizing Radiation: Sources and Bi-9.
ological Effects. United Nations, New York 1982
Medical Ethics, Human Rights and Socio-medical affairs
26
Medical Ethics, Human Rights and Socio-medical affairs
Prof. (Dr.) Ketan Desai, Council Member,
World Medical Association, Past National
President, Indian Medical Association, Past
President, Medical Council of India
Medical ethics can be defined as principles
of proper professional conduct concerning
the rights and duties of patients, doctors
and fellow practitioners, as well as physi-
cian’s action in the care of patients and in
relation with their families.
With the explosion of scientific knowledge,
introduction of newer medical technologies
of investigation and treatment, as well as
an increasing level of consciousness of the
public, the importance of Medical Ethics
has evolved tremendously over the years.
The question of medical ethics and its dis-
cussion became very relevant and urgent in
contemporary times owing to the practice
of medicine increasingly becoming more
and more legalistic. Consumer laws also
embraced medical practice which became
more defensive with doctors taking recourse
to writing many investigations.
The relation between the doctor and the pa-
tient,which was essentially based on mutual
respect and trust, came to be based more on
evidence and documentation.
Medical practice in India is governed by the
regulations of the Medical Council of India
which is the apex medical regulatory body of
the country, legally endowed not only with
regulatory powers, but also with the author-
ity to discipline errant doctors as well.Being
the statutory authority to register doctors,
it can punish them also with deregistration
for a certain time or permanently. This is a
function no court of law does, but only the
Medical Council. In the contemporary sce-
nario, the ethical role of the Medical Coun-
cil has also increased greatly. Basically, eth-
ics are the moral requirements of medical
practice. It has various areas. We will try to
highlight few of them.
Doctor – Patient Relationship:
The doctor has to be careful at all times so as
to be able to earn the trust and respect of pa-
tients.And to be able to do so,he has not only
to be professional and competent, but has to
be compassionate and caring and well versed
in codes of ethics and the laws governing this
sphere as well.Truthfulness is the first ethical
principle a doctor has to follow and also it is
the first expectation of the patient.
A doctor’s attitude towards the patient is of
vital importance. When a person chooses
the medical profession the die is cast. He or
she is then expected to behave in a certain
way, uphold certain value systems, follow
an exemplary and disciplined conduct both
in public and private life, be transparent in
all dealings including financial ones and be
aware at all times that once the profession
of medicine has been chosen, it will be nec-
essary to have a mentality of service towards
the people, towards the patient.
Patient Autonomy:
The patient has the right not only to choose
the modality of treatment, but also the doc-
tor who would be treating him. Thus, doc-
tor must explain the details of treatment,
diagnostic procedures, surgical procedural
details and others, if any.
Only in emergencies, a doctor should know
what has to be done and why.In such situation,
proper documentation is important which
doctor must bear in mind. Doctors otherwise
should always respect the patient’s right of
autonomy and never fail to inform about the
various treatment modalities available and the
details of the management plan chosen for the
patient in a particular case. Even in ward set-
tings these principles must be adhered to.
Confidentiality:
Preserving confidentiality is another area
of a doctor-patient relationship, a doctor
is bound by his code of honour (read eth-
ics code) not to divulge this information to
anyone at anytime except possibly in a court
of law and that too in camera. A patient’s
trust of his doctor (and respect too) greatly
depends on this. It also involves not divulg-
ing medical secrets of wives to husbands and
vice versa. The principles of ethics demand
that the patient and the patient alone must
be told fully about the diagnosis.
Communication with the patient:
This is another central aspect of doctor-
patient relations.
Informed Consent:
A patient’s acceptance is required in writing,
but it has to be obtained after informing the
patient regarding invasive procedures, dan-
gerous drugs (such as in Chemotherapy),
anaesthesia and surgery to be undertaken.
Even at the stage of investigation, where
invasive procedures, endoscopic procedures,
biopsy etc. are required then it is also neces-
sary to obtain informed consent. It is a legal
requirement and not only an ethical require-
ment alone. Consent from nearest relatives,
children or legal guardians have to be ob-
tained if legal consent from the patient is
unobtainable owing to patient’s condition.
Medical Ethics in the Present Scenario:
Revisiting the Basics and Recognizing
Emerging Concerns
27
Medical Ethics, Human Rights and Socio-medical affairs
The doctor must never forget that a patient
has the right to withhold consent.
A doctor must also know what are the
patient’s rights and what are the doc-
tor’s rights i.e. the respective rights of the
patient and the service provider. There are
many authorities who have charted out
these rights of the patient. Mostly, these are
matters of ethical principles, but in USA
and some countries these have the sanctity
of law. Whether such rights are within the
realm of law or morality (ethics), the doctor
must be well conversant with them.
There should be no discrimination on the
basis of race, religion, language, colour and
culture.The doctors must also ensure that in
all treatment decisions there is participation
of the patient.
No doctor can refuse to attend to a patient
if called in an emergency; however, in non-
emergency situations, in routine practice, a
doctor has every right to refuse to see a pa-
tient. A Doctors function within rules and
at certain times only they may be available
for consultation.
A doctor may have to take certain tough
decisions at the end stage of the patient’s
life, specially, death declaration of patients,
on life support systems which should de-
pend to a large extent on the relevant laws
of the country. These are called end of life
decisions. One aspect of it concerns eutha-
nasia. In India, euthanasia is not allowed.
But for every medical action there is a code
of ethical conduct which is based on com-
monsense, cultural practices, social codes
and even law. For not following these self
regulatory codes, a doctor can be accused of
misconduct or infamous conduct which may
attract various censures, penalties, fines, etc
as per the laws set by the regulatory authori-
ties, government, employers and courts.
Medical negligence is one part of the
sphere of ethics which every doctor is afraid
of and is a very serious matter. Civil and
criminal negligence is the broader indexing
of all negligence.
If a doctor, without required and recog-
nized competence performs a procedure on
a patient for which the doctor has no legal
sanction and competence, he is bound to be
committing an act of medical negligence,
whether something untoward occurred to
the patient or not.This could be act of com-
mission by a medical doctor.
Negligence can be by an act of omission,
the doctor has not done a particular act he
was required to do, or by forgetting it or not
having the competence. To avoid malprac-
tice and negligence suits, it is essential that
the doctors follow a disciplined scientific
approach and maintain self regulation.
Doctors need to be firm to refuse the lure
of unethical gratification and withstand the
inappropriate promotion practices of the
pharmaceutical industry. Similarly, work-
ing in private practice brings many ethical
dilemmas before the doctor. Management
pressure on the doctors to perform in terms
of more patients, more investigations, more
operations, more revenue can create an un-
healthy atmosphere and pose serious ethi-
cal problems. The doctors should be strong
enough to withstand these pressures and in-
sist of working in a professional atmosphere
only.
The tremendous development of scientific
knowledge and treatment techniques in the
last two-three decades have brought many
new ethical problems for the doctors. But,
this field is so vast that it is not possible
to cover the entire sphere of these newly
emerging ethical concerns in medical prac-
tice in the scope of one single article.
Genetic screening, gene therapy, sex deter-
mination of the foetus and female foeticide,
organ transplantation and donation all de-
serve special attention owing to newer laws
of the land. In India, where female foeticide
abuse is not insubstantial, has quite strict
laws regarding these (Prenatal sex determi-
nation test act 1994 PNDT act). Similarly,
in India,the whole spectrum of organ dona-
tion and transplantation is covered by the
Transplantation of human organ act, 1994.
Such screenings have to be kept confiden-
tial; as such genetic information can be used
to discriminate individuals by employers,
insurers and even by spouses and relatives.
Doctors must ensure that such test results
are kept strictly confidential and disclosure
should be only done in a manner prescribed
by law. Doctors should not attempt genetic
counselling unless they are trained and usu-
ally such counselling should be confined to
ones own speciality.Breach of laid down law,
professional protocols, need of maintaining
confidentiality can be considered as serious
ethical infamous conduct.
Drug trials, animal experimentation, stem
cell research, everywhere newer ethical is-
sues are cropping up which are subject
and situation specific. In India, the Indian
Council of Medical Research and also the
Drug Controller of India have laid down
legal and ethical guidelines for medical
research and doctor should strictly follow
these guidelines. Those who are in the field
of medical research should scrupulously
follow the principles of the Helsinki Dec-
laration. No doctor should undertake drug
trials or clinical research unless these are
specifically approved.
Ethical issues are emerging in the treatment
of patients suffering from HIV/AIDS. Re-
fusal to treat, stigmatization, and unfair re-
source allocation are some of the most un-
ethical practices that a doctor can indulge
in. Ethical issues also crop up in instances
where notification or partner tracing are re-
quired to be done.
With the development of medical science,
with newer treatment and diagnostic mo-
dalities,newer ethical issues are cropping up
everyday and they are likely to continue to
do so in the foreseeable future as well. It is
the legal, moral and ethical duty of all doc-
tors to keep track of these newly emerging
medical issues. Ethical practice is the bed-
rock where the reputation and respect of
a medical practitioner is based. We must
never lose sight of this.
28
Education
Masami ISHII, MD, Executive Board
Member of JMA, Council Member of WMA
1. Introduction
In 1987 the Japan Medical Association
(JMA) initiated systematized continuing
medical education (CME) programs to
provide systematic support to the broad-
based, effective engagement of physicians in
CME under the philosophy of professional
autonomy based on self-regulation.
2. School Education
System in Japan
The compulsory education in Japan con-
sists of nine years from elementary school
to junior high school. After compul-
sory education, students must undergo
a three-year high school education and
then complete a university medical course
to be eligible for qualification as physi-
cians. The university medical education
comprises six years, including basic and
clinical education. The courses up to this
point are under the supervision of the
Ministry of Education, Culture, Sports,
Science and Technology. There are pres-
ently 80 medical colleges and university
medical departments in Japan, admitting
approximately 7,500 students every year.
In response to the shortage of physicians,
the annual admission capacity is expected
to increase gradually. After the six-year
medical education program, students must
pass the National Examination for Medi-
cal Practitioners, be registered with the
Ministry of Health, Labour and Welfare,
and complete two years of postgraduate
training. While this postgraduate train-
ing was voluntary in the past, it was made
compulsory in 2004. With this education,
new physicians are trained and allowed to
perform medical acts in Japan.
3. CME Program of JMA
(1) Basic Policy
The CME Promotion Committee of the
JMA has been established to promote and
support the CME of members. Local as-
sociations also have similar committees for
physicians in respective regions, and the
JMA is working in close cooperation with
these committees.The CME Committee of
each local association supports the teaching
of members with programs incorporating
regional policies and characteristics. The
content of learning covers not only medical
science but also various fundamental issues
physicians must understand in their daily
practice, such as medical ethics. Respecting
the self-determination of physicians, the
CME activities undertaken by individual
physicians are evaluated on the principle of
self-reporting, and no penalty is imposed
on physicians who fail to report.“The CME
Certificate” is awarded to physicians who
declare that they have completed 10 credit
units or more in a year. Physicians achieving
this certificate in three successive years are
granted “the Certificate of Recognition for
Completion of CME.”
(2) Curricula
The curricula sets the goals and outlines the
learning directions of the physicians. The
study topics in the curricula are divided into
basic healthcare topics and medical topics.
1) Basic Healthcare Topics
These include about 100 basic healthcare
topics that all physicians should know, ir-
respective of the fields in which they spe-
cialize. Examples of such topics are medi-
cal ethics, laws, welfare, social security, and
health economics. This part of the curricu-
lum is intended for the acquisition of broad
knowledge related to healthcare.
2) Medical Topics
These are the learning of medical science,
comprising the two parts covering “impor-
tant matters in medical practice” and “im-
portant diseases,” respectively. The former
part, “important matters in medical prac-
tice,” assesses the attainment of knowledge,
skills, and attitudes related to the important
matters in the process of medical practice.
The latter part, “important diseases,” is a
curriculum that assesses the attainment of
sufficient knowledge and treatment skills
for diseases commonly seen in daily prac-
tice and diseases of clinical importance.
The JMA recommends the following ways
of utilizing these curricula.
The CME Committee of a local medical as-
sociation may plan a CME workshop, fea-
turing some of the themes in the curricula.
The curricula may be used in self-directed
home learning and group learning.
It is recommended to select study topics
referring to the curriculum of experience-
based learning in hospital-clinic collabora-
tion.
(3) Main Learning Media
Main learning media tools include the Jour-
nal of JMA published in Japanese by the
JMA. The Journal, produced by the Edito-
rial Committee of the JMA, is published in
twelve regular issues and two special issues
The Continuing Medical Education Program
of the Japan Medical Association
29
Education
every year. The JMA CME Courses refer
collectively to the CME courses supported
by collaborating companies, reflecting the
diversification of learning media. These
courses are also planned by the Editorial
Committee.
The JMA website allows visitors to search
and read papers in the Journal of JMA, to
search titles in the video library, to view
video-streamed medical TV programs, and
to view Internet-based CME courses.
In addition, journals and websites of local
medical associations are also used as learn-
ing media.
(4) Learning Methods
Learners may obtain credit units defined as
follows.
A learner attending a lecture meeting or a
workshop receives a certificate (card, sticker,
etc.) from the host organization and sub-
mits it with the declaration to acquire 3-5
credit units. In the case of experience-based
learning (learning in hospital-clinic or clin-
ic-clinic collaboration), the learner submits
the theme, the name of facility, and other
details with the report form, and receives
five credit units. Some professional achieve-
ments may be recognized as credit units. A
learner making an academic presentation or
publishing a paper attaches the records of
presentation title, author name, etc. to the
declaration and receives 3-10 credit units.
Home learning, such as sending an answer
to a question in the Journal of JMA via mail
or the Internet or answering the self-assess-
ment in the Internet-based CME courses,
is worth one credit unit each time.
(5) Self-declaration Practice
The acquisition of credit units is based on
the principle of self-reporting. Some local
medical associations collect declarations
from the members send them to the JMA.
The report form is distributed as a supple-
ment to the March issue of the Journal of
JMA every year. A person making a decla-
ration fills in the report form, attaches the
certificates of attendance to seminars and
other events and records of achievements,
and submits the completed form to the
county, city, or ward medical association or
the university medical association to which
he or she belongs by the end of April ev-
ery year. The submitted declaration forms
are sent to the JMA via prefectural medical
associations and processed and managed by
computer.
(6) Interchangeability of Credit Units
The certificates of attendance obtained from
the participation in the JMA CME Courses
are interchangeable with the credit units
needed for the renewal of specialist certi-
fication in several specialty societies. In the
CME system of JMA, attendance of a lec-
ture meeting or other events of a specialty
society is counted as three credit units.As of
2008, arrangement for credit interchange-
ability has been made with the specialist
physician/certificate physician systems of
27 specialty societies
(7) Awarding of “the CME Certificate”
and “the Certificate of Recognition
for Completion of CME”
“The CME Certificate”is awarded to physi-
cians submitting the CME declaration and
documented (by certificates of attendance,
records, etc.) to have achieved ten credit
units or more in a year. Physicians achieving
this certificate in three successive years are
granted “the Certificate of Recognition for
Completion of CME”.
Although these certificates of completion
and certificates of recognition do not signify
any qualification, the proof of participation
in CME as indicated by the declaration rate
provides a yardstick for measuring the atti-
tude of a physician towards CME.The phy-
sician may display these certificates in the
clinic, for example, as a means of building a
trust relationship with patients.
4. Conclusion
The medical care system of Japan faces a
crisis as a result of the government’s policy
of cutting expenditure and curtailing social
security measures. In this difficult situation,
the JMA is doing everything in its power
to enrich community health, ensure patient
safety and build a reliable foundation for
social security. The CME program is one
of the most reliable means of improving
the quality and skills of individual physi-
cians, and the importance of CME is will
undoubtedly increase in the future.
In addition, the JMA has been engaged
in international affairs through participa-
tion in WMA and continuing interactions
with the medical associations of various
countries to exchange opinions regarding
world healthcare problems.The enrichment
of community health in Japan is directly
linked to Japan’s contribution to the health
of people in the world. From this perspec-
tive, the JMA is committed to continue its
efforts to improve the health standard of the
world from the standpoint of patients. The
JMA intends to compile records of success-
ful solutions of various problems of com-
munity health and share these experiences
with the physicians of the world, so that
it may be of help to physicians working in
various environments.
30
International, Regional and NMA news
Dr. Tin Chun Wong, FDI Treasurer
Despite oral diseases being some of the most
commonandmostwidespread in populations
around the world there has been,and remains
in many countries, surprisingly little atten-
tion paid to them. This may be a reflection
of their often chronic and low grade nature,
except for episodes of acute pain manifested
as toothache, or that other diseases and con-
ditions steal the limelight due to their more
dramatic or life threatening potential.
As part of its role,and enshrined in its Mission
Statement, the FDI World Dental Federa-
tion has the vision of optimal oral health for
all and strives through its activities to achieve
this goal.This article,by Dr.Tin Chun Wong,
Treasurer of the FDI and based on her pre-
sentation to the World Assembly in Seoul –
Oral Health and Human Rights – describes
the work of the FDI and its importance in
relation to oral health and human rights, and
in turn the importance of oral health within
the context of general health.
The FDI
Founded in 1900 in Paris, France the Fé-
dération Dentaire Internationale (FDI)
was the brainchild of Dr. Charles Godon,
Dean of the Ecole Dentaire de Paris who
has planned three International Dental
Congresses in that city in the years 1889,
1893 and 1900. With a founding group of
five other colleagues, on the morning of 15
August 1900 the Federation was born. Lit-
tle could those dentists have imagined that
over a century later the organisation would
represent 135 countries, 190 national dental
associations and special interest groups and
through them effectively speak for over one
million dentists and dental care profession-
als worldwide.
The FDI’s mission
As a federation of National Dental Asso-
ciations the FDI’s main roles are to bring
together the world of dentistry, to repre-
sent the dental profession of the world and
to stimulate and facilitate the exchange of
information across all borders with the aim
of optimal oral health for all peoples. It has
four main areas of activity:
The voice of dentistry
To be the worldwide, authoritative and in-
dependent voice of the dental profession.
This it achieves by producing position state-
ments on various aspects of dentistry and oral
health, providing authoritative information
for governments,the media and other organi-
sations, and holding the Annual World Den-
tal Parliament as part of its Congresses. The
FDI develops and disseminates policies, stan-
dards and information related to all aspects of
oral health care around the world.FDI Policy
Statements lay out the profession’s views on
various issues related to oral health,oral health
policies and the dental profession.
Optimal oral health
To promote optimal oral and general health for
all peoples
Being an advocate for oral health at the
WHO, UN and in a variety of other fora,
the Federation also runs projects through its
Dental Development Fund (see below).
Member support
To promote the interests of the Member Asso-
ciations and their members
With its headquarters in the Geneva area,
the FDI gives support and promotion to
its constituent associations across a variety
of project areas including sponsorship, oral
health campaigns and expert advice net-
works.
Information transfer
To advance and promote the ethics, art, science
and practice of dentistry
This aim is achieved through a range of
activities including the Federation’s three
main publications and website (www.fdi-
worldental.org) as well as its Annual World
Dental Congress (AWDC). This encom-
passes an extensive scientific programme
with international speakers, as well as those
from the host country or region, focusing
on the latest scientific topics affecting the
dental profession globally. Recent venues
have included China, Dubai and Sweden,
with Singapore and Brazil in 2009 and
2010 respectively. Congresses also provide
the opportunity for meetings of the Practice
Committee, Science Committee and other
specialist groupings whose ongoing projects
produce position papers, papers for publi-
cation and fora for discussion and develop-
ment.
Advocacy Activities
As well as its Policy Statements the Federa-
tion’s involvement in global health extends
to the promotion of general health, with
oral health as an integral component as one
of the elements of a healthy lifestyle and a
productive society. Oral health inequalities
are addressed through the implementation
of effective oral health policies. The FDI is
a member of the World Health Professions
Alliance, together with the International
The FDI World Dental Federation and the
growing realisation of oral health worldwide
31
International, Regional and NMA news
Council of Nurses, International Pharma-
ceutical Federation and World Medical As-
sociation. It is also active in tobacco control
since use of tobacco has both direct impact
on oral health, such as oral cancer, as well
as on general health issues. Tobacco cessa-
tion advice is effectively given by members
of the oral health care team, which the FDI
promotes as an active role.
Development Projects
The FDI promotes and supports global oral
health development for deprived communi-
ties and populations in various ways.
Projects at grassroots level
These are carried out in co-operation with
FDI member associations and non-govern-
mental organisations and supported through
grants from the FDI’s World Dental Devel-
opment Fund.Projects have been established
in Latin America, Asia and Africa.
Support in developing appropriate policies
The FDI supports governments and other
organisations in the formulation of com-
prehensive oral health policies and helps in
their implementation.
Global partnerships to improve oral health
WorkinginclosepartnershipwiththeWHO,
other UN agencies, health professions and
organisations the Federation collaborates
to improve oral health worldwide. Active
involvement with FDI’s corporate partners
is another way of engaging broadly in pro-
moting better oral health. The Live. Learn.
Laugh programme, created as a unique part-
nership with a corporate partner, aims to in-
crease oral health education and promotion
in countries throughout the world.
Education Programmes
Continuing Dental Education
Together with its member associations, the
FDI participates in and supports continu-
ing dental education programmes in many
regions. The organisation is currently in-
volved with more than 20 continuing dental
education programmes each year.
As mentioned above, the AWDC plays an
important role in the advancement of den-
tistry. In addition to the scientific element,
theprogrammealsofeaturesspecialitywork-
shops and forums on oral health promotion,
the World Dental Exhibition – a showcase
of state-of-the-art advanced dental technol-
ogy,equipment and products and the World
Dental Parliament,a gathering of about 350
representatives from FDI member associa-
tions to establish the organisation’s strategic
direction and adopt policy statements that
influence the world of dentistry.
Communications
The Federation produces a series of repu-
table publications on topics related to oral
health through its publishing division, FDI
World Dental Press, based in the United
Kingdom.
The International Dental Journal (IDJ)
The renowned IDJ has been FDI’s flagship
publication for nearly 60 years. It features
peer-reviewed, scientific papers relevant to
international oral health issues in addition
to practical and informative articles aimed
at clinicians. Published six times a year, IDJ
is the FDI’s main scientific publication. It is
available in print and online (www.idj.org).
Developing Dentistry
This biannual journal is the worldwide voice
of oral health development. It offers a posi-
tive, forward-looking approach to dental
development and tries to provoke discus-
sions and debates around these topics by
featuring papers from around the world.
Developing Dentistry is distributed free of
charge.
Worldental Communiqué
This newsletter provides FDI member asso-
ciations and other dental and health related
groups with updates of our organisation. It
is published six times a year.
Annual Report
Provides members,partners and other inter-
ested parties with an overview of the FDI’s
recent achievements and an outlook of the
organisation’s future. It includes messages
from the organisation’s President, Execu-
tive Director and Chairman of the Finance
Committee, in addition to financial state-
ments and reports on the FDI’s activities.
Website
The website features information about the
FDI as a federation of member associa-
tions a world renowned section on scientific
guidelines for the dental profession, details
about FDI development and public health
activities and information about Annual
World Dental Congresses and continuing
education programmes.
Oral health worldwide
It is now widely held that good oral health
is a basic human right and should not be
regarded as a privilege of a minority. The
FDI believes strongly in this and indeed
this emerged as the declaration of the April
2004 Nairobi Conference for Oral Health
in the African Region, organised by the
Federation. This was the first conference on
oral health on the African continent and
was supported by WHO.
There is a strong association between oral
health and socio-economic status so that
poor oral health is often a feature of low
societal position also leading to a similarly
strong association between oral health and
inequalities.
There are two main oral diseases; dental
decay and gum disease. Both are mediated
by dental plaque which is formed of micro-
32
International, Regional and NMA news
organisms that colonise tooth surfaces. De-
cay, or caries, is essentially a gradual process
of demineralisation with calcium being re-
moved from the outer enamel surface of the
teeth by acid attack from the plaque bacte-
ria.The process is driven primarily by sugars
and carbohydrates in the diet which are then
metabolised by the micro-organisms which
create acidic by-products and toxins.
Gum disease is similarly promoted by the
toxins from bacterial plaque that grows
around the gum margins. In its early stages
it causes inflammation of the gingivae (gin-
givitis) but can progress to destroy the sup-
porting tissues of the teeth, the periodon-
tium (periodontitis).
In an ideal world, removal of dental plaque
in an efficient way and on a regular basis
would prevent or limit the extent of both of
these conditions. In the real world however
this is either not possible at all, or only in
part depending on a wide range of factors.
Prevention rather than cure
Because the conditions are preventable,
the FDI is a strong supporter of the two
main methods of prevention and this runs
throughout its activities and programmes.
Periodontal disease prevention, reliant on
effective and thorough removal of plaque,
relies on good oral hygiene through tooth-
brushing, flossing and other mechanical
means such as the miswak, as well as chemi-
cal adjuncts such as appropriate mouth
rinses and on occasion other anti-microbial
agents.
As far as caries is concerned there are two
approaches to prevention. One is dietary
modification to reduce the frequency and
quantity of refined carbohydrates consumed
combined with good oral hygiene.However,
this necessarily involves not only motivation
from the patient but also the resources of
time, finance and equipment to achieve it.
It is in these situations in which inequali-
ties impact so heavily on oral health. An-
other approach is the use of fluoride as an
agent to help strengthen the tooth enamel
against the acid attack from the plaque.
The incorporation of fluoride into the outer
surface of the enamel makes it chemically
more resistant to acid meaning that it can
sustain an attack for longer, enabling it to
survive intact for longer and until the saliva
can restore the pH balance in the mouth al-
low remineralisation to take place from the
calcium in the saliva.
Fluoride advocacy
Currently only 20 % of the global popula-
tion benefits from fluoride as a form of car-
ies prevention.The FDI,working with other
stakeholders, recommends to governments
and other international organisations ways
of increasing this availability on a popula-
tion and individual basis.
Community fluoridation schemes are par-
ticularly effective as public health measures
and none more so than water fluoridation.
This is one of the great achievements in
public health in the last century and is an
inexpensive and cost effective way of reduc-
ing caries rates that benefits all members
of society, preventing or reducing the pain,
disruption to life suffering and hardship
caused by caries; especially for children.This
universal access to fluoride is a central part
of the basic human right to oral health as
noted above.
Fluoride in toothpaste is also a valuable
preventive tool.Moves to provide affordable
fluoride toothpaste in less advantaged coun-
tries are increasing in pressure as are discus-
sions to convince governments that taxes
and duties on fluoride toothpaste should be
reduced or abolished so as to increase its af-
fordability and spread its health gain.
Oral health and general health
There is increasing evidence of the connec-
tion between poor oral health and other
systemic health problems. In particular
there are links between periodontal dis-
ease and both premature births and low-
weight births.Diabetes is another condition
strongly associated with periodontal disease
and there is a growing body of research sug-
gesting links with heart disease and stroke.
Although not fully explained, the mediation
of bacterial plaque is never far away from the
centre of suspicion and it may be that the mi-
cro-organisms cause problems either through
the production of their toxins escaping into
the blood stream or that they somehow alter
the host immunological response.The net ef-
fect however has been to create a framework
in which it makes perfect sense for oral dis-
ease prevention to operate in tandem with
general disease prevention. The days of per-
ceiving the mouth as being separate from the
rest of the body are numbered.
This concept found particularly strong back-
ing in 2007 at the World Health Assembly
(WHA) where, thanks to the work of the
FDI and others over a long period of time,
the WHA passed a resolution which calls
for oral health to be integrated into chronic
disease prevention programmes. Whilst
perhaps not seeming to be earth shattering
in its extent, the recognition of this is a ma-
jor breakthrough and means that the FDI’s
member associations can use the resolution
in advocacy for oral health programmes
throughout the world, citing to govern-
ments the WHA’s acknowledgment of the
importance of this health measure.
Working at many levels
The Federation’s long history and its ability
to attract the best of the profession means
that it can work at many levels. Recent in-
novations have included the development
of a Dental Ethics Manual which has found
considerable popularity and is currently be-
ing translated into the FDI’s main languag-
es French, German, Spanish and Japanese.
The manual includes FDI Guidelines for
dentists against torture, again strengthen-
ing the Federation’s stand on human rights.
Through this means the organisation is
aiming towards better integration of eth-
ics into dental curricula around the world
to help guide an influence the dental care
professionals of tomorrow.
33
International, Regional and NMA news
Dr. José Luiz Gomes do Amaral, President of
Brazilian Medical Association
The Brazilian Medical Association (AMB)
(www.amb.org.br) was founded in 1951
with a mission to ensure the dignity of the
medical profession and quality health care
for the Brazilian people. It consists of 27
State medical associations and 396 regional
associations. In addition, 53 Medical Soci-
eties compose its Scientific Council, repre-
senting all specialties accredited in Brazil.
The AMB is a member of the Council of
the World Medical Association and is the
founder of the Portuguese Language Medi-
cal Community.
In 2000, the AMB launched a team to elab-
orate medical guidelines based on scientific
evidence in order to standardize procedures
and assist physicians in making clinical di-
agnostic and treatment decisions. Each of
the specialty societies affiliated with AMB
is responsible for the substantive content
and written elaboration of their guidelines.
So far, more than 300 guidelines have been
developed. They are available on the web-
site: www.projetodiretrizes.org.br.
The AMB collaborates with the Ministry of
Education and House of Representatives to
fight for the quality of medical education.
In pursuit of scientific improvement and
professional validation since 1958, the
AMB grants specialization certificates to
physicians who pass strict oral and practi-
cal evaluations.Through its National Com-
mission of Credit, the AMB records credits
earned and updates physicians’ certificates.
The Continuing Medical Education Pro-
gram (EMC) is freely accessible to all
Brazilian physicians and includes distance
learning.
Through the Parliamentary Affairs Com-
mission, the AMB actively participates in
the development of legislation that affects
the health profession and health system.
The AMB has three key channels of com-
munication: the Jornal da Associação Médi-
ca Brasileira (the AMB’s journal), which is
published every two months tracking devel-
opments in medical politics ; the Revista da
Associação Médica Brasileira (the AMB’s
magazine), which gathers scientific articles
from renowned physicians throughout the
country; and its website – www.amb.org.br.
The Brazilian Hierarchical Classification of
Medical Procedures (CBHPM), developed
and continually reviewed by the AMB, the
Federal Council of Medicine and Specialty
Societies, includes all scientifically accepted
medical procedures and serves as a critical
reference in the provision of quality health
care. The present CBHPM was designed
based on technical criteria. The AMB also
participates on a Commission created to
elaborate a proposed Plan of Position, Ca-
reer and Salaries within the Public Health
System, enabling medical entities to nego-
tiate their implementation with States and
municipal districts.
Information about Brazil
Brazil has 190 million inhabitants and oc-
cupies an area of 8,514,876.599 km², equal
47% of South American continent. There
are 331,000 active physicians (1 doctor per
600 inhabitants).
Brazil has a public health system available
to everyone, as well as a supplementary
health insurance system that benefits ap-
proximately 40 million citizens. The public
health system is structured with three levels:
federal, state and municipal. It is financed
by taxes and social contributions paid by the
population.
In 2006, the federal government spent R$
40.78 billions (US$ 22.45 billions). State
and municipal sectors spent,respectively,R$
18.69 (US$ 10.2) and R$ 19.44 (US$ 10.7)
billions, in total R$ 78.91 (US$ 43.4) bil-
lions were invested in public health. The
private sector invested R$ 87.54 (US$ 48.2)
billions, including health insurance, direct
disbursement and medicines. Summarizing
both private and public investments, the
Brazilian health system received R$ 166.45
(US$ 91.6) billions (around R$ 892 per in-
habitant – US$ 491).
According to the Brazilian Institute of Sta-
tistics, the main diseases in the country are:
circulatory system, cancer, diabetes, respira-
tory diseases and AIDS.
The fertility rate among Brazilian women is
1.95 child per woman.In 1960,this rate was
6.3 children per woman; in 1980, it was 4.4;
and in 2000, it was 2.3.The ratio of males to
females in Brazil is 48.8 (93 million) males
to 51.2% (97 million) females.
* Currency values converted on September
15th
, 2008
Comunication Deptartment of AMB
The Brazilian Medical Association (AMB):
purpose and actions
34
International, Regional and NMA news
Dr. Wong Chiang Yin, President of the 49th
SMA Council, Hospital Administrator,
a Public Health Physician
Dr. Lee Hsien Chieh, a Public Health Trainee
at Changi General Hospital under the Singa-
pore Health Services Group
Singapore Healthcare System
Singapore, a city-state with a land area
of 707.1 square kilometres [1], is located
137 kilometres north of the equator at the
southern tip of the Malay Peninsula. The
Republic has a total population size of 4.59
million [1] and a population density of
6489 persons per square kilometre [1]. As
of 31 December 2007, there were a total of
7348 registered medical practitioners,out of
which 2781 (37.6%) were trained specialists
in 35 recognised specialties [2].The doctor-
to-population ratio is 1:620 [2], and there
are about 2.6 hospital beds per 1000 total
population [3].
Primary healthcare is easily accessible
through an extensive network of 2000 pri-
vate medical practitioners’ clinics, which
provide 80% of primary healthcare services,
as well as 18 government polyclinics, which
provide the remaining 20% [3]. In contrast,
the public sector accounts for 80% of tertiary
hospital care vis-à-vis 7 public hospitals and
6 national specialty centres, with 16 private
hospitals accounting for the remaining 20%
[3]. Patients are free to choose their health-
care providers within this dual healthcare
delivery model. The average length of stay
in acute care hospitals is 4.7 days [3], and
the average waiting time for elective surgery
is one week [4].
In 2007, the Life Expectancy at Birth was
80.6 years (78.2 years for males; 82.9 years
for females) [1]. Total Fertility Rate was
1.29 per female, while Infant Mortality
Rate was 2.1 per 1,000 live-births [1]. The
Crude Birth Rate was 10.3 per 1,000 popu-
lation and Crude Death Rate was 4.5 per
1,000 population [1].
Healthcare Financing
Singapore’s healthcare financing framework
is formed by the “3M” system – Medisave,
Medishield and Medifund. Medisave is
a state-run compulsory medical savings
scheme introduced in 1984, under which
every working employee contributes 6.5
% to 9.0 % [3] of his monthly income to a
personal Medisave account.The savings can
be withdrawn either to pay his own hospi-
tal bills, or those of his immediate family
members.
Medishield is a medical insurance scheme
introduced in 1990 to help members cover
medical expenses and protect against finan-
cial ruin from major illnesses. Premiums for
Medishield can be paid for by savings under
the Medisave account. Medishield covers
almost 80 % of the Singaporean population
today [3].
Medifund is an endowment fund set up in
1993 for needy patients who have exhaust-
ed all other means and cannot afford their
medical expenses. Starting with an initial
capital of S$200 million in 1993 [3], ad-
ditional capital injections are made during
budget surpluses. Only the interest income
from the capital sum,which currently stands
at S$1.66 billion [3] is utilised. Medifund
ensures that no Singaporean is denied ac-
cess to the healthcare system due to an in-
ability to pay.
In 2005, Singapore spent a total of S$7.6
billion, the equivalent of 3.8% Gross Do-
mestic Product (GDP) on healthcare. The
amount of government healthcare expendi-
ture made up S$1.8 billion (0.9% of GDP)
[3].
Singapore Medical Association
The Singapore Medical Association (SMA)
is the national body for the medical profes-
sion.It is a voluntary NGO with 4917 mem-
bers, or about 64% of all registered medical
practitioners in Singapore (as at 31st
Au-
gust 2008). The membership make-up re-
flects the medical profession in Singapore
with approximately 30 % who are general
practitioners, 31 % who are specialists and
the remainder being doctors-in-training.
This makes the SMA the largest voluntary
organisation for doctors in both the private
and public sectors in Singapore.
The SMA was formed in 1959 when the
Malayan Branch of the British Medical As-
sociation split to form the Malaysian Medi-
cal Association and the SMA. Some of the
core activities of the SMA include promot-
ing ethics and professionalism, publishing
the monthly Singapore Medical Journal and
SMA Newsletter, dealing with professional
practice issues and organising medical talks/
workshops for doctors. The SMA is also
the secretariat for Medical Associations in
South East Asian Nations (MASEAN), as
well as a member of the World Medical As-
sociation and Confederation of Medical As-
sociations in Asia and Oceania (CMAAO).
References
1. Singapore Department of Statistics website http://
www.singstat.gov.sg/stats/keyind.html#keyind
(Last accessed 22 Sep 08)
2. Singapore Medical Council Annual Report 2007
3. Singapore Ministry of Health website http://www.
moh.gov.sg (Last accessed 22 Sep 08)
4. World Health Organization (Regional Office for the
Western Pacific) website http://www.wpro.who.int/
countries/
05sin/health_situation.htm (Last accessed 24 Sep 08)
Healthcare in Singapore and the Singapore
Medical Association
35
International, Regional and NMA news
Jovan Tofoski, Prof. Dr. Sci. Med, President
of the MMA
The Macedonian Medical Association –
MMA, in Macedonian language Makedon-
sko lekarsko drustvo – MLD, was founded as
an Association of doctors,dentists and phar-
macists (then it joined only 123 doctors and
dentists and 96 pharmacists).Today it gath-
ers around 5000 doctors in all the branches
of medicine,of whom 3025 are specialists in
various fields while there are 2106 general
practitioners of whom 35 % are family doc-
tors. The doctors in the MMA are formed
in 70 specialists and sub-specialist associa-
tions, as well as 20 local associations in the
large towns of Macedonia.
In the course of its existence and its contin-
uous growth and development the Macedo-
nian Medical Association has, among other
things,held sixteen congresses for all doctors
and more than sixty-five congresses of its
specialized branches,and all the papers sub-
mitted and edited, numbering 12 077 in all,
have been published in special Proceedings
or supplements of the Macedonian Medical
Review (Makedonski Medicinski Pregled). In
the period in question the regular profes-
sional meetings of the associations, which
are held on average four times a year,with at
least three subjects apiece, have reached an
overall total of more than 12 800 meetings
with that a great number of various courses,
workshops, seminars and other forms of
continuous and higher education of the
members have also been organized. Within
the framework of the MMA the medical
journal Macedonian Medical Review has
been coming out for sixty-three years now
with a total of 5196 papers reviewed and
published in Macedonian and abstracts in
the English language.
The Macedonian Medical Association was
proceeded of the Medical Faculty (1947)
and many of its members later became pro-
fessors in the Faculty. The MMA also took
the initiative of forming, from among its
own ranks, the Macedonian Chamber of
Medicine as a separate institution (1992).
During the period of its activity the MMA
has managed to accomplish an enormous
amount of work and activities, which has up
to the present,been carried out on an entirely
voluntary basis. This shows of the enormous
enthusiasm of generations of doctors-mem-
bers of the MMA,in their efforts to offer the
Macedonian public health protection which
is wide-ranging and of as high quality as
possible, by the application of good medical
practice and high ethical standards.
Throughout its existence the MMA has not
only followed, but also been an active par-
ticipant, initiator and consultant in the cre-
ation and improvement of the laws affecting
the sphere of health service provision in the
country. Its proposals and conclusions have
frequently been influential in the passing of
specific legislation.There have also been oc-
casions where these have been rejected only
for it to be recognised later that such rejec-
tions have had a negative effect in practice.
Throughout its long continuous activity and
fruitful and successful work the Macedo-
nian Medical Association has established
itself as one of the pillars of health protec-
tion in Macedonia, as an exceptionally im-
portant factor in the development of medi-
cine in the country, and as one of the key
elements in the improvement and raising of
the standards of the health protection of the
population.
At the same time the Macedonian Medi-
cal Association established its identity and
gained recognition as an extremely signifi-
cant segment in the overall social develop-
ment of the Republic of Macedonia and as a
relevant factor in the development of medi-
cal profession and science in Macedonia.
There has so far been a high level of co-
operation on the part of the MMA with
the Faculty of Medicine, the Macedonian
Chamber of Medicine and the Ministry of
Health.
As a recognition of all its worthy and vis-
ible services the Macedonian Medical As-
sociation, on its 60th
Jubilee, has received
The Macedonian Medical Association
Delegates of General Assembly of MMA.
36
International, Regional and NMA news
the highest state honour, the 11th
October
Award.
The basic task of the MMA is to contribute
to more efficient, rational and high-quality
health protection for the population and to
reconciling those health needs with the real
possibilities of the society.
Continuing medical education, continu-
ing medical development and professional
guidelines are key factors in high quality
and rational health protection, therefore the
Educational Centre has been established for
the regulation,promotion,organizing,mon-
itoring and evaluation of CME and CPR.
The MMA with financial support of Minis-
try of Health produced and distributed free
of charge to all doctors GUIDLINES FOR
PRACTICING EVIDENCE BASED
MEDICINE (4500 pages), in printed and
electronic form.
The MMA has a clear stand that more pro-
found education in ethics is an integral part
of CME. Besides the textbook on ethics
for our colleagues, the MMA translated in
(2005) the Medical Ethics Manual (WMA)
into the Macedonian and Albanian lan-
guages and it was distributed to all indi-
vidual doctors in Macedonia.The Manual is
also available in pdf form on the web site of
the MMA www.mld.org.mk
Work on patients rights, doctors rights and
patients safety are very high on the agenda
of the MMA, especially fostering and pro-
motion of good medical practice and high
ethical standards, as well as harmonization
of the Macedonian health service provision
with that of the EU and membership of
Europe, which presupposes the acceptance
of appropriate standards.
The Macedonian Medical Association
makes a continuous effort to a positive
change in the social status of doctors and
an equitable and worthy recognition of the
medical profession,protection of the respect
and the dignity of medical profession and
fighting for the freedom and independence
of the medical profession and the provi-
sion of the best medical services available
for the patients, in a system of increasingly
state controlled health management in the
country.
The Royal Dutch Medical Association
(KNMG) is the professional organisation
for physicians of The Netherlands. It was
established in 1849. Since 1st
January 1999
the KNMG has become a federation of
medical practitioners’ professional associa-
tions.The federation consists of the Nation-
al Association of Salaried Doctors (LAD),
the National Association of General Prac-
titioners (LHV), the Dutch Association for
Occupational Health (NVAB), the Dutch
Association for Nursing Home Physicians
(NVVA), the Dutch Association of Insur-
ance Medicine (NVVG), the Dutch Order
of Medical Specialists (Orde van Medisch
Specialisten) and a group of individual
KNMG members and students.
The main objectives of the KNMG are to
improve the quality of medical care and
healthcare in general. This is achieved by
proactively responding to technological and
social developments, by developing policy,
lobbying and influencing stakeholders and
by providing services to our members. We
work in close collaboration with other stake-
holders, e.g. government, politics, health
care insurance companies, patient organisa-
tions, and other organisations in healthcare.
The goal is to promote the medical and as-
sociated sciences, and achieve high quality
healthcare. Our policies cover the full range
from public health issues, medical ethics,
science, health law to medical education.
Another important task of the KNMG is
the legal system concerning the postgraduate
training and registration of specialists.Legis-
lative boards issue rules on specialist training,
recognition of trainers, hospitals etc., spe-
cialist registration and the recertification of
specialists.The registration committees carry
out legislation regarding the tasks mentioned
above in the interest of the public.
KNMG activities in 2009
1.A campaign on medical professional-
ism. In 2009 a national campaign will
be launched, aimed at all physicians. The
main goal is to support doctors in their
professional conduct: good quality, earn-
ing trust of their patients and account-
ability.
2.Promoting quality of healthcare, safety
and transparency of medical practice and
professional integrity, through the estab-
lishment of guidelines and advice and in-
fluencing government and politics.
The Royal Dutch Medical Association
(KNMG)
Prof. Dr. A.C. Nieuwenhuijzen Kruseman, President. Mr. Paul Rijksen, General Manager
37
International, Regional and NMA news
Dr. Ifereimi Waqainabete, Hon. President, of
the Fiji Medical Association
The Fiji Medical Association (FMA) is a
professional association, established under
the Fiji medical and dental practitioner
act of 1978 and is financed by its members
through an annual subscription of $260.00.
The Act itself specifies that “membership of
FMA shall be open to every person who is
registered in Part II of the Medical Regis-
trar”,however,membership is voluntary and
open to any medical practitioner registered
in Part II of the Register, maintained by the
Fiji Medical Council.
FMA is recognized by Fiji’s civil service ad-
ministrative body (Fiji Public Service Com-
mission) as the collective voice of doctors in
the Civil Service. FMA has a considerable
role in the medical profession, (within the
guidelines of the ACT) and appoints 3 of
the 7 members of the Fiji Medical Coun-
cil. FMA is also represented on all various
advisory bodies which deal with health is-
sues including: National Advisory Council
on AIDS (NACA), Non Communicable
Disease (NCD) Taskforce, Mental Health
Services Planning, National Research Eth-
ics Committee, Fiji School of Medicine
Council, and the Tobacco Act monitoring
task force. The FMA is also included with
other NGOs in such bodies as the summit
working Groups monitoring the National
Development Plans implementation.
The operational functions of FMA are guid-
ed by its constitution which in turn is over-
seen by an Executive council whose mem-
bers are elected during our annual general
meeting. The FMA annual general meeting
is usually held during our annual Medical
Scientific conference which encompasses
all specialties and includes overseas and lo-
cal speakers. During the year the FMA also
keeps members informed through:
The Fiji Medical Association Journal•
(FMAJ) which is released every four
months
The Fiji Medical Association Newsletter•
namely Medmail, which is released every
two months and by Email
The Fiji Medical Association
Activities are:
Development of a quality framework: the•
quality and patient safety requirements
any doctor in The Netherlands should
meet;
Contribute to educational modernisation•
of the training of medical specialists and
the curriculum in accordance with the
CanMEDs model;
Contribute to the modernisation of the•
Individual Health Care Professionals
Act (Wet BIG). This Act is concerned
with the quality of care and protection
provided to patients, and provides a reg-
ister of health care professionals (the
BIG-register). The BIG-register registers
pharmacists, physicians, physiotherapists,
health care psychologists, psychothera-
pists, dentists, midwives and nurses. Only
those listed in this register may carry the
legally protected titles belonging to these
professions;
Monitoring Health Insurance Act: under•
the new Health Insurance Act, all resi-
dents of the Netherlands are obliged to
take out a health insurance. The system
is a private health insurance with social
conditions.The system is operated by pri-
vate health insurance companies; the in-
surers are obliged to accept every resident
in their area of activity. A system of risk
equalisation enables the acceptance obli-
gation and prevents direct or indirect risk
selection.
Contribute to strengthening patients and•
patient organisations. Especially in the
fields of quality, safety and legal com-
plaints.
Activities related to “end of life” care: im-•
plementing the Directive palliative seda-
tion, research on decisions of physicians
concerning the final stage of life.
3. The KNMG studies trends and influ-
ences legislation in relevant areas where
professional values and responsibilities
are of major significance.
Monitoring, and if possible, influencing•
developments on health insurances and
the Exceptional Medical Expenses Act
(AWBZ) which is a national insurance
scheme for long-term care.This is intend-
ed to provide for insured with chronic
and continuous care. This involves con-
siderable financial consequences, such as
care for disabled people with congenital,
physical or mental disorders;
Commenting on reports from govern-•
ment advisory boards;
ICT in healthcare, Electronic Medical•
Record (EPD).This is a plan for a nation-
wide system which is intended to facili-
tate the exchange of patient information.
Data from different healthcare informa-
tion systems will be brought together
in the EPD. KNMG is involved in the
development and implementation of the
EPD, lobbying etc.
4. International activities:
The KNMG is an active member in the
Standing Committee des Médecins Euro-
péens (CPME) and the World Medical As-
sociation (WMA). The CPME is involved
in influencing policy at European level and
this is of great importance, because the
practice of doctors is increasingly a Euro-
pean dimension.
38
WMA news
Order of Physicians of Albania (OPA)
Rr. Dibres. Poliklinika Nr.10, Kati 3
Tirana
ALBANIA
Tel/Fax: (355) 4 2340 458
E-mail: albmedorder@albmail.com
Website: www.umsh.org
Col’legi de Metges
C/Verge del Pilar 5,
Edifici Plaza 4t. Despatx 11
500 Andorra La Vella
ANDORRA
Tel: (376) 823 525
Fax: (376) 860 793
E-mail: coma@andorra.ad
Website: www.col-legidemetges.ad
Ordem dos Médicos de Angola (OMA)
Rua Amilcar Cabral 151-153
Luanda
ANGOLA
Tel. (244) 222 39 23 57
Fax (221) 222 39 16 31
E-mail: secretariatdormed@gmail.com
Website: www.ordemmedicosangola.com
Confederación Médica de la República
Argentina
Av. Belgrano 1235
Buenos Aires 1093
ARGENTINA
Tel/Fax: (54-11) 4381-1548 / 4384-5036
E-mail: comra@confederacionmedica.com.ar
Website: www.comra.health.org.ar
Australian Medical Association
P.O. Box 6090
Kingston, ACT 2604
AUSTRALIA
Tel: (61-2) 6270 5460
Fax: (61-2) 6270 5499
E-mail: ama@ama.com.au
Website: www.ama.com.au
Osterreichische Arztekammer
(Austrian Medical Chamber)
Weihburggasse 10-12 – P.O. Box 213
1010 Wien
AUSTRIA
Tel: (43-1) 514 06 64
Fax: (43-1) 514 06 933
E-mail: international@aerztekammer.at
Website: www.aerztekammer.at
Armenian Medical Association
P.O. Box 143
Yerevan 375 010
REPUBLIC OF ARMENIA
Tel. (3741) 53 58 68
Fax. (3741) 53 48 79
E-mail: info@armeda.am
Website: www.armeda.am
Azerbaijan Medical Association
P.O. Box 16
AZE 1000, Baku
REP OF AZERBAIJAN
Tel.(99 450) 328 18 88
Fax. (99 412) 431 88 66
E-mail.info@azmed.az / azerma@hotmail.com
Website: www.azmed.az
Medical Association of the Bahamas
Javon Medical Center
P.O. Box N999
Nassau
BAHAMAS
Tel. (1-242) 328 1857
Fax (1-242) 323 2980
E-mail: mabnassau@yahoo.com
Bangladesh Medical Association
BMA Bhaban 5/2 Topkhana Road
Dhaka 1000
BANGLADESH
Tel. (880) 2-9568714 / 9562527
Fax. (880) 2 9566060 / 9562527
E-mail: bma@aitlbd.net
Association Belge des Syndicats
Médicaux
Chaussée de Boondael 6, bte 4
1050 Bruxelles
BELGIUM
Tel: (32-2) 644 12 88
Fax: (32-2) 644 15 27
E-mail: absym.bvas@euronet.be
Website: www.absym-bvas.be
Colegio Médico de Bolivia
Calle Ayacucho 630
Tarija
BOLIVIA
Fax. (591) 4 666 3569
E-mail: colmedbol_tjo@hotmail.com
Website: www.colegiomedicodebolivia.
org.bo
Associaçao Médica Brasileira
R. Sao Carlos do Pinhal 324 – Bairro Bela
Vista
Sao Paulo SP – CEP 01333-903
BRAZIL
Tel. (55-11) 3178 6810
Fax. (55-11) 3178 6830
E-mail: presidente@amb.org.br
Website: www.amb.org.br
Bulgarian Medical Association
15, Acad. Ivan Geshov Blvd.
1431 Sofia
BULGARIA
Tel: (359-2) 954 11 81
Fax: (359-2) 954 11 86
E-mail: int@mbox.contact.bg
Website: www.blsbg.com
Canadian Medical Association
P.O. Box 8650
1867 Alta Vista Drive
Ottawa, Ontario K1G 3Y6
CANADA
Tel: (1-613) 731 8610 ext. 2236
Fax: (1-613) 731 1779
E-mail: karen.clark@cma.ca
Website: www.cma.ca
Ordem Dos Medicos du Cabo Verde
(OMCV)
Avenue OUA N° 6 – B.P. 421
Achada Santo António
Ciadade de Praia-Cabo Verde
CABO VERDE
Tel. (238) 262 2503
Fax (238) 262 3099
E-mail: omecab@cvtelecom.cv
Website: www.ordemdosmedicos.cv
Colegio Médico de Chile
Esmeralda 678 – Casilla 639
Santiago
CHILE
Tel: (56-2) 4277800
Fax: (56-2) 6330940 / 6336732
E-mail: rdelcastillo@colegiomedico.cl
Website: www.colegiomedico.cl
Chinese Medical Association
42 Dongsi Xidajie
Beijing 100710
CHINA
Tel: (86-10) 8515 8136
Fax: (86-10) 8515 8551
E-mail: intl@cma.org.cn
Cyprus Medical Association (CyMA)
14 Thasou Street
1087 Nicosia
CYPRUS
Tel. (357) 22 33 16 87
Fax: (357) 22 31 69 37
E-mail: cyma@cytanet.com.cy
Federación Médica Colombiana
Carrera 7 N° 82-66, Oficinas 218/219
Santafé de Bogotá, D.E.
COLOMBIA
Tel./Fax: (57-1) 8050073
E-mail: federacionmedicacolombiana@
encolombia.com
Ordre des Médecins du Zaire
B.P. 4922
Kinshasa – Gombe
DEMOCRATIC REP. OF CONGO
Tel: (243-12) 24589
Unión Médica Nacional
Apartado 5920-1000
San José
COSTA RICA
Tel: (506) 290-5490
Fax: (506) 231 7373
E-mail: unmedica@racsa.co.cr
Croatian Medical Association
Subiceva 9
10000 Zagreb
CROATIA
Tel: (385-1) 46 93 300
Fax: (385-1) 46 55 066
E-mail: hlz@email.htnet.hr
Website: www.hlk.hr/default.asp
Czech Medical Association – J.E. Purkyne
Sokolská 31 – P.O. Box 88
120 26 Prague 2
CZECH REPUBLIC
Tel: (420) 224 266 201-4
Fax: (420) 224 266 212
E-mail: czma@cls.cz
Website: www.cls.cz
Colegio Médico Cubano Libre
P.O. Box 141016
Coral Gables, FL 33114-1016
UNITED STATES
717 Ponce de Leon Boulevard
Coral Gables, FL 33134
Tel: (1-305) 446 9902/445 1429
Fax: (1-305) 4459310
Danish Medical Association
9 Trondhjemsgade
2100 Copenhagen 0
DENMARK
Tel: (45) 35 44 82 29
Fax: (45) 35 44 85 05
E-mail: er@dadl.dk / clr@dadl.dk
Website: www.laeger.dk
Egyptian Medical Association
«Dar El Hekmah»
42, Kasr El-Eini Street
Cairo
EGYPT
Tel: (20-2) 3543406
Colegio Médico de El Salvador
Final Pasaje N° 10
Colonia Miramonte
San Salvador
EL SALVADOR, C.A.
Tel: (503) 260-1111, 260-1112
Fax: (503) 260-0324
E-mail: marnuca@hotmail.com
Estonian Medical Association (EsMA)
Pepleri 32
51010 Tartu
ESTONIA
Tel: (372) 7 420 429
Fax: (372) 7 420 429
E-mail: eal@arstideliit.ee
Website: www.arstideliit.ee
Ethiopian Medical Association
P.O. Box 2179
Addis Ababa
ETHIOPIA
Tel: (251-1) 158174
Fax: (251-1) 533742
E-mail: ema.emj@telecom.net.et /
ema@eth.healthnet.org
Fiji Medical Association
304 Wainamu Road
G.P.O. Box 1116
Suva
FIJI ISLANDS
Tel. (679) 3315388
Fax. (679) 3315388
E-mail. fma@unwired.com.fj
WMA Directory of Constituent Members
39
WMA news
Finnish Medical Association
P.O. Box 49
00501 Helsinki
FINLAND
Tel: (358-9) 393 091
Fax: (358-9) 393 0794
E-mail: fma@fimnet.fi
Website: .www.medassoc.fi
Association Médicale Française
180, Blvd. Haussmann
75389 Paris Cedex 08
FRANCE
Tel: (33) 1 53 89 32 41
E-mail: deletoile.sylvie@cn.medecin.fr
Georgian Medical Association
7 Asatiani Street
0177 Tbilisi
GEORGIA
Tel. (995 32) 398686
Fax. (995 32) 396751 / 398083
E-mail: gma@posta.ge
Website: www.gma.ge
Bundesärztekammer
(German Medical Association)
Herbert-Lewin-Platz 1
10623 Berlin
GERMANY
Tel: +49-(0) 30-4004 56-361
Fax: +49-(0) 30-4004 56-384
E-mail: auslandsdienst@baek.de
Website: www.baek.de
Ghana Medical Association
P.O. Box 1596
Accra
GHANA
Tel. (233-21) 670510 / 665458
Fax. (233-21) 670511
E-mail: gma@dslghana.com
Website: www.ghanamedassn.org
Association Médicale Haitienne
1ère
Av. du Travail #33 – Bois Verna
Port-au-Prince
HAITI, W.I.
Tel: (509) 245-2060
Fax: (509) 245 6323
E-mail: secretariatamh@hainet.net
Website: www.amhhaiti.net
Hong Kong Medical Association, China
Duke of Windsor Building
5th Floor
15 Hennessy Road
HONG KONG
Tel: (852) 2527-8285
Fax: (852) 2865-0943
E-mail: hkma@hkma.org
Website: www.hkma.org
Association of Hungarian Medical
Societies (MOTESZ)
Nádor u. 36 – PO.Box 145
1051 Budapest
HUNGARY
Tel: (36-1) 312 3807 – 312 0066
Fax: (36-1) 383-7918
E-mail: international@motesz.hu
Website: www.motesz.hu
Icelandic Medical Association
Hlidasmari 8
200 Kópavogur
ICELAND
Tel: (354) 864 0478
Fax: (354) 5 644106
E-mail: icemed@icemed.is
Indian Medical Association
Indraprastha Marg
New Delhi 110 002
INDIA
Tel: (91-11) 23370009/23378819/23378680
Fax: (91-11) 23379178/23379470
E-mail: inmedici@vsnl.com
Website: www.imanational.com
Indonesian Medical Association
Jl. G.S.S.Y. Ratulangie N° 29 Menteng
Jakarta 10350
INDONESIA
Tel: (62-21) 3150679 / 3900277
Fax: (62-21) 390 0473
E-mail: pbidi@idola.net.id
Website:www.idionline.org
Irish Medical Organisation
10 Fitzwilliam Place
Dublin 2
IRELAND
Tel: (353-1) 6767273
Fax: (353-1) 662758
E-mail: imo@imo.ie
Website: www.imo.ie
Israel Medical Association
2 Twin Towers, 35 Jabotinsky St.
P.O. Box 3566, Ramat-Gan 52136
ISRAEL
Tel: (972-3) 610 0444
Fax: (972-3) 575 0704
E-mail: saraf@ima.org.il
Website: www.ima.org.il
Ordre des Médecins de la Côte d’Ivoire
(ONMCI)
Cocody Cité des Arts, Bât. U1, Esc.D,
RdC, Porte n°1
BP 1584
Abidjan 01
IVORY COAST
Tel. (225) 22 48 61 53 /22 44 30 78/
Tel. (225) 02 02 44 01 /08 14 55 80
Fax: (225) 22 44 30 78
E-mail: onmci@yahoo.fr
Website: www.onmci.org
Japan Medical Association
2-28-16 Honkomagome, Bunkyo-ku
Tokyo 113-8621
JAPAN
Tel: (81-3) 3946 2121/3942 6489
Fax: (81-3) 3946 6295
E-mail: jmaintl@po.med.or.jp
Association of Medical Doctors of
Kazakhstan
117/1 Kazybek bi St.,
Almaty
KAZAKHSTAN
Tel. (7-327 2) 624301 / 2629292
Fax. (7-327 2) 623606
E-mail: sadykova-aizhan@yahoo.com
Korean Medical Association
302-75 Ichon 1-dong, Yongsan-gu
Seoul 140-721
REP. OF KOREA
Tel: (82-2) 794 2474
Fax: (82-2) 793 9190/795 1345
E-mail: intl@kma.org
Website: www.kma.org
Kuwait Medical Association
P.O. Box 1202
Safat 13013
KUWAIT
Tel. (965) 5333278, 5317971
Fax. (965) 5333276
E-mail: kma@kma.org.kw/alzeabi@hotmail.
com
Latvian Physicians Association
Skolas Str. 3
Riga 1010
LATVIA
Tel: (371) 67287321 / 67220661
Fax: (371) 67220657
E-mail: lab@arstubiedriba.lv
Liechtensteinische Ärztekammer
Postfach 52
9490 Vaduz
LIECHTENSTEIN
Tel: (423) 231 1690
Fax. (423) 231 1691
E-mail: office@aerztekammer.li
Website: www.aerzte-net.li
Lithuanian Medical Association
Liubarto Str. 2
2004 Vilnius
LITHUANIA
Tel./Fax. (370-5) 2731400
E-mail: lgs@takas.lt
Website: www.lgs.lt/
Association des Médecins et
Médecins Dentistes du Grand-
Duché de Luxembourg (AMMD)
29, rue de Vianden
2680 Luxembourg
LUXEMBOURG
Tel: (352) 44 40 33 1
Fax: (352) 45 83 49
E-mail: secretariat@ammd.lu
Website: www.ammd.lu
Macedonian Medical Association
Dame Gruev St. 3
P.O. Box 174
91000 Skopje
MACEDONIA
Tel: (389-91) 232577
Fax: (389-91) 232577
E-mail: mld@unet.com.mk
Malaysian Medical Association
4th Floor, MMA House
124 Jalan Pahang
53000 Kuala Lumpur
MALAYSIA
Tel: (60-3) 4041 1375
Fax: (60-3) 4041 8187
E-mail: info@mma.org.my / research@
mma.org.my
Website: http://www.mma.org.my
Ordre National des Médecins du Mali
(ONMM)
Hôpital Gabriel Touré
Cour du Service d’Hygiène
BP E 674
Bamako
MALI
Tel. (223) 223 03 20/ 222 20 58/
E-mail: cnommali@gmai.com
Website: www.keneya.net/cnommali.com
Medical Association of Malta
The Professional Centre
Sliema Road, Gzira GZR 06
MALTA
Tel: (356) 21312888
Fax: (356) 21331713
E-mail: martix@maltanet.net
Website: www.mam.org.mt
Colegio Medico de Mexico
(FENACOME)
Adolfo Prieto #812
Col.Del Valle
D. Benito Juárez
Mexico 03100
MEXICO
Tel. 52 55 5543 8989
Fax. 52 55 5543 1422
E-mail: fenacome_relint@teyco.com.mx
Website: www.cmm-fenacome.org
Medical Association of Namibia
403 Maerua Park – POB 3369
Windhoek
NAMIBIA
Tel. (264) 61 22 4455
Fax. (264) 61 22 4826
E-mail: man.office@iway.na
Nepal Medical Association
Siddhi Sadan, Post Box 189
Exhibition Road
Katmandu
NEPAL
Tel. (977 1) 4225860, 4231825
Fax. (977 1) 4225300
E-mail: nma@healthnet.org.np
Royal Dutch Medical Association
P.O. Box 20051
3502 LB Utrecht
NETHERLANDS
Tel: (31-30) 282 38 28
Fax: (31-30) 282 33 18
E-mail: j.bouwman@fed.knmg.nl
Website: knmg. artsennet. nl
New Zealand Medical Association
P.O. Box 156, 26 The Terrace
Wellington 1
NEW ZEALAND
Tel: (64-4) 472 4741
Fax: (64-4) 471 0838
E-mail: lianne@nzma.org.nz
Website: www.nzma.org.nz
Nigerian Medical Association
74, Adeniyi Jones Avenue Ikeja
P.O. Box 1108, Marina
Lagos
NIGERIA
Tel: (234-1) 480 1569, 876 4238
Fax: (234-1) 493 6854
E-mail: info@nigeriannma.org
Website: www.nigeriannma.org
40
WMA news
Norwegian Medical Association
P.O.Box 1152 sentrum
0107 Oslo
NORWAY
Tel: (47) 23 10 90 00
Fax: (47) 23 10 90 10
E-mail: ellen.pettersen@legeforeningen.no
Website: www.legeforeningen.no
Asociación Médica Nacional
de la República de Panamá
Apartado Postal 2020
Panamá 1
PANAMA
Tel: (507) 263 7622 /263-7758
Fax: (507) 223 1462
Fax modem: (507) 223-5555
E-mail: amenalpa@cwpanama.net
Colegio Médico del Perú
Malecón Armendáriz N° 791
Miraflores
Lima
PERU
Tel: (51-1) 241 75 72
Fax: (51-1) 242 3917
E-mail: decano@cmp.org.pe
Website: www.cmp.org.pe
Philippine Medical Association
2/F Administration Bldg.
PMA Compound, North Avenue
Quezon City 1105
PHILIPPINES
Tel: (63-2) 929-63 66
Fax: (63-2) 929-69 51
E-mail: philmedas@yahoo.com
Website: www.pma.com.ph
Polish Chamber of Physicians and
Dentists
(Naczelna Izba Lekarska)
110 Jana Sobieskiego
00-764 Warsaw
POLAND
Tel. (48) 22 55 91 300/324
Fax: (48) 22 55 91 323
E-mail: secretariat@hipokrates.org
Website: www.nil.org.pl
Ordem dos Médicos
Av. Almirante Gago Coutinho, 151
1749-084 Lisbon
PORTUGAL
Tel: (351-21) 842 71 00/842 71 11
Fax: (351-21) 842 71 99
E-mail: ordemmedicos@mail.telepac.pt /
Website: www.ordemdosmedicos.pt
Romanian Medical Association
Str. Ionel Perlea, nr 10,
Sect. 1, Bucarest
ROMANIA
Tel: (40-21) 460 08 30
Fax: (40-21) 312 13 57
E-mail: amr@itcnet.ro
Website: www.ong.ro/ong/amr/
Russian Medical Society
Udaltsova Street 85
119607 Moscow
RUSSIA
Tel./Fax (7-495) 734-12-12
Tel. (7-495) 734-11-00/(7-495)734 11 00
E-mail: info@russmed.ru
Website: www.russmed.ru/eng/who.htm
Samoa Medical Association
Tupua Tamasese Meaole Hospital
Private Bag – National Health Services
Apia
SAMOA
Tel. (685) 778 5858
E-mail: vialil_lameko@yahoo.com
Ordre National des Médecins du Sénégal
(ONMS)
Institut d’Hygiène Sociale (Polyclinique)
BP 27115
Dakar
SENEGAL
Tel. (221) 33 822 29 89
Fax: (221) 33 821 11 61
E-mail: onms@orange.sn
Website: www.ordremedecins.sn
Singapore Medical Association (SiMA)
Alumni Medical Centre, Level 2
2 College Road
SINGAPORE 169850
Tel. (65) 6223 1264
Fax. (65) 6224 7827
E-mail. sma@sma.org.sg
Website: www.sma.org.sg
Slovak Medical Association
Cukrova 3
813 22 Bratislava 1
SLOVAK REPUBLIC
Tel. (421) 5292 2020
Fax. (421) 5263 5611
E-mail: secretarysma@ba.telecom.sk
Website: www.sls.sk
Slovenian Medical Association
Komenskega 4
61001 Ljubljana
SLOVENIA
Tel. (386-61) 323 469
Fax: (386-61) 301 955
Somali Medical Association
14 Wardigley Road – POB 199
Mogadishu
SOMALIA
Tel. (252-1) 595 599
Fax. (252-1) 225 858
E-mail: drdalmar@yahoo.co.uk
The South African Medical Association
P.O. Box 74789, Lynnwood Rydge
0040 Pretoria
SOUTH AFRICA
Tel: (27-12) 481 2045
Fax: (27-12) 481 2100
E-mail: sginterim@samedical.org
Website: www.samedical.org
Consejo General de Colegios Médicos
Plaza de las Cortes 11, 4a
Madrid 28014
SPAIN
Tel: (34-91) 431 77 80
Fax: (34-91) 431 96 20
E-mail: ccuesta@cgcom.es
Website: www.cgcom.es
Swedish Medical Association
(Villagatan 5)
P.O. Box 5610
SE – 114 86 Stockholm
SWEDEN
Tel: (46-8) 790 35 01
Fax: (46-8) 10 31 44
E-mail: info@slf.se
Website: www.lakarforbundet.se
Fédération des Médecins Suisses (FMH)
Elfenstrasse 18 – C.P. 170
3000 Berne 15
SWITZERLAND
Tel. (41-31) 359 11 11
Fax. (41-31) 359 11 12
E-mail: info@fmh.ch
Website: www.fmh.ch
Taiwan Medical Association
9F, No 29, Sec.1
An-Ho Road
Taipei 10688
TAIWAN
Tel: (886-2) 2752-7286
Fax: (886-2) 2771-8392
E-mail: intl@tma.tw
Website: www.tma.tw
Medical Association of Thailand
2 Soi Soonvijai
New Petchburi Road, Huaykwang Dist.
Bangkok 10310
THAILAND
Tel: (66-2) 314 4333/318-8170
Fax: (66-2) 314 6305
E-mail: math@loxinfo.co.th
Conseil National de l’Ordre
des Médecins de Tunisie
16, rue de Touraine
1002 Tunis
TUNISIA
Tel: (216-71) 792 736/799 041
Fax: (216-71) 788 729
E-mail: cnom@planet.tn
Turkish Medical Association
GMK Bulvari
Şehit Daniş Tunaligil Sok. N° 2 Kat 4
Maltepe 06570
Ankara
TURKEY
Tel: (90-312) 231 31 79
Fax: (90-312) 231 19 52
E-mail: Ttb@ttb.org.tr
Website: www.ttb.org.tr
Uganda Medical Association
Plot 8, 41-43 circular rd.
P.O. Box 29874
Kampala
UGANDA
Tel. (256) 41 321795
Fax. (256) 41 345597
E-mail: myers28@hotmail.com
Ukrainian Medical Association (UkMA)
7 Eva Totstoho Street
PO Box 13
Kyiv 01601
UKRAINE
Tel. (380) 50 355 24 25
Fax: (380) 44 501 23 66
E-mail: sfult@ukr.net
Website: www.sfult.org.ua
British Medical Association
BMA House,Tavistock Square
London WC1H 9JP
UNITED KINGDOM
Tel: (44-207) 387-4499
Fax: (44- 207) 383-6400
Website: www.bma.org.uk
American Medical Association
515 North State Street
Chicago, Illinois 60654
UNITED STATES
Tel: (1-312) 464 5291 / 464 5040
Fax: (1-312) 464 5973
E.mail: ellen.waterman@ama-assn.org
Website: www.ama-assn.org
Sindicato Médico del Uruguay
Bulevar Artigas 1515
CP 11200 Montevideo
URUGUAY
Tel: (598-2) 401 47 01
Fax: (598-2) 409 16 03
E-mail: secretaria@smu.org.uy
Associazione Medica del Vaticano
00120 Città del Vaticano
VATICAN STATE
Tel: (39-06) 69879300
Fax: (39-06) 69883328
E-mail: servizi.sanitari@scv.va
Federacion MedicaVenezolana
Av. Orinoco con Avenida Perija
Urbanizacion Las Mercedes
Caracas 1060 CP
VENEZUELA
Website: www.
federacionmedicavenezolana.org
Vietnam Medical Association (VGAMP)
68A Ba Trieu-Street
Hoau Kiem District
Hanoi
VIETNAM
Tel: (84) 4 943 9323
Fax: (84) 4 943 9323
Zimbabwe Medical Association
P.O. Box 3671
Harare
ZIMBABWE
Tel. (263-4) 791553
Fax. (263-4) 791561
E-mail: zima@zol.co.zw
www.zima.org.zw
Contents
Editorial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Result of Regional Elections,
the Members of WMA Council 2009 – 2010 . . . . . . . . . . . . . . . . . 1
Declaration of Helsinki. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
The Return of Primary Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Counterfeit Medicines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Health Sciences Online: the First Authoritative,
Comprehensive, Free andAd-Free Resource
for the World’s Physicians . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Social Determinants of Health
as a Driving Force Towards Health Equity . . . . . . . . . . . . . . . . . . . . 8
The Avicenna Directories –
a new tool in quality assurance of medical education . . . . . . . . . . . . 9
National Health Serwice (England).
Next Stage Review – “high quality care for all? ” . . . . . . . . . . . . . . . . . 11
Gender aspects in Cardiovascular Drug Therapy. . . . . . . . . . . . . . . 14
Building a Consensus in Regenerative Medicine . . . . . . . . . . . . . . 17
Barriers to Smoking Cessation:
Are they really insurmountable? . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Ocular Risk Standards and Medical Ethics.
A development on Occupational Radiation Exposure
in an Epidemiological Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Medical Ethics in the present scenario:
Revisiting the Basics and recognizing emerging concerns. . . . . . . . 26
The Continuing Medical Education Program
of the Japan Medical Association . . . . . . . . . . . . . . . . . . . . . . . . . . 28
The FDI World Dental Federation
and the growing realisation of oral health worldwide . . . . . . . . . . . 30
The Brazilian Medical Association (AMB):
purpose and actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Healthcare in Singapore and
the Singapore Medical Association . . . . . . . . . . . . . . . . . . . . . . . . . 34
The Macedonian Medical Association . . . . . . . . . . . . . . . . . . . . . . 35
The Royal Dutch Medical Association (KNMG) . . . . . . . . . . . . . . 36
The Fiji Medical Association. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Wma Directory of National Constituent Members
Association And Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
The World Medical and Health Games . . . . . . . . . . . . . . . . . . . . . 41
The World Medical
and Health Games
In the beautiful Spanish city, Alicante will tace part the World
Medical and Health Games. So, don’t waste time and join Spain
from July 4th
to 11th
to celebrate all together the 30th
edition of the
World Medical and Health Games!
Since their creation in 1978, the WMHG have claimed to have
“The Olympic Spirit” as it was intended by the Baron Pierre De
Coubertin: Beauty of sport and abundance of effort.
These are the values that still guide us today in the organisation of
this event: every sports enthusiast that enrols in the Games agrees
to honour the following motto : “In the World Medical and Health
Games, we agree to face each other in our sporting challenges with
the willingness to try our chances, in a spirit of friendship, with re-
spect for our counterparts and for sporting and indeed professional
ethics, hoping to revive a spirit of “fair-play” even beyond our per-
formance, a spirit that might act as an example for more important
international competitions. “
54 countries have already participated in the Games since their cre-
ation: South Africa, Algeria, Germany, Argentina, Australia, Aus-
tria, Belgium, Bosnia, Brazil, Cameroon, Canada, Chile, Colom-
bia, Korea, Croatia, Denmark, Spain, Estonia, The United States,
Finland, France, Georgia, Greece, Hungary, India, Iran, Ireland,
Israel, Italy, Japan, Latvia, Liechtenstein, Lithuania, Luxembourg,
Morocco, Mexico, Moldavia, Norway, The Netherlands, Pakistan,
Poland, Portugal, The Republic of Slovakia, The Czech Repub-
lic, The United Kingdom, Slovenia, Sweden, Tunisia, Turkey, The
Ukraine, Uruguay, Venezuela, Yugoslavia
Sports in the Programme
Athletics, Badminton, Basket-Ball, Beach-Volley, Cycling, Chess,
Fencing, 11-a-side Football, 11-a-side Senior Football and 6-a-side
Football, Power Lifting, Golf, Judo, Squash Rackets, Swimming,
Windsurfing,Tennis,Table Tennis, Pistol Shooting, Rifle Shooting,
Clay Pigeon Shooting, Triathlon, Sailing, Volley-Ball, Mountain
Biking.
The Age Categories
The date of reference that is taken into consideration is the date on
which the Games are scheduled to begin, therefore 4th July 2009.
A – under 35 years; B – from 35 to 45 years ; C – from 45 to 55 years;
D – from 55 to 65 years; E – over 65 years; F – Students: all those
registered as students,without consideration of age Students will not
be able to be part of the classifications in categories A, B, C, D or
E. There are no age categories for collective sports, golf and chess.
www.medigames.com
WMA news