WMJ 03 2004

WorldMMeeddiiccaall JJoouurrnnaall
Vol. No.3,september200450
OFFICIAL JOURNAL OF THE WORLD MEDICAL ASSOCIATION, INC.
G 20438
Contents
EEddiittoorriiaall
Fifty Years Of Smoking Research 57
Public/Private Financing and Health Research 58
Genetics Underlying Diabetes 59
MMeeddiiccaall EEtthhiiccss aanndd HHuummaann RRiigghhttss
Migration of Health workers:
Critical issues in the global debate 60
Biomedical Research In Europe 64
UN Standard Minimum Rules for the
Treatment of Prisoners 66
MMeeddiiccaall SScciieennccee,, PPrrooffeessssiioonnaall PPrraaccttiiccee
aanndd EEdduuccaattiioonn
Medical Associations and Global Health
Emergencies – The Canadian Experience 67
Patient Safety – the Collaboration
between the health professions in Japan 69
WWMMAA
How does the world treat our children? 70
A new online course for prison doctors 72
WWMMAA SSeeccrreettaarryy GGeenneerraall 74
WWHHOO
Mental disorders are widespread,
disabling and often go untreated 75
The Health Academy: a first step
towards a virtual school to
promote public health world-wide 76
The WHO Framework Convention
on Tobacco Control on track
to become law by the end of the year 77
Medical Plants – Guidelines To
Promote Patient Safety And Plant
Conservation For A US$ 60 Billion Industry 78
Dire Health Consequences For
Millions Of People In Darfur, Sudan,
And Calls For Intensified Health Response 79
RReeggiioonnaall aanndd NNMMAA NNeewwss 80
RReevviieeww 83
00_US_03_2004.qxd 14.09.2004 15:46 Seite 1
Fifty Years Of Smoking Research
Sir Richard Doll*
The fiftieth anniversary of the first publication of the Journal of the World Medical
Association also saw the fiftieth anniversary of the publication of the results of an epidemi-
ological study1
of the effects of something that many people at the time thought to be of
little or no international importance, but which is now beginning to equate internationally
with the big three: AIDS, Malaria and Tuberculosis. The study, which was continued for
50 years, was the first of a series of cohort studies of the effect of smoking, and was begun
in October 1951 to test the validity of the conclusion that had been reached a year earlier2
that cigarette smoking was “an important cause of carcinoma of the bronchus.”
This conclusion had been based on the results of personal enquiries of 709 pairs of patients
with and without lung cancer and had been tentatively supported, with varying degrees of
strength, by seven other studies of a similar type in Germany, the Netherlands and the
USA3
. Few people, however, and no Government had taken the conclusion seriously. A
new approach, by some different method of investigation, was evidently needed. In the UK
this took the form of writing, with the help of the British Medical Association, to all doc-
tors resident in the country and seeking details of their smoking habits, with the intention
of following them for 5 years to see if knowledge of their habits would enable their risk of
developing cancer of the lung to be predicted.
In the event, replies were received from over 34 000 male and 6000 female British doctors.
Within 3 years the first results confirmed the predicted relationship. When, however, five
years had passed and the study was planned to stop, other diseases began to be seen to be
associated with smoking and observations were continued for 50 years, before the final
results of the study were published earlier this year4
. By then, other similar studies had
been carried out in Canada, Germany, Japan, the Netherlands, Sweden and the USA. The
associations observed with some 40 diseases had, for the most part, proved to be causal,
and the epidemic of cigarette (or bidi) smoking, so much more hazardous than the smok-
ing of pipes or cigars, had been shown to be a major cause of mortality in nearly all devel-
oped countries. In the extreme case of the UK, where the prevalence of cigarette smoking
by young men had first became predominant, smoking was estimated to have been respon-
sible in the mid 1970s for as much as 25% of all deaths (in men) from all causes5
. For the
regular cigarette smoker who persisted with the habit the average loss of expectation of life
was 10 years and, of course, much more for the half of them who died prematurely as a
result of their habit in middle age.
Fifty years, one might have thought, was more than enough for the lesson to have been
learned and action taken internationally to counter the blandishments of the tobacco indus-
try. But as smoking has been reduced in countries where the total effects first began to be
seen, and a substantial proportion of smokers in them had abandoned the habit, the indus-
try has turned its attention more and more to the billions of men and women in the devel-
oping countries, who have not yet had the bitter experience of seeing the worst effects
amongst their own relatives and friends. That it will have a comparable effect in all coun-
tries is already clear, although the types of disease most affected will differ from country
to country depending on the background distribution of disease – cancer of the lung every-
where, but chronic obstructive pulmonary disease, oesophagus cancer and stroke in China
rather than myocardial infarction6,7
, and tuberculosis, most notably in some parts of India8
.
The lessons of fifty years are not, however, all depressing; for it is now clear that stopping
smoking reduces the risk and can reduce it to a very large extent. In the study of British
doctors who began smoking an average of 18 cigarettes a day at a mean age of 18 years,
stopping around 50 years of age halved the risk, while stopping around 30 years of age
almost eliminated it4
.
Guest Editorial
57
OFFICIAL JOURNAL OF
THE WORLD MEDICAL
ASSOCIATION
Hon. Editor in Chief
Dr. Alan J. Rowe
Haughley Grange, Stowmarket
Suffolk IP14 3QT
UK
Executive Editor
Dr. Ivan M. Gillibrand
19 Wimblehurst Court
Ashleigh Road
Horsham
West Sussex RH12 2AQ
UK
Co-Editor
Prof. Dr. med. Elmar Doppelfeld
Ottostr. 12
D-50859 Köln
Germany
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J. Führer, D. Weber
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The action of the World Health
Organisation in seeking an International
agreement to discourage the spread of
smoking may be thought to have been
unduly delayed, but it is welcome now and
deserves the full support of the World
Medical Association.
At the time of writing, this Framework
Convention on Tobacco Control had
already been signed by 168 of the 192
countries of the world and ratified by 24. It
bans the promotion of the use of tobacco,
prevents the industry from interfering in
any legislation to improve public health,
and inter alia requires the public to be fully
informed about the hazards of smoking. If it
succeeds it will have a major effect on mor-
tality in the second half of the 21st century.
It will, however, be possible to diminish
seriously the 450 million deaths from
smoking that are estimated to occur world-
wide in the first half of the century if pre-
sent smoking habits continue5
, only if there
is intensive education to persuade current
smokers to stop and to provide medical help
for the many who are already heavily
addicted.
1. Doll, R. and Hill, A.B. (1954) The mortality of doctors
in relation to their smoking habits. A preliminary report.
BMJ 228(i):1451-55.
2. Doll, R. and Hill, A.B. (1950) Smoking and carcinoma
of the lung. BMJ 221(ii):739.
3. Doll, R. (1998) Uncovering the effects of smoking: his-
torical perspective. Stat Methods Med Res 7,87-117.
4. Doll, R., Peto, R., Boreham, J. and Sutherland, I. (2004)
Mortality in relation to smoking 50 years observations
on male British doctors. BMJ,320 ,1097-1102.
5. Peto, L., Lopez, A., Boreham, J., Thun, M., Heath, C.
(1994) Mortality from tobacco in developed countries:
indirect estimation from national vital statistics. Oxford
University Press, Oxford.
6. Liu, B.Q., Peto, R., Chen Z.M., Boreham, J., Wu Y.P., Li,
J.Y., Campbell .TC., Chen, J.S. (1998) Emerging hazards
in China: proportional mortality studies of one million
deaths. Brit Med J, 317, 1411-1422.
7. Niu, S-R., Yang, G-H., Chen, Z-M., Wang, J-L., Wang,
G-H., He, X-Z., Schoepff, H., Boreham, J., Pan, H.C.,
Peto, R. (1998) Emerging tobacco hazards in China: 2.
Early mortality results from a prospective study. Brit
Med J, 317, 1423-1424.
8. Gajalakshmi, V., Peto, R., Kanaka, T.S. and Jha, P.
(2003) Smoking and mortality from tuberculosis and
other diseases in India: retrospective study of 43,000
adult male deaths and 35,000 controls. Lancet 362:507-
15.
9. www.who.int/tobacco/fctc/text/final
* Epidemiological Studies Unit, University of Oxford,
Harkness Laboratory, Radcliffe Infirmary, Oxford OX2
6HE.
Financing of every aspect of health care has
been of major concern at both national and
international levels for decades. At the
national level the more developed and
sophisticated the society, the greater the
political problem in seeking to meet the high
expectations of the population. For the
developing countries and relevant interna-
tional bodies the concern is to ensure ade-
quate support to finance health care for the
major causes of morbidity and mortality, not
only because of the threats to the individual
citizen, but because of the impact of disease
on the national economy.
Over the past two decades there has been a
move to explore alternative methods of
finance, notably the establishment of pub-
lic/private financing partnerships. This
applies to both countries with so-called
nationalised health care systems such as the
British National Health Service and other
so-called “liberal” systems, in which, how-
ever, government regulation also plays a
part even if only by regulating the activities
of health care providers or insurance
schemes.
Public/Private initiatives have been variously
viewed with enthusiasm and scepticism.
Nevertheless over the past few years there
has been increasing experimentation with
this concept, which has been encouraged by
both the present and immediate-past Director
Generals of the World Health Organisation.
This is well illustrated by the Stop TB pro-
gramme and the HIV/AIDS initiatives. In
both cases partnerships involved both phar-
maceutical and non-health related institu-
tions. Collaboration included both funding of
joint research initiatives and also facilitating
the availability of measures to contain and
reduce the incidence of specific diseases and
also to provide appropriate treatment.
The recently announced potential break-
through in anti-malarial treatment promises
to add weight to the evidence of the value of
public/private partnerships. In the World
Medical Journal (WMJ(2004) 50 (2),p46),
reference was made to the potential value of
Artemisinin in the treatment of Malaria, one
of the three great global scourges of morbid-
ity and mortality. In a partnership involving
several international funding sources (a non
profit making organisation, a Generic drug
manufacturer, scientists from various uni-
versities, a research Foundation and propri-
etary drug manufacturer), research has
developed a new drug based on the structure
of Artemesinin, which appears to be an even
more effective anti-malarial than
Artemesinin itself. Furthermore, this prod-
uct, by avoiding the expensive and laborious
extraction processes involved in extracting
Artemesinin at present, the cost of treatment
is likely to be one US dollar or less. This
intensive research effort, made possible by
the use of public/private partnership, will no
doubt encourage the use of this financing
mechanism for research relating to major
international diseases. It is important to note
that in the context of this initiative it is
understood that any profits will be shared
between one funder and the drug manufac-
turer, but that the profits will be re-deployed
back into research. If the promise of the
effectiveness of the new drug is confirmed
in trials over the next two years, this promis-
es to save a million lives a year in Africa
alone.
Editorial
58
Public / Private Financing and Health Research
Classification
Type I diabetes1
is caused by an absolute
lack of insulin, and its treatment is based on
insulin replacement. Type I diabetes repre-
sents 15-20 % of cases of diabetes mellitus.
The peak incidence is between 10-14 years
of age. The incidence varies markedly from
country to country (from about 3-40 ca-
ses/100.000/year) and is increasing in
many countries. The average increase in
European children under 15 years of age
for example is 3-4 % each year.
Antigen targets for auto-immunity in pancre-
atic β-cells (islets of Langerhans) include
glutanic acid decarboxylase and insulin. The-
re are genetic and environmental influences –
the major susceptibility is associated with
human leucocyte antigen (HLA) class II im-
mune response genes – but in more than 90
% of cases there is no family history of dia-
betes. Likely environmental triggers for type
I diabetes in genetically susceptible individu-
als include toxins and viruses.
Type 2 diabetes2
(which replaces the terms
‘non-insulin-dependent’ and ‘maturity-on-
set’ diabetes) is the commonest form of the
disease, accounting for 85-95 % of all cases
worldwide, and effecting 5-7 % of the worl-
d’s population. The prevalence varies great-
ly throughout the world from less than 1 %
in rural China to over 50 % in the Pima In-
dians of Arizona. Differences may result
from the impact of the diabetogenic Wester-
nised lifestyle (decrease in physical activity,
lack of exercise; increased energy intake
from excessive sugar, fats and ‘junk’ foods)
on diverse genetic backgrounds – which
may include ‘Thrifty’genes that in evolutio-
nary selection favour fat storage and/or bu-
ild up of insulin resistance by the tissues.
It is estimated that the global prevalence of
type 2 diabetes will have doubled by 2025,
relative to 1995 figures, to a total of 270
million people. The greatest increases will
be in the developing world, among econo-
mically productive adults aged 45-65
years.
Environmental risks for type 2 diabetes in-
clude obesity (which accounts for 90 % of
acquired risk) and physical inactivity. Mal-
nutrition in utero and infancy may predis-
pose to type 2 diabetes in adult life by ‘pro-
gramming’ pancreatic β-cell failure and
the development of insulin resistance. Ob-
esity, especially with abdominal and visce-
ral fat accumulation, induces insulin resi-
stance in the tissues and is associated with
glucose toxicity and cardiovascular risk
factors such as hypertension and dyslipi-
daemia. Potentially diabetogenic factors
produced by adipose tissue include free
fatty acids, which can interfere with gluco-
se metabolism and therefore the action of
insulin in liver and skeletal muscle.
Clinical presentations of type 2 diabetes
include raised blood sugar, intercurrent
urinary or genital tract infections – and as
an incidental finding in 30 % of cases. In
the UK fifty patients present with type 2
diabetes, and a further fifty don’t know
they are developing the disease (which can
take several years). Hyperosmolar non-ke-
totic coma occurs, but ketoacidosis is rare
unless precipitated by severe intercurrent
illness, such as myocardial infarction or
overwhelming infections.
Diabetic complications such as retinopa-
thy, macular degeneration, nephropathy,
neuropathy, coronary, cerebrovascular and
peripheral vascular disease, in particular in
the feet, are commonly found at diagnosis.
A new classification of diabetes was adop-
ted in 1997 by the American Diabetes Asso-
ciation3
and later in 1999 by a group of ex-
perts under the auspices of WHO4
. This was
based on aetiology rather than treatment.
Type Ia (about 90 % of type I cases in Euro-
pe) is due to autoimmune destruction of the
β-cells in the islets of Langerhans, and type
Ib where these is no evidence of autoimmu-
nity. Another diabetic subtype resembling
type 2, but showing serological evidence of
autoimmunity, is referred to as latent auto-
immune diabetes in adults (LADA), com-
prising about 10-25 % of type 2 cases.
There may be other forms of insulin-defi-
cient diabetes. Modern techniques for hor-
mone and receptor characterisation, toget-
her with molecular genetics, show diabetes
to be a family of diseases. It is clear that pe-
ople are affected by the immune process of
the diabetic condition both before and be-
yond the stage of strict insulin dependence.
Genetic factors in diabetes
A striking feature of mature-onset diabetes
is the strength of its genetic component,
which is much greater than in type I diabe-
tes – it is estimated to account for 40-80 %
of total disease susceptibility. In identical
twins type 2 diabetes is highly concordant
(60-90 %), but in non-identical twins this is
less so, at 17-37 %. The risk of developing
type 2 diabetes increases strikingly if there
is a family history of the disease, especially
among the first-degree relatives.
Diabetogenic genes could influence either
or both of the basic defects in type 2 diabe-
tes, namely insulin resistance genetically
expressed in the tissues or the inability of
the pancreatic β-cells in the islets of Lan-
gerhans to secrete enough insulin. Candida-
te genes therefore include: (1) signalling
mediators and enzymes on metabolic path-
ways (1 gene for each protein chain) that re-
gulate the biological actions of insulin, and
(2) components of the pancreatic β-cell
energising secretion, together with mecha-
nisms that ensure β-cell survival.
Many studies to date have attempted to lo-
cate and identify genes that predispose to
type 2 diabetes, such as glycogen synthase
The public/private financing mechanism is,
of course, also being introduced at national
levels in health care services. This is sub-
stantially in hospital development, but it is
also emerging in funding treatment centres
and other sectors of health care. Whilst
there are marked divisions of opinion on the
appropriateness of the application of this
concept in this context, it is still too early to
determine the outcome. One can only wait
and see whether a similar success in the
context of national healthcare provision
occurs and how it will influence the debate.
Alan J. Rowe
Editorial
59
Genetics Underlying Diabetes
and its tandem repeat DNA polymorphisms,
protein phosphatase and its regulatory sub-
units, coding regions for messenger RNA,
and calpain – one of the proteolytic enzy-
mes. It is now clear that no single major lo-
cus explains the inheritance of type 2 diabe-
tes, and the disease is caused by the interac-
tion of multiple genes operating in unison
with environmental factors. The strongest
evidence to date for a type 2 diabetes
susceptibility gene is for a locus designated
‘NIDDMI’ on the short arm of chromosome
2, which accounts for as much as 30 % of
the genetic susceptibility among Mexican-
American sibling pairs.
‘Thrifty’ genes
During the course of human evolution, have
some genes been rendered detrimental by
progressive selection? Major stressors have
been periodic food shortages, famine, and
the resulting depletion of the body’s energy
stores. Some animals may be able to cope
with this by hibernating through winter but
in the case of humans, it was first suggested
by Neel5
(1962) that the evolutionary re-
sponse could have been the selection of
‘thrifty’ genes which favour energy storage
as triglyceride in adipose tissue. Candidate
thrifty genes could include those involved
with insulin resistance in the liver (regula-
ting blood glucose levels) and in skeletal
muscle (regulating protein synthesis). Such
genes could promote substrate uptake into
adipose tissue. Expression of the genes
would be selected in populations living in
extreme or precarious environments – in-
deed, such a selection process would have
operated throughout human history.
So, at the present day, humans are poorly
adapted from a tree-dwelling existence in
the jungle to a modern environment of the
‘concrete jungle’ in cities. In the 21st centu-
ry humans are forced to adapt to the novel
stresses, in evolutionary terms, of overnu-
trition from ‘junk’foods containing excessi-
ve sugar, fats and salt from an early age
(even in utero), and lack of exercise. Such
factors could explain the pandemic of ob-
esity in the last 20 years among societies
that have adopted a Western-type lifestyle.
Obesity
Total body adiposity, a central fat distribu-
tion, together with a duration and time-cour-
se of developing obesity, are all established
risk factors for clinical diabetes in both se-
xes. Indeed, having a body-mass index
(BMI) of >35 kg/m2
increases the risk of de-
veloping diabetes over a 10-year period by a
staggering 80-fold, as compared with slim
individuals with a BMI <22 kg/m2 . Lifestyle factors such as diet and exercise account for 90 % of this excess susceptibility to type 2 diabetes, of which obesity is the most impor- tant. Biochemical factors promoting obesity include ageing, circulating free fatty acids, expressive glucose, and the action of local hormones in the tissues (cytokines). Genetic control of the central metabolic pathways into (a) protein synthesis, (b) free fatty acid utilisation from glucose via acetyl coenzy- me A, or (c) synthesis of cholesterol and ar- terial plaque, all contribute to an increasing prevalence of diabetes. Ivan M. Gillibrand References 1. Gérard Slama (2003). Chapter 3. Type I dia- betes: an overview, in Textbook of diabetes edited by J. C. Pickup and G. Williams. 3rd edi- tion, Oxford, Blackwell Science Ltd. 2. Nicholas Katsilambros and Nicholas Tento- louris (2003). Chapter 4. Type 2 diabetes: an overview, in Textbook of diabetes, edited by J. C. Pickup and G. Williams. 3rd edition, Oxford, Blackwell Science Ltd. 3. Report of the Expert Committee on the Diagno- sis and Classification of Diabetes Mellitus. Dia- betes Care 1997; 20: 1183-97 4. Alberti KGMM, Zimmet PZ, for the WHO Consultation. Definition, diagnosis and classifi- cation of diabetes mellitus and its complica- tions, 1: diagnosis and classification of diabetes mellitus-provisional report of a WHO consulta- tion. Diabet Med 1998; 15: 539-53. 5. Neel JV, Diabetes mellitus: a thrifty genotype rendered detrimental by progress. Am J Hum Genet 1962; 14: 353-62. Medical Ethics and Human Rights 60 The following article deals with a major issue affecting all health professionals, but more notably doctors and nurses. Unlike many resource problems, this one has major ethical and moral aspects, which need to be addressed by all concerned, including the professionals, both individu- ally and collectively. Orvill Adams* The World Health Organization at the 57th World Health Assembly debated extensive- ly the international migration of health per- sonnel.1 The existence of an important pub- lic health issue that had to be addressed was never in question. How to reverse current trends, and reduce adverse effects of migra- tion of health personnel on service delivery ,was at the heart of the discourse. The subsequent resolution recognized that action needed to be taken by all involved both in sending and receiving countries. The critical role played by health workers in tackling health problems, and the poten- tial negative impact of migration on the delivery of health services is explicitly stat- ed. Member States are urged to develop strategies, frame and implement policies, use government to government agreements and to do all of this with a view to strength- ening health systems. Medical Ethics and Human Rights Migration of health workers: Critical issues in the global debate * Director Dpt. Health Service Provision, W.H.O. Geneva The need to engage a large and diverse number of stakeholders in tackling the issues of international migration of health workers is the focus of the resolution, which calls on the Director General of WHO to work with international organiza- tions to monitor the changing situation, conduct research, and seek options to address identified problems arising from migration of health personnel. The debate and the resulting resolution are far reaching, in that they acknowledge that to reverse and/or slow down trends, it is necessary to look at the workings of coun- try health systems, and the labour market for different types of health workers. It also reinforces the notion that there are fair and unfair practices in international recruitment of health personnel. The Commonwealth Code of Practice for the International Recruitment of Health Workers is noted, and the Director General is requested “to explore additional meas- ures that might assist in developing fair practices in international recruitment of health personnel, including the feasibility, cost, and appropriateness of an internation- al instrument.” Also “to develop, in consul- tation with Member States and all relevant partners, including development agencies, a code of practice2 on the international recruitment of health personnel, especially from developing countries, and to report on progress to the Fifty-eighth World Health Assembly.” Why this debate at this time Over the past five years there has been a growing recognition of an impending if not an actual crisis, in health worker migration. The plight of nurses has been the primary focus, and organizations such the Interna- tional Council of Nurses, the World Health Organization, the Commonwealth Secreta- riat, the World Bank, the Royal College of Nursing in the United Kingdom and others have undertaken surveys and commissioned studies that have described mobility trends, identified “pull” and “push” factors, and the policies and strategies being used by diffe- rent countries. While there are significant challenges in measuring migration flows due to differ- ences in definitions of categories of health workers, in what constitutes the migration, and the lack of timeliness of data collec- tion3 , there is growing agreement that the trend is rising. Stilwell et al.4 argue that “The number of people migrating has never been higher than it is now and the majority of migrants are highly skilled.” Figure 1 shows that between 1992 and 2002 the trend in health professional migra- tion is similar to that of other migrants to the United States of America. Data for other countries show similar trends. Figure 2 uses data from the United Kingdom (and corrob- orates the trend in the US) to demonstrate that the trend in the movement of nurses is much more pronounced that that of physi- cians. Aitken et al. refer to countries that receive migrating health workers as “host coun- tries” and countries that send or export health workers as "source countries". They recognize, however, that countries can be host and source countries at the same time. The study examined six host countries, the United States of America, the United Kingdom, Ireland, Canada, Australia and New Zealand. They found that “each coun- try's health workforce planning bodies pro- ject a sizeable increase in national require- ments for nurses within the decade.”5 The authors suggest that the demands of these six countries are enough to deplete the sup- Medical Ethics and Human Rights 61 Fig. 1 Trends in migration of profession- als to the U.S. Fig. 2. Trend in migra- tion of physicans and nurses to the UK ply of qualified nurses throughout the developing world. There has not been as much focus on the migration of physicians. A study released in 20026 finds that within the OECD countries there is a reliance on foreign physicians. The percentage of the workforce from other countries, ranged from a low of 1.9% in Austria to 21.3% (1998) in Australia, 23% (2001), 25 % (1998) in Canada and 31% (2001) and 34.5% (2000) in the United Kingdom and New Zealand respectively. The OECD conducted a case study of inter- national mobility of health workers from South Africa. The study found that in the year 2001, 23,407 South African-born workers were practising a medical profes- sion in the five OECD countries shown in Table 1. The report states that South African health workers are appreciated for their pro- fessional and language skills. A recent report by Physicians for Human Rights states that “By one measure, about 50% of graduate physicians emigrate with- in 4.5 years and 75% within 9.5 years. Further, during the 1990s, 1,200 physicians were trained in Zimbabwe; only 360 were still practising in the country in 2001”.7 Ethiopia is said to have lost one third of its physicians during the period 1988 to 2001. Internal migration International migration compounds internal migration from the public to the private sec- tor. The Report of the Physicians for Human Rights above states that “Zambia's public sector has retained only 50 of the 600 physicians that have been trained in the country’s medical school from approxi- mately 1978 to 1999”.8 Awases et al9 in a study of migration of health professionals in the six African countries of Cameroon, Ghana, Senegal, South Africa, Uganda and Zimbabwe found that internal migration is a large and growing problem for the public health sector. This concern is highlighted by the follow- ing example from South Africa “In 1998, 52.7% of all general practitioners and 76% of all specialists worked in the South African private health sector. By 1999, 73% of general practitioners were estimated to be working in the private sector in South Africa, despite the fact that this sector catered for less than 20% of the popula- tion”.10 The movement from the private to the public sector is often accompanied by movement from the rural to urban areas, resulting in increased inequities in the delivery of health services. Factors affecting the move- ment of health workers The migration of health workers is affect- ed by personal and external or environ- mental factors. These include political and socio-economic differences between countries, as well as formal and informal information networks for migrants and prospective migrants. Authors 11,12,13 have identified “pull” and “push” factors. Poor working conditions, low wages, economic instability, health and safety concerns are some of the "push" factors. Opportunities to earn higher wages, to have better work- ing conditions, access to education and career advancement, are among the “pull” factors. These factors are interrelated and will take on different degrees of impor- tance in the decision of the prospective migrant depending on age, economic and social position in their country. It is important to note that the relative importance of the "push and pull" factors differ across countries. An unpublished WHO African Regional Office study of six countries found that health workers, when asked if they had an intention to migrate, responded with the proportions of those saying yes ranging from 26% in Uganda to 68% in Zimbabwe. The four Medical Ethics and Human Rights 62 Table 1. Number of South African-born workers practising a medical profession in certain OECD member countries in 2001 1. Doctors, dentists, veterinarians and other diagnostic practitioners. 2. Including assistants. 3. Possibly including some assistant nurses. Source: OECD, Trends in International Migration- ISBN 92-64-01944-8 Countries Practitioners (1) Nurses and midwives Other health professionals (2) Total Australia 1114 1085 1297 3496 Canada 1345 330 685 2360 New Zealand 555 423 618 1596 United Kingdom 3282 2923 (3) 2451 8999 United States 2282 2083 2591 6956 Total 8921 6844 7642 23 407 top factors affecting their decisions were their expectations for better management of health services, continuing education and training opportunities, conducive working environment and better and real- istic remuneration for their work. Prospective migrants from Ghana gave more weight, for example, to better man- agement of health services and to a con- ducive working environment than did health workers interviewed in the other countries. Ethical recruitment Aggressive recruitment of health workers has attracted a lot of international atten- tion and some of the practices have been viewed as unethical and unfair. This notion of unethical and unfair includes the impact of the practices on the individual health worker as well as their impact on the health systems from which the health worker is recruited. The ICN describes aggressive recruitment campaigns as “focussing on large numbers of recruits, sometimes significantly depleting a given health facility or contracting an important number of newly graduated nurses from a given educational institute…. Nurses may be employed under false pretences or mis- led as to the conditions of work and possi- ble remuneration and benefits.”14 The aggressive recruitment of health workers from vulnerable health systems has resulted in a call for ethical recruit- ment practices. These practices are volun- tary and have not yet proven to be very effective. The codes can be put into three categories based on the source of their development. In the first, the Department of Health in England has developed two instruments, one in 1999 and the other in 2001. The codes are aimed at protecting vulnerable developing countries from the recruitment of nurses unless there is an agreement between England and the respective country. Ireland developed a similar instrument in 2001. The second category is that of multiple governments. The Commonwealth code of practice for international recruitment of health professionals was developed by the Commonwealth Secretariat at the instiga- tion of the member countries. In the third category are non-governmen- tal membership organizations The In- ternational Council of Nurses, the World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians, the Royal College of Nursing in England, and a group of independent sector employers have also developed and adopt- ed statements that can be said to be in sup- port of ethical recruitment practices. Willett and Martineau, after conducting an analysis of the above instruments, con- cluded that “it is currently far from clear whether codes of practice or other such instruments – on ethical international recruitment of health professionals-will actually succeed in protecting developing countries health systems.”15 The authors call for more focus on the ethical recruit- ment objective of existing or new codes. Improved data collection systems on international recruitment to facilitate monitoring of the implementation of the codes and more sustained external pres- sure to apply the code are also required. Conclusion The recruitment, retention and migration of health workers requires concerted efforts by a mix of nationally based and international stakeholders. The factors determining why health workers choose to move or stay are complex. There are no simple solutions. More evidence is needed and this requires the active and willing participation of governments, employers and professional bodies at national and international levels. Health systems have to be strengthened to provide better condi- tions and opportunities to practice one’s career while getting fulfilment from being able to practice one’s profession. All interested parties-, governmental, non- governmental, health care providing agen- cies and the health care professionals themselves – will have to address the moral and ethical issues underlying the problems of recruitment and migration. 1 World Health Organization, WHA57. 19, Agenda item 12.11, International migration of health personnel: a chal- lenge for health systems in develop- ing countries, May 2004. 2 The meeting accepted that within the United Nations system, the expres- sion "code of practice" refers to in- struments that are not legally binding. 3 Diallo K, Data on the migration of health-care workers: sources, uses, and challenges, Bulletin of the World Health Organization, August 2004, 82(8) 4 Stilwell B, Diallo K, Zurn P, Vujicic M, Adams O, Dal Poz M. Migration of health-care workers from Develop- ing countries: strategic approaches to its management. Bulletin of the World Health Organization, august 2004, 82 (8) 5 Aitken H, Buchan J, Sochalski J, Nichols B, Powell M. Trends in Inter- national Nurse Migration. Health Af- fairs, Volume 23, no.3 2004. 6 Bourassa-Forcier M, Giuffrida A. In- ternational Migration of Physician and Nurses: Causes, Consequences and Health Policy Implications. Orga- nization for Economic Co-operation and Development, Human Resources for Health Care OECD Project. 2002 7 Physicians for Human Rights. An Ac- tion Plan To Prevent Brain Drain: Building Equitable Health Systems in Africa. June 2004. Boston 8 Physicians for Human Rights. An Ac- tion Plan To Prevent Brain Drain: Building Equitable Health Systems in Africa. June 2004. Boston 9 Awases M, Nyoni J, Gbary A, Chatora R. Migration of Health Professionals in Six Countries: A Synthesis Report. World Health Organization, WHO Regional Office for Africa, April 2003 (Draft report – Unpublished). 10 Padarath A, Chamberlain C, McCoy D, Ntuli A, Rowson M, Loewenson R. Health Personnel in Southern Africa: Confronting misdistribution and brain drain. EQUINET Discussion Paper no. 4, 2003 Medical Ethics and Human Rights 63 Biomedical research as part of science has ,since the end of the 2nd World War, tradi- tionally been performed in an international context, which includes exchange of results, errors and benefits. Some aspects of this scientific sector are subject to some regulation by specific provisions within legislation covering broader frameworks, such as those covering the use of personal data for medical epidemiological research. For decades there have been no internation- al legally binding instruments covering the entire area of biomedical research on humans. Nevertheless, most medical researchers followed the Declaration of Helsinki (1964) as amended in Tokyo 1975 and subsequent later amendments.(3) The International Ethical Guidelines of CIOMS played a similar role addressing researchers in medicine and other disciplines (5). Research is becoming more and more com- plex with respect to the aims, the methods used, and involving researchers coming from both medical and non-medical scien- tific disciplines. Research entails the risk of violations of human rights and basic ethical principles. Therefore States are more and more disposed to regulate this sector by national legislation and no longer leave it to professional standards established by the professions and codes of ethics alone. This new thinking was in part prompted by the developments in in-vitro-fertilisation tech- niques. Taking into account these and other developments in biology and medicine, the Council of Europe decided to establish a special Steering Committee on Bioethics (CDBI), for consideration of ethical and legal questions linked to these new research practices and their application in humans. As a result, one remarks more and more national and international efforts to imple- ment legally binding instruments regulating research on humans. Regarding the trans- border flow of research, it has been recog- nised that there is a need to base national legislation on international legal provisions. The following two examples illustrate the importance of these developments to the medical profession, its national and its international organisations. Directive 2001/20/EC In 2001 the European Union adopted the “Directive 2001/20/EC” (4) on good clini- cal practice in research on drugs for human use within Member States. In implementing the provisions of this directive in national legislation (which was required at the latest by 1st of May 2004), Member States are allowed to deviate to some extent if the intentions of this European law are not altered. The directive covers the whole field of drug research in the course of which it also introduces changes in the meaning of some terms used by the medical profession in this field. In contrast to the traditional understanding, the directive defines (Art.2) “sponsor” as an “individual, company, institution or organisation which takes responsibility for the initiation, manage- ment and/or financing of a clinical trial.” The sponsor, understood in that sense e.g. as interpreted by the new German drug law of 5 August 2004, has in addition to other obligations, to negotiate with the ethics committees and the competent national authority. Members of the medical profes- sion are no longer the only partners of an ethics committee established at their med- ical association or their Faculty of Medicine. This is also introduced in the new definition of an investigator. In future, the function of an investigator or of a principal investigator in drug research is no longer restricted to physicians. The directive definition states “investigator”: a doctor or a person follow- ing a profession agreed in the Member States, for investigations because of the sci- entific background and the experience in patient care it requires.” The Member States as already mentioned, have some freedom of interpretation. The new German drug legis- lation uses this right by prescribing that an investigator, a principal investigator or a co- ordinating investigator should be a duly qualified physician. Any exception to this basic principle has to be justified to the ethics committee. The status and the rights of ethics commit- tees are widened. The directive obliges the Member States to establish a system of ethics committees (Art 6), leaving all spe- cific details to national law. Germany decid- ed to maintain the well proven system of ethics committees in the Faculties of Medicine and the Medical Associations within the States (“Bundesländer”). In the future, drug research on humans may only be started following the favourable opinion of an ethics committee and “inasmuch as the competent authority of the Member State concerned has not informed the sponsor of any grounds of non-acceptance” (Art. 9). In this 11 Stilwell B, Diallo K, Zurn P, Vujicic M, Adams O, Dal Poz M. Migration of health-care workers from Developing countries: strategic approaches to its management. Bulletin of the World Health Organization, august 2004, 82 (8) 12 Aitken H, Buchan J, Sochalski J, Nichols B, Powell M. Trends in Inter- national Nurse Migration. Health Affairs , Volume 23, no.3 2004. 13 Padarath A, Chamberlain C, McCoy D, Ntuli A, Rowson M, Loewenson R. Health Personnel in Southern Africa: Confronting misdistribution and brain drain. EQUINET Discussion Paper no. 4, 2003 14 International Council of Nurses. Ca- reer Moves and Migration: Critical Questions. Geneva, 2003. 15 Willetts A, Martineau T. Ethical Re- cruitment of health professionals: Will codes of practice protect developing country health systems? Liverpool School of tropical medicine, 2004. Medical Ethics and Human Rights 64 Biomedical Research In Europe New International Legal Instruments Elmar Doppelfeld way, in incorporating the provisions of the directive into the new German drug law, the vote of an ethics committees has changed its character from that of advice to the researcher to a legally binding decision. Fearing for good reasons some kind of liabil- ity coming from this new status of the vote, Medical Associations in Germany discussed refusing the duty to maintain their ethics committees for the new purpose imposed by the Federal Drug Legislation, although tech- nically these professional bodies and institu- tions are bound by Lande law. There are a number of other implications for change in carrying out drug research in this EU Directive. These cannot be outlined in this short communication which only aims to highlight key issues. The directive calls for detailed study and, bearing in mind the global nature of drug research,will merit stu- dy by the relevant sector of the profession outside Europe. Protocol “Biomedical Research” of the Council of Europe The “Convention on Human Rights and Biomedicine”(2) of the Council of Europe, opened for signature in Oviedo on 4 April 1997 and has been signed by more than 30 and ratified by 18 Member States. It outlines the basic principles for the protection of human rights and dignity with regard to the application of biology and medicine in humans. This convention, also known as “Convention of Oviedo” permits regulation in special fields such as organ transplanta- tion or biomedical research in human in additional protocols in accordance with the principles of the convention itself. Only States which have signed and ratified the convention are admitted to sign and to rati- fy these additional protocols. By signing and ratifying the Convention and additional protocols, Member States implement these international treaties into their national leg- islation, normally giving them by this proce- dure a high position in the internal hierarchy of legal provisions. On 30 June 2004 the Committee of Ministers of the Council of Europe adopted the additional protocol concerning biomed- ical research (1). It is planned to open it for signature on 18 October 2004 in Oslo. This protocol respecting the principles laid down in the Convention of Oviedo addresses med- ical as well as non medical researchers, who carry out biomedical research in humans. As there is no restriction of this type of research to physicians, the term “physician” or the term “doctor” does not appear. The protocol covers various types of research. Research on healthy volunteers without a potential direct benefit for the per- son concerned and aimed to achieve basic knowledge, e.g. in human physiology, is included, as well as research linked to clini- cal care. Attention is given to special condi- tions such as pregnancy, or the situation of persons deprived of liberty. Research on the latter group is in some Member States of the Council of Europe permitted, in others it is strictly prohibited. This situation shows the difficulty, as in many other fields, to find a legal solution which satisfies all the differ- ent views. Usually such problems are left to national legislation. The additional protocol sets the conditions under which such a dero- gation can be used. Research with potential direct benefit for the person concerned in emergency situations and on persons not able to consent is widely accepted and is also addressed in the proto- col. In contrast, research on persons not able to consent – e.g. minors, victims of traffic injuries, persons suffering from dementia such as Alzheimers disease – without the potential direct benefit for the participant concerned but with an expected benefit for the group, entails major legal problems in some Member States. The protocol requires that the State concerned should provide a legal clarification of the conditions to be respected for that research, in first line: min- imal risk and minimal burden. Leaving the special legal position of ethics committees to the internal legislation of the Member States, the protocol prescribes precisely how to fulfil the basic condition of informed con- sent of participants in research and the duties of representatives of persons not able to consent. There are precisely elaborated chapters on how to inform the participants and how to inform the ethics committees. The list of items to be used for the applica- tion to seek an ethics committee's assess- ment should serve as a tool for the harmon- isation of research in humans in the Member States of the Council of Europe. In addition to the scientific quality of the pro- ject, legal aspects and ethical considerations, the ethics committee has for example to know something on contracts between researchers and participants, financial remu- neration or other awards for both parties, how to offer to the individual findings relevant for his or her health, publication of results and safeguarding that any necessary healthcare is not delayed for research reasons. The proto- col allows the use of placebo only under the classic conditions: no methods of proven effectiveness exist or the withdrawal or with- holding of such methods does not present an unacceptable risk or burden. In contrast to the Declaration of Helsinki 2000, scientific rea- sons as such are not accepted as justification for the use of placebo. It should be stressed that the protection of the rights of the participants is the leading aim of the protocol, in the same way providing the necessary framework for research of a high scientific level in accordance with accepted principles of ethics and human rights. Details of that new international legal provi- sion can be found in the text itself. Final considerations The new international legal instruments for biomedical research in humans as a basis for legislation in the Member States of the EU and in the 45 Member States of the Council of Europe, (representing about 800 millions of habitants) will replace as tools of first legal choice traditional and without any doubt, proven regulations coming from other groups such as the World Medical Association or Medical Associations in the States concerned. In any case of conflict, the national or international legal provi- sions prevail over regulations coming from a non-legal source. In a State which, for example, has adopted the additional proto- col on biomedical research, the use of 65 Medical Ethics and Human Rights 66 placebo is only permitted under the condi- tions of that protocol. A physician who fol- lows the wider provisions of the Declaration of Helsinki, using placebos also for scientific reasons as the only justi- fication, could be found guilty by a court. On the other hand, if non-legal provisions give a range more narrow as compared to the research protocol, the researcher may always decide to stick to legal provisions as justification. Nevertheless, the recommendations of the NGOs mentioned will not become worth- less in the future. Legislation may adopt them as an auxiliary tool for regulation inasmuch they are in accordance with national and international legally binding instruments. They may as recommenda- tions or principles given by the profession be of assistance, for example to physicians, in deciding whether or not to perform research under the legal conditions of the country in which they are living. Members of the profession should respect these rec- ommendations and principles in decision making, but they must follow the legal frame given for research. Literature 1. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, Strasbourg, 30 June 2004, European Treaty Series – No……..Provisional Edition 2. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo, 4. IV. 1997. In: European Treaty Series – No. 164, Council of Europe, Strasbourg 3. Declaration of Helsinki, see different issues at The World Medical Association Inc., www.wma.net 4. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, reg- ulations and administrative provisions of the Member States relating to the implementa- tion of good clinical practice in the conduct of clinical trials on medicinal products for human use; Official Journal of the European Communities, L 121/34 – 44, 1.5.2001 5. International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS, Geneva 2002 Prof. Elmar Doppelfeld MD Chairman of the Permanent Working Group of Scientific Ethics Committees in Germany Dieselstraße 2 D-50859 Köln e-mail: med.ethik.komm@netcologne.de Following a recent decision of the Board of the Norwegian Medical Association, the President, Dr. Hans Kristian Bakkem, has written in the following terms to all nation- al medical associations seeking their sup- port in actions to ensure the full implemen- tation of the UN Minimum Rules for the Treatment of Prisoners. “With reference to recent disclosure of episodes of torture and other degrading treatment of prisoners in Iraqi prisons: Recalling UN Standard Minimum Rules for the Treatment of Prisoners which state: “At every institution there shall be avail- able the services of at least one qualified medical officer who should have some knowledge of psychiatry. The medical ser- vices should be organised in close relation- ship to the general health administration of the community or nation. They shall include a psychiatric service for the diagno- sis and, in proper cases, the treatment of states of mental abnormality.” The Norwegian Medical Association (NMA) is concerned about prisoners' health not only in Iraq but also in other countries, where international regulations are being violated. The Norwegian Medical Association would emphasise physicians' ethical obligation to speak out against torture and/or other degrading treatment in prisons, whenever disclosed. Governments, as well as penal authorities should accept physicians’obligations in this respect. They should also inform and encourage their physicians to speak out regarding inhuman and/or other degrading treatment. The Norwegian Medical Association encourages all National Medical Associations to call upon their governments to organise prison health care according to the international regulations mentioned above.” [June 2004] Medical Ethics and Human Rights Medical Ethics and Human Rights UN Standard Minimum Rules for the Treatment of Prisoners Henry Haddad, MD, FRCPC, Professor of Medicine, University of Sherbrooke, Quebec; Jill Skinner, RN, BA(Hons), Senior Project Manager, Canadian Medical Association; Dr. Isra Levy, MB, BCh, MSc, FRCPC, Chief Medical Officer & Director, Office of Public Health Canadian Medical Association Introduction In a world that seems characterized by an increasing number of natural disasters, ter- rorist threats and an array of new diseases that can travel around the globe at jet speed, all nations, now more than ever before, need to be adequately prepared to respond to an emergency situation. During a large- scale health emergency such as an emerg- ing infectious disease outbreak, while pub- lic health is often the first line of defense the resources of the entire health system will be called upon to respond to the crisis. In 2003 both the resources and the resourcefulness of Canada’s public and acute care health systems were put to the test when Severe Acute Respiratory Syndrome (SARS) entered the country. While SARS brought out the best in Canadians' commitment to one another, it also turned a bright, sometimes uncomfort- able spotlight on the ability of Canada's health care system to respond to a crisis. During the SARS crisis, the critical role played by physicians and their professional associations quickly became apparent. This paper will briefly review the course and impact of SARS in Canada; outline the role of the Canadian MedicalAssociation (CMA) during and after the crisis; review the evolu- tion of public health policy in Canada post- SARS; and reflect on the role of the World Medical Association (WMA) in preparing for future health emergencies. A companion article that addresses the role of the CMA and lessons learned during the SARS out- break can be found in Business Briefings: Global Healthcare – Advanced Medical Technologies 2004, prepared for the WMAi . The Course of SARS in Canada On February 23, 2003 SARS entered Canada. In the manner of many emerging infectious diseases it entered quietly and initially went unrecognized. Canada's first SARS death occurred before the WHO issued its initial global alert on March 12th. By the time Canada's SARS outbreak was declared over at the beginning of July 2003, 44 people had died. Overall 438 SARS cases, 251 probable and 187 suspect, were reported in Canada during the period of the outbreak and tens of thousands of individu- als, including hundreds of health care work- ers, were quarantined. The entire health system, from preventive public health through acute care to long- term care, was severely disrupted in Toronto, one of Canada's most populated and medically advanced cities. Local public health authorities in the Greater Toronto Area (GTA) as well as their provincial counterparts, diverted almost all of their resources to respond to the crisis. Many public health professionals from outside the GTA volunteered weeks of service to assist in the response, sometimes leaving local public health units elsewhere in the country with significant human resource gaps in their own ongoing programs. Acute care services were also adversely affected as stringent infection-control and screening measures were put into place to control the spread of SARS. Institutions closed their doors, limiting access to emer- gency departments, clinics and physicians' offices. Intensive care units were full and surgeries were cancelled. Front-line health care professionals involved in critical care were stretched to their physical and mental limits. Remarkably, others found them- selves underutilized due to the impact of the infection-control measures on their practice settings. “Feast and famine“ co-existed. Although the GTA bore the brunt of the impact of SARS, the entire province of Ontario and indeed all of Canada was affected. Business suffered. The tourism industry was severely impacted. The dis- ruption that SARS caused continues to reverberate through the health care systems and economies of Canada. The Role of the Canadian Medical Association Front line physicians played a critical role in the health emergency, both in terms of the public health and laboratory response, and in their community and institutional acute care roles. During the outbreak physi- cians were engaged in identifying and tracking down the emergence, cause and modes of transmission of a new disease, and caring for patients in an environment of shifting and evolving clinical knowledge. They collaborated with researchers and sci- entists to determine optimum therapy and clinical best practice guidelines. And through all of this clinicians dealt with the personal stress, anxiety and burnout associ- ated with a desperate race to control and contain the unknown, in a context of human resources inadequate to function optimally even in normal circumstances. The CMA's primary goal was to support physicians during the crisis. It became appar- ent very early in the outbreak that govern- ments did not have the ability to communi- cate in real time with front line clinicians across the country. CMA and its provincial counterpart, the Ontario Medical Association (OMA) moved quickly to plug this gap. CMA activated its national electronic com- munication networks to alert physicians to crucial information such as public health management guidelines, about SARS. A dedicated website, e-mail and fax broad- casts to physicians, coupled with the sup- port and assistance of provincial divisions and national speciality affiliates, meant that over 90% of physicians in Canada had access to relevant expert information about SARS as it became available. The OMA was critical to ensuring the flow of informa- tion to clinicians in Ontario, Canada’s most affected province. The association used its web site, fax and e-mail networks as well as 67 Medical Science, Professional Practice and Education Medical Associations and Global Health Emergencies – The Canadian Experience personal telephone calls when necessary to ensure that clinicians received pertinent information that was clear, consistent, and relevant. During the early days of the out- break the OMA communicated with its membership every 24 to 48 hours and its web site was updated frequently. Throughout the crisis, the CMA maintained close liaison with Health Canada, federal, provincial and territorial public health authorities and relevant national medical organizations, notably the Canadian Infectious Disease Society and the Canadian Association of Emergency Physicians. The CMA also co-ordinated regular meetings of non-physician national health professional organizations, including the Canadian Nurses Association and the Canadian Public Health Association, to facilitate rapid information-sharing among all health care providers. Facilitating communications, reviewing information, and providing the clinician perspective on government directives became a key activity for medical associa- tions during the SARS outbreak. The CMA also ensured that the physicians' voice was heard at Federal decision-making tables during the crisis. It must be noted that while governments eventually welcomed this assistance, the valuable role that profes- sional associations can play during a crisis had not been considered in their emergency planning and was not uniformly embraced or recognized as the outbreak unfolded. Evolution of Canadian Public Health Policy Post SARS As the crisis subsided, a number of nation- al and provincial committees were set up to examine the country's response to SARS. In June 2003, Answering the Wake-Up Call: CMA's Public Health Action Planii was sub- mitted to the National Advisory Committee on SARS and Public Health (Naylor Committee) established by the Federal Minister of Health to report on learnings from the SARS outbreak. The CMA has a long tradition of participating in the devel- opment of health policy in Canada. It has always been a very vocal advocate for a strong and effective health system and had repeatedly called for governments to enhance public health capacity and strengthen the public health infrastructure. The CMA's action plan focused on three key areas: legislative reform, capacity enhancement and communications. Key recommendations included: • A national public health agency led by a chief public health officer • Increased funding to strengthen the pub- lic health infrastructure and increase capacity • A real-time communication and coordi- nation initiative for front line clinicians. Similar recommendations were also made in the CMA submissioniii to the Canadian Senate Standing Committee on Social Affairs, Science and Technology's (Kirby Committee) study of the governance and infrastructure of the public health system in Canada and its response during public health emergencies. SARS was indeed a wake up call to the dete- riorating condition of Canada's public health system and to the country's ability to respond to a health emergency from a health care sys- tem perspective. Both national and provin- cial inquiries pointed out many systemic deficiencies in the response to SARS. Lack of surge capacity in the clinical and public health systems; difficulties with timely infor- mation sharing among levels of government; lack of co-ordinated business processes across institutions and jurisdictions for out- break management and emergency response; inadequacies in institutional outbreak man- agement protocols, infection control, and infectious disease surveillance; and weak links between public health and the personal health services system, including primary care, institutions, and home care were some of the problems cited.iv There has been a consistency in the recom- mendations of the main inquiries into the impact of SARS on the health care system and these recommendations reflect those made by the CMA. All inquiries have stressed the need for a coordinated collabora- tive framework among different levels of government. This coordination of activity should be integral to the core functions of public health and is essential to an effective response during times of crisis. The rules for a seamless public health system must be sort- ed out in advance of a health emergency in a spirit of partnership and shared commitment to health. Both the Naylor and Kirby reports called for the establishment of a national pub- lic health agency in Canada with authority to provide leadership and action on public health matters such as national disease out- breaks and emergencies. It was further rec- ommended that a Chief Public Health Officer of Canada head up the Agency and serve as the national voice for public health particu- larly during health emergencies. The need for new funding to shore up the public health infrastructure in Canada was also widely recognized. In addition, the importance of disease surveillance and dis- semination of information to clinical and public health information systems and rele- vant stakeholders was raised in provincial and national reports. Governments wasted no time in responding to the lessons learned from SARS. In September 2003 the Canadian Conference of Federal/Provincial/Territorial Ministers of Health acknowledged the need to work together to improve public health infrastruc- ture, and increase institutional, provincial, territorial and federal capacity. They also agreed to work collaboratively on such issues as clarifying roles and responsibilities of the differing jurisdictions when respond- ing to public health threats; ensuring the adequacy of health human resources; strengthening capacity to respond to region- al and national public health emergencies; and enhancing national surveillance and information infrastructure.v In the fall of 2003 the federal government accepted many of the recommendations of the Naylor report and appointed the first ever Minister of State for Public Health. It committed itself to the establishment of a national public health agency and a chief public health officer. The 2004 Federal bud- get directed new investment to public health in Canada. Details of the new Public Health Agency for Canada were announced in May 2004 as was the creation of six National Collaborating Centres for Public Health. 68 Medical Science, Professional Practice and Education While SARS in Canada was an undeniably tragic chapter in Canada’s history it did serve to bring attention to the plight of the public health system and has spurred the federal and provincial governments to strengthen public health systems and capac- ity to be better prepared in the future. The lessons learned from SARS in Canada and the steps being taken to improve the public health system and its emergency pre- paredness and response capabilities may be of value to others as they assess their own state of readiness. World Medical Association The World Medical Association has recog- nized the critical role of physicians during a health emergency. Physicians are often the first point of contact with the emergence of new diseases, and therefore are in a position to aid in all elements of diagnosis, treat- ment of affected patients and prevention of disease. At its September 2003 General Assembly, the WMA adopted a Resolution on SARS that: “strongly encouraged the World Health Organisation to enhance its emergency response protocol to provide for the early, ongoing and meaningful engage- ment and involvement of the medical com- munity globally.“ In the aftermath of SARS, the WMA and the CMA have worked closely together to examine the lessons learnt for physicians and medical associations. A discussion paper, SARS in Canada,vi informed the deliberations of the WMA Socio-Medical Affairs Committee on implications of the SARS experience for physicians in Canada. Key among them is the need for: • a co-ordinated system to notify acute care facilities and front line health care professionals of global health alerts and ensure real time communication of crit- ical information to physicians; • cross training to boost surge capacity by equipping health professionals with the knowledge and skills that can be called upon in times of health emergency; • rapid distribution of supplies of protec- tive equipment to health professionals and their patients to reduce anxiety and the spread of infectious disease • the incorporation of physicians with key expertise into the health emergency decision-making process so that the impact of directives on clinical settings and patient care is understood. These implications apply, in general terms, in all countries of the world, no matter the type, structure or capacity of the health care system. In May 2004 the WMA Council adopted a resolution on health emergency communi- cation and co-ordination which includes recommendations for physicians, national medical associations, national governments and the WHO. The resolution seeks to improve physician reporting of suspicious illness; disaster preparedness and response protocols for infectious disease outbreaks; coordination of stockpiles of supplies; and international co-operation on emergency communication. Conclusion A dispassionate assessment of the experi- ence with the SARS outbreak of 2003 clear- ly indicates that the global medical commu- nity and the global public health communi- ty must strive to build mechanisms togeth- er, and also with governments, to closely link the clinical, public health and govern- ment responses to emerging infectious dis- eases, and bridge communications between these communities. The WMA will seek, in partnership with the WHO and others, to develop a Health Information Communication initiative that meaningfully does just this, both in times of global health emergencies, and also in times of routine health system operations. i Avaliable at: http://www.touchbriefings.com/cdps/cditem.cfm?NID=95 0&CID=5&CFID=1688258&CFTOKEN=90 ii (Available on the CMA website http://www.cma.ca/index. cfm/ci_id/3429/la_id/1.htm; iii Available on the CMA website at http://www.cma.ca/ index.cfm/ci_id/40463/la_id/1.htm iv Learning from SARS: Renewal of Public Health in Canada; A Report of the National Advisory Committee on SARS and Public Health, Health Canada, October 2003; http://www.hc–sc.gc.ca/english/protection/warn- ings/sars/ learning.html v News Release, Conference of Federal/Provincial/Territorial Ministers of Health, Halifax, Nova Scotia - September 4, 2003, http://www.hc- sc.gc.ca/english/media/releases/ 2003/2003_67.htm vi Available on the WMA website at https://www.wma.net/e/pdf/sars_discussion_paper.pdf 69 Medical Science, Professional Practice and Education Dr. Harauo Uematsu President, Japan Medical Association (based on a presentation at the WHPA, Geneva 2004) People in Japan especially health profes- sionals, have been sorely troubled by the inability to come up with effective mea- sures to curb the increasing number of med- ical errors in this country. Although statis- tics on all medical errors that have occurred in Japan have not been compiled, the num- ber of civil cases in this area has doubled during the past decade from 442 incidents in 1993 to 896 in 2002. The increase in the overall number of errors cannot be debated if it is focused only on the number of civil suits, but it is a reality that national public interest has become focused on reducing the number of medical errors. Several extremely serious medical errors have been widely reported in Japan in recent years, notably medication and dosage mistakes, patient mix-ups, inade- quately trained physicians conducting unfa- miliar surgical operations, and other errors stemming from negligence of basic precau- Patient Safety – the collaboration between the health professions in Japan tionary measures that have caused patient deaths and other serious consequences. The majority of those involved have been indicted as criminal case defendants. Many of these errors have occurred at large uni- versity and major city hospitals that are equipped with the latest equipment and facilities and where there is a team of physi- cians, nurses, pharmacists and other health personnel working conjointly. The main cause of medical errors at these hospitals appears to be a lack of communication and misinformation. In the wake of a medical error stemming from a patient mix-up involving a medical team at a major university hospital in January 1999, the Ministry of Health, Labour and Welfare created a committee of specialists to review measures aimed at pre- venting the reoccurrence of medical errors. In March 2000, the MHLW organized a liaison meeting of representatives from medical associations, pharmacist associa- tions, nurses associations, hospital associa- tions, and other health organizations aimed at raising the awareness about the impor- tance of all health-related organizations to implement patient safety protection coun- termeasures. Prior to this, the JMA had established its own committee on medical safety counter- measures in 1997 with the goal of creating a framework for medical error prevention countermeasures. This committee consisted of JMA members, members from the Japan Pharmaceutical Association and the Japanese Nursing Association to ensure the participation of not only physicians but also health professions representing all aspects of the health care sector in providing rec- ommendations on how to improve patient safety. According to the committee's 1998 report, the major factor in preventing med- ical errors and realizing patient safety was to create an atmosphere at the health care site where all health professions could freely voice their opinions and hold con- structive discussions outside the confines of established authority. To achieve this change in awareness successfully, upper management and the physicians themselves must take the initiative in promoting this change. Presently, many hospitals in Japan have established committees consisted of a vari- ety of professions dedicated to preventing medical errors. They are responsible for discussing and recommending measures to prevent the reoccurrence of actual medical errors as well as compiling reports on errors that did not harm patients. What is impor- tant about these measures is not the quanti- ty of data collected for x-number of cases, but rather how many errors were prevented as a result of the lessons that were learned from past experiences. It is the health pro- fessions from all walks of the health sector that are in direct contact with the problems at the actual health site who can identify truly beneficial information from the lessons that are extracted from the enor- mous amount of data that is available. In addition to medical associations, each health organization has conducted signifi- cant recommendations and activities to realize patient safety in medicine. For example, the Japan Pharmaceutical Association has focused its efforts on pre- venting errors related to dispensing drug prescriptions and the Japanese Nursing Association has published accident preven- tion guidelines. Needless to say, health care activities are not carried out by one health profession. They requires the mutual col- laboration of all health professions. Patient safety countermeasures require the collec- tive effort of the entire health care team and they must be based on shared knowledge and an awareness that go beyond the con- fines of each profession. Members of a health care team are col- leagues that have been brought together by a mutual goal – the task of saving the life of a patient. Therefore, they must engage in wholehearted discussions, mutually assist each other and collectively face the many dangers that threaten the safety of patients. 70 WMA Presentation given by Dr. Appleyard, President of the World Medical Association, to the Scientific Conference of the Dominican Medical & Dental Society 16 July 2004 Violence is a leading public health problem. As a profession we need to have a fundamen- tal re-think of the role we physicians can play both to mitigate the effects of the current epi- demic of violence and to develop strategies to prevent violence in the longer term. The World Medical Association was found- ed after the turbulence, terror and torture of World War II in 1947, to unite physicians worldwide in a shared mission founded on traditional Hippocratic principles. These have been enshrined in the Declaration of Geneva, which commits members of the profession to “consecrate their lives in the service of humanity and that the health of each patient will be their first considera- tion”. Further work on repairing the dam- age resulting from some doctors' conduct during that War was undertaken to establish the Declaration of Helsinki which defines the ethical principles underlying clinical research. Later, after wide consultation, the Declaration of Tokyo was forged which states that doctors “shall not countenance, condone or participate in the practice of tor- ture or other forms of cruel, inhuman or degrading procedures.” More recently, the Declaration of Ottawa on the Right of a Child to Health Care encouraged physicians to “eradicate all forms of child abuse”. After the end of the ‘Cold War’, a ‘peace dividend’ never materialized. Expenditure on arms decreased in the early 1990s, but the savings were not allocated to children’s needs. A decade of ethnic conflict and civil wars ensued, characterised by deliberate violence against children on a vast scale. Children have become targets as well as perpetrators of violence, perpetuating the How does the world treat our children? Violence and child health WMA cycle of violence into the next generation. During these conflicts, children have been maimed, killed, uprooted from their homes, orphaned, exploited and sexually abused. They have been abducted and recruited as soldiers. During conflict, a country's food production is compromised, malnutrition ensues with a life-long effect, and with the disintegration of the local 'infrastructure' health services disappear and mortality rates rise. These are clearly reflected in UNICEF league tables of under-5 mortality rates per 1,000 live births. Those countries riven by conflict and thrown into poverty have the highest rates of childhood mortal- ity. An enormous sacrifice, which those countries cannot afford to bear. An estimated 300,000 children are actively involved in armed conflicts. AIDS follows in the wake of such conflicts, leaving large numbers of orphans and by killing teachers, health workers and public servants under- mines the stability of the country. Immunization programmes disintegrate, leaving a further burden of disability and death for the poorer countries to bear. Thus, Angola has the highest polio infection rate in all Africa and the Democratic Republic of the Congo has had a ten-fold increase in polio since 1999. The epidemic of violence perpetuates poverty giving a further twist to the vicious cycle of poverty, poor health and death to more poverty, more ill health and more deaths. Violence becomes endemic in communities and is continued in such institutionalised cultural practices as female genital mutila- tion affecting 2 million children and women worldwide. Rape and domestic violence also cause a 5% loss of healthy life years. “The 20th century was one of the most vio- lent periods in human history. An estimated 191 million people lost their lives directly or indirectly, as a result of armed conflict and well over half were civilians” (Rummel R J 1994). The risk factors are well known. • Lack of the democratic process and denial of the rights of the individual • Social inequity with unequal access to wealth and health • Control of natural resources by a single group • Rapid demographic change (Carnegie Commission) To prevent violence nations must; - reduce poverty and ensure that develop- mental assistance in the form of social and health care reaches those who need it - reduce inequity - reduce access to arms - abide by international treaties. Physicians are very much involved in the first action and by their example will encourage others to seek the 2nd, 3rd, and 4th. The costs of violence have been calculated in Latin America. It costs Colombia and El Salvador 25% of their gross national bud- gets, Brazil and Venezuela about 11% and Mexico 1.3% If those countries are to emerge from pover- ty, their internal conflicts must cease through the example of their neighbours. We can do more to undo the harm of terror and torture which are the hallmarks of the oppressive regime, by exposing the practice of torture. Physicians are in a dangerous but crucial position to identify the victims and document their injuries so that the perpetra- tors can be brought to justice. It is a gradual process. Torture is undertak- en in intense secrecy, though it instills fear from the knowledge that it is taking place. Once brought to the light of day with the naming and shaming of the perpetrators, the will of the people will prevail. That is why the WMA is partnering in the International Council for the Rehabilitation of Torture Victims in pilot projects in five countries to promote the Istanbul Protocol, which pro- vides guidance on the identification of the injuries of torture victims so that they can be documented and the perpetrators brought to justice. In my view, as a profession we need to do more. We must also tackle the root causes of child abuse, instill in societies non-vio- lent means of resolving disputes, and we must start in childhood. The chastisement of children promotes a culture of violence; this is exacerbated by the severer forms of child abuse. Idi Amin was a prime example of how devastating the long term consequences can be. I smacked my own children on a very few occasions. Each time it was a failure by me as their father to manage an annoying provocative act. No one can be perfect, but we can change our way of thinking and learn nurturing ways of bringing up our children. The case against chastising children is overwhelming. Under UK law, reasonable chastisement is allowed. Not to allow chastisement is more reasonable. Like the introduction of seat belts in the UK, change of behaviour comes over time. The important message is that the community agrees that it does not con- done violence towards children or adults. In this way communities and the world will be much safer places for their chil- dren and the future of the world. Dr James Appleyard 71 WMA UNICEF in highlighting the plight of thousands of children abducted by the rebel Lord's Resistance Army in Nor- thern Uganda has said that the plight of these children as child soldiers and sex slaves is being forgotten. UNICEF Executive Director Carol Bellamy is quoted as saying, “The world may be awakening to the emergency in Sudan, but it has all but forgotten the tragedy of neighbouring Uganda, where in the past two years some 12,000 boys and girls have been abducted by the LRA” (UN Office for the Coordination of Humanitarian Affairs, 27 July 2004). 72 Dr. Bjørn Oscar Hoftvedt, Head of Department of Professional Affairs, Norwegian Medical Association Introduction Medical services in prison should be avail- able to prisoners and organised to the same quality and standards available to persons in the community at large. A prison doctor is responsible for the prisoners' physical and mental health, and if necessary a pris- oner should have access to specialised health care outside the custodial setting. The doctor's duty to secure that the prison- er receives appropriate health care can, however, come into conflict with the inter- ests of the prison administration. Referring a patient to a specialist service can be expensive, particularly when the patient needs a guard or other security measures 24 hours a day. For economical reasons many prison directors could try to put pressure on the doctor to refrain from referring patients to clinics outside the prison. Prison doctors can be called upon to exam- ine whether a prisoner is fit for isolation or other forms of special punishment. They can also be ordered to give medical treat- ment to prisoners who have been tortured. Situations like these can cause difficult dilemmas for the doctor. On the one hand, he/she should comply with the same ethical rules and human rights standards that are applicable to all patients outside the prison. On the other hand, the prison doctor is a part of the correctional system. Regardless of the organisational structure, it can be dif- ficult to defend the rights of the prisoners. The prison doctors therefore should have the knowledge and skills needed to identify situ- ations where they are in danger of violating medical ethics and human rights, and how they should deal with such situations. Educational programmes on ethics and human rights for prison doctors are not, however a priority in most countries. The Norwegian Medical Association, in co-oper- ation with the World Medical Association, has therefore developed an Internet course on ethics and human rights for doctors and other health personnel working in prisons. Structure of the course The course is interactive, using cases and real-life material on which the student can reflect. Each module ends with a multiple choice test and there are also exercises and open questions on which the doctor is required to comment. When the doctor has finished all the modules and completed the tests and the evaluations, he can receive a diploma and earn 12 hours/points in post- graduate and continuing education. Accreditation The Norwegian Medical Association has accredited the course, but we have also applied for accreditation from the European Accreditation Council for Continuing Medical Education. The course is free of charge. The World Medical Association is the main distributor of the programme. How to access the course The course can be accessed via the World Medical Association's website: www.wma. net or directly on http://lupin-nma.net. Those wishing to get an impression of the course can log on as a guest. Doctors and others who wish to take the course must register and are required to answer all the exercises and tests and com- plete the evaluation form which appears at the end of each module. Content The course consists of twelve modules: 1. International statements on human rights, medical ethics and international humanitarian law Jim Welsh, Amnesty International, London, UK. This module discusses the general princi- ples underlying the body of law and ethics relevant to the work of prison doctors and how it can assist doctors in structuring their work with prisoners. The module also outlines the main differences between human rights standards, medical ethics and humanitarian law. 2. Patient confidentiality and informed con- sent Ann Sommerville, Head of Ethics, British Medical Association, Visiting Professor of Medical Ethics, Queen Mary College, University of London. Regardless of where they are employed, doctors have ethical duties to treat all patients with respect. Seeking patient con- sent and co-operation is part of this. Prisoners are entitled to the same respect as other patients, from the time of their admis- sion and throughout their period of detention. Having completed this module, the doctor should understand when consent is needed from prisoners as from other patients, have knowledge of the prisoners' right to confi- dentiality, be able to assess when non-med- ical staff have a right to look at prisoners' medical records, and identify situations in which doctors can breach confidentiality. 3. The prison doctor's responsibility to report abuses of human rights Jim Welsh, Amnesty International, London, UK. Incarceration and lack of power, as well as prisoners' relative deprivation, contribute to making them vulnerable to abuses. They represent a population whose rights are WMA In WMJ50(1) we published a preliminary note that a course on Ethics and Human Rights for Prison Doctors was being developed by the Norwegian Medical Association and the WMA. This course is now accessible on the WMA website and his article sets out in some detail the motivation for the course, its content and how doctors can participate. A new online course for prison doctors inherently at risk - from staff, from other inmates and from the prison environment. This chapter focuses on situations in which doctors are obliged to take action and what actions are possible. It also suggests sources of support and cites standards which can be used to support action. 4. Dual loyalties Bjørn Oscar Hoftvedt MD, The Norwegian Medical Association, and Hernan Reyes, Medical Division, International Committee of the Red Cross. The interests of the penitentiary or correc- tional system are clearly security and con- trol, and not primarily the prisoners' health. In many prison systems, doctors are obliged by the prison rules to see every prisoner before he or she can be punished for break- ing some prison rule and sent to the punish- ment cell. Should the doctor declare a pris- oner as fit for punishment, or monitor pris- oners in solitary confinement fit for the con- tinuation of the punishment? There are often no clear solutions to such dilemmas. After completing this module the doctor should be able to identify situations where medical independence can be violated and be acquainted with international codes and de- clarations that ensure medical independence. 5. Hunger strike Hernan Reyes, Medical Division, International Committee of the Red Cross. A hunger strike is a way of fasting that involves some form of protest. It is usually undertaken by prisoners or other persons in a custodial setting. There are different types of hunger strikes, some of which involve complex situations and conflicts. Prison doctors need to know about the clinical sit- uations and physiology of fasting, but also have to be aware of the ethical issues at stake. This chapter discusses these issues and presents the medical and ethical guide- lines relating to hunger strikes of which all doctors should be aware. The module concentrates on the definitions of hunger strike and how to analyse the hunger striker's motives. The doctor should be acquainted with Ethies and human rights the doctor's role and be able to counsel a per- son on a hunger strike. 6. Health services for female prisoners Ingrid Lycke Ellingsen, Member Committee for Prevention of Torture, Council of Europe. Female prisoners serve their sentences under the same conditions as men, enjoy the same rights and incur the same obliga- tions. They belong, however, to the catego- ry of especially vulnerable prisoners - a fact which poses challenges for prison manage- ment as well as for health care personnel working in the prisons. The main points in this module are the international instruments which give the doctor authority within the prison context to seek ways to protect female prisoners. It also deals with signs to look for which may indicate the specific problems women will experience in a prison setting, the impor- tance of clinical assessment on admission and during imprisonment and appropriate management and treatment proposals. 7. Health care for vulnerable groups Rosemary Wool, International Council for Prison Medical Services. The very nature of imprisonment inevitably increases the vulnerability of any person entering prison custody. There is no way to escape the close proximity of fellow prison- ers or the culture of the prison community, which has its own hierarchical structures and its own value system. Within the prison community there are some groups of pris- oners (adolescents, HIV-infected, homosex- uals, etc.) who are particularly vulnerable to physical and/or mental abuse. By the end of this module the prison doctor will have learnt the important role of the doctor in the management of vulnerable prisoners, the main vulnerability factors of each category of prisoner mentioned, and ways of reducing the risk of physical and mental harm and deterioration of health. 8. Care of the mentally ill in prison Dusica Lecic-Tosevski, MD, Professor of Psychiatry, Institute of Mental Health School of Medicine, University of Belgrade Serbia and Montenegro, and Vladimir Jovic, MD, Psychiatrist and Psycho- therapist, Psychiatric Service "Median", Belgrade, Serbia and Montenegro. The high level of psychiatric morbidity in the prison population means that doctors providing health care within prisons come into frequent contact with mental health problems, often of considerable severity. In most respects, care of the mentally ill in prisons is no different from such care in other areas of the mental health services. However, it does differ in some ways. It occurs in an environment of compulsion and coercion. The modern concept of men- tal health care focuses on therapy and reha- bilitation rather than control and contain- ment. This is not easy to achieve in prisons, where dual loyalties and responsibilities are dominant. There is no doubt, however, that doctors should consider the care of mental- ly disordered offenders as their primary function. The goals to reduce symptoms and improve function are not in conflict with prevention of recidivism (social func- tion). Prevention and rehabilitation of men- tal disorders should not be neglected in prison settings. 9. Violence in Prisons: The Role of the Medical Professional James McManus, Professor of Criminal Justice at Glasgow Caledonian University. Violence is endemic in prisons. Indeed, the very act of depriving someone of his or her liberty is an act of violence, but one which almost all societies accept as legitimate in certain circumstances. Not surprisingly, however, the generally accepted legitimacy of imprisonment does not in itself always prevent the inherent violence of the act from setting a general tone of violence in penal institutions. In this module the prison doctor will be able to understand the different kinds of vio- lence which can arise in this arena, develop strategies for medical responses to each of the categories of violence in prisons, and consider his/her contribution to strategies for violence reduction. 10. Medical signs of torture and other degrading treatment Sverre Varvin, PhD, Senior Consultant Psychiatrist, Researcher, National 73 WMA As the WMA approaches its 55th General Assembly, scheduled to take place in Tokyo during October 2004, the organization cele- brates its long and fruitful partnership with the Japan Medical Association. This associ- ation joined the WMA in its early years and ever since has made a formidable contribu- tion in every sense of the word. Not only have the physicians from Japan been able to help build cultural bridges between other nations and Japan, but they have also man- aged to produce great leaders. The leg- endary Dr. Takeo Takemi was a hugely influential leader in Japan and one of the trusted advisers of the Emperor of Japan. He also served as the President of the WMA and managed to make a great impact on how the medical profession and its ethi- cal codes evolved. Another JMA leader who made a huge contribution to interna- tional medicine was Dr. Eitaka Tsuboi. During his reign as JMA President, he man- aged to help defend the profession's clinical autonomy and ethics in a time of rapid change and globalization. As WMA President, he represented the organization with great honour throughout the world, including cross-sectoral interchanges such as the World Economic Forum in Davos. During 2004, another great leader emerged when Dr. Harano Uematsu, long-time President of the Osaka Medical Asso- ciation, was elected as the new JMA President. He will be welcoming some 200 medical leaders from all over the world to Tokyo this October. As two organizations with an ever-growing influence, the WMA and JMA will facilitate the international debate on a wide-ranging spectrum of issues, from the ethics of research to the management of human resources for health. In addition, the JMA was one of the initia- tors of the policy debate on the link between water resources and public health, and the WMA will most probably adopt its first pol- icy statement on the important links between water and health. It will again be a privilege to welcome the Emperor and Empress as well as the Prime Minister of Japan to the General Assembly, a great honour for all the international participants present. Tokyo was the site where one of the land- mark policies of the WMA, the famous Declaration of Tokyo, was adopted. In 1975, the WMA General Assembly devel- oped and adopted this Declaration to pro- vide guidelines for physicians to detect, treat and help prevent the torture and abuse of detainees or prisoners. The importance of this policy document has always been valued by partners such as the Red Cross, who perform prison visits throughout the world and know how vulnerable prisoners are to torture and abuse. But in the last few months, with much being written in the press about the possible involvement of physicians in the torture and abuse of detainees in different countries, the impact 74 WMA Secretary General Knowledge Centre for Trauma and Violence, University of Oslo, and Önder Ozkalipci, MD, Human Rights Foundation of Turkey. Trauma affects the mind and body and gives symptoms and signs that originate in a disturbance in the mind-body organisa- tion. Mental trauma is an experience of overwhelming fear and helplessness. Habitual ways of coping break down, and the person must use desperate and primitive means to survive, both mentally and physi- cally. Repeated or prolonged traumatic experiences strain the capacities, exhaust the individual and commonly may lead to severe and prolonged after-effects. After going through this section the learner should understand and be able to diagnose psychic trauma and set up a treatment plan for the traumatised person. 11. Research involving members of the prison population Julian Sheather, Ethics Adviser, British Medical Association. As a general principle, prison inmates have exactly the same rights to consent and to refuse involvement in research projects as the general population. Prisoners are also entitled to benefit from research and innovative treatment in the same way as individuals in the communi- ty. They have the right to act altruistical- ly through involvement in research pro- jects which, while carrying only minimal risk, might benefit others in the same cat- egory without directly benefiting them- selves. This module particularly explores what rights prisoners have to consent or refuse involvement in research programmes, and to what extent, if any, these differ from the rights of the general population; how to assess the various ethical considerations that apply when designing research using prison populations; and the factors that need to be taken into account when assess- ing the fairness of procedures for recruiting prison participants into research pro- grammes. 12. Capital punishment Vivienne Nathanson, MD, Director of Professional Activities at the British Medical Association, Professor, School of Health, University of Durham. Capital punishment has been removed from the statute books in many countries. Of those that retain it within their legislative framework, only a minority continue to use it. A very small number of countries use capital punishment extensively. The pur- pose of this section is not to consider the moral and ethical issues covering its avail- ability and appropriateness as a sanction, but the issues that surround its use, and in particular the roles that may be played by doctors. Doctors working in prisons should be able to identify the areas in which they might be asked to become involved, and the ethical dilemmas relating to treatment decisions. Capital punishment is not a uniform sys- tem, and the dilemmas will therefore differ, depending upon the legislation. From the Secretary General’s Desk, August 2004 75 and importance of this policy has been emphasized even more. The Declaration states in no uncertain terms that physicians should in no way facilitate, condone or par- ticipate in the practice of torture or other forms of cruel, inhuman and degrading pro- cedures of prisoners and detainees. This ethical obligation applies to all physicians in all situations, including armed conflict and strife. It is evident that physicians working in prisons have a greater challenge to deal with these realities, and for this rea- son the WMA, in collaboration with the Norwegian Medical Association, have developed a training manual to help bolster knowledge of the subject of the prevention of torture and abuse. This distance learning course will be launched during September 2004 and will hopefully provide a much - needed resource for prison personnel world-wide. Lastly, the General Assembly in Tokyo will mark the change of guard of the WMA Presidency. Dr. Jim Appleyard, a paediatri- cian and seasoned medical politician from Britain, will hand over the reins to Dr. Yank Coble, a Past President of the American Medical Association. Dr. Appleyard has served the WMA and the medical profes- sion with great distinction. His Presidential theme, the protection and development of children's rights to health care, was timely, appropriate and well received both by members and world bodies such as the World Health Organization. His successor, Dr. Coble, plans to launch a "Caring Physicians" campaign during his term. As the classic example of a caring physician himself, he will visit the six regions of the WMA promoting and highlighting the fun- damental values of medicine - science, care and ethics. For the first time, the President will have his own website and end the year with the publication of a book depicting role model physicians from all over the world. Truly an Assembly and Presidency to look forward to. Geneva – Up to half of all people with seri- ous mental disorders in the United States and several European Countries are not receiving treatment, and the situation is even worse in some developing countries, according to major studies by the World Health Organization. The findings from the first of a series of WHO World Mental Health Surveys are published in the current issue of the Journal of the American Medical Association (JAMA)1 . They clearly show the high prevalence and burden of mental disorders globally which, despite available treat- ments, remain largely untreated. The first WHO World Mental Health Survey report includes data from 14 coun- tries (six less developed, eight developed) on the prevalence, severity, and treatment of mental disorders from 60,463 face-to- face interviews with adult individuals rep- resenting the general population. The Surveys were conducted from 2001–2003 in the Americas (Colombia, Mexico, United States), Europe (Belgium, France, Germany, Italy, Netherlands, Spain, Ukraine), the Middle East and Africa (Lebanon, Nigeria), and Asia (Japan, separate surveys in Beijing and Shanghai in the People's Republic of China). The six countries classified as less developed by the World Bank are China, Colombia, Lebanon, Mexico, Nigeria, and Ukraine. All surveys used a structured diagnostic interview to assess disorders and treatment. Disorders considered included anxiety dis- orders, mood disorders, disorders that share a feature of problems with impulse control, and substance abuse disorders. The researchers found that the prevalence of having any mental disorders in the prior year varied widely from 4.3% in Shanghai to 26.4% in the United States. “Between 33.1% (Colombia) and 80.9% (Nigeria) of 12-month cases were mild,” the researchers report. “Serious disorders were associated with substantial role dis- ability [inability to carry out usual activi- ties] 35.5% to 50.3% of serious cases in developed countries and 76.3% to 85.4% in less-developed countries received no treat- ment in the 12 months before the inter- view.” “The fact that many people with subthresh- old disorders are treated while many with serious disorders are not shows that unmet need for treatment among serious cases is not merely a matter of limited treatment resources, but that misallocation of treat- ment resources is also involved”, the authors, Drs Ronald C. Kessler and T. Bedirhan Ustün on behalf of the 28 country network, concluded. “To the extent that early intervention can prevent progression, early treatment might be cost effective. A new focus on develop- ment and evaluation of secondary preven- tion programs for the early treatment of mild cases is needed to guide rationaliza- tion of treatment resource allocation,” the authors conclude. Dr. Benadetto Saraceno, Director of the WHO Department of Mental Health and Substance Abuse, commended the study as “conclusive evidence on indicating the global burden of disease due to mental and substance abuse disorders” and “good insight into the treatment gap that exists all over the world largely because of stigma and under-recognition of mental and sub- stance abuse disorders.” 1. JAMA 2004; 291: 2581-2590. Available at www.jama.ama-assn.org/cgi/reprint/291/21/2581. Please see Jama paper for list of authors and for fund- ing information. World Health Organization Mental and substance abuse disorders Mental disorders are widespread, disabling and often go untreated Philippe Stroot, WHO Geneva The Health Academy is a WHO initiative to create a global health and technology net- work. Its uniqueness lies in its capacity to provides health information to the general public for the purpose of health improve- ment. It provides guidance in terms easily understood by people from all walks of life and all age groups, taking into considera- tion their individual cultural sensitivities. Health is a universal value that transcends cultures and classes and is considered by the World Health Organization (WHO) to be at the heart of human development. The opportunity to enjoy the highest attainable standard of health has been enshrined in the World Health Organization's Constitution for more than half a century. Yet today, an intolerable burden of illness still afflicts a large part of the world population. For mil- lions of people around the world, particu- larly those who live in the poorest segments of society, the reality today is one of ram- pant disease aggravated by poverty and lack of knowledge. On the other hand, it is quite obvious that development, economic growth, stability, human dignity and the ful- filment of human rights will only be achieved when people are given the oppor- tunity to live healthy lives. Since health-care is increasingly expensive, the key to break the cycle of disease and poverty has to be health promotion and pre- vention. But the question is how to do it effectively? How to help people prevent disease and fully benefit from the care they need? WHO believes that one solution could be the efficient harnessing of modern technology to convey electronic informa- tion on health to all levels of society. In the last half of the twentieth century, advances in technology and telecommunications, while bringing human beings closer in one sense, have also contributed to the ever- widening gap between prosperity and poverty and between health and sickness. New drugs and vaccines are being devel- oped and new disease prevention and con- trol mechanisms envisaged. Technological advance has been unbelievable. But who really benefits from this progress? Bridging the digital divide Information, and its corollary, knowledge, can indeed either divide or unite, depending on its use. It gives the means to either correct social inequities or create them, enhance sustainable development or deplete valuable and irreplaceable resources. The Health Academy's aim is to reach the poorest of the poor all over the world and give them the knowledge they need to protect and improve their health. It will bring information, technology and health together, in the form of e-learning, to create awareness and convey pertinent basic health knowledge in a language that everyone can understand. This is expected to help improving the quality of life and promoting more positive attitudes, eventu- ally leading to a more productive society of individuals. It will also contribute to bridg- ing the digital divide, which is obviously linked to the social and economic inequali- ties that exist in the world today. WHO's conviction is that information tech- nology must be used in the field of educa- tion, for the schoolchild, undergraduate, and postgraduate, providing the knowledge of health specialists for all citizens of the world, particularly in the field of health and specifically in educating future health pro- fessionals. Research is providing insights into diseases that were not known before. To keep abreast of the latest knowledge on physiology, pathology, and genetics is an enormous task. It is essential that doctors' and health professionals' skills and compe- tence be maintained and validated. One major advantage of communication tech- nologies is that materials can be instantly updated and disseminated. Textbooks take time to prepare and publish, and are costly to distribute. By making health information accessible, WHO believes that people will attain a safe, healthy, and productive lifestyle. It should also stimulate a dialogue between the pub- lic, medical professionals and policy-mak- ers. The Health Academy especially takes into consideration individual cultural sensi- tivities. With its globally spread education- al networks, it will eventually be able to connect people from different nationalities and cultures. Such an enhanced global interaction will lead to an exchange of knowledge and cultural customs that can engender a global society that is rich in its diversity and united in its humanity. Carefully validated health content and state of the art technology WHO's rich information resources and expertise in health issues, as well as its world-wide access to health information in all countries, is the main source of validated health content for the Health Academy. As the main partner in this new initiative, Cisco Systems Inc. is providing and developing the e-learning methodology, which goes far beyond simple distance learning. Its essen- tial feature is its interactivity, which allows the learner to construct from first principles the very essence of what is being taught and to consolidate vital relationships between each building block. This approach helps to develop critical thinking and enhances con- centration capacities. The curriculum is exciting to both educators and students, as it is a truly interactive mix of different media technologies. E-learning courses will cover major health issues including tobacco use, blood infections, food safety, nutrition, physical activity, rational use of medicines, personal hygiene, etc. The portal concept has been developed and two pilot studies were carried out, one in Egypt and the other in Jordan. They were directed at 12 to 18-year old students in 20 schools in each of the two countries. Based on the evaluation of this experience, the 76 World Health Organization The Health Academy: a first step towards a virtual school to promote public health world-wide Health Academy will be expanded to other countries and regions of the world, with a view to eventually reach the entire popula- tion of our planet. Two major dimensions will be taken into account in order to achieve the overall vision: the health condition dimension and the cultural dimension. On this basis, the following regional clusters may be identified: Latin and Central America, North America and Western Europe, the Arab World and the Middle-East countries, Central and Eastern Europe, Sub- Saharan Africa, the Indian subcontinent, Japan and South East Asia, and Oceania. An initiative with limitless possibilities By following these e-learning courses, young people will rapidly learn the modern technological skills to acquire new knowl- edge. They will develop new attitudes and healthier behaviours and promote good health messages in their family and com- munity. Improved mental and physical health will facilitate clarity of mind and emotional stability. This in turn will enable students to take empowering, life-changing steps in all aspects of their lives. As a result, individuals, families, communities and nations will become healthier and more able to partake in global society. The educational process will not stop at the participating users enrolled in the courses. Once the Health Academy is established, the equipment and courses provided within the education system can be used in the evenings by the parents and the general public under the guidance of mentors. This could have important benefits in improving the teacher- parent relationships as well as educating peo- ple of all age groups in the use of the comput- er, accessing Internet and in the subjects selected. In addition, the Health Academy may be extended to community Internet cen- tres and other points of access. As such, it is hoped that health development will become entrenched in the society at large. The Health Academy has developed com- pletely four courses in English. Because the pilot study was carried out in two Middle Eastern countries, these courses are also available in Arabic. All courses will eventu- ally become available in the six United Nations official languages. “The Health Academy provides unprece- dented opportunities for effective health promotion through people-centred partner- ships” said Dr LEE Jong-wook, Director- General of WHO, at the launch of this new initiative last December. “It is more than just education; it is a means to influence attitudes and behaviour towards a healthier lifestyle, which in turn may help reduce gaps between prosperity and poverty and health and sickness.” The launch generated a lot of interest world- wide. Government offices, medical institu- tions, educational and health organizations, universities and individuals from all parts of the world contacted the Health Academy to request more information or to propose col- laboration, suggesting to expand it to specif- ic regions, countries and languages. This high level of expectation meets the very aim of the Health Academy, which is to become a virtual school of public health disseminat- ing validated knowledge and information to the entire global community. Further information: contact Philippe Stroot,Information and External Relations, WHO, 20 avenue Appia, 1211 Geneva 27, Switzerland, tel 41 22 791 4316 e-mail strootp@who.int. 77 The Treaty closed for signature with nearly 90% of countries having signed and over half the ratifications needed for its entry into force having been received Geneva, 2 July 2004 – The World Health Organization Framework Convention on Tobacco Control (WHO FCTC) closed for signature this week, with nearly 90% of countries having signed and over half of the required ratifications, keeping the Convention on track to become binding international law by the end of 2004. The WHO FCTC has become one of the most rapidly embraced United Nations conven- tions, with 168 WHO Member States and the European Community (EC) signing, and 23 countries ratifying, accepting, approving or acceding to the Convention, just one year after it opened for signature in Geneva. WHO is now helping countries prepare for the moment when the WHO FCTC reaches 40 ratifications and it comes into force. An important step in this process included a five-day Intergovernmental Working Group in Geneva, chaired by Brazilian Ambassador Luiz Felipe de Seixas Corrêa, Chair also of the last three rounds negotia- tions that led to the accepted text of the WHO FCTC. The rapid response to the WHO FCTC demonstrates the increasing commitment worldwide to control the tobacco epidemic, which continues to expand at alarming rates, especially among people in less-developed countries. “Although we have good reason to be con- fident, a relentless effort will still be need- ed for the foreseeable future. Current pro- jections show a rise of 31% in tobacco- related deaths during the next twenty years, which will double the current death toll, bringing it to almost ten million a year,” said WHO Director-General Dr. LEE Jong- wook to countries attending the Inter- governmental Working Group. “When the Treaty comes into force, national and local activities aimed at reversing these trends will be enormously strengthened. The result will be improved public health and reduced poverty.” WHO has urged countries that have signed to ratify the Treaty as soon as possible. “The sooner the 40 ratifications are in place, the sooner effective and coordinated actions within the Framework Convention World Health Organization The WHO Framework Convention on Tobacco Control on track to become law by the end of the year at country level can begin. Countries can rely on WHO for continued support,” said Dr. Catherine Le Galès-Camus, Assistant Director-General, Noncommunicable Diseases and Mental Health, at WHO. The WHO FCTC, adopted unanimously by all WHO Member States in May 2003, is the first public health treaty negotiated under the auspices of WHO. It was designed to become a tool to manage what has become the single biggest preventable cause of death. There are currently an estimated 1.3 billion smokers worldwide. Half of them, some 650 million people, are expected to die prematurely of a tobacco-related disease. Note The WHO FCTC has, as of 30 June 2004, 168 signatories (including the European Community) and 23 ratifications or the equivalent. The Parties to the WHO FCTC as of 30 June 2004 are Bangladesh. Brunei Darussalam, Cook Islands, Fiji, Hungary, Iceland, India, Japan, Kenya, Maldives, Malta, Mauritius, Mexico, Mongolia, Myanmar, Nauru, New Zealand, Norway, Palau, Seychelles, Singapore, Slovakia and Sri Lanka.* The WHO FCTC has provisions that set international standards on tobacco price and tax increases, tobacco advertising and sponsorship, labelling, illicit trade and sec- ond-hand smoke. The Treaty will enter into force and become law for the countries that are parties to it 90 days after the 40th ratifi- cation or equivalent instrument. Seventeen more Parties are needed for the entry into force of the Treaty. During the Intergovernmental Working Group from 21 to 25 June in Geneva, dele- gates elaborated proposals on different proce- dural, institutional, financial and budgetary issues that will be presented to the WHO FCTC Conference of the Parties for its con- sideration and adoption. The Conference of the Parties (COP), formed by all Parties to the Treaty, will take place during the year follow- ing the entry into force of the WHO FCTC. Countries that have not signed at this date wishing to become party to the Treaty can do so by means of accession. For signato- ries of the Treaty, there is no deadline for ratification (equivalent). For the current status and full text of the WHO FCTC, please visit: www.who.int/tobacco/areas/framework/sig ning_ceremony/countrylist/en/ For further information, please contact Marta Seoane, Communications Officer, Tobacco Free Initiative, WHO Geneva, Tel.: +41 22 791 2489, mobile: +41 79475 5551, e-mail: seoanem@who.int 78 WHO issues new recommendations for Ginseng, Echinacea and other medicinal plants Geneva: The World Health Organization has released guidelines for good agricultur- al and collection practices for medicinal plants – an industry estimated to be worth more than US$ 60 billion. The guidelines are intended for national governments to ensure that production of herbal medicines is of good quality, safe, sustainable and poses no threat to either people or the envi- ronment. Herbal medicines could be the natural answer to some ailments and can often be readily available. For these reasons, they are growing in popularity in wealthy coun- tries and their use remains widespread in developing regions. However, reports of patients experiencing negative health consequences caused by the use of herbal medicines are on the rise. One of the major causes of adverse events is directly linked to the poor quality of herbal medicines, including raw medicinal plant materials, and to the wrong identification of plant species. Cultivating, collecting and classifying plants correctly are therefore of the utmost importance for the quality and safety of products. In addition to patient safety issues, there is the risk that a growing herbal market and its great commercial benefit might pose a threat to biodiversity through over-harvest- ing of the raw materials for herbal medi- cines and other natural health care prod- ucts. If not controlled, these practices may lead to the extinction of endangered species and the destruction of natural habitats and resources. The WHO guidelines on good agricultural and collection practices (GACP) for medici- nal plants are an important initial step to ensure good quality, safe herbal medicines and ecologically sound cultivation practices for future generations. In an easy-to-under- stand style they cover the spectrum of culti- vation and collection activities, including site selection, climate and soil considerations and identification of seeds and plants. Guidance is also given on the main post-harvest opera- tions and includes legal components such as national and regional laws on quality stan- dards, patent status and benefit sharing. Background facts The safety and quality of raw medicinal plant materials and finished products depend on intrinsic (genetic) or external (environment collection methods, cultiva- tion, harvest, post-harvest processing, transport and storage practices) factors. Inadvertent contamination by microbial or chemical agents during any of the produc- tion stages can also lead to deterioration in safety and quality. Medicinal plants collect- ed in the wild may be contaminated by other species or plant parts through World Health Organization * edit: The number of countries which have ratified or taken equivalent action had risen to 30 (August 2004) Herbal medicines Medicinal Plants – Guidelines to Promote Patient Safety and Plant Conservation for a US$ 60 Billion Industry misidentification, accidental contamination or intentional adulteration, all of which may have unsafe consequences. Adverse reactions due to substitu- tion of incorrect plant: Digitalis: Cases of serious cardiac arrhyth- mias were reported in the USA in 1997 fol- lowing the accidental substitution of plan- tain, to be used as a dietary supplement, with Digitalis lanata, generally used for heart conditions. Subsequent investigations were reported to reveal that large quantities of the misidentified plantain had been shipped to more than 150 manufacturers, distributors and retailers over a two-year period. Podophyllum: Fourteen cases of Podophyllum poisoning have been reported from Hong Kong Special Administrative Region of China, following the inadvertent use of the roots Podophyllum hexandrum instead of the Gentiana and Clematis species for the antiviral qualities. It is reported that this accidental substitution arose because of the apparent similarity in the morphology of the roots. Aconitum: Cases of cardiotoxicity resulting from the ingestion of Aconitum species used in complementary medicine for acute infec- tions and panic attacks have been reported from Hong Kong, China. Aconitum root- stocks are processed by soaking or boiling them in water in order to hydrolyse the aconite alkaloids into their less toxic, aco- nine derivatives. Toxicity can, however, result when such processes are mismanaged. In the United Kingdom, the internal use of aconite is restricted to prescription only. Endangered medicinal plants: The wild types of the popular medicinal plant ginseng (Panax ginseng), used to address digestive conditions resulting from nervous disorders, is currently reported to be rapidly declining due to increasing demand and collection. Wild Amercian ginseng, goldenseal, echi- nacea, black cohosh, slippery elm and kava kava top the “at-risk list” of endangered species of medicinal plants. Cultivation has replaced wild collection for the supply of some essential drugs used in modern medicine. The Madagascar rosy periwinkle, Catharanthus roseus, is widely cultivated in Spain and the United States for its properties which are considered useful in treating childhood leukaemia and Hodgkin’s disease. A traditional medicine for which demand is greater than the potential for supply is the African Pygeum tree (Prunus africana). The bark is a very popular natural remedy for prostate disorders in some European coun- tries such as Spain – but it is harvested from wild trees growing in the mountain forests of continental Africa and in Madagascar and is unsustainable under current practices. While the bark can be harvested sustainably, harvesters either cut too much, which results in the death of the trees, or they fell whole trees. The International Centre for Research in Agroforestry (ICRAF) and others are working to establish sustainable sources of Prunus africana through conservation of wild tree populations and assistance to smallholders to grow the tree – something that will also help increase farmers’ incomes. ICRAF is also working on a breed- ing programme to select varieties which will take less time to reach harvestable age. Devil’s Claw, Harpagophytum procum- bens, is another popular remedy that is unsustainably harvested and may become extinct in the wild under current practices. It has been used as a tonic, as a treatment for arthritis and rheumatism, to reduce fever, ease sore muscles, and reduce choles- terol, and externally the ointment is used to treat sores, boils, and ulcers. It is also used to cleanse the lymph system and to remove toxins from the blood. Devil’s Claw is produced in southern Africa, and Namibia is the biggest exporter in the region. Just under 200 tonnes were exported from Namibia between January and August 2000. Between 10,000 and 15,000 har- vesters rely on sales from its collection as their only source of cash. However, current prices are not a true reflection of the real value of their work; indeed, over the last 24 years the price has dropped by as much as 85%. In 1998, a sustainably harvested Devil’s Claw project was set up on a reset- tlement farm in Namibia and has rapidly expanded. The following year, 10,210 kg of certified organic Devil’s Claw was pro- duced, providing local people with a sus- tainable product at a guaranteed and fair price. This could be the way forward, pro- vided that users of Devil’s Claw demand that suppliers stock only certified products. 79 World Health Organization Geneva – The World Health Organization has warned of dire health consequences for millions of people in Darfur, Sudan. A sig- nificant increase in disease and death is inevitable without a rapid increase in exter- nal help. The catastrophe can only be pre- vented through an urgent scaling up of the current international response. Greater Darfur is comprised of three States with a population of 6.7 million. The humanitarian crisis has displaced more than 1.2 million people from their villages and homes and Iffected two million in total. In at least one instance, the child mortality rate rose to three times higher than the interna- tional threshold for a humanitarian emer- gency (two deaths per 10,000 under-five children per day). On 3 June, Ministers and senior officials from donor nations met in Geneva to inten- sify their response to the crisis in Darfur. Bold and decisive action is needed now. WHO estimates that a humanitarian crisis can only be prevented through a rapid scal- ing up in the responses, especially during the next three months, WHO now seeks Humanitarian aid Dire Health Consequences for Millions of People in Darfur, Sudan, and Calls for Intensified Health Response US$ 7.6 million for the health response in Darfur as part of US$ 30 million needed for health work throughout Sudan, to help the Government coordinate the response of the health sector and tackle disease outbreaks, improve sanitation, respond to public health needs and improve access to medical care. The deepening Darfur crisis “Death and disease spiral upwards when there is inadequate food, unsafe water, improper sanitation and shelter, widespread violence, lack of public health inputs like vaccinations and insufficient access to med- ical care. These are the realities of the cur- rent crisis in Darfur,” said WHO Director- General LEE Jong-wook. “The world must not stand by as conflict is compounded by rising rates of death that could be prevented through concerted action.” In October 2003, the United Nations warned of an imminent humanitarian crisis in Darfur and appealed for extra resources. After a long delay, funds are now being pledged. Subsequently, needs have increased. During April 2004, the number of affected people rose to two million, with at least 1.2 million internally displaced and 100,000 refugees in Chad. Reports suggest continuing increases in levels of malnutrition (doubling each week in some settings), diarrhoea, measles and death. WHO has, so far, been promised a total of US$ 3.9 million for its response. Dr Hussein Gezairy, WHO Regional Director for the Eastern Mediterranean Region, stated that, “Delivering much- needed aid is an immense challenge in Darfur because people are scattered over a vast land area, and communications have been badly disrupted. Accessing those in need requires intense collaboration by all. A massive scale-up in international commit- ment, action and effective ground presence is needed now to save precious lives.” The UN and non-governmental orga- nisations have faced many challenges in their efforts to scale up action in Darfur dur- ing the past few months. The immediate pri- ority now is to save lives and mitigate the overall risk, exacerbated by the onslaught of the rainy season, to the health of the affected populations. This will require skilled public health staff properly equipped to tackle dis- ease, initiate immunization campaigns, ensure water quality and proper sanitation and make sure that priority surgical and medical care is available where it is needed. The Ministry of Health, WHO and partners have identified needs and priorities, and are together working to deploy Sudanese physi- cians and surgeons to Darfur hospitals and health centres urgently, in coordination with the UN system as well as NGOs. In the short term, there is an urgent need for skilled and experienced international senior public health specialists, together with sur- geons, physicians, nurses and logisticians, to work in Darfur under the direction of the Government of Sudan and WHO. They need equipment and supplies in order to be effective. WHO welcomed recent assurances from the Government of Sudan that permits for humanitarian workers to travel from Khartoum to Darfur would be issued within 48 hours, and that movement of relief sup- plies will be facilitated. A call to action Now the misery of Darfur is becoming apparent to all the world's leaders. WHO reiterated its call for action to counter this human suffering. The UN system and NGOs need sustained and committed finan- cial and political backing to counter what can only be described as a disaster. Some recent actions for health in the Darfur crises WHO has had staff in Darfur since the end of 2003 and provides regular assessments of people's health situation and needs. WHO helps coordinate and oversee interna- tional support for public health in Darfur. • Disease Surveillance and Preparation for Outbreaks: an early warning system for cholera, dysentery, and malaria, is run by 52 trained surveillance officers, with pre-placement of outbreak response materials in the three States. • Measles Vaccination Campaign: the Ministry of Health, UNICEF, WHO and partners are making final preparations for a massive measles vaccination cam- paign covering more than two million children in Darfur. This will supplement the measles care being undertaken by NGOs, targeting children between the ages of nine months and 15 years. As part of the campaign, children will receive vital Vitamin A supplements and vaccination against poliomyelitis. • Environmental Health: 172 environ- mental health workers have been trained and equipped to ensure that vector con- trol, waste disposal measures and health promotion are in place for 310,000 peo- ple in four locations: El Mashtel, Abu Shouk and Kaalma, and Geneina. For more information: IN KHARTOUM: Dr Guido Sabatinelli, WHO Representative to Sudan, Tel: 24911 780 190, Mobile: 249 121 39 448, Fax 249 11 77 62 82 E-Mail: whsud@sudanmail.net.sd; IN CAIRO: Dr Ibrahim Kerdany, Senior Information Officer, WHO, Tel: 00202 2765037, E-Mail kerdanyi@emro.who.int; More informa- tion on WHO's response in Darfur can be found on http://www.who.int/disasters. 80 Regional & NMA News Regional and NMA News Drug Costs in Europe While there is universal concern about the cost of medicines, it is interesting to note the report in Euro Observer* that in Denmark while drug prices have fallen by about 20% since 1995, public sector prescription drug costs continue to rise. Costs in 2003 showed a 5.7% rise over the previous year. This is attributed to “rising drug consumption due to demographic developments and the intro- duction of new drugs on the market.” In the same newsletter, it is reported that in Finland, generic substitution, which was introduced into the Social Insurance System (Kela) in April 2003, produced a 81 Because Canada is a federation of one fed- eral, three territorial and ten provincial gov- ernments, political jockeying at different levels is a well-established part of Canadian life. At no time is this more abundantly clear than when health care is involved. In fact, health care issues dominate Canadian political life to such an extent that they were the overriding theme of most political advertising and debate during the June 2004 federal election. These diverging views and opinions can place an organization like the Canadian Medical Association (CMA) in the no- man’s land between competing political interests and visions. And although life in no-man’s land can be difficult, it also pre- sents powerful opportunities to affect polit- ical outcomes. In Canada, these opportunities have never been greater. First, after a strident election the political gods conspired on June 28 to give Canada its first minority federal government in 25 years. This means the new Liberal govern- ment will have to attract allies because it holds only 135 of the 308 seats in Canada’s House of Commons. (The CMA takes a neutral stance in all federal elections and supports no political party before or during an election campaign. Although it raises health care issues, it never supports a par- ticular political party during a campaign.) Second, from this new minority position Prime Minister Paul Martin must deal with a restive group of provincial and territorial politicians who appear more ready than ever to challenge the federal government on health care funding. Combine these two facts, says Dr. Sunil Patel, who was the CMA’s president during the federal election, and the health care debate in Canada is approaching a crucial juncture. He thinks Canada’s physicians are ideally placed to affect the outcome. It is notable, he says, that Canada’s new federal minister of health, Ujjal Dosanjh, chose the CMA’s 2004 annual meeting in August as the venue for his first major speech – exactly one month before the provincial premiers and federal prime min- ister hold an extraordinary “First Ministers” meeting dealing solely with health care. “It will be interesting to see what messages the federal government chooses to deliver at our meeting,” said Dr. Patel, whose term ended during the 2004 annual meeting. “A lot of people, and not just doctors, will be watching this closely.” He was right. Delegates were addressed by Premier Dalton McGuinty of Ontario, (which, with a population of 11 million people is Canada’s biggest province) as well as by Mr. Dosanjh and Roy Romanow, who led a 2002 federal royal commission on health care. Their comments dominated Canadian media reports while the Aug. 16- 18 CMA meeting was taking place. The health care issues confronting Canada’s politicians are both considerable and controversial. For example: • How much should each level of govern- ment spend to provide health care? The cur- rent annual bill is C$120 billion for every- thing from physicians’ fees to drug costs and dentists’ bills. Governments are responsible for about 70 percent of the total, and the provinces and territories claim they have been left with too large a share to pay because of deficit-cutting efforts at the federal level. • What role should privately owned for- profit facilities play in the delivery of health care? This is supposed to be strictly con- trolled under federal legislation, but length- ening waiting lists within the public system are causing concern. The key question: Is the existing system sustainable? The CMA has responded with a multi- pronged effort to publicize problems and potential solutions. For example, the Association’s 137th annu- al meeting was held in Toronto Aug. 16-18, and it kicked off with a one-hour “strategic session” on health care waiting times, chaired by Dr. David Naylor, dean of med- icine at the University of Toronto. The next day Dr. Dana Hanson, the CMA’s past pres- ident, released results of a year-long study of personnel problems facing Canada’s health care professions. However, although a maximum of only 260 physician dele- gates attend the CMA’s General Council, the real audience is much larger because many reporters attend the meeting. Dr. Patel says it was easy to choose this year’s accessibility-to-care theme. “The federal election proved that it is Canadians’ major concern,” he said, “and we already knew that it is the issue that worries doctors most.” The CMA, which launched a major cam- paign promoting the need for better access to care in February, commits significant resources to public opinion polling, and those results play a major role in its advoca- cy efforts. Waiting lists are a case in point. The CMA is trying to convince Canadian governments at all levels that the country has a shortage of health care personnel. To support its arguments, it polled 1500 adults in February 2004 and learned: • Barely one in ten Canadians (14 percent) now believes that the country has an ade- quate supply of physicians, a significant decline since 1999 (35 percent). • Concern about access to advanced diag- nostic procedures has risen significantly. Regional & NMA News saving of € 39.7 (US$47.6) million in the first six months. While prescribing physi- cians can refuse to authorise “substitution”, during this period only 0.4% were not allowed by the prescriber. The savings are continuing, with combined savings of approximately € 48.6 (US$58.3) million between October 2003 and March 2004.** * Euro Observer 2004, 6 (2). ** see also Kela website, www.kela.fi/research, consulted on 02.08.04 The politics of health care – tackling health care problems Canadian style Otmar Kloiber In 1994 a chip-based electronic patient card replaced a paper-based voucher granting access to medical care under statutory health insurance for 70 million people. High expectations in the new tool came to a quick end when the state data protection officers pointed out that the chip must not to be used for any other purpose than identification. As the law only permitted storage of ID data, any other use would require legislation. This decision today looks like an act of wise prescience as the main effect of the patient card has been an excessive “doctor- hopping“, accompanied by a variety of fraudulent uses. The old card turned out to be completely unsafe: it can easily be copied, has no crypto-functions for confi- dential or private information and practical- ly it cannot be revoked. Fraudulent use pro- duces an estimated damage of more than 1 billion Euro a year. There is no doubt that telematics in medicine (“e-health”) will help to provide better med- icine and to provide medicine in better way. However, estimates of how much money could be saved by using telematics (they range between 300 and 500 thousand Euro per year for the introduction of the electron- ic prescriptions alone) are rather speculative. Nevertheless, the government introduced an intelligent mandatory “Health Card“ in leg- islation last year as part of over 400 pages of amendments to the Social Code which were adopted. The intelligent cards as described in the law will obligatorily carry electronic pre- scriptions, as they should give “room” for a medication history, emergency information and an electronic patient record. Currently there is no card with all these anticipated functions on the market and in use. On the other hand, nobody seems to doubt that they are technically possible. During the parliamentary procedure the proposal was passed without opposition. From the medical community two things were criticised: first, the time frame set by law for the introduction of the Health Card was unrealistic; second, there was no men- tion of financing the Health Card imple- mentation in the Law. The countrywide introduction of the Health Card for virtually all people living in Germany by January 1, 2006 appeared to most experts and leaders of the health care system completely unrealistic. As with all things in the statutory health care system the realization of the project has to be done by the self-governing institutions of the sick funds and the providers. Usually they regu- late their interaction by contracts, without influence from the government. For the intro- duction of the Health Card into the Social Security system, the government introduced an amendment into the law. This enabled the government to withdraw the implementation from the self-governing bodies, if it decided that they are unable to carry out this task. While the self-governing bodies claimed that the time frame was unrealistic, the govern- ment claimed that the self-governing bodies are simply unable to do the job. Obviously to augment the tension, the gov- ernment did not introduce any indication as to how to finance the introduction of the Health Card. This is a tricky situation as the investment, that may amount to 1.6 billion Euro, would substantially fall on the providers who had to purchase card readers, new software, DSL or ISDN – lines, equip- ment, and the health professional card. However, the return on investment would almost exclusively go to the sick funds. 82 Regional & NMA News When asked if they had to wait “longer than you thought was reasonable” for these pro- cedures in the past year, 31 percent answered affirmatively, compared with only 14 percent in 1999. The CMA, which represents 58 000 practis- ing physicians, residents and medical stu- dents, responded with a National Health Access Campaign. “We are making a sim- ple argument,” Dr. Patel told reporters dur- ing the campaign launch. “Accessibility is the currency of the health care system, and if people lose faith in that currency – in their ability to get care when they need it – Canada’s medicare system won’t survive. We want to ensure its survival.” The same message was delivered via a CMA “Election Tool Kit” prepared for the 2004 federal election. It outlined the major challenges facing health care and provided questions physicians could ask their local candidates. Finally, a major report on the personnel issues facing medicine was released during the 2004 annual meeting. It called for Canada to rely less on doctors imported from other countries – international med- ical graduates account for about 24 percent of Canada’s doctors, and the country has faced charges of poaching, particularly from South Africa. The report proposed that enrolment at Canada’s 16 medical schools be increased to 2,500 spaces per year (cur- rently 2,200). Although problems dogging the health care system account for much of the CMA’s advocacy efforts, it also takes concerted action on specific medical issues. For instance, when SARS struck Canada in 2003, the CMA compiled a list of physi- cians who were willing to help out their hard-pressed colleagues in Toronto – the epicentre of the epidemic in North America. And it remains an impassioned critic of smoking. In March the CMA sent letters to all major cities that host conventions announcing that it will no longer hold annu- al meetings in cities that allow smoking in indoor public places such as restaurants. More than 100 Canadian cities have already announced such bans. Patrick Sullivan Senior Manager, Member Communications, CMA Personal View Card Games – lessons on high stake gambling from the German Health Care System With this constellation of an unrealistic time frame and a potential financial dispute, the Ministry increased the chances of fail- ure. This appears to be deliberate as the Ministry had always suggested giving the whole project to the IT-service industry. The idea of the Ministry is that IT-service companies would provide the whole system for health telematics at their own cost, and make a charge for each transaction that will be made with the system. Of course the IT- industry looks for more. With the introduc- tion of the Health Card and the telematic infrastructure, they are looking towards tak- ing over the whole financial management of the health care system. The game is not about the small change for telematics, it is about the ownership of the process. This of course would lead to a totally new health care system. Currently the law does not permit the government to interfere with the financing of the health care system. Financing has to be regulated between sick funds and providers only. Taking the health card introduction away from the self-gov- erning bodies on the grounds of incompe- tence as proposed would allow the govern- ment indirectly to contract the transaction steering to the IT-industry, thus gaining influence over the cash flow in the health care system, which by law has to be strictly separated from the government. The seri- ousness of the Ministry's intention may be indicated by the fact that several employees of different IT companies are working in the ministry full time – paid by the industry. Deus ex machina Sometimes relief comes from a side one does not expect. Earlier the Ministry of Transport contracted a toll collection system out to the IT-Industry. The system would collect road fees from those lorries using the German Autobahn. Instead of choosing an established technique, the German Government contract- ed a highly sophisticated model that would allow the contractors not only to collect the toll for the government but also to offer hauler services, such as fleet management and cargo dispatch. But unlike the technolog- ically simpler models already in use in other countries, the German “Toll Collect” system was not more than an idea. The introduction of the toll collect system became a complete disaster. Its failure led to major deficits in toll collection and also to the realisation that the IT-industry does not always deliver what they promise, and that the commercialisation of state func- tions may not always be the best way to go. Every politician now has to be aware that such a liaison with the industry may be his political end if it fails – and the possibility of failure is a real, one. The simple sociological principle that two counterparts will unify if they are disturbed by a third one worked for the self-government in the health care system. In a very short time since the beginning of this year, a common institution was set up and the financing of the whole system is about to be agreed. That is more than could have been expected in such a short time. However, a previous apparently academic dispute about the way an electronic prescription should travel resurfaced: As gov- ernment and providers assume that the health card would be a good place to carry the e-pre- scription, the sick funds wish to have a serv- er-based push and pull system. The nearly religious way sick funds make this a dogma can only be explained by their wish to provide these prescription servers and have direct con- trol over the doctors' prescriptions as means of a concurrent review. But again the cards are not open and the game continues. Address for correspondence: otmar.kloiber@baek.de. The views expressed in this article are those of the author and not those of the WMJ or the WMA. 83 Review Ruth Macklin Cambridge University Press, 2004 £50.00 (hb), £22.99 (pb), pp. viii, 280 ISBN 0 521 83388 4 (hb), 0 521 54170 0 (pb) Ruth Macklin, Professor of Bioethics at Albert Einstein College of Medicine in New York, has been for many years both an active participant-observer in, and a widely- published analyst of, the debates over stan- dards for research on human beings in developing countries. In this book she reviews the principal ethical issues that have been addressed in these debates, analyses the responses that have been provided by organizations such as the WMA, and offers her own proposals for resolving the issues. As the title of the book indicates, the author’s principal concern is whether it is ethically acceptable to have standards in research ethics for developing countries that differ significantly from those in indus- trialized countries. She poses four ques- tions to illustrate this concern: 1. How can biomedical research be designed and conducted so as to con- tribute to the health needs of developing countries and at the same time contain adequate protections for the rights and welfare of the human subjects recruited for these studies? 2. If a particular study may not be conduct- ed in the sponsoring country for ethical reasons, is it acceptable to carry out an identical study in a developing country, and, if so, with what justification? 3. When completed research yields suc- cessful products or other beneficial inter- ventions, what obligations, if any, do the sponsors have to the community or coun- try where the research was conducted? 4. Should the provisions of international ethical guidelines for research, such as the Declaration of Helsinki, be inter- preted and applied in the same way in resource-poor countries as they are in wealthier countries? (p. 14). In responding to these questions, Macklin analyses and evaluates the different answers provided in such recent documents as the Review Double Standards in Medical Research in Developing Countries 2000 Declaration of Helsinki (with its 2002 Note of Clarification), the 2000 UNAIDS document, Ethical Considerations in HIV Preventive Vaccine Research, the 2001 National Bioethics Advisory Commission (USA) report, Ethical and Policy Issues in International Research, the 2002 Nuffield Council on Bioethics (U.K.) report, The Ethics of Research Related to Healthcare in Developing Countries, the 2002 Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects, and related policy documents from the USA National Institutes of Health, and the Food and Drug Ad- ministration, and the U.K. Medical Research Council, as well as comments on earlier ver- sions of some of these documents and articles in medical and bioethical journals. The two articles in the 2000 version of the Declaration of Helsinki that have generated the most controversy, paras 29 and 30, are given particular scrutiny by Macklin. The requirement of para. 29, that an experimental treatment be tested against the best current one, where such exists, has been modified or rejected in most, if not all, of the more recent documents listed above. Macklin criticizes these documents for deferring to pragmatic considerations, such as the extra cost of com- paring an experimental drug to an existing one instead of a placebo, rather than focusing on ethical principles such as justice and how they can be achieved. She also has harsh words for the WMA’s Note of Clarification to para. 29: “A major problem is that the clarifi- cation fails to clarify. …it provides no criteria for the ‘compelling reasons’ that could justi- fy departure from the principle… [and there- fore] it would allow participants in research to be subject to predictable serious or irre- versible harm” (p. 48). Like many critics of the Note of Clarification, Macklin does not pay sufficient attention to its last sentence, “All other provisions of the Declaration of Helsinki must be adhered to…” Para. 30 of the Declaration of Helsinki has likewise proved extremely challenging in the development of subsequent documents. Its requirement that participants in research stud- ies should be among the beneficiaries of the study if the study succeeds has been widely contested, both on principle and on pragmatic grounds. Macklin cites the National Institutes of Health and the Food and Drug Administration of the USA as the strongest critics of para. 30, and a related but somewhat broader CIOMS Guideline that “any product developed will be made reasonably available to that population or community.” Macklin accuses those who reject the prin- ciples embodied in paras. 29 and 30 of the Declaration of Helsinki of legitimizing an unacceptable double standard in research, since there are stricter rules for placebo- controlled trials and much easier access to new drugs in wealthy countries than in poor ones. Against those who claim that medical research should not be used as a tool to fight world poverty, Macklin suggests that the ethical principle of justice and various international human rights statements require efforts on the part of the powerful and wealthy, whether governments or cor- porations, to lessen international disparities wherever they exist, including the treatment of human research subjects. However, she acknowledges that there are irreconcilable differences regarding the extent of this obligation and how it can best be fulfilled. The appropriateness of double standards arises in discussions of other issues in research ethics besides those dealt with in paras. 29 and 30 of the Declaration of Helsinki. Macklin rejects the suggestion that promising the best current treatment and/or access to the benefits of a research study would constitute undue inducement to potential research subjects in developing countries and thereby compromise their abil- ity to give informed consent to participation in the study. As to whether the standard requirements for informed consent in devel- oped countries can be relaxed elsewhere, for example, by allowing a potential research subject’s husband or a community leader to consent on behalf of others, Macklin favours universal application of the basic principles of research ethics, such as the requirement of individual consent, but flexibility in the processes by which the principles are applied, e.g., written vs. oral consent. Besides addressing the substance of the var- ious research ethics documents, Macklin raises issues concerning their nature. Should they be pragmatic or aspirational, descriptive or prescriptive? In her view they should be both pragmatic and aspirational but prescrip- tive rather than descriptive: “Since ethics is about what ought to be, rather than simply what is, the answer … is easy. The difficulty, however, is to craft guidelines that are use- fully prescriptive without being hopelessly aspirational” (p. 30). As to whether it is pos- sible to harmonize the various international statements, she is pessimistic because of the radically different interests of the parties concerned, including protection of research subjects, addressing international inequali- ties, promotion of research and maximizing commercial profits. Moreover, none of the organizations that have produced these doc- uments has unquestioned authority in the area of research ethics. Although she does not hesitate to state her own views on the various issues she treats, Macklin consistently provides thorough and accurate summaries of all the positions on the issues, including those she criticises. In addition, she analyses with care the prin- cipal concepts in the debate on double stan- dards, including ‘double standard’ itself, ‘standard of care’, ‘equity’/‘equality’, and ‘exploitation’, and criticizes their use as jar- gon or slogans. She does not hesitate to suggest practical solutions for overcoming double standards in research, such as: 1. differential pricing and financing of essential drugs; 2. negotiations followed by prior agree- ments before research is initiated; 3. collaborative efforts among internation- al agencies and the creation of public- private partnerships; and 4. manufacture of generic copies of patent- ed drugs in developing countries and sale of such drugs to other poor coun- tries (p. 165). Through the adoption of such measures, Macklin concludes, “Maintaining the same ethical standards for research will not thwart the research enterprise, but can help to ensure that judgments made at some future time will not condemn the current era as one that accepted and even endorsed double standards of research ethics” (p. 260). John R. Williams 84 Review