2004 Law and Medical Ethics in A

G 20438

OFFICIAL JOURNAL OF THE WORLD MEDICAL ASSOCIATION VOL. 50 NO 1, March 2004

Editorial Ð The World Medical Journal 1954 Ð 2004 Ð yesterday, today and tomorrow ...... 1 A Rational Approach To Drug Design ...... 2 Medical Ethics and Human Rights Ð Medicine, the Law and Medical Ethics in a Changing Society ...... 5 Helsinki and the Declaration of Helsinki ...... 9 Linking moral progress to medical progress: New opportunities for the Declaration of Helsinki ...... 11 WMA Ð "Getting it Right for our Children" ...... 13 Medical Science, Professional Practice and Education Ð Orthopaedic Surgeons Are Failing To Prevent Osteoporotic Fractures ...... 17 Relationship Based Health Care in Six Countries ...... 18 WHO Ð More Research, More Resources Needed To Control Expanding Global Diseases ...... 19 Health And Finance Ministers Address Need For World-wide Increase In Health Investment ...... 20 WHO welcomes new initiative to cut the price of Aids medicines ...... 20 Maternal Deaths Disproportionately High In Developing Countries...... 21 Photo: Prof. Dr. Dr. M. Putscher Dr. Photo: Prof. Dr. HIPPOKRATES WMA Ð Secretary General: From the Secretary General's Desk ...... 22 World Medical Journal 1954 Ð 2004 Regional and NMA News Ð Social Security is a National Security Issue ...... 23 Health Reform in Germany Law and Medical Ethics in a "sustaining or diluting social insurance?" ...... 24 The South African Medical changing society Association's work on the HIV/Aids front ...... 25 Norwegian Medical Association ...... 27 U.K.: New report details the impact of smoking “Getting it right for our children” on sexual, reproductive and child health ...... 27 Fiji and India ...... 28 News from the Regions Book Review ...... 28 WMA OFFICERS OF NATIONAL MEMBER MEDICAL ASSOCIATIONS AND OFFICERS

Vice-President President Immediate Past-President Dr. J.D.Coble Dr. J. Appleyard Dr. K. Millymaki American Medical Association British Medical Association Finnish Medical Association 515 North State St. BMA House,Tavistock Square P.O. Box 49 Chicago, Illinois 60610, USA London WC1H 9JP, UK 00501 Helsinki, Finland

Treasurer Chairman of Council Vice-Chairman of Council Dr. K. Vilmar Dr. Y Blachar Dr. T.J. Moon German Medical Association Israel Medical Association Korean Medical Association Herbert-Lewin Strasse 1 2 Twin Towers, 35 Jabotisky St. 302-75 Ichon1-dong,Yongsan-gu, 50931 Köln P.O. Box 3566, Ramat-Gan 52136 Seoul 140-721

Secretary General Dr. D. Human World Medical Association BP63, 01212 Ferney-Voltaire Cedex France Tel (33) 4 50 40 75 75 E-mail: [email protected] Fax (33) 4 50 40 59 37

Website: http://www.wma.net

WMA Directory of National Member Medical Associations Officers, Council

Association and address/Officers

ANDORRA AUSTRIA Nassau BRAZIL Col’legi Oficial de Metges Österreichische Ärztekammer Tel: (1-242) 328 6802 Associaçao Médica Brasileira Edifici Plaza esc. B (Austrian Medical Chamber) Fax: (1-242) 323 2980 R. Sao Carlos do Pinhal 324 Ð Bela Vista Verge del Pilar 5, Weihburggasse 10-12 - P.O. Box 213 E-mail: [email protected] Sao Paulo SP Ð CEP 01333-903 1010 Wien 4art. Despatx 11, Andorra La Vella Bangladesh Tel: (55-11) 3266 9391 Tel: (43-1) 51406-931 Bangladesh Medical Association Fax: (55-11) 3266 6631 Tel: (376) 823 525 Fax: (376) 860 793 Fax: (43-1) 51406-933 Dhaka 1000 E-mail: [email protected] E-mail: [email protected] E-mail: [email protected] Website: www.col-legidemetges.ad Tel: (880) 2-9568714/9562527 Website: www.amb.org.br REPUBLIC OF ARMENIA Fax: (880) 2 9566060/9562527 ARGENTINA Armenian Medical Association E-mail: [email protected] BULGARIA Bulgarian Medical Association Confederación Médica Argentina Yerevan 375 010 BELGIUM 15, Acad. Ivan Geshov Av. Belgrano 1235 Tel: (3741) 53 48-63 E-mail: [email protected] Association Belge des Syndicats 1431 Sofia Buenos Aires 1093 Médicaux Tel: (359-2) 954 -11 69/Fax:-1186 Tel/Fax: (54-114) 383-8414/5511 AZERBAIJAN Chaussée de Boondael 6, bte 4 E-mail: [email protected] E-mail: [email protected] Azerbaijan Medical Association 1050 Bruxelles Website: www.blsbg.com Website: www.comra.health.org.ar AZE 370001, Baku Tel: (32-2) 644 -12 88/Fax: -1527 Tel: (994 50) 328 1888 CANADA AUSTRALIA Fax: (994 12) 315 136 BOLIVIA Canadian Medical Association E-mail: [email protected] / Australian Medical Association Colegio Médico de Bolivia P.O. Box 8650 [email protected] P.O. Box 6090 Casilla 1088 1867 Alta Vista Drive Kingston, ACT 2604 BAHAMAS Cochabamba Ottawa, Ontario K1G 3Y6 Tel: (61-2) 6270-5460/Fax: -5499 Medical Association of the Bahamas Tel/Fax: (591-04) 523658 Tel: (1-613) 731 9331/Fax: -1779 Website: www.ama.com.au Javon Medical Center E-mail: [email protected] E-mail: [email protected] E-mail: [email protected] P.O. Box N999 Website: www.colmedbo.org Website: www.cma.ca i see page ii Editorial

OFFICIAL JOURNAL OF THE WORLD MEDICAL ASSOCIATION

Hon. Editor in Chief Dr. Alan J Rowe Haughley Grange Stowmarket The World Medical Journal 1954 – 2004 Suffolk IP 14 3 QT UK – yesterday, today and tomorrow

Executive Editor The issue is the first of the fiftieth volume of the World Medical Journal, which we celebrate Dr. Ivan M. Gillibrand with the appearance of a new style quarterly journal. Readers may not be aware that this 19 Wimblehurst Court journal was not the first ”house publication” of the WMA. Following the early meetings Ashleigh Road Horsham starting in 1945 which led to the setting up to the World Medical Association in 1947, a reg- West Sussex RH12 2AQ ular publication entitled ”The World Medical Association Bulletin” made its first appear- UK ance in 1950. It was printed in three languages, English, French and Spanish and appeared quarterly. The Bulletin of October 1953 was the last, being replaced by World Medical Jour- Co-Editor nal in January 1954. According to the editorial of the first issue, it was renamed ”because it Prof. Dr. med. Elmar Doppelfeld has become more important and deserves such a name. It also reduces the possibility Ottostr. 12 D-50859 Köln of confusion with other bulletins, particularly those published by other international Germany societies”. The editorial also comments that as ”an official organ for a medical organisation, (it) must reproduce the actions of that organisation”. With the new style journal Business Managers we intend to enlarge on this by reinstating the views from the desk of the Secretary Gener- H. Dinse, D. Weber al, including reporting on the activities of the Chief Officers. There will also be informative 50859 Köln background articles on topical issues, some of which may be under consideration by Coun- Dieselstraße 2 Germany cil and its committees. Information about major problems and initiatives of National Medical Associations (NMAs) Publisher are not only of general interest to members but may also identify issues relevant to the med- THE WORLD MEDICAL ASSOCIATION, INC. ical profession in other parts of the world and facilitate exchange of experiences. Therefore BP 63 a new section ”Regional and N M A News” will in future appear as a separate section of the 01212 Ferney-Voltaire, Ledex France Journal. It is appropiate that this new section opens with a contribution from Japan, providing an informative and thoughtful background for the Tokyo WMA General Assembly later Publishing House this year. Deutscher Ärzte-Verlag GmbH, Die- selstr. 2, P. O. Box 400265, 50832 Köln/ Articles will be grouped in sections devoted to ”Medical Ethics & Human Rights”, and Germany, Phone (02234) 7011-0, ”Medical Science, professional practice and education”. In these sections it is our aim not to FAX (02234) 7011-255, Postal Cheque duplicate the plethora of material already available in the journals dealing with scientific and Account: Köln 19250-506, Bank: Com- technical matters for individual medical disciplines, but to address issues which relate to the merzbank Köln No. 1500057, Deutsche Apotheker- und Ärztebank, aims of the WMA. At the same time we will try to reflect the comment in WMJ 1(1) ”While 50670 Köln, No. 01513330. doctors are always interested in medical economic and social problems, they also want At present rate-card No. 3a is valid. additional items, and these must be offered to arouse and maintain interest and support”. This will of course not preclude useful reference to, and comment on, important epi- The magazine is published quarterly. demiological, preventive and therapeutic innovations and other issues, including WHO and Subscriptions will be accepted by other relevant international agencies’ initiatives and policies. Deutscher Ärzte-Verlag or the World Medical Association. With the current trends in globalisation impacting on all parts of society, this cannot be dis- regarded by the medical profession, and increasingly individual physicians are recognising Subscription fee $ 28.— per annum (incl. 7% MwSt.). For members of the that these developments affect them directly or indirectly, both personally and in their indi- World Medical Association and for As- vidual medical practice. As a non-governmental organisation comprising a membership of sociate members the subscription fee is national medical associations, the World Medical Association is in a unique position to in- settled by the membership or associate fluence international opinion, both in the interests of the medical profession and of society payment Details of Associate Members- whom it serves. The WMJ therefore aims to inform the profession and hopefully engage its hip may be found at the World Medical support for these WMA activities on its behalf. Association website [email protected] We hope that these changes will enhance the value and interest of the Journal as it moves Printed by into its sixth decade and beyond. Meanwhile, during this year we will include some com- Deutscher Ärzte-Verlag mentaries on the remarkable scientific and other changes which have taken place over the Köln — Germany past 50 years. In this connection it is interesting to note that in 1954 the first issue of the Jour- ISSN: 0049-8122 nal reported that the Council has discussed ”Ethical problems of Bacteriological warfare and

1 Editorial

experiments on humans”, ”preparation of the programme for the First World Congress on drugs to market more rapidly. ”Rational Medical education”, ”recommendations to WHO on the International Pharmacopoeia”, and drugs discovery is a systematic process ”seeking information from NMAs on Social Security”. It also reported the WHO aid to six based on screening for a particular biologi- countries to produce antibiotics and insecticides – with special reference to the problem of cal effect,” explains Professor Philippe Van malaria, and WHO’s call for enhanced services to control Tuberculosis. Looking at the der Auwera, Lifecycle Leader Roche Basel. medical scene today one may well comment ”plus ça change, plus c’est la même chose!” ”Rational drug design uses our intimate knowledge of the target’s molecular shape Alan Rowe and structure to develop specific medicines.” Both approaches offer powerful methods for discover of new medicines.

Track record A Rational Approach To Drug Design In some ways, of course, drug discovery has ”Essentially, health is another name for human harmony, harmony not only among our sev- always been rational – at least within the eral parts, but also between ourselves and our environments.” prevailing intellectual culture. In the mid- Earle P. Scarlett eighteenth century, for example, the Rev- erend Edward Stone of Chipping Norton in Oxfordshire, England developed a new The future for delivery of healthcare treatment for fever. As he explained later, the idea was a rational extrapolation of the prevailing scientific view that ”remedies lie Technological advances, increased expectations for medicine, an ageing population and le- not far from their causes”. Swamps and gal, ethical and economic factors coupled with a move towards ”evidence-based” medicine marshes, doctors believed, caused fevers are all driving the rapid change in the delivery of healthcare at the start of the new millenni- and agues. Willow grows near swamps and um. marshes. Ergo, willow should cure fevers. In a fast-changing world, where increasing healthcare regulation co-exists with globalisation The discovery that willow bark was an ef- of business, we encounter on a daily basis, more diversity and more uncertainty. fective treatment for fever led, ultimately, to aspirin’s development (Vane 2000) Al- At no other time in global history has healthcare, its benefits, its risks and its structure been though scientists no longer accept the logic, so frequently and so widely discussed. From the man in the street through the pressure Stone’s discovery was an example of ratio- groups and governments, everyone is talking ”healthcare”. The language may vary, but the nal drug discovery within the intellectual topics remain the same. framework of the time. Both as producers and consumers as doctors, patients and healthcare providers, we face Probably the first drug to emerge from a higher demands and higher expectations in targeted drug treatment. modern rational drug design programme Over the years, the pharmaceutical sector has had some notable successes. Antibiotics and was the angiotensin converting enzyme vaccines mean that many infections our parents and grandparents feared are now little more (ACE) inhibitor captopril. ACE is an en- than medical curiosities. Antihypertensives, cholesterol lowering agents and other cardio- zyme that cleaves an inactive precursor to vascular drugs are making considerable in-roads into the morbidity and mortality arising produce the protein angiotensin II. This con- from the epidemic of heart disease. In the area of osteoporosis, which often leaves sufferers trols blood pressure by action of the heart, disabled and debilitated, bisphosphonates are tackling the increasing problem of osteoporo- blood vessels and kidneys. In the 1950s, sis. Sergio Farreira, in Sao Paulo, found that the Brazilian pit viper’s venom contains pep- However, pharmacologists cannot rest on their laurels. There is a continuing need for new tides that inhibit an enzyme that degrades medicines. But, finding innovative, more effective and safer drugs is not easy. A recent edi- another protein called bradykinin. Eventual- torial in Nature noted that some 99.9 % of drugs either fail during development in the labo- ly, researchers recognised that ACE and the ratory or during clinical trials. This attrition rate means that the cost of bringing a drug to enzyme that degraded bradykinin were market is around US$ 800 million (Nature 2002). This wastage delays the launch of drugs identical. One of the venom’s peptides – that could potentially reduce the morbidity and mortality associated with cancers, heart dis- teprotide – lowered blood pressure when ease, osteoporosis and other common conditions. given to humans. Researchers from Squibb So for the last few years, pharmacologists advocated ”rational drug discovery” and ”ratio- identified teprotide’s active site and devel- nal drug design” as ways to reduce the attrition rate, lower development costs and advance oped specific inhibitors. Captopril was the

2 Editorial

first of the ACE inhibitors to reach the mar- 5,000 and 10,000. Drugs available in 1996 nightmare. But ultimately we are usually ket (Landau 1999 p 186–187). targeted just 483. In other words, there are at able to identify a target that we can produce least 10 times as many molecular targets in large quantities for high-throughput On the other hand, for scientists to recognise than the pharmaceutical sector currently ex- screening assays.” that an idea is ”rational”, it must link logi- ploits6 (Drews 2000). Screening all these us- cally to other aspects of the current knowl- For example, researchers developed iban- ing conventional drug discovery techniques edge base. If not, scientists tend to dismiss dronate using a rat model that induced hy- would prove impossible. or ignore the idea – however rational it percalcemia (raised calcium levels in the seems in retrospect. For instance, DNA was Fortunately, rational drug discovery through blood) using retinoids. This example of ra- first discovered as a constituent of the nu- molecular biology offers powerful means to tional drug discovery uses the rise in serum cleus of living cells by the Swiss biochemist develop, prioritise and test medicines aimed calcium levels as a marker for increased os- Frederick Miescher in 1869, but not until at these targets. For example, during rational teoclast activity. In this model, bisphospho- 1953 was its true nature as the unique sub- drug discovery, researchers systematically nates and other drugs targeting the osteo- stance of heredity identified. But the intel- screen compounds against the target. The clasts lead to lower calcium levels compared lectual framework was not in place for other screening test depends on the disease and to controls. Recently, the target of a drug biologists to appreciate its importance be- target. So researchers could use the strength like ibandronate has been identified and fore the pioneering work of James Watson, of the drugs’ binding to a particular receptor could be used to better understand the inter- Francis Crick and Maurice Wilkins was involved in blood pressure control for an an- action between the enzyme [fiarnesyl dis- awarded the Nobel Prize in 1962. This was tihypertensive, or an ability to inhibit osteo- phosphate (FPP) synthase] and its specific based on their model building of the con- clasts when screening for a drug for osteo- inhibitor. The enzyme activates essential in- stituent DNA base pairs and Rosalind porosis. However, all screens need to be tracellular signalling proteins (”intracellular Franklin’s X-ray diffraction patterns of the very sensitive – so that researchers do not hormones”) which regulate a variety of cell DNA double helix. Even today the proper- miss a potential drug – and also specific, to processes important for osteoclast function. ties of the genes remain elusive, despite our avoid false leads. When these signalling proteins are no knowledge of the complete sequence of the longer activated, the osteoclast triggers its Traditionally, screening was time consum- human genome, in terms of embryonic apoptosis (programmed cell death). ing, especially when using biological growth, organ development and the phased screening systems such as cells or even ani- switching on and off for gene sequences in mals. In some cases, researchers had no al- human development. Gene expression ternative but to test every possible drug on Mendel’s work lay unread for years, partly animals. However, recent technological ad- because his findings about inherited charac- vances, in particular, high throughput Rational drug design takes a different ap- teristics did not fit in the prevailing intellec- screening (HTS) and laboratory robotics proach. A gene encodes a protein. But this tual paradigms4 (Sacks 1997 p. 158). More- dramatically increase productivity. Auto- protein is rarely the final biologically active over the now well-accepted idea that viruses mated HTS can test some 10,000 possible form. Often the ”first generation” gene caused some cancers proved so controver- drugs against the target each day, without product undergoes considerable modifica- sial that one of the concept’s pioneers was using animals. Increasingly sophisticated tion in the cell’s cytoplasm. Enzymes in the virtually ostracised by some of his col- computer programs can prioritise the hits cell may, for example, cleave the active pro- leagues5 (Kevles 1997 p. 82–3). for further development. tein from the precursor – as ACE does to form angiotensin II. In other cases, the cell Such examples are relatively rare, however. ”At first, there is a disease and a ‘dream’, adds sugars to the protein backbone. More- Rational drug discovery and computer-aid- such as inhibiting osteoclasts to alleviate os- over the allostery between the amino acids ed design are emerging as valuable means to teoporosis,” says Professor Van der Auwera. in the protein means that the protein folds develop new medicines. The explosion in ”We then identify a potential molecular tar- into a complex three-dimensional shape, to the number of possible drug targets arising get, such as a receptor or enzyme, based on achieve its biological effect. from, in part, genomics, gave the move to- literature and pathophysiological research. wards rational drug discovery and design Even a single acid change can dramatically If the target can be isolated, we clone it us- extra impetus. alter the protein’s three-dimensional shape ing genetic engineering. This allows us to and function. That is one reason why muta- Around 1,000 disease genes might be rele- build a specific and sensitive screening as- tions and polymorphisms, which often sub- vant for therapeutic development by big say. But in many cases we don’t know the tly change the amino acid sequence, can so business. Not all these offer direct therapeu- target. So, we have to identify the gene’s dramatically influence the risk of develop- tic targets. However, many disease genes are function and, if applicable, the gene prod- ing a particular disease. linked to between 5 and 10 physiological or uct, the latter using so-called proteomic ap- pathological proteins that might offer alter- proaches. However, identifying what the So genetically encoded differences in the vi- native targets. Thus, the total number of product does in the body – a procedure tamin D receptor seem to influence patients’ possible drug targets might lie between called functional genomics – can be a real risk of developing osteoporosis7 (for exam-

3 Editorial

ple, Tofteng 2002). The mutation alters vita- For example, Professor Van der Auwera notes ciated with increased mortality and psy- min D’s ability to bind to its receptor. As vi- that up to half the patients using current oral chosocial morbidity and pose an enormous tamin D contributes to bone mineral density, bisphosphonates may stop taking the treat- human and financial burden. Notwithstand- the reduced binding ultimately weakens the ment within a year, which precludes any re- ing the seriousness of the problem, remark- skeleton. duction in the risk of sustaining a fracture. ably little attention has been paid to the bio- ”Treatment schedules such as a once a month logical basis of refractory epilepsy. Workers Researchers can grow crystals of these pro- tablet, instead of weekly (52 tablets) or daily in the field of epilepsy-those concerned with teins. By examining the way in which the (365 tablets) can make a huge difference to the basic science of resistance and the crystal scatters X-rays, biologists can gain an compliance”, he comments. ”Likewise for blood-brain barrier, and those with clinical insight into the protein’s structure. A comput- patients already taking lots of oral medica- experience of drug resistance in cancer are er can integrate these X-ray results with the tion, a quarterly intravenous injection can al- collaborating with a view to exploring par- protein sequence to show the shape of, for low them to benefit from a very effective allels between the fields and suggesting fur- example, a receptor or an enzyme. This al- medicine that they would not otherwise take.” ther potentially profitable avenues for ex- lows researchers to home in on the active site ploration on drug resistance in epilepsy. and design drugs that fit specifically into the Professor Van der Auwera adds that in addi- site-rather like a lock and key mechanism. tion to optimising anti-resorptive agents, an- Ageing other key objective for researchers is to find Nevertheless, validating targets can prove dif- Social and medical developments during the drugs that stimulate the formation of new ficult, especially when the lead comes from past century have led to a dramatic increase bone (anabolism). ”It is predictable that, at genomic rather than clinical studies. ”Tradi- in life expectancy. The study and under- least for patients with the most severe bone tionally, we associate the target and the dis- standing of the endocrine organismic loss, combination or sequential therapy with ease from clinical studies. So we knew from changes associated with ageing are there- an anabolic drug, probably for a short period clinical and pathophysiological studies that, fore matters of urgency. Basic scientific such as 6 months, and an anti-resorptive agent in comparison to osteoclasts (bone forming facets and clinical aspects relevant to age-re- will become the rule. So we need ‘smart’ cells), overactive osteoclasts contribute to lated changes in the multiple endocrine sys- treatment schedules allowing the patients to low bone mass,” Professor Van der Auwera tems have been discussed. The implications improve their quality of life without the con- comments. ”However, genomic studies link a of therapeutic reconstitution with hormones stant reminder of their disease.” gene to the disease. Discovering what the in the elderly, could be very important in the gene’s product does can be difficult. Knock- In many ways, drug discovery has always future. out animals, which are genetically engineered been rational. But biologist’s limited under- Mucus hypersecretion in respiratory disease not to express the gene, are fashionable and in standing of the body’s complexities hindered many cases allow us to better understand the attempts to develop targeted drugs. And tradi- A number of chronic respiratory diseases in- link with the disease. Nevertheless, we often tionally time-consuming screening slowed cluding chronic bronchitis, asthma, cystic have to go to phase II or even phase III clini- the development of much needed medicines. fibrosis and bronchiectasis are characterised cal studies to validate the target – which has Today, the genomics revolution has massive- by mucus hypersecretion and this excessive an enormous failure rate! Nevertheless, as we ly increased biologists’ understanding of the mucus production can lead to a pathological hone our understanding of the gene’s func- nature of common diseases and identified a state with increased risk of infection, hospi- tion, our failure rate is declining.” plethora of possible targets. Fortunately, ra- talisation and morbidity. Despite a high and tional drug design and development give re- increasing prevalence and cost to healthcare searchers the power to identify and develop services and society, this phenomenon has Drug discovery specific and selective drugs that target a sin- received little attention until recently, prob- gle cell type or even a single gene product. ably because of the difficulties inherent in Against this background, the next generation The possibilities for new medicines tackling studying its pathology. Basic scientists and of drugs for osteoporosis is likely, Professor some of the commonest diseases seem end- clinicians need to discuss recent advances Van der Auwera believes, to emerge from ra- less.8 and their implications for the development tional drug design and discovery. ”Molecular of novel, rational therapies, particularly as a biology and genomics identified many targets potential cure for CF is on the horizon. that either reduce resorption or increase bone Modern pharmacological Autism as a spectrum formation,” he says. ”However, ibandronate advances and the other anti-resorptive agents are now Twin and family data convincingly indicate just about as effective as they can be. Any ad- that the heritability for the underlying liabil- Epilepsy vances in anti-resorptive agents are likely to ity to autism exceeds 90 % and these studies be relatively minor, such as enhancing safety, Around 30 % of patients diagnosed with point to a multi-factorial causation involv- tolerability and convenience. The key objec- epilepsy fail to respond to prescribed ing an interaction among a relatively small tive today is finding a drug to stimulate an- antiepileptic drugs and continue to have number of susceptibility genes. New tech- abolism, the formation for new bone.” seizures. These refractory seizures are asso- niques are now available for examining the

4 Medical Ethics & Human Rights

neurobiology of autism and imaging studies Calcium ion flux in smooth muscle most important relationship between calci- have been used to explore the contributions um release and inhibition and/or promotion Ion channels play a crucial role in regulating of different brain regions. The most impor- of contraction, the control and modulation diverse cell functions in both electrically ex- tant practical question facing medical and of the SR in smooth muscle, the extent to citable and non-excitable cells, and have psychological practitioners is how to help which the SR may vary between smooth been found in organisms ranging from children with autism. Data on possible psy- muscles and therefore potential therapeutic viruses and bacteria to plants and mammals. chological or psychiatric interventions for implications. An increasing number of diseases (”chan- rehabilitation of children with autism need nellopathies”) are associated with dysfunc- to be thoroughly investigated in child pa- References tion of ion channels. Control of calcium ion tients in order to prove the link between 1. Editorial “Bigger isn’t always better“ Nature flux and compartmentalisation in terms of MMR injections, inflammatory bowel dis- 2002; 418: 353. theoretical biology would be illuminated by ease and autism. 2. Vane JR The fight against rheumatism: from ● the structure of channels and pores, willow bark to COX-1 sparing drugs. J Physiol Design of new drugs ● computer simulations of channel func- Pharmacol 2000; 51: 573–86. Biological modelling and oscillatory prop- tion, and 3. Landau R, Achilladelis B and Scriabine A eds erties represent fundamental approaches to ● detailed data on potassium channels, Pharmaceutical Innovation Chemical Heritage collating data on gene structure and func- chloride and calcium channels and lig- Press 1999. tion. Since cell signalling systems form a and-gated ion channels. 4. Sacks O Scotoma: Forgetting and neglect in sci- particularly complicated aspect of all cellu- Smooth muscle contraction is crucial to ence in Silvers RB (ed) Hidden histories of sci- lar function and are extremely important health as in, for example, blood vessels, the ence Granta 1997. both in the understanding of basic cellular uterus, airways and bladder and its malfunc- 5. Kevles DJ Pursing the unpopular in Silvers RB processes and in the practical problems of tion can lead to serious pathological condi- (ed) Hiddeen histories of science Granta 1997. selecting targets for drugs, much work has tions such as hypertension and pre-term 6. Drews J Drug discovery: A historical perspec- been devoted to integrating data on cell sig- labour. The calcium ion plays a central role tive Science 2000; 287: 1960–4. nalling into computer models. Building on in its function, increasing in concentration 7. Tofteng CL, Jensen JE, Abrahamsen B, et al. these approaches, computerised models of for contraction and decreasing for relax- Two polymorphisms in the vitamin D receptor intact cells and ultimately of whole organs ation. The source of calcium is through entry gene-association with bone mass and 5-year can be developed. Not only do computer across the surface membrane and release change in bone mass with or without hormone- models aid understanding of the basic na- from the sarcoplasmic reticulum (SR). How- replacement therapy in postmenopausal women: ture of biological systems, but they also ever, recent data have challenged the view the Danish Osteoporosis Prevention Study. J help in the design of new drugs for specific that the SR is simply a source and sink of Bone Miner Res 2002; 17: 1535–44. diseases. calcium ions. Indeed the SR probably also 8. Osteoporosis Care Club e-bulletin, Issue 4, pp acts to limit contraction, via ion channel- 8–12, October 2002, The intrinsic measurement of time in based feedback mechanisms. There is a Ivan M. Gillibrand biological systems The primary hallmark of biological clocks is their ability to entrain to environmental stim- uli and the dominant, and therefore physio- logically most important, entraining stimu- lus comes from environmental light cues. The classical view of the circadian system describes it as diverse physiological rhythms Medical Ethics & Human Rights regulated by a centralised clock structure. Data coming from both vertebrate and inver- tebrate systems have challenged this view, Medicine, the Law and Medical Ethics in a demonstrating that the circadian timing system is dispersed throughout the animal and Changing Society that possibly every cell contains a functional circadian clock. The mechanism of light signalling to the vertebrate clock, the connec- Paula Kokkonen, LL.M., Director Gener- First of all I wish to express my great plea- tions between central and peripheral clocks, al, National Authority for Medico-legal sure for this opportunity to address such an the genetics of the clock and clock proteins Affairs, Finland influential audience as represented by this remain to be evaluated at the molecular lev- WMA General Assembly. You represent a el, for example pairs of enzymes working in Address given at the Ceremonial Session of profession which in well organised coun- harmony across membrane. the World Medical Association, Helsinki 2003 tries issues both birth and death certificates,

5 Medical Ethics & Human Rights

thus controlling human life not only when bears the major part, if not all of the costs of a given society and time. Ethical rules are of- people are patients, but also at the beginning health care. In Democracies, the modern ten compromises that lie on sound ethical of life and at its end. This fact leads to dis- way to organise relationships between indi- grounds but to which reservations can be cussion of power, responsibility, liability, viduals and between citizens and society is made, and from which it is possible to deviate ethics, trust and control. to use legislation as well as agreements. under special circumstances. The medical profession has for a long time Earlier, Medical Law was very much in- Ethical discussions in medicine focused first been in the forefront of discussions on Med- volved in questions like setting limits for (with the Hippocratic Oath) on the character- ical Ethics. You all know very well the his- "the profession" (i. e. medical doctors), istics of the doctor, and the point of departure tory of the WMA, established in Paris in drafting legislation concerning patients with was that a good doctors performs good deeds. 1947 due to the acts that had been revealed contagious diseases, involuntary care of the Wider ethical discussion in medicine dates during the Nuremberg trials. mentally ill etc. Then came the discussion of back to the Nuremberg trials and the event in medical negligence, and slowly after that, of Hiroshima. It was realised that ethical discus- Although I usually present myself as a patients' rights. Patients were not any more sion in medicine and in medical research can- lawyer who has sacrificed her life for medi- considered as material, but they were indi- not be limited to the medical profession, but cine, I have tried to bridge the two disci- viduals who had a say in their own treat- that society at large has the right to a dia- plines - Law and Medicine - both at home ment. By this time the scientific develop- logue. and also "globally". Thus I thought that it ments in medicine had been enormous. Pa- may be worth while drawing your attention Human dignity, autonomy and the right to tients could in many cases be offered the to the existence of the World Association for self-determination have been the focus of the choice of their own preferred treatment from Medical Law. The purposes of this associa- discussion since the Nuremberg trials. The amongst a few alternatives. This again in- tion are above mentioned values have also been docu- creased the demand for more information in mented in many human rights texts such as – to encourage the study and discussion of order to allow patients to really make an in- the Universal Declaration of Human Rights problems concerning Medical Law and formed choice. (1948), International Covenants on Econom- their possible solutions, in ways that are The result of this, we can recognise in pa- ic, Social and Cultural Rights and on Civil beneficial to humanity, tient insurance schemes and legislation, and Rights (1966) and the European Convention – to promote the study and discussion of also legislation on patients' rights. The Pa- on Human Rights (1959), as well as the Con- new developments in medicine and re- tients' Rights movement can be seen as an vention on Bioethics of the Council of Eu- lated sciences, reflection of the modern discussions rope, which is the latest of them and entered – to address any matters that involve is- strengthening human rights and consumer into force on December 1st 1999. sues of Health Law. rights. The values expressed in the Human Rights The Association was founded in Gent, Bel- documents mentioned above are appropriate gium in 1967, that is twenty years later than for legislation as well. In fact they are includ- the WMA. This is a very concrete sign that From Ethics to Law and Law ed in many Constitutions - not to mention oth- the Law usually follows behind the ethics. I er legislation. hope that the gap will be less than twenty to Ethics years today. In "western societies", a Law passed in Par- Why doesn't the system work in a satisfacto- liament reflects the stage of common agree- ry way although there are so many rules? One At the time when the Association was ment. Legislation thus consists of the ethical of the reasons is probably the fact that the founded, "Medical Law" was the term used. minimum. good principles cannot easily be found from The question as to whether we should use the sources mentioned earlier. Or if they are the term "Health Law" instead has recently The values documented and instructions found they need interpretation, which is not been raised. This discussion reflects very commonly and voluntarily accepted by the very easy even for lawyers, not to speak of well the developments in the health-care members of a given association or profession lay-people. field. Modern health-care is a very complex are called ethical rules. The most well-known teamwork of many actors and disciplines. of them is, as this audience knows, the Hip- This is also reflected in the legislation. pocratic Oath, which focussed on the relations between doctors and doctors vis-a-vis Medical Ethics or health-care The development of science has created a their patients. ethics draws a great deal of world where we live much longer than did our ancestors. Many of us who live in the so- Ethical rules drafted lately by the WMA have, attention called developed countries have a curricu- to my mind, approached legislation. They aim lum of diseases each of which would have at giving concrete directives in anticipation of Most of the topics discussed in the sphere of killed our ancestors. There are many actors foreseeable conflicts. Like legislation, ethical medical ethics have been discussed during interfering in the doctor-patient relation- rules are based on facts and values. Values are decades. To these topics belong the begin- ship. One of them is society, which often culturally bound and thus stand in relation to ning of life as well as the end of it. We have

6 Medical Ethics & Human Rights

been able to witness how insemination has cy to try to medicalise social problems and It also establishes a Patient Ombudsman in- been developed into assisted reproduction ask doctors to testify more and more in mat- stitution. and surrogate motherhood. Mercy killing is ters that are not medical, or to ask them to not any more offered as a topic for scientific isolate people for reasons other than med- meetings, but euthanasia and terminal care, ical. In our society we are to discuss for Right to care as well as assisted suicide are. Dialysis has whom we are designing health-care services, been changed into transplantation, which has and what are the values of the population. Every person who stays in Finland perma- brought about a new type of scarcity discus- nently is entitled, without discrimination, to Pressure, routine generally accepted behav- sion. This Discussion has escaped the cabi- the health and medical care required by iour, and the atmosphere, may be used as an nets where doctors used to take difficult de- his/her state of health, within the limits of excuse to deviate even from the ethical prin- cisions as to who was to get dialysis and live, resources available to health care at the time ciples accepted by ourselves. The most com- and who was not. International declarations, in question. mon excuse is, of course, that the patient as well as many Constitutions secure the does not really understand his/her own best This provision has drawn much attention right to health care. What does this mean in interest. But this way of thinking brings us to now that the discussion concerning the divi- the era of priorities? a weak soil, both ethically and legally. sion of scarce resources has once again sur- faced. It was originally designed with the The Transplantation debate has reached the In health-care we need both legislation and notion in mind that society has the right to level where many countries have already for- ethical rules. The aim of both is to promote limit how much and what kind of care it pro- bidden the selling of human organs. Interna- co-operation and minimise conflicts. As time vides for its citizens. (There had at that time tional Declarations and Conventions also passes our values may change, and the leg- been cases of Finnish citizens demanding condemn buying and selling of organs. Yet islative process is often rather slow. In the that they be sent abroad at society's expense there are actors who advocate in favour of meantime ethics may guide us and cast a for treatment which was not available in commercial activities in this field, arguing light for the developing legislation. An ex- Finland.) that a poor person should not be denied the ample of ethical discussion leading to legis- right to improve his/her standard of living by lation is The Finnish Law on the Status The care has to be of good quality, the pa- selling organs to those in need. The argu- and Rights of a Patient. tients' dignity must not be violated and mentation is that this would just be using fi- her/his individual needs and culture have to nancial incentives and commercial consider- be taken into account as far as possible. ations to save lives. Finnish Law These provisions sound perhaps like mere declarations, but they are still important. Human cloning can be used for the develop- Following a long-almost twenty years de- They can be especially important in cases ment of tissue for transplantation, but bate, the Law on the Status and Rights of a where psychiatric care is required, since "cloning" can also refer to a wide range of Patient was finally passed in the Finnish Par- mental patients and their relatives are, at activities, from bringing into existence ge- liament in 1992 and it entered into force on least according to our Finnish experience, netically identical individuals to pre-implan- 1st March 1993, ten years ago. very often not capable of defending their tation diagnostics. Distinctions between var- own rights. ious techniques need to be drawn, and their In all legislative work, the history and cul- acceptability has to be discussed thoroughly. tural tradition of a country, as well as previously existing legislation and administrative When discussing ethics and legislation, it is Patient's right to be informed systems and structures, have to be taken into useful to keep in mind that theoretical dis- consideration. Legislation may be described cussion may widen our perspectives and give as a safety net. If you are going to mend the The right to information is closely connect- new ideas. It may thus enrich our thinking net, you have to know where the holes are. ed to the right of self-determination, be- and decision making, and will help us to Thus I do not offer our law as a global solu- cause the latter cannot be exercised without recognise at least our own motives. tion applicable to all societies and problems the former. Lay-people very often think that legislation a patient may ever experience in the field of How much information and in which form it is an open process of fundamental thinking health-care. is given to patients, seems to vary between and great elegance, as the ideal would de- Our law regulates, inter alia, the patients' countries. The right to information has dur- mand. The common truth is very different. right to good health care, to medical care ing the last quarter of the century, been in- Open, profound discussion is often either ab- and related treatment when needed; the right creasingly emphasised in Finland. Yet, judg- sent or takes place in very small circles. of access to treatment, to be informed and of ing from the patients' complaints the situa- Health-care is an area of great common in- self-determination; the status of minor pa- tion is far from satisfactory. The law speci- terest. There has been, still is, and may be tients; emergency treatment; powers of the fies that various alternative methods of treat- even a growing tendency to try to increase representatives of the patient in certain situ- ment and their effects have to be explained the sphere of health-care. There is a tenden- ations, and a new complaint procedure. to the patient. It is noteworthy that the law

7 Medical Ethics & Human Rights

also gives the patient the right not to know, Complaints strengthen a few of those rights of patients and the "therapeutic exception" – the with- which in everyday clinical practice, seem to holding of information from the patient in have caused insecurity, and have resulted in A patient who is not satisfied with the health certain cases. The information to be given varying interpretations and complaints to care or medical care and related treatment should be tailored to the individual patient supervising authorities. We have tried to received by her/him, has the right to make a and interpreters should be used if needed. keep in mind that the rights of the health- complaint on the matter to the director re- care personnel and the patients ought not to sponsible for the health care unit in ques- conflict but should be seen as complemen- tion. A decision on the complaint must be Patients' right to self-determi- tary. given within a reasonable time after the nation making of a complaint. It is obvious that we need both Ethical Rules With the provision of health care, a mutual Making a complaint does not restrict the and Law. Nowadays they seem to be in in- understanding between patient and care- right of a patient to appeal to the authorities teraction. Health care professionals are very giver must exist. If the patient refuses a cer- controlling health care or related treatment conscious about the situation. Professional tain treatment or measure s/he has to be received by her/him. organisations, both domestic and interna- treated according to the possibilities provid- tional, draft Ethical Rules with the aim of If, once the complaint has been dealt with it ed by another medically acceptable way, in improving quality control of the work of becomes obvious that the care or treatment mutual understanding. There had been cas- their members. Yet society also drafts legis- of the patient my cause liability for patient es in which, for example, a terminal cancer lation, as it wants to control the professions injury, indemnification liability, taking legal patient had refused radiation because of and the work of professionals, and to guide action, cancelling or restricting the right of side effects. This led to a discussion in them. vocational practice of health care staff, or which the patient was threatened with de- taking disciplinary proceedings, the patient The training and curricula of health care portation. shall be advised as to how the matter can be professions are under reflection. I want to There are also provisions in the law accord- initiated through a competent authority or inform you that there is a world-wide pro- ing to which a legal representative etc. can organ. ject under the UNESCO Chair of Medical interpret the patient's will. It is, however, to Ethics, Professor Amnon Carmi, to draft a When investigating a complaint, special at- be emphasised that it is the patient's will universal curriculum for teaching medical tention is paid to patient safety, the equality which is decisive and not the representa- ethics. The project involves more than 50 of citizens, and good service to consumers tives. If the patient's will cannot be assessed, universities in different parts of the world of health services. that patient has to be given the treatment that and 124 professors. The aim is to collect can be considered to be in accordance with some 20-30 booklets dealing with living his/her personal interests. Patient Ombudsman cases, offering from two to three ethical solutions. The approach is multicultural and aims at showing that ethics cannot be taught A Patient Ombudsman, who may also be Emergency treatment by just giving information. Students have to common for two or more units, has to be ap- be involved in discussions and trained in de- pointed for health care units. The tasks are to A patient has to be given treatment necessary cision making. advise patients on issues concerning the ap- to ward off a hazard imperilling her/his life plication of the Law on Patients' rights, to New challenges are ethics, behavioural sci- or health even if it is not possible to assess help patients in complaints and liability ences, genetics and information technology. the patient's will because of unconsciousness questions, to inform patients of their rights, The two latter disciplines offer powerful or other reason. However, if the patient has and to act also for the promotion and imple- tools to be used in health care for the bene- previously steadfastly and competently ex- mentation of patients' rights. fit of humanity, but they also carry risks if pressed her/his will concerning the treatment they are used irresponsibly. A more compre- given to her/him, s/he must not be given There are hundreds of Patient Ombudsmen hensive approach than today's strictly bio- treatment that is against her/his will. in Finland. The National Authority of medical one towards patients is a "must" for Medico-legal affairs has organised sym- The latter part of this section is aimed at health care professionals in the future, if posia for them at the State level, and the guaranteeing the patient's right to self-de- they want to be trustworthy. It is clear from Provincial Boards at the provincial level. termination. For instance, the patient's statements made in public speeches that right to draft a valid „living will“ is based ethics is widely being introduced into the on this provision, as is the right of an adult curricula. In addition to the ethical and the Jehovah's Witness to refuse a blood trans- Ethics and Law biological, other aspects of human life are fusion even after losing consciousness – also being discussed. This will no doubt both are topics constantly debated in The Law on Patients' Rights is our attempt bring "added value" to the well being of the health care. in Finnish society to try to clarify and to people.

8 Medical Ethics & Human Rights

The only agreement that could be reached Helsinki and the Declaration of Helsinki in Pretoria was that the Declaration of Helsinki had to remain the most important P. G. DE ROY guideline in the field of research. The few countries which could hardly accept the Member of the Belgian National Council of the Order of Physicians paragraphs 29 and 30 would just have to come to terms with it. However these "few" countries were clearly the richer The 55th General Assembly of the WMA1 paragraph 29, institutions, including uni- countries who persisted in protesting and took place in Helsinki on September 2003, versities, have taken the risk of a negative asking for revision. A revision of the dec- a long-waited meeting which it was hoped response from their Institutional Review laration hardly a few months after its adop- would have allowed the controversies that Board4, from the NIH5 and obviously tion was politically not feasible, as it would arose from the latest version of the Decla- from the FDA. Therefore several scientific have undoubtedly led to the view that the ration of Helsinki to settle. A final agree- projects involving human subjects have WMA had bowed to the financial interests ment in the town where the Declaration been interrupted and others not even start- of the rich countries. had been established for the first time in ed. In the circumstances the protests are 1964 would give a symbolical value to the understandable. To get out of the deadlock, the Council of event. This paper sets out a personal view the WMA has simply attributed this impor- of the twists and turns of the ethical dis- The opponents of paragraph 30 empha- tant difference of opinion to difficulties in cussion concerning the most recent ver- sised the very poor functioning of the interpretation of the controversial para- sion. healthcare systems in poorly resourced na- graphs, which could be easily resolved by tions where most experimentation involv- adding notes of clarification and through The 6th edition of the Declaration of ing human beings is carried out. This para- amendments if necessary. The United Helsinki2 was adopted in Edinburgh on Oc- graph would oblige the pharmaceutical States agreed with the proposal that the de- tober 7, 2000. During the debates, several companies to provide the participants with claration would not be rewritten, but para- delegates had asked that the adoption of the best-proven treatment identified at the graphs 29 and 30 would be examined this new version be postponed. They were end of the study. From the drug industry's closely. The situation was defused! expecting many criticism from researchers point of view this cannot be afforded. and sponsors, but their warnings were soon A working group would examine whether swept away, it being said that the credibili- The academic authorities and spokesper- paragraph 29 was really an obstacle to reli- ty of the WMA would be compromised if sons of the pharmaceutical industry insist- able scientific research and also consider the revision (already announced for a long ed very firmly that the Declaration of the financial implications of paragraph 30. time) would be delayed after so many Helsinki should be amended. They would It was felt advisable to involve in the dis- years of preparatory work. otherwise seriously be thinking of not re- cussions external representatives respected ferring anymore to the strong mandatory for their moral authority and expertise. Nevertheless those who had argued for a character of the Declaration of Helsinki. Thus the CIOMS7 took part in the debates time of further reflection had been right: Such a boycott would mean a loss of pres- despite engaging in rewriting its own "eth- suddenly some members of the WMA tige for the WMA whose Declaration of ical guidelines for biomedical research"8. raised serious objections to the previous Helsinki is its pride. Basically nobody in- unanimously adopted version. The United The working group decided to add a note of tended to undermine the moral leadership States especially had rebukes from their clarification to paragraph 29 rather than of the WMA regarding research, and cer- rearguard – read the FDA3. The sources of rewrite it. The note of clarification was tainly not the developing countries. irritation were paragraphs 29 and 30, re- adopted by the 160th the Council of the spectively concerning the use of placebo, WMA, October 7, 2001, and is now an inte- In order to avert an imminent crisis the and the participants' right of access to the gral part of the Declaration of Helsinki. WMA organised a conference in Pretoria best-proven treatment identified by the on March 2001, in collaboration with the study. The unchanged paragraph 29 and its added EFGCP6 and the University of Pretoria note of clarification read as follows: The opponents of paragraph 29 considered School of Health Systems and Public that studies controlled by placebo were es- Health, which had the appearance of an sential for a reliable statistical assessment emergency sitting. Representatives of the of the results of the trial. This is moreover pharmaceutical industry, of the FDA and of "Paragraph 29: the reason why the FDA recommends sys- the NIH were numerous. In contrast the at- tematic control, because the methodology tendance of developing countries was on of the scientific study is otherwise worth- the other hand very sparse, possibly be- The benefits, risks, burdens and effective- less, and if worthless, the research projects cause they were financially too weak to be ness of a new method should be tested do not receive subsidies. By following represented. against those of the best current prophylac-

9 Medical Ethics & Human Rights

tic, diagnostic and therapeutic methods. Paragraph 19: is not able to decide which is the best treat- This doesn't exclude the use of placebo, or ment at the end of the research, the results of no treatment, in studies where no proven „Medical research is only justified if there is which must be compared with others before prophylactic, diagnostic or therapeutic a reasonable likelihood that the populations knowing which treatment is best; it can take method exists." in which the research is carried out stand to decades before a medicine becomes avail- benefit from the results of the research.“ able on the market. "Note of clarification on paragraph 29 of the WMA Declaration of Helsinki Both paragraphs deal with the sensitive sub- Those who have ever heard the plea of rep- ject of experimentation on human beings in resentatives of developing countries recall The WMA hereby reaffirms its position that developing countries. Without these para- how distressing their message is. With dig- extreme care must be taken in making use of graphs, the protection of participants is vir- nity, they make a distinction between their a placebo-controlled trial and that in gener- tually non-existent. frustrations and the harm done to them with- al this methodology should only be used in out anger, but resigned to the misfortune of the absence of existing proven therapy. The supporters of an unchanged paragraph having to cope with a poor health care sys- However, a placebo-controlled trial may be 30 recalled that the Declaration of Helsinki tem and a cruel lack of technology, pharma- ethically acceptable, even if proved therapy adopted in 1964 was directly inspired by the ceuticals and basic welfare. For many this is available, under the following circum- Nuremberg Code. This Code refers to the means utmost poverty and reliance on char- stances: mandatory safeguard of participants' rights, ity to survive. They don't have Social Secu- especially for the most vulnerable. Other in- – Where for compelling and scientifically rity (= the Heath Service) based on solidari- ternational authorities such as the CIOMS sound methodological reasons its use is ty as in the wealthier countries and fre- and the EGE9-10 also favoured the protection necessary to determine the efficacy or quently mentioned in the WMA. of population groups involved in clinical re- safety of a prophylactic, diagnostic or search. Virtually everyone is convinced that these therapeutic method; or well founded concerns are justified and that – Where a prophylactic, diagnostic or The dispute about paragraph 30 showed a many things need to be done for developing therapeutic method is being investigated gap between North and South, between countries, but by whom it is to be done ap- for a minor condition and the patients wealthy nations and poor nations. The re- pears much less clear. For the rich countries, who receive placebo will not be subject source-poor nations consider that they have this large-scale problem can't be solved by to any additional risk of serious or irre- a right to the best-proven treatment identi- the Declaration of Helsinki but by the local versible harm. fied by the study. In practice however, the authorities. But the response is that this is experimental treatments usual cease at the another debate (in which the term "corrup- All other provisions of the Declaration of end of the study. The group in question for tion" often appears), and in which the eco- Helsinki must be adhered to, especially the whom the only available treatment is that in nomically weak are reduced to silence. It need for appropriate ethical and scientific the investigation, is then left on its own, with rests with the poorer countries to interpret review." no-one concerned about them.11 The devel- paragraph 30 correctly. Its aim is not to make oping countries invoke paragraph 30 specif- Commentators judged that rather than throw drugs available to the population of the Third ically to prevent conduct which, in their light on the paragraph, this note of clarifica- World but to protect that population from view, is unethical. Paragraph 30 is their last tion by reintroducing the use of placebo, possible exploitation in clinical trials. defence. certainly on well-defined conditions, made In this period of growing commercialisation it meaningless. Some claim that this would The resource-rich countries say that these and globalisation, the poorer countries won- finally be of benefit to scientific research; people would not anyway have access to der anxiously, what will be left of paragraph while others considered that the ethical im- some treatments. The pharmaceutical com- 30, their only glimmer of hope, after its clas- plications for poor countries didn't get panies are not inclined in these conditions to sification by the wealthy countries. enough attention. engage in heavy financial commitments. Companies are not humanitarian aid organi- The General Assembly promised to contin- sations, but are, fully prepared to sustain re- ue working on the problem meanwhile leav- Paragraph 30: search knowing that they will profit from ing the paragraph unchanged – hopefully for some of it allthough they don't intent to set not too long, think those countries which re- up and pay the cost of effective healthcare member well where they buried the hatchet "At the conclusion of the study, every pa- systems for under-resourced countries. The in May 2001. Certainly the debate will con- tient entered into the study should be as- companies are not satisfied with paragraphs tinue … sured of access to the best proven prophy- 19 and 30, taking a less absolute approach to lactic, diagnostic and therapeutic methods the right of participants to the best treatment No-one questions the Declaration of identified by the study." and its cost. An ethical declaration is not a Helsinki as being an authoritative reference This paragraph needs to be read with para- law and it is ultimately only mandatory to do document. Its implications are ethically graph 19. one's best to observe it. Often the researcher binding on everyone involved in scientific

10 Medical Ethics & Human Rights

clinical research, including both the inves- The Member States of the European Union 2002; ISBN 92-9036-075-5. Text available tigator as sponsor on the study, and the have to transpose the directive into their na- online members of ethic committees. It is there- tional legislation for May 1, 2004. Although 9. European Group on Ethics in Science and New fore satisfying that the Declaration of the directive refers to the version of the De- Technologies; Helsinki is often referred to in both Euro- claration of Helsinki of 1996, we hope that http://europa.eu.int/comm/european_group_eth pean and national law. In March 2001 in national legislators will take into account ics Pretoria, the draft European directive the last stance of the WMA thus avoiding 10. Advice of February 17, 2003: Ethical aspects of 2001/20/EC on "the approximation of the (by way of parody!) that someone consults clinical research in developing countries; text laws, regulations and administrative provi- an invalidated version of the Highway Code available online sions of the Members States relating to the to determine his way of driving! The time 11. To be perfectly honest, a few remarkable excep- implementation of good clinical practice in has come both for WMA and for the phar- tions must be noticed the conduct of clinical trials on medicinal maceutical industry to decide on driving ei- 12. Official Journal of the European Communities L products for human use" was presented. ther on the left or on the right, in other 121/34 1.5.2001 The Assembly was very keen that the direc- words, to choose in favour of the rich or the tive should refer to the Declaration of poor. Helsinki which would give it the force of References: law, at least in the Members States of the 1. World Medical Association European Union. 2. http://www.wma.net/e/policy/17_e.html Editorial note: The Directive was published on May 1, 3. Food and Drug Administration 200112, and refers to the Declaration of 4. Similar to the committees of ethics in Belgium Following the September 2003 Council Helsinki in its preamble. But one is amazed 5. National Institutes of Health meeting in Helsinki (see WMJ 49 (5/6), 71), to discover that it refers to the obsolete ver- 6. European Forum on Good Clinical Practice the working group on the Helsinki Declara- sion of 1996 and not to that of 2000. Thus 7. Council of International Organisations of Med- tion has continued its work and following the last revised version with its hindering ical Sciences, www.cioms.ch the many comments, discussions and con- prescriptions regarding to drug industry is 8. CIOMS Revised ethical guidelines for biomed- sultations, and will present a report to the considerably weakened. ical research involving human subjects. August WMA Council meeting in May 2004.

Linking moral progress to medical progress: Summary

New opportunities for the Declaration ● Progress in science and medicine is essential for human advancement. 1 of Helsinki ● Ethical values are essential in direct- ing the application of scientific and Solomon R Benatar MBChB, FRCP, Professor of Medicine, University of Cape Town medical advances. ● Moral progress requires that the benefits of progress be shared more widely and more equitably throughout the world. Introduction progress has matched scientific progress. ● Scientific and medical progress Given the limited value of progress for hu- should be inextricably linked to moral The Declaration of Helsinki has played a mankind as a whole if its benefits are not progress. seminal role in promoting protection of re- widely shared, it is essential that scientific search subjects from abuse and exploitation. progress be coupled to moral progress in re- cus on the future of the Declaration of However, as medical advances have benefit- search and in access to health care. We have Helsinki at the 2003 World Medical Associ- ed only a small proportion of the world's previously argued that moral progress will ation (WMA) General Assembly scientific population it cannot be claimed that moral require more than new or refashioned decla- meeting provides an opportunity to consider rations, as it is people with the will and the the potential for making moral progress 1 Based on a presentation at the WMA General capacity to implement the content of decla- through visionary modifications to this Dec- Assembly in Helsinki in September 2003 rations that are the key factor. The recent fo- laration.

11 Medical Ethics & Human Rights

Discussion Suggested Changes to the Box 3. Newer ethical values Declaration of Helsinki Moral progress in research on human sub- in research ethics jects since the infamous Nazi human exper- ● Justice An appropriate preamble to the declaration iments, is evident in many activities. These ● Fair access to participation in re- could sensitise research workers to imbalance include the development of many codes, search studies in the research agenda. guidelines and procedures for research ● Fairness in distribution of harms/ben- "Spectacular developments in science, tech- ethics that aim to protect research subjects efits - long term as well as short-term nology and medical practice have transformed from harm and exploitation, and the increas- ● Non-Exploitation of the vulnerable health care and improved the lives of many. ing attention being paid by scientists and ● Coupling the research endeavour to Despite such progress millions of people live others to the requirements for ethical re- improvements in health care through in degrading poverty with little access to search. Expansion of international collabo- partnerships and improves overall health care and are denied even basic medical rative research has prompted generous fund- standards of care in research treatments. Because improving the potential ing from the US National Institutes of ● Relevance of research to local needs for good health for a greater proportion of the Health's Fogarty International Centre for - the importance of context world's population is one of the most pressing promotion of capacity building in research ● Narrowing the 10 : 90 gap by re- moral problems of our time, research should ethics in developing countries.1 shaping the research agenda increasingly be directed towards diseases that ● Cultural and linguistic sensitivity However, there is a wide gap between scien- afflict poor and marginalised people. Those in obtaining informed consent tific/medical progress and moral progress in undertaking research in developing countries ● Solidarity and interdependence - medical research and practice. This is stark- should also have some understanding of and acknowledging and facing global ly evident from widening disparities in be sensitive to the social, economic and politi- threats health, longevity and health care and in the cal milieu that frames the context in which ● Addressing deteriorating global expenditure on medical research. Indeed such research is undertaken. Lessons learned health questions must be raised about the moral from research should be made more equitably ● Focusing on re-emerging and new credibility of a medical research endeavour available world wide and used to improve re- infectious diseases in which 90 % of US$ 73 billion is spent on lationships between host and sponsoring ● Global health information equity diseases that cause 10 % global burden of countries, as part of the endeavour to improve disease (10 : 90 gap),ii and only 16 of the health globally." 1393 new drugs marketed from 1975-1999 In evaluating the research enterprise and The declaration states that medical research were for tropical diseases or tuberculosis.iii possible future changes to the Declaration of involving human subjects must conform to Dealing with such moral challenges requires Helsinki from a moral perspective, a critical generally accepted scientific principles, and that in addition to preserving and enhancing question that could be asked is what the pri- be based on a thorough knowledge of the commitment to long-standing values in re- orities of the World Medical Association scientific literature. An accompanying state- search ethics (Box 2), several new values be (WMA) and its Declaration should be. That ment should indicate that all such research built into the research endeavour (Box 3). is, whose agenda should the WMA be ad- should conform to accepted ethical princi- dressing through the Declaration? Choices ples, be based on a thorough knowledge of Box 2. Long-standing include the pharmaceutical industry; med- the research ethics literature, and that med- ethical values in research ical associations in North America and Eu- ical research involving human subjects ethics rope; the US Federal Drug Administration; should be conducted by scientifically quali- researchers in privileged countries; the fied persons with knowledge of research health of those who already have the ethics. ● Do not harm prospect of long lives; the health of those dy- ● Minimisation of risk It should also be explicitly stated that exploita- ing prematurely from preventable diseases, ● Protection of the vulnerable tion of subjects, or their use as means to the or the health of all people at a global level. ● Respect for dignity of patients/sub- ends of others, must be avoided by ensuring jects Given the widening disparities in health that the research is of relevance to the individ- ● Informed consent globally,iv and the presumption that the uals participating in the research as well as to ● Protection of confidentiality health of all people globally is the concern of their communities. The balance of benefits and ● Freedom to withdraw the WMA, it is suggested that incorporation burdens of research should be fairly distrib- ● Justice of new ethical values in research (Box 3) into uted with due consideration of the benefits that ● Compensation for injury the Declaration of Helsinki could enhance could accrue to sponsors in the long term, and ● Appropriate remuneration for the "moral capital" of the Declaration. This to ensuring that studies are not done with the participation in turn may lead to reduction in disparities in intention of spending as little as possible on health and medical research. care of research subjects and the communities

12 WMA

in which they live, when large profits may re- References viii Fitzgerald D, Pape J W, Wasserheit J N, Counts G sult from the research. W, Corey L. Provision of treatment in HIV-1 vac- i Singer P A, Benatar S R. Beyond Helsinki: a vision cine trials in developing countries. Lancet 2003; Care should be taken that research does not in- for global health ethics. Brit. Med. J. 2001; 322: 362: 993-4 appropriately deflect local human or material 747-8 ix Tucker T, Slack C. Not if but how? Caring for HIV- resources away from the health care system in ii Commission on Health Research for Development. 1 vaccine trial participants in South Africa. Lancet the host country towards research projects, Health Research: Essential link to equity in devel- 2003; 362: 995. thus more deeply entrenching existing dispari- opment. OUP. Oxford. 1990. x Benatar S R. The coming catastrophe in interna- ties. Priors evaluation by a local committee or iii Trouiller P, Olliaro P, Torreele E, Orbinski J, Laing tional health: an analogy with lung cancer. Interna- governing body should include consideration R, Ford N. Drug development for neglected dis- tional Journ 2001; LV1 (4)611-631 of whether study findings can, and will be in- eases: a deficient market and a public health fail- corporated into the local health care system. ure. Lancet. 2002; 359: 2188-94 4 Informed consent should be obtained in the iv Benatar S R. Some reflections and recommenda- Address for correspondence language spoken by the research subject and tions on research ethics in developing countries. Bioethics Centre, with insight into, and respect for the subject's Social Science & Medicine. 2002; 54 : 1131-41 Department of Medicine culture. &1147-48 University of Cape Town v Benatar S R, Singer P A. A new look at interna- J Floor, Old Main Building At the conclusion of the study, every patient tional research ethics. Brit Med J 2000; 321: 824- Groote Schuur Hospital should receive interventions identified as ben- 26 Observatory eficial by the study, or access to other appro- vi Lo B, Bayer R. Establishing ethical trials for treat- 7925 Cape priate care. This is particularly important for ment and prevention of AIDS in developing coun- South Africa patients with serious conditions for whom ces- tries. Brit Med J 2003; 327: 337-9 Tel +27 +21 406 6115 sation of the study intervention could have se- vii Berkley S. Thorny issues in the ethics ofAIDS vac- Fax +27 +21 448 6815 vere consequences. Research in developing cine trials. Lancet 2003; 362: 992. Email [email protected] countries should be linked to a broader notion of standard of care, to capacity building in health care, and to economic and educational empowerment that could benefit delivery of health care specifically, and progress general- World Medical Association ly, in the host country. Some of these issues are being addressed in an expanding discourse on research ethics and much remains to be ”Getting it Right for our Children” done.v vi vii viii ix Presidential Address of Dr. James Apple- The Hippocratic tradition recognises our re- yard to the General Assembly of the World sponsibility to respect the individual Medical Association, Helsinki, September ”rights” of those who entrust themselves to Conclusions 2004 our care. This respect for our patients, nur- tured by our profession in the patient/physi- ”The level of civilisation attained by any so- Disparities in global health pose the greatest cian relationship, is fundamental for the sur- ciety will be determined by the attention it potential security risk to the lives of all people vival and development of communities and has paid to the welfare of its children.” Pro- in the world.x We are challenged to recognise nations. fessor Billy Andrews (1964) this risk and to take appropriate action. To The standards we set in our WMA Declara- paraphrase Virchow "health is political and The continuing challenge facing the World tions are important safeguards for our pa- population health is politics writ large". Re- Medical Association is to maintain and pro- tients. The Declarations of Geneva(1), search is also political and it does not take mote the professional values that underpin Helsinki (2) and Tokyo (3) in particular re- place in a vacuum. medical practice world-wide. At the 90th established ourselves as a trustworthy ethi- birthday celebrations of our hosts the Scientific progress must be coupled to moral cal profession after the horrors of World Finnish Medical Association entitled ”pro progress, and in particular in relation to social War 2. More recently we have established humanitate”, the Emeritus Archbishop of justice. The Helsinki Declaration has the po- essential standards for the care of children Helsinki encouraged physicians to reaffirm tential to stimulate moral progress in research. world-wide in the Declaration of Ottawa on our shared values so that they became ”in- Such progress, if made, will be reflected in re- the ”Right of a Child to healthcare”(4) ternalised” as our professional conscience. ductions in health inequity, and in improve- Our conscience should become our compass Children are a country’s most valuable re- ments in population health. in the everyday practice of medicine and for source. Poverty and the denial of children’s Acknowledgement. I thank Peter Singer for construc- our role as leaders and teachers in the field rights have devastating effects on our chil- tive comments. of healthcare. drens’ survival. The World Health Organisa-

13 WMA

tion’s Commission on Macro-economics tion, less children will die and less Table 3 – Selected countries – under 5-year and Health has recognised that substantially children will be conceived. Mortality ranking and GNI improved health outcomes are a pre-requi- UNICEF publish international com- site if developing countries are to break out Country Value Rank Gross National parative tables of the under five mor- of the cycle of poverty.(5) Healthy children Income per capita tality rate per 1,000 births.(7) This is become healthy, more productive adults and US$ a remarkably sensitive indicator of remain healthier in their old age. Japan 5 11 35,990 how individual nations ”value” their Greece 5 11,780 A study of the ”Value of Children” was con- children. Top of the list with the low- Germany 5 23,700 ducted in nine countries comparing parents’ est mortality rate is Sweden, which Finland 5 23,940 motivation for child bearing.(6) It was found has only around 3 children dying un- Czech 5 5,270 that in less developed countries where chil- der five year of age per 1,000 births Austria 5 23,940 dren were conceived to be ”used” for eco- (Table 1). Bottom of the world list is Switzerland 5 36,970 nomic reasons, there was a relatively high Sierra Leone with 316 children per Spain 5 14,860 fertility rate. In more affluent countries 1,000 dying under the age of five San Marino 6 19 n/a where children were conceived as loved in- years (Table 2). That country is ”sac- Portugal 6 10.670 dividuals in what was termed their ”psycho- rificing” nearly one third of its logical value”, there was a lower fertility young children. The difference be- rate. With improvement in health and educa- tween the top and bottom nations is Country Value Rank Gross National 100 fold. This differential reflects Income per capita that widening gap between the US$ ”rich” and ”poor” nations which is Israel 6 24 16,710 Table 1 – Under 5-year mortality – Top 10 unsustainable for clear humanitari- United Kingdom 7 31 24,230 Country Value Rank Gross National an, health and economic reasons. United States 8 34 34,870 Income per capita Cuba 9 42 1,170 Just how sensitive this ”index” is to US$ Kuwait 10 43 18,070 the ”political” factors of a nation can Sweden 3 1 25,400 Occ. Palestine 24 80 1,350 be seen in table 3. With a very simi- China 39 110 890 Singapore 4 2 24,740 lar birth rate and gross national in- Iran 42 114 1,750 Norway 4 35,530 come per capita to Tanzania, Uganda Iceland 4 28,880 has ”saved” the lives of some Zimbabwe 123 156 480 Denmark 4 31,090 50,000 children under five in 2001 Iraq 133 162 2,170 Slovenia 5 6 9,780 as compared to the rate in 1990. Monaco n/a Neighbouring Tanzania however Malta 9,120 made no real progress. Likewise Luxembourg 5 41,770 over the same ten year period, the devastat- mortality rate of only 5 with a GNI of Korea 5 9,4000 ing deterioration in the survival of children 9,780 US$, which is significantly above under five in Iraq contrasts dramatically the United Kingdom (31st) with a GNI of with neighbouring Iran. The additional well over twice as much! Table 2 – Under 5-year mortality – 10 na- loss of around 20,000 children under five The major causes of the under 5 mortality tions with highest rates per 1,000 births in Zimbabwe as compared to ten years ago world-wide are diarrhoea, malnutrition, will have very serious consequences for malaria, measles, HIV/AIDS and Pul- Country Value Gross National the future of that country. Income per capita monary Tuberculosis. Each of these conditions is easily preventable and treated. In- US$ Though the difference in the Gross Nation- deed the World Bank has estimated that if Sierra Leone 316 140 al Income per capita in US$ between the the burden of infectious disease were lifted top and bottom ten nations in the UNICEF Niger 265 170 from the developing world, the gap be- list is enormous, the correlation between Angola 260 500 tween the richest 20 and poorest 20 nations how rich a country is and how much it in- Afghanistan 257 250 would largely be bridged.(17) Liberia 235 490 vests in its children is variable. For in- Mali 231 210 stance Cuba has had half the gross nation- So what action can national medical asso- Somalia 225 120 al income per capita of Iraq but they are ciations take to effect change? Their mem- ranked 42nd, whereas Iraq has fallen to bers are involved in and affected by all as- Ginea Bissan 211 160 162nd of the 195 nations in the world pects of these problems. There needs to be Congo 205 700 which are recognised by the WHO both the central political will to make Zambia 202 320 (Table 4). Slovenia (6th) has an under five changes as well as an effective local infra-

14 WMA

structure in which changes can be made. Table 4 – Rate of progress This requires advocacy with professional and allied partners, and the setting of prior- Country Gross Under 5 Under 5 Annual Change ities for action. National mortality mortality births Income per 1,000 per 1,000 1000’s in per capita births births 2001 Water and Sanitation US$ 1990 2001 About 1,2 billion people world-wide lack Tanzania 270 163 165 1,393 2,786 + access to safe drinking water and 2,4 billion Uganda 280 165 124 1,222 50,000 + lack adequate sanitation, giving rise to diseases such as diarrhoea, cholera and tra- Zimbabwe 480 80 123 459 20,000 – choma. In poor countries it has been esti- South Africa 2,900 60 71 1,105 12,155 – mated that at any one time, about half the ur- Iran 1,750 72 42 1592 47,600 + ban population is suffering from one or more of the diseases associated with the lack Iraq 2170 50 133 823 66,840 – of water and proper sanitation.(8) The inci- Occ. Palestine 1350 40 24 132 2,112 + dence of diarrhoea can be reduced by near- Israel 16,710 12 6 126 756 + ly a quarter and the number of deaths by close to 2/3rds, through improvements in Afghanistan 250 260 257 1,078 3,234 + safe water supply with sanitation and hy- Rwanda 220 178 183 320 1,600 – giene. The cost of realising universal access to health, water sanitation and education, Russian Federation 1,750 21 21 1,230 – 0 – was estimated by the United Nations and the World Bank in 1995 to be an additional Romania 1,170 32 21 233 2,330 + 70–80 billion dollars per year. The World leaders can and must afford this. The Ugan- dan Medical Association has made ”sanitation” their theme for the coming year.(9) and psychologically scarred. Violence practised in private hospitals.(10) Girls are The Japan Medical Association is leading breeds violence! Children have been dis- also being sent abroad to those countries the WMA’s current initiative on key issues placed, placed in unsanitary conditions with where the operation is allowed. Physicians concerning water world-wide. poor or absent social infrastructure, and have a duty to do all in their power to expose with no system of justice. There are 35 mil- unethical practice and try and prevent all Malnutrition lion displaced persons and refugees world- forms of child abuse. wide, 80 % are women and children. This is More than half the deaths of children in the a severe indictment on the responsibilities of world under the age of five are associated some nations’ leaders and the ineffective- Smoking with malnutrition. The number of malnour- ness of the United Nations to resolve inter- ished children in sub-Saharan Africa has in- More than five million children alive today national conflicts. creased over the last ten years. Malnutrition will die prematurely of smoking related dis- is a cause as well as a consequence of pover- eases.(11) Recent studies have revealed that ty. Despite the high profile and the work of Abuse, Neglect and in Bangladesh as a result of marketing by a large number of non-governmental organ- Exploitation the tobacco industry, family members are isations, the essential infrastructure has not spending money on cigarettes rather than on been properly developed to relieve this to- In the wake of armed conflict, poverty and a food for their children, even to the extent of tally preventable burden. culture of violence, children are increasing- causing malnutrition.(12) It is crucial that ly becoming victims of abuse, neglect and the tobacco ”epidemic” that has swept the Armed Conflict exploitation. It has been estimated that there western world causing such a toll of respira- may be as many as 35 million child victims tory, cardio-vascular and neurological dis- More children have suffered from armed of child prostitution, sex tourism and child ease, is not inflicted on the poor nations al- conflicts and violence in the last ten years ”slavery”. One form of gross breach of hu- ready bearing an intolerable and financially than in any other comparable period in his- man rights affecting young girls is female overwhelming burden of disease by the mar- tory.(8) Ethnic conflicts and civil wars have genital mutilation. The WMA believe that keting practices of a selfish and unscrupu- come in the wake of the ”cold war”. Con- this practice is completely unethical.(18) Yet lous tobacco industry. Cigarette Companies flicts killed 2 million children in the ‘90s. in the UK where the practice is outlawed, it spend more then US$ 11,22 billion on pro- They left large numbers of children disabled is widely alleged that FGM continues to be moting their products. It is well known that

15 WMA

children are more susceptible to cigarette ad- Leishmaniasis which affects some 12 million impact of all their policies on the health of vertising than adults. To quote Philip Morris: people world-wide. In Africa, Asia and Amer- children. The World Medical Association has ”Today’s teenager is tomorrows regular cus- ica 146 million are affected by Trachoma and built on the foundations of the UN Declaration tomer, and the overwhelming majority of in 6 million this has caused blindness. Like- of the Rights of the Child in the WMA Decla- smokers first begin to smoke in their teens. wise Onchocercosis affects 18 million with ration of Ottawa on the Right of a Child to The smoking pattern of teenagers is particu- nearly a third of a million blinded. The agen- Healthcare.(4) National Medical Associations larly important to Philip Morris.” National cies active in the field of drugs for the ”ne- with others need to use these standards as a medical associations need to advocate in the glected diseases” include the WHO/World measurement of progress to achieve improved strongest possible terms for their country to Bank’s Tropical Disease Research Unit, the healthcare for, and the health of children. sign up to the UN Framework Convention on Global Alliances for ”TB” and ”Vaccines and The World Summit for Children’s ”Plan of Tobacco Control (13) which will provide Immunisations”, Medicines for Malaria and Action” in 1990 called on Government to their fellow citizens with some protection the International AIDS Vaccine Initiative. But prepare their own national programmes, in from the predicted tobacco epidemic. all these entities with the few others involved order to implement their World Summit com- only have a combined budget of around mitments on children. It is the will to incor- HIV/AIDS 100 million dollars a year.(15) It is only a porate the needs of children into each nation’s fraction of the reported cost of up to US$ The HIV/AIDS pandemic is a global disas- mainstream developmental thinking together 800 million that it takes the pharmaceutical ter. There are 10.4 AIDS orphans, 95 % of with a robust local infrastructure that will industry to develop a single new drug. In or- whom live in Sub-Saharan Africa. In chil- produce results. Local communities often der to restore a proper balance to the current dren under five years, it has been predicted struggle to meet the needs of children without 10/90 dis-equilibrium, it is essential that Gov- that the virus will cause 2/3rds of deaths in a fair share of the country’s resources. In the ernments of all nations, global industries, Botswana and half the deaths in Zimbabwe 1990s, the World Health Organisation’s 20/20 academia, universities and the non-govern- and South Africa. In Uganda of the initiative was based on the premise that an av- ment organisations involved, urgently start 100,000 people suitable for anti-retroviral erage of 20 % of the national budget in devel- focusing on these neglected diseases. Nation- therapy, only 10,000 can be afforded the oping countries and 20 % of the Official De- al medical associations need to encourage treatment.(14) velopmental Assistance (ODA), would be and foster academic partnerships between sufficient to achieve universal access to basic universities and academic centres in the rich social and health services. Most countries Medicines, Resources and and poor countries which could provide a continue to seriously under invest in these ba- Responsibilities valuable research network world-wide.(16) sic social and health services for children, The affordability of medications is a key issue with only 12–14 % of the national budget and The modern pestilences due to HIV, Ebola in the battle against infectious diseases in only 11 % of the ODA being allocated to Virus and more recently SARS have arisen poor nations. The development of life saving these basic services. in the aftermath of conflict and/or in areas of drugs is however largely subject to market great poverty. When faced with a greater Developing countries spent on average more forces. Those nations with the highest burden risk of dying and the serious financial con- on defence than on either basic education or of disease have the smallest financial market. sequences of the SARS epidemic, it was re- basic healthcare.(8) Levels of defence spend- Indeed only 10 % of the global health remarkable that in the ”rich” world the coming by developed countries were about search is devoted to conditions that account bined resourcefulness of humans and human 10 times the level of spending allocated to in- for 90 % of the global disease burden – the so resources were mobilised, commercial com- ternational development. Yet the increasing called 10/90 dis-equilibrium. Of the 1393 petition set aside and the causative organism gap between the rich and poor nations has new chemical entities developed between of SARS, its genetic sequence, likely mode been shown to foster violence and terrorism 1975 and 1999, only 1/3rd were truly ”break- of transmission and some possible therapeu- and to promote conflict. This vicious circle through” drugs and only 16 were for tropical tic agents identified within a very short time. can and must be broken.(17) diseases, TB and AIDS. All these 16 drugs If the same energy could be sustained to re- were developed with ”public sector” sup- solve the burden of infectious diseases in the Physicians individually and collectively port.(15) poor countries, great strides would be made through their national medical associations, There are seriously disabling and life threat- in relieving the widening inequalities in the are strong advocates for the health needs of ening diseases, mainly affecting the poor in health and wealth of nations. their local communities and nations. Medical developing countries, that may be considered students and young doctors in the rich coun- as ”neglected diseases”, where treatment op- Future Progress tries need to experience the health facilities of tions are inadequate or simply do not exist. the ”poor” countries first hand as an elective These include Malaria – causing over a mil- There are clear and well trodden paths to and as part of their postgraduate training. lion deaths – and Tuberculosis, over 2 million progress. These require children to be at the Such experience will change their lives. In deaths each year, HIV/AIDS which result in centre of each nation’s thoughts for their fu- turn their work and their advocacy will some 3 million deaths each year, and visceral ture, and governments need to examine the change the lives of those currently over-

16 Medical Science, Professional Practice and Education

whelmed by the burden of disease. The final Medical Science, Professional Practice and Education thought I leave with them is a quote from Nel- son Mandella and Graca Machel: ”We cannot waste our precious children. Orthopaedic Surgeons Are Failing To Prevent Not another one. Not another day. It is long past the time for us to act on their behalf.” Osteoporotic Fractures

References A multinational study of orthopaedic surge- A multinational survey involving 3,500 or- 1. Declaration of Geneva 1948 World Medical Asso- ons has found that in as much as 95 % of ca- thopaedic surgeons from France, Germany, ciation. ses, orthopaedists fail to investigate osteo- Italy, Spain, the UK and New Zealand was 2. Declaration of Helsinki 1964 Recommendations porosis as a cause of the fracture and are in- conducted earlier in 2003 to determine the guiding physicians in biomedical research involv- consistent in offering specific treatment or scope of the problem and areas for improve- ing human subjects. (Revised 2000) World Med- referrals. ment. The results revealed striking examples ical Association. of ineffective care of osteoporosis: Full results of the study co-sponsored by the 3. Declaration of Tokyo 1975 Guidelines for med- Bone and Joint Decade and the International ● Fifty percent of orthopaedic surgeons ical doctors concerning Torture. World Medical Osteoporosis Foundation (IOF), were pre- practising today received little or no Association. sented by Dr Karsten Dreinhöfer, Ulm Uni- training in osteoporosis. 4. Declaration of Ottawa 1998 The Right of a Child versity Hospital, Germany on October 15th ● Only roughly one in four orthopaedic to Health Care. during the first global 24-hour eLecture con- surgeons in France and the UK feel 5. WHO 2001 Report of the Commission on Macro- ference on musculoskeletal disorders, orga- knowledgeable about managing the dis- economics and Health WHO Geneva. nised by the Bone and Joint Decade for the ease in their patients. 6. Kagitcibasi Cigdem The Value of Children. Inter- medical community and in recognition of ● Only in Germany are the majority of national Child Health Vol. 9 1 Jan 1998. World Osteoporosis Day, October 20th. fracture patients referred for a bone den- 7. The State of the 3 Worlds Children 2003 sity test; in the UK, this figure is as low UNICEF. Until recently, the only fractures considered as 16 %. 8. We the Children: End of decade review of the fol- to be osteoporotic in nature were spinal ● Only half of the orthopaedic surgeons in low up to the World Summit for children. Report wedge, hip and wrist fractures as these cau- Southern Europe know about the impor- of Secretary General 2001 United Nations Gener- sed the majority of problems for patients tance of external risk factors for hip frac- al Assembly. and hospitals. ”However, it is now clear that tures (cataracts, poor lighting, pathway 9. Margaret Mungherera Presidential Address fractures of the pelvis, ankle, knee and obstacles, poor balance). Uganda Medical Association Scientific Meeting shoulder, as well as fractures of the clavicle ● In four of the countries surveyed, more Kabale Uganda 2003. should all be treated as osteoporotic fractu- than half of the surgeons have not heard 10. Joint Committee on Human Rights 10th Report to res,” said Dr Karsten Dreinhöfer. about their national osteoporosis patient the Houses of Lords and Commons. UK 2002. ”All orthopaedic surgeons who treat midd- society. 11. National Centre for Tobacco Free Kids 2002. le-aged and elderly patients with fractures ”Since orthopaedic surgeons are often the 12. GM Leung, L-M Ho, T-H Lam “The economic have a duty to consider and institute mecha- first and only physicians to see fracture pa- burden of environmental tobacco smoke in the nisms for preventing future fractures. This tients, they are in a unique position to iden- first year of life” Arch Dis Child Vol. 88 9 Sept can be done by instituting protocols for the tify untreated cases of osteoporosis, and as 2003. screening, identification and treatment of such reduce the risk of subsequent fracture,” 13. United Nations Framework Convention on Tobac- those who have sustained a fracture”, he said Professor Olof Johnell, International co Control WHO 2003. said. Osteoporosis Foundation, who led the de- 14. Okongo Bernard “Development of Resistance to velopment of guidelines for orthopaedic ARVs” Ugandan Medical Association Scientific Studies show that 50 % of women and 30 % surgeons to identify and treat osteoporosis. Meeting, Kabale 2003. of men will experience an osteoporotic frac- He cautioned, ”It is important to act at the 15. Patrice Trouiller et al. “Drug Development for ture in their lifetime and a prior fracture in- time of fracture. It is the responsibility of or- Neglected Diseases”. Lancet Vol. 359 June 22, creases the risk of subsequent fracture as thopaedic surgeons to investigate whether 2002. much as five-fold. Osteoporotic fractures osteoporosis is the underlying cause.” 16. Weatherall David Leading Article BMJ 2003 are associated with increased morbidity and Vol. 327 20th Dec. 1415–1416. mortality: 50 % of hip fracture patients will Osteoporosis is a condition that affects peo- 17. Poverty and Health OECD World Health Organi- have long-term disability, and 25 % will re- ple of all ethnic and cultural groups from sation 2003. quire long-time nursing home care. With the around the world. Although there is no cure 18. Statement on Condemnation of Female genital population ageing world-wide, the number for osteoporosis, there are treatments and Mutilation. Budapest 1993 World Medical Asso- of fragility fractures is expected to increase lifestyle changes such as regular exercise that ciation. dramatically over the next few years. can stop further bone loss and reduce the risk

17 Medical Science, Professional Practice and Education

of fractures. For example, a recent study in standing of musculoskeletal disorders Main Outcome Measures China by Professor Kai Ming Chan, shows world-wide through research, and to im- Relative importance of patient-physician re- that regular tai chi chuan exercises can delay prove the quality of life for those affected by lationships compared to other critical rela- bone loss in postmenopausal women. these disorders. The Bone and Joint Decade tionships in society. Type of relationship as is supported by National Action Networks, defined by patients and physicians. Levels professional medical societies, patient advo- Background of patient empowerment and self-manage- cacy groups, governments, industry and re- The Bone and Joint Action Week, ment of care. Actual and ideal performance searchers who are to effect change. The October 12–20th 2003 ratings in 5 dimensions in the humanistic Bone and Joint Decade is delighted to have domain (compassion, trust, understanding, As a highlight of the Bone and Joint Decade the personal and active support of Kofi An- patience, listening) and 5 dimensions in the Action Week, leading authorities in the mus- nan, Secretary-General of the UN, the WHO access domain (access to physician, time culoskeletal field presented a 24-hour series and the World Bank. with physician, appointment scheduling, of eLectures via webcast. Subjects ranged The Bone and Joint Decade encompasses choice of treatment, choice of specialists). from prevention, to state-of-the-art treatment diseases associated with musculoskeletal and from how to best teach musculoskeletal disorders such as joint diseases, osteoporo- disorders to the best biological approaches. Results sis, osteoarthritis, rheumatoid arthritis, low The patient-physician relationship ranked The Action Week was a major driving force back pain, spinal disorders, severe trauma to second in importance only to family rela- for prevention and advocacy and included: the extremities, crippling diseases and defor- tionships in all countries studied. Physicians World Arthritis Day (Oct 12th), World Spine mities in children. were the leading source of health informa- Day (Oct 16th), World Trauma Day (Oct 17th) For more information and a copy of the os- tion, the most trusted source, and the source and World Osteoporosis Day (Oct 20th). teoporosis guidelines, see: The Bone & Joint most likely to instigate positive behavioural Launched in January 2000, the Bone and Decade: http://www.boneandjointdecade.org change in patients in all countries studied. Joint Decade is an NGO, headquartered in and: International Osteoporosis Foundation: All countries agree that authoritarian pater- Sweden. Its mission is to advance under- http://www.osteofound.org. nalistic relationships between physicians and patients are relatively uncommon today. These relationships are being replaced by mutual partnerships or advisor models. Pa- tients and physicians in all countries foresee future movement toward partnership and Relationship Based Health Care in Six Countries team based models. Compared to 10 years ago, most patients in all countries believe they ask more questions, make more choices, actively evaluate benefit and risk, and A comparative study of patient and with each other in six countries on four take better care of their own health. Patients' physicians' perceptions world-wide continents. confidence in managing their own health is The following is an abstract summary of very high in all countries except Japan. this study carried out and presented at Design and Setting Physician confidence in patients self-man- the Helsinki General Assembly, Septem- agement is lower than patients scoring in ber 2003 by Dr. Mike Mcgee, WMA, Fel- Patients and physicians were simultaneous- five of the six countries. In general, all co- low in Humanities 2003 The full text can ly studied in six countries using nationally horts rate physician humanistic perfor- be obtained from the author* representative telephone surveys between mance higher than access performance. July 22, 2002 and October 13, 2002. 2506 Physicians in all countries rate their ideal Context of study interviews were conducted on patients (63 humanistic performance higher than do pa- % response rate) and 1201 interviews were tients. In contrast, physicians in the United A number of forces have transformed the conducted on physicians (58 % response Kingdom and Germany rate their ideal ac- practice of medicine in the past two decades. rate) using a random digit dialing (RDD) cess performance lower than the patients' Evidence suggests that these forces are im- methodology. expectation for ideal access performance. In pacting on both patients and physicians and actual performance both in humanistic and on their relationship with each other. access domains, physicians score them- Participants selves higher than do patients in 8 of the 10 Objectives dimensions. Patients and physicians scoring Patients had to be at least 21 years of age. of opportunities for improvement is relative- To simultaneously survey patients' and Physicians had to be general practitioners ly well aligned in five of the six countries physicians' perceptions of their relationship and in practice for five or more years. studied. The greatest variance in opportuni-

18 World Health Organisation

ty scores between patient and physician ex- tient self-management is more modest. Pa- takes local knowledge and strength to turn ists in the United Kingdom in both humanis- tients possess high confidence in physicians that possibility into reality. We have learnt tic domain (17 % difference) and access do- but also demonstrate higher expectations for this through successes such as controlling main (26 % difference) and in Germany ac- ideal physician performance and higher ex- the SARS epidemic and major advances in cess domain (19 % difference), with patients pectations for improvement along five di- the polio eradication campaign, and we have seeing more opportunity than do physicians. mensions of humanistic care and five di- learnt it through setbacks as well, such as mensions of access to care. The ability to continuing rise of AIDS, TB and malaria. align expectations of patients and physi- Conclusions All of these lessons have prepared us for the cians, and meet commonly held objectives, task ahead. The findings indicate a fundamental shift in will be increasingly important in assuring the patient-physician relationship away the future health of this critically important Twenty-five years ago, the Declaration of from an authoritarian and paternalistic mod- societal relationship. Alma-Ata challenged the world to embrace el and toward partnership and team based the principles of primary health care as the approaches. Patients are significantly more * Mike Magee, Pfizer Medical Humanities way to overcome gross health inequalities confident and empowered than they were Initiative, 235 East 42nd St, New York NY between and within countries. ”Health for ten years ago. Physician confidence in pa- 10017 all” became the slogan for a movement. It was not just an ideal but an organizing principle: everybody needs and is entitled to the highest possible standard of health. The principles defined at that time remain indis- pensable for a coherent vision of global World Health Organisation health. Turning that vision into reality calls for clarity both on the possibilities and on the obstacles that have slowed and in some More Research, More Resources Needed To cases reversed progress towards meeting the health needs of all people. This entails work- Control Expanding Global Diseases ing with countries – especially those most in need – not only to confront health crises, but to construct sustainable and equitable health Dr. Lee Jong-wook, WHO Director General dren under 5 years old who die every year, systems. in his introduction to the World Health Re- almost all are in developing countries. port 2003, writes „Today’s global health sit- I urge the global health community to set its A world marked by such inequities is in very uation raises urgent questions about justice. sights on bold objectives. All countries of the serious trouble. We have to find ways to In some parts of the world there is a contin- world have pledged to reach the Millenium unite our strengths as a global community to ued expectation of longer and more com- Development Goals set at the United Nations shape a healthier future. This report on the fortable life, while in many others there is Summit in 2000. These include ambitious tar- world’s health, my first since taking office, despair over the failure to control disease al- gets for nutrition, maternal and child health, gives some initial indications of how to do it. though the means to do so exist. infectious disease control, and access to essen- The message (running through the report) is tial medicines. With this support we have a real This contrast is starkly evident in lack of ac- that progress in health, including rapid and opportunity now to make progress that will cess to HIV/AIDS treatment, which led me, sustainable expansion of emergency treat- mean longer, healthier lives for millions for earlier this year, to declare a global health ments, depends on viable national and local people, turn despair into realistic hope, and lay emergency. WHO decided to take this rare health systems. Scaling up ARV therapy in the foundations for improved health for gener- measure after evaluating the global situation resource-poor settings has to be done in such ations to come. and finding that only 5 % of those in the de- a way as to strengthen health systems based veloping world who require antiretrovirals To reach our goals, increased resource on primary health care. In most countries, (ARVs) are getting them. In sub-Saharan commitments and intensified collabora- there will be only small and short-lived ad- Africa, only 50,000 of the 4 million people tion among partners will be required. The vances towards acceptable standards of in need have access to ARVs. This spells cat- [...] report describes the challenges we health without the development of health astrophe, not only for the societies hardest face and points the way for a united re- care systems which are strong enough to re- hit but for the world as a whole. Our first sponse from WHO and the global health spond the current challenges. step to respond to this crisis must be to reach community.“ ”3 by 5” – 3 million people in developing To lend impetus to this process WHO is now countries on antiretrovirals by 2005. Major making results in countries its main objec- Geneva disparities also exist in areas such as child tive. Effective action to improve population October 2003 mortality. Of the more than 10 million chil- health is possible in every country but it

19 World Health Organisation

Poverty Americans: Argentina, Brazil, Mexico, Nicaragua, Peru and the Caribbean Com- munity including Haiti. From the Eastern Mediterranean: Djibouti, Iran (Islamic Re- Health And Finance Ministers Address Need public of), Jordan, Pakistan, Sudan, Yemen. From Europe: Azerbaijan and Estonia. For World-wide Increase In Health Investment From South East Asia: Bangladesh, Bhutan, India, Indonesia, Myanmar, Nepal, Sri Lan- Geneva – Ministers of Health, Finance and assistance for health are encouraging, they ka and Thailand. From the Western Pacific: Planning from 40 developing countries still fall short of meeting real needs. Cambodia, China, Philippines and Viet came together with development partners at ”On taking office, I declared the target of Nam. WHO headquarters from 29 to 30 October ‘3 by 5’ – to have 3 million people with AIDS to address the need to significantly increase in developing countries on treatment with an- * Development investments in health. This is the first time tiretrovirals by the end of 2005. Only 300,000 Assistance for health (DAH): Recent Trends and that the World Health Organisation has host- resource Allocation Dr. Catherine Michaud, Senior are on treatment at the moment. To achieve ed a meeting so widely attended by non- Reserach Associate, Harvard Center for Population ‘3 by 5’ and other health priorities we need health officials, underlining the urgency of and Development Studies considerably more funds than those currently building national capacity to absorb in- available. If we don’t increase resources for creased health funding. health and target these resources to activities ”This meeting signifies real political commit- that will have the greatest impact, we stand to ment from the highest levels of government lose millions of men, women and children to and donor representatives. Let us capitalize on disease. This also means trapping individuals WHO welcomes new this unique opportunity to regognize health as and families in poverty and disillusionment,” a critical investment and together develop a said Dr Lee. initiative to cut the common understanding of how countries and During the meeting, the combined work of their partners can transform these commit- countries, WHO and partners was to devel- price of AIDS ments into immediate actions. We must op concrete plans for increased health in- choose to make equitable and efficient health vestment in countries. Continued global medicines investments a reality,” said WHO Director- leadership and follow-up from the develop- General Dr Lee Jong-wook. ment community, combined with inter-min- Geneva – The World Health Organisation This meeting comes nearly two years after isterial collaboration is needed: first, to in- has welcomed a new initiative to further cut the launch of the 2001 Report of the Com- crease resources for health from domestic the price of AIDS medicines in developing mission on Macroeconomics and Health resources, debt relief and development as- countries. WHO also underlined the impor- (CMH), which recommends that by 2007, sistance for health, and second to eliminate tance of speedy delivery and distribution, as donors should increase assistance for health health system and institutional constraints, well as effective treatment and care to en- to US$ 27 billion. The Commission also enabling greater absorption of increased re- sure equitable access to treatment around calls for more budgetary resources for pub- sources. This will be critical for pursuing the world. lic health from both developed and develop- country action to reach the ‘3 by 5’ and oth- In New York, the William J. Clinton Foun- ing countries, and more political and organ- er health targets. dation announced that it had reached agree- isational effort than has been seen in the past ”We need country-specific blueprints for ment with some manufacturers to cut the decades to achieve real improvements in making real increases in health investment. price of AIDS medicines in half. health. Developing countries and their partners ”Providing AIDS treatment to those who Two years on, the world still has not shown need to collectively and quickly do much most urgently need it in poor countries is the determination in increase investment in more, for health and global stability. This most urgent health challenge the world health to the levels needed to measurably meeting can identify ways to make this hap- faces,” said the WHO Director-General, Dr impact major diseases that affect the world’s pen,” added Dr Lee. LEE Jong-wook. ”WHO welcomes this poor. A recent study* has shown that the to- Clinton Foundation initiative and all private tal development assistance for health from National Macroeconomics and Health activ- and public sector efforts that will both re- major selected sources increased by US$ ities are ongoing in the countries participat- duce the price of AIDS medicines and en- 1.6 billion, from an average of US$ 6.1 bil- ing in the Consultation: From Africa: Ango- sure their availability to the people who lion (1997–1999) to US$ 7.7 billion (2001). la, Botswana, Congo, Ethiopia, Ghana, most urgently need them.” Most of the increase in funding was allocat- Kenya, Malawi, Mozambique, Nigeria, ed to fighting HIV/AIDS in sub-Saharan Rwanda, Senegal, South Africa, Uganda, WHO and its partners are fully committed Africa. Although these recent increases in United Republic of Tanzania. From the to delivering antiretroviral therapy to three

20 World Health Organisation

million people in developing countries by ”Further price reductions are vital for coun- to emergency obstetric care, especially in sub- the end of 2005, the ”3 by 5” target. To do tries to be able to provide treatment to those Saharan Africa,” said UNICEF Executive Di- this, WHO is leading emergency response who need it,” said Dr Paulo Teixeira, Direc- rector Carol Bellamy. ”The widespread provi- teams to assist developing countries in in- tor of the HIV/AIDS Department at WHO. sion of emergency obstetric care is essential if creasing the availability of treatment for ”But lower price medicines alone will not we want to reduce maternal deaths.” people with AIDS, developing simplified deliver treatment. Improving the ability of The maternal mortality ratio, was estimated treatment guidelines, building an AIDS countries to deliver the medicines, building to be 400 per 100,000 live births globally in drugs and diagnostics facility, and ensuring stronger health systems and training more 2000. By region, it was highest in Africa the widespread availability of training for health workers are also vital if we are to (830), followed by Asia – excluding Japan health staff and volunteers. reach the ‘3 by 5’ target.” (330), Oceania – excluding Australia and New Zealand (240), Latin America and the Caribbean (190) and the developed countries Maternal mortality (20). Worldwide, 13 developing countries ac- counted for 70 % of all maternal deaths. The Maternal Deaths Disproportionately High In highest number occurred in India where 136,000 women died, followed by Nigeria Developing Countries where there were 37,000 deaths.

African women are 175 times more likely to and provide or refer for life-saving care In 2000, world leaders agreed to reduce ma- die in childbirth than women in developed when complications arise. They also provide ternal mortality by three-quarters by 2015, regions of the world mothers with basic information about care as part of the Millenium Development Goals for themselves and their children before and (MDGs). Tracking progress remains diffi- Geneva – New findings on maternal mortal- after giving birth.” cult, except where comprehensive registra- ity by WHO, UNICEF and UNFPA show tion of deaths, including causes of death, ex- that a woman living in Sub-Saharan Africa Reducing maternal mortality is a key factor ists. For this reason, the use of indicators has a 1 in 16 chance of dying in pregnancy in ensuring that all children, especially in such as the proportion of women who have a or childbirth. This compares with a 1 in the world’s poorest countries, survive and skilled attendant at delivery is essential to 2,800 risk for a woman from a developed re- thrive through adolescence. track change. gion. These findings are contained in a new ”These new estimates indicate an unaccept- global report on maternal mortality released ably high number of women dying in child- The use of skilled attendants at delivery in online by the three agencies at. birth and an urgent need for increased access developing countries increased between www.who.int/...... Of the estimated 529,000 maternal deaths in 2000, 95 % occurred in Africa and Asia, WHO/UNICEF/UNFPA Estimates of number of maternal while only 4 % (22,000) occurred in Latin deaths, lifetime risk and maternal mortality ratio, America and the Caribbean, and less than by MDG regions, for the year 2000 one percent (2,500) in the more developed Number of Lifetime risk of Maternal regions of the world. maternal deaths* maternal deaths: mortality ratio 1 in: (maternal deaths Experience from successful maternal health MDG region per 100,000 livebirths) programs let show that much of this death World 529,000 74 400 and suffering could be avoided if all women Developed regions ² 2,500 2,800 20 had the assistance of a skilled health worker Europe 1,700 2,400 24 Developing regions 527,000 61 440 during pregnancy and delivery, and access to Africa 251,000 20 830 emergency medical care when complica- Northern Africa 4,600 210 130 tions arise. Sub-Saharan Africa 247,000 16 920 Latin America and the Caribbean 22,000 160 190 ”Many women deliver their children alone Asia 253,000 94 330 or with family members or other untrained Eastern Asia 11,000 840 55 attendants who lack the skills to deal with South-central Asia 207,000 46 520 South-eastern Asia 25,000 140 210 complications during delivery,” said Dr LEE Western Asia 9,800 120 19 Jong-wook, Director-General of WHO. Oceania 530 83 240 ”Skilled attendants are vital because they * includes Canada, United States of America, Japan, Australia and New Zealand. can recognise and prevent medical crises

21 WMA Secretary General

1990 and 2000 from 42 to 52 %, suggesting Education on family planning and the provi- understand and combat the SARS virus a potential decrease in maternal deaths. sion of family planning services of high when it hit that country during 2003. Buil- Findings show the greatest improvements in quality can also make a difference. ding on the CMA example and following a South East Asia and Northern Africa and the resolution by the WMA General Assembly, As the focal agencies within the United Na- slowest change in sub-Saharan Africa, which the CMA and WMA are now preparing a tions systems for the health of women and went from 40 % in 1990 to 43 % in 2000. new policy on NMA preparedness for epide- children, WHO, UNICEF and UNFPA mics. The WMA has been negotiating with pledge to enhance – both individually and Most maternal deaths and disability occur as WHO to develop a more effective communi- jointly in collaboration with their partners – the result of one or more of three delays: a cation channel and network to provide in- their efforts in assisting countries strengthen delay in recognising complications; a delay formation and resources to NMAs and their their maternal health programs. in reaching a medical facility; or a delay in members in times of epidemics such as receiving good quality care. Efforts to ad- For further information contact: Chris Powell, Com- SARS or the current Avian Flu; dress these delays are essential in order to munications Advisor; Family and Community save the lives of mothers and babies. Health, WHO, Geneva, Email: powelle @who.int Russian Medical Society (RMS) comes of age WMA Secretary General It took the WMA four years of persistent and often difficult negotiations to identify and help develop a National Medical Asso- From the Secretary General’s Desk ciation in Russia. When the Russian Medi- cal Society was admitted as member to the It is fascinating to look back on the history WMJ Editor-in-Chief and his team all of the WMA in 2002, it was a historic moment, of the World Medical Association (WMA) very best in this worthy endeavour. long overdue. In this process, Dr Leonid in this historic 50th edition of the World Me- Mikhailov, RMS Secretary General, deser- Much has been done to promote the medical dical Journal (WMJ). The roots of the WMA ves credit for his committed efforts to forge profession since the WMA General Assem- are described in an article of the British Me- together medical groups in Russia and build bly last met in Helsinki during September dical Journal on October 5, 1946, where it links with the international community. 2003: was reported that physician’s leaders had Russia has such vast intellectual riches that met to discuss the establishment of the a world body simply cannot afford to grow World Medical Association (WMA). This Working against torture without the Russian medical leadership. Du- Association would ”promote closer ties bet- ring February 2004, this was strengthened ween National Medical Associations, study The WMA, in partnership with the Interna- even more when one of the fathers of Russi- the problems which confront the medical tional Council for the Rehabilitation of Tor- an medicine, Prof. Valerie Pokrovsky, was profession throughout the world, organise ture Victims (IRCT), has developed a suc- elected as President of the RMS for the next the exchange of information and establish cessful project to help train physicians in the year. Prof. Pokrovsky is also the President of relations with the World Health Organisati- detection, documentation and treatment of the prestigious Academy of Russian Medici- on and present the views of the profession”. torture victims, using the so-called ”Istanbul ne and is thus in a very good position to fur- Protocol”. Funded by the European Union, ther strengthen the uniting role of the RMS Subsequently the WMA was formally esta- the partnership has now completed the first in the Russian medical profession; blished on September 18, 1947, and has gro- phase of establishing links and building trai- wn into a formidable organisation. What I ning centres in five pilot countries (Georgia, find most appealing of the work of National Morocco, Mexico, Uganda and Sri Lanka). Advocacy at the WHO Medical Associations and the WMA is its One of the highlights over the last few dual purpose – serving the profession, but Never before in the history of the WMA have months has been the determined efforts by always making sure that the best interest of there been a stronger links and more colla- Dr. Yoram Blachar, WMA Chair of Council the patient remains our first consideration. borative work between the WMA and WHO. (and President of the Israel Medical Asso- This is one reason why medical leaders are During the annual meetings of WHO, WMA ciation) to help establish these centres as he often, as it should be, gifted social leaders. leaders regularly present the views of the undertook the trip to Sri Lanka on behalf of As the WMJ turns a new page and embarks profession in a concise and forthright man- the WMA; on a new style, format and list of contents, ner. Most recently the Chair of Council, Dr we stand on the shoulders of these medical Blachar represented the WMA views on and social giants of the past and present to Fight against SARS health promotion and healthy lifestyles at the build an even greater WMA, the global re- WHO Executive Board Meeting during Ja- presentative body for physicians. We con- The Canadian Medical Association was par- nuary 2004. Other examples of collaboration gratulate and wish Dr. Alan Rowe, our new ticularly effective in helping their members over the last 6 years include:

22 Regional and NMA News

The WMA has as one of its stated objectives Social security is a dynamic system that is ● The WMA has been a forceful partner that every nation in the world should be re- constantly evolving to enable us to live and and supporter of the Framework Conven- presented in its membership. This ideal has work in prosperity. In terms of the health tion on Tobacco Control not yet been achieved. Furthermore, the care sector, social security has evolved in ● Leadership of health professional groups WMA Council has set some priorities for tandem with the era of infectious diseases in in the World No Tobacco Day 1999 action over the next few years. The organi- the aftermath of the war, followed by the era ● Development of a policy on safe injec- sation will focus on medical ethics, health of lifestyle related diseases, the current era tions as part of the Safe Injection Global related human rights, the development of a of medical care for the elderly and the fu- Network database of physician and NMA informati- ture era of preventive medical care. Japan ● Development of a policy on Violence and on, and to be the foremost central advocate has become a nation with the world’s Health for the medical profession, especially at the longest life expectancy and the lowest in- ● Survey on Human Resources for Health level of WHO and other United Nations fant mortality rate. Although individual is- ● Inclusion of the WMA in the Global Alert agencies. At the Secretariat, we are very ex- sues remain, the fact that the entire nation and Response Network for the combat of cited about this growth of enthusiasm and functions quietly on a system that guaran- communicable diseases and now the de- energy in the organisation, and hope that all tees these living standards for its people has velopment of a more comprehensive net- physicians and NMAs will unite and help raised Japan’s national worth and has con- work to respond more rapidly and effec- build the WMA into a truly world class as- tributed to high quality human resources. tively against diseases such as SARS. sociation. We owe this to our dual constitu- This social security system is a paramount encies, our patients and our colleagues in the task that maintains and strengthens national Even though it is reassuring that progress medical profession, the noblest profession stability. As common social capital, social has been made, much still needs to be done. on earth. security must be strategically invested to achieve the combined components of health care, long-term care, pension, education, employment and others. Based on this fun- Regional and NMA News damental recognition of the social security system, those of us who have been entrusted with the country’s health care must fulfil Social Security is a National Security Issue the following three responsibilities. 1) Recognise that the universal national Eitaka Tsuboi, MD President, Japan Medical Association health insurance is national security. Strongly demand that the government The time for government intervention is al citizens to contribute confidently to buil- substantiate, improve and strengthen the when the national security of its citizens is ding society and the economy in good mental national health insurance system. threatened. That is why the national popula- and physical health through gainful employm- 2) Secure that individual rights of citizens ce pays taxes to enable their national leaders ent. What supports employment is health care, to have access to physicians at all time to deal with national crises. If the Japanese long-term care, education, pension, employm- and in all areas throughout the country, government does not adequately address na- ent insurance and livelihood protection – in order to guarantee the equality of life. tional security or the social security of its components of the social security system. 3) Individual payments of medical expens- people, our country may undergo the expe- es are required under the prevent sys- rience of total national dysfunction. The ability to work is developed through edu- tem. However they should be limited to cation, while national securityprotects our To rescue Japan from this kind of crisis situa- a 20 % maximum of the medical cost. In lives through health care. Employment insur- tion, it is vitally important for the government future, individual payments should be ance provides assistance in the unfortunate to pursue a national policy that will provide completely abolished. event we become unemployed. Livelihood in- Japanese citizens with a sense of security. Fo- surance provides assistance when we experi- Physicians should continue to advocate stering a national sense of security, removes ence permanent unemployment. Pension is re- this responsibility while enduring the criti- apprehensions about the future and creates an muneration for yielding our job to a younger cism and disapproval of market principle atmosphere of social pace. A sense of securi- person. Pensions help us maintain our liveli- supporters. ty must be restored, in other words, national hood in our twilight years as we prepare for security must be definitely promised. death. Long-term care helps us through our fi- Substantiating, improving and strengthen- This must be regarded as a national task that is nal stage of life. The social security system is ing health care is a welcome means of main- a segment of the overall national security stra- our common social capital that supports the taining and increasing the health of the na- tegy without diminishing social security as a cycle of transitions in our lives. The govern- tional populace. But as we pursue the bene- safety net. The ultimate goal of social securi- ment has an obligation to permanently en- fits that are derived from this process and ty is employment, i. e., the ability of individu- hance this common social capital. those stemming from the introduction of ad-

23 Regional and NMA News

vanced medical technology, there is always ”The Internet and Health Care”, is planned for as this has resulted in an increase in price for the risk that medical ethics will be aban- the WMA General Assembly, Tokyo 2004, low-cost prescribed drugs, it has reduced the doned. and many successful developments are antici- cost of the higher priced ones. pated. It is hoped that the medical profession, At the time of my inauguration as the 52nd The introduction of these co-payments is which has been entrusted with the control of president of the WMA in Edinburgh, 2000, highly criticised by consumer organisations advanced medical technology and cutting- I discussed the subject of ”channelling the and unions. Due to unclear wording in the edge information technology in the 21st cen- abundant benefits of advanced medical law and lack of regulations at the time of im- tury, will raise its awareness about its respon- technology”. The JMA submitted a pro- plementation, many problems and argu- sibility of overseeing humanity’s health based posed declaration on this issue, and ”the ments occurred. on a code of medical ethics that is the essence WMA Declaration on Medical Ethics and of all medical practice. Sick funds may provide some relief to their Advanced Medical Technology” was adopt- members by offering the use of internet ed by the WMA General Assembly, Wash- I look forward to the contribution of your pharmacies, which was previously prohibit- ington 2002. wisdom and the participation of all WMA ed, or of enrolment in a primary care model A scientific session on the theme, ”Advanced member associations of the WMA Tokyo in which the insured would agree always to Medical Technology and Medical Ethics” and General Assembly. consult a GP first. Definition of Basket A common body of the sick funds, physicians and hospitals, will define the services Health Reform in Germany ”sustaining or and treatment that can be rendered under SHI. In the past this covered only ambulato- diluting social insurance?” ry treatment, but now also includes the hospital sector. The decisions have to be based Dr. Otmar Kloiber, German Medical Association on evidence, thus giving Health Technology Assessment and EBM a strong boost. In ad- The German Health Care System (social in- been raised significantly and can in some in- dition a patients’ representative has been insurance system) has been financed on the stances reach 100 %, including prescribed stalled (Bundesbeand is to be heard before basis of contributions linked to wages and ”Over-the-Counter”-Drugs (OTC), trans- decisions will be taken). Furthermore the salaries. For many years now Co-payments portation costs, and many remedies includ- self-government of sick funds and providers have also been a feature of the system but ing glasses. For hospital stays the co-pay- has to introduce a new institute for quality these were only set at a symbolic level. ment has been raised from 9 Euros for a matters. (The initial plan to copy the British maximum of 14 days per year, to 10 Euros In a major reform act the government coali- National Institute for Clinical Excellence for 28 days per year. A 10 Euro co-payment tion with support of the opposition Christian was not followed.) is required for the first consultation with a Democrats have introduced multiple physician in each quarter. If another physi- Selective contracting – new provider types changes in the Statutory Health Insurance cian is consulted without referral by a Gen- (Gesetzliche Krankenversicherung). The While until now contracts between the sick eral practitioner, an additional co-payment changes are of considerable concern to Ger- funds and the ambulatory physicians only ex- is applied. It is thought that this will reduce man doctors but will be of interest to others isted as group contracts negotiated between the common ”doctor hopping” in Germany. whose health care systems are based on this the ”umbrella” organisations of the sick funds type of social insurance. A limit of 2 % of annual income has been set and the association of the office based physi- on the yearly sum of co-payments for which cians (Kassenärztliche Vereinigung – KV) (a The major aim is the reduction of expendi- participants are responsible. If co-payments statutory body with obligatory membership), ture. As the financing of the SHI is based on exceed this value the excess is covered. For sick funds are now permitted to make con- contributions linked to wages and salaries, serious chronically ill patients (needing at tracts with physicians and groups of physi- increasing cost for health insurance is being least one physician consultation per quarter) cians directly on a limited basis. One percent seen as an economic burden to the export the capping operates a 1 % of income. Cer- of the budget for ambulatory treatment is to orientated German industry. The following tain exceptions much more rigid than in the be set aside for such new types of contracts, note indicates some of the major concerns past may however be set in the future. whose number is planned to be increased in about the changes in the SHI. the future. At the same time new types of am- Co-payments Whilst in the past Pharmacists income de- bulatory institutions owned by third parties pended in part on a percentage payment based will be eligible to provide ambulatory treat- Co-payments have existed for many years on the cost of drugs, this has been replaced by ments. Hospital emergency rooms, which in but only on a symbolic level. Now they have a fixed pharmacy charge of 8.10 Euro. Where- the past have been strictly limited to use for

24 Regional and NMA News

emergency cases, will also be eligible to pro- In the beginning of the SHI it took more lities competing with established specialists vide ambulatory services. than 30 years to understand that selective and GPs. contracting of physicians leads to a suppres- Although there have never been formally Commentary: sion of the provider side by powerful sick mandated patient representatives in Ger- The reform brings back some of the birth funds. Finally after years of strikes and many, the patient’s voice has always been defects of the SHI, namely the high burden fights the situation was resolved, as it was effective. If not, public movements resulted for the sick and a market (financial interest) ordered by government and later by law, that in change, and the courts decided very often driven system for the relations between sick contracts could only be made with the trade in favour of patients and continuously ex- funds and physicians. union of ambulatory physicians. The union tended benefits for patients. The underlying was later transformed into a statutory body In the beginning of the SHI, the sick funds notion was that neither sick funds nor provi- with obligatory membership for all physici- only paid compensation for lost income. ders in their contractual relationship should ans who wished to treat patients insured un- Over time it became more and more evident be able to deprive patients of benefits. Now, der SHI in ambulatory settings. Also, in or- that it is better to care for the medical treat- with a formally installed patient representa- der to avoid Sick Funds circumventing this ment in a comprehensive way, including fi- tive included in the procedures, the argu- mutual bargaining, they were not permitted nancial protection. Access to care is limited ment that decisions were taken without par- to have their own establishment for ambula- by high co-payments. However, while one ticipation of patients may no longer be ap- tory treatment or to contract with third par- might correctly argue that contributing an plicable. This may lead to more effective lities. This gave enormous stability and pre- extra 1 or 2 % of income is not very much, mitation of the basket than in the past. In- vented competition for prices. it hits especially the seriously ill patients. deed the introduction of a patient represen- Often they already have only a very small The new regulation shifts the provision of tative may in the end do just this: limiting income because of their disease or handi- ambulatory care towards a commodity bu- patient claims. In the context of the overall cap. 1 or 2 % percent may be above what siness, as it will put financial considerations aim of the reform, namely limiting health they can afford - just the money they can’t before medical ones. The same is true for care expenditure, this of course would be a decide about. Taking this away may have ef- permitting third parties e. g. commercial success but at what cost to be principle of fects on compliance. entities, to open ambulatory treatment faci- equity in providing for the needs of the sick

the Minister of Health in August 2002. In The South African Medical Association’s work discussions with the Minister, Dr Manto Tshabalala-Msimang, SAMA re-cemented on the HIV/Aids front its views that an HIV/Aids treatment policy that includes the provision of ART was essential to slow down the impact of The South African Medical Association A year later SAMA praised government HIV/Aids in South Africa. Following the (SAMA) has for years been the association for the provision of Nevirapine for the pre- unsuccessful meeting with the Department taking doctors forward and into the future. vention of mother-to-child transmission of of Health, SAMA continued to persevere As an Association with many social res- HIV. Dr Anant Chetty, then Chairperson of in its efforts to facilitate treatment for peo- ponsibilities, we have dedicated ourselves SAMA’s Human Rights, Law and Ethics ple living with Aids, irrespective of the go- to fighting the HIV/Aids scourge. Committee, emphasising that doctors need vernment’s position of not providing ART. not be afraid to prescribe HIV/Aids drugs, In July 2001, SAMA criticised the govern- After the meeting Letlape stated, ”We have said ”Doctor’s ethical and moral rights are ment for their lack of direction in rolling not changed our position, and neither has protected in our constitution, their clinical out an HIV programme, and called on go- the Department of Health. But both parties independence is fully supported by the vernment to provide antiretroviral treat- are committed to further dialogue, and we Health Professions Council of SA and in- ment (ART) to South Africans in the public will continue urging the department to re- ternationally by world health organisati- sector. SAMA Chairperson, Dr Kgosi Let- view its stance on making ART available in ons.” lape, said South Africa was the only coun- the public sector. Unfortunately time is not try in the world where there was no policy Yet, still adamant that a treatment pro- on our side. We would like to see the im- for the treatment of HIV. gramme was necessary, SAMA met with plementation of pilot projects for

25 Regional and NMA News

HIV/Aids treatment in all provinces as a tionally vulnerable group in South Africa As part of awareness campaigns the Junior matter of urgency, and will pursue all possi- society,” said Dr Chetty. Doctors’ Association of SA (Judasa), an af- bilities towards facilitating treatment filiate group of SAMA, created the Black through efforts with other organisations.” Doctors’ clinical independence came under Armband Campaign to show solidarity with fire with the von Mollendorff case. Dr Thys HIV/Aids victims. Judasa emphasised that Meanwhile, SAMA joined forces with the von Mollendorff was dismissed for treating their campaign was not an attack on govern- Treatment Action Campaign and the Nelson HIV-positive patients. SAMA worked close- ment, but rather an offer to assist in any go- Mandela Foundation to strengthen its positi- ly with the Greater Nelspruit Intervention vernment action aimed at fighting the on in the fight against the disease. Programme (GRIP) and the Aids Law Pro- HIV/Aids pandemic. As part of the cam- ject to see that the case was concluded for paign, junior doctors intended to keep SAMA has over the years used all means ne- the positive. Letlape referred to the dismis- thorough records of patients they saw dying cessary to inform its members, and patients, sal of Dr von Mollendorff as an example in of HIV. The records would then be sent to on the right to treatment of HIV. SAMA has which doctors’ responsibility to their pati- the relevant authorities, to share with gover- reiterated the profession’s commitment to ents was severely disrupted, which was in nment what junior doctors’ experienced in the alleviation of the HIV pandemic by all direct contrast with the rights of individuals dealing with the HIV/Aids pandemic every means possible, and affirmed its strong sup- which are entrenched in the constitution. He day. port for the fundamental rights of medical emphasised that urgent discussion with go- practitioners to clinical independence and Awareness campaigns continued with vernment was needed to look at the principle autonomy. This includes the right to treat SAMA closely watching the development of of interference in the profession’s obligati- patients without undue influence, pressure the country’s HIV/Aids programme. ons and duties on a broad scale. ”We need or victimisation from employers or govern- guidelines and rules to stimulate and nurtu- On December 1, 2002 SAMA launched the ment institutions. re private public interface,” Letlape said. Tshepang Treatment Programme, named after baby Tshepang who had been savagely The Association then adopted a set of guide- SAMA continued to reiterate the profes- raped and was put back together by caring lines, ”HIV Human Rights and Ethical Gui- sion’s right to clinical independence and au- doctors. delines” which informed members how to tonomy. Letlape referred to the 38th World deal with the management of HIV. Members Nearly a year later the Association’s dream Medical Assembly (WMA) in 1986 when were kept informed of rulings by the Labour came true – supplying ART to people living the WMA unambiguously denounced politi- Court regarding HIV through our Human with HIV. On December 1, 2003, World cal interference in health care delivery. Rights, Law and Ethics Unit, and adopted a Aids Day, SAMA launched an ART treat- ”Physicians must have the professional fre- document on ”Doctors’ and Patients’ Rights ment programme at the GF Jooste Hospital edom to care for their patients without inter- and Responsibilities”. What makes this do- in the Western Cape. The Association plans ference. The exercise of the physician’s pro- cument unique, is that it translates the hu- to gather more financial support from the fessional judgement and discretion in ma- man rights found in the South African Con- role-players in the industry, and eventually king clinical and ethical decisions in the stitution into real-life situations affecting have two treatment sites in every province. care and treatment of patients must be pre- doctors and patients. A second distinctive served and protected.” The Association SAMA’s Foundation for Professional Deve- feature is the inclusion of responsibilities or made it clear that it would continue to assist lopment (FPD), the educational arm of duties. For example, every doctor has the and support doctors who acted in the best in- SAMA, has developed an HIV management right to life, which includes the right not to terest of patients and their rights to access to course for doctors and other health person- be placed in disproportional life-threatening health care. nel. To date they have trained 3,500 health situations. But every doctor has the duty to care professionals in South Africa, and also protect life, within the confines of patient Later Amnesty International (A.I.) urged the train health workers in Africa. autonomy and decision-making power. On Minister of Health to put a stop to the haras- the other hand, patients have the right to SAMA’s motto is ”Uniting doctors for the sment of health care professionals and other have their lives protected by means of the health of the nation,” and we plan to do just service providers in Mpumalanga Province, benefits of medicine when available, and so. KL/TS to end discrimination against women in when they so wish. However, patients also need and to uphold professional ethics. have the duty to ensure that their illness or A.I.’s involvement in this issue started in incapacity does not endanger the lives of November 2001 when renewed action was others. taken against Dr von Mollendorff for his in- SAMA has always stressed the fact that its volvement in GRIP, which offered counsel- members were fighting the pandemic in ling and treatment to rape survivors. Accor- their everyday work. ”Medical practitioners ding to A.I., its correspondence with the re- are under an ethical duty to act in the best in- levant authorities requesting information on terest of their patients, who form an excep- the issue remained unanswered.

26 Regional and NMA News

prisoner (patient) and the prison administra- Norwegian Medical Association tion, e. g. during hunger strikes; the patient's right to confidentiality; certifying prisoners for special punishment etc. Health care for prisoners: human rights international human rights and ethical stan- The course will be accessible to everyone with and ethical dilemmas for doctors working dards. an Internet connection. Doctors and other in prison - a web-based course for health health personnel working in prison can take the In many countries education of prison doc- care personnel working in prison course at their own pace and whenever they tors is a priority area. Many doctors do not want. Participants do not have to complete the In 2001 the Norwegian Medical Association even have access to international conventions whole course in one go. The course is divided took the initiative to develop a web-based and rules regulating the health care service into lessons and the system remembers which course on Human rights and ethics for prison for prisoners. We are aware that many doctors lessons the participant has completed. doctors. Various associations and organisa- know about human rights violations, but do tions have contributed to this course, and not know how to deal with them in an ade- No course fee will be charged for those who World Medical Association will be the main quate way. We hope this course will con- wish to complete the course. When it is fin- provider. tribute to meeting some of the needs for more ished we will apply for approval at European knowledge and skills in human rights and Accreditation Council for CME. Doctors working in prisons face problems medical ethics felt by many prison doctors. This course is sponsored by The Norwegian that are different from the problems encoun- Ministry of Foreign Affairs. The authors and tered by doctors working with the ordinary The objectives of the course are to present editors have contributed without receiving population. Prison doctors must be able to relevant international statements regulating any fees. provide adequate health care in the special medical treatment of prisoners, and to raise environments to be found in prisons, and en- prison doctor's awareness of their role in var- A preliminary version of the course is acces- sure that this practice does not conflict with ious areas of conflicting interests between the sible at http://www.lupin-nma.net/b.m.

U.K. ke is a cause of cot death, and increases the risk of respiratory illness and middle ear infection. It can cause asthma, and exacerbates New report details the impact of smoking on attacks in those already affected. sexual, reproductive and child health The good news is that giving up smoking reduces or eliminates many of the risks to re- A new report from the British Medical Asso- The peer-reviewed report draws together ma- productive life and health. In contrast to much ciation presents a disturbing picture of the ef- terial from more than 200 reference sources, of the excess risk of death associated with fects of smoking on sexual, reproductive and including expert evaluations by the US Sur- smoking, much of the bürden of smoking on child health - and demands national and inter- geon General and the World Health Organi- reproductive life falls in younger adults, befo- national action to tackle the issue. Smoking sation, as well as more recent original rese- re age 40. In coming years. this bürden looks and Reproductive Life, a joint publication of arch. Among the effects linked to active smo- set to increase: smoking rates look set to triple the BMA board of Science and Education and king are impotence, sperm damage, delayed among women in the next generation, and the BMA-funded Tobacco Control Resource conception, infertility. increased risk of ecto- more than half the world’s children are expo- Centre, is the first focused overview of its pic pregnancy and miscarriage. damage to sed to secondhand smoke. kind. the foetus, low birthweight, placental compli- The report frames smoking as an important cations, premature birth. Smoking is also a The picture that emerges is disturbing. Smo- consideration in sexual, reproductive and cause of early menopause, and increases the king harms sexual and reproductive health in child health. It makes recommendations to re- risk of malignant cervical cancer up to three both men and women. Its damaging effects duce the burden of sexual, reproductive and fold. are seen throughout reproductive life - from childhood ill health caused by tobacco. inclu- puberty, through young adulthood and into The effects of passive smoking are also high- ding recommendations for research, healthca- middle age. Smoking can compromise the ca- lighted. Non-smoking women exposed to re professionals and public policy. pacity to have a family, and parental smoking other people’s tobacco smoke during preg- The full report is available from the Tobacco can have long-term and serious consequences nancy have lighter babies. and are at increa- Control Resource Centre website: for child health. Exposure to second-hand sed risk of having a low birth-weight baby. smoke is a risk during pregnancy, and harms Even relatively low-level exposure has a sig- http://www.tobacco-control.org. For further infants and children. nificant effect. In children, secondhand smo- information, contact: [email protected].

27 Reviews

The Fiji Medical Association is seeking re- count in their everyday practice. And when Fiji and India vision of the Medical Act and is also en- the guidance is specifically ethical, it is Licensing and Regulation countering problems in generating politi- sometimes formulated in prescriptive terms cal will to provide legislative time. The without any ethical reasoning, for example, The WHO Bulletin WHO Bull. 82/2 reports key issues are to bring the licensing re- ”doctors with a conscientious objection to concern that legislative delays are slowing quirements into line with global trends in providing contraceptive advice or treatment down the progress of continuing medical ed- 2004, to introduce obligatory CME as a have an ethical duty to refer their patients ucation in India. ”The Medical Council has condition for renewal of registration and to promptly to another practitioner or family been campaigning for CME to be made update professional disciplinary proce- planning service” (p. 233). compulsory” and has ”proposed a draft dures. The Fiji Medical Association has Where ethical dilemmas occur for which amendment to a law that would standardise also joined the Fiji Human Rights Com- there is no explicit legal or regulatory re- medical practice across the country while mission to become actively involved in as- quirement, the book recommends that the making sure that it is up to date with the lat- sessment of treatment of persons in cus- BMA Ethics Department and/or the medical est medical developments”. tody. indemnity bodies be consulted. However, in these circumstances the book frequently also Book Review treatments of the chapter subtopics with recommends that doctors seek legal advice. summaries of the main points, abstracts of The reader is entitled to question the value of Medical Ethics Today: The BMA’s handbook pertinent legal cases, and extensive endnotes. this approach, since legal opinions can and of ethics and law (2nd edition). British Med- The chapters are generally quite comprehen- do differ greatly, especially when the law is ical Association Ethics Department. Pp. xxv, sive in their treatment of the issues, as least unclear, and seeking such advice is both 882, London, BMJ Books, 2004, £ 60.00 insofar as they affect doctors in the UK. time-consuming and costly. Clinical ethics In 1993 the BMA published Medical Ethics There are very few citations of publications committees, which in other countries have Today: Its Practice and Philosophy, which from other countries. proved useful for dealing with ethical dilem- was the fifth in a series of handbooks on mas, are mentioned only in connection with Like the 1993 edition, the aim of this book is ethics dating back to 1980. Now, a decade assisted reproduction. to produce a working tool for doctors rather later, a revised version of the 1993 edition than a philosophical treatise: ”Since doctors Despite the book’s massive size, there are has appeared. Its greatly increased bulk, tend to need a quick and workable solution several topics that would have merited more more than twice that of its predecessor, is for an immediate case, the guidance focuses extensive treatment. These include alloca- largely due to the addition of legal issues that on practical responses to these common tion/rationing of health care resources, par- were formerly treated in a separate BMA questions, but this process inevitably brings ticularly the role of the individual doctor; the publication, Rights and Responsibilities of in reference to philosophy and law” (p. 2). participation of doctors in medical research, Doctors. Indeed, the title of the present vol- For many issues the practical response is rel- including their qualifications, compensation ume is somewhat inaccurate, since the law atively unproblematic, since the legislators, and responsibility for ethical committee re- receives at least as much consideration as the courts or the General Medical Council view; the relationship of doctors and com- does ethics. have already reached a conclusion and the mercial organisations, especially pharmaceu- Unlike the 1993 edition, the authorship and book states categorically that ”it is … neces- tical companies; multicultural health care; status of this book is unclear. The front cov- sary to ensure that the action proposed is not and ethics education in medical schools. er assigns authorship to the BMA Ethics De- contrary to law or to guidance issued by the Doctors in the UK will find this book to be a partment whereas on p. xxiii the book is re- GMC” (p. 10). useful reference for a great variety of clinical, ferred to as a publication from the BMA’s professional and public policy issues. Since Medical Ethics Committee. The text fre- Other issues are not so clear-cut because the so much of the book is devoted to British law, quently speaks in the name of the BMA (”In law and the GMC are silent or inconclusive. however, it has limited applicability in other the BMA’s view …,”, ”the BMA believes However, as with the unproblematic issues, countries. …,”, ”BMA advice is that …,” etc.) but it is the book encourages doctors to look for ex- seldom evident what type of approval any ternal advice rather than deciding on their A CD-ROM version of the book, with a particular statement has received within the own how to deal with the situation. The guid- handy search feature, is included at no extra BMA. ance provided by the book on these issues is cost or can be purchased separately. Updates derived from previous BMA statements, re- on the issues covered in the book are to be The book comprises an introduction and ports from various organisations, the ethics provided on the BMA Ethics web site. 21 chapters on topics ranging from the doc- and legal literature, and especially standards tor-patient relationship to public health and of good clinical practice. Indeed, much of the John R. Williams from assisted reproduction to responsibilities guidance is neither ethical nor legal but Director of Ethics after a patient’s death. Each chapter includes rather descriptive of social and organisation- World Medical Association a statement of relevant principles, detailed al factors that doctors need to take into ac- Ferney-Voltaire, France

28 Association and address/Officers

CHILE DOMINICAN REPUBLIC Tel: (995 32) 39868 / Fax: -398083 10 Fitzwilliam Place Colegio Médico de Chile Asociación Médica Dominicana E-mail: [email protected] Dublin 2 Esmeralda 678 - Casilla 639 Calle Paseo de los Medicos Tel: (353-1) 676-7273 Santiago Esquina Modesto Diaz Zona GERMANY Fax: (353-1) 6612758/6682168 Tel: (56-2) 4277800 Universitaria Bundesärztekammer Website: www.imo.ie Fax: (56-2) 6330940 / 6336732 Santo Domingo (German Medical Association) E-mail: [email protected] Tel: (1809) 533-4602/533-4686 Herbert-Lewin-Strasse 1 ISRAEL Website: www.colegiomedico.cl /533-8700 50931 Köln Israel Medical Association Vicepresidente Fax: (1809) 535 7337 Tel: (49-221) 400-4360/Fax: -4384 2 Twin Towers, 35 Jabotinsky St. E-mail: [email protected] Teletex: 2211315 - BAK P.O. Box 3566, Ramat-Gan 52136 CHINA E-mail:[email protected] Tel: (972-3) 6100444 / 424 Chinese Medical Association ECUADOR Website: www.bundesaerztekammer.de Fax: (972-3) 5751616 / 5753303 42 Dongsi Xidajie Federación Médica Ecuatoriana E-mail: [email protected] Beijing 100710 V.M. Rendón 923 – 2 do.Piso Of. 201 GHANA Website: www.ima.org.il Tel: (86-10) 6513 4885 P.O. Box 09-01-9848 Ghana Medical Association P.O. Box 1596 JAPAN Fax: (86-10) 6512 3754 Guayaquil Accra Japan Medical Association E-mail: [email protected] Tel/Fax: (593) 4 562569 E-mail: [email protected] Tel: (233-21) 670-510/Fax: -511 2-28-16 Honkomagome, Bunkyo-ku E-mail: [email protected] Tokyo 113-8621 COLOMBIA Tel: (81-3) 3946 2121/3942 6489 Federación Médica Colombiana EGYPT HAITI, W.I. Fax: (81-3) 3946 6295 Calle 72 - N¡ 6-44, Piso 11 Egyptian Medical Association „Dar El Hekmah“ Association Médicale Haitienne E-mail: [email protected] Santafé de Bogotá, D.E. ère 42, Kasr El-Eini Street 1 Av. du Travail #33 Ð Bois Verna Tel: (57-1) 211 0208 Port-au-Prince KAZAKHSTAN Tel/Fax: (57-1) 212 6082 Cairo Tel: (20-2) 3543406 Tel: (509) 245-2060/511-0253 Association of Medical Doctors E-mail: federacionmedicacol@ Fax: (509) 223-9885 of Kazakhstan hotmail.com EL SALVADOR, C.A E-mail: [email protected] 117/1 Kazybek bi St., Colegio Médico de El Salvador Website: www.amhhaiti.org Almaty DEMOCRATIC REP. OF CONGO Tel: (3272) 62 -43 01 / -92 92 Ordre des Médecins du Zaire Final Pasaje N¡ 10 Colonia Miramonte HONG KONG Fax: -3606 B.P. 4922 Hong Kong Medical Association, China E-mail: [email protected] Kinshasa Ð Gombe San Salvador Tel: (503) 260-1111, 260-1112/ Duke of Windsor Building, 5th Floor Tel: (242-12) 24589/ 15 Hennessy Road REP. OF KOREA Fax: -0324 Fax (secr.Gen): (242) 8846574 Tel: (852) 2527-8285 Korean Medical Association E-mail: [email protected] Fax: (852) 2865-0943 302-75 Ichon 1-dong, Yongsan-gu COSTA RICA E-mail: [email protected] Seoul 140-721 ETHIOPIA Unión Médica Nacional Website: www.hkma.org Tel: (82-2) 794 2474 Ethiopian Medical Association Apartado 5920-1000 Fax: (82-2) 793 9190 P.O. Box 2179 San José HUNGARY E-mail: [email protected] Addis Ababa Tel: (506) 290-5490 Association of Hungarian Medical Website: www.kma.org Tel: (251-1) 158174 Fax: (506) 231 7373 Societies (MOTESZ) Fax: (251-1) 533742 E-mail: [email protected] Nádor u. 36 KUWAIT E-mail: [email protected] / 1443 Budapest, PO.Box 145 Kuwait Medical Association [email protected] CROATIA General Director P.O. Box 1202 Tel: (36-1) 312 3807 Ð 311 6687 Safat 13013 Croatian Medical Association FIJI ISLANDS Subiceva 9 Fax: (36-1) 383-7918 Tel: (965) 5333278, 5317971 Fiji Medical Association E-mail: [email protected] Fax: (965) 5333276 10000 Zagreb nd 2 Fl. Narsey’s Bldg, Renwick Road Website: www.motesz.hu E-mail: [email protected] Tel: (385-1) 46 93 300 G.P.O. Box 1116 Fax: (385-1) 46 55 066 Suva E-mail: [email protected] ICELAND LATVIA Tel: (679) Ð315388 Icelandic Medical Association Latvian Physicians Association Fax: (679) 387671 Hlidasmari 8 Skolas Str. 3 CZECH REPUBLIC E-mail: [email protected] Czech Medical Association . 200 Kópavogur Riga Tel: (354) 5 864 0478 1010 Latvia J.E. Purkyne FINLAND Sokolská 31 - P.O. Box 88 Fax: (354) 5 644106 Tel: (371-7) 22 06 61; 22 06 57 Finnish Medical Association E-mail: [email protected] Fax: (371-7) 22 06 57 120 26 Prague 2 P.O. Box 49 E-mail: [email protected] Tel: (420-2) 242 66 201/202/203/204 00501 Helsinki INDIA Fax: (420-2) 242 66 212 / 96 18 18 69 Tel: (358-9) 3930 826/Fax-794 Indian Medical Association LIECHTENSTEIN E-mail: [email protected] Telex: 125336 sll sf Indraprastha Marg Liechtensteinischer Ärzteverein Website: www.cls.cz E-mail: [email protected] New Delhi 110 002 Postfach 52 Website: www.medassoc.fi Tel: (91-11) 337009/3378819/3378680 9490 Vaduz UNITED STATES Fax: (91-11) 3379178/3379470 Tel: (423) 232 -3440 Colegio Médico Cubano Libre FRANCE E-mail: [email protected] / Fax: (423) 232 3455 P.O. Box 141016 Association Médicale Française [email protected] Website: www.aerzte-net.li Coral Gables, FL 33114-1016 180, Blvd. Haussmann Tel: (1-305) 446 9902/445 1429 75389 Paris Cedex 08 INDONESIA LITHUANIA Fax: (1-305) 4459310 Tel: (33) 1 53 89 32 41 Indonesian Medical Association Lithuanian Medical Association Fax: (33) 1 53 89 33 44 Jalan Dr Sam Ratulangie N¡ 29 Liubarto 2 DENMARK E-mail: cnom-international@ Jakarta 10350 2004 Vilnius Danish Medical Association cn.medecin.fr Tel: (62-21) 3150679 Tel/Fax: (370-5) 2731400 9 Trondhjemsgade Fax: (62-21) 390 0473/3154 091 E-mail: [email protected] 2100 Copenhagen 0 GEORGIA E-mail: [email protected] Tel: (45) 35 44 -82 29/Fax:-8505 Georgian Medical Association LUXEMBOURG E-mail: [email protected] 7 Asatiani Street IRELAND Association des Médecins et Website: www.laegeforeningen.dk 380077 Tbilisi Irish Medical Organisation Médecins Dentistes du Grand-

ii Association and address/Officers

Duché de Luxembourg Fax: (234-1) 585 1432 (ext 2197) Legionarska 4 1082 Tunis Cité Jardins 29, rue de Vianden E-mail: [email protected] 81322 Bratislavia Tel: (216-1) 792 736/799 041 2680 Luxembourg Tel: (421-2) 554 24 015 Fax: (216-1) 788 729 Tel: (352) 44 40 331 NORWAY Fax: (421-2) 554 223 63 E-mail: [email protected] Fax: (352) 45 83 49 Norwegian Medical Association E-mail: [email protected] E-mail: [email protected] P.O.Box 1152 sentrum TURKEY Website: www.ammd.lu 0107 Oslo SLOVENIA Turkish Medical Association Tel: (47) 23 10 -90 00/Fax: -9010 Slovenian Medical Association GMK Bulvary,. MACEDONIA E-mail: ellen.pettersen@ Komenskega 4 Pehit Danip Tunalygil Sok. N¡ 2 Kat 4 Macedonian Medical Association legeforeningen.no 61001 Ljubljana Maltepe Dame Gruev St. 3 Website: www.legeforeningen.no Tel: (386-61) 323 469 Ankara P.O. Box 174 Fax: (386-61) 301 955 91000 Skopje PANAMA Tel: (90-312) 231 Ð3179/Fax: -1952 E-mail: [email protected] Tel/Fax: (389-91) 232577 Asociación Médica Nacional SOUTH AFRICA de la República de Panamá The South African Medical Association MALAYSIA Apartado Postal 2020 UGANDA P.O. Box 74789, Lynnwood Rydge Uganda Medical Association Malaysian Medical Association Panamá 1 0040 Pretoria 4th Floor, MMA House Tel: (507) 263 7622 /263-7758 Plot 8, 41-43 circular rd. Tel: (27-12) 481 2036/7 124 Jalan Pahang Fax: (507) 223 1462 P.O. Box 29874 Fax: (27-12) 481 2058 53000 Kuala Lumpur Fax modem: (507) 223-5555 Kampala E-mail: [email protected] Tel: (60-3) 40418972/40411375 E-mail: [email protected] Tel: (256) 41 32 1795 Website: www.samedical.org Fax: (60-3) 40418187/40434444 Fax: (256) 41 34 5597 E-mail: [email protected] PERU SPAIN E-mail: [email protected] Website: http://www.mma.org.my Colegio Médico del Perú Consejo General de Colegios Malecón Armendáriz N¡ 791 UNITED KINGDOM MALTA Miraflores Oficiales de Médicos Villanueva 11 British Medical Association Medical Association of Malta Lima BMA House, Tavistock Square The Professional Centre Tel: (51-1) 241 75 72 Madrid 28001 London WC1H 9JP Sliema Road, Gzira GZR 06 Fax: (51-1) 242 3917 Tel: (34-91) 4317780 Tel: (44-207) 387-4499 Tel: (356) 21312888 E-mail: [email protected] Fax: (34-91) 5764388 Fax: (356) 21331713 Website: www.colmed.org.pe E-mail: [email protected] Fax: (44- 207) 383-6711 E-mail: [email protected] E-mail: [email protected] Website: www.mam.org.mt PHILIPPINES SWEDEN Website: www.bma.org.uk Philippine Medical Association Swedish Medical Association MEXICO PMA Bldg, North Avenue (Villagatan 5) UNITED STATES OF AMERICA Colegio Medico de Mexico Quezon City P.O. Box 5610 American Medical Association Fenacome Tel: (63-2) 929-63 66/Fax: -6951 SE - 114 86 Stockholm 515 North State Street Hidalgo 1828 Pte. Cons. 410 E-mail: [email protected] Tel: (46-8) 790 33 00 Chicago, Illinois 60610 Colonia Obispado C.P. 64060 Fax: (46-8) 20 57 18 Tel: (1-312) 464 5040 Monterrey, Nuevo Léon POLAND E-mail: [email protected] Fax: (1-312) 464 5973 Tel/Fax: (52-8) 348-41-55 Polish Medical Association Website: www.lakarforbundet.se Website: http://www.ama-assn.org E-mail: [email protected] Al. Ujazdowskie 24 Website: www.fenacome.org 00-478 Warszawa SWITZERLAND URUGUAY Tel: (48-22) 628 86 99 Fédération des Médecins Suisses Sindicato Médico del Uruguay NEPAL Fax: (48-22) 628 86 99 Elfenstrasse 18 Ð POB 293 Bulevar Artigas 1515 Nepal Medical Association 3000 Berne 16 CP 11200 Montevideo Siddhi Sadan, Post Box 189 PORTUGAL Tel: (41-31) 359 Ð1111/Fax: -1112 Tel: (598-2) 401 47 01 Exhibition Road Ordem dos Médicos E-mail: [email protected] Fax: (598-2) 409 16 03 Katmandu Av. Almirante Gago Coutinho, 151 Website: www.fmh.ch/ww/fr/pub/fmh/ E-mail: [email protected] Tel: (977 1) 225860, 231825 1749-084 Lisbon histoire_fmh.htm Fax: (977 1) 225300 Tel: (351-21) 842 71 00/842 71 11 VATICAN STATE E-mail: [email protected] Fax: (351-21) 842 71 99 TAIWAN E-mail: [email protected] Associazione Medica del Vaticano Chinese Medical Association - Taipei Stato della Citta del Vaticano 00120 NETHERLANDS / [email protected] 201, Shih-pai Rd., Sec. 2 Royal Dutch Medical Association Tel: (39-06) 6983552 Website: www.ordemdosmedicos.pt P.O. Box 3043 P.O. Box 20051 Fax: (39-06) 69885364 Taipei 11217 3502 LB Utrecht ROMANIA Tel: (886-2) 2871-2121, ext 7358 Tel: (31-30) 28 23-267/Fax-318 Romanian Medical Association VENEZUELA Fax: (886-2) 28741097 E-mail: [email protected] Str. Progresului 10 Federacion Médica Venezolana E-mail: [email protected] Website: http://www.knmg.nl Sect. 1, Bucarest, cod 70754 Avenida Orinoco Tel: (40-1) 6141071 Torre Federacion Médica Venezolana NEW ZEALAND Fax: (40-1) 3121357 THAILAND Medical Association of Thailand Urbanizacion Las Mercedes New Zealand Medical Association E-mail: [email protected] Caracas P.O. Box 156 Website: www.cdi.pub.ro/CDI/ 2 Soi Soonvijai New Petchburi Road Tel: (58-2) 9934547 Wellington 1 Parteneri/AMR_main.htm Fax: (58-2) 9932890 Tel: (64-4) 472 Ð4741/ Fax-0838 Bangkok 10320 Website: www.saludfmv.org and Fax: (64-4) 471 0838 RUSSIA Tel: (66-2) 314 4333/318-8170 [email protected] E-mail: [email protected] Russian Medical Society Fax: (66-2) 314 6305 Website: www.nzma.org.nz 34, Build. 1, Novy Arbat E-mail: [email protected] 121099 Moscow Website: http://www.medassocthai.org/ ZIMBABWE NIGERIA Tel: (7-095)205-7371 index.htm. Zimbabwe Medical Association Nigerian Medical Association Fax: (7-095) 205-3293 P.O. Box 3671 74, Adeniyi Jones Avenue Ikeja E-mail: [email protected] TUNISIA Harare P.O. Box 1108, Marina Conseil National de l’Ordre Tel: (263-4) 791/553 Lagos SLOVAK REPUBLIC des Médecins de Tunisie Fax: (263-4) 791561 Tel: (234-1) 497 7262, Slovak Medical Association 16, rue de Touraine E-mail: [email protected] iii