- Email: [email protected]
EC directives and specialists
1017
set up cancer registries. The federal Government wants all the registries to be standardised. Doctors and dentists would be requested, but not obliged, to register their cancer patients, and they would receive a fee for each case registered. A case can be registered only if the patient gives consent. The patient must be informed that he can withdraw his consent at any time. The patient would also be able, at any time, to inquire whether and what information is held in the registry. However, if telling the patient that he has cancer is likely to affect him adversely, the doctor may delay seeking consent until the patient is judged ready to discuss the subject. Despite these limitations the Health Ministry expects to obtain a representative set of data in each registry. The registry would also receive a copy of the death certificate and necropsy report. To avoid the biggest obstacle to cancer registries-the data protection law—epidemiological data would be separated from data that would reveal the identity of the patient. The separation would be done at a "place of trust", an institution led by a doctor, where the data would first be inspected for their plausibility. Both epidemiological and personal data would then be sent to the registry. The patient may be identified if the specified authority-possibly the state health ministry-gave permission. However, the personal data may be used for research purposes only if the patient-or the relatives, if the patient has died-agrees to it. The chances that this proposed law will come into force by 1995 are fairly good-the data protection officers have on the whole reacted positively.
Annette Tuffs
Conference WHO seeks ways to improve control of drug
promotion Although the pharmaceutical industry has a clear right to promote its products, it must always stop short of encouraging the excessive or inappropriate use of drugs. In most industrialised countries restraints are provided by a combination of national legislation and the industry’s own professional codes, but some promotional practices continue to generate alarm. In developing countries, where codes of behaviour have been more difficult to establish and where the need for rational prescribing is even greater, controls on drug promotion have been much less effective. What can be done? In 1988 The World Health Organization published its Ethical Criteria for Medicinal Drug Promotion-a set of international "minimum" standards for activities including advertising, the work of medical representatives (detail men), and sponsored meetings. Sad to say, these clear and straightforward criteria have been much neglected. So WHO, through the Council for International Organizations of Medical Science (CIOMS), convened a meeting in Geneva for April 5-7 to look at ways of improving their
uptake. The atmosphere was one of strained goodwill; the various factions had battled hard in previous encounters and clearly wanted consensus rather than confrontation on this occasion. The 50 or so attenders were chosen to reflect wide interests and skills, but the key players were the representatives of industry and of consumers. (Some of the latter group had brought specimens of bad advertising, but in the interests of harmony public displays were not
permitted.)
Legislators, educators, and journal editors added their voices now and then. In three days of presentations and debate the group examined the roles and responsibilities of governments, the pharmaceutical industry, health professionals, patient and consumer groups, and journals in implementing the criteria. Finally the group drew up a list of points for the World Health Assembly to consider in just over a year’s time. One important recommendation was for better monitoring of the promotional activities of companies, both local and multinational: without some idea of the scale of dubious practices, systematic remedies can never be devised. To put control on a sound footing, self-regulation by industry will need to be coupled with legislation and supervision by governments. But the answer does not lie with governments and industry alone. The consensus in Geneva was that improvements in promotional practice are most likely if adherence to the WHO ethical criteria is a shared concern of all those who provide health care. A "coalition" of
industry, consumers, educators, health professionals, and the media was seen as the best prospect; teachers in particular, whether of schoolchildren or of medical students, must spread the word about rational use of drugs; physicians, pharmacists, and nurses must learn how to interpret commercial material that, despite inherent bias, carries useful information; consumer groups must continue their monitoring function; patients must press for their right to know about the medicines prescribed to them; independent drug bulletins should be encouraged as sources of accurate and independent advice; and journal editors should accept responsibility for the standard of promotional material carried in their publications, including those with local print-runs outside the country of origin. Finally, what of the pharmaceutical industry? Those whom we heard in Geneva may not speak for all; but they at least were determined that promotion of drugs must always be done in government,
a manner
consistent with WHO’s ethical criteria.
Drug and Therapeutics Bulletin
Joe Collier
The Lancet
Robin Fox
Medicine and the Law EC directives and specialists On March 30, 1993, Dr A. J. Goldstein applied for judicial review, seeking inter alia declarations that the UK was in breach of its obligation to implement the first and second EC medical directives by failing to publish a list of doctors who had completed specialist training as recognised under EC regulations. He could go to any other EC member
country and exercise the rights that the directives covered but in the UK he was subject to the same restraints he would have been under had the directives not been adopted. Although certificated by the UK General Medical Council on Jan 31, 1990, as having completed specialist training in rheumatology, Goldstein could not make this known to the
public.! Mr Justice Schiemann said that the Council of Ministers of the EC had been faced with widely differing periods and methods of training for doctors in the member states and with a wide variety of diplomas and other qualifications. Each state no doubt thought that its method of training was the best, and the tradition
was one
of reluctance
to
let loose
foreign doctors in one’s own country. The 1975 directives were designed to facilitate the exercise of the Treaty rights to
1018
freedom to provide medical services in countries other than the member state of qualification-yet without going so far as to harmonise all provisions on specialist training. They were not designed to enable a national of one member state who had not acquired a qualification abroad to improve his position at home. EC certification as a specialist provided a "medical passport" to other EC states. The judge distinguished the 1981 case of Broekmeulen vs Huisarts Registratie Commissie, where the European Court had rejected the refusal of the Dutch equivalent of the GMC to register its own national who had qualified in Belgium. Dr Broekmeulen would have had to undergo a further year’s training before registration in the Netherlands. It seemed to have been assumed throughout that judgment that a member state could impose on its own nationals what requirements it pleased as to training before practice. Although the judge accepted Goldstein’s submissions that bodies granting medical training certificates (eg, accreditation by the Royal Colleges) did not comply with EC directives, he held this to be of no consequence since these documents did not purport to be issued pursuant to the mutual recognition protocol established by the EC directives but were internal certifications of distinction. The judge also held that since the UK citizen and resident had no right under EC law to have the specialist list published, the question of discriminating against a national of another member of state by denying him such right did not arise. This finding of non-discrimination is on the face of it at odds with the decision arising from the complaint of Dr Querci della Rovere (mentioned in the draft transcript), who was told on arrival in the UK that his medical passport was worthless and that his name could not appear in the Medical Register with the indicator signifying completion of specialist medical training that appeared against those accredited in the UK. The respondent in that case accepted that this situation amounted to a breach of EC law, and consultations are in hand to bring practice into line. Goldstein’s submission that the UK should afford to its own nationals who hold a medical passport in rheumatology the facility to practise their specialty openly in the UK as afforded to EC passport holders seems reasonable and in accordance with EC principles on the exchange of services between member states. In his attempt to secure publication of the specialist list (and to require withdrawal of the 1993 Medical Register) he has failed. Nonetheless, in the light of the della Rovere decision, it could be argued that a UK specialist medical passport holder should be entitled to equivalent recognition so that he or she can "shop in the same market place" as nationals from member states. Although Goldstein has in the past received some support from medical bodies, including the Hospital Doctors’ Association, on this occasion he appeared in person and he will be responsible for the costs of the respondent (the Secretary of State for Health), which have been estimated at ,E60 000. The current review of this vexed and somewhat embarrassing situation seems to recognise the strength of some of Goldstein’s arguments and for that reason I hope that the Department of Health will not pursue him for those costs. Indeed a possible outcome of the as yet unpublished review is that in the UK "accreditation, as it currently exists, will 90 .a The judge’s decision will affect the position of many UK doctors who are recognised by EC law as specialists but have not acquired the accreditation under domestic UK
provisions without which a consultant appointment is unlikely. As Mr Justice Schiemann recognised, such accreditation requires the completion of specified training to the satisfaction of the relevant Royal College which involves "a fair amount of subjective assessment by seniors in the profession". Local autonomy in the recognition of diplomas has been raised in another recent European case. On March 31,1993, the European Court gave its judgment on a question posed by a Stuttgart court, ruling that it was legitimate for German authorities to demand the formal authorisation of university diplomas acquired elsewhere in the EC. Dieter Kraus, holding a master of laws degree from Edinburgh, had submitted
authorised copy to the authorities of BadenWurttemberg but refused to do so formally or to pay the DM130 fee required. That, he argued, unsuccessfully, was a discrimination prohibited by the Treaty of Rome.3 an
Diana Brahams 1.
Regina v Secretary of State for Health, ex parte Goldstem. Times, April 5, 1993: 26. EUROBrief 1993;
2. Anon. UK Government due to report on specialist training. BMA 49: 1.
3. Krausv Land Baden-Württemberg.
Times, April 6, 1993: 37.
Noticeboard Bovine
growth hormone and mastitis
A US FDA advisory panel has acknowledged that there is an increased risk of mastitis in cows treated with recombinant bovine growth hormone (BGH, bovine somatotropin, sometribove, Monsanto) to increase milk production but has concluded that the resultant antibiotic use to treat bovine mastitis does not pose any significant risk to human health. This conclusion contrasts with the recommendation by the General Accounting Office that FDA should halt the marketing of dairy products from BGH-treated cows until the potential risk from increased antibiotics use is evaluated (see Lancet 1992; 340: 782). Up to now the hormone has been approved for research purposes and milk from these cows can be used for human consumption. It is believed that the FDA has authorised BGH testing on more than 20 000 cows in the US. "Although the Committee concluded that the risk posed by BGH is manageable, the approval process is still not complete", said Dr Richard Teske, deputy director of FDA’s Center for Veterinary Medicine. However, anticipating approval of BGH for commercial use, consumer groups have launched a massive boycott of milk, meat, and dairy products from cows injected with BGH, and in response several grocery stores and dairy and milk corporations, including Abbott/Ross and Wyeth/Ayerst Laboratories, have announced that they will not accept or sell milk from BGH-treated cows, irrespective of FDA approval. Dr Michael Hansen of the Consumers’ Union, who testified before the panel, said that "the FDA concedes that BGH use increases mastitis by 50%. But the mastitis rate in cows may actually be much higher". A study which suggested that mastitis rates could be considerably higher was blocked from publication in a British journal by Monsanto, said Dr Hansen. This allegation about Monsanto refers to a meta-analysis done by Eric Brunner of University College London and colleagues there and at Sussex University, the National Institute of Economic and Social Research, London, and the Polytechnic of North London. The meta-analysis was of eight randomised controlled trials done in several countries and in which one of the end-points was somatic-cell (leucocyte) counts in cow’s milk. When submitted to a veterinary journal the paper was on its way towards acceptance in November, 1991, the only obstacle being the need for Monsanto’s permission to use raw data from the trials. In February, 1992, Monsanto refused that permission and told Brunner that it had submitted one paper on this topic to a different journal and had another paper in preparation. When Brunner proposed that the
set up cancer registries. The federal Government wants all the registries to be standardised. Doctors and dentists would be requested, but not obliged, to register their cancer patients, and they would receive a fee for each case registered. A case can be registered only if the patient gives consent. The patient must be informed that he can withdraw his consent at any time. The patient would also be able, at any time, to inquire whether and what information is held in the registry. However, if telling the patient that he has cancer is likely to affect him adversely, the doctor may delay seeking consent until the patient is judged ready to discuss the subject. Despite these limitations the Health Ministry expects to obtain a representative set of data in each registry. The registry would also receive a copy of the death certificate and necropsy report. To avoid the biggest obstacle to cancer registries-the data protection law—epidemiological data would be separated from data that would reveal the identity of the patient. The separation would be done at a "place of trust", an institution led by a doctor, where the data would first be inspected for their plausibility. Both epidemiological and personal data would then be sent to the registry. The patient may be identified if the specified authority-possibly the state health ministry-gave permission. However, the personal data may be used for research purposes only if the patient-or the relatives, if the patient has died-agrees to it. The chances that this proposed law will come into force by 1995 are fairly good-the data protection officers have on the whole reacted positively.
Annette Tuffs
Conference WHO seeks ways to improve control of drug
promotion Although the pharmaceutical industry has a clear right to promote its products, it must always stop short of encouraging the excessive or inappropriate use of drugs. In most industrialised countries restraints are provided by a combination of national legislation and the industry’s own professional codes, but some promotional practices continue to generate alarm. In developing countries, where codes of behaviour have been more difficult to establish and where the need for rational prescribing is even greater, controls on drug promotion have been much less effective. What can be done? In 1988 The World Health Organization published its Ethical Criteria for Medicinal Drug Promotion-a set of international "minimum" standards for activities including advertising, the work of medical representatives (detail men), and sponsored meetings. Sad to say, these clear and straightforward criteria have been much neglected. So WHO, through the Council for International Organizations of Medical Science (CIOMS), convened a meeting in Geneva for April 5-7 to look at ways of improving their
uptake. The atmosphere was one of strained goodwill; the various factions had battled hard in previous encounters and clearly wanted consensus rather than confrontation on this occasion. The 50 or so attenders were chosen to reflect wide interests and skills, but the key players were the representatives of industry and of consumers. (Some of the latter group had brought specimens of bad advertising, but in the interests of harmony public displays were not
permitted.)
Legislators, educators, and journal editors added their voices now and then. In three days of presentations and debate the group examined the roles and responsibilities of governments, the pharmaceutical industry, health professionals, patient and consumer groups, and journals in implementing the criteria. Finally the group drew up a list of points for the World Health Assembly to consider in just over a year’s time. One important recommendation was for better monitoring of the promotional activities of companies, both local and multinational: without some idea of the scale of dubious practices, systematic remedies can never be devised. To put control on a sound footing, self-regulation by industry will need to be coupled with legislation and supervision by governments. But the answer does not lie with governments and industry alone. The consensus in Geneva was that improvements in promotional practice are most likely if adherence to the WHO ethical criteria is a shared concern of all those who provide health care. A "coalition" of
industry, consumers, educators, health professionals, and the media was seen as the best prospect; teachers in particular, whether of schoolchildren or of medical students, must spread the word about rational use of drugs; physicians, pharmacists, and nurses must learn how to interpret commercial material that, despite inherent bias, carries useful information; consumer groups must continue their monitoring function; patients must press for their right to know about the medicines prescribed to them; independent drug bulletins should be encouraged as sources of accurate and independent advice; and journal editors should accept responsibility for the standard of promotional material carried in their publications, including those with local print-runs outside the country of origin. Finally, what of the pharmaceutical industry? Those whom we heard in Geneva may not speak for all; but they at least were determined that promotion of drugs must always be done in government,
a manner
consistent with WHO’s ethical criteria.
Drug and Therapeutics Bulletin
Joe Collier
The Lancet
Robin Fox
Medicine and the Law EC directives and specialists On March 30, 1993, Dr A. J. Goldstein applied for judicial review, seeking inter alia declarations that the UK was in breach of its obligation to implement the first and second EC medical directives by failing to publish a list of doctors who had completed specialist training as recognised under EC regulations. He could go to any other EC member
country and exercise the rights that the directives covered but in the UK he was subject to the same restraints he would have been under had the directives not been adopted. Although certificated by the UK General Medical Council on Jan 31, 1990, as having completed specialist training in rheumatology, Goldstein could not make this known to the
public.! Mr Justice Schiemann said that the Council of Ministers of the EC had been faced with widely differing periods and methods of training for doctors in the member states and with a wide variety of diplomas and other qualifications. Each state no doubt thought that its method of training was the best, and the tradition
was one
of reluctance
to
let loose
foreign doctors in one’s own country. The 1975 directives were designed to facilitate the exercise of the Treaty rights to
1018
freedom to provide medical services in countries other than the member state of qualification-yet without going so far as to harmonise all provisions on specialist training. They were not designed to enable a national of one member state who had not acquired a qualification abroad to improve his position at home. EC certification as a specialist provided a "medical passport" to other EC states. The judge distinguished the 1981 case of Broekmeulen vs Huisarts Registratie Commissie, where the European Court had rejected the refusal of the Dutch equivalent of the GMC to register its own national who had qualified in Belgium. Dr Broekmeulen would have had to undergo a further year’s training before registration in the Netherlands. It seemed to have been assumed throughout that judgment that a member state could impose on its own nationals what requirements it pleased as to training before practice. Although the judge accepted Goldstein’s submissions that bodies granting medical training certificates (eg, accreditation by the Royal Colleges) did not comply with EC directives, he held this to be of no consequence since these documents did not purport to be issued pursuant to the mutual recognition protocol established by the EC directives but were internal certifications of distinction. The judge also held that since the UK citizen and resident had no right under EC law to have the specialist list published, the question of discriminating against a national of another member of state by denying him such right did not arise. This finding of non-discrimination is on the face of it at odds with the decision arising from the complaint of Dr Querci della Rovere (mentioned in the draft transcript), who was told on arrival in the UK that his medical passport was worthless and that his name could not appear in the Medical Register with the indicator signifying completion of specialist medical training that appeared against those accredited in the UK. The respondent in that case accepted that this situation amounted to a breach of EC law, and consultations are in hand to bring practice into line. Goldstein’s submission that the UK should afford to its own nationals who hold a medical passport in rheumatology the facility to practise their specialty openly in the UK as afforded to EC passport holders seems reasonable and in accordance with EC principles on the exchange of services between member states. In his attempt to secure publication of the specialist list (and to require withdrawal of the 1993 Medical Register) he has failed. Nonetheless, in the light of the della Rovere decision, it could be argued that a UK specialist medical passport holder should be entitled to equivalent recognition so that he or she can "shop in the same market place" as nationals from member states. Although Goldstein has in the past received some support from medical bodies, including the Hospital Doctors’ Association, on this occasion he appeared in person and he will be responsible for the costs of the respondent (the Secretary of State for Health), which have been estimated at ,E60 000. The current review of this vexed and somewhat embarrassing situation seems to recognise the strength of some of Goldstein’s arguments and for that reason I hope that the Department of Health will not pursue him for those costs. Indeed a possible outcome of the as yet unpublished review is that in the UK "accreditation, as it currently exists, will 90 .a The judge’s decision will affect the position of many UK doctors who are recognised by EC law as specialists but have not acquired the accreditation under domestic UK
provisions without which a consultant appointment is unlikely. As Mr Justice Schiemann recognised, such accreditation requires the completion of specified training to the satisfaction of the relevant Royal College which involves "a fair amount of subjective assessment by seniors in the profession". Local autonomy in the recognition of diplomas has been raised in another recent European case. On March 31,1993, the European Court gave its judgment on a question posed by a Stuttgart court, ruling that it was legitimate for German authorities to demand the formal authorisation of university diplomas acquired elsewhere in the EC. Dieter Kraus, holding a master of laws degree from Edinburgh, had submitted
authorised copy to the authorities of BadenWurttemberg but refused to do so formally or to pay the DM130 fee required. That, he argued, unsuccessfully, was a discrimination prohibited by the Treaty of Rome.3 an
Diana Brahams 1.
Regina v Secretary of State for Health, ex parte Goldstem. Times, April 5, 1993: 26. EUROBrief 1993;
2. Anon. UK Government due to report on specialist training. BMA 49: 1.
3. Krausv Land Baden-Württemberg.
Times, April 6, 1993: 37.
Noticeboard Bovine
growth hormone and mastitis
A US FDA advisory panel has acknowledged that there is an increased risk of mastitis in cows treated with recombinant bovine growth hormone (BGH, bovine somatotropin, sometribove, Monsanto) to increase milk production but has concluded that the resultant antibiotic use to treat bovine mastitis does not pose any significant risk to human health. This conclusion contrasts with the recommendation by the General Accounting Office that FDA should halt the marketing of dairy products from BGH-treated cows until the potential risk from increased antibiotics use is evaluated (see Lancet 1992; 340: 782). Up to now the hormone has been approved for research purposes and milk from these cows can be used for human consumption. It is believed that the FDA has authorised BGH testing on more than 20 000 cows in the US. "Although the Committee concluded that the risk posed by BGH is manageable, the approval process is still not complete", said Dr Richard Teske, deputy director of FDA’s Center for Veterinary Medicine. However, anticipating approval of BGH for commercial use, consumer groups have launched a massive boycott of milk, meat, and dairy products from cows injected with BGH, and in response several grocery stores and dairy and milk corporations, including Abbott/Ross and Wyeth/Ayerst Laboratories, have announced that they will not accept or sell milk from BGH-treated cows, irrespective of FDA approval. Dr Michael Hansen of the Consumers’ Union, who testified before the panel, said that "the FDA concedes that BGH use increases mastitis by 50%. But the mastitis rate in cows may actually be much higher". A study which suggested that mastitis rates could be considerably higher was blocked from publication in a British journal by Monsanto, said Dr Hansen. This allegation about Monsanto refers to a meta-analysis done by Eric Brunner of University College London and colleagues there and at Sussex University, the National Institute of Economic and Social Research, London, and the Polytechnic of North London. The meta-analysis was of eight randomised controlled trials done in several countries and in which one of the end-points was somatic-cell (leucocyte) counts in cow’s milk. When submitted to a veterinary journal the paper was on its way towards acceptance in November, 1991, the only obstacle being the need for Monsanto’s permission to use raw data from the trials. In February, 1992, Monsanto refused that permission and told Brunner that it had submitted one paper on this topic to a different journal and had another paper in preparation. When Brunner proposed that the