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489 European case law supporting Goldstein These examples, says Goldstein, apply directly to the issue of specialist certification in medicine. When Community laws are enacted they are "fully applicable at the same time and with identical effects over the whole territory of the Community without the member states being able to place any obstacles in the way" (Commission v Italy [ 1972] ECR 527) *The requirement for implementation of EC law is unambiguous: the purpose of EC articles "is to ensure that Community law is interpreted and applied in a uniform manner in all the member states" (Hoffman La Roche v Centra farm [ 1977] ECR 957) w EC law "provides for directives intended to ensure mutual recognition of diplomas, certificates, and other evidence of formal qualifications and in a general way for the coordination of law with regard to establishment and pursuit of activities as self-employed persons" (Reyners v Belgium [1974] ECR 631) w In cases of infringement of EC directives, courts can act "at any given moment" in the conduct of the case to overcome the infringement concerned (Camera care v Commission [1980] ECR 119) . < If EC law is breached, the responsibility and "the liability of the member state... arises whatever the agency of the state whose action or inaction is the cause of the failure to fulfil its obligation" (Commision v Belgium [1970] ECR 237) . "Community law lays down a principle according to which a member state is obliged to make good damage to individuals caused by a breach of Community law for which it is responsible" (Francovich v Italy [1993] 2 CMLR 66) Goldstein’s last stand By serving a writ last week against Sir Nicholas Lyell, the UK Attorney General, Dr Anthony J Goldstein has embarked on what is likely to be the final phase of his legal battle to see the immediate implemen- tation of European Community directives on specialist certification. : Despite repeated losses in the High Court, refusals by the Court of Appeal earlier this month to allow him to pursue his case in the House of Lords, and a demand for D8 000 by the court as security of costs against any future appeal, Goldstein maintains that the medical royal colleges and General Medical Council are engaged in restrictive practices in breach of the Treaty of Rome by preventing special- ists being appointed in accordance with Community directives to which the UK was a co-signatory. During the past two years, Goldstein has amassed a substantial body of European case law in support of his arguments (see panel). : His claim that he has been deprived of the right to practise as a specialist even though he had specialist certification has now led him to take action against the Attorney General. Goldstein hopes to secure an injunction against Lyell to ensure that UK courts adhere to their obligations set out in EC law. His case was noted to be merely "an interesting intellectual argument" by Mr Justice Latham on Aug 11. Goldstein is seeking substantial damages for loss of : reputation as a result of being prevented from delivering his specialist services as a rheumatologist. He is also asking the competition office (DG 4) of the European Commission to initiate action against the UK government through the European Court of Justice. : Although the Calman report (see Lancet May 1, p 1144), which accepts the need to adopt the European Certificate of Completion of Specialist Training, is still out for consultation, there are dissenting voices from several prominent members of the GMC and organisations such as the National Association of Health Authorities and Trusts. NAHAT believes that the single consultant grade should be replaced by junior and senior specialist grades. : The Calman proposals preserve the essence of the specialist consultation system within the National Health Service. By contrast, Goldstein is seeking to establish a free market for specialists, together with the right to advertise and to treat patients without referral from a general practitioner. Richard Horton Aid delayed After a nine-day visit to Serbia, Mon- tenegro, and Macedonia, a Council of Europe delegation has issued an immediate recommendtion on the "urgent" need to examine how UN economic embargo sanc- tions are being applied to humanitarian aid. The full report of the fact-finding mission will not be disclosed until next month’s meeting of the Council’s Committee on Migration, Refugees and Demography. The delegation voiced particular alarm about the situation of the 550 000 refugees and displaced persons now in Serbia and Montenegro, 95% of whom are living with host families and expected to survive on an average monthly wage equivalent to DM 10-15. The delegation pointed out that although deliveries of food and medical supplies are in principle exempt from the trade embargo, they are in practice subject to delays in the authorisation process by the UN Sanctions Committee and to "misap- propriation". Dr Andrzej Wojtczak, WHO’s acting special representative in Belgrade, pointed out that it is impossible to differentiate between the health prob- lems of the refugees and those of the population at large. Citing data from the Federal Institute of Public Health, he said the comparative index of mortality in 1991 versus 1986 indicated an increase of inci- dence of ischaemic heart disease by 544%, cerebrovascular diseases by 251%, different psychoses by 591 %, and pul- monary tuberculosis by 128-4%. The WHO’s own inquiries at a hospital in the Sandzak area has indicated an increase of : tuberculosis among admissions from 0-4% to 10%. At the same hospital, he said, "About 45 per cent of deliveries end up by caesarian section as the women are so anaemic and undernourished that they are unable to deliver their babies naturally". In psychiatric hospitals patients are chained to the beds because there are no sedatives. : Arthur Rogers DNase for cystic fibrosis A US Food and Drug Administration advisory panel has unanimously recom- mended approval of Pulmozyme, an aerosolised recombinant human DNase, for the treatment of cystic fibrosis. : In test-tube studies, DNase has been shown to improve the viscoelasticity of the mucous secretions of cystic fibrosis patients. A phase III clinical trial (parallel- design, randomised, placebo-controlled, three-armed, double-blind, multicentre) with (968) outpatients with cystic fibrosis found that the drug improved patients’ FEV by roughly 5 %, reduced the number of respiratory tract infections by a quarter to a third, and lessened cystic-fibrosis- related symptoms, such as dyspnoea.1 The trial was limited to patients aged over five years who had vital capacities of more than 40% of predicted and who were clinically stable. The study did not determine whether the drug will extend life or prove useful in more severely ill patients. The drug’s manufacturer, Genentech, from San Francisco, California, has also submitted marketing applications for Canada and Europe. Michael McCarthy 1 HJ Fuchs, et al. Aerosolized recombinant human DNase reduces pulmonary exacerbations and improve pulmonary function in patients with cystic fibrosis. Presented at 36th Annual Conference on Chest Disease, Intermountain Thoracic Society, January 26, 1993.

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489

European case law supporting GoldsteinThese examples, says Goldstein, apply directly to the issue of specialist certification inmedicine. When Community laws are enacted they are "fully applicable at the same time andwith identical effects over the whole territory of the Community without the memberstates being able to place any obstacles in the way" (Commission v Italy [ 1972] ECR 527)*The requirement for implementation of EC law is unambiguous: the purpose of ECarticles "is to ensure that Community law is interpreted and applied in a uniformmanner in all the member states" (Hoffman La Roche v Centra farm [ 1977] ECR 957)w EC law "provides for directives intended to ensure mutual recognition of diplomas,certificates, and other evidence of formal qualifications and in a general way for thecoordination of law with regard to establishment and pursuit of activities as

self-employed persons" (Reyners v Belgium [1974] ECR 631)w In cases of infringement of EC directives, courts can act "at any given moment" in theconduct of the case to overcome the infringement concerned (Camera care vCommission [1980] ECR 119) .

< If EC law is breached, the responsibility and "the liability of the member state...arises whatever the agency of the state whose action or inaction is the cause of the failureto fulfil its obligation" (Commision v Belgium [1970] ECR 237). "Community law lays down a principle according to which a member state is obligedto make good damage to individuals caused by a breach of Community law for which it isresponsible" (Francovich v Italy [1993] 2 CMLR 66)

Goldstein’s last stand

By serving a writ last week against SirNicholas Lyell, the UK Attorney General,Dr Anthony J Goldstein has embarked onwhat is likely to be the final phase of hislegal battle to see the immediate implemen-tation of European Community directiveson specialist certification. :Despite repeated losses in the High

Court, refusals by the Court of Appealearlier this month to allow him to pursuehis case in the House of Lords, and ademand for D8 000 by the court as securityof costs against any future appeal,Goldstein maintains that the medical royalcolleges and General Medical Council areengaged in restrictive practices in breach ofthe Treaty of Rome by preventing special-ists being appointed in accordance withCommunity directives to which the UKwas a co-signatory. During the past twoyears, Goldstein has amassed a substantialbody of European case law in support of hisarguments (see panel). :His claim that he has been deprived of the

right to practise as a specialist even thoughhe had specialist certification has now ledhim to take action against the AttorneyGeneral. Goldstein hopes to secure aninjunction against Lyell to ensure that UKcourts adhere to their obligations set out inEC law. His case was noted to be merely"an interesting intellectual argument" byMr Justice Latham on Aug 11. Goldstein is

seeking substantial damages for loss of :

reputation as a result of being preventedfrom delivering his specialist services as arheumatologist. He is also asking thecompetition office (DG 4) of the EuropeanCommission to initiate action against theUK government through the EuropeanCourt of Justice.

: Although the Calman report (see LancetMay 1, p 1144), which accepts the need toadopt the European Certificate of

Completion of Specialist Training, is stillout for consultation, there are dissenting

voices from several prominent members of

the GMC and organisations such as theNational Association of Health Authoritiesand Trusts. NAHAT believes that the

single consultant grade should be replacedby junior and senior specialist grades.

: The Calman proposals preserve the

essence of the specialist consultation systemwithin the National Health Service. Bycontrast, Goldstein is seeking to establish afree market for specialists, together with theright to advertise and to treat patientswithout referral from a general practitioner.

Richard Horton

Aid delayed

After a nine-day visit to Serbia, Mon-tenegro, and Macedonia, a Council ofEurope delegation has issued an immediaterecommendtion on the "urgent" need toexamine how UN economic embargo sanc-tions are being applied to humanitarian aid.The full report of the fact-finding missionwill not be disclosed until next month’smeeting of the Council’s Committee onMigration, Refugees and Demography.The delegation voiced particular alarmabout the situation of the 550 000 refugeesand displaced persons now in Serbia andMontenegro, 95% of whom are living withhost families and expected to survive onan average monthly wage equivalent toDM 10-15. The delegation pointed out thatalthough deliveries of food and medicalsupplies are in principle exempt from thetrade embargo, they are in practice subjectto delays in the authorisation process by theUN Sanctions Committee and to "misap-propriation". Dr Andrzej Wojtczak,WHO’s acting special representative in

Belgrade, pointed out that it is impossibleto differentiate between the health prob-lems of the refugees and those of the

population at large. Citing data from the

Federal Institute of Public Health, he saidthe comparative index of mortality in 1991versus 1986 indicated an increase of inci-dence of ischaemic heart disease by 544%,cerebrovascular diseases by 251%,different psychoses by 591 %, and pul-monary tuberculosis by 128-4%. TheWHO’s own inquiries at a hospital in theSandzak area has indicated an increase of :tuberculosis among admissions from 0-4%to 10%. At the same hospital, he said,"About 45 per cent of deliveries end up bycaesarian section as the women are soanaemic and undernourished that they areunable to deliver their babies naturally". Inpsychiatric hospitals patients are chained tothe beds because there are no sedatives. :

Arthur Rogers

DNase for cystic fibrosis

A US Food and Drug Administrationadvisory panel has unanimously recom-mended approval of Pulmozyme, anaerosolised recombinant human DNase,for the treatment of cystic fibrosis. :

In test-tube studies, DNase has been

shown to improve the viscoelasticity of themucous secretions of cystic fibrosis

patients. A phase III clinical trial (parallel-design, randomised, placebo-controlled,three-armed, double-blind, multicentre)with (968) outpatients with cystic fibrosisfound that the drug improved patients’FEV by roughly 5 %, reduced the numberof respiratory tract infections by a quarterto a third, and lessened cystic-fibrosis-related symptoms, such as dyspnoea.1 Thetrial was limited to patients aged over fiveyears who had vital capacities of more than40% of predicted and who were clinicallystable. The study did not determinewhether the drug will extend life or proveuseful in more severely ill patients.The drug’s manufacturer, Genentech,

from San Francisco, California, has alsosubmitted marketing applications for

Canada and Europe.

Michael McCarthy

1 HJ Fuchs, et al. Aerosolized recombinanthuman DNase reduces pulmonaryexacerbations and improve pulmonaryfunction in patients with cystic fibrosis.Presented at 36th Annual Conference onChest Disease, Intermountain ThoracicSociety, January 26, 1993.