South Africa's AIDS care thrown into confusion

USA shakes up privacy rules for medical records to enact comprehensive legislation to S President Bill Clinton proprotect the privacy of medical posed the first-ever nationwide information. While several measures rules to protect the confidentiality of have been introduced in Congress on medical records on Oct 29. the subject, lawmakers have been Under the rules, which are unable to agree on an approach. scheduled to take effect in 2002, But the 1996 law restricted some doctors, hospitals, health plans, and of the steps the administration could others who maintain personal take. For example, the medical information confidentiality rules would not be permitted cover only information to release these data on computer or data without written consent transmitted electronifrom the patient for cally, not paper purposes unrelated to records, which still the direct provision represent the main of care or protection of source of medical public health. information. The reguPatients would also lations do not extend to be given new rights to all entities that may view their own records, have identifiable and to seek corrections medical information, of inaccurate informa- Paper records excluded such as employers. And tion. Privacy rules now the rules cannot provide patients in effect for federally funded research whose information has been wrongly would also be extended to private disclosed a right to sue, a top priority research. for confidentiality advocates. The President was forced to act when Congress failed to follow a 1996 Act, which ordered Congress Julie Rovner

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outh Africa’s President Thabo Mbeki’s claims that zidovudine has “toxic” side-effects and is “a danger to health” have led to a storm of controversy in South Africa. Glaxo Wellcome, the manufacturers of the drug, said Mbeki appeared to have been “gravely misinformed”, AIDS activists have rejected Mebki’s claims, and opposition parties have expressed outrage at Mebki’s comments. AIDS activists argued that the government’s problem with providing zidovudine was financial not medical. South Africa’s Health Minister Manto Tshabalala-Msimang met Glaxo Wellcome representatives on Nov 9 to resolve the matter. At the meeting, Tshabalala-Msimang said she would not call for anyone to stop using zidovudine while the country’s drug regulatory authority prepared a comprehensive report on the matter. But on the same day the row intensified when South Africa’s Human Rights Commission ruled that the government’s decision to prevent the use of the drug in the public health sector could go against the constitutional right for universal access to health-care services. The Commission was reacting to a complaint filed by a state doctor who

THE LANCET • Vol 354 • November 13, 1999

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alleged that denying the anti-AIDS drug to pregnant women violated the state’s obligation to provide primary health-care services, including reproductive health care. The furor on zidovudine was initially sparked in parliament on Oct 28 when Mbeki said the government was under pressure to make the drug available in public hospitals (see Lancet 1999; 353: 908). Mbeki argued that cases were pending locally, in the UK, and in the USA about the drug’s toxicity, and that it would be irresponsible not to heed medical researchers’s “dire warnings”. Mbeki added that he had studied zidovudine on the internet and found evidence that it could be harmful. A Glaxo Wellcome spokesman responded by saying the drug was approved a decade ago by regulatory authorities worldwide. There was no legal action on its safety pending anywhere and after clinical trials, use of the drug to prevent mother-tochild transmission of HIV had been endorsed by WHO, UNAIDS, and the US Centers for Disease Control and Prevention.

last-minute snag postponed a vote by the European Parliament on Nov 4 on the working hours of junior doctors in the European Union (EU). But the debate in Brussels confirmed that the pace of reform will be a key issue when the assembly reconvenes in Strasbourg on Nov 15. The 15 EU national governments want a long transition to an average maximum 48-hour week, pleading that they need time to recruit additional doctors. The ministers’ preferred timetable would extend over 13 years, beginning with a 4-year standstill before the EU legislation comes into force, followed by a 9year “transitional period” consisting of 3-year phases in which successive limits of 60 hours, 56 hours, and 52 hours would be introduced. The European Commissioner for employment and social affairs Anna Diamantopoulou reported that ministers had latterly indicated that they might be prepared to trim the 9-year transitional period to 7 years—compared with the 4-year period sought by the parliament. She felt that 5 years would be an “appropriate” compromise. However, the parliament’s Employment and Social Affairs Committee also recommends that the initial 4-year transition period should be halved. In Strasbourg, deputies will decide whether or not to demand negotiations with ministers. The estimated 270 000 “doctors in training” are among workers hitherto excluded from the scope of a 1993 EU Directive on “the organisation of working time”, along with transport workers and fishermen. The Nov 4 vote was actually postponed to seek clarification of proposals for fishermen. The main requirements of the 1993 Directive include a maximum working week of 48 hours, a daily rest period of 11 hours, and a weekly rest period of 24 hours. Whatever the outcome of the Strasbourg vote, EU governments are free to be more generous to their own doctors. For example, the UK labour representative Peter Skinner has claimed that UK government proposals are already more favourable than the EU draft.

Adele Baleta

Arthur Rogers

South Africa’s AIDS care thrown into confusion

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EU junior doctors working hours could take 13 years to reduce

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