Product liability proposals, Sweden

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New York

City is supporting the case, as are many organisations that support abortion rights. The latter are raising large sums of money, both for state legislators and congressional candidates who openly uphold abortion rights. Those who so favour abortion seem to be succeeding, and at the expense of the

anti-abortionists, who seem to be

mostly republicans. A 1. Anon. Abortion USA. Lancet

correspondent

1989; i: 879-80.

Poland: New legislation

on

abortion

Poland’s Senate has taken the first steps towards new legislation outlawing abortion. After a stormy three-day debate, which removed or toned down the most draconian clauses of the original proposals, it eventually approved a draft which has been passed to the Sejm (lower house) for further debate. The "lex Ceaucescu", as it has been dubbed by its opponents (in reference to the compulsory pregnancy policies of the late Romanian dictator) is generally assumed to have been rushed forward on the urging of the Catholic hierarchy. Yet among those who spoke against it were such prominent Catholics as Senator Zoigniew Romaszewski (former head of underground Solidarity’s human and civil rights panel) and Dr Zofia Kuratowska, vice-marshal of the Senate, who during the martial law period of 1981-83 headed the Church’s medical relief to internees. Opponents of the Bill did not, they made clear, advocate abortion in any but the most extreme circumstances. Even the feminist pickets outside the Parliament building accept as self-evident the traditional Polish lifestyle in which spinsterhood is virtually unknown outside convent walls and a childless marriage is a tragedy. But the majority of Polish women who seek abortion do so as a last resort under pressure of inadequate and crowded housing, lack of social security support and day-care facilities for children already born, low rates of pay (making the wife’s wages essential), and queues, and-an unwelcome endemic shortages side-effect of the collapse of socialism-galloping inflation and the ever-growing threat of unemployment in a system where, as yet, there is no proper dole. The people have little knowledge of contraceptive techniques, even of the rhythm method advocated by the Catholic Church. Artificial means of contraception are difficult to obtain and for the most part either unreliable (if of eastern-bloc provenance) or impossibly dear (in the case of western items bought on the black market). Put the economy in order, opponents of the Bill argued, get a proper social security system with adequate support and facilities for expectant mothers, whether married or single, and the vast majority of abortions will simply become unnecessary. Moreover, as Dr Kuratowska pointed out, if the Bill was intended to "protect the life of the conceived child", then logically it ought also to apply to the thousands of pregnancies which annually end in miscarriage as a result of industrial pollution and the harsh working conditions to which women in Poland are exposed. Some senators queried whether delegalisation would reduce the number of abortions or would simply drive them underground or abroad and whether the proposed mandatory two-year prison sentence for both the women and the medical personnel was the most appropriate penalty. In the event, the Senate decided that the mother herself should not be liable to legal penalty and that although "persons bringing about the death of a conceived child" will still be liable to two years’ imprisonment, the courts should be able to waive this penalty in exceptional circumstances:

abortion should still be permitted in the case of a serious threat to the mother’s life or if the pregnancy resulted from rape, while in the case of miscarriage resulting from violence or the threat of violence to the mother, the penalty should be five years’ imprisonment. In addition, interference with the genetic material of an unborn child for purposes other than treatment or for saving life should carry a lesser penalty of up to two years’ "limitation of liberty" (eg, community service, or restrictions on leaving one’s place of abode). The civil code, the Senate recommended, should be amended to grant the unborn child the status of a legal person, but its property rights (including the right to sue for damage sustained in utero) should become operative only if it was born alive. Local-government bodies, community organisations, and the churches should be urged to promote social support for pregnant women in fmancial or social hardship, and-in the event of the Bill passing the Sejm-a six-month moratorium was recommended before it came into force, during which a public education campaign should be mounted. Whether the Bill will pass the Sejm, even in its amended form, is, however, uncertain. For the Senate is a creation of the 1989 "Round Table Accords", elected on fully democratic principles, with 99 of its 100 members returned to the Solidarity ticket. But the Sejm still has a built-in majority of members from the former ruling Polish United Workers’ Party, who have now regrouped into two "socialdemocratic" parties but who still preserve their old hostility to the Catholic Church. Meanwhile, in the correspondence columns of the press and on the placards of the pickets, the campaign against the Bill continues.

Vera Rich

Medicine and the Law Product

liability proposals, Sweden

The Swedish Ministry of Justice has lately circulated a draft Product Liability Act to public and private organisations for comment. The legislation would be strict, and the proposals have not been welcomed by trade and industry, who want legislation that conforms with that adopted by most European Community (EC) countries, including retention of a development risk defence. Consumer groups, on the other hand, strongly support the proposals. The draft Act borrows much (but not all) from the EC directive.

Compensation is payable if damage is caused by a product which, "when it was put into circulation, was not as safe as could reasonably have been expected at that time". The safety of a product "shall be assessed with regard to the use to which it may be expected to be put, the marketing of the product, instruction for use and all other circumstances". "If damage arises due to lack of safety of a product that constitutes a component part of another product, both products shall be deemed to have caused the damage." Liable will be anyone who has manufactured or produced the product, who has imported it, or has marketed it by affixing his own name or trademark to it. The Act offers little comfort to the potential defendant. Defences available are that the product was not a commercial one; that, on a balance of probabilities, the lack of safety complained of did not exist when the product was put into circulation; or that the product (eg, a drug or a medical device) has a use-by date or has to be stored under certain conditions which, arguably, were not met by the supplier or consumer. The limitation periods generally are (as in the UK) that proceedings must be instituted within three years of learning that a claim might be invoked, but the outside limit is 10 years for property (as in the EC) and, most controversially, 25 years for personal injuries.

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This

legislation would be especially relevant to pharmaceutical products. Indeed, the EC initiatives on product liability (which sparked off the Swedish proposals) had their origin in the thalidomide tragedy. In 1977 the Council of Europe Strasbourg Convention on Product Liability in Regard to Personal Injury and Death led to consensus that liability for injury caused. Especially controversial has been the development risks (or state of and other medical

the art) defence and the limit on a producer’s liability for damages caused by an identical product each with the same defect. The EC directive allowed member states the option; the UK adopted the first but not the second and the Swedish proposals adopt neither. The Swedish government, which has yet to take a stand on the issue, is expected to formulate its own bill early next year, and with a target approval date of July 1, 1991. Sweden’s pharmaceutical industry has less to fear from the imposition of strict liability for personal injuries because the pharmaceutical insurance scheme, which the industry funds, already pays out on a strict liability basis for injuries caused by unexpected adverse drug reactions. The scheme, however, limits damages that may be awarded. There is also a three year limitation period during which claims must be made-but no overall limitation period so that latent and second generation injuries can be compensated if they arise. For all other manufacturers, including those of medical devices and implants not covered by the pharmaceutical insurance scheme, the proposed 25-year limit could make insurance costs high.

Britain, claims for personal injuries must usually be brought within three years, in contrast to the six year limitation period for property damage. In a background report accompanying the draft Act the Swedish Ministry of Justice considers it important "that an injured person should have a right to compensation even in the case of damage that appears at a late date... At the same time, it is in the interests of the producer that he should not be exposed to the risk of compensation claims for a long time after a In

product has been put into circulation". The aim has been to strike a balance. These two considerations referred to in the Swedish report are precisely those that have prevailed in Britain, with a different outcome. This hardens the suspicion that in the UK damage to property is more important than injury to people. It may not be without significance that the maximum limitation period is fifteen years under Britain’s Latent Damage Act 1986 (in cases where there are no claims for personal injuries) but only ten years under the Consumer Protection Act 1987.

Diana Brahams

Obituary Ralph Wright Ralph Wright, professor of medicine at the University of Southampton, died on Aug 17, aged 60, as the result of an accident. Born and educated in South Africa, he came to Oxford in 1960 because of disaffection with apartheid. Under the influence of Witts, Truelove, and Taylor he acquired an interest in clinical immunology, particularly in relation to the gastrointestinal tract, that led to his DPhil thesis on immunological aspects of ulcerative colitis. His subsequent research interests changed abruptly during a year spent at Yale as James Hudson Brown Fellow. There he became closely associated with the early evaluation of Australia antigen, and with McCollum and Klatskin produced the first major paper on its association with chronic liver disease (Lancet 1969; ii: 117-21). After his return to Oxford in 1969 his research was largely on the liver. His prolific output was only briefly interrupted by his appointment to the chair of medicine in Southampton in 1971. The initial interest in hepatitis B was followed by research in the immunological function of the liver and this in turn led to a series of publications on hepatic macrophages which continued throughout

rest of his life. Possibly his most lasting contribution to hepatology was the production of Liver and Biliary Disease, which has established itself as one of the major reference hepatology textbooks in the world. At the time of his death he was working on the final chapters of a third edition. Beneath Ralph’s giant physique and his easy-going, good humoured conviviality lay a man with immense energy and drive. Throughout his life he was a keen advocate of clinical research and greatly supported its development in the new medical school in Southampton, both in hepatology and in other aspects of medicine. No environment was too hostile to permit academic investigation and he took much pride in the fact that the research from his unit in the early years at Southampton was carried out in a newly converted brothel next to the Royal Southampton Hospital. He was a gifted teacher, and his sensitivity and ready accessibility made him particularly popular with medical students and junior doctors. He was equally sought after in more august circles both nationally and internationally. He had recently completed terms of office as Censor of the Royal College of Physicians and President of the British Association for the Study of the Liver. In his few moments of leisure time he was an enthusiastic yachtsman as well as a keen football supporter. He is survived by his wife Morag, a consultant haematologist, and his five daughters, three of whom have followed

the

their parents into medicine.

David R. Triger

Noticeboard Recommended changes in the Prison Medical Service The Prison Medical Service should have its role widened to encompass health promotion (among staff as well as prisoners), it should be renamed the Prison Health Service, and it should be a purchaser, not a provider, of medical services, says the report of an efficiency scrutiny of the service, whose deficiencies were highlighted earlier this year by HM Chief Inspector of Prisons in his annual report (see Lancet Aug 4, p 303). The scrutiny, which cost 54 000, was to take "as given the need to retain a separate medical service" for prisoners. The scrutiny team found confusion about lines of accountability on medical matters, which inhibited prison governors from challenging medical officers on managerial issues and medical officers from accepting responsibilities for the use of resources; seriously defective financial management; a medical service seen as isolated, and unattractive to potential recruits; and mismatch between needs and services. The report recommends that the post of director of the Prison Medical Service be replaced by a health director post that does not carry an executive management function; the holder’s job would be to advise the director general of the Prison Service on all health-care matters. Similarly, there should be area physicians to advise area managers, but clinical manager posts should be created where there are prison hospitals or special medical units. Primary care should be provided by general practitioners visiting prisons daily, and the full-time clinicians needed for prison hospitals should be obtained by contracts with local authorities for named clinicians. Arrangements for specialist NHS services, provided either by visiting specialists or at NHS hospitals, should continue. Psychiatric assessment-for the courts, for the parole board, and as part of the management of mental illness--are now done by visiting psychiatrists and by prison medical officers. The report recommends that in the long term the psychiatric services should be provided wholly on a contracted-in basis. Psychiatric facilities should be considered in conjunction with the NHS in the light of findings on the psychological profile of prisoners (which the Home Office says have been completed and are now being examined by the medical directorate). The report also recommends that attention be given to a study in progress since last year in which psychiatrists are in attendance at two Inner London magistrates’ courts to assess for suitability for diversion to hospital or community facilities defendants who would otherwise be remanded in custody for