Old World News: Divide and Rule

Abstract

English Channel has long been the great divide in Europe, as shown in the prewar newspaper headline: FOG IN CHANNEL; CONTINENT CUT OFF. divide is not only a matter of geography, nationality, and language, but of all sorts of subtle differences in culture as well, including medical culture. Little was done in the first four decades of the European Community (EC) to try to bring together the different medical cultures of member states. Health care was not mentioned in any of the basic treaties, although reciprocal arrangements to provide treatment for citizens of other EC states were developed. Only in the 1991 Maastricht treaty was there for the first time specific mention of the Community's role in promoting public health. Title XV of the treaty, entitled Public Health, begins: The Community contributes to the maintenance of a high level of health protection by encouraging cooperation between the member states and, if necessary, by supporting their actions. Whether any such cooperation can be further developed depends on what, if anything, can be salvaged of the Maastricht treaty now that the Danish people have rejected it by referendum. Obviously some forms of cooperation already exist independent of the EC and its commission. EC cooperation, on the other hand, has so far mostly been in medical research projects. Yet these illustrate the Community's talent for giving confusingly mixed signals: just as the commission announced a large increase in the funds available for medical research, it also issued a draft directive on data protection that could severely curtail some areas of research. There are various levels of advice, instructions, and directives that the commission may promulgate. first statement on medical research, for example, was issued in 1990 as guidelines, Good Clinical Practice for Trials on Medicinal Products in the European Community.[1] As guidelines they have no legal force anywhere in the Community, although drug companies that do not comply with them may find it increasingly difficult to have new products licensed in member states. When issued, however, it was intended that the guidelines become a directive this year. As a directive they would have to be subsumed, within a limited period, into the national law of each member state. There may be some hesitation, however, about giving the guidelines the force of law, perhaps related to the French experience. A law to protect subjects of biomedical research that came into force in France in 1990 created several new criminal offenses, such as performing research without the subject's consent, or without prior approval by an ethics review committee.[2] It has greatly increased the pressure on those committees, resulting in many resignations, including one of a whole committee. …