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Europe: EC pharmaceutical directives
483
overuse and anxiety over whether health care will be affordable when desperately needed. A large majority of Americans continue to express personal satisfaction with their own health care. But these sentiments are accompanied by a growing fearfulness about rising premiums, shifts of insurance costs from employer to worker, and the cancellation of insurance when jobs are lost. The rising costs of insurance keep pushing employed people outside the medical marketplace. Increasingly, employers don’t provide insurance-they are not required to except in a few states-and the employers can’t afford it. The formulas offered by the President’s Democratic rivals vary substantially in details, but all tend toward universal coverage, strict cost constraints, and financing through taxation or requirements that employers provide insurance or pay into a pool for the uninsured. At this point, the only agreement across the political spectrum is that major changes are coming in the American health-care system. But with energies absorbed by the election campaign, and the President wielding potent veto power, 1992 is not likely to be the historic year.
Daniel S.
Greenberg
Round the World Europe:
EC
pharmaceutical directives
Legislation on drug advertising was one of a package of four pharmaceutical directives endorsed by the European Parliament in Strasbourg, on Feb 12. The others were wholesale distribution, classification of drugs as "prescription only" or "over the counter", and labelling. The first reading of this legislation last June turned into a procedural paperchase, when MEPs tabled 500 amendments. Roughly a third have been taken over by the European Commission in the revised drafts; of the remainder only 33 were tabled again and only 7 of those survived the requirement that second reading amendments have to be carried by a large majority in the European Parliament to carry any weight. At one stage last year it seemed that medical conferences hosted by drug companies in exotic locations would fall victim to an EC prohibition on inducements. However, fun-packed social programmes have been reprieved in the revised directive on promotion, although the reworked text insists that "hospitality extended to participants must be subordinate to the main scientific objective of the event" and adds that "Hospitality shall be extended only to health care professionals". We are not told how these restrictions might be enforced. Bouncers on the door at cocktail parties, checking medical qualifications? Security patrols around the hotel pool, hauling unqualified spouses off their sunbeds? The advertising measure confirms an EC-wide prohibition
advertising prescription-only preparations (with exemptions for publications intended for health professionals), with rules on the provision of free samples and on how over-the-counter drugs can be advertised. Several MEPs complained that the four directives had been re-tabled while a crucial fifth measure establishing a European medicines agency, approved at first reading by the Parliament, was still log-jammed in the Council of Ministers. One MEP argued that without agreement on this agency, which would offer a properly controlled system of mutual recognition of drug licences, implementation of the on
other directives would be very difficult. EC Commission vice-president Martin Bangemann, who has overall responsibility for the single market legislation programme, explained that the agency directive was the subject of a legal dispute. The Commission, he said, was insisting that the measures should be treated under single market procedures, in which final approval can be given by a qualified majority in the Council of Ministers when dealing with matters requiring a high level of public protection. Ministers had not been enthusiastic about this, and Mr Bangemann hinted that the dispute might have to go to the European Court of Justice
Arthur
Rogers
Europe: Ethics of biotechnology The Palais d’Europe in Strasbourg became the focus of the European debate on the ethics of biotechnology on Feb 10-14 when the 26-nation Council of Europe-which for five days every month gives up the building to the peripatetic members of the 12-nation European Parliament--discussed the issue. The contrasting
preoccupations of the two organisations were neatly exemplified; while the European Parliament seeks to define what might be ethically permissible in the commercial exploitation of biotechnology, the Council of Europe is laying down areas of prohibition on genetic screening and tests, from the viewpoint of human rights. In bioethics, the devil is not so much in the small print as in those overlapping areas where commerce and human dignity may conflict. The Parliament’s debate on Commission proposals for a directive on biotechnology patents (Feb 8, p 355) stalled when MEPs decided that yet
more
detailed consideration
though legislative proposals have been under consideration since June, 1989. Perhaps EC policymaking in this area is being overtaken by the speed of events. On Feb 12 the Council of Europe published codes of conduct on genetic testing and screening for health care purposes and on use of DNA analysis in criminal justice.1,2 These documents are recommendations from expert panels to member states. However, the guidelines come with the endorsement of the Council of Europe’s Committee of Ministers, and it is likely that they will be transposed into protocols to a European bioethics convention, to be the subject of a preliminary meeting in Madrid on March 24-25. A draft of such a convention could be published by the end of the year, and once ratified by signatory states, it would carry the weight of law. Underlining European anxiety on bioethics, it has been announced that a joint conference of representatives of Parliament and Council has called for speedy implementation of the convention. The guidelines on bioethics in health carel extend beyond was
required,
even
the conduct of clinicians and researchers and propose a code of civil rights in genetic screening to meet "growing public concern over a future characterised by exorbitant genetic testing and discrimination on grounds of genetic features". Testing should be non-compulsory for any activity covering social security benefits, employment, or education, the guidelines say, and insurance companies should not have the right to require genetic testing or to inquire about the results of previous tests. More controversially, perhaps, test findings would be disclosed to the person tested only if they are of "direct clinical importance to the person or the family", and "communication of unexpected findings to family members of the person tested should only be authorised... if the person tested refuses expressly to release
overuse and anxiety over whether health care will be affordable when desperately needed. A large majority of Americans continue to express personal satisfaction with their own health care. But these sentiments are accompanied by a growing fearfulness about rising premiums, shifts of insurance costs from employer to worker, and the cancellation of insurance when jobs are lost. The rising costs of insurance keep pushing employed people outside the medical marketplace. Increasingly, employers don’t provide insurance-they are not required to except in a few states-and the employers can’t afford it. The formulas offered by the President’s Democratic rivals vary substantially in details, but all tend toward universal coverage, strict cost constraints, and financing through taxation or requirements that employers provide insurance or pay into a pool for the uninsured. At this point, the only agreement across the political spectrum is that major changes are coming in the American health-care system. But with energies absorbed by the election campaign, and the President wielding potent veto power, 1992 is not likely to be the historic year.
Daniel S.
Greenberg
Round the World Europe:
EC
pharmaceutical directives
Legislation on drug advertising was one of a package of four pharmaceutical directives endorsed by the European Parliament in Strasbourg, on Feb 12. The others were wholesale distribution, classification of drugs as "prescription only" or "over the counter", and labelling. The first reading of this legislation last June turned into a procedural paperchase, when MEPs tabled 500 amendments. Roughly a third have been taken over by the European Commission in the revised drafts; of the remainder only 33 were tabled again and only 7 of those survived the requirement that second reading amendments have to be carried by a large majority in the European Parliament to carry any weight. At one stage last year it seemed that medical conferences hosted by drug companies in exotic locations would fall victim to an EC prohibition on inducements. However, fun-packed social programmes have been reprieved in the revised directive on promotion, although the reworked text insists that "hospitality extended to participants must be subordinate to the main scientific objective of the event" and adds that "Hospitality shall be extended only to health care professionals". We are not told how these restrictions might be enforced. Bouncers on the door at cocktail parties, checking medical qualifications? Security patrols around the hotel pool, hauling unqualified spouses off their sunbeds? The advertising measure confirms an EC-wide prohibition
advertising prescription-only preparations (with exemptions for publications intended for health professionals), with rules on the provision of free samples and on how over-the-counter drugs can be advertised. Several MEPs complained that the four directives had been re-tabled while a crucial fifth measure establishing a European medicines agency, approved at first reading by the Parliament, was still log-jammed in the Council of Ministers. One MEP argued that without agreement on this agency, which would offer a properly controlled system of mutual recognition of drug licences, implementation of the on
other directives would be very difficult. EC Commission vice-president Martin Bangemann, who has overall responsibility for the single market legislation programme, explained that the agency directive was the subject of a legal dispute. The Commission, he said, was insisting that the measures should be treated under single market procedures, in which final approval can be given by a qualified majority in the Council of Ministers when dealing with matters requiring a high level of public protection. Ministers had not been enthusiastic about this, and Mr Bangemann hinted that the dispute might have to go to the European Court of Justice
Arthur
Rogers
Europe: Ethics of biotechnology The Palais d’Europe in Strasbourg became the focus of the European debate on the ethics of biotechnology on Feb 10-14 when the 26-nation Council of Europe-which for five days every month gives up the building to the peripatetic members of the 12-nation European Parliament--discussed the issue. The contrasting
preoccupations of the two organisations were neatly exemplified; while the European Parliament seeks to define what might be ethically permissible in the commercial exploitation of biotechnology, the Council of Europe is laying down areas of prohibition on genetic screening and tests, from the viewpoint of human rights. In bioethics, the devil is not so much in the small print as in those overlapping areas where commerce and human dignity may conflict. The Parliament’s debate on Commission proposals for a directive on biotechnology patents (Feb 8, p 355) stalled when MEPs decided that yet
more
detailed consideration
though legislative proposals have been under consideration since June, 1989. Perhaps EC policymaking in this area is being overtaken by the speed of events. On Feb 12 the Council of Europe published codes of conduct on genetic testing and screening for health care purposes and on use of DNA analysis in criminal justice.1,2 These documents are recommendations from expert panels to member states. However, the guidelines come with the endorsement of the Council of Europe’s Committee of Ministers, and it is likely that they will be transposed into protocols to a European bioethics convention, to be the subject of a preliminary meeting in Madrid on March 24-25. A draft of such a convention could be published by the end of the year, and once ratified by signatory states, it would carry the weight of law. Underlining European anxiety on bioethics, it has been announced that a joint conference of representatives of Parliament and Council has called for speedy implementation of the convention. The guidelines on bioethics in health carel extend beyond was
required,
even
the conduct of clinicians and researchers and propose a code of civil rights in genetic screening to meet "growing public concern over a future characterised by exorbitant genetic testing and discrimination on grounds of genetic features". Testing should be non-compulsory for any activity covering social security benefits, employment, or education, the guidelines say, and insurance companies should not have the right to require genetic testing or to inquire about the results of previous tests. More controversially, perhaps, test findings would be disclosed to the person tested only if they are of "direct clinical importance to the person or the family", and "communication of unexpected findings to family members of the person tested should only be authorised... if the person tested refuses expressly to release