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Brain-death guidelines revised in Japan
European regulations set to protect research uropean Bioethics Convention rules on medical research and genetics should come into force in six signatory states by Jan 1, 2000—on Sept 1 Spain became the latest country to complete national approval procedures . The Convention was actually activated in August through the crucial fifth ratification by Denmark—following approvals by Greece, San Marino, Slovakia, and Slovenia. The Convention is “the first internationally binding legal text designed to protect people against the misuse of biological and medical advances”, says the 41-nation Council of Europe. The Convention covers human genetics, consent in medical research, embryo research, organ transplantations, and rights to information. Of the 22 other nations that have signed the Convention since the final draft was agreed in 1997, many are expected to proceed to ratification. But German public opinion remains divided on whether ratification would compromise far stricter national rules, while the UK government— initially enthusiastic about the Convention—seems latterly to have concluded that ratification might impose restraints on UK research.
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Arthur Rogers
News in brief Agree to differ Patients who reject their doctor’s advice on, for example, immunisation should not be removed from their doctor’s list, says the BMA’s general practitioner’s committee (GPC). In response to a paper in the Sept 13 issue of the Journal of the Royal Society of Medicine, GPC chairman John Chisolm says “the paper seeks to suggest that some patients are being struck off GP’s lists for economic reasons”. Chisolm reaffirmed that “the sole criterion for removal should be an irretrievable breakdown of the doctor–patient relationship”. European pharmocpoeia Hungary became the 28th member of the European Pharmocopia (EP) convention on Sept 9. The EP allows medicines produced and dispensed in Europe to comply with “a single quality standard”.
THE LANCET • Vol 354 • September 18, 1999
Brain-death guidelines revised in Japan
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apan’s health and welfare disappointed that the transplantaministry was forced to revise its tion was called off by the ministry. guidelines for organ Under the revised guidelines, transplantation on Sept 6 because doctors will not be able to do tests of uncertainties about checks to for brain-death on potential donors determine brain death. with damaged The decision foleardrums or lowed a controversial eyeballs. intervention by the Explaining its ministry to abort a stance, the ministry transplant procedure said it was essential after it was discovered to win public trust in that the potential organ transplantadonor had a ruptured tions by applying eardrum. The rupture strict rules to the made it difficult to do process. one of the key tests There have only involved in ascertainbeen four organ ing brain death, which transplantations involves injecting cold from brain-dead water into both ears to Putting safety first donors in Japan, try to stimulate eye where the issue has movement. been under constant media scrutiny Such a situation was not covered since parliament enacted a law by the guidelines, but doctors had to allow such procedures in been willing to proceed with the October, 1997. transplantation procedure. The Jonathan Watts donor’s family said they were
EU nominee for research portfolio looks ahead uropean Commissioner-designate for research Philippe Busquin, a 58 year-old physicist from Belgium and president of Belgium’s Socialist Party, came under heavy fire in a confirmation hearing before the European Parliament on Sept 1. If appointed—the Commision votes on Sept 15—Busquin will be in charge of the EU’s 5th Framework Programme for Research and Development (FPRD), which has a budget of e14·96 billion. But many Members of the European Parliament (MEPs) have expressed serious doubts about Busquin’s qualifications for the job. Spanish MEP Alejandro VidalQuadras Roca noted that “[Busquin’s] curriculum reveals considerable teaching and political experience but no research activities, including no scientific publications”. In his reply Busquin, a former lecturer at the Free University in Brussels for 15 years, emphasised the interest he has shown during his political career for research and technological development issues. Busquin told MEPs that Europe needs to attract young people into research to bring the proportion of scientists in Europe up to US and Japanese levels. He added that
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Europe should “pay attention to [areas] with a high job-creation potential such as biotechnology” and that he would encourage south European regions to improve their research performances to eliminate the gap between development in the north and south . Busquin also expressed his desire to increase the participation of women in scientific and research activities. When asked whether “a member state [should] have to co-finance biomedical research projects—through its participation in the FPRD—if its national legislation prohibits research involving [for example] embryos”, Busquin said that “in no case may participation in the FPRD lead a partner to breach the statutory ethical provisions in force in its own country”. He added that “since the rules on ethics sometimes vary substantially from country to country, a participant in a project may carry out work which would not be authorised in the country of one of its partners”. Busquin also acknowledged that alternative therapies “could have a role to play in the healing process” but stated that “priority will be given to clinical research”. Xavier Bosch
1011
E
Arthur Rogers
News in brief Agree to differ Patients who reject their doctor’s advice on, for example, immunisation should not be removed from their doctor’s list, says the BMA’s general practitioner’s committee (GPC). In response to a paper in the Sept 13 issue of the Journal of the Royal Society of Medicine, GPC chairman John Chisolm says “the paper seeks to suggest that some patients are being struck off GP’s lists for economic reasons”. Chisolm reaffirmed that “the sole criterion for removal should be an irretrievable breakdown of the doctor–patient relationship”. European pharmocpoeia Hungary became the 28th member of the European Pharmocopia (EP) convention on Sept 9. The EP allows medicines produced and dispensed in Europe to comply with “a single quality standard”.
THE LANCET • Vol 354 • September 18, 1999
Brain-death guidelines revised in Japan
J
apan’s health and welfare disappointed that the transplantaministry was forced to revise its tion was called off by the ministry. guidelines for organ Under the revised guidelines, transplantation on Sept 6 because doctors will not be able to do tests of uncertainties about checks to for brain-death on potential donors determine brain death. with damaged The decision foleardrums or lowed a controversial eyeballs. intervention by the Explaining its ministry to abort a stance, the ministry transplant procedure said it was essential after it was discovered to win public trust in that the potential organ transplantadonor had a ruptured tions by applying eardrum. The rupture strict rules to the made it difficult to do process. one of the key tests There have only involved in ascertainbeen four organ ing brain death, which transplantations involves injecting cold from brain-dead water into both ears to Putting safety first donors in Japan, try to stimulate eye where the issue has movement. been under constant media scrutiny Such a situation was not covered since parliament enacted a law by the guidelines, but doctors had to allow such procedures in been willing to proceed with the October, 1997. transplantation procedure. The Jonathan Watts donor’s family said they were
EU nominee for research portfolio looks ahead uropean Commissioner-designate for research Philippe Busquin, a 58 year-old physicist from Belgium and president of Belgium’s Socialist Party, came under heavy fire in a confirmation hearing before the European Parliament on Sept 1. If appointed—the Commision votes on Sept 15—Busquin will be in charge of the EU’s 5th Framework Programme for Research and Development (FPRD), which has a budget of e14·96 billion. But many Members of the European Parliament (MEPs) have expressed serious doubts about Busquin’s qualifications for the job. Spanish MEP Alejandro VidalQuadras Roca noted that “[Busquin’s] curriculum reveals considerable teaching and political experience but no research activities, including no scientific publications”. In his reply Busquin, a former lecturer at the Free University in Brussels for 15 years, emphasised the interest he has shown during his political career for research and technological development issues. Busquin told MEPs that Europe needs to attract young people into research to bring the proportion of scientists in Europe up to US and Japanese levels. He added that
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Europe should “pay attention to [areas] with a high job-creation potential such as biotechnology” and that he would encourage south European regions to improve their research performances to eliminate the gap between development in the north and south . Busquin also expressed his desire to increase the participation of women in scientific and research activities. When asked whether “a member state [should] have to co-finance biomedical research projects—through its participation in the FPRD—if its national legislation prohibits research involving [for example] embryos”, Busquin said that “in no case may participation in the FPRD lead a partner to breach the statutory ethical provisions in force in its own country”. He added that “since the rules on ethics sometimes vary substantially from country to country, a participant in a project may carry out work which would not be authorised in the country of one of its partners”. Busquin also acknowledged that alternative therapies “could have a role to play in the healing process” but stated that “priority will be given to clinical research”. Xavier Bosch
1011