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European bioethics treaty finally approved
THE LANCET
POLICY AND PEOPLE
US agencies issue proposals for xenotransplantation
T
he US Department of Health and Human Services has issued a new draft guideline that aims to encourage xenotransplantation without introducing potentially deadly new pathogens into the human species. The proposal was jointly developed by the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health. With a growing need for transplants and a dearth of human tissue and organs, there has been a rising use of animal-derived materials. However, with that has come the threat of cross-species transmission of animal diseases. One of the guideline’s recommendations is that researchers and physicians screen animals before transplantation to minimise such transmission. The guidelines also call for: archiving of biological samples from source animals and transplant recipients to aid future investigations; selection of xenotransplantation team members based on safety expertise; establishment of local review boards to assess infectious disease risk; and monitoring of patients post-xenotransplantation for infectious agents. “This guideline represents the consensus of physicians and scientists regarding the best way to move ahead in the field of xenotransplantation”, said HHS Secretary Donna Shalala. The agency will solicit comments from the public over the next 90 days and then issue final guidance. The guidelines dovetail with recommendations made earlier this year by the Institute of Medicine, which said that xenotransplantation should be allowed to go forward despite the risks of infection (see Lancet, Aug 3, p 324). The US federal health agencies are also coordinating a national registry that will provide a database of all xenotransplantation procedures. Xenotransplantation products—such as animal organs or cells—are already regulated by the FDA as biological agents; thus researchers or companies seeking to do trials with such products must seek FDA permission first. Alicia Ault Barnett
Vol 348 • October 5, 1996
European bioethics treaty finally approved
T
hat most somnolent of Strasbourg political gatherings, the Parliamentary Assembly of the Council of Europe sprang into life on Sept 26 for the final vote on the European bioethics convention. The outcome was a qualified approval for the text, coupled with a demand that the convention should be opened for signature by the end of the year, clearing the way for implementation of the first, legally binding international rules on medical practice, research, and genetics. Ambassadors representing the organisation’s 39 member states will meet Oct 14–17 to discuss timing and responses to ten last-minute amendments sought by the assembly. In the text, 38 articles cover issues including equitable access to health care, confidentiality, patients’ rights to information including the right “not to know”, ethical guidelines on research, organ and tissue transplantations, a prohibition on financial gain from the human body, and rules for disposal of human body parts. The convention, however, side-steps abortion and euthanasia.
In genetics, the convention will ban discrimination on the grounds of “genetic heritage” and prohibit disclosure of genetic data for employment or insurance purposes. The Assembly called for prohibition on disclosure of genetic test results to be reinforced through a stipulation that this should apply even “where the person concerned has consented or is bound by contract”. Otherwise, the convention would restrict genetic testing to health purposes, with disclosure permitted only where results “serve to determine a person’s descent or as evidence in official procedure to try a criminal offence”. Many of the convention’s more detailed early provisions have been removed; it is intended that they will be refined in a series of subsequent protocols covering medical research, embryology, organ transplantation, and genetics. Protocols on research and transplants are already at an advanced stage of drafting and an international seminar on embryology is planned. Arthur Rogers
WHO and UNICEF produce report on vaccines
T
he expeditious delivery of vaccines to every community is the issue expounded in the 160-page report State of the World’s Vaccines and Immunization compiled jointly by WHO and UNICEF. Under WHO’s expanded programme on immunisation launched in 1974, some 80% of the world’s 130 million children born each year are now vaccinated during theira first 12 months against measles, diphtheria, pertussis, tuberculosis, tetanus, and polio (scheduled for eradication by the year 2000). The report assesses the status of vaccines already available but not widely used in developing countries, including those against Haemophilus influenzae type b, rubella, chickenpox, Japanese encephalitis, hepatitis A, cholera, and typhoid fever. New concepts include inhaled vaccines. Realising that universal availability is, of course, a question of price “the new generation vaccines”, says the
report, “are likely to cost not cents but dollars a dose from now on, even perhaps in the poorest countries. Research and development costs today for a single vaccine can range from US$50 million to $200 million. On top of that, new vaccines will also be constrained by a web of intellectual property rights—each adding a fixed percentage to the price of a single dose, as well as restricting its manufacture elsewhere”. Proposed solutions include sharply tiered pricing, according to countries’ per caput income levels. “We have to change our thinking”, said Ralph Henderson Assistant Director-General of WHO. “The dollars we have to pay in the future need to be compared to the benefits, which are very large, rather than to the few cents paid for vaccines developed in the past.” Alan McGregor
953
POLICY AND PEOPLE
US agencies issue proposals for xenotransplantation
T
he US Department of Health and Human Services has issued a new draft guideline that aims to encourage xenotransplantation without introducing potentially deadly new pathogens into the human species. The proposal was jointly developed by the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health. With a growing need for transplants and a dearth of human tissue and organs, there has been a rising use of animal-derived materials. However, with that has come the threat of cross-species transmission of animal diseases. One of the guideline’s recommendations is that researchers and physicians screen animals before transplantation to minimise such transmission. The guidelines also call for: archiving of biological samples from source animals and transplant recipients to aid future investigations; selection of xenotransplantation team members based on safety expertise; establishment of local review boards to assess infectious disease risk; and monitoring of patients post-xenotransplantation for infectious agents. “This guideline represents the consensus of physicians and scientists regarding the best way to move ahead in the field of xenotransplantation”, said HHS Secretary Donna Shalala. The agency will solicit comments from the public over the next 90 days and then issue final guidance. The guidelines dovetail with recommendations made earlier this year by the Institute of Medicine, which said that xenotransplantation should be allowed to go forward despite the risks of infection (see Lancet, Aug 3, p 324). The US federal health agencies are also coordinating a national registry that will provide a database of all xenotransplantation procedures. Xenotransplantation products—such as animal organs or cells—are already regulated by the FDA as biological agents; thus researchers or companies seeking to do trials with such products must seek FDA permission first. Alicia Ault Barnett
Vol 348 • October 5, 1996
European bioethics treaty finally approved
T
hat most somnolent of Strasbourg political gatherings, the Parliamentary Assembly of the Council of Europe sprang into life on Sept 26 for the final vote on the European bioethics convention. The outcome was a qualified approval for the text, coupled with a demand that the convention should be opened for signature by the end of the year, clearing the way for implementation of the first, legally binding international rules on medical practice, research, and genetics. Ambassadors representing the organisation’s 39 member states will meet Oct 14–17 to discuss timing and responses to ten last-minute amendments sought by the assembly. In the text, 38 articles cover issues including equitable access to health care, confidentiality, patients’ rights to information including the right “not to know”, ethical guidelines on research, organ and tissue transplantations, a prohibition on financial gain from the human body, and rules for disposal of human body parts. The convention, however, side-steps abortion and euthanasia.
In genetics, the convention will ban discrimination on the grounds of “genetic heritage” and prohibit disclosure of genetic data for employment or insurance purposes. The Assembly called for prohibition on disclosure of genetic test results to be reinforced through a stipulation that this should apply even “where the person concerned has consented or is bound by contract”. Otherwise, the convention would restrict genetic testing to health purposes, with disclosure permitted only where results “serve to determine a person’s descent or as evidence in official procedure to try a criminal offence”. Many of the convention’s more detailed early provisions have been removed; it is intended that they will be refined in a series of subsequent protocols covering medical research, embryology, organ transplantation, and genetics. Protocols on research and transplants are already at an advanced stage of drafting and an international seminar on embryology is planned. Arthur Rogers
WHO and UNICEF produce report on vaccines
T
he expeditious delivery of vaccines to every community is the issue expounded in the 160-page report State of the World’s Vaccines and Immunization compiled jointly by WHO and UNICEF. Under WHO’s expanded programme on immunisation launched in 1974, some 80% of the world’s 130 million children born each year are now vaccinated during theira first 12 months against measles, diphtheria, pertussis, tuberculosis, tetanus, and polio (scheduled for eradication by the year 2000). The report assesses the status of vaccines already available but not widely used in developing countries, including those against Haemophilus influenzae type b, rubella, chickenpox, Japanese encephalitis, hepatitis A, cholera, and typhoid fever. New concepts include inhaled vaccines. Realising that universal availability is, of course, a question of price “the new generation vaccines”, says the
report, “are likely to cost not cents but dollars a dose from now on, even perhaps in the poorest countries. Research and development costs today for a single vaccine can range from US$50 million to $200 million. On top of that, new vaccines will also be constrained by a web of intellectual property rights—each adding a fixed percentage to the price of a single dose, as well as restricting its manufacture elsewhere”. Proposed solutions include sharply tiered pricing, according to countries’ per caput income levels. “We have to change our thinking”, said Ralph Henderson Assistant Director-General of WHO. “The dollars we have to pay in the future need to be compared to the benefits, which are very large, rather than to the few cents paid for vaccines developed in the past.” Alan McGregor
953