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Canadian Parliament finally agrees human reproduction research act
POLICY AND PEOPLE
Canadian Parliament finally agrees human reproduction research act arliamentary passions reached fever pitch last week as the Canadian government made another bid to introduce wide-ranging human reproductive technologies legislation that prohibits human cloning and regulates stem-cell research. After 10 years of contentious debate and several false starts, the federal government introduced its long-overdue Act Respecting Human Reproduction on May 9 only to quickly discover that the compromises they were proposing still do not satisfy disgruntled Parliamentarians irrespective of their political stripe. Like all previous manifestations of the legislation, the new bill prohibits practices such as human cloning; paying donors for sperm or eggs; buying or selling human embryos; creating animal-human hybrids; or the sex selection of embryos. But it deviates from earlier editions and from the recent recommendations of a Parliamentary committee by allowing surrogate mothers to be paid for “reasonable expenses”, like mater-
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nity clothes, if they’re approved by a proposed US$10 million per year Assisted Human Reproduction Agency of Canada, whose other responsibilities will include licensing fertility clinics and maintaining a national registry of donors and recipients of sperm and eggs. Another deviation will require scientists to obtain licenses and agency approval if they wish to do research on stem cells derived from embryos developed in-vitro. Earlier forms of the legislation had also specified that stem cells could be derived from embryos obtained from miscarriages or elective abortions. In its recent investigation, the Parliamentary committee had become so embroiled by the notion of using stem cells derived from fetal tissue that they ultimately recommended a ban on stem-cell research unless it was a last resort because no other “biological material” could be used. In hopes of making the bill palatable to anti-abortionists, Health minister Anne McLellan opted instead to regu-
late stem-cell research derived from in-vitro embryos, lashing out at suggestions that they shouldn’t be used. The bid at a compromise creates a situation in which scientists using stem cells from fetal issue won’t have to jump through as many hoops to do their research. Rather than seeking licenses and approval from the new agency, they’ll simply have to meet guidelines established by the Canadian Institutes of Health Research. But whether that clever attempt to side-step abortion politics will save the legislation is unclear. Even governing Liberal party backbenchers are lining up against the bill, while Canadian Alliance health critic Rob Merrifield is promising a fight if the government doesn’t impose an immediate 3-year moratorium on all stem-cell research. “Let’s let science catch up a little bit before we open this Pandora’s box of going down and destroying embryos”, he says. Wayne Kondro
Ethics group advises caution before EC issues stem-cell line patents
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ioethics experts advised the European Commission (EC) that patenting unmodified embryonic stem-cell lines was like “commercialisation of the human body” and strict controls should be enforced so that patents should only be issued on lines that have been modified to create new characteristics for specific industrial applications. In a report published on May 7, Nöelle Lenoir, chairperson of the European Group on Ethics (EGE), said the dilemma for the group was how to control the ethical aspects of stem-cell work without jeopardising European research, which lags behind the USA and Japan EGE suggested that the EC should “avoid granting too broad patents that would impair further research and development . . . only stem-cell lines which have been modified by in-vitro treatments or genetically modified so that they have acquired characteristics for specific industrial application fulfil the legal requirements for patentability”, said EGE. The bioethics group suggested that a “publicly accessible” European registry of unmodified human embryonic stem-cell lines should be created and “compulsory
licences” should be considered when access to stem-cell lines is blocked by the misuse of patent rights. The report, entitled Ethical aspects of patenting inventions involving human stem cells, was produced in response to a request by Romano Prodi, president of the EC, in accordance with the 1998 European Union (EU) Directive on the Legal Protection of Biotechnological Inventions. Ethical dilemmas arose from the fact that patents could encourage scientific progress and benefit patients, said Lenior, but at the same time research could be impeded because researchers would have to pay fees to patent holders before being allowed to access modified stem-cell lines. “It’s necessary to secure a right balance between the inventors’ interests and the society’s interests”, argued Lenoir. The report said unmodified stem cell lines—cultured lines of fresh embryonic stem cells that are undifferentiated and pluripotent—“do not . . . fulfil the legal requirements, especially with regard to industrial application, to be seen as patentable” since such cells are “so close to the human body, to the fetus, or to the embryo”.
THE LANCET • Vol 359 • May 25, 2002 • www.thelancet.com
Robin Lovell-Badge, MRC National Institute for Medical Research, London, UK, says he is “broadly in agreement with the report” although he is “a little concerned about the idea to exclude patentability of the process of therapeutic cloning as this is such a new area that it is difficult to know how it might progress”. Peter Andrews, chairman of the Department of Biomedical Science, University of Sheffield, UK, said the report is a “reasonable and fair position”. But he considered that in addition to “regenerative medicine”, understanding the molecular processes that regulate the proliferation and differentiation of human embryonic stem cells could provide important insights into human embryonic development, causes of birth defects and infertility, and into diseases such as cancer. “It would be a pity if access of researchers and companies to the basic ‘raw material’ for such research, namely the stem cells that can be obtained from embryos, were restricted in any way by patent considerations.” Xavier Bosch
1839
For personal use. Only reproduce with permission from The Lancet Publishing Group.
Canadian Parliament finally agrees human reproduction research act arliamentary passions reached fever pitch last week as the Canadian government made another bid to introduce wide-ranging human reproductive technologies legislation that prohibits human cloning and regulates stem-cell research. After 10 years of contentious debate and several false starts, the federal government introduced its long-overdue Act Respecting Human Reproduction on May 9 only to quickly discover that the compromises they were proposing still do not satisfy disgruntled Parliamentarians irrespective of their political stripe. Like all previous manifestations of the legislation, the new bill prohibits practices such as human cloning; paying donors for sperm or eggs; buying or selling human embryos; creating animal-human hybrids; or the sex selection of embryos. But it deviates from earlier editions and from the recent recommendations of a Parliamentary committee by allowing surrogate mothers to be paid for “reasonable expenses”, like mater-
P
nity clothes, if they’re approved by a proposed US$10 million per year Assisted Human Reproduction Agency of Canada, whose other responsibilities will include licensing fertility clinics and maintaining a national registry of donors and recipients of sperm and eggs. Another deviation will require scientists to obtain licenses and agency approval if they wish to do research on stem cells derived from embryos developed in-vitro. Earlier forms of the legislation had also specified that stem cells could be derived from embryos obtained from miscarriages or elective abortions. In its recent investigation, the Parliamentary committee had become so embroiled by the notion of using stem cells derived from fetal tissue that they ultimately recommended a ban on stem-cell research unless it was a last resort because no other “biological material” could be used. In hopes of making the bill palatable to anti-abortionists, Health minister Anne McLellan opted instead to regu-
late stem-cell research derived from in-vitro embryos, lashing out at suggestions that they shouldn’t be used. The bid at a compromise creates a situation in which scientists using stem cells from fetal issue won’t have to jump through as many hoops to do their research. Rather than seeking licenses and approval from the new agency, they’ll simply have to meet guidelines established by the Canadian Institutes of Health Research. But whether that clever attempt to side-step abortion politics will save the legislation is unclear. Even governing Liberal party backbenchers are lining up against the bill, while Canadian Alliance health critic Rob Merrifield is promising a fight if the government doesn’t impose an immediate 3-year moratorium on all stem-cell research. “Let’s let science catch up a little bit before we open this Pandora’s box of going down and destroying embryos”, he says. Wayne Kondro
Ethics group advises caution before EC issues stem-cell line patents
B
ioethics experts advised the European Commission (EC) that patenting unmodified embryonic stem-cell lines was like “commercialisation of the human body” and strict controls should be enforced so that patents should only be issued on lines that have been modified to create new characteristics for specific industrial applications. In a report published on May 7, Nöelle Lenoir, chairperson of the European Group on Ethics (EGE), said the dilemma for the group was how to control the ethical aspects of stem-cell work without jeopardising European research, which lags behind the USA and Japan EGE suggested that the EC should “avoid granting too broad patents that would impair further research and development . . . only stem-cell lines which have been modified by in-vitro treatments or genetically modified so that they have acquired characteristics for specific industrial application fulfil the legal requirements for patentability”, said EGE. The bioethics group suggested that a “publicly accessible” European registry of unmodified human embryonic stem-cell lines should be created and “compulsory
licences” should be considered when access to stem-cell lines is blocked by the misuse of patent rights. The report, entitled Ethical aspects of patenting inventions involving human stem cells, was produced in response to a request by Romano Prodi, president of the EC, in accordance with the 1998 European Union (EU) Directive on the Legal Protection of Biotechnological Inventions. Ethical dilemmas arose from the fact that patents could encourage scientific progress and benefit patients, said Lenior, but at the same time research could be impeded because researchers would have to pay fees to patent holders before being allowed to access modified stem-cell lines. “It’s necessary to secure a right balance between the inventors’ interests and the society’s interests”, argued Lenoir. The report said unmodified stem cell lines—cultured lines of fresh embryonic stem cells that are undifferentiated and pluripotent—“do not . . . fulfil the legal requirements, especially with regard to industrial application, to be seen as patentable” since such cells are “so close to the human body, to the fetus, or to the embryo”.
THE LANCET • Vol 359 • May 25, 2002 • www.thelancet.com
Robin Lovell-Badge, MRC National Institute for Medical Research, London, UK, says he is “broadly in agreement with the report” although he is “a little concerned about the idea to exclude patentability of the process of therapeutic cloning as this is such a new area that it is difficult to know how it might progress”. Peter Andrews, chairman of the Department of Biomedical Science, University of Sheffield, UK, said the report is a “reasonable and fair position”. But he considered that in addition to “regenerative medicine”, understanding the molecular processes that regulate the proliferation and differentiation of human embryonic stem cells could provide important insights into human embryonic development, causes of birth defects and infertility, and into diseases such as cancer. “It would be a pity if access of researchers and companies to the basic ‘raw material’ for such research, namely the stem cells that can be obtained from embryos, were restricted in any way by patent considerations.” Xavier Bosch
1839
For personal use. Only reproduce with permission from The Lancet Publishing Group.