Regulation Of hEs Cell And Nt Research In Other Countries

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There is no international consensus yet on whether and how to pursue hES cell research. For example, in February 2005, a committee of the U.N. General Assembly abandoned attempts to craft a global treaty on NT research and satisfied itself with a plurality vote in favor of a nonbinding resolution calling for a ban on all forms of human cloning or genetics research that are contrary to "human dignity," a phrase left to the interpretation of member countries.31 Thus, the regulation of hES cell research varies from country to country. In many cases, there is no law explicitly addressing such research. In some countries, such as Poland and Italy, the research is forbidden or substantially curtailed. In others, however, there seems to be a trend toward liberalization of the laws. France and Germany, for example, have taken steps to permit research on cell lines derived from surplus in vitro fertilization (IVF) blastocysts,32 and Japan33 and Sweden34 have lifted restrictions on making blastocysts for research with NT.

Given the increasing frequency of international collaboration in hES cell research, it is important to monitor regulatory developments in other countries. As the guidelines recommended by this committee in Chapter 6 require that the provenance of hES cell lines be consistent with the ethical standards and procedures adopted here, understanding the points of similarity and difference between the guidelines and the rules in other countries will help investigators and the ESCRO committees proposed in Chapter 3 to manage collaboration.

Some countries place limitations on the importation of cell lines whose origins are inconsistent with their laws. Australia, for example, adopted the Research Involving Human Embryos Act in 2002 and the Human Cloning Act, which prohibits NT for reproductive or therapeutic purposes.35 Of possible importance to U.S.

31Associated Press, U.N. Group Calls for Cloning Ban, Feb. 18, 2005.

32"Europe Sends Mixed Signals on Stem-Cell Work," Victoria Knight, Wall Street Journal Jan. 26 2005. Note that that German liberalization applies only to cell lines produced prior to 2002. See http:// www.germany-info.org/relaunch/education/new/edu_stemcells.html.

33htt p://web2.innovationworld.net/biotechconnect/000312.html.

34http://www.geocities.com/giantfideli/art/CellNEWS_Sw_thera_cloning.html.

35Research Involving Human Embryos Act, 2002, No. 145, 2002, An Act to regulate certain activities involving the use of human embryos, and for related purposes (http://scaleplus.law.gov.au/html/comact/ browse/TOCN.htm); Prohibition of Human Cloning Act 2002, No. 144, 2002, An Act to prohibit human cloning and other unacceptable practices associated with reproductive technology, and for related purposes (http://scaleplus.law.gov.au/html/comact/browse/TOCN.htm).

investigators seeking to collaborate with Australian centers, Australia forbids the importation of cloned, parthenogenetic, androgenetic, or chimeric embryos (a chi-meric embryo is defined as one in which nonhuman cells have been introduced into a human embryo). It is also an offense to create a human embryo by any method other than fertilization and for any purpose other than for the treatment of infertility. So-called hybrid embryos are specifically forbidden and such entities are defined to include an animal egg into which the nucleus of a human cell has been introduced. Commercial trading in human eggs, sperm, or embryos is not allowed. Those bans are backed by criminal sanctions with prison terms of up to 15 years, depending on the offense.

Australia's law allows research to be performed on embryos remaining in excess of clinical need, and the consent requirements for donors are consistent with those outlined in this committee's recommendations (see Chapter 5). Research is subject to oversight by a new committee, the National Health and Medical Research Council Licensing Committee, which has the authority to review research programs, grant licenses, and maintain a database regarding the licenses granted. That committee also has the authority to inspect licensee facilities to ensure compliance with its licensing conditions.

The United Kingdom has adopted an approach that depends on a central licensing authority, called the Human Fertilisation and Embryology Authority (HFEA). The role of HFEA is to monitor and license clinics that carry out any of the established IVF or other assisted reproductive technology procedures and to regulate human embryo research and the storage of reproductive materials. As in the present committee's Recommendation 8 above, donors in the United Kingdom must give consent for use of their gametes or embryos in research. Egg and sperm donors are paid a nominal fee and reasonable expenses.36

HFEA will grant a license to make embryos for research only if the research program meets the purposes outlined in U.K. law. Allowable research purposes include increasing knowledge of genetic disorders, developing better contraceptive techniques, and advancing the treatment of infertility. As of early 2005, HFEA had granted 28 research licenses, including 10 related to hES cells and two related to parthenogenesis.37 Two licenses were granted for work with NT blastocysts.38

The United Kingdom also has created a Stem Cell Bank, launched by the Medical Research Council in September 2002. The bank exists to establish fully characterized and quality-controlled cell lines (see Chapter 5 for a discussion on banking). The cell lines will be supplied to accredited scientific research teams and eventually to pharmaceutical companies to enable the development of broad-ranging cell therapies.39

36htt p://www.hfea.gov.uk/PressOffice/Archive/34673456).

37htt p://www.hfea.gov.uk/Research.

38See "British to Clone Human Embryos for Stem Cells," Rick Weiss, Washington Post, February 9, 2005; Page A02; see also http://www.hfea.gov.uk/PressOffice/Archive/1092233888.

39htt p://www.hfea.gov.uk/PressOffice/Backgroundpapers/Stemcellresearch.

Israel does not have a central licensing authority, but it does have well-developed guidelines emerging out of the work of the Bioethics Advisory Committee of the Israel Academy of Sciences and Humanities, and, because the Health Ministry delegates decisions regarding new genetic research involving human beings to the Helsinki Committee for Genetic Experiments on Human Subjects, it also has a centralized review process for hES cell research.40 Consistent with the guidelines proposed in this report, the Israeli guidelines require informed consent from donors of surplus blastocysts. The guidelines state that best practices include mentioning research uses from the beginning of the IVF process and separating the medical team responsible for the IVF treatment and donation from the scientific teams involved in embryo research who receive the donation. As in the recommendations made in the next chapter, buying and selling of embryos is forbidden in Israel, but making new embryos solely for research, including blastocysts made by NT, is permissible. Research and possible applications must be justifiable in terms of the benefit that it offers humanity, and confidentiality and privacy of the donors should be respected. As in the recommendation proposed in Chapter 3 for purely in vitro work on hES cell lines, Israel allows such work to be conducted without further need for specific ethical authorization.

In June 2002, Singapore's Bioethics Advisory Committee released its report Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning, in which it recommended that NT be permitted under centralized regulation. Consistent with the guidelines proposed here, the regulatory framework should require the informed voluntary consent of donors, prohibit the commerce and sale of donated materials, require strong scientific justification before making new embryos solely for research purposes, and stipulate that no one shall be under a duty to participate in any manner of research on human stem cells to which he or she has a conscientious objection. The report has been presented to the relevant ministries, and the government will decide on the recommendations later.41

Canada is still debating legislation to regulate assisted reproductive technologies and embryo research, but it operates under guidelines that incorporate both centralized and local review. Under the guidelines issued by the Canadian Institute for Health Research,42 review and approval by the central Stem Cell Oversight Committee, by local research ethics boards (REBs), and, where appropriate, by animal care committees is required for all research involving the derivation, in vitro study, and clinical trial of hES cell lines. At any time, however, the local REB or animal care committee may refer an hES cell research proposal to the Stem Cell Oversight Committee for ethics review if it considers the research to be within the oversight committee's purview according to the above criteria. Such decisions by the

40htt p://www.academy.ac.il/bioethics/articles/embryonic_ibc_report.pdf.

41www.bioethics-singapore.org.

42htt p://www.cihr-irsc.gc.ca/e/15349.html.

REB or animal care committee are not subject to appeal. Like the guidelines recommended in this report, the Canadian guidelines require a medical rationale for the research, the informed consent of donors, protection of donors' privacy, and a prohibition on payment to donors (see Chapter 5). And like the current policy of the U.S. government (but unlike that of New Jersey or California), the Canadian guidelines prohibit public financial support for making embryos solely for research or of research in which hES cells are combined with a nonhuman embryo.43

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