from many aspects of this law and subject instead to new guidelines to be adopted by the newly created California Institute for Regenerative Medicine.

State laws on dispositional authority over embryos and on hES cell research are in flux and are largely untested in the courts. Investigators working with NT or hES cell lines are well advised to seek advice on the latest rules applicable in their states.

REGULATION OF hES CELL AND NT RESEARCH IN OTHER COUNTRIES

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.

31  

Associated 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.

33  

http://web2.innovationworld.net/biotechconnect/000312.html.

34  

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

35  

Research 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).



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