Background No two countries have adopted identical regulatory measures on cloning. Understanding the complexity of these regulatory variations is essential. It highlights the challenges associated with the regulation of a controversial and rapidly evolving area of science and sheds light on a regulatory framework that can accommodate this reality. Methods Using the most reliable information available, we have performed a survey of the regulatory position of thirty countries around the world regarding the creation and use of cloned embryos (see Table (...) 1). We have relied on original and translated legislation, as well as published sources and personal communications. We have examined the regulation of both reproductive cloning (RC) and non-reproductive cloning (NRC). Results While most of the countries studied have enacted national legislation, the absence of legislation in seven of these countries should not be equated with the absence of regulation. Senator Morin was not correct in stating that the majority of recent legislation bans both RC and NRC. Recent regulatory moves are united only with regard to the banning of RC. While NRC is not permitted in seventeen of the countries examined, it could be permitted in up to thirteen countries. Conclusions There is little consensus on the various approaches to cloning laws and policies, and the regulatory position in many countries remains uncertain. (shrink)

The scientific challenges and ethical controversies facing human embryonic stem cell (hESC) research continue to command attention. The issues posed by patenting hESC technologies have, however, largely failed to penetrate the discourse, much less result in political action. This paper examines U.S. and European patent systems, illustrating discrepancies in the patentability of hESC technologies and identifying potential negative consequences associated with efforts to make available hESC research tools for basic research purposes while at same time strengthening the position of certain (...) patent-holders' rights. Differences between the U.S. and the European contexts may in part explain why the course of hESC research in those jurisdictions ultimately diverges. Nevertheless, questions about whether and how patenting, related agreements, and licensing practices progress and shape the field of hESC research in both the U.S., Europe, and elsewhere must no longer be marginalised. These questions are fundamentally important in determining what benefits are likely to result from hESC research. Assuring these benefits is the moral issue with which patent systems are most intrinsically concerned, and that governments must begin to directly address rather than assume or ignore. (shrink)

Somatic cell nuclear transfer (SCNT) remains a controversial technique, one that has elicited a variety of regulatory responses throughout the world. On March 29, 2005, Canada's Assisted Human Reproduction Act came into force. This law prohibits a number of research activities, including SCNT. Given the pluralistic nature of Canadian society, the creation of this law stands as an interesting case study of the policy-making process and how and why a liberal democracy ends up making the relatively rare decision to use (...) a statutory prohibition, backed by severe penalties, to stop a particular scientific activity. In this article, we provide a comprehensive and systematic legal analysis of the legislative process and parliamentary debates associated with the passage of this law. (shrink)

This article is the second in a two-part review of policy design for human embryo research in Canada. In the first article in 6(1) of the JBI , we explain how this area of research is circumscribed by law promulgated by the federal Parliament and by guidelines adopted by the Tri-Agencies, and we provide a chronological description of relevant policy initiatives and outcomes related to these two policy instruments, with particular attention to the repeated efforts at public consultation. This second (...) article analyses the history of policy design for human embryo research in Canada, applying a typology of modes of public consultation developed by Eric Montpetit to better understand the various episodes of policy design and their corresponding outcomes. On this basis, we suggest that the degree to which the views of Canadian residents and citizens on human embryo research have been solicited as part of the policy-making process has diminished significantly over time. We also suggest that this diminished participation is likely to continue given the presence of powerful interest groups and policy communities “speaking for” Canadians. This raises interesting questions about the legitimacy of future policy initiatives for human embryo research in Canada. (shrink)