Final Report (all chapters)

6 International Legislative and Regulatory Approaches
In this chapter, we take a detailed look at legislative initiatives in four countries: Italy,
Australia, Canada, and Britain. Each case provides a distinctive perspective on possible
approaches to the regulation of reproductive technologies and biomedical research. Italy
exemplifies a legislative approach to controversial biomedical developments that, while favored
by some in the United States, in our view would be costly at best and counterproductive at worst.
The Italian legislation goes well beyond simply targeting deeply troubling practices such as
reproductive cloning and the creation of human embryos solely for research purposes. The scope
of its prohibitions is very broad and its bans are sweeping. Not surprisingly, the Italian approach
has triggered a considerable amount of controversy, and we present it here as an illustration of
how not to approach controversial ethical dilemmas in the United States. Australia, by contrast,
has passed legislation that seems to enjoy the support of all relevant constituencies and of the
general public. Its approach to regulating controversial biomedical developments is restrictive –
from an American perspective, perhaps too restrictive – but it also recognizes the importance of
providing a legally protected space to controversial biomedical research. Finally, Canada and
Britain provide an illustration of our claim that similar regulatory infrastructures are compatible
with different ethical concerns. Both countries emphasize the need to closely monitor the field of
reproductive medicine and biomedical research through a specialized regulatory entity, yet
Britain is considerably more liberal in its regulatory stance than Canada. Britain is also the only
country with many years of experience in regulating controversial reproductive technologies.
None of the legislative approaches examined in this chapter provides a template that could
mechanically be used to implement a new regulatory structure in the American context. With the
exception of Italy, each of these approaches does, however, provide important insights into how
a U.S. system of regulation could be implemented. To facilitate this task, we have also examined
legislative and regulatory approaches in 13 industrialized countries. Our analysis shows that
there is virtually no agreement among these countries on what constitute the most appropriate
legislative responses to new biomedical dilemmas, the notable exception being reproductive
cloning. On the other end, there is considerable agreement on which reproductive practices and
research protocols should be regulated. 1 For each of these practices, a majority of the reviewed
countries has either adopted specific legislative measures or crafted regulation. Only one country
– the United States – has taken little or no action. This observation underscores the need for the
U.S. Congress to pay closer attention to medical and scientific developments in the area of
reproductive medicine and biomedical research.
1
In Appendix H, we have identified 10 activities pertaining to reproductive medicine and biomedical research that
in recent times have been targeted for legislative or regulatory intervention in 13 OECD countries.
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