The art of regulation and the regulation of ART: the impact of regulation on research and clinical practice

How a society regulates Assisted Reproduction Technologies (ART) depends on cultural context. The challenge for the regulatory regime is to balance protection for patients and society with freedom for medico-scientific creativity. Neither an exclusively market-regulated nor a peer-regulated approach is realistic politically, or desirable socially, ethically and legally. Legitimate social issues that go beyond the exclusive expertise of doctors and scientists or market choice by patients need to be accommodated within the regulatory regime. Within this context, four key issues are discussed: the lack of a shared social ethic that helps the needs of the community to be balanced against those of its individual members; the negative impact of intrusive external regulation on scientists and doctors; the requirement for doctors and scientists to review their professional structures reflectively and critically if they are to be entrusted with peer-regulation; and the desirability of constructive dialogue between regulators and regulated rather than the use of coercion and criminal sanctions.