Sir

In her Essay '30 years: from IVF to stem cells' (Nature 454, 280–281; 2008), Ruth Deech reminds us of the role that the Human Fertilisation and Embryology Authority (HFEA) has played through regulation in guiding the practice and scientific investigation of assisted-reproduction technology in the United Kingdom. But I disagree with her opinion that assisted reproduction in the United States is “nearly an unregulated black market”. The medical aspects of assisted reproduction are in fact regulated extensively.

It is true that individuals and their physicians in the United States have the freedom to make decisions regarding who can reproduce and under what circumstances without the type of regulation provided by the HFEA. But it is against federal law to perform an in vitro fertilization (IVF) cycle without reporting that cycle and its results to the federal government; federal regulations require registration of clinics and extensive screening of potential gamete donors; all drugs and devices must be approved by the federal government; and health-care providers must be licensed by state governments.

In addition to complying with codified regulations, more than 90% of IVF clinics in the United States subscribe to unannounced on-site inspections and adhere voluntarily to guidelines developed jointly by the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Publications in the scientific literature attest to the positive impact of these guidelines on patient outcomes.

The HFEA has had an important impact on assisted-reproduction technology and is an excellent example of extensive regulation. We cannot guess whether this degree of regulation in other countries would either be necessary or have comparable impact. Regulation can assume different forms, each dependent on individual cultures.