Final Report (all chapters)

The relevance of the Code of Practice can hardly be overemphasized. It makes it much
easier for licensees to comply with the HFE Act by reducing legal uncertainty. It also
demonstrates how a regulatory body can promote the adoption of best practices without crafting
rigid rules and regulations. The code accomplishes this through the HFEA system of monitoring
and compliance assurance. Clinics are audited on a regular basis, typically yearly. Inspections are
unannounced, and violations can lead to suspension of the license. In this regard, the HFEA’s
approach to compliance assurance is no different than any other enforcement system. However,
many inspections are conducted not by HFEA officials but ART professionals themselves,
typically colleagues at other ART clinics. This measure was taken not to increase economic
efficiency or to reduce personnel costs, but to promote reciprocal learning and the adoption of
best practices. According to HFEA officials, this approach has proven very successful in
ensuring that clinics become aware of potential areas of concern, and has indeed promoted the
adoption of best practices among ART practitioners. 114 The HFEA capitalizes on this process by
carefully scrutinizing audit results and by using this information to improve existing policies and
practices.
6.5 Summary and Conclusions
Our review of legislative initiatives at the international level provides several lessons. Most
industrialized countries and many developing nations have responded to the ethical dilemmas
raised by reproductive medicine and biomedical research not only by appointing ethics
commissions, but also by passing new legislation. As Appendix H demonstrates, there is a
remarkable agreement among legislative bodies around the world on which reproductive
practices and scientific developments may call for governmental interventions. These include
embryo research, reproductive cloning, research cloning, stem cell research, pre-implantation
genetic diagnosis, the creation of chimeric animals, the creation of hybrids, germ-line genetic
modifications, surrogacy, and the trade or sale of gametes and embryos. The United States is the
exception, having refrained to adopting any specific measures for most of these developments.
Among the countries included in our survey, there is little agreement on how to respond to
new developments in biomedicine. Most countries have banned reproductive cloning. In other
respects, however, important differences remain. Interestingly, prevailing religious and cultural
orientations seem to be weak predictors of legislative choices. Spain, for example, has much
more liberal stem cell research legislation than France or Italy. Important differences exist
been a failure to comply with the conditions of a license and, in particular, conditions requiring anything to be
“proper” or “suitable,” take account of any relevant provision of the Code, and (b) a License Committee may, in
considering, where it has power to do so, whether or not to vary or revoke a license, take into account any
observance or failure to observe the provisions of the Code.
114
This practice is not as uncommon as one might think. In many industrial sectors that have adopted voluntary
environmental and safety codes, “compliance” is often ensured through an analogous mechanism. For example,
in the United States, the National Paint and Coatings Association, an organization that has adopted a
comprehensive and mandatory system of environmental management known as “Coating Care,” relies on
reciprocal audits to monitor compliance and promote the adoption of best practices.
178