Public interest or public meddling? Towards an objective framework for the regulation of assisted reproduction technologies.
BACKGROUND
Assisted reproductive technologies (ART) bear a heavy regulatory burden in some jurisdictions. This burden constrains patient autonomy and the professional autonomy of doctors and scientists.


METHODS
We question why this should be by analyzing the possible public interests in ART regulation under the headings: health, financial, ethico-legal and socio-political. Throughout, we try to identify whether comparable public interest claims are made for other areas of medicine, but accommodated without the requirement for specialized statutory frameworks such as those exemplified in the UK and Victoria (Australia).


RESULTS
We identify a small core of public interest concerns that seem to justify some sort of special regulatory structure, but not one as elaborate as those currently in place. We then develop a five-step quality control model, familiar to biomedical practice but novel in the context of legal thinking, to aid development and review of regulatory policy and practice. This model is applied both prospectively to the proposal to record 'by donation' on birth certificates, and retrospectively to the regulation of parental choice about the genetic make-up of offspring in UK and Victorian jurisdictions.


CONCLUSIONS
The model provides a useful and robust framework for pin-pointing problems with regulatory regimes, to stimulate empirical research, and to facilitate both the review and development of regulatory policy.
Johnson
Martin H
MH
Department of Physiology, Development and Neuroscience, University of Cambridge, UK. mhj21@cam.ac.uk
Petersen
Kerry
K
D001315:Australia; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008962:Models, Theoretical; D026684:Personal Autonomy; D010817:Physician-Patient Relations; D017009:Professional Autonomy; D011634:Public Health / Q000331:legislation & jurisprudence; D027724:Reproductive Techniques, Assisted / Q000191:economics / Q000941:ethics* / Q000331:legislation & jurisprudence*; D006113:United Kingdom