Public consultation launched on draft fertility regulations

Following the granting of Royal Assent to the UK's Human Fertilisation and Embryology Act in November 2008, the Department of Health has launched a public consultation on draft regulations to implement the Act. While certain aspects of the Act's provisions will come into force as early as April 2009, other provisions may not come into force until sometime in 2010, and the majority of provisions will come into force in October 2009.

The consultation document (available from the Department of Health website) solicits feedback on 10 specific proposals embodied in 85 draft regulations. These proposals and regulations fall into four broad categories - 'storage period for embryos and gametes'; 'procedure for revocation, variation or refusal of licences'; 'appeals'; and 'disclosure of information for research purposes'.

The first category, 'storage period for embryos and gametes', concerns circumstances in which embryos and gametes might be frozen for longer than has previously been permitted. Respondents are asked whether the same criteria should apply to embryos as to gametes; whether extended freezing should be permitted in cases of premature infertility (for example in children) and in cases involving embryo or gamete donation or surrogacy; and whether the extended period should be for a set time period rather than an age limit.

The second category, 'procedure for revocation, variation or refusal of licences', concerns the consideration of licence applications by the Human Fertilisation and Embryology Authority (HFEA). Respondents are asked whether there should be a lay majority on the relevant HFEA committee; and whether the relevant HFEA procedures should be detailed in regulations.

The third category, 'appeals', concerns the reconsideration of licence applications by the HFEA when its decisions are appealed. Respondents are asked whether current and former HFEA members should be prohibited from sitting on appeals committees; and whether the individuals heading appeals committees should be legally qualified.

The fourth category, 'disclosure of information for research purposes', concerns the disclosure of identifiable information held on the HFEA's register, including in circumstances where it is not practicable to obtain consent from the relevant patient(s). Respondents are asked whether the organisation best placed to consider applications for information is the HFEA (working with the Patient Information Advisory Group); whether the information that can be disclosed should exclude details of embryo or gamete donation; and what conditions should apply to such disclosure of information.

The consultation will close on 30 March 2009. Until then the Department of Health is keen to solicit feedback, both on its 10 specific proposals and on the draft regulations as a whole. To respond to the consultation, or to request a hard copy of the consultation document, email hferegulations@dh.gsi.gov.uk