Certain key proposals within the Draft Bill have generated significant concerns for the committee, not least the proposed merger of the Human Tissue Authority (HTA) with the Human Fertilisation and Embryology Authority (HFEA) to form the Regulatory Authority for Tissue and Embryology (RATE), which was absolutely rejected by the committee in the face of 'overwhelming and convincing' evidence. Few of us, concerned by the national failure to implement the NICE Guidance on the management of the infertile, have been convinced by the siren like suggestion that 'cost savings or benefits [of the merger] to be passed to the regulated sector and free-up more resources for the delivery of services to patients'. A significant concern of the committee, which is shared by many, is whether RATE, constituted as proposed, could adequately deliver on its statutory responsibilities, particularly given the very distinct areas which HFEA and HTA regulate at present.
If, as the committee suggest, the HFEA is to be retained in some form then its range of responsibilities needs to be re-examined. Balancing the need for adequate reassurance to the public in respect of what is permitted in law and the need to retain flexibility in approach to take account of advances in science and changes in attitude within society will be difficult. Responsibilities need to be appropriately assigned between parliament, the regulator, clinicians and individuals. The committee have sensibly argued against an approach which is absolutist in primary legislation save in only a few areas, for example reproductive cloning and sex selection for social reasons. This provides the needed flexibility to allow for regulation to respond to advances in science, but will require the constitution and membership of the regulator to be carefully determined in order to retain universal confidence in its decision-making processes.
There continues to be vigorous public and political debate in the UK about human reproductive technologies. Recent examples include donor anonymity, screening for adult onset disorders, egg donation for research, and sex selection. The British Fertility Society (BFS) believes that there should be a clear separation between this necessary open debate and the regulatory process. The debates should involve all relevant stakeholders, but should also afford the articulation of views by those with particular subjective interest in matters of controversy such as patients and providers, as well as those with wider interests, for example in ethics, social policy, politics, religion and philosophy. The scrutiny committee concur with the BFS recommendation that consideration be given to the establishment of an independent parliamentary based Bioethics Commission in parallel with the new authority, based within, and accountable to, parliament.
Particular criticism of the government's approach to the regulation of inter-species embryo research, which is critically relevant to the advancement of stem cell science, is aired. The Bill's proscription against research using 'true hybrids' is argued to be inconsistent and it is suggested that the regulator should decide what is permitted. This is sensible, and a free vote in the House of Commons and the House of Lords on this section of the Bill is advised. There is new guidance with respect to storage limits for embryos suited to research; currently there is a dearth of available embryos and time limits on storage contribute in part to this.
An area which will no doubt generate significant debate in the weeks to come relates to the issue of the 'need for a father' provision. The management of requests for fertility assistance from single sex partners or single women has always been challenging for clinics. The committee recommends that the wording of the Bill should make the need for a 'second parent' the substitute. Perhaps the 'need for a family', as we have suggested, is a more pragmatic and sensible way of approaching this issue.
Extending saviour sibling approaches to include 'serious' and not just 'life threatening' conditions will be welcomed in some quarters. However, the suggestion that birth certification should include information on gamete donation will be a very difficult area in practice to promote and enforce.
Unquestionably, the preparation of the Bill has generated significant interest. A key responsibility not only for the Government, but also the media, in the coming months is to ensure that public understanding of the complex, controversial and human issues in this area is maximised to allow debate to be both informed and intelligent. The scope of the review is enormous but will affect our professional and personal lives for years to come. We should continue to participate.