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The Human Tissue and Embryos Bill: a chance for further debate

6 August 2007
By Dr Mark Hamilton
Chair of the British Fertility Society and Consultant Gynaecologist, Aberdeen Maternity Hospital'
Appeared in BioNews 419
"Last week saw the publication of the UK parliamentary report of the Joint Committee on the Human Tissue Embryos (Draft) Bill. The government is now tasked to respond over the next two months in time for the Bill to be included in the Queen's Speech in November.

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.

12 November 2007 - by Dr Kirsty Horsey 
A new Human Fertilisation and Embryology Bill was published last week by the UK's Department of Health. The Bill is designed to update and reform the existing laws on assisted conception and human embryo research in the UK, established by the 1990 Human Fertilisation and Embryology...
12 November 2007 - by Professor Marcus Pembrey 
This conference (organised by the Progress Educational Trust (PET), held at the Institute of Child Health, London on 1 November) was extremely timely, given that the new Human Fertilisation and Embryology (HFE) Bill revising regulation of assisted reproduction and embryo research was published last week. This Bill is intended to...
6 August 2007 - by Danielle Hamm 
A joint UK parliamentary committee, established to scrutinise the Human Tissue and Embryos (Draft) Bill, has recommended that fundamental changes be made to the Bill before it commences its passage through parliament. The draft Bill will replace the Human Fertilisation and Embryology Act 1990, which frames the...
6 August 2007 - by MacKenna Roberts 
A UK all party parliamentary committee has recommended that children born through fertility treatments involving donated sperm or eggs should have this information recorded on their birth certificates. The MPs and Peers stated that children have a right to know of their donated biological parentage and believe...
27 July 2007 - by Nicholas de Lacy-Brown 
On 16 July, Progress Educational Trust (PET) held a highly successful debate in London, deliberating the role of parents and parliament in the decision-making process for the use of pre-implantation genetic diagnosis (PGD). Describing the procedure as a 'disruptive technology', John Wyatt, Professor of Neonatal Paediatrics at University College London...
23 July 2007 - by Antony Starza-Allen 
Scottish Catholic, Cardinal Keith O'Brian, has called on the UK Prime Minister to reconsider proposals to remove the current reference to 'the need for a father' contained in legislation governing IVF. Section 13 (5) of the 1990 Human Fertilisation and Embryology Act stipulates that in offering IVF...
19 July 2007 - by James Lawford Davies 
I will miss the UK's Human Fertilisation and Embryology (HFE) 1990 Act when it is gone. I am no great supporter of our regulatory model and the 1990 Act is flawed and idiosyncratic. However, if you are going to regulate IVF and embryo research, ours is a reasonably solid regulatory...
4 July 2007 - by Danielle Hamm 
The Roman Catholic Bishops of England (RCBE) have told the UK parliament that inter-species embryos - those containing genetic information from both human and animals - should not be treated any differently from 'normal' embryos, and that women should be given the chance to carry their genetic offspring to...
19 June 2007 - by Antony Starza-Allen 
The UK's Academy of Medical Sciences has backed the creation of human-animal embryos for use in stem cell research, which is says should be subject to the same rules as research on human embryos, including the 14-day rule and a ban on implanting embryos into a...
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