Joint committee on the Human Tissue and Embryos (Draft) Bill First Report


CHAPTER 8: recommendations

Chapter 3

293.  We recommend that the Government should commission independent public policy research into general public opinion on issues arising from scientific and ethical developments in this field and the wider field of bioethics, either through the Research Councils, for example, the ESRC and AHRC, or other appropriate organisations.

294.  We recommend that the Government and the regulator should take a more active approach to fulfilling their duty to improve and inform public understanding of the issues in this area.

Chapter 4

295.  Ultimately it must be for Parliament to set the ethical framework, taking the widest range of advice. We consider that an ethical input should be found from within Parliament and we recommend that Parliament should establish a joint bioethics committee of both Houses to provide ethical input to legislation raising significant issues in bioethics, such as the current draft Bill.

296.  We recommend that the draft Bill should be amended to provide a clear framework based on the principle of devolved regulation. Legislation should devolve regulatory authority and decision making to the regulators, who in turn should be given the power in legislation to define areas of 'exemption' within their regulatory remit. This would provide a framework of 'permitted regulation' and give greater freedom and authority to the regulator and clinicians except where there is a good reason to do otherwise. The draft Bill should also provide a statutory power for the Secretary of State to make regulations subject to affirmative resolution and only on the application of the regulator, to make provisions where necessary for the remit or authority of the regulator. We also note the criteria used by the Medical Research Council to judge applications for research grants and we recommend that that these could be built on to provide legislative parameters for research set out in the draft Bill. If this recommendation is accepted, it follows that the appointment of members of the regulatory body would require a balance of ethical, scientific, legal and medical expertise; and the Chair should be a proven leader of the highest calibre and appropriately remunerated.

Chapter 5

297.  We have found the evidence against establishing RATE overwhelming and convincing and we recommend that the Government abandons the proposals in Part 1 of the draft Bill. We consider that the regulatory oversight provided by the HFEA and the HTA is better than the oversight that could be provided by RATE and we recommend that the HFEA and the HTA (as well as the MHRA) should be retained as separate authorities. However we note the lack of research undertaken as to the workings of the current regulatory structure, and improvements that could be made. We recognise that greater savings, consistency, efficiency and co-operation might be achieved both within and between the two organisations. We recommend that the Government, in consultation with the HFEA, HTA and their stakeholders, look at ways to achieve such improvements.

298.  In accordance with our recommendation about a framework of permissive regulations, we recommend that the draft Bill should be amended to give the regulator statutory power to define areas of exemption from the current regulatory remit where appropriate. We also support calls for a lighter touch and, where it would be appropriate, we urge the regulators to investigate ways in which the unnecessary duplication of regulation can be eliminated.

299.  In consultation with the Human Tissue Authority and its stakeholders, we recommend that the Government use the opportunity presented by the draft Bill to make necessary amendments to the Human Tissue Act 2004.

300.  We recommend that Research Council grants should include the cost of research licences.

301.  We are concerned by some of the comments we have heard about fees and unproven treatments and we recommend that the draft Bill is amended to meet the HFEA's suggestion that assisted conception clinics should provide patients with fully costed treatment plans. We recommend that the HFEA works with the Royal Colleges and other appropriate professional bodies to protect patients from any risk of exploitation.

302.  We recommend that the Government takes steps to ensure that Primary Care Trusts and Foundation Trusts implement NICE guidance which sets out minimum levels of treatment.

Chapter 6

303.  We support the definitions in clauses 14 and 15 of the draft Bill and recommend that the detail in relation to how these definitions will be applied be left to the regulator.

304.  We consider that the Government's approach on this issue is misguided and rests on no sound point of principle. We can see no clear reason why certain categories of inter-species embryo should be permitted under licence and 'true' hybrids proscribed. We recommend that the HFEA should be left to judge which entities may be created, kept and used for research purposes under licence.

305.  We note that, when what is now the 1990 Act was before Parliament, the issue of embryo research was put to a free vote. We consider that the creation and use of inter-species embryos for research purposes is a comparable issue, and we recommend that the issue is put to a free vote in both Houses.

306.  If Parliament supports the provisions regulating inter-species embryo research, we would make the following further recommendation. In line with our recommendation supporting an architecture of 'permitted regulation', we recommend that the Government should revisit its approach to the definition of inter-species embryos in the draft Bill with a view to providing a general definition along the lines of the approach set out in paragraph 176, with authority given to the regulator to interpret and apply that definition to individual research applications, based on the principles set out in legislation; statutory authority to exempt areas of research from the licensing provisions where appropriate; and with a statutory power for the Secretary of State to make regulations, only on the application of the regulator, to make provisions in respect of a particular research application.

307.  We recommend that the Explanatory Notes to the draft Bill be revised to make clear and explicit that a "permitted embryo" cannot be created from the genetic material of two women alone and that, in the case of mitochondrial donation, the child will essentially have only two parents, one male and one female. We also recommend that the Government gives an ongoing commitment that, if the technology became available to create an embryo only from the genetic material of two women without the need for fertilisation by a sperm, any question of whether such an embryo should be allowed to be inserted into a woman should be a matter for Parliament to decide.

308.  We recommend that the Explanatory Notes to the draft Bill be revised to make clear and explicit that a cloned embryo cannot be a "permitted embryo" and we also recommend that the Government gives an ongoing commitment that any question of amending these provisions should be a matter for Parliament to decide.

309.  We recognise that this is a delicate area. However, given the Government's apparent acceptance of the principle of selecting for 'saviour siblings' we do not understand why the practice is limited to "life-threatening" conditions capable of treatment using umbilical cord blood stem cells. We recommend that the draft Bill be amended to substitute "serious" for "life-threatening".

310.  Although we have heard some arguments in favour of sex selection for non-medical reasons and in some circumstances we recognise that it may not do harm, on balance we recommend that the draft Bill be amended in line with the HFEA's current policy.

311.  There is clearly some confusion surrounding the Government's decision to omit from the draft Bill the current provision which prohibits the genetic modification of embryos for research purposes. We make no determination on this point but we recommend that the Government clarifies its policy decision to allay the concerns which have been expressed.

312.  We recommend that the Government should consider the concern raised by the HFEA in relation to donor gametes and the withdrawal of consent to the storage of an embryo. Subject to this, we support the provisions [on consent to storage and use of gametes and embryos] in Schedule 3 to the draft Bill.

313.  We agree with the Government that there should be some mechanism for allowing the storage of gametes in cases where an individual lacks the capacity to give consent, either through temporary mental incapacity or because of legal minority. We recommend that the Government consider more carefully the technical point raised by the Royal College of Pathologists; and consider making express provision for the circumstances in which it would be lawful to take gametes without explicit consent. This aside, however, we support the provisions on storage without consent.

314.  We recommend that the proposal to remove the 'need for a father' provision from section 13(5) of the 1990 Act should be put to a free vote of both Houses of Parliament. To inform that vote, the balance of view of this Committee is that it would be detrimental to remove entirely the requirement to take into account the 'need for a father'. Instead, we recommend that the current provision in section 13(5) on "(including the need of that child for a father)" should be retained but in an amended form in a way that makes clear it is capable of being interpreted as the 'need for a second parent' in line with the parenthood provisions currently in Part 3 of the draft Bill. In making this recommendation, we do not seek to discriminate against single women seeking treatment and we recommend that in such circumstances and the requirement to consider the need of a child for a second parent should, as now, not be a barrier to treatment.

315.  We recommend that, in relation to gametes or embryos created or donated for research, the ten year limit should either be extended or removed.

316.  We also recommend that there should be a system of consent such that, at the commencement of fertility treatment, couples are asked for their consent that any gametes or embryos left unused for treatment at the expiry of the ten years become the property of the HFEA and may then be used for research purposes. At any point up to the 10 year limit, there should be the ability to withdraw consent so that gametes or embryos would be destroyed in accordance with patients' wishes.

317.  We recommend that the draft Bill be amended to extend to cohabiting couples and those planning intimate relationships the right of access to the register to find out whether they are related to the other person. We also recommend that the Government amends the draft Bill to require consent from the other person before access is provided.

318.  We recommend that the draft Bill be amended to allow the HFEA to set up a voluntary contact register [for donor conceived people].

319.  We recommend that the age of access to the Register should be reduced to 16.

Chapter 7

320.  We recognise the force of the argument that the fact of donor conception should be registered on a person's birth certificate. This would create the incentive for the parent(s) to tell the child of the fact of his or her donor conception and would go some way to address the value of knowledge of genetic history for medical purposes. Moreover, unlike where children are born through natural conception, assisted conception by its nature involves the authorities and we are deeply concerned about the idea that the authorities may be colluding in a deception. However, we also recognise that this is a complicated area involving the important issue of privacy, as well as issues of human rights and data protection. We therefore recommend that, as a matter of urgency, the Government should give this matter further consideration.

321.  We recognise that, given the issues involved in the practical application of these provisions, counselling is important and we recommend that the Government should ensure that counselling services in these areas are available and have sufficient funding to provide services to all who require them.

322.  We recommend that clause 65 should be removed from the draft Bill.

323.  We recommend that the draft Bill be amended to bring the regulation of surrogacy within the remit of the HFEA.


 
previous page contents next page

House of Lords home page Parliament home page House of Commons home page search page enquiries index

© Parliamentary copyright 2007
Prepared 1 August 2007