Joint Committee on the Draft Human Tissue and Embryos Bill

Press Notice 1, 24 May 2007

CALL FOR EVIDENCE

The two Houses of Parliament have established a Joint Committee on the draft Human Tissue and Embryos Bill (Cm 7087) which was published by the Government on 17 May 2007.

The remit of the Committee is to consider the draft Bill, and to report on it to both Houses by 25 July. The Committee's Report is likely to be published in early August.

Membership

The members of the Committee are as follows:

Lords Members:
Baroness Deech
Baroness Hollis of Heigham
Lord Jenkin of Roding
Lord Mackay of of Clashfern
Baroness Neuberger
Bishop of St Albans
Lord Selsdon
Lord Turnberg
Lord Winston

Commons Members:
Mr David Burrowes
Ms Katy Clark
Dr Ian Gibson
Robert Key
Chris Mole
Dr Doug Naysmith
Geraldine Smith
Ms Dari Taylor
Mr Phil Willis (Chairman)

At its first meeting on 26th May the Committee elected Phil Willis MP as Chairman.

Members' declared interests are available on the Committee's website:
www.parliament.uk/parliamentary_committees/jchumantissue.cfm

The Committee expects to take oral evidence during June. The programme for these evidence sessions will be announced as soon as possible. It is likely that the Committee will meet most Tuesdays at 1.15 pm and Wednesdays at 3.15 pm during June to hear evidence.

The Joint Committee invites interested organisations and individuals to submit written evidence as part of its inquiry into the Human Tissue and Embryos (Draft) Bill. Submissions, reflecting the guidance on written evidence given in this notice, should reach the Committee as soon as possible and no later than 15 June 2007. Evidence received after this date will be recorded but we cannot guarantee it will form part of the Committee's consideration.

SCOPE OF THE COMMITTEE'S INQUIRY

The Joint Committee will be looking at all provisions in the draft Human Tissue and Embryos Bill and welcomes Written Evidence on all aspects of it.

However, as the Committee has to report by 25 July, it has had to prioritise some provisions of the Bill on which it would particularly welcome Written Evidence. These are:

The draft Bill overall

1. Are the proposals in the draft Bill necessary, sufficient and workable? Could the proposed outcomes be achieved by better means?

2. Does the regulatory architecture set out in the draft Bill contain the right balance between:

(i) Parliamentary control via primary legislation and secondary legislation (regulation making powers);
(ii) Regulation by the regulatory body (or bodies);
(iii) Appropriate flexibility and freedom for clinicians and researchers; and
(iv) Appropriate opportunities for individuals to access treatment.

3. How should Parliament and the regulatory body or bodies ensure an appropriate ethical framework to secure and maintain public confidence?

PART 1 of the draft Bill

R ATE and the new regulatory architecture

Clause 1 of the draft Bill proposes a new Regulatory Authority for Tissue and Embryos (RATE) to replace the existing Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA). Schedule 1 sets out the constitution of RATE and how it will operate.

4. (a) What are your views on the transfer of the functions of the HFEA and HTA to a single new regulatory authority, RATE?

(b) What are your views on the provisions in Schedule 1 about RATE's constitution and administration?

Funding RATE

The Government proposes to continue existing funding arrangements so that RATE would be funded in part by grant-in-aid from the Department of Health, with the bulk of the costs of regulation recovered via licence fees (see Regulatory Impact Assessment, paragraph 4.42). Clauses 35, 37, 38, 68 and 69 of the draft Bill allow RATE to charge fees in respect of licenses.

5. Would the proposed funding of the regulatory body or bodies allow it (or them) to carry out its functions fully and effectively?

6. Should the regulatory body or bodies be allowed to make charges for licenses?

PART 2 of the Draft Bill

Definitions

Clause 14 of the draft Bill revises the statutory definitions of 'embryo', 'egg', 'sperm' and 'gamete'. Clause 15 revises the statutory definition of 'nucleus'. Clause 14 also gives the Secretary of State regulation-making power to expand these definitions if it appears to him to be necessary or desirable to do so in the light of developments in science or medicine (subject to some restrictions).

7. (a) Do you agree with new definitions in the draft Bill of 'embryo', 'egg', 'sperm', 'gamete', 'nucleus'? If not, how would you propose to amend them?

(b) Should the Secretary of State have the regulation-making power to expand these definitions as proposed in the draft Bill?

Inter-species embryos (for example, cytoplasmic hybrid embryos)

The text of the draft Bill (particularly in clause 17 and Schedule 2) reflects the position in the Government's White Paper that the creation of hybrid and chimera embryos in vitro is prohibited, but that a regulation-making power would allow Parliament to agree exceptions to that prohibition for research purposes.

On publication of the draft Bill, the Government announced that it now intends to accept (in part) the approach advocated by the Commons Science and Technology Select Committee, that legislation should provide for certain inter-species entities to be created for research purposes under licence by the Regulator within a 14-day limit. The Government proposes that the entities to be permitted should be limited to those listed in clause 17(2) inserted section 4A(5)(b) to (d) on page 9 of the draft Bill (see also paragraph 1.12 of the introduction to the draft Bill on page ix). This would exclude from the licensing regime 'pure hybrids' as described in clause 17(2) inserted section 4A(5)(a) and (e) on pages 9 and 10.

The Science and Technology Committee, in its recent Report 'Government proposals for the regulation of hybrid and chimera embryos', goes further than the Government's new position and recommends that legislation should be permissive and provide that 'in general, the creation of all types of human-animal chimera or hybrid embryos should be allowed for research purposes' under licence by the Regulator (recommendations 22 and 26 on page 63 of that Report). Furthermore, the Committee recommended that licensing should not allow for the development of interspecies embryos past the 14-day limit unless proved necessary.

8. Do you support:

(i) the approach signalled by the Government in the White Paper,
(ii) the new approach announced by the Government (as outlined above); or
(iii) the approach recommended by the Commons Science and Technology Committee?

Research licences

In addition to the new provisions on inter-species embryos, clause 18 and Schedule 2 of the draft Bill consolidate the purposes for which licences for research can be granted and extend the principle purposes listed in paragraph 6 of Schedule 2.

8. How should Parliament approach legislating for those purposes for which licences for research may be granted in the future (arising out of future research) but that are not yet determined? Should such judgements be left to the regulatory body or bodies to determine?

9. How should Parliament or the regulatory body or bodies take public views and public engagement into account?

Embryo testing and sex selection practices

Clause 18 and Schedule 2 of the draft Bill propose changes to existing statutory limits on those activities that can be licensed. This covers conditions under which embryo testing may be carried out, for example to test for tissue compatibility that could be used to treat siblings with a life-threatening medical condition (tissue typing), or testing for an abnormality that may affect the embryo's capacity to result in live birth. It also covers the conditions under which practices involving sex selection may be licensed ' where there is a particular risk of a woman giving birth to a child with a chromosomal abnormality involving a significant risk of developing a serious physical or mental disability, a serious illness or any other serious medical condition'. Sex selection for non-medical reasons is not permitted, nor is it permitted to select specifically for an abnormality, such as deliberately choosing an embryo which would result in a deaf child.

10. What are your views on the provisions in paragraph 3 of Schedule 2 setting out the conditions under which (a) embryos can be tested and (b) sex selection practices can be carried out?

Consent to storage and use of gametes and embryos

Clause 20 (and Schedule 3) make changes to existing provisions about consent to, and use of, gametes and embryos.

11. What are your views on the proposed changes to consent provisions?

Treatment conditions

Clause 21 of the draft Bill proposes changes to the conditions of licences for providing treatment services. It proposes to remove from the existing conditions of licences the requirement to take account of 'the need of that child for a father' before treatment services can be provided.

12. What are your views on the proposal in the draft Bill to remove from the existing conditions of treatment the requirement to take account of 'the need of that child for a father' before treatment services can be provided?

Clause 21 also extends the requirement to take account of the welfare of the child to all treatment services (not just those currently covered by the 1990 Act) as a result of the European Tissue Directive.

13. What are your views on the approach to the welfare of the child provisions in clause 21?

Storage limits

Clause 22 of the draft Bill proposes to increase the statutory storage period for embryos from 5 years to 10 years to match the statutory storage period for gametes.

14. Do you support the proposal to increase the storage period from 5 to 10 years? Should the storage period for gametes and embryos be limited by statute at all?

Register of information and access to the Register

Clause 32 of the draft Bill replaces existing legislative provisions about the Register of information with new provisions about the Register of information that RATE must keep and the entitlements of certain persons to access information on the Register. This includes extending to a donor-conceived person about to enter a civil partnership the existing provision allowing a donor-conceived person to obtain information about whether they are related to the person they intend to marry. Clause 33 contains restrictions on the disclosure of information.

15. What are your views on the provisions about the Register and access to it in clauses 31, 32 and 33 of the draft Bill?

PART 3 of the draft Bill

Parenthood and the use of sperm or transfer of embryo after death

Part 3 of the draft Bill (clauses 39 to 64) makes provision for legal parenthood in cases involving assisted reproduction, including making more precise provision for unmarried couples or partners and clarifying provisions about consent that must be provided before treatment.

16. What are your views on the provisions covering parenthood and consent in Part 3 of the draft Bill? Are there any particular provisions in these clauses you would seek to change?

PART 4 of the draft Bill and other provisions

Legislating for future scientific development

In certain places, the draft Bill seeks to legislate now to regulate future scientific developments that are necessarily uncertain. In particular, it seeks to make provision:

(i) for Parliament to pass Regulations making the sale, supply and advertisement of sperm sorting kits an offence, if such kits are developed in the future (clause 65); and

(ii) for Parliament to pass Regulations to allow relevant provisions of the Act to have effect in cases where an egg or an embryo has been created from mitochondrial material provided by 2 women (sometimes called 'artificial gametes') (clause 34).

17. Is it either desirable or appropriate for Parliament to seek to legislate in this way for future technology, both in general terms and in the particular cases identified? Is such legislation likely to be legally effective?

Embryo transfer in treatment

The draft Bill does not cover regulations relating to the conditions of transfer of embryos during treatment.

18. Should this be a matter for the regulatory body? Or for the National Institute for Health and Clinical Excellence (NICE)? Should it be regulated at all?

Other issues

19. Are there any other provisions in the draft Bill, or provisions you would like to see in the draft Bill, on which you would like to give your views?

GUIDANCE FOR THOSE SUBMITTING WRITTEN EVIDENCE

Short submissions of 6 pages or fewer are preferred; longer submissions should include a summary. Annexes may be submitted, but will not necessarily be published. Relevant material prepared for other purposes (such as reports or submissions to other inquiries and consultations) may be submitted to the Committee for information, but will not be printed. Witnesses who submit original written evidence may be invited to give oral evidence at Westminster; transcripts of such sessions are published.

Evidence should be clearly printed or typed on single sides of A4 paper, unstapled, and should be set out in numbered paragraphs. If drawings or charts are included, we ask that these are black-and-white and of camera-ready quality. The submission should be signed and dated, together with a note of the author's name and status and whether the evidence is submitted on an individual or corporate basis. Submissions by e-mail are preferred (as attachments in Word), with a signed, hard copy to follow. Please ensure that you include relevant contact details. These will be removed before publication.

Evidence and inquiries should be addressed to:

Kate Lawrence
Clerk to the Joint Committee on the Draft Human Tissue and Embryos Bill
House of Lords
London SW1A 0PW
and preferably by email to
[email protected]

Tel: 020 7219 8675; Fax: 020 7219 4931

The deadline for submitting written evidence is 15 June 2007.

Once submitted, evidence submitted becomes the property of the Committee, and may be published. Witnesses may publicise their written evidence themselves, but in doing so should indicate that it was prepared for the Committee.

You can follow the inquiry via the Committee web pages, accessed from www.parliament.uk/parliamentary_committees/jchumantissue.cfm

This is a public call for evidence. Please bring it to the attention of other groups and individuals who may not have received a copy directly.