CONSULTATION ON REGULATIONS TO BE MADE UNDER THE HUMAN TISSUE ACT 2004

RESPONSE FROM THE WELLCOME TRUST AND THE MEDICAL RESEARCH COUNCIL

4 October 2005

General comments

1 We welcome the introduction of Regulations under sections 1, 6, 16, 33, 34 and Schedule 5 of the Human Tissue Act 2004.

2 We note that Regulations have not yet been introduced under section 7 of the Act, although a power to do so exists.We would strongly urge that Regulations are introduced under this section of the Act (both sub-sections 1-3 and 4) as early as possible in order to ensure that this mechanism for dispensing with the need for consent is available to health practitioners and researchers as and when it may be needed.As we indicated during the passage of the Act through Parliament, we believe the circumstances where it will be necessary and appropriate to utilise this mechanism will arise relatively frequently.

Comments on draft Regulations A

Section 1: Ethical Approval of Research

3 In general, we support the part of the Regulations relating to ethical approval of research as drafted.However, we have a specific concern in relation to research that would not normally be considered within the remit of the NHS research ethic committees (“RECs”), including:

- research involving human tissue held within museums or similar institutions;

- research involving the armed forces;

- research conducted within private medical establishments;

- research using imported tissue.

If this is to have the desired effect and work equitably and effectively across research as a whole, it is essential that RECs are willing and able to consider applications for ethical approval for research projects including human tissue that would currently be outside of their remit.Failing this, we would ask the Secretary of State to specifically recognise, pursuant to paragraph 1 (2) (b) of these Regulations, that where research falls outside the remit of RECs, ethical approval may be obtained from a suitably constituted committee established for this purpose.We would suggest a committee that would be suitably constituted.

Section 16 (3) – Power for Secretary of State to specify circumstances in which storage of tissue is excepted from licensing

4 We welcome the proposal to make exceptions to the licensing requirements under the Act.As we indicated during the passage of the legislation, we believe that the licensing requirements as they appear on the face of the Act are excessive, disproportionate and liable to create unnecessary administration and expense.We therefore support the proposal to limit the scope of the licensing regime through Regulations under section 16(3), and to target the requirement for a licence to those circumstances where there is real need.

5 We agree with the principle to except ‘end-user’ researchers from the licensing requirement in relation to post mortem tissue, and to limit the application of licensing the storage of tissue from the living to storage within tissue banks for the purposes of research.At first glance, this would appear to be a reasonably proportionate approach.However, we have significant concerns with the proposal as presented; for example that

(a)the approach will be unworkable and incoherent in practice,

(b) the Regulations as drafted will not actually achieve the stated policy objective, and

(c) the distinction between ‘tissue banks’ and ‘end-user’ researchers is artificial, as many end-user researchers will store tissue for future research. This distinctionwill discourage sharing of research materials and encourage hoarding, contrary to the public interest.

6 We believe the Regulations will in fact capture so called ‘end-user’ researchers on a significant scale, undermining the stated policy intention because, for example:

6.1 Paragraph 3(3)(b) excepts (as ‘end-use’) ‘a specific research project which is ethically approved or for which an application for ethical review is pending’.This exception does not extend to the period during which the application for ethical approval is being prepared, either at the outset of a project or where an application has been rejected and is being prepared for re-submission.The preparation of an application for ethical review (and of the Protocol associated with that) is an intrinsic part of the research process and this will frequently require access to the tissue on which it is proposed to conduct the research.In practice, an ‘end-user’ researcher will commonly find himself in one of these two situations and in doing so, would fall outside the ‘end-user’ exception and accordingly need to obtain a licence.

6.2 Researchers will generally need to retain and store tissue that is utilised in a research project after the project has been completed in order for example to support their research findings or for future studies.It is not entirely clear to us that this would be considered to be part of a use for a specific approved project either in law, or by a Research Ethics Committee.Even if it would, it would appear that the sharing of those tissues with other researchers, either to assess the merits of the specific findings or to conduct further research, would be outside of the ‘end-use’ exception.Again, this would appear to undermine the stated policy intention.More importantly, we are very concerned that this will discourage the sharing of such research materials and thereby limit the value of the donated tissue for research for the public good.

7 We have a number of further concerns with the Regulations relating to section 16(3).These are as follows:

7.1 The provision under section 3(2) excepts from the licensing regime storage for the purpose of a specific research project which is ethically approved or for which an application for ethical approval is pending.This creates particular difficulties for those research activities that are normally outside the remit of the RECs (including in particular, research conducted within museums and research involving imported tissue). If this exception is to have the desired effect and to apply equitably across research as a whole, it is essential that RECs are willing and able to consider applications for ethical approval for research projects involving human tissue that would currently be outside of their remit.Failing this, the Secretary of State must specifically recognise that where research falls outside of the remit of RECs, ethical approval may be obtained from an alternative suitably constituted committee established for this purpose.

7.2 It is unclear to us how the Human Tissue Authority would regard the storage of tissue for several purposes, some of which would require a licence, some of which would not.For example:

-if tissue is stored principally to diagnose a patient (which is a non-scheduled purpose), but may also be available for the purposes of research or the treatment of his relatives (both scheduled purposes under the Act), would a licence still be required?If so, where such ‘secondary use’ is opportunistic (on the part of the person requesting it) and responsive rather than actively sought out (by the storer of the tissue), there may be considerable uncertainty as to when a licence is first required.Furthermore, this may act as a significant disincentive to the altruistic storer to share the tissue for the secondary purpose.

-if a doctor is treating two related patients (e.g. a mother and new baby) and blood samples are taken for use in their treatment or diagnosis, their tissue may well be relevant to and used for the treatment of each of them.Although the primary purpose of the storage of such blood would be their own treatment (a non-scheduled purpose), a secondary purpose would be the use for the treatment of the other (a scheduled purpose).Unless it is the primary purpose that dictates the position, it seems to us to be inevitable that the vast majority of primary and secondary health care facilities will need a licence.This seems an unnecessary and disproportionate administrative and financial burden on the National Health Service.

8 Solutions

We would urge that the Secretary of State re-considers the approach taken to the exceptions to licensing of storage for research.Instead, we would recommend the following, which we believe is a workable and proportionate solution to the position and conducive to the sharing of tissue donated for research purposes for public good:

(a) The ‘end-user’ distinction should be retained for tissue taken post mortem but the wording in paragraph 3(3)(b) should be extended to cover ‘a specific research project which is ethically approved or for which an application for ethical review is pending, or is being prepared, including any incidental storage that is necessary for these purposes.’

(b) All storage of tissue taken from the living for the purposes of research should be excepted from the licensing regime.This would be in line with the approach in Scotland and consistent with the EU Tissues and Cells Directive.

Failing this, as an absolute minimum, we believe it is essential that:

(a) it is made absolutely clear in these Regulations that the need for a licence is determined by the primary purpose for which it is stored, so that if the primary purpose of storage is not a scheduled purpose, a licence will not be required and,

(b) paragraph 3(3)(b) as currently drafted is extended to cover ‘a specific research project which is ethically approved or for which an application for ethical review is pending, or being prepared, including any incidental storage that is necessary for these purposes.’

Schedule 5: Information to be given on enforcing powers of entry

9 We have no comment on this part of the Regulations.

Comments on draft Regulations B

Section 6: Storage and use of tissue from incapacitated adults

10 We support this part of the Regulations as drafted and welcome its introduction.These are essential transitional provisions, which will enable the continuation of important research involving adults lacking capacity until such time as the Mental Capacity Act 2005 comes into force.

Comments on draft Regulations C

11 We have no comments on these Regulations.