§ Bob SpinkTo ask the Secretary of State for Trade and Industry (1) what action she will take to prevent a conflict between the Polkinghorne guidelines on separation and the MRC initiative to target IVF clinics to make more embryonic stem cells available via the donation of embryos; [89042]
(2) what criteria were used by the MRC to decide which clinics would be approached as part of the national stem cell initiative; [89038]
(3) what annual sums the MRC is proposing to make available as part of its targeted call for expressions of interest in developing consortia that foster two way collaborations between IVF clinics and researchers in the context of the national stem cell initiative; [89036]
(4) what incentives the MRC will use to increase the supply of human embryos for the national stem cell initiative; [89035]
(5) if she will estimate the number of human embryos the MRC are aiming to obtain as part of their seeking expressions of interest in the national stem cell initiative; [89033]
(6) if she will list the clinics that received the MRC letter seeking expressions of interest in developing consortia that foster two way collaboration between IVF clinics and researchers in the context of the national stem cell initiative. [89037]
§ Ms HewittRegulations were introduced in January 2001 to extend the purposes for which human embryos may be used in research. The regulations enable the Human Fertilisation and Embryology Authority (HFEA) to issue a licence for research for the purposes of increasing knowledge about the development of embryos and serious disease and to enable such knowledge to be applied in developing treatments for serious disease.
The Medical Research Council (MRC) has taken the lead, in collaboration with the UK regulatory authorities (Human Fertilisation and Embryology Authority, Department of Health, Medicines Control Agency) and other funding agencies, in generating a coordinated national stem cell strategy. As part of this, MRC has appointed the National Institute for Biological Standards and Control to set up a UK Stem Cell Bank for the curation and distribution of ethically sourced, quality controlled human adult, foetal and embryonic stem (ES) cell lines.
MRC, HFEA, the Department of Health and the Medicines Control Agency are collaborating to generate a UK-wide framework that will include: provision for oversight of national activities in stem cell research, standard donor information and consent forms, and route maps for researchers wishing to develop, bank and use stem cell lines for research and therapeutic purposes. 643W The HFEA license will require that samples of all ES cell lines be deposited in the UK stem cell bank. This will reduce the number of embryos required as individual researchers will not need to generate their own stem cell lines.
In relation to the Call for Expressions of Interest in establishing consortia, applicants will be able to request pump priming support for up to three years. It is expected that more substantial support would be sought through conventional grant schemes. Examples for which funds might be sought through this call include:
- a nurse co-ordinator post to aid consenting by potential donors and facilitate interactions between the clinics and researchers
- travel expenses to assist liaison between researchers and clinics
- essential small equipment (e.g. a dedicated incubator or insulated containers to transport samples between sites)
- short-term secondments between collaborating centres for the purpose of training
The Polkinghorne guidelines refer to the use of foetal tissue. The House of Lords Select Committee report on Stem Cell Research (February 2002) recommends the separation of clinical and research roles to be standard practice for donation of eggs and embryos. MRC will adhere to this recommendation in funding stem cell research. The nurse co-ordinators mentioned in the Call will be employed by the IVF clinics and will ensure that the donor couple fully understands the aims of the research and that it might reveal information about their health. The nurse co-ordinators will never become engaged in the research, but will liaise with the researchers to inform them if embryos become available.
It is illegal in the UK for payment to be made for the donation of gametes (nominal expenses are provided however). MRC will not under any circumstances contribute to the costs of IVF treatment for those couples who choose to donate embryos for research. Donation will be entirely voluntary and by the free will of the couples involved. The decision to donate or not to donate will have no effect on their IVF treatment.
Additionally, as recommended by the Select Committee, a high level Oversight Body has been established, chaired by Lord Patel, that will be responsible for the custody of stem cell lines, ensuring their purity and provenance, monitoring their use, and for establishing codes of practice for the use of ES cells, whether obtained from the bank or imported from elsewhere. The committee will review on a case by case basis applications to deposit and access ES cell lines and will monitor the use of foetal and adult stem cell lines. The committee reports to MRC Council and will brief Ministers on request.
Clinics undertaking IVF treatment in the UK were asked whether they were interested in participating in the national stem cell initiative. A list of these clinics is available in the HFEA website (www.hfea.gov.uk). Those that expressed an interest were invited to attend a meeting at MRC Head Office and were subsequently sent an invitation to submit an expression of interest in establishing a consortium to develop collaborations. The process is ongoing, with the deadline for submissions of interest being 31 January 2003. It is not known yet how many applications will be submitted, 644W nor the level of support requested or to be awarded. When awards are made, they will be published on the MRC website in the usual way.
Stem cell research will be conducted on embryos that are surplus to IVF treatment needs and would otherwise be discarded. The MRC does not know how many surplus embryos are discarded and cannot know how many surplus embryos will be donated for stem cell research.