Strict research licence requirements are too prohibitive

On the eve of the final debate in the House of Commons on the UK's Human Fertilisation and Embryology (HFE) Bill, many people are hoping that the it will pass through the House without further delay so that it can be approved by the House of Lords and gain royal assent before the end of this Parliamentary session. Much work has gone into advocacy around ensuring the scientific and medical research provisions of the Bill are fit for purpose to enable UK scientists working at the cutting edge of stem cell and embryo research to continue to carry out their work under the tightly regulated environment that has enabled this type of research to flourish in the UK to date.

The Wellcome Trust, along with the Medical Research Council, Academy of Medical Sciences, Royal Society and the Association of Medical Research Charities continue to support the provisions as they are currently drafted in the Bill for the regulation of 'human admixed embryos'. These provisions will enable all avenues of stem cell research to continue in a tightly regulated environment. Such research offers a potentially revolutionary way to repair diseased and damaged body tissues, replacing them will healthy new cells.

However, the Trust is concerned about amendments which have been tabled for debate at Report Stage seeking more stringent licensing conditions for researchers seeking licences from the Human Fertilisation and Embryology Authority (HFEA) for the creation of human admixed embryos.

The amendments propose the following requirements for the issuing of a licence:

(a) any proposed use of embryos or human-admixed embryos is necessary and desirable for the purposes of the research; and

(b) there is evidence, which must include published, peer-reviewed scientific data, demonstrating that -

(i) the rationale underlying the proposed research and applicability of the proposed methodology has been established by analogous research, such that the proposed use of human or human admixed embryos would be likely to achieve its specified purposes; and

(ii) that the purposes of the proposed research cannot be achieved satisfactorily by any method not entailing the use of human or human admixed embryos.'

The requirement that research must demonstrate it is likely to 'achieve its specified purpose' before being undertaken runs contrary to the fundamental nature of research. Existing legislation and the current draft of the Bill already enable the HFEA to operate a rigorous process of review for all research licence applications. Licences will only be granted for a specific research purpose where the HFEA is satisfied that the use of embryos or human admixed embryos is necessary. Furthermore, funding will only be granted for such research following a process of scientific peer review, to determine the validity of the proposed work, and its potential utility, based on the best available evidence.

The very nature of research is experimental, and it is not possible to predict outcomes with certainty in advance. The legislation should enable researchers to pursue the most effective approaches to addressing pressing scientific and medical needs, as judged by both the independent regulator - the HFEA - and by experts with up-to-date knowledge of this rapidly advancing field.