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Human Embryo Experiments: Licensing

Volume 471: debated on Tuesday 29 January 2008

To ask the Secretary of State for Health which centres have had research licence applications refused by the Human Fertilisation and Embryology Authority; on what grounds such refusals were made in each case; on how many occasions amended applications were received following initial refusal; and in how many such cases licences were granted, giving the changes made to the re-application in each case. (181155)

The Human Fertilisation and Embryology Authority (HFEA) has advised that since 1999, the year from which a central record of licence committee decisions has been maintained, it has refused one application for a research licence.

In 2004 the Newcastle Fertility Centre at LIFE applied for a licence to use embryos to study mitochondrial DeoxyriboNucleic Acid (DNA) disorders. This application was considered by the HFEA’s Research Licence Committee on 15 July 2004. The Committee refused to grant a licence on the grounds that the proposed research activities were prohibited under paragraph 3(4) of Schedule 2 to the Human Fertilisation and Embryology Act 1990. Representations against this decision by the centre were heard by the Research Licence Committee on 24 November 2004. The Committee decided to uphold its original decision and refused to grant a research licence. An appeal by the centre against this decision was heard by a HFEA Appeal Panel on 1 September 2005. After hearing arguments from both sides and obtaining independent scientific and legal advice, the Appeal Committee was satisfied that none of the activities in the proposed research involved altering the genetic structure of any cell while it formed part of an embryo. The Appeal Panel decided to grant a research licence authorising the use of human embryos to study the prevention of mitochondrial DNA disorders.

The numbers of applications refused by the HFEA’s Research Licence Committee is limited because the HFEA works closely with research teams on the development of the project, prior to a licence application being submitted, to ensure that it meets the requirements of the Human Fertilisation and Embryology Act 1990 and the HFEA’s code of practice. In this way, applications for projects that would not be considered suitable for licensing tend not to be submitted.

Where a project would, in principle, be suitable to be licensed but insufficient information has been submitted to the Licence Committee, or the Committee is of the view that an aspect of the project needs to be reconsidered, it is usual practice for the Committee not to reject the application but to ask the applicant to submit further information or undertake changes to the specifications of the project, for reconsideration at a later date.