Question to the Department of Health and Social Care:

To ask Her Majesty’s Government which European Union legislation they have considered in framing the proposed draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015; what view they have taken on the applicability of the European Union legislation; and what is the basis for their view.

As I said in the debate on the Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 on 24 February 2015 (columns 1570 and 1617-8) the Government is satisfied that the Regulations do not contravene any aspect of European Union law. It has carefully considered recent arguments relating to the Clinical Trials Directive (Directive 2001/20/EC) but is satisfied that the Directive is not relevant in this context as it relates to clinical trials of medicines.