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Question for Department of Health

UIN HL4788, tabled on 9 February 2015

To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 4 February (HL4327), to what extent the Human Fertilisation and Embryology Authority contributed towards the content of the Draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015; why the design of the regulatory process for assessing safety was omitted from the Regulations; what proportion of the Regulations are concerned with children conceived via the proposed techniques having access to identifying information about donors; whether potential children conceived via either of the proposed techniques would be expected to ask about the source of their mitochondria before the regulatory process for assessing safety has been designed; and if not, why Regulations governing children’s access to identifying information about donors have taken precedence over the design of procedures for assessing safety.

Answered on

20 February 2015

As the Human Fertilisation and Embryology Authority (HFEA) will have to apply the draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, if passed, the Department of Health had discussions with the HFEA on the proposed content of the regulations from a factual and practical perspective.

Three reports on safety and efficacy have been published by the Expert Panel convened by the HFEA. As a statutory independent regulator, it is for the HFEA to determine its own procedures for assessing applications for a licence to carry out a treatment service regulated by the Human Fertilisation and Embryology Act 1990, as amended (1990 Act). Applications for a licence to provide mitochondrial donation treatment are no exception to this rule and the HFEA will not issue a licence if it does not consider it safe to do so.

The 1990 Act sets out in detail what information may be disclosed when other donated material, i.e. gametes, is used in treatment. That is why related provisions need to be specified in detail in the draft regulations. Mitochondrial donor-conceived people would not be able to apply to receive information about their mitochondrial donor until they reach age 16.

The Government is satisfied that the draft 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.

The Expert Panel has stated that in its 2014 Report that:

“based on 2014 considerations the Panel still believes that there is at present insufficient evidence to choose between PNT and MST as a preferred technique”.

The Government is, therefore, satisfied that there is sufficient scientific evidence to justify Parliament being asked to consider regulations to enable the use of two mitochondrial donation techniques in clinical practice. It would be for clinicians in consultation with families to decide which technique would be best in each case.

It is likely that through the use in treatment of both techniques, further evidence is generated to indicate which technique is the most effective. In these circumstances, we do not believe there is a case for making separate regulations for each individual technique.