March 11, 2011

expert reaction to mitochondrial DNA transfer story

The Secretary of State for Health asked the Human Fertilisation and Embryology Authority to conduct a scientific review of a Newcastle teams of scientists’ research on mitochondrial DNA transfer in IVF.

Prof Alison Murdoch, Head of Department of Reproductive Medicine, Newcastle University, said:

“We are not ready to do this in patients now but the science is progressing very rapidly and we need to get Parliament to discuss this again now. We anticipate that the process of review could take about a year so we are asking for this process to start now. Of course there is no guarantee that we will have all the evidence we need to secure a license in a year but we need to anticipate that we may have and prepare accordingly. We recognise this process is necessary and will co-operate fully.

“As doctors we have a duty to treat disease and where possible to prevent disease. With diseases for which there are no treatments the imperative to develop new treatments is even greater. Of course no treatment is ever risk free and if there are risks we will need to quantify these so that doctors can discuss the relative risks and benefits with patients and their families.”

Legislative status: 1. The Human Fertilisation and Embryology Act 2008 (the Act) only allows the HFEA to issue licences for therapy where the egg or embryo is a ‘permitted egg’ or ‘permitted embryo’. A ‘permitted egg’ or ‘permitted embryo’ is currently defined as one where its mitochondria has not been altered. In 2008, the regulations did not provide for licences for therapy for such techniques as it was thought these were some way off entering the clinic and would require further consideration and ethical debate. It did however envisage clinical use to result from this research as the Act includes a regulation making power. This power enables the Secretary of State to make regulations to amend the definition of a ‘permitted embryo’ or ‘permitted egg’ to include one which has had applied in a ‘prescribed circumstance’ a prescribed process’ to ‘prevent the transmission of serious mitochondrial disease’.[1] Such regulations would enable the HFEA to issue a licence for such therapy. 2. To make such a regulation, the Secretary of State can take one of two approaches. He can lay a draft of the provisions before each House of Parliament for approval. Alternatively, he can make such a regulation without laying it before each House for approval, but as the primary legislation makes clear this approach runs the risk of the provisions being annulled by a resolution in either House of Parliament.[2] [1] Section 3, Human Fertilisation and Embryology Act 2008 [2] Section 30 Human Fertilisation and Embryology Act 2008