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The ethical approval of mitochondrial replacement therapy

5 minute read

Researchers within Queen’s University Belfast have played an integral role in philosophy-research-led development of ethical regulations, assessment procedures, and public consultation on mitochondrial replacement treatment.

Research Challenge

The ethical approval of mitochondrial replacement therapy

The Human Fertilisation and Embryology Authority (HFEA) is an independent regulator with sole authority for the statutory review of fertility treatment and human embryo research throughout the United Kingdom. Its role is to protect patients and the public interest, to drive improvement in treatment and research, and to provide information to the public and policymakers about treatment and research. 

In December 2014 the UK Parliament approved regulations allowing the licencing of mitochondrial replacement treatment, a pioneering medical intervention that seeks to prevent the transmission from mother to child of extremely serious genetic conditions. Since Parliament approved the regulations allowing licencing of mitochondrial treatment, fourteen licences have been granted by the HFEA’s Statutory Approvals Committee. To grant these licences, the HFEA needed to develop detailed standing orders, regulations, and decision trees to be used when making decisions about individual applications. 

Our Approach

Developing philosophy-research-led regulations and assessment procedures

A key constraint in the regulation of fertility treatment is the welfare and interests of any future child. Ensuring that any new regulation meets this constraint requires interpreting what the vague and ill-defined principle of acting in a child’s best interests demands in the given context. 

Professor David Archard has developed authoritative and ground breaking research on this topic, including work on how to determine the proper limits of the best interests principle in the context of regulating reproduction, and how it should be weighed against other principles applicable in that context (such as the presumptive rights of parents, and considerations of the public good).

As the only philosopher on the HFEA and as the HFEA’s Statutory Approvals Committee Chair, Professor Archard played a significant role in the process that led to the approval of the HFEA’s regulations and to establishing the procedures to be used by the HFEA when assessing individual applications for mitochondrial replacement treatment. 

“The ethical basis on which science is conducted in this country is world leading.” Andrew Miller (Chair of the House of Commons Science and Technology Select Committee)

- Andrew Miller (Chair of the House of Commons Science and Technology Select Committee)

What impact did it make?

Mitochondrial treatment can only be provided in the UK under licence. Before that could happen Parliament had to approve regulations allowing such licences to be granted. Professor Archard played an integral role in developing the HFEA’s 2014 recommendations (in its role as the relevant licensing body) on the form these regulations should take, and thus significantly affected the content of the regulations subsequently approved by Parliament. 

That role was highlighted in the Parliamentary debates on the regulations:

  • Lord Turnberg commented during the House of Lords debate “Remember that the HFEA is no pushover. It has in its membership not just three scientists and a clinical geneticist but three patients who have gone through IVF, a barrister, a professor of philosophy, a bishop and a national security adviser. That is quite an interesting mix but not one likely to be easily moved by faulty argument. It is they and their scientific advisory panel who will be assessing applications when these regulations come into force in October.”
  • In the Commons debate it was noted that “we should be proud to be leading the world in medical treatments and [of the fact] that .....we can provide some of the best ethical safeguards in the world”. 

These remarks are generally commendatory of the HFEA but Professor Archard plays a particular and central role, as a moral philosopher, in the shaping and protection of these ethical safeguards and the ethical role of the HFEA. Professor Archard also played a key role in the HFEA’s public consultation on the safety, efficacy, and moral integrity of mitochondrial treatment.

Our impact

Impact related to the UN Sustainable Development Goals

Learn more about Queen’s University’s commitment to nurturing a culture of sustainability and achieving the Sustainable Development Goals (SDGs) through research and education.

UN Goal 03 - Good Health and well-being

Key Facts

Mitochondrial replacement treatment is a pioneering medical intervention that seeks to prevent the transmission from mother to child of extremely serious genetic conditions. Queen’s researchers developed philosophy-research-led ethical regulations for administering this new treatment.

  • United Kingdom
Professor Dave Archard
School of History, Anthropology, Philosophy and Politics
Improving welfare for humans and animals