UK – HFEA advises Government on necessary safeguards for IVF-based mitochondria replacement

Agency’s public consultation shows broad support

The HFEA has agreed its advice to Government on the ethics and science of new IVF-based techniques designed to avoid serious mitochondrial diseases.

In January 2012, the Government asked the HFEA, with the support of Sciencewise, to seek the public’s views on mitochondria replacement. It also asked for updated advice on the safety and efficacy of this potential treatment.

The findings of the public dialogue showed broad support for mitochondria replacement being made available to families at risk of passing on a serious mitochondrial disease. The Authority agreed to advise Government that, should Regulations be drafted to permit the technique, the following policies and safeguards should be put into place:

  • Clinics wishing to offer mitochondria replacement should be specifically licensed by the HFEA to do so. 
  • The HFEA should approve each use of mitochondria replacement, though Regulations should provide the flexibility to modify this in the future. 
  • Clinics should ensure that follow-up research on the children born takes place. 
  • Mitochondria donors should be thought of as a kind of tissue donor: the resulting child should not have a right to identifying information about the donor, although information exchange and contact could be arranged locally by mutual consent. 
  • A further assessment of the safety and efficacy should be commissioned by the HFEA once a clinic has submitted an application to carry out one of the techniques. This follows advice from an expert scientific panel that there is no evidence to suggest that mitochondria replacement is unsafe, but that further specific experiments should be conducted.

The HFEA will now formally pass the advice to the Government, which will decide whether or not to seek Parliamentary permission to allow mitochondria replacement in treatment.

The findings of the public dialogue and the papers considered by the Authority can be found from the link below




Authority meeting – March 2013

Wednesday 20 March 2013


1. Welcome, Apologies and Declaration of Interests

2. Mitochondria Replacement Consultation: Advice To Government
Decision: approved

3. Minutes of 20 February 2013
Decision: agreed

4. Chair’s Report

5. Chief Executive’s Report

6. Guidance on Witnessing In Clinics
Decision: deferred

7. Surrogacy and Legal Parenthood
Decision: agreed

8. Addressing Regulatory Overlap Between The HFEA and CQC
Decision: agreed

9. Authority Governance Transition Programme: Progress Report and Revision of Standing Orders
Decision: agreed

10. Authorisation of pre-Implantation genetic diagnosis
Decision: agreed

11. Applying The Lessons From The Report of The Mid Staffordshire NHS Foundation Trust Inquiry
Decision: agreed

12. Business Plan
Decision: agreed

13. Update from Committee Chairs

14. Directorates Reports
Decision: agreed

15. Any Other Business


Meeting papers

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