1. www.hfea.gov.uk Genome editing: What lessons can we learn from the mitochondrial donation debate? Peter Thompson Human Fertilisation & Embryology Authority 4 November 2015 Swedish National Council on Medical Ethics

2. Summary Context –About the HFEA –Mitochondrial donation and the law –Genome editing and the law –Genome editing in practice The mitochondrial donation debate –How did we go about it? –Methodologies –What did we find? Some lessons for genome editing

3. A statutory regulatory body for IVF which makes policy and handles requests for information ●At ‘arm’s length’ from Government ●12 members (majority lay) making licensing and policy decisions ●Inspects 113 treatment clinics and 22 laboratories, treating 60,000 patients each year ●Substantial experience and expertise in public dialogue around ethical issues About the HFEA

4. Human Fertilisation & Embryology Act 1990 (amended 2008), s3ZA(5) Human Fertilisation & Embryology (Mitochondrial Donation) Regulations 2015 Allows defined techniques (MST and/or PNT) in treatment where there is a particular risk that an egg or embryo may have mitochondrial abnormalities and there is a significant risk that a person with those abnormalities will have or develop a serious mitochondrial disease Mitochondria donation and the law

5. Human Fertilisation & Embryology Act 1990 (amended 2008) Permits new technologies like genome editing in germ cells and human embryos up to 14 days old for research purposes. Research allowed only where the HFEA considers that it is necessary or desirable, eg. to increase knowledge about serious disease Genome editing in treatment is illegal Genome editing and the law

6. Genome editing in practice New technologies like CRISPR/Cas9 have provoked widespread debate in UK, as elsewhere Nuffield Council on Bioethics began project on ethical issues in April 2015 Hinxton Group statement issued September 2015 UK Government has no plans to allow genome editing in treatment. However, research that led to new treatments or therapies that did not require the genetic alteration of sperm or eggs, “would be welcomed” HFEA has recently received a research application to use CRISPR/Cas9 – decision reasonably soon

7. 2005 The mitochondrial donation debate April 2011 February 2015 March 2013 June 2014 July 2014 29 October 2015 HFEA issued research licence to Newcastle group HFEA review of safety and efficacy HFEA update on safety and efficacy HFEA report on public dialogue exercise and regulatory implications Department of Health consultation on draft regulations Parliament approves Mitochondrial Donation Regulations UK clinics can apply for licence to offer mitochondrial donation in treatment

8. Interested audiences: Open consultation questionnaire Open consultation meetings Patient focus group Wanted to understand: How did we go about it? Difference between informed and uninformed public views and how they change over time Interested stakeholders’ views and ‘public’ views …so we took a multi-method approach Selected public audiences: Public representative survey Deliberative public workshops (reconvened)

9. Methodology: consultation website Aimed to direct public through information before they responded Listed events, newsletter sign up and links to further information Lay friendly Clear navigation

10. Methodology: a patient’s perspective ●Allowed people to hear from a family affected by mitochondrial disease ●Put the issues into context

11. ●Key reference tool ●The best way to communicate scientific techniques and concepts ●We took it one step further… Methodology: diagrams

12. Methodology: animation

13. What did we find? ●We found that there was general support for permitting mitochondria donation in treatment in the UK ●But that support is contingent upon the techniques being safe enough and that they are carried out under strict regulatory control ●Perhaps surprisingly, the public was largely relaxed about modifying embryos and changing the germline ●They worried more about safety issues and unforeseen consequences ●There were some concerns about ‘slippery slopes’

14. ●The public can understand difficult science and complex ethical issues: we found general support for permitting mitochondria donation ●Taking a multi-method approach provides a richer understanding of public views and prevents groups with entrenched positions dominating ●Safety and ethics are linked – considering them alongside one another is helpful ●Public placed importance on regulation – key to clearly convey how proposals/new techniques will be regulated Some lessons for genome editing (1)

15. ●The public are more accepting of new technologies where there is clear benefit. Mitochondrial donation will provide new treatment options to a group of patients at risk of passing on life threatening diseases ●Genome editing does not, at present, have such a defined patient group. That alone raises additional ethical issues. ●Process and governance matters: any public dialogue must be fair and be seen to be fair ●The different political actors must play their respective roles and stick to them: HFEA, Department of Health, Parliament Some lessons for genome editing (2)

16. Contact me: Peter.Thompson@hfea.gov.uk Thank you