Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Lord Gordon of Strathblane Excerpts

Tuesday 24th February 2015 Lords Chamber

In humans, it is possible that the future work to which the noble Lord, Lord Deben, referred, on embryonic stem cells derived from human embryos created by either maternal spindle cell or pronuclear transfer, where very different mitochondrial haplotypes—characteristics within the mitochondrion—are exchanged, might reveal issues. But any effect is likely to be subtle. If people are asking for these experiments to be done, if the view of some scientists now is that it is not necessary to take the next step of offering this treatment to mothers and fathers, it would require—

[Lord Gordon of Strathblane (Lab)]

Would the noble Lord comment on the HFEA’s recommendation that, as available data are limited, an extensive range of pre-clinical research should be carried out before proceeding?

[Lord Patel]

The data that the report suggested were not available were actually presented to the committee. They have not been published because, as any scientist would know, if you publish—

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[Lord Gordon of Strathblane]

Is the noble Earl equally confident that the regulations are compliant with the European directive that is due to come into force in 2016, and which might explain the timing?

[Earl Howe]

My Lords, I think I can make an unequivocal statement that all the legal advice I have received is that the regulations we are considering are fully compliant with European law.

As has been said, any legislation agreed in Parliament could be subject to challenge, and it would be up to the Government at the time of challenge to defend their position. The noble and learned Lord, Lord Hope, made that point. Let me reassure noble Lords that we have considered these issues very carefully, and we are confident that the regulations are compliant. I am pleased that other noble Lords who have spoken agree with that.

The noble and learned Baroness, Lady Scotland, cited the European charter. The EU charter does not apply in this context, because Article 51 says that it applies to member states,

“only when they are implementing Union law”.

This means that a state must be either directly implementing an EU law obligation or acting within the scope of EU law. The regulations do not do either of those things.

We have considered the issues raised and, as I have said, we are very confident that these regulations do not contravene European law. The issue comes back to whether the clinical trials directive is engaged here. It is not. Our view, incidentally, was agreed with independent legal advice commissioned by the Wellcome Trust from Thomas de la Mare QC: mitochondrial donation simply does not come within the definition of medicinal products, to which the directive applies.