My Lords, as I fully expected, this has been a debate of very high quality, with a range of views, both for and against the regulations, eloquently expressed. My principal job now is to respond to the Motion moved by my noble friend Lord Deben and to some of the additional points raised by other speakers.
My noble friend’s Motion covers three main points—safety, compliance with EU and UK law, and the key definitions in the draft regulations. My noble friend and the noble Lord, Lord Brennan, in his legal opinion, argued that there was some doubt about whether the regulations were compliant with EU law, in particular the EU directive on clinical trials. With respect to both noble Lords, the Government do not agree. The EU clinical trials directive does not apply here because it is concerned with medicinal products, and mitochondrial donation techniques simply do not fall under that definition.
My noble friend asked whether we had checked our position with the European Union. The simple answer is no. Within a framework of subsidiarity, it is entirely the responsibility of each member state to ensure that its own legislation is consistent with EU law. That is what we have done. The EU would be inundated with extensive queries from member states if a “legal advice” facility existed, and there is no such facility.
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