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Can Maternal Spindle Transfer and Pronuclear Transfer Be Prohibited under EU Legislation?

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The question whether maternal spindle transfer (MST) and pronuclear transfer (PNT) can be prohibited under EU legislation was examined by the non-governmental organisation European Bioethics Research (EBR). It did so by submitting an official complaint to the EU Commission proposing that the UK Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 breached the prohibition on the modification of a person’s germ line genetic identity of the EU Clinical Trials Directive 2001/20/EC and the new Regulation EU 536/2014. A discussion then took place, during 2016, between EBR and the EU Commission whether MST and PNT principally involved a ‘medicinal product’ in which case the EU Clinical Trials Directive 2001/20/EC and Regulation EU 536/2014 would be applicable or whether the procedures just involved a medical procedure in which case the Tissue and Cells Directive 2004/23/EC was applicable which did not include any prohibition on the intentional modification of a person’s germline.

Affiliations: 1: Scottish Council on Human Bioethics EdinburghUK


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