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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. [ABSTRACT FROM AUTHOR]

Mitochondrial DNA diseases are rare genetic disorders, which can have a devastating effect on the patients' health and well-being. There is no cure for such diseases, although recent experiments suggest that there may be a way to prevent them by genetically altering the eggs or embryos through a procedure known as mitochondrial donation. However, such a procedure not only raises serious safety and ethical concerns, but legal challenges as well, since it involves germline gene modification, which until recently was not legal in the UK or elsewhere. In February 2015, the British Parliament amended the relevant legislation to allow such. a procedure, making the UK the first state to openly challenge the global policy on germline gene modification. The article presents the scientific background to the procedure and discusses the regulatory challenges brought by the first case of its legalisation. [ABSTRACT FROM AUTHOR]