Question to the Department of Health and Social Care:

To ask Her Majesty’s Government what body will be responsible for overseeing clinical trials of pronuclear transfer and spindle-chromosomal complex transfer.

The provision of treatment services involving the use of the Maternal Spindle Transfer and Pronuclear Transfer mitochondrial donation techniques will not be provided as a clinical trial.

Clinical trials are regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004, which implements the Clinical Trials Directive 2001/20/EC. The Regulations do not cover treatment services.

The Regulations define a clinical trial as:

“clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended—

(a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products,

(b) to identify any adverse reactions to one or more such products, or

(c) to study absorption, distribution, metabolism and excretion of one or more such products,

with the object of ascertaining the safety or efficacy of those products;”.

If the Draft Human Fertilisation and Embryology Authority (Mitochondrial Donation) Regulations 2015 are approved by Parliament, clinics wishing to offer this service will need to seek prior approval from the Human Fertilisation and Embryology Authority. Applications will be considered by the Authority on a case by case basis.