Written question asked by Lord Morrow (Democratic Unionist Party) on Thursday, 29 January 2015, in the House of Lords. It was due for an answer on Thursday, 12 February 2015. It was answered by Earl Howe (Conservative) on Thursday, 12 February 2015 on behalf of the Department of Health.

IVF

Question: To ask Her Majesty’s Government whether robust clinical trials are planned to take place for both pronuclear transfer and spindle-chromosomal complex transfer; and if not, why not.

Answer

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

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.

Secondary information

Type: Written question
Reference: HL4557
Session: 2014-15
Related items: Private Infrastructure Development Group
Tuesday, 17 March 2015
Written questions
House of Lords
Grouped for answer: Yes
Subjects: Genetic engineering IVF Clinical trials
Link: View this Written question on www.parliament.uk

IVF

Secondary information

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