Question to the Department of Health and Social Care:

To ask Her Majesty’s Government which department is responsible for regulating clinical trials that involve gametes or embryos; and how many clinical trials they have authorised to date.

The Human Fertilisation and Embryology Authority is responsible for licensing research involving the use of human embryos but has no role in authorising those clinical trials governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 (2004 Regulations).

The Medicines and Healthcare products Regulatory Agency is responsible for the regulation of clinical trials of medicinal products carried out under the 2004 Regulations, 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;”.

Gametes and embryos are not used in medicinal products so any research involving gametes and embryos is outside the scope of the 2004 Regulations and the Directive. Consequently, there have been no “clinical trials”, as defined by the 2004 Regulations, involving gametes and embryos.