Gene Therapy Legislation in the United Kingdom
Part of the United Kingdom Department of Health, the Medicines and Healthcare products Regulatory Agency (MHRA) is the government executive agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
The competent authority for clinical trials with GMOs is either the Health and Safety Executive (HSE) or the Department of the Environment, Food and Rural Affairs (DEFRA). Both HSE and DEFRA are part of the Joint Regulatory Authority (JRA), ensuring close collaboration. The GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs can be regulated under either the contained use or the deliberate release frameworks. A decision is taken case-by-case taking into account the biological characteristics and environmental risk assessment of the GMO. Where there is uncertainty regarding which regulatory framework is appropriate, applicants should seek guidance from the regulatory authorities (including the SACGM compendium of guidance on using GMOs in a clinical setting).
The applications to seek authorization under clinical trials and under GMO frameworks are not linked (i.e. the applicant can decide the timing of the submission of the GMO application). Both applications can be submitted in parallel but it is not mandatory.
The Scientific Advisory Committee on Genetically Modified Organisms (SACGM) provides technical and scientific advice to the UK Competent Authorities on all aspects of the human and environmental risks of the contained use of genetically modified organisms (GMOs).
From the 1 June 2011 operational responsibility for the Gene Therapy Advisory Committee (GTAC) transferred to the National Research Ethics Service (NRES). The GTAC pages have been archived by the National Archives.
Additional information can be found at:
- https://www.gov.uk/government/collections/genetically-modified-organisms-applications-and-con sents
- Medicines and Healthcare products Regulatory Agency (MHRA)
- Health and Safety Executive (HSE)
- Department of the Environment, Food and Rural Affairs (DEFRA)
- Scientific Advisory Committee on Genetically Modified Organisms (SACGM)
- National Research Ethics Service (NRES)
Application forms to seek authorisation for the GMO aspects
Contained use: https://www.hse.gov.uk/forms/genetic/.
Deliberate release (Directive 2001/18- Part B): Potential applicants are encouraged to make enquiries via the e-mail address provided.
When the clinical trial is regulated as a deliberate release, the application is published on the Defra website and the GMO public register. The public are invited to make any representations within a given deadline and can do so by e-mailing Defra, or writing to them at their London office.
National authorities involved
Authorization of clinical trials:
Medicines and Healthcare products Regulatory Agency (MHRA)
151 Buckingham Palace Road, Victoria, London SW1W 9SZ
Authorisation of GMO aspects:
Deliberate Release (Directive 2001/18- Part B):
Department for Environment Food & Rural Affair (Defra)
Nobel House, 17 Smith Square, London, SW1P 3JR
The UK competent authority (CA) for the Genetically Modified Organisms (Contained Use) Regulations comprises representatives of the four responsible authorities for GMO(CU) in the UK. The GMO(CU) 2014 regulations apply to England, Scotland and Wales. The GMO(CU) (Northern Ireland) 2015 Regulations apply to Northern Ireland.
In England and Wales, HSE and the Secretary of State for Defra acting jointly form the competent authority. The functions are delegated to HSE and Defra officials. Officials from Welsh Government are included in any matters relating to Wales.
In Scotland, the competent authority comprises Scottish Ministers and HSE acting jointly and similarly these functions are delegated to HSE and Scottish Government officials.
In Northern Ireland, the competent authority is the Health and Safety Executive for Northern Ireland (HSENI) and the Department of Agriculture, Environment and Rural Affairs, acting jointly.
HSE and HSENI take the lead on behalf of the other parts of the CA for administering the respective Regulations and act as the point of contact for notifications and enquiries in Great Britain and Northern Ireland respectively.
Health and Safety Executive (HSE).
Redgrave Court, Merton Road, Bootle, L20 7HS
Health and Safety Executive for Northern Ireland (HSENI)
83 Ladas Drive, Belfast, BT6 9FR
Department of Agriculture, Environment and Rural Affairs
Dundonald House, Upper Newtownards Road, Ballymiscaw, Belfast BT4 3SB
Scottish Government GM Policy Team
Saughton House, Broomhouse Drive, Edinburgh, EH11 3XD
Nature Environment and Agriculture Team, Welsh Government
Rhodfa Padarn, Llanbadarn Fawr, Aberystwyth, SY23 3UR
(Last reviewed by the Competent Authority: December 2017)