This EU document is politically important because:
5.1In order to accelerate clinical trials on potential COVID-19 vaccines, the European Commission proposed waiving the requirement for an environmental risk assessment to be undertaken before a clinical trial on an investigational medicinal product (IMP) containing a genetically modified organism (GMO) can commence. This only applies if the IMP relates to COVID-19 and the waiver will expire once COVID-19 is no longer regarded as a pandemic by the World Health Organisation or the EU does not consider there to be a situation of public health emergency due to COVID-19. The Commission noted in its proposal that some of the COVID-19 vaccines under development are based on genetically modified viruses and may fall within the definition of GMO.
5.2The rule change — which has been agreed without amendment by the European Parliament and Council — is one of the regulatory flexibilities suggested in the EU’s wider COVID-19 Vaccines Strategy on which we have reported separately. The change will apply to the whole of the UK during the remainder of the Transition Period. After the Transition Period, it will remain in force across the UK as EU retained law — unless amended or revoked domestically — and it will be relevant in Northern Ireland as IMPs used in clinical trials in Northern Ireland will need to stay aligned with certain requirements of EU legislation in this area, including certification of good manufacturing practice and batch testing to EU standards.
5.3In his , the Parliamentary Under Secretary of State for Innovation (Lord Bethell) notes that some legislative change may be required in the UK and that the Health and Safety Executive, along with its devolved administration competent authority partners, is actively considering how to best achieve this in a proportionate manner. It is anticipated that, across the EU, the change will result in faster start-up times for clinical trials of COVID-19 medicines that contain or consist of GMOs, including potential vaccines.
5.4Looking forward, says the Minister, Great Britain’s future regulatory regime for clinical trials will be a national system and the UK is seeking to be able to share clinical trial information with EU partners through the Future Relationship negotiations with the EU. He acknowledges that IMPs used in clinical trials in Northern Ireland will need to stay aligned with the requirements of the EU legislation in this area.
5.5The Minister emphasises that, from 1 January 2021, clinical trials will continue to be approved at a national level, working to international standards as they are now, and the Medicines and Healthcare Products Regulatory Agency (MHRA) — along with partners across the UK — has taken steps to ensure there will be no interruption to the UK clinical trials regulatory regime so trials can continue seamlessly. The UK will still have the ability to participate in multinational trials and it will still be possible for sponsors (the organisations that run clinical trials, such as pharmaceutical companies and academic institutions) to run multistate trials that involve UK patients. Data generated in a UK clinical trial will continue to be admissible to support regulatory activity in the EU, and indeed globally.
5.6We report this document to the House as politically important given that the Regulation will apply to the whole of the UK during the Transition Period and will have an impact in Northern Ireland beyond that. It is also the case that the Regulation may facilitate clinical trials on potential COVID-19 vaccines and therapies which include genetically modified organisms.
5.7We require no further information from the Government. We draw the document to the attention of the Health and Social Care Committee, the Future Relationship with the EU Committee and the Northern Ireland Affairs Committee.
10 Proposal for a Regulation on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease; ; Legal base: Articles 114 and 168(4)(c) TFEU, QMV; Department: Health and Social Care; Devolved Administrations: Consulted; ESC number: 41349.
12 Commission Communication: EU Strategy for COVID-19 vaccines; , COM(20) 245.
13 Under the terms of the Withdrawal Agreement, Northern Ireland will remain aligned with the provisions of Article 13 of the Clinical Trials Directive ( on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) and with the provisions of Chapter IX of the Clinical Trials Regulation ( on clinical trials on medicinal products for human use), which will supersede the Clinical Trials Directive once the necessary IT systems are in place.
Published: 29 July 2020