MHRA opens consultation on ‘no deal’ contingency legislation for the regulation of medicines and medical devices
On 4 October 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) opened a consultation on how its legislation and regulatory processes would need to be modified in the event of the UK exiting with EU without securing a deal, with no Implementation Period. This consultation builds on the Government’s technical notice published earlier this year on how medicines and medical devices would be regulated following a ‘no deal’ Brexit, by expanding and giving additional detail. Through this consultation and the proposed legislative changes, the MHRA aims to minimise disruption, and provide certainty and guidance to the wider healthcare industry, along with regulatory continuity to ensure the ongoing safety of medicines and medical devices being placed on the UK market. (Examples of this approach would be converting European Centrally Authorised Products (CAPs) issued before Exit Day to UK Marketing Authorisations (MAs) and time-limited recognition of the CE market for medical devices.) The consultation is published at a time where fears of a shortfall of essential medicines and medical supplies is attracting a high level of press and political attention in the UK as a key risk of a no deal scenario.
The UK is currently part of the European medicines and medical devices regulatory framework, with regulatory processes undertaken at EU-level. However, in the event of no deal being agreed with the EU before 29 March 2019, contingency legislation would be needed in order for the MHRA to be able to take on regulatory processes and become a stand-alone medicines and medical devices regulator (a “trusted standalone sovereign UK regulator”), with authority to carry out all functions or take all decisions which are currently carried out or taken at EU-level. This would include decisions on Marketing Authorisation applications which are currently authorised through the Centralised Procedure, paediatric investigation plans and orphan status, as well as pharmacovigilance responsibilities.
The consultation covers proposed changes to four different Statutory Instruments:
- Medical Devices Regulations 2002;
- Medicines for Human Use (Clinical Trials) Regulations 2004;
- Human Medicines Regulations 2012; and
- Medicines (Products for Human Use) (Fees) Regulations 2016.
The consultation is open for the rest of the month and encourages responses from industry, allied healthcare professionals, medical charities and the public on some of the key proposed changes. As part of the published consultation, there is a Draft SI legal text, Consultation Impact Assessment, Consultation Annex and Consultation questions full printout. Responses may be made here. The deadline for responding is 1 November 2018.
For further information please contact Julia Gillert of our London office or Els Janssens of our Abu Dhabi office.