The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be amended in the event of a “no deal” scenario, i.e. if the UK leaves the EU on 29 March 2019 without the framework for a future EU-UK trading relationship agreed or a transition period.
The MHRA reiterates in the consultation that the UK government is committed to reaching agreement on a deal, but that it needs to prepare for all possible outcomes, including a “no deal” scenario.
In the event of a “no deal” scenario, the MHRA would become a standalone medicines and medical devices regulator. This means that the MHRA would take decisions and carry out functions for the UK market that are currently taken or carried out at an EU level, such as by the European Medicines Agency (EMA). For example, this would include decisions on all marketing authorisations, orphan designations and paediatric investigation plans, and all pharmacovigilance functions in the UK.
The consultation covers three Statutory Instruments (SIs) which would amend (i) the Human Medicines Regulations 2012 (HMRs) and the Medicines (Products for Human Use) (Fees) Regulations 2016, (ii) the Medicines for Human Use (Clinical Trials) Regulations 2004, and (iii) the Medical Devices Regulations 2002.
The changes are centred on three principles: patients should not be disadvantaged, innovators should be able to get products to the UK market as quickly and simply as possible, and the UK should continue to play a leading role promoting public health.
The proposed changes set out in the SIs reflect the policy positions in the UK government’s “no deal” technical notices covering medicines and devices, and provide additional detail as to the implementation mechanics. For example, the proposed amendments include a new schedule to the HMRs setting out the legal basis for converting an EU marketing authorisation into a UK national marketing authorisation immediately on the UK exiting the EU. This step would be in addition to any transfer of a central marketing authorisation from a UK marketing authorisation holder to a holder in one of the 27 EU Member States.
The purpose of the consultation is to give industry and other stakeholders an opportunity to scrutinise the proposed amendments before they become law. The consultation closes on 1 November 2018.