The UK Government has today launched a consultation on the role of the Medicines and Healthcare products Regulatory Agency (MHRA) post-Brexitseeking views on how the MHRA legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period“. As the consultation closes at 11.45 pm on 1 November 2018, time is short for making a response.

Also today, the Government has released an overview of the UK’s relationship with the EU’s Horizon 2020 science and innovation funding programme including a link to the portal where those with current funding can submit data which will be used to guarantee funding post-Brexit.

MHRA Consultation

  • This consultation was promised in the no-deal technical notice on medicines, clinical trials and medical devices, discussed in our blog post of 29 August 2018. It is expressed to be set in the context of “the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period“, i.e. a “cliff edge” no-deal scenario, with no transitional period. However, if the EU Withdrawal Agreement (which sets out the terms on which the UK leaves the EU and is currently being negotiated between the UK and the Commission) is concluded on the terms that have so far been declared as agreed between the negotiators, then there would be a period until the end of 2020 when the UK would still effectively be part of the EU, despite technically having exited at 11pm on 29 March 2019.
  • A direct link to the consultation can be found here. More detail on the consultation, including the specific areas being covered, can be found in the Consultation Introduction. As the introduction to states, “the overall approach in no-deal is for the MHRA to be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level. This would include decisions on Marketing Authorisation (MA) applications which are currently authorised through the Centralised Procedure, paediatric investigation plans and orphan status, as well as pharmacovigilance responsibilities“. The consultation also asks for comments on clinical trials issues.
  • The introduction recommends that you read the Draft Statutory Instrument (SI) text, Impact Assessment and Consultation Annex before responding. The Draft SI text relates to statutory instruments that will be needed to update the Human Medicines Regulations 2012, the Medicines for Human Use (Clinical Trials) Regulations 2004, the Medicines (Products for Human Use) (Fees) Regulations 2016, and the Medical Devices Regulations 2002.
  • Response to the consultation is in the form of an on-line survey. Each section of the survey is optional, so you can limit your response to the sections you are interested in.

Horizon 2020 funding

  • Following on from the no-deal technical notice on Horizon 2020 funding which was issued with the other life sciences related notices in August (here), the UK Government has published an overview of the UK’s relationship with Horizon 2020, followed by a Q&A, which aims to clarify the UK’s eligibility to participate in Horizon 2020 – here. Current UK recipients of Horizon 2020 funding are invited to provide data about their projects on a portal managed by UK Research and Innovation (UKRI) (linked on the same page), so that the UKRI has the information it needs in order to underwrite the guaranteed payments if this becomes necessary.
  • As we previously stated in our blog post: If there is ‘no deal’, the Government says it has taken steps to provide continued support for research and innovation currently being funded through this EU project fund. The Government will guarantee funding in most cases, for the full duration of the project, where the funding relates to successful bids submitted by UK participants before the UK exits the EU. Funding will only be for UK participants however. Where UK participants are leading consortia of non-UK parties and would normally be distributing the Horizon 2020 funds, the Government will seek to discuss with the EU Commission how best to address this. In it’s no-deal notice, the Government said it was considering what other measures may be necessary to support UK research and innovation in the event that the EU’s funding is no longer available. Looking beyond 2020, the notice said that “the UK remains committed to ongoing collaboration in research and innovation and wants to work with the EU on a mutually beneficial outcome“.