Brexit Update

Catch up below on recent Brexit-related matters ……

Leaders from associations representing the entire EU and UK pharmaceutical industry pharmaceutical have requested that Brexit negotiations deliver ongoing cooperation between the EU and UK according to a report in the PharmaTimes Online.

A joint letter was sent to chief Brexit negotiators Michel Barnier and David Davis asking them to make such an agreement a priority, to ensure that across EU and the UK patients are not adversely affected by Brexit and they continue to have rapid access to safe and effective medicines and medical devices.

The leaders specifically requested the continuation of previously granted EU marketing authorisations (MAs) both in the UK and EU.  This seems very logical and likely to happen although if and how future (post-Brexit) centralised approvals will be recognised in the UK, is less clear.  It would certainly be advantageous to UK patients and drug developers if this were the case.

The letter also calls for continued cooperation between national authorities as facilitated by the European Medicines Agency (EMA) and European Commission.  The letter points out the substantial involvement the UK Medicines and Healthcare products Regulatory Agency (MHRA) currently has in the EU regulatory network.  The leaders make a case or continued cooperation, because loss of the MHRA’s manpower and expertise would mean adversely impacting the network’s ability to assess medicines and monitor their safety.  It should, however, be pointed out that the EMA has already initiated the process of allocating the MHRA’s workload across the other EU member state agencies.

Another point raised in the letter is a concern that the supply of medicines could be disrupted with goods due to be moved between the UK and EU potentially held either at border checks or in warehouses prior to extensive retesting requirements.

The PharmaTimes Online article can be accessed by clicking here.

The MHRA has very recently published a Brexit update – “MHRA and making a success of Brexit”.  They say the agency is working closely with the UK Government to “analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK.”

The MHRA statement also says that “while negotiations continue, the UK remains a full and active member of the EU, with all the rights and obligations of EU membership firmly in place.”  In other words, no change during the period of negotiation.

The MHRA hints at a possible future regulatory partnership with the EU, referencing the UK Government’s statement made on 4th July 2017 which described its “desire to retain a close working partnership in respect of medicines regulation after the UK leaves the EU, in the interests of public health and safety.”  The statement laid out three post-Brexit principles:

  • Patients should not be disadvantaged
  • Drug and device Innovators should have quick and simple access to the UK market
  • The UK will play a leading role in both Europe and the world in promoting public health.

Please click here to read the MHRA statement in full.

Whilst there is still a long way to go before the post-Brexit future for the healthcare industry is clear, Regulis is actively working with companies to prepare them for Brexit.  Please get in touch if you would like our assistance.