Situation Far From Ideal But EU Network Will Survive Brexit
Executive Summary
Brexit undoubtedly will cause some short-term disruption to the EU medicines regulatory network but the network will survive without the UK. That’s according to former European Medicines Agency head Thomas Lönngren. Meanwhile, the timetable for relocating the EMA is likely to be finalized in a few days’ time – as are the criteria for hosting the agency when it moves from London.
The EU medicines regulatory network has neither the capacity nor the competence - at least in the short term - to replace the contribution the UK currently makes to the system. In the long term, the EU and the UK drug regulatory systems will survive without each other, but the net result will not be good for either patient health and safety. Those are the views of former European Medicines Agency executive director Thomas Lönngren.
The departure of the UK from the EU regulatory network, together with the staffing problems that the EMA is likely to experience when it moves from London, could affect the performance and quality of work the network undertakes, Lönngren warned.
Speaking at the “Forum On UK Pharmacovigilance Post-Brexit” organized by the Southampton-based Drug Safety Research Unit in London on April 26, Lönngren said that while Brexit would create “temporary disruptions in the performance of the EU [medicines] regulatory system for sure”, these could be minimized with good management, planning, timing and support from member states.
It won’t be clear for some time whether and, if so, how the UK Medicines and Healthcare products Regulatory Agency will still be able to collaborate with the EU medicines network. In the meantime, there has been talk among the EU Heads of Agencies about outsourcing some regulatory work to the UK, according to DSRU director Professor Saad Shakir.
No details are available on what this outsourcing might involve, said Shakir. We don’t know whether this will result in just using the MHRA as a consultancy or whether it might also involve mutual recognition, he remarked.
There has been talk among the EU Heads of Agencies about outsourcing some regulatory work to the UK after Brexit.
Shakir referred to suggestions from the MHRA that, in order to keep the EU and UK approaches aligned, the EU medical device model may be adopted for drugs. This model allows for some form of recognition by countries that are not part of the EU. “However, this model has not been developed and it could be that in the end, the UK may come up with an entirely new model of its own,” Shakir added.
The industry has made it clear that, irrespective of the final model, the authorities need to ensure that Brexit does not negatively impact the regulatory capacity and processes of the EU medicines network, and that the timeframes for the introduction of new medicines are not affected.
EMA Relocation Criteria And Timetable On April 29
The presidents of the European Commission and the European Council, Jean-Claude Juncker and Donald Tusk respectively, will present the criteria for the relocation of the EMA to EU heads of state and government at a special Brexit summit on April 29.
The meeting, at which the EU’s Brexit negotiating guidelines will be adopted, should see leaders agreeing on a timeframe for the EMA’s relocation. “The Commission will remain neutral and will not rank countries, unless the European Council asks us for an evaluation to assess what would be the most effective, sustainable and safe way to continue the current work of the agency,” EU Health Commissioner Vytenis Andriukaitis told the Spanish newswire EFE.
The pharmaceutical industry is more concerned about the impact the relocation might have on the agency’s processes than on where the agency goes. Among other things, it fears a slowdown in marketing authorization procedures. Virginia Acha of the Association of the British Pharmaceutical Industry said she often gets asked where the industry wants the EMA to be relocated. “To be honest, that’s the last thing on my mind right now,” Acha told the DSRU forum.
The industry has had some good conversations in the UK about minimizing the impact of Brexit, according to Acha. It was, she said, now time to move them to the EU so that all parties were aware of the issues that need to be addressed.
From the editors of Scrip Regulatory Affairs.