2. Questions to the Counsel General and Minister for European Transition (in respect of his European Transition responsibilities) – in the Senedd on 9 December 2020.
7. What discussions has the Counsel General had regarding the impact of the Brexit process on the pace of regulatory approvals for COVID-19 vaccines? OQ56016
It is extremely good news that the Medicines and Healthcare products Regulatory Agency has been able to approve the supply of the Pfizer/BioNTech vaccine. It has been able to do so using provisions under European law, which will apply until 1 January 2021.
Last week, the Financial Times carried on its front page an article emphasising the extent to which the European Medicines Agency, when it was based at Canary Wharf, leaned on our MHRA for assistance with much of its work. It has also faced very real challenges, at least from the FT evidence, since the relocation to Amsterdam because so many senior staff have not wanted to relocate from London. Would the Counsel General support and can he see any way perhaps that our regulators might be able to offer mutual aid and support to the EMA to support them in the regulatory requirements they need to fulfil for the European Union, hopefully, to speed up vaccines for them as well as for us?
The capacity of the MHRA to act swiftly, as it has done, has been within the framework of existing European Union regulation, as the Member will know. I think his question points in the direction of international collaboration in this space, and I think it's important to recognise the development of the vaccines have, in fact, been an incredibly international effort. In a sense, looking at a competitive environment between regulators I think isn't necessarily the helpful way of looking at it. The history of the Pfizer/BioNTech vaccine process has been one of great European collaboration and significant European investment, and that is a very positive thing. Generally speaking, the process of Brexit will be adverse to a number of our existing arrangements in relation to health mutual aid, as he describes it, whether that's around early warning systems as well as regulatory barriers. So, I regret those new obstacles that will be put in the place of mutual aid and collaboration into the future.