So much vitriol and gloating about the fact that (having signally failed in every other aspect of pandemic management) the UK government has a vaccine rollout plan that is proving so much swifter in delivery than the one across the Channel in the European Union (EU). Sluggish, rule-bound European Medicines Agency (EMA), the naysayers say: they’d only managed to approve one vaccine, with the second coming on stream this week – whilst nimble, post-Brexit Britain is steaming ahead, having already delivered doses into more than 10 million arms. Our very own Medicines and Healthcare products Regulatory Authority (MHRA) had stolen a march on Johnny Foreigner, by approving the two vaccines before the end of December, all because of Brexit.
Hold on a minute – didn’t Dr June Raine, head of the MHRA, explicitly say the whole regulatory assessment and process “was undertaken under the terms of European law”, which was in force until completion of the Brexit transition at the end of 2020? And anyway, who knows what would have happened had the EMA been able to continue as before, in its highly successful London base?
Four years ago, an EMA staff survey raised concerns about the future of public health in Europe as a result of the disruption and upheaval involved in the move to the Netherlands, forced by the UK decision to leave the EU. Unsurprisingly, worries voiced here were more about how London and Britain would lose out. There was a large economic cost, not least because the EMA employed some 900 people, many in well-paid jobs. Apart from all that employee spending power, EMA activity generated demand for 350 hotels per night, five days a week, in order to host its 40,000 visiting guest experts each year. Many of the London-based pharmaceutical companies chose their location to be close to the EMA. London’s Francis Crick Institute (the new UK Centre for Medical Research and Innovation) celebrated moving into purpose-built premises, close to the EMA and St Pancras Eurostar terminal, just months before that fateful Brexit vote. This critical mass of esteemed researchers, industry and regulators had provided a sound basis for cross-fertilisation of scientific ideas and critique, informal support and easy access to expert colleagues within a small geographical area: all essential ingredients for research and regulatory excellence.
Health is not an EU competence, and nation states all issue their own licenses for drugs. However, the EMA can respond to requests from EU member states or manufacturers to issue a Europe-wide licence for medicines. To do this, it relies heavily on outsourcing scientific assessment to national regulators, with the MHRA playing a leading role in seven out of 10 products in the past. UK experts conducted about 20 per cent of the EMA’s scientific work in 2017. By the end of 2019 (the year after it moved to Amsterdam and just weeks before the Covid-19 emergency began), the agency had lost around 100 ‘staffers’ and was “still in the process of rebuilding its workforce after its relocation”.
So how did the MHRA manage to approve the two vaccines so much more quickly? Licensing of medicines (including vaccines) follows a very clearly defined set of procedures. The safety and the effectiveness of drugs are assessed by a panel of experts in the field, who are completely independent of those involved in the trials and the pharmaceutical company developing them. Strict attention is paid to the way the trials were developed, funded and carried out, as well as how the results were collated and interpreted. Each step of the development process is scrutinised with great care, with the assessors checking all the original data.
These procedures were all followed, just as robustly as they would have been for any new medicine, but given the urgency of the situation, the MHRA adjusted the timing for receiving information about the developing vaccines and starting the assessment process. Instead of receiving the whole submission at once, they developed a rolling review process, asking to be sent information as each stage was complete. This process ran the risk of wasting expert time, because they might be assessing data from a trial that ultimately proved unsuccessful, but it still ensured that every stage of assessment and evaluation was completed with equivalent rigour. Developing this rapid review approach required not just scientific and regulatory expertise, but the authority to involve the necessary number of experts in assessing many chunks of intermediate information, before making a final decision ahead of other regulators.
Much of their cutting-edge expertise in regulatory assessment was nurtured in the MHRA’s London base, when the EMA was an embedded part of the wider pharmaceutical and scientific endeavour. If Brexit had not happened, the MHRA could still have adopted the approach they did, under European law. On the other hand, had it not been for the EU and the part played by the EMA in developing and nurturing that critical mass of pharmaceutical researchers and regulators in London, where might the UK have been? We cannot know, and of course I cannot speak for the brilliant MHRA or the experts involved. But perhaps at least some of their confidence and expertise was down to their time spent working closely with the EMA? Just imagine that! Maybe, by helping to develop this infrastructure, the EU played a part in enabling the UK’s speedy vaccine approval. And if the EMA had not just had to rebuild its own (undoubted) expertise because of Brexit, perhaps they could have moved more rapidly to a conclusion about the safety of the vaccines as well.
Whatever the background, the time from the start of the process, to completing the trials and approving the vaccines is incredibly short. The few weeks’ difference between MHRA, EMA (and, indeed, America’s Centre for Disease Control) is vanishingly small and hardly worthy of comment. Time for the sneering to stop.
Have you seen our Covid-19 Mythbuster page?