Experts react to 25 Government papers that outline its preparations for a Brexit ‘no deal’.
Aisling Burnand, CEO of Association of Medical Research Charities (AMRC), said:
“Publication of the Brexit no deal contingency planning needed for the life sciences sector is a welcome but overdue step in the drive to make sure that there is no negative impact on patients whatever the final Brexit deal looks like. But there is still more guidance needed for patients, carers and their families.
“Delays at border controls are clearly anticipated in the event of a no-deal Brexit. The Secretary of State has written to reassure the public that plans are in place, so patients do not need take action themselves. However, patients, and the medical research charities who support them, will need more clarity that they will still be able to continue to get vital medication in the event of a no-deal Brexit.
“Given the tight timeframes, all those affected will need as much support as possible from Government in order to minimise disruption to the development of new treatments, the supply of vital medicines and opportunities to take part in clinical trials.
“We know that we, European patient groups and advocates all speak with a single voice with when we say no-one should have their health put at risk by the Brexit deal.”
Prof John Hardy, Professor of Neuroscience, University College London (UCL), said:
“Through our integration with our European partners scientific cooperation and drug industry regulation cooperation has benefited all Europeans but has especially benefited the UK. Brexit is an uncontrolled experiment and everyone who understands the level of cooperation forecasts the outcome will be worse than the present excellent arrangement. Brexit no deal will be a disaster. Soft Brexit will only be a major mistake.”
Dr Sam Barrell, Chief Operating Officer at the Francis Crick Institute, said:
“A ‘no deal’ Brexit would undoubtedly be bad for science; the only real question is how bad. We should not underestimate the value of the UK’s strong international position in science, and the potential impact of failing to reach a deal.
“Although it’s nice to hear the Secretary of State’s reassurances that we can still enjoy a sandwich after Brexit, it’s less clear if the UK will still be able to enjoy our status as a world-leading scientific power.
“We will assess the latest guidance to establish what the impact of a no deal Brexit would have on the important research we’re doing at the Crick, but ultimately government needs to reach an agreement that will preserve the international status of UK science.
“The Francis Crick Institute is an international institute with scientists from over 70 different countries, working together to make discoveries that change lives. More than a third of our scientists come from the EU and we need certainty for them and their families.
“Collaboration is the lifeblood of science. If we fail to reach a sensible agreement with the EU, it could seriously damage our ability to work with key EU partners and, as a result, harm the quality of UK science and our position on the world stage.
“We also need further assurances to secure the UK’s place in major European science projects. Before the Brexit vote, the UK was involved in more EU-funded science projects than any other country. Since the Brexit vote we’ve already been overtaken by Germany.”
Dr Beth Thompson, Wellcome’s Head of UK & EU Policy, said:
“These preparations are a step in the right direction to reducing risks, but even with the best preparation a ‘no deal’ will be damaging for research and science. It’s critical to keep focusing on a strong science deal, to reduce uncertainty for researchers and maintain the exchange of talent between the EU and UK. Collaboration and international mobility make science stronger. Keeping the UK open to international talent is critical to Britain’s scientific success now and in the future.”
Commenting on the release of the first tranche of 25 technical notices with regard to ‘no deal’ Brexit, Steve Bates, CEO, UK Bioindustry Association (BIA) said:
“A Brexit deal involving continued close cooperation on medicine regulation is in the best interests of patients. Today’s technical notices gives greater clarity on how UK medicines regulation will work in the scenario of ‘no deal’, something we do not want to see. It’s helpful that the technical guidance on medicines regulation is pragmatic, essentially proposing unilateral recognition of existing process, is in line with industry expectation, and echoes the position of Ministers expressed last year. We look forward to further discussion of the detail to build greater clarity around how the complex regulation and supply of medicines would work in the event of ‘no deal’. We will now engage our membership on the MHRA technical consultation promised for early autumn.
“As we have repeatedly articulated since 2016, it is now clear that a ‘no deal’ Brexit would mean a significant increase in replicative bureaucratic red tape for developers of innovative medicines. Introducing additional regulatory process for a market worth less than 3% of the world’s value adds additional time and expense for companies who have a choice as to where they launch new therapies. It would not add to the UK’s attractiveness for life science businesses. It would likely mean that NHS patients would get access to new therapies later than other countries in Europe.”
Commenting on the letter from Government on the medicine supply contingency plan programme, Steve Bates, CEO, UK Bioindustry Association (BIA), said:
“We encourage BIA members and other pharmaceutical companies that supply medicines for NHS patients from, or via, the European Union or EEA, to engage actively with the Department of Health request for information as to how, or whether, they can, or cannot, ensure an additional minimum of six weeks supply in the UK, over and above their business as usual operational buffer stocks, by 29th March 2019. Companies should receive an email from the Department within 24 hours with an ask to engage next week, and respond formally by 10th September. We have stressed and recognise that endeavouring to deliver on this in less than 200 days will be a massive challenge for industry and the MHRA alike. Given that over 150 BIA members are actively involved in clinical development in the UK we will pay particular attention to the implications of this work with regard to ongoing clinical trials.
“A ‘no deal’ Brexit would mean the biggest dis-integration of the complex regulated medicines market in Europe in terms of regulation, cross border movement of goods, comparative pricing and intellectual property. On behalf of patients we encourage all participants to be as prepared as possible for a scenario industry really does not want, but we should be under no illusions that this will be easy or smooth.”