After three years since the United Kingdom’s vote to leave the European Union and a number of extensions, the country is fast approaching the latest deadline of October 31, 2019. The new Prime Minister, Boris Johnson, and the leaders of the EU have been at loggerheads, and the possibility of a deal or no deal remains in the balance.
Speculation abounds over what this will mean for business, law, borders, and immigration. But perhaps one of the most concerning areas of uncertainty is the impact on pharmaceuticals and medical devices – because of the lack of a deal as yet, there are no concrete plans for the regulators and the industry to work with in preparation for the UK leaving the EU. We wrote about industry’s concerns over Brexit earlier this year, but since that time, little has been resolved.
Brexit from the regulator’s perspective – still looking uncertain
Things started off looking promising for more clarity earlier this year. At that time, Prime Minister Theresa May raised hopes in March 2018 that the UK would be able to remain an ‘associate member’ of the European Medicines Agency (EMA), touting the importance of the UK regulatory experience for the EMA, and the strength of the UK universities. But this didn’t pan out in discussions with the remaining 27 countries in the EU, and in April 2018, the UK’s hopes that it could remain linked to the EMA for a transition period until the end of 2020 ended up in tatters. So, unless a withdrawal deal can be put in place within the next few weeks, it looks like the UK regulators will be going it alone very soon.
The UK Medicines & Healthcare products Regulation Agency (MHRA) – which incidentally is losing its Chief Executive Officer, Ian Hudson, and its Director of Devices, John Wilkinson, before the Brexit deadline – has issued a guidance note ‘on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal’. This note, updated on September 3, 2019, lists detailed proposals for regulating medicines in a no deal scenario. Briefly, the MHRA will take over the role of the European Medicines Agency in the UK. All Centrally Authorized Products (CAPs) will automatically become UK Marketing Authorizations (MAs), and the MHRA will put in place assessment procedures for new drugs and biosimilars, rare disease medicinal products with orphan status, medical devices, clinical trials, and everything else currently covered by the European agency. The UK has committed to aligning its clinical trials regulations with those in the EU.
It’s not just the UK regulators that will be affected by the UK’s farewell. The UK has long played a key role in EU medicines regulation, as a base for the EMA, as a rapporteur, and as a developer of legislation. The need to move the EMA from London to Amsterdam has resulted in suspension and scaling back of additional activities such as guideline development in order to safeguard core activities. The impact of the loss of the UK’s expertise on the EMA isn’t yet clear.
Brexit from the industry’s perspective – a mixed bag
The uncertainty is also impacting the pharma and biotech industries. While companies are working to build up stocks, duplicate processes between EU and UK, and assess their supply chains, they have no power to speed up governmental decisions. Even though the UK government is putting contingency plans in place, this means that there will likely be disruptions of supply, causing problems for pharmacies and potentially putting patient’s lives at risk.
UK-based big pharma AstraZeneca has been lobbying the EU to accept UK testing standards, as well as changing packaging, updating licenses and duplicated batch testing in the UK and the EU. The company has also moved stock to European distribution centers and has increased its stockpiles by 20%. European companies, including Sanofi and Novartis, are hurrying to stockpile drugs both in Europe and the UK.
Novartis has taken a stand by calling out to the authorities, saying “it is vital that Government makes minimizing disruption to the medicines supply the highest priority as it prepares for a potential hard or disorderly Brexit.”
Contract development and manufacturing organizations (CDMOs) are also making preparations. Almac now has sites in both Northern Ireland and Ireland, to ensure that it has a manufacturing base in both the EU and the UK. UK CDMOs PCI Pharma Services and the Wasdell Group also have an Irish base, to ensure that their services face as little disruption as possible post-Brexit.
“As we have said before, we should be under no illusions that ensuring UK medicines supply in a ‘no deal’ Brexit will be easy or smooth, but with patients at the end of the supply chains, companies will continue to be as prepared as possible for a scenario they really do not want,” said a UK BioIndustry Association spokesperson in August 2019.
The missing piece(s)
What’s missing from the Brexit preparations? Certainty.
With time running out, there are still concerns. Will the MHRA be able to take on the workload and be up to speed in time? Will the stockpiles and precautions from the biopharma companies be enough to counter patients’ anxiety? How will Brexit affect the UK-based pharmaceutical industry as it tries to continue supplies in the UK as well as export products to Europe? In turn, what will the impact be for EU companies that use ingredients sourced from the UK?
And if no agreement with another regulator is reached, will companies be willing to go through a separate marketing authorization submission for an individual market the size of the UK, with a population of just 66 million — compared with a population of 327 million in the US, ~450 million in a post-Brexit EU, or 127 million in Japan?