The Brexit countdown clock is ticking. Since the announcement of the referendum on whether the UK should remain part of the European Union, and then the 52%:48% vote, there has been uncertainty across the European pharmaceutical industry. While some things are starting to slot into place, there are still concerns over the unknowns.
The EMA finds a home
The new home for the European Medicines Agency is now settled – it's going to be located in Amsterdam. After four rounds of voting and a dead heat, the decision was made when Amsterdam's name was drawn out of a bowl against Milan, Italy, BioIndustry Association CEO Steve Bates explained in the BIA November Brexit Briefing Webinar.
"Internal surveys at the EMA indicated that the Amsterdam was the top choice for the majority of the EMA staff, and its hoped that this means there will be some continuity," said Bates. "Wherever the location, a close alignment on medicines regulation is in the best interest of both the UK and the EU."
Not everyone was happy with the result. The dead heat was due, at least in part, to Slovakia abstaining in the second and subsequent rounds, as a response to the lack of a candidate from the newer members of the EU.
But with Amsterdam now chosen as the final destination, the EU must march forward. The EMA needs to be fully operational by the end of March 2019, and so the next step will be the EMA and the Netherlands establishing a joint governance structure.
"As a sector we need to be aware that business may not be as usual," added Bates.
Brexit approaches: What's next
The EU Withdrawal Bill is now in the committee stage, with eight days of meetings in mid-November and throughout December, in a committee of the House of Commons. The next deadline is December 14, when the EU leaders will meet for a summit, and will decide whether the UK has moved forward sufficiently for talks to go ahead.
"The next month will be a key one for the UK for progressing talks to phase 2," said Bates.
One of the concerns about a so-called "hard Brexit" — where the UK gives up access to the single market and the customs union, thereby losing free movement of goods, services, capital and people — is the impact on EU citizens working for companies in the UK, including biopharma companies. And it's not just uncertainty in the UK that could have an impact on Brexit talks. The recent collapse of the coalition talks in Germany and the potential for new German elections could also have a knock-on effect.
"The UK is preparing a legislative framework for post-EU life, and David Davies, the UK's Secretary of State for Exiting the European Union, believes that the UK can remain in all EU regulations and agencies during the transition period," said Bates.
Brexit and biopharma
The EMA and the UK's Medicines and Healthcare Products Regulatory Agency are both aware of the challenges of ongoing pan-European clinical trials, submissions and approvals over the transition period. The BIA's next steps will be to continue working with the Brexit Health Alliance, a group that includes the NHS, medical research, industry, patients and public health organizations "to safeguard the interests of patients and the healthcare and research they rely on during the Brexit negotiations."
"Companies are looking at how they should handle clinical trials through the exit date," said Bates. "They are also looking at how they will be able to submit drugs for approval, and are putting contingency plans in place. We are keen to get clarity on this but haven't yet gotten a formal answer. It will depend on whether a close cooperation model is agreed in the negotiations."
The associations representing the European and British life science industry have underlined the importance of securing cooperation between the UK and EU on medicines regulation, requesting a transition period that reflects the time needed by companies and regulatory authorities at EU and national level to adapt to the changes incurred by the UK exiting the EU. The associations have called for continued EU-UK partnership on the regulation and supply of medicines, to avoid supply disruption.
"Businesses now need certainty. The best way to do this is by an early agreement to a transition timeframe and continued close regulatory co-operation. We must now ensure Brexit does not disrupt the safe supply of vital medicines to tens of millions of families in the EU 27 and the UK," Bates added.
The UK government has committed to support the sector through industrial strategy, and has just announced the biggest ever increase in R&D investment in the latest budget. The promise is to increase investment to 2.4% of gross domestic product by 2027. The £20 billion ($26.9 billion) package will support investment in UK innovative companies over the next decade, and will include tax relief changes and new investments, including a £2.5 billion ($3.4 billion) co-investment fund with private finance to invest in innovative companies, and an extra £2.8 billion ($3.8 billion) for the National Health Service.
"Using tax reliefs to nudge wealthier investors into crucial growth sectors for the UK economy post-Brexit is sensible, combined with rules to ensure that taxpayer support is correctly targeted and not gamed," said Bates.