The pharmaceutical industry has sounded the alarm on the massive scale and complexity of maintaining medicine supplies across Europe after Brexit, with new data revealing the intricate web of cross-border dependencies that could be disrupted when the UK leaves the European Union.
A comprehensive survey conducted by the European Federation of Pharmaceutical Industries and Associations (EFPIA) has quantified the extent of the challenge: over 45 million patient packs are supplied from the UK to other EU-27/EEA countries each month, while more than 37 million packs flow in the opposite direction.
"The survey underlines the scale of the task ahead. For life-saving and life-improving medicines, the EU and UK cannot afford to wait any longer to ensure that the necessary co-operation on medicines is in place from the day the UK leaves the EU," warned Nathalie Moll, EFPIA's Director General.
Regulatory Challenges Loom Large
The regulatory implications are equally daunting. Post-Brexit, over 12,000 centrally-authorized Marketing Authorizations (MAs) for medicines will require separate UK approval to remain available to British patients. Simultaneously, approximately 17% of centralized MAs currently held in the UK must be transferred to an EU27 country.
Clinical trials face similar disruption, with more than 1,500 multi-country EU trials currently operating under UK sponsorship. Over half of these trials are scheduled to continue beyond the March 2019 Brexit deadline, creating urgent questions about their regulatory oversight.
Industry experts note that many European politicians remain unaware that these challenges affect both UK and EU patients alike, mistakenly viewing medicine supply disruption as a UK-only problem.
Industry Leaders Express Pessimism
A separate survey of UK pharmaceutical industry leaders conducted by pharmaphorum reveals deep concern about Brexit's long-term impact. Among the respondents, which included managing directors of UK operations at six major pharmaceutical companies:
- 64% believe Brexit is "likely to cause long term damage to the UK pharmaceutical industry"
- 36% expect short-to-medium term problems with a neutral long-term impact
- None anticipated positive outcomes from Brexit
When asked about preferred Brexit scenarios, most respondents favored a "Soft Brexit" that would maintain the UK's participation in the European Economic Area or customs union. Some supported sector-specific deals, while three respondents went further, suggesting Brexit should be stopped entirely.
Sarah Rickwood, Director of Thought Leadership at QuintilesIMS, commented: "The pharmaceutical industry is a long term industry, and has to plan for things which might not bear fruit for a decade or more. Brexit brings with it a set of uncertainties which make that planning much more difficult."
Critical Timelines and Worst-Case Scenarios
The industry has identified March 2018 as a critical deadline for reaching agreements on pharmaceutical regulation, significantly earlier than the October 2018 EU summit that represents the last formal opportunity for a deal. Without clarity by March, companies will be forced to implement contingency plans for a "no deal" scenario.
While pharmaceutical trade can technically fall back on World Trade Organization rules in a "no deal" outcome, 45% of EFPIA members still anticipate trade delays under such an arrangement.
The UK government has proposed maintaining close ties with the European Medicines Agency (EMA), but EU27 negotiators have refused to engage on regulatory questions until "divorce settlement" issues are resolved.
Talent Concerns Compound Regulatory Worries
Beyond regulatory challenges, pharmaceutical executives express significant concern about potential restrictions on the movement of skilled workers. The industry relies heavily on international talent, with many companies employing multinational teams across research, development, and commercial operations.
"It's at the mercy of a much bigger politically driven set of decisions. But for pharma these are going to directly affect its economic and investment plans," noted Rickwood regarding the industry's inability to unilaterally address freedom of movement concerns.
Market Access and Launch Sequencing
Industry leaders also worry about the UK's future status as an early launch market for new medicines. While recent investments from companies like GSK and Takeda suggest continued commitment to UK operations, the country's position in global launch sequences remains uncertain.
"Brexit raises the risk that companies have to consider whether the UK should be a key market for launches and investment," Rickwood explained. "However I don't think there is yet clear evidence for companies to conclude they should be downgrading the UK, because there are both positive and negative aspects in the market."
Underlying NHS Funding Challenges
The pharmaphorum survey also highlighted that Brexit isn't the only challenge facing the UK pharmaceutical industry. Respondents identified NHS financial constraints and local market access barriers as significant obstacles, independent of Brexit concerns.
"This reflects that there isn't enough money in the system at the moment, and the NHS at a local level is slow in the uptake of new medicines," Rickwood concluded.
As Brexit negotiations continue, pharmaceutical industry leaders on both sides of the Channel are urging politicians to prioritize patient safety by ensuring uninterrupted medicine supplies. With the complex web of regulatory approvals, manufacturing dependencies, and supply chains at risk, the industry warns that the 16 months remaining until Brexit may already be insufficient to implement necessary changes without a comprehensive agreement.
