Are You Ready?

In January, the EMA launched a survey to learn how (or if!) pharma companies were preparing for Brexit (1). And towards the back end of last year, I spent the best part of an afternoon at CPhI conducting my own straw poll on people’s thoughts about Brexit and its potential impact. (No, I’m not a masochist). A number of delegates told me they had plans in place, but a considerable proportion of companies weren’t particularly prepared. And some even refused to believe Brexit would happen.

At the show, I also chatted with Sascha Sonnenberg, VP Commercial Operations Americas and EMEA at Marken – a company that specializes in supply chain solutions for clinical trials. Sascha spends much of his time explaining what Brexit might mean for his clients – and what they should be doing about it. Bigger firms tend to be prepared, he says, but smaller companies, particularly those outside of Europe, “do not have Brexit on their radar.” (Read more of his views by visiting our feature article). The EMA has been pretty explicit in explaining what Brexit will look like in the absence of an agreement. Although, industry is hoping for mutual recognition agreements, for now, the EMA is assuming the UK will be treated as any other third country – with MAs, orphan designations, batch release, Qualified Person Responsible for Pharmacovigilance, and Pharmacovigilance System Master Files, all needing to be transferred to the European Economic Area before March 30, 2019. Sascha shared his concerns about a bottleneck on the EU side as companies rush to make sure they’re ready to carry out batch release, as it could delay or endanger ongoing trials.

But even if the industry gets everything it wants in terms of regulatory equivalence and mutual recognition, pharma companies will be using the same ports and roads as exporters from other industries. Unless there’s an agreement that effectively eliminates the need for customs checks across all sectors, pharma companies will inevitably face delays at the border... Who knows what shape Britain’s relationship with the EU will take after Brexit or what the costs/benefits might be in long term? But are you really willing to wager that things won’t be any different on Brexit? I feel it’s appropriate to quote my countryman, Roger Moore: “It is better to be prepared for illness than to wait for a cure.”

James Strachan Deputy Editor

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