Joy to the World?

‘Tis the season to be voting (in the UK at least). And though, at the time of writing, it remains to be seen whether the Conservatives will win enough seats to pass the Revised Withdrawal Agreement, I have been thinking about life after the UK leaves the EU – and the implications for pharma.  

The Brexit debate can arguably be characterized as a trade-off between “parliamentary sovereignty” and “free trade.” In other words, to what extent can parliament minimize trade friction while also being free to set its own rules and regulations? This dichotomy applies to any trading relationship – not just the EU – and will be central to the UK’s negotiations with trading partners across the globe, including the US, Australia and Japan. 

From a pharmaceutical and healthcare perspective, trade agreements clearly have the potential to impact policy, potentially constraining regulatory sovereignty in these areas in return for market access. For example, a recent analysis identified 10 types of provisions in a data set of trade agreements (1). These included extended periods of exclusivity for patented medicines, investor-state dispute settlement mechanisms, procedural requirements for national pharmaceutical pricing and reimbursement programs, regulation of pharmaceutical marketing, and rules applying to state-owned enterprises and government procurement of pharmaceuticals. According to the authors, many of these provisions have the potential to impact access to affordable medicines, as well as local production and health security. 

I’m not trying to be disparaging about trade agreements. In fact, I have detected some optimism in the UK pharma industry when it comes to the prospect of enhancing trade with the US market. For example, during a panel discussion at Pharma Integrates, London, Scott Johnstone, CEO of the Scottish Lifesciences Association, said, “Our companies are focused on the US rather than Europe. And that’s where the opportunity is.” At the same time, we must be clarify what “enhancing trade” really means, and understand that tipping the “sovereignty scale” too far (in either direction) has the potential to impact the industry – and ultimately patients.

Assuming Brexit goes ahead, leaving the EU is really the first step in the Brexit process. It will be up to industry associations and patient advocacy groups to ensure that their voices are heard as the UK reformulates its relationships with the rest of the world. 

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