By: Ben Locwin
The Brexit event has made it clear that pharmaceutical regulation, including market approvals and sales, will be changing. With the divorce between Britain and the European Union (EU)—perhaps it’s more accurate to call it a “conscious uncoupling”—the financial markets have been in flux, including Britain’s credit rating being downgraded, and the falling value of the British pound. In turn, pharmaceutical regulation will also change as a result. How the Medicines and Healthcare Products Regulatory Agency (MHRA) fits into the decision-making of worldwide regulatory approvals, how the European Medicines Agency (EMA) is substantiated in Britain after the uncoupling, and what this means for manufacturers and patients are the three top questions for our industry post-Brexit.
As far as regulatory effects, the most critical components are how to ensure a well-regulated pipeline of drug therapies for patients who need them, and to not allow bureaucracy slow the vetting of effective and safe pharmaceutical products to market. In addition, on the other side of the equation, to not let unsafe and/or nonefficacious therapies slip through the appropriate processes of regulation during this time of political flux. It’s important to consider what this means in practice for the MHRA and EMA, specifically that certain EU Directives, such as Directive 2001/83/EC governing healthcare and medicinal products, would require Britain to implement relevant legislation. This is done by reference to the European Communities Act of 1972 and through the implementation of the Human Medicines Regulation of 2012. Changes to Britain’s status post-Brexit would mean these laws remain in place unless the British government decides to amend them.
Currently, the MHRA and EMA work closely together on inspections of manufacturing facilities. The future state could be that MHRA independently authorizes drug products while still working with EMA under shared agreements. After invoking Article 50 of the EU treaty, Britain has two years to exit the EU. With its execution, there is now a scramble to shore-up all of the components that were tethered to the EU so that they can minimize collateral effects. This paradigm also applies to pharma. I recently spoke with someone close to the Brexit decision-makers in the industry, and there are plans being enacted to tie up as many loose ends as possible, as quickly as can be reasonably done. However, there are many “unknown unknowns” and unanticipated effects that are part of the systemic shift of this magnitude. There are undoubtedly many issues that will arise, but we will only learn of them once they become salient issues for patients or the market – our data on the situation are underpowered to allow accurate forecasting.
People in the pharma industry will tend to fall into two camps: one of over-worrying (over-pessimism), or the other of not being concerned enough (over-optimism) with the changes coming to the pharmaceutical landscape as a result of Brexit. But what we can all do as an industry in order to insulate ourselves from adverse outcomes is to be more agile and adaptable in how we respond to the changes that are coming. This concept is known as “antifragility,” where the idea isn’t to become more impervious to change and market forces, but to be more adaptable to these changes. Standing immutable behind hardline policies can make the necessary operational changes difficult to absorb and lead to more variance and extended costs in the long run. As the ancient philosopher Heraclitus of Ephesus said, “Change is the only constant.” This is true in pharma as well. Closing our eyes, covering our ears, and hoping the changes will pass us over are not viable strategies. However, expecting change and being adaptable and resilient to its effects are strategies for success. Just ask Charles Darwin.
Excerpted from Pharma Life After Brexit, with permission from Contract Pharma.
Ben Locwin, Ph.D., M.B.A., M.S., is president at Healthcare Science Advisors and an author of a wide variety of scientific articles for books and magazines. He is an expert contact for AAPS, a committee member for the American Statistical Association (ASA), and also a consultant for many industries including biological sciences, pharmaceuticals, psychology, and academia. Follow him at @BENLOCWIN.