Brexit Won't Change Britain's Drug Regulatory Scheme

The Brexit has sent quivers through the ranks of the pharmaceutical industry. There are fears that the UK’s withdrawal from the European Union will also translate into an unraveling of its relations to the European Medicines Agency.

The life science crowd should rest easy. Any material change in Europe’s drug regulatory scheme, or even the function of the EMA, seems highly unlikely.

The immediate fears were stoked by the fact that the EMA is currently headquartered in London. It will likely have to find a new home–inside a European Union member country–once Britain formally leaves the Union. That outcome is unlikely to happen anytime soon. Nor is Britain likely to exit the EMA scheme and cause drug makers to pursue two separate and costly regulatory processes to launch products, as Politico predicted–one for the UK and one for EU member countries.

For one thing, packing up the existing EMA and moving to another European capital is likely to be a slow process that sees significant pieces left in place for quite some time. The EMA’s current office in London’s financial district houses almost 900 regulatory and scientific experts. Many wont be eager to relocate to Brussels. Replicating that talent inside another capital won’t happen easily.

Moreover, the EMA reflects a global effort toward harmonization of regulatory processes that is decades in the making. Those who orbit that process are going to be hard-pressed to preside over its dissolution. Both the EU member countries and their British counterparts will be invested in seeing the UK remain part of that joint regulatory scheme. EU member countries won’t want to impose separate inspections on products made in Britain. This is the sort of tertiary issue that will be resolved through the negotiations over the contours of Britain’s eventual exit.

Non-EU members like Norway still adhere to the EMA process and all of its rules. The Swiss regulatory agency, Swissmedic, which is ostensibly separate from the EMA, still works alongside EMA and has largely seamless sharing agreements.

The life of the EMA is also the sort of side issue that was hardly on the minds of British voters who opted for exit. That fight was largely over tax and labor policy, and decrees from Brussels that imposed work rules that many British resented, and situations where they had little recourse to challenge the bureaucratic dictates from Belgium. An informal review of the British press can find no reference to the EMA in concert with the calls for the UK’s exit. One would be hard-pressed to see how the drug regulatory scheme fits with the grievances that animated the British electorate.

Warwick Smith, director general of the British Generic Manufacturers Association and the British Biosimilars Association, issued a statement praising the benefits that a single European marketing authorization has had for drug makers and Britain’s National Health System. Among other things, he argued that the common scheme reduces complexity and cost for drug makers, and in turn helps lower medical costs.

The biggest drug issues related to Brexit may be with IP that’s domiciled in Britain, how it gets taxed and its treatment under the pending “unitary patent” that will take effect when the Agreement on the Unified Patent Court goes into force. Britain could still decide to ratify the Unitary Patent Treaty despite its exit from the EU. That unified process wasn’t set to go into full effect for at least seven years, anyway.

Of course, in the end Britain could decide to stay in the European Economic Area. In that instance, the drug approval process would remain fully unchanged. The bottom line is that a British exit from the EMA--and its withdrawal from Europe’s common regulatory scheme--is a Brexit aftermath that’s unlikely to come about.

You can follow Dr. Scott Gottlieb on Twitter @ScottGottliebMD