Plunging Through the Other Brexit Fog: How to Keep the EU Authorization System Running

Applied Clinical Trials

The operational subject of how the centralized authorization procedure is going to work when the UK is no longer part of the European Union is being discussed.

You'll have to wait for later in the year to see how the European Medicines Agency and the European Commission see the best way for drug sponsors to adapt to the coming strains of Brexit-not that controversial question of where the EMA is going to be located, which should be clarified on November 20, but the much more operational subject of how the centralized authorization procedure is going to work when the UK is no longer part of the European Union.

Some hints emerged at the first EMA meeting with industry stakeholders, in London in October. The meeting also offered some interesting glimpses of how the industry views the challenges, but the issue is still plagued by deep uncertainties.

EMA boss Guido Rasi's message was that companies and European regulators should work together to prepare for "the possible impact" on industry and the availability of medicines in Europe. In particular, companies should keep EMA well informed of any foreseen changes to the timing of initial marketing authorization applications submissions and do more to share post-authorization lifecycle submission planning. For regulators, the UK absence from the EMA means redistributing the work it would have done to experts from the other 27 EU member states.

For industry, the principal objective is to see that their centralized marketing authorizations remain valid, once the United Kingdom has left the Union. The risk companies see is in part that their European approvals may no longer be valid in the UK, and UK approvals may no longer be valid in the EU, but there are also question-marks over European approvals when the authorization procedure is based on UK leadership.

Agonizingly, for neither industry nor regulators are the current negotiations between the UK and the EU predictable enough to make even an informed guess at the shape of the likely outcome. So EMA and the European Commission admit they "are working on the assumption that the UK will leave the EU as of March 30, 2019", while recognizing that "the approach may need to be adapted accordingly." 

As of now, UK experts are still engaged in EMA activities and will continue until the UK withdraws from the EU and they are no longer eligible-but they are already starting to be excluded as rapporteurs for marketing authorization applications, because they would be unable to complete new assignments before the withdrawal. Given the high proportion of UK applications led by a UK rapporteur, that presents an immediate challenge. To tackle the post-authorization workload, similar changes are not expected to come into effect before late 2018, "with adequate time foreseen for knowledge transfer."

Representing European industry stakeholders, Alan Morrison voiced concerns around business continuity and disruption in the medicines supply chain, and expressed resistance to the concept of a UK withdrawal without any agreement with the EU-still the preferred scenario of many hard-core UK pro-Brexit politicians. Industry wants agreement on a transition period that would extend beyond March 2019, to ensure that the necessary changes (such as technology transfers) can be undertaken. But in the short term, there are also numerous challenges in ensuring that the necessary legal and regulatory arrangements are put in place in time to cover batch testing, certification, and release of products.

Other outstanding questions on which industry still wants urgent answers include what happens when an authorization is transferred between regulatory authorities, how the manufacturing and supply chain will be governed in terms of good manufacturing practice, future acceptance of UK quality testing, and what will happen to pharmacovigilance reporting and control.

An EMA survey of industry is under discussion to obtain company-or product-specific Brexit-related preparedness activities, to forecast the workload and submission schedule for 2018. Meanwhile, the EMA’s Brexit preparedness business continuity plan is still under discussion, and will not be launched until 2018. But the picture is grimly discouraging, and the threat remains high of serious disruption to European drug regulation and to the health of the European drug market.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.