Where, When and How: Brexit Poses Many Questions over the Future Location of the EMA

As the United Kingdom prepares to leave the European Union, the pharmaceutical industry has been battling with uncertainty, particularly with regard to the impact on regulatory processes and market authorization of drugs.

Exactly how Brexit will affect the industry remains uncertain, since the UK’s withdrawal from the EU is unprecedented.

UK Prime Minister Theresa May set in motion the country’s departure from the EU over the next two years, guaranteeing the European Medicines Agency (EMA) will undergo some significant changes.  From March 30, 2019, when Brexit goes into effect, the UK is expected to officially become a third-country regime in terms of its relationship with the EU.

This means that the EMA will likely be leaving London, though it is not yet known when that will occur. The other unknown is where the new headquarters will be, a decision that will be determined by member state representatives through a common agreement.

There is widespread interest across EU member states in hosting the EMA, although the Netherlands has been most vocal with its interest in having the EMA and has issued a formal letter to the European Council and the European Commission to announce its candidacy.

Almost every member state and several cities are eager to host the agency. Among those vying for the opportunity are Romania, which currently hosts no European agencies and has a high number of medical graduates; Copenhagen, which has touted its world-class research environment, innovative life sciences cluster, strong infrastructure and patient-safety focus; Dublin, which has the advantage of close proximity to London; and the Stockholm-Uppsala region of Sweden, home to a rich life sciences environment. Other countries include Spain, France, Italy and Poland.

Sooner rather than later

While the timing of the move is still unknown, it’s widely recognized that the decision on a new headquarters needs to be settled quickly. The agency has noted that it is planning its own workload shift to fill the gaps when UK experts no longer work with EMA.

The EMA Management Board and heads of the national competent authorities (NCAs) of the EU and European Economic Area (EEA) member states have already started discussions on how to share the work of evaluating and monitoring medicines without the UK’s help. We know that the UK will no longer participate in the work of the EMA as of March 30, 2019.

While there is much discussion about the benefits to the UK’s continued participation in the EMA, how the country could continue to cooperate with the agency after Brexit and what its level of influence will be is unclear. There are certainly advantages to the UK’s continued involvement, particularly given the enormous role that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has played in developing EMA standards.

If the UK were to retain membership in the EMA, it would probably have to comply with EU law in the areas covered by the EMA. The Court of Justice of the European Union (CJEU) has jurisdiction over proceedings against any EU agency.

There is talk about some options, but nothing has been decided. These options include: 1) continuing to align with the EMA (particularly given the “potential disadvantages of losing mutual recognition with the EU”, as described by a Deloitte report to the UK government’s EU External Affairs Subcommittee); 2) aligning with another regulatory framework (such as the U.S. Food and Drug Administration (FDA); or 3) creating a new/enhanced UK regulatory organization.

An analyst report cited in Regulatory Focus News noted that aligning with another regulatory body such as the FDA might be “time-consuming and costly,” while the “size and complexity” of the task of creating a new regulatory body and supporting a new regulatory framework means that this was “unlikely to be feasible in the time available.”

DXC Technology is following developments closely to ensure that our advice and guidance best supports the needs of our clients.

There is much to do and consider between now and the time when EMA moves, and even more to do before March 30, 2019. Learn how DXC Technology can help you prepare for the most significant transition in EMA history at www.dxc.technology/life_sciences.

Usha Sharp is a senior professional in DXC’s Life Sciences Regulatory Engagement Management group, and Leslie Wan is global head of DXC’s Regulatory Engagement Management group.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: