Challenges to the European Medicine Agency

Team Leader: Haley Daniel

Research Analyst: Thurka Brabaharan

Key Words: BREXIT, European Medicines Agency, EMA, Pharmaceuticals, European Union


On March 29th of 2017, the European Council was publicly informed of the United Kingdom’s decision to depart from the European Union. Following the referendum in 2016, Prime Minister Theresa May prompted the departure process, scheduling the exit scheme to be complete as of the 29th of March in 2019; in accordance with Article 50 of the Treaty on European Union. Those who advocated for Britain remaining within the EU, assert that one of its biggest achievements was the establishment of the European Union single market in 1992. This permitted for the fluid movement of individuals, currency, goods and services as if within a single country. Following Theresa May’s declaration that the UK is not to remain in the single market, institutions such as the European Medicines Agency (EMA) are forced to take measures to ensure that this transition remains as seamless as possible.

The EMA’s primary role is to regulate the operations of the single market for medicines within the European Union. As of present, the EMA is based at Canary Wharf in East London, and in combination with the European Banking Authority (EBA), employs approximately 1000 people. In turn, since Britain decided it would not participate in the EU’s single market, it has been determined that the European Medicines Agency will be moved to Amsterdam, the Netherlands, while the European Banking Authority will be moving to Paris, France. Of the two institutions, the EMA has more appeal due to its great influence, in converting the host-country to a central constituent of the European medical industry.

In the uprooting of both of these institutions, the lives of 1000 of individuals will change drastically. However, not only will this influence administrative personnel at headquarters, the relocation of the EMA is predicted to impact Britain’s medical researchers profoundly. The relationship that the EMA has with the UK’s Medicines Health and Regulatory Agency (MHRA) and Veterinary Medicines Department (VMD) has been tightly wound and profitable. The MHRA is responsible for regulating medicine and health care products within the United Kingdom, and is currently partaking in between 20% and 35% of the EMA’s licensing work. This implies, that following Britain’s official departure from the EU, it is likely that work currently being carried out by the UK’s MHRA and VMD will drastically decline. The MHRA and VMD serves the agency in a multitude of ways, including scientific research assignments and regulatory advice for health care.

Furthermore, with the United Kingdom’s withdrawal from the European Medicines Agency, it is likely to significantly affect the drug administration process for citizens. Both the work force and leaders within the UK’s pharmaceutical industry are concerned that the British are likely to encounter longer wait times for crucial treatments. Furthermore, the UK is expected to experience delayed access to drugs that will be readily available in larger markets; similar to the current predicaments faced by Australia and Canada. The UK’s departure from the EU indicates that Britain is going from constituting 25% of the world’s pharmaceutical market, to a mere 3%. With the UK market shrinking to a fractional size, this means that patients have the possibility of waiting six to twelve months longer than European Union states to obtain newly advanced treatments.

This official decision on which EU member state will take on the European Medicines Agency has illustrated the drastic implications of ‘Brexit’ that are to take place within the next two years. There is little that can be done in order to mitigate the risks in this current political climate, as the intricacies of the post- ‘Brexit’ relationship between the United Kingdom and the European Union are still in the midst of negotiation between Theresa May and EU leaders. Although the likelihood is uncertain, it is still possible for the United Kingdom to be separate from the single market and work closely with the EMA; which would be economically ideal for Britain. The details and provisions of the future UK-EU relationship in regards to medicine is virtually completely in the hands of EU governments. The UK-EU partnership in regards to the medical industry has been incredibly beneficial, in the production and licensing of 130 products to combat rare disease. In addition, if there was to be a more disciplined approach to the UK severing its relationship with the EMA, the government would need to act swiftly in creating a domestic regulatory system for Britain. In such a case, Britain’s economy and health care system is put at greater risk, with recovery time remaining ambiguous.