Brexit: fully prepared

The United Kingdom (UK) is leaving the European Union in March 2019. The terms on which the UK is going to leave the EU are still unclear. The main priority for the Medicines Evaluation Board (MEB) is that the quality, safety and efficacy of medicinal products must not be allowed to suffer as a result of Brexit. For that reason the MEB is making preparations to cope as best as possible with the consequences of Brexit.

The United Kingdom plays a considerable role in the EU in terms of assessing medicinal products. It is responsible for approximately 20% of all assessments. These 20% are currently being divided among the remaining 27 EU Member States.

Preparing for a hard Brexit

At the moment there is still a great deal of uncertainty about the consequences of Brexit for the MEB. However, the MEB has already started taking steps to prepare for the extra work that may arise as a result of Brexit. That is why the internal capacity of the MEB has recently been expanded with temporary financial support from the Ministry of Health, Welfare and Sport (VWS). As the MEB director, Hugo Hurts, explains, "We are therefore preparing for a worst-case scenario, namely a hard Brexit."

In addition, the focus is now on reinforcing the European network from within. With support from the Dutch government, the MEB has offered to help a number of Member States to continue increasing their assessment capacity and training. In the future this will help to achieve a much more balanced distribution of the work between European medicines agencies.

Continuity is paramount

All projects and activities relating to Brexit and the relocation of the EMA to Amsterdam have been accommodated in a programme of which the aim is to ensure that the MEB is prepared for these changes. The continuity of the MEB's work is paramount. As Hugo Hurts explains, "It is important that the consequences of Brexit for patients is minimised." Combining various projects and activities will lead to better (internal) coordination, cohesion and a more effective way of working. This will enable the MEB to respond more effectively to new Brexit-related developments.

European cooperation

The consequences of Brexit are also being assessed at European level. "Brexit is certainly also an opportunity to reinforce cooperation with other European medicines authorities," Hugo Hurts stresses. "The MEB is not only focusing on expanding its own capacity. We also want to distribute the work more effectively among the various European medicines authorities. By doing so we also intend to build up long-term relationships for future cooperation in terms of flexible distribution of work in the area of multinational assessments."

Nine countries have now agreed a Memorandum of Understanding with the MEB. Following an initial assessment there primarily appears to be a need for capacity and training on the issues of pharmacovigilance, quality and pharmacology, toxicology and kinetics.

Relocation of EMA to the Netherlands

One consequence of Brexit is that the European Medicines Agency (EMA) is relocating from London to Amsterdam in 2019. "That presents opportunities," says Hurts, "but, without doubt, also more work." The Ministry of Health, Welfare and Sport (VWS) is working hard to ensure that the relocation goes as smoothly as possible. Currently the MEB is investigating the extent to which the EMA might call upon the services of the MEB in the coming period.

See also