The EMA prepares itself for Brexit

The European Medicines Agency (EMA) recently released a business continuity plan dealing with the potential implications of Brexit. Based in London, the EMA will be required to transfer its headquarters to another EU member state upon the UK's exit from the union. In preparation for this, they recently issued a press release defining their planned actions.

“Preparing for the move, managing the necessary changes, and addressing challenges such as possible losses in skilled and experienced staff, proactively and efficiently requires considerable internal resources,” said Noel Wathion, EMA’s Deputy Executive Director and head of EMA’s Brexit task force. "With the business continuity plan, we aim to ensure that the assessment of medicines is not disrupted and that patients in Europe continue to have access to high quality, safe and effective medicines.”

The business continuity plan categorizes and prioritizes the EMA’s activities by their impact on public health. It places the EMA’s activities into three priority categories. Activities of the highest priority are placed in Category 1, high-priority activities in Category 2, and activities of lower importance in Category 3.

As of May 2017, the EMA had already started scaling back its Category 3 activities to focus on Brexit. This included the suspension of several key projects, including:

the European Medicines Web Portal - a new publicly-available online information source on all medicinal products marketed in the EU
contribution to the e-submission project, which allows applicants to submit documents linked to authorization requests electronically
the development of a transparency roadmap for EMA future measures and the participation in the benchmarking of medicines regulatory authorities in the EU as of 2018

In addition to these measures, the EMA intends to reduce the number of audits and participation by its members in external meetings and conferences. The purpose of these changes is to allow essential staff to support other core activities. The EMA will, however, periodically review the duration of this suspension to avoid undermining its critical work.

Regarding Category 2, the EMA highlights that activities of this category will be maintained for as long as possible to secure the development of medicinal products. Examples of Category 2 activities include the proactive publication of clinical data and various initiatives promoting the availability of medicines.

The EMA’s first priority is ensuring activities continuity within Category 1. These activities are related to the assessment and safety monitoring of medicinal products. Any disruption in these activities would have a detrimental impact on the health and well-being of the population in Europe.

Another risk the EMA examines is the potential loss of staff caused by the move and the related impact on categories 1 and 2. In the worst case, a longer-term loss of a skilled and experienced team driven by the agency’s relocation may lead to a situation where it cannot operate properly.

As it moves from its current London headquarters following Britain's decision to leave the EU, the European Commission has said it will assess 19 offers from various EU cities to host the European Medicines Agency's (EMA) headquarters. A final decision will be taken at the General Affairs Council and announced on 20 November 2017. The cities that have applied to host the EMA as of 1 August 2017 are: