European Medicines Agency (EMA) has released a business continuity plan dealing with the potential implications of Brexit. EMA, which is currently established in London, will be required to transfer the Agency’s headquarters to another EU Member State. With the aim to conserve Agency’s capacities to protect public and animal health, EMA has issued a press release which defines related changes.
The business continuity plan categorises and prioritises EMA’s activities in accordance with their impact on public health. It places EMA’s activities into three categories of priority. Activities of the highest priority are placed in Category 1, high priority activities in Category 2 and activities of lower importance in Category 3.
In May 2017, EMA had already started to scale back activities in Category 3 in order to focus on Brexit. EMA had decided to suspend the development of the European Medicines Web Portal. This is a new publicly-available online information source on all medicinal products marketed in the EU. EMA had also suspended its contribution to the e-submission project which allows applicants to electronically submit documents linked to authorisation requests. Additionally, EMA had suspended 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, EMA intends to reduce the number of audits and participation by its members in external meetings or conferences. The purpose of these changes is to allow EMA to support other core activities. EMA will, however, analyse later the duration of suspension of these activities in order to avoid undermining Agency’s quality work.
As regards Category 2 , EMA highlights that activities of this category will be maintained for as long as possible in order to secure the development of medicinal products. Examples of activities of Category 2 concern the proactive publication of clinical data and various initiatives promoting the availability of medicines.
EMA’s first priority is to properly run the activities of 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.
EMA will further examine potential loss of staff higher than expected and the related impact on categories 1 and 2. If the Agency’s relocation will cause a more permanent loss of skilled and experienced staff, EMA may be led to a situation where it cannot operate properly.
Further updates will be provided by EMA on the implementation of the business continuity plan.