EMA Provides Business Continuity Plan Post Brexit
The European Medicines Agency (EMA) has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the UK’s withdrawal from the European Union (EU) and the agency’s relocation.
The business continuity plan is a tool that is intended to help the EMA take the decision to reallocate the available resources as needed to maintain its priority activities over the coming years. The plan sets out three layers of priority. In May 2017, the EMA started to scale back activities in the outer layer, so-called Category 3 activities, to free up 43 staff by the end of 2017 who are focusing on the preparations for the UK’s withdrawal from the EU and EMA’s relocation.
To achieve this, the agency decided to temporarily suspend a number of activities including: (1) the development of the European Medicines Web Portal, a new publicly available online information source on all medicines marketed in the EU; (2) the EMA’s contribution to the e-submission project that will allow applicants to electronically submit documents linked to authorization requests for human and veterinary medicines; (3) the development of a transparency roadmap for the EMA that lays out future transparency measures of the agency; (4) and participation in the benchmarking of medicines regulatory authorities in the EU as of 2018.
In addition, the EMA reduced the number of audits as well as some corporate governance and support activities. Participation of EMA staff in external meetings or conferences also has been reduced as has the organization of EMA meetings and workshops. The EMA said these types of activities can be put on hold for some time to free up or channel resources into core activities that need to be maintained under any circumstances. However, mid-to-long-term, the EMA said it will need to analyze how long these activities can be put on hold before they start to “seriously undermine the quality of the agency’s work and its planning and the expectations of stakeholders.”
Category 2, the second highest priority, consists of activities, such as the proactive publication of clinical data, and various initiatives aimed at promoting availability of medicines as well as some political priorities of the EU, such as the EMA’s contribution to combating antimicrobial resistance or the agency’s interactions with Health Technology Assessment bodies. The EMA said that these activities will be maintained for as long as possible, workload and staffing situation permitting, in order to maintain the development of new medicines.
Category 1 includes the highest priority activities that are either directly related to the assessment and safety monitoring of medicines or vital to maintaining the infrastructure of the European regulatory system for medicines. Category 1 activities include the coordination of actions to protect the safety of patients in all EU member states, inspections across the EU, and the maintenance of the functionality and security of critical information technology applications used by all member states, according to the EMA.
The EMA said that further iterations of the business continuity plan will also take into account various scenarios for staff losses and how these may affect the delivery of Category 1 and 2 activities. The agency cautioned that “unexpected higher, faster or more permanent loss of staff as a consequence of the agency’s relocation may lead to a situation in which EMA’s operations can no longer be maintained.” The EMA said it will provide further updates on the implementation of its business continuity plan as necessary.
In a separate Brexit development, the European Council, an institution within the EU that defines the general political direction and priorities of the EU, reported that it received 19 offers from potential host cities of the EMA. The EMA is currently located in London, and in a post-Brexit move, would have to relocate to an EU member state.
Offers to hold the EMA came from: Amsterdam (The Netherlands), Athens (Greece), Barcelona (Spain), Bonn (Germany), Bratislava (Slovakia), Brussels (Belgium), Bucharest (Romania), Copenhagen (Denmark), Dublin (Ireland), Helsinki (Finland), Lille (France), Milan (Italy), Porto (Portugal), Sofia (Bulgaria), The applications will be assessed on the basis of six criteria agreed by the 27 EU member states: (1) guarantees that the agency will be operational when the UK leaves the EU; (2) accessibility of the location; (3) schools for the children of the staff; (4) access to the labor market and healthcare for the employees’ families; (5) business continuity; and (6) geographical spread.
In terms of the next steps, the European Commission will publish an assessment of the offers based on the agreed criteria by September 30, 2017. EU ministers will have a political discussion based on the European Commission’s assessment in October 2017 within the General Affairs Council, a body mainly made up of the European affairs ministers from all EU member states responsible for ensuring consistency in the work of the European Council. In November 2017, the General Affairs Council through a vote of the 27 ministers will take a vote on the city to host the EMA.