The European Medicines Agency (EMA) has issued an update on its Brexit preparations, specifically in relation to: (i) dealing with ‘at-risk’ medicines; (ii) staff retention and recruitment issues; and (iii) the resumption of certain activities that were temporarily suspended or scaled-back. The update is based on the EMA’s management board meeting held in December last year.
- Regulators and companies alike are concerned about the status of ‘critical’ medicines, which are ‘at-risk’ of being able to remain on the market post-Brexit due to the inability of manufactures to make necessary changes. The EMA’s human and veterinary medicines evaluation committees have finalised the first step of the ‘criticality assessment’. The next step involves sending data to the national competent authorities to determine whether any products in each respective member state should be considered ‘critical’.
- Brexit preparations will take place in two phases over the course of 2019. During the first half, the EMA will operate under phase 4 of the Brexit Business Continuity Plan (BCP), which will involve further activities being slimmed down. In parallel, the EMA will be dealing with the physical relocation to Amsterdam, associated loss of staff and increased Brexit-related workload. In the second half of 2019, the EMA aims to resume activities which would be reduced or temporarily suspended during the first half.
- The EMA predicts that Brexit related costs in 2019 will amount to €45 million, which includes staff relocation, removal, archiving and legal and consultancy costs. This budget also accounts for a 20% staff loss as a result of the relocation. Estimates suggest that staff losses will reach a peak by the end of February 2019. Between March to June 2019, the EMA predicts that it will be reliant upon remote working as further resignations are expected. From July onwards, resignations are likely to be matched by increased recruitment of new staff.
- The EMA is moving into temporary headquarters at the Spark building in Amsterdam. Throughout 2019, the focus will be on (i) the completion of the permanent EMA building, which the agency states is ‘on track’; (ii) the implementation of the General Data Protection Regulation; (iii) security; (iv) analytics; (v) the Clinical Trials Information System; and (vii) the IRIS platform that will support future EMA tracking systems.
Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.
Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.