STRATEGY
UK left the EU on 31 January 2020 with an agreed transitional period until 31 December 2020. Philipp Hofmann, MD, Head of Pharmacovigilance and QPPV, Navitas Life Sciences (a TAKE Solutions Enterprise) explores the potential impact of Brexit to Pharmacovigilance (PV) in both the UK and the EU. Hard Brexit was not to be
The ghost of a hard Brexit, one in which “no deal” between the UK and EU could be reached, luckily disappeared. According to a study in the Lancet 2019, a “no deal” Brexit would have an adverse impact on health in the UK under every scenario, and that “no deal” would have the worst impact. In total, a “no deal” Brexit could have cost the UK GBP 90 billion . The transition period, published on 19 March 2018, gave pharmaceutical companies time to prepare for Brexit, to continue with the current PV system to ensure patients’ safety .
The current situation: Soft Brexit
As of December 2020, the negotiators in the UK and the EU reached an agreement on the regulation. Many details still need to be agreed upon in specialist working groups to cover all aspects of daily life. So far it seems clear that the Medicines and Healthcare products Regulatory Agency (MHRA) will not continue to be part of the European PV system, including the PV Risk Assessment Committee (PRAC) or EudraVigilance. This will have a tremendous impact for both the involved Health Authorities and pharmaceutical companies. This approach will require double efforts in PV in order to satisfy the needs of Health Authorities in the UK and the EU, and could leave room for certain conjectures. Consequences for Marketing Authorisations
With this in mind, just what are the consequences for Marketing Authorisations (MA), and how can
supply with Centrally Authorised Products (CAP) be ensured in the UK and in the EU? After 31 December 2020, a pharmaceutical company solely located in the UK will no longer be able to hold an EU MA. On the other hand, an EU pharmaceutical company can continue to hold a UK MA for a period of time after 31 December 2020, but they will have had to establish a contact person based in the UK. The MHRA has issued a businesscontinuity plan for more than 370 CAPs to rapporteurs and co-rapporteurs, which are registered within the EU. All MAs need to be converted to national licenses. The plan is that CAPs will automatically be converted to UK MAs on the day of Brexit. Mutual recognition and decentralised MAs will be unaffected since they already hold national UK MAs. Additionally, MAs, which are only held in the UK, will need to be transferred to an entity or affiliate which is located within the EU. Submission of Individual Case Study Reports (ICSR) and Aggregate Reports
Post Brexit on 31 December 2020, the UK requires submission of all UK ICSRs (serious and non-serious) and serious ICSRs from other countries via the new MHRA Gateway and/or ICSR Submissions portal which have been developed. Obligatory registrations should have been made prior to Brexit. The MHRA may, at some point, issue a new list of UK-specific reference dates for Periodic Safety Update Reports (PSURs) potentially resulting in the submission of PSURs at different times in the UK and the EU. In the meantime, the European Union Reference Dates (EURD) should be followed and, from 01 January 2021, PSURs should be submitted in parallel to the UK and EU. The Authorities may require joint signatories for both the UK and the EU.
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