Time is progressing, towards the official transition date in the Brexit process 30 March 2019 (actually as this is a Saturday, the implementation should be effective as of 29 March), as per notice from EMA in May of last year:
When the United Kingdom will have become a ‘third country’ all regulatory and practical consequences will become applicable. Although deeply affecting all business sectors, EU regulatory authorities, and individual citizens, the prospect of this transition, is specifically important for the pharmaceutical industry.
The heath authority of the UK published at 6th of August 2018 that the UK and EU agreed upon the terms of an implementation period to the end of December 2020, once finalised as part of the Withdrawal Agreement. It states amongst other things that marketing authorisation holders and qualified persons for pharmacovigilance will continue to be able to be based in the UK and access EU markets during the transition period. The Withdrawal Agreement as a whole still has to be finalised, aimed for October 2018.
One example of where the impact will be particularly highly felt is the role of the Qualified Person for Pharmacovigilance (QPPV) with European responsibility.
EU law stipulates that companies marketing medicinal products in the EU are not just authorized in the EU/EEA, but they even enforce specifically that some activities must be performed in the EU (or EEA). For example, the execution of the QPPV role and its pertaining activities such as oversight of the pharmacovigilance system and safety of the medicinal products marketed by the EU MAH. This aspect is also directly important for patient safety in the EU and even globally. Hence, the consequences of the UK becoming a third country are therefore significant and preparatory activities need to be started in a timely fashion.
QPPVs fulfill a complex and difficult role as central pivot of the MAHs pharmacovigilance system and are uniquely responsible for the PV QMS as well as its outcomes, such as the benefit-risk balance of all the MAH’s medicinal products in the EU Market. The QPPV role requires therefore highly qualified, trained and scientifically and medically aware persons. QPPV are scarce resources and especially with so many currently established in the UK there will be a resounding impact when these QPPV drop out of the EU system more or less at the same time. According to the Article 57 database, there are about 150 UK-based QPPVs. In fact, this will be challenging to cope with for all MAH with products in the EU, since simultaneously with a move of MAH’s from the UK, the need for QPPVs will increase in the remaining EU countries. This will lessen the average available QPPV resources thereby putting the MAH already residing in the EU under additional pressure to find suitable personnel to occupy the QPPV role.
To help clarify where and how changes may be required, an extensive and very practical Guidance Document has been published on 19 June 2018 (EMA/478309/2017 Rev. 2). This document complements the Questions and Answers (Rev 03 from 19 June 2018 ) prepared jointly by the European Commission and EMA related to the United Kingdom's withdrawal from the European Union and is drafted to provide procedural and practical guidance to marketing authorisation holders (see also Notice to Applicants, updated on 23 January 2018). These documents and many more are available on the EMA website to support the MAH in their transition and it is advisable to use them.
BREXIT consequences will also enforce MAHs with their EU headquarter in the UK to consider relocation to a remaining EU country, change the EU QPPV location accordingly as well as the location of the Pharmacovigilance System Master File (PSMF). This pivotal pharmacovigilance document, likewise, needs to be located in an EU country. Each MAH that will need to transfer the QPPV/PSMF responsibility must be aware that continued compliance with the regulations surrounding the QPPV role needs to be guaranteed throughout the change process and change control should cover all processes. This is at the same time fully under the responsibility of the QPPV incumbent at that moment, making the controlled change processes extra challenging. And at the end, the QPPV and PSMF details need to be updated in the Article 57 database.
It may be prudent for all MAHs affected by Brexit to evaluate carefully where in the post-Brexit EU they want to establish the QPPV and PSMF. Aspects to use for this assessment may be qualification and numbers of potential QPPV resources and reflect this e.g. against (co)rapporteurs, language as well as footprints of their company and medicinal products market to ensure a more evenly spread distribution of QPPVs. As a spin-off effect, this may even cause a more even distribution of regulatory burden for Health Authorities.