Brexit is Approaching:

What are the Implications for the EU QPPV?

In the history of Pharmacovigilance (PV), one of the most important milestones was the European Medicines Agency (EMA) and EU Commission-led development and enactment of Good Vigilance Practices (GVP) in 2012. With this brought the update of responsibilities and accountabilities for product safety and quality, distilled into the EU Qualified Person for Pharmacovigilance (EU QPPV). The EU QPPV is now a well-established role in European drug safety, which is mandated by the EMA, and holds legal accountability for the safety of medicinal products in the EU and provides oversight of the marketing authorisation holder’s PV system. Current EU directives require the EU QPPV to reside and operate in an EU member state.

An estimated 70% of all EU QPPVs are located in the UK. With the UK set to leave Europe, what are the implications for the EU QPPV as a critical part of Europe’s drug safety structure?

Brexit deal and potential EU QPPV options

Since the UK referendum in June 2016 and the people’s decision to leave the EU, the nation (and Europe more broadly) has been awaiting the specific terms of this withdrawal. As the 29th March 2019 deadline for defining the terms of Brexit draws closer, the UK biopharmaceutical industry and regulatory landscape is facing a binary set of paths to change:

  • ‘No deal’ BREXIT

  • Brexit deal with the EU and subsequent transition period

This leaves four potential options regarding the EU QPPV:

All of these scenarios will be disruptive to the oversight of drug safety both in the UK and the EU, though some less disruptive than others. Aside from uncertainty, it is clear, however, that the EU QPPV will no longer have legal jurisdiction in the UK market and will likely have to be physically located within the European Economic Area (EEA).

  • Option 1 will be the least disruptive to on-going activities, though there won’t be legal accountability for the safety of products in the UK market. Retention of PV capabilities in the UK could become diminished as the EU QPPV role will be based in Europe (thereby reducing the pool of UK-based talent).

  • Option 3 requires changes to UK legislation to define new PV guidelines, separate to GVP, for the responsibilities of the UK ‘QPPV-like’ position. The nature of how these could evolve is uncertain.

  • Option 4 involves dissolving the EU QPPV role with a distribution of existing responsibilities, implying no single individual will be accountable for PV within an organisation. This could cause disarray if responsibilities are not clearly defined and drug safety is not monitored in a consistent manner.

  • Options 3 and 4 both carry the additional burden of relocating existing EU QPPVs to mainland Europe, and for the UK to develop its own PV system, and potentially also an equivalent system to EudraVigilance.

  • Option 2, by deduction, would seem to be the most likely direction to take.

What approach is the UK likely to adopt?

On the 12th of March 2019, the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) published the requirement of a UK QPPV to be appointed in the event of a no deal scenario. So far, the following is known about this new role:

  • It will be equivalent in form and function to the EU QPPV, and as outlined in the GVP

  • The UK QPPV will hold legal responsibility for the establishment and maintenance of the PV system for all products authorised and marketed in the UK

  • The UK QPPV must operate and reside in the UK; as an interim measure, the EU QPPV can assume responsibility for UK authorised products until a UK QPPV is established

So what are the implications for this approach?

Actions to come

  • The UK will be required to recruit its own UK QPPV, or source a contract QPPV

  • The UK will be required to develop its own PV system, with a supporting PV system master file and establishment of a UK-based QPPV office

  • The UK will be required to develop UK-based GVP legislation for the conduct of PV in the UK

Implications of

  • With majority of QPPVs currently being based in the UK, there will be a need to rapidly appoint Europe-based EU QPPVs

  • Likely significant operational, organisational and administrative disruption for those companies with joint UK and EU presence

  • Requires lengthy approval and mandating by UK parliament. In the interim, UK will likely continue to utilise EU directives.

With the recent relocation of the EMA’s headquarters from London to Amsterdam, the shift in EU QPPVs to Europe would seem an appropriate next step. Furthermore, there is precedence for the UK to adopt the EU GVP guidelines as is, similar to countries outside of Europe, which would result in less disruptive changes to UK legislation.

Regardless of whether a deal is reached by the 29th of March 2019 (which, at this current juncture, is looking increasingly unlikely), it seems more likely that the UK will adopt its own UK QPPV role. More crucially, it is important that the UK takes appropriate measures to ensure the safety of our medicinal products in the UK.

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