Brexit roundtable: the only certainty is uncertainty

Posted on 21 May 2019
Regulatory affairs professionals joined a roundtable discussion at TOPRA’s headquarters in London, UK, on 11 April to take stock of where we stand on Brexit planning for medicines. 

As originally planned, this roundtable should have been reflecting on the UK’s departure from the EU on 29 March 2019 (or anticipating this happening the following day, 12 April). But as has been the defining characteristic of Brexit, even that long-defined milestone was erased and new timelines for a final date were established as – for now – 31 October 2019. And as has also become characteristic of any Brexit workshop, these changes were read out in real time for the speakers and the participants alike, which made for a lively discussion of possibilities but fewer certainties.      

Roundtable participants listened to presentations from AbbVie's Emma Du Four and MSD's Virginia (Ginny) Acha, with an extended update from Jonathan Mogford of the UK Medicines and Healthcare products Regulatory Agency. Ms Du Four focused on the planning efforts companies have already undertaken in readiness for the 29 March deadline, using examples from AbbVie’s Brexit readiness work. This presentation stimulated a full discussion on different approaches that companies have considered in light of the responses from the EU regulatory authorities, the EU Commission and the UK authorities. The final presentation from Dr Acha opened up the discussion to considerations of what companies should take into account as we approach the unexpected “flextension” period up to 31 October 2019.  

Some of the key themes discussed follow below.  

Certainty to counter uncertainty
Although many factors were still up in the air, including the certainty over the conduct of the EU elections in the UK, the conclusion drawn by many organisations is that you have to create your own certainty. Although a no-deal Brexit may not be the outcome, the prudent approach taken by many medicines manufacturers has been to execute a plan that addresses no-deal requirements and be ready for alternative scenarios. Some of the issues addressed in discussion were:

  • Transfer of EU marketing authorisation holder
  • Implications on packaging from regulatory guidance
  • UK stockpile plan per UK government request 
  • Transitioned UK-based batch release sites into the EU
  • Plan to manage clinical trial supplies to UK sites and exiting voluntary harmonisation procedures
  • Discussions with MHRA on “in-flight” submissions

Since May 2017, the European Medicines Agency, the European Commission and the Heads of Medicines Agencies have published a series of notices and guidances, with the latest revision including the possibility to request a delay for the transfer of batch control testing to the EU and European Economic Area (EEA). The no-deal details have been provided earlier by the EU (as it follows from the current legal and regulatory framework for third countries) than the UK, but the guidance now available from the MHRA and UK Government sets out a practical approach to managing existing and new medicines.

The conservative approach to plan on no deal was shared by many roundtable participants. Indeed, according to a recent Harvard Business Review article, this is a view that is not unique to medicines: “Paradoxically, the businesses that will survive and ultimately stand out are those that create certainty for themselves, forging a path depending on how the situation unfolds” (Laker and Roulet 2019).

What did seem to vary was the extent and timing of these changes. The nature and extent of changes depend on the organisation’s current activities in the UK, and there was consistency in approach revealed in the discussion. Timing also differed, with some organisations either unable to make the changes in the time available or willing to bear a risk where guidance was less clearly defined. There were also examples where the regulator’s response to proposed changes (for example, in-flight submissions) varied without apparent basis. This was a reminder that, for all organisations – including the public bodies – we are in uncharted territory and procedures for dealing with the scale and type of changes, particularly in the UK, may need further discussion and review.

Making necessity an opportunity for innovation
The uncharted territory of Brexit-readiness planning has also provided companies with an impetus for further discussion and review of our current working arrangements. In many cases, these revisions to account for no-deal requirements offer no added value to our working capacity or effectiveness. However, occasionally, the need to change working arrangements can offer an opportunity to innovate procedures for global benefit.  

One such example was discussed for pharmacovigilance. As the no-deal requirements stand for qualified person responsible for pharmacovigilance (QPPVs), all QPPVs for the EU will need to reside in the EU/EEA by the UK’s date of departure from the EU. However, the legal and practical requirements for effective pharmacovigilance are more correctly based on the system and not just the individual. Moreover, as QPPV requirements increase globally, there is an opportunity to reconsider the organisational design of PV in a company, with governance now linked to an international QPPV and a holistic system for PV management.

Beyond 31 October
The final discussion topic for the roundtable moved to expectations beyond the “flextension” period. The UK government and the life sciences industry remain committed to the objective that regulatory cooperation for medicines between the UK and the EU would be the best outcome for all stakeholders, notably patients. The question is: what will that mean in practice and how will it be delivered?

There was interest among participants in making this topic a focus for further discussion between the MHRA and stakeholders in the coming months. Perhaps, as we have with no deal, we can find our certainty for that constructive future for regulatory alignment and engagement for the UK, the EU and the global regulatory community.

– By Virginia Acha, Executive Director – Global Regulatory Policy (EU, EMEA, APAC), MSD, UK, and Emma Du Four, Head of International Regulatory Policy and Intelligence, Abbvie, UK