The future shape of European regulation is top of mind for many country managers in the UK at the moment, which is hardly surprising given the uncertainty forced on both the industry and regulators themselves by Brexit.
So far the EMA is stressing that while the UK moves towards leaving the European Union in 2019 it is still, broadly speaking, business as usual. At the same time the regulator has begun the legwork of shoring up its regulatory framework once Brexit occurs, beginning with the assumption that work currently undertaken by the MHRA will have to be shared out among regulators whose nations remain within the European Union.
So, on the one hand, the regulator is able to say “The EMA’s procedures are not affected by Brexit” – that is, operations will continue following its usual timelines. But at the same time the EMA is busy scenario-planning on the assumption that the UK will no longer participate in the work of the EMA and the European medicines regulatory system as of 30 March 2019.
At the end of a meeting in late April with the heads of national competent authorities, EMA executive director Guido Rasi said: “I am reassured to see the overall commitment of the member states to step up their efforts and to explore the options to take on a bigger share of the workload. The expertise available across the network is impressive and this is an opportunity to streamline the way we work, increase our capacity and work even more efficiently.”
With the UK’s MHRA handling some 40% of the EMA’s evaluation work, the stepping-up Rasi mentioned will be sorely needed. Before that’s finalised, some general principles for workload distribution were agreed at the meeting, including:
Ensuring business continuity
Maintaining the quality and robustness of the scientific assessment
Continuing to comply with legal timelines
Ensuring knowledge retention, either by building on existing knowledge, or through knowledge transfer
Assuring an easy implementation and medium- and long-term sustainability.
The expectation from the regulator is that all national competent authorities will contribute to EMA activities in line with their capacity and capability, and it’s eyeing an “optimised and robust allocation” of the workload across the network. Ahead of that there is work to do to map the regulatory network’s current and future capacity and identifying any potential gaps that might exist. With general principles in place, the EMA and its various scientific committees and working parties, along with national competent authorities, are currently assessing different options for workload distribution ahead of the next meeting on the subject on 5 July 2017.
Countdown
So, there’s the outline of a plan in place for plugging the gaps left by the expected loss of the MHRA from the EMA’s network of assessors, but what of the position for pharmaceutical companies in the UK? At the beginning of May the European Commission and EMA gave notice to marketing authorisation holders of centrally authorised medicines that, in regulatory terms, and unless a deal is struck, the UK will become a ‘third country’ and all EU primary and secondary law will cease to apply to the UK.
Sounding a warning note about the implications of this, the EMA said: “Preparing for the consequences of the UK’s withdrawal from the Union is not just a matter for European and national administrations, but also for private parties.”
Consequently pharmaceutical companies that hold marketing authorisations for centrally authorised medicines will be required to take certain steps. First and foremost EU law requires marketing authorisation holders to be established in the EU (or EEA) – for many this won’t be an issue, but not all companies will be in the same position as the industry’s largest firms. Added to that the EMA and European Commission confirmed that some activities would have to be performed in the EU (or EEA), giving as examples those related to pharmacovigilance and batch release.
Marketing authorisation holders may be required to adapt their processes and even consider changes to the terms of their marketing authorisations for ‘continuous validity and exploitation’ post-Brexit. Underlying this are concerns from regulators that the supply of medicines might be disrupted if their paperwork is not in order.
Placing the onus for checking this on pharma companies, the EMA and European Commission expect marketing authorisation holders to “prepare and proactively screen authorisations they hold for the need for any changes”, with – if the language used is any guide – no plans to fast-track the process.
Chasing answers
There was further clarity on the preparations needed at the end of May with the publication of the first piece, in a promised series of pieces, of guidance from the EMA and European Commission to help pharmaceutical companies prepare for Brexit. This first document, set out in a Q&A format, covers information on company location, with respect to centralised procedures and certain other activities, including the location of orphan designation holders and qualified persons for pharmacovigilance.
Marketing authorisation holders for medicines, including orphan drugs, must be established in the EU or EEA. So for centrally authorised products the marketing authorisation holder will therefore normally need to transfer its marketing authorisation to a holder established in the EU/EEA. There are personnel aspects to this too if a qualified person for pharmacovigilance lives and works in the UK. European Commission regulations require them to reside and carry out their tasks in a member state of the EU/EEA. When it comes to records some of these too will have to be moved. If a Pharmacovigilance System Master File is located in the UK it will have to be relocated to within the EU/EEA union.
The EMA has a dedicated webpage on the consequences of Brexit, and it’s there that the first Q&A documents as well as further guidance will appear. While for products authorised in decentralised or mutual recognition procedures, information is set to be provided through the websites of the relevant coordination groups.
A place in the sun?
The location of the EMA is also up in the air, with Copenhagen, Barcelona, Lisbon and Dublin mounting some of the noisiest PR campaigns to host the London-based regulator. At stake is not just the nearly 900 people it employs, but also the 36,000 scientists and national regulators that visit the EMA each year.
For now all the EMA will say is that its post-Brexit location “will depend on the future relationship between the UK and the EU” and will be determined by common agreement of EU member states, which of course will soon not include the UK. The regulator said: “The EMA is confident that the member states will make the most appropriate decision on the Agency’s location and arrangements, taking the complex political and legal environment into account.”
Deal or no deal?
Even before the EMA and European Commission had started to clarify some of these issues, the UK pharma industry was nervous about the outcome of Brexit. It warns that without an early Brexit deal in place it will face a crisis, not least because of reduced access to European markets.
Meanwhile, PME goes to press the day after the UK voted in the snap general election, an unexpectedly unsuccessful move by prime minister Theresa May, who – at the time of writing – appears to have secured support for a minority government. The election itself had already shortened the negotiating timeline for the next government, so this, at least, will avoid any further delays. With Brexit negotiations due to begin on 19 June, and a deal currently needing to be reached by 30 March 2019, the window of opportunity to successfully navigate the immensely complicated process is already a shrinking one.