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The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.
A big worry for the European pharmaceutical industry about Brexit is the impact it will have-at least temporarily-on the efficiency of the operations of the European Medicines Agency (EMA). As a result of the United Kingdom’s departure from the European Union following a referendum on the issue of its membership in June 2016, EMA is having to move its headquarters from London to a location, yet to be decided, in one of the 27 remaining EU member states. EMA, which has been based in London since its foundation in 1995, runs the EU’s centralized system for the approval of new medicines and its pharmacovigilance system, as well as coordinating the European Union’s regulatory network of national competence authorities (NCA) responsible for licensing and regulating drugs in each member state.
There have been hopes that the effects of the agency’s move would be minimized by the transfer taking place over a phased transition period of a few years in line with a gradual withdrawal by the UK from the EU starting in March 2019. This approach would enable the UK to continue to assist in the agency’s operations to help avoid delays in approvals of medicines and licence variations, as well as in the publication of key documents such as guidelines. However, it is now possible that the relocation may have to take place relatively quickly. The agency revealed in late April 2017 that it is starting to draw up contingency plans for a complete break between the EU and the UK in March 2019.
“Although negotiations on the terms of the UK’s departure have not yet officially commenced and one cannot prejudge their outcome, work will now start on the basis of the scenario that foresees that the UK will no longer participate in the work of EMA and the European medicines regulatory system as of 30 March 2019,” the agency said in a press release (1).
The UK and the EU are due to start negotiations in June 2017 on a withdrawal deal, which is increasingly expected to amount to what is dubbed as a “hard Brexit” without an agreement on trade and regulatory issues, covering matters such as an extended timetable for EMA’s transfer to a new location.
Minimizing disruptions and delays
“We don’t want any disruption of EMA’s operation leading to delays causing the build-up of a backlog of work,” says a spokesman for the Brussels-based European Federation of Pharmaceutical Industries and Associations (EFPIA). “It is essential that we have regulatory continuity across Europe,” he told Pharmaceutical Technology Europe.
EFPIA published in April 2017 an open letter (2) signed by heads of R&D in 19 multinational drug companies expressing anxieties about the “stark and alarming reality that [EMA’s] fundamental activities would undoubtedly be impeded were the operations of the agency to be disrupted as a result of the United Kingdom’s exit from the EU.” It added that “in the event of obstruction or failure, Europe possesses no backup option.”
A disorderly departure by EMA is of particular concern to UK pharmaceutical manufacturers, which include leading international drug companies GlaxoSmithKline (GSK) and AstraZeneca. The country needs a smooth transition to what is likely to be a stand-alone medicines regulatory system operating separately from the EU’s regulatory network.
“Moving an agency like EMA is a huge task,” Virginia Acha, executive research director at the Association of the British Pharmaceutical Industry, told Pharmaceutical Technology Europe. “We have made clear that we would like the EMA and all 28 national competent authorities to work closely to ensure that we avoid delays to the important work of regulating and ensuring supply of medicines for patients across the EU.”
A big challenge for EMA is filling the post-Brexit gap being left by the loss of the expertise of the UK’s drugs regulator-Medicines and Healthcare products Regulatory Agency (MHRA). Its experts have been contributing 30–40% of assessments of new medicines and other items, according to an MHRA official. EMA says that in 2016, the agency acted as a rapporteur for 14% and co-rapporteur for 16% of the products approved by EMA’s Committee for Medicinal Products for Human Use (CHMP). Now EMA has started work on sharing out contributions from experts in national agencies much more evenly. “The expertise available across the network is impressive and [Brexit] is an opportunity to streamline the way we work, increase our capacity, and work even more efficiently,” said EMA’s Executive Director Guido Rasi (1).
Changes in the EU regulatory framework
The agency started discussions in April 2017 on changes to the system for evaluating and monitoring medicines. The changes will be based on the principles of “ensuring business continuity; maintaining the same high standards of the scientific assessment; continuing compliance with legal timelines; and ensuring knowledge retention, either by building on existing knowledge, or through knowledge transfer,” an EMA spokesperson told Pharmaceutical Technology Europe.
A number of EU member states are already preparing to increase their capacity for assessment and monitoring work so what has been done by 28 member states will be able to be carried out as efficiently by 27. Furthermore, the work will be carried out by more mixed teams of experts from different EU countries rather than, as previously, by teams from single states.
“EMA has found an effective response to the challenge [of Brexit],” the spokesperson said. “We have put in place multinational assessment teams. Traditionally, the assessment of medicines was carried out by teams from individual member states. This shows that science works best without borders.
“This multilateral approach benefits the EU system as a whole but it also benefits the individual member states as it raises standards and increases participation,”
she continued. “This approach will become even more crucial as EMA faces a loss
of expertise through Brexit. Increasing skills across Europe and promoting participation in EMA’s activities will allow us to keep our complex machinery
working and delivering for patients in the EU.”
EMA claims that the EU regulatory network, the largest of its kind in the world,
is strong and flexible enough to adapt to changes such as Brexit without putting at risk the quality of its work. “Using a timely and inter-connected process, it brings together the best experts from across the EU to do the right job at the right time with the right people,” the spokesperson said. “EMA and the patients in Europe cannot afford that this well-oiled machinery starts to stutter.”
In its efforts to maintain continuity, the agency also faces the challenge of keeping as many of its 890 staff as possible, particularly employees who provide expertise and experience. “We have seen a decrease in the number of [job] applications received by the agency,” the spokesperson said. “We are looking at this closely to understand if it could have any implication for the agency’s work and to keep possible disruptions to a minimum.”
EMA’s new headquarters
The choice of a new location for EMA, a decision that is due to taken by the
governments of the 27 EU member states in 2017, is seen as being crucial to the need to attract adequately qualified staff as not all existing employees are expected to stay with the agency. More than 20 countries are reported to have expressed
an interest in hosting the new EMA headquarters with the favourites being
countries that have relatively large domestic pharmaceutical industries, such as France, Germany, Italy, Spain, Ireland, and Denmark.
Among the essential requirements for the location listed by the R&D heads in their open letter are a capability to accommodate approximately 36,000 visits of experts annually, excellent transport links, and an adequate number of hotel rooms. Also, there must be “sufficient and decent housing and access to international schools for staff with children,” they say.
Another cloud hanging over the transfer of EMA’s headquarters is a lease agreement that commits it to paying rent on its offices in London until 2039. With business rates and services charges, the total debt could be approximately €400 million. A European Parliament report on the agency’s finances published in April (3) reveals that the total payable rent for the period from 2017 until 2039 amounts to €347.6 million because of the absence of a break clause in the rental agreement signed in 2011 when “the potential exit of the UK from the Union was not foreseeable.”
The report expresses concern about the “risk of budgetary volatility faced by the agency” as a result of the need to move its offices. It suggests that “in the spirit of sound financial management,” EMA should be authorized to maintain a budgetary reverse to cover unforeseen costs due to the transfer.
Some EU politicians are arguing that the UK should pay the outstanding rental and the costs of the move of offices because it voted to leave the Union rather than being made subject to an involuntary exit. This issue should be a matter to be sorted out in the withdrawal negotiations. But with the agreement having to be finalized by March 2019, there may not be time to resolve issues relating to the costs associated with the EMA’s new location.
1. European Medicines Agency, “EMA and Heads of National Competent Authorities Discuss Consequences of Brexit-Key Principles and Working Methodology Established,” Press release, EMA/271635/2017 (London, 28 Apr. 2017).
2. EFPIA, Open Letter from the Pharmaceutical Industry Heads of Research and EFPIA on the Relocation of the European Medicines Agency (Brussels, 24 Apr. 2017).
3. European Parliament, Decision on Discharge of the European Medicines Agency Budget for the Financial Year 2015, 2016/21/2169–DEC (Brussels, 27 Apr. 2017).