This article is part of our special report European Medicines Agency: What’s at stake?.
EU leaders should make a patient-oriented decision on the relocation of the European Medicines Agency (EMA) from London and ensure “minimal disruption”, according to the pharmaceutical industry and consumer groups.
The discussion about the relocation of the EMA has kick-started and EU leaders are expected to make a final decision in November.
More than 20 member states have already expressed their interest in hosting the EU drug agency. Analysts say the talks have inevitably been politicised.
However, the pharmaceutical industry and consumer groups are urging EU leaders to focus on business continuity and avoid potential risks for patients.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has said that the main priority is to put an end to the uncertainty over the location of the EMA, as well as to ensure transitional arrangements are in place for issues that can impact on patient safety and health.
“Scientific recommendations, new medicines approvals, pharmacovigilance and safety monitoring activities are vital elements of the ongoing effort to provide EU citizens with effective, safe and high-quality medicines,” said Elizabeth Kuiper, EFPIA’s director of European affairs.
EFPIA has expressed concern that any delay in relocating the EMA will have an impact in several areas. Kuiper noted that EU leaders should avoid unnecessary and potentially risky delays to the effective functioning of the EMA.
Alan Morrison, chair of the EFPIA Brexit Task Force and vice-president for Europe and International Regulatory Affairs at pharmaceutical company MSD, noted that the criteria laid out by the Commission are “objective and correct”.
“From our standpoint, the biggest issue is business continuity, the pharmaceutical assessment workload, maintaining the speed, quality, and efficacy of the regulatory process,” he explained.
Asked about the “geographical balance” criterion pushed by newer member states which do not currently host any EU agencies, Kuiper replied, “It’s one of the criteria, of which there are six in total.
But he insisted about the necessity to come to a decision quickly. “We need a quick decision and we appreciate the fact that all six criteria should be taken into account,” Kuiper said.
Politics, however, is making some nervous that the decision could be delayed.
Ilaria Passarani, a member of the EMA management board and head of food and health at the European Consumer Organisation (BEUC), said that “unfortunately” the process is likely to be made political.
“We call on member states to put the interests of European patients before their own,” she told EURACTIV, emphasising the need for a decision as soon as possible to ensure minimal disruption.
“Any delay could hamper the agency’s ability to monitor the safety of medicines on sale and swiftly remove the harmful ones from the market,” she warned, adding that if it takes longer for the Agency to approve new medicines, consumers might struggle to access the treatment they need.
“To avoid these negative situations, the decision must be a swift one,” she said.
UK’s post-Brexit role
Another important element of the ongoing discussion is the role of the UK in the EMA’s activities after Brexit.
The UK currently contributes around 20% of the scientific rapporteurs that lead many of the agency’s assessments. The pharma industry believes there are mutual benefits to be gained from the UK remaining a member of the EMA, not least that the EU will continue to benefit from British scientific expertise.
For the pharmaceuticals industry, the continued alignment between the UK and EU regulatory regimes is essential in order to maintain current capacity, processes and time-frames for the introduction of new medicines for patients.
“Avoiding divergence and duplication of regulatory standards and practices is therefore critical,” Kuiper stated.
For Morrison, the collaboration on a technical level post-Brexit could work well.
Replacing British scientific talent
The EU’s centralised procedure for authorising medicinal products includes a scientific assessment by the EMA’s scientific committee and a decision-making process by the Commission.
According to Morrison, the UK could continue to participate in the scientific assessment process in future.
“Essentially, even if the ultimate post-Brexit decision-making is separate, the process of gathering the evidence and scientific assessment could remain collaborative, allowing citizens of both the UK and the EU-27 to benefit from the expertise in the UK.”
Asked by EURACTIV whether the 20% UK contribution could easily be replaced by another national agency, Morrison replied, “Probably yes, but it will definitely take some time to build on that scientific talent.”
He explained that the reason why the EU originally put in pace a centralised procedure in 1995 was because of the recognition that the scientific talent in Europe was spread across the community.
“I am sure, over time, everything can be replaced but it’s challenging to replace this talent in the short and medium term, that’s why we support the business continuity to preserve this level and quality of scientific talent,” he said.
Speaking in April at the Biovision World Life Sciences Forum 2017 in Lyon, Virginia Acha, executive director of the Association of the British Pharmaceutical Industry, said that for her sector the development of medicines should not be seen as something on which to “wait and see”. She emphasised the need for “practical and pragmatic planning from now”.
“We are looking for as close a line to the EU regulation as we can arrive at,” Acha said. “The partnership with Europe has been productive,” she added, stressing that the main priority is to ensure that the UK will have no problem in delivering medicines the day after it leaves the bloc.