European pharma pulls together to ensure ‘minimal disruption’ from Brexit

pharmafile | July 10, 2017 | News story | Research and Development, Sales and Marketing EMA, Europe, UK 

As a consequence of the triggering of Article 50 and the UK’s exit from the EU, the EMA – currently headquartered in Canary Wharf, London – will be forced to move its operations in order to base itself in another EU state. Discussion on this topic is well underway, while more than 20 member states have vocalised a desire to become the new host of the agency. Now, following the agreement over the procedural criteria at the June European Council summit, pharmaceutical firms and patient groups have made it clear that they are united in the EMA’s relocation in order to ensure patient safety and health are not compromised.

“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, Director of European Affairs at the European Federation of Pharmaceutical Industries and Associations. The European pharma group has noted that failure to find a new headquarters for the EMA could result in delays in drug access for patients in need. However, this risk is very real, with fears rising that European leaders could politicise the process.  

“From our standpoint, the biggest issue is business continuity, the pharmaceutical assessment workload, maintaining the speed, quality, and efficacy of the regulatory process,” explained Alan Morrison, Chair of the EFPIA Brexit Task Force and Vice-President for Europe and International Regulatory Affairs at MSD.

“We call on member states to put the interests of European patients before their own,” added Ilaria Passarani, a member of the EMA management board and head of food and health at the European Consumer Organisation (BEUC). “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.”

20% of the EMA’s assessment leaders originate from the UK, which could mean a considerable loss of scientific talent. EU-UK collaboration could continue after the divorce, and the industry is keen to push for a regulatory situation which resembles the current one as much as possible. “We are looking for as close a line to the EU regulation as we can arrive at,” noted the ABPI’s Executive Director Virginia Acha.    

Laurent Louette, Communications Officer of the European Patient Form, remarked: “The relocation of the EMA is a critical question for patients; even in an ideal scenario there will inevitably be some delays and disruptions, due to fewer resources being available over the next couple of years and the need to prioritise activities. We focus on the importance of minimal disruption to the agency’s work, and of ensuring its capacity to retain as much staff as possible, to continue to attract the best expertise in the future, and to facilitate the involvement of civil society. We are pleased that the Commission’s criteria of 22 June reflect these concerns.

“We now hope that the member states will bear in mind that the decision to relocate the EMA is due to exceptional circumstances, and we urge them to make a wise decision that puts public health needs and the interests of all EU patients and citizens ahead of purely political factors.”

A final decision is due to be reached in November, via a Eurovision-style voting system.

Matt Fellows

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