In the wake of Brexit, the European Medicines Agency will be relocated. Dublin is one of many EU cities bidding for the relocation and Matheson’s Michael Finn explains the bidding process that lies ahead.
The European Medicines Agency (EMA) is a decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
The EMA began operating in 1995. It is currently based in London, and employs almost 900 people. The Irish Government and the wider pharmaceutical industry are pitching Dublin as the best location for the EMA.
Health Minister Simon Harris launched a formal bid for the EMA on April 28th 2017, and final submissions are due by July 31st 2017. The new location of the EMA will be hotly contested with as many as 21 cities competing to host the agency.
The UK’s Brexit secretary David Davis has suggested that the EMA and the European Banking Authority may remain in London or will, in any event, form part of the wider Brexit negotiations.
However, this has been rejected by EU officials declaring Britain will have no say in the agencies’ new locations.
The new location must be decided by the heads of government of the Member States. European Council President Donald Tusk and European Commission President Jean-Claude Juncker recently issued a document to Member States clarifying the selection process and criteria which will be taken into account in reaching the ultimate decision.
These include the host country having enough hotel space for an average of 30,000 visitors a year as well as adequate schooling for the staff’s children.
The EMA’s current headquarters in Canary Wharf hosts thousands of national regulators and scientists every year from across the EU, and the ability to accommodate these visitors is a key factor in deciding the ultimate location of the EMA.
Dublin currently satisfies these criteria. With a new international school due to open in September 2018 and numerous hotel development projects identified, additional capacity will be created over the next few years.
Dublin is an obvious choice for the future location of the EMA and offers an easy set up and guarantee of smooth operations
The Commission will assess applications and a decision will be made in November 2017. There will be rounds of voting until two finalists emerge and the winner will need a majority of votes from EU Member States.
In an open letter published on April 24th 2017, the EU’s pharmaceutical industry heads of research and the European Federation of Pharmaceutical Industries and Associations (EFPIA) called for an early decision, citing world-class connectivity and excellent transport links among the fundamental requirements for the new location.
Dublin is an obvious choice for the future location of the EMA and offers an easy set up and guarantee of smooth operations. The Irish Government has promised to work with the EMA and the European Commission to ensure a seamless transition from its current headquarters.
A key development site in the Dublin docklands, with excellent transport links and infrastructure, has been ring-fenced as the location on offer for the EMA.
In launching Ireland’s formal bid, Minister Simon Harris stated: “The future location of the EMA is too important to be a purely ‘political decision’. Europe must find a solution that is in the best interests of European citizens and the innovative bio-pharmaceutical industry.
“We must look objectively at the issue and achieve, on behalf of European citizens, a seamless transition and business continuity. I believe that Dublin ticks every box in this respect, with geographical and cultural proximity for ease of transition, excellent air connectivity, world-class ICT services, an open and stable political system for long term surety, government commitment to the project and a significant pool of highly skilled life science professionals.”
At Matheson, we support Ireland’s bid to host the EMA in Dublin. There are a host of unique selling points that underscore Ireland’s bid to host the EMA in Dublin, including:
- Ireland has a dynamic life sciences sector, with a long tradition of pharmaceutical operations excellence. Ireland has a strong regulatory environment and the Health Products Regulatory Authority is one of the most well-respected authorities in the EU
- Like the UK, Ireland is an English-speaking, common law jurisdiction
- Dublin offers a seamless transition for the relocation of the EMA, and will allow the EMA to retain key staff members. With excellent air links to London, staff would have the option of commuting as many Irish people currently do from Dublin to London each week
- World-class talent pool and workforce
- Excellent quality of life;
- Dublin is a centre of FDI and domestic industry, and offers excellent career opportunities for spouses, partners and children of EMA staff
- The can-do attitude – with a track record of attracting and retaining FDI business, Dublin offers flexible and adaptable solutions.
About the author:
Michael Finn is a partner in the Commercial Litigation and Dispute Resolution Department at Matheson. Finn also co-leads the Life Sciences Group.
He advises clients in relation to the regulation of medicinal products and medical devices in Ireland, and has built up a strong expertise in navigating clients through interactions with regulators and payors.
He also advises on the regulatory aspects of acquisitions and divestitures and spin-offs of companies and assets.