As the UK government moves closer to making its Brexit from the European Union a reality, the split creates a major problem for the European Medicines Agency. Where will it live?
Currently headquartered in London, the EU regulatory body needs to relocate now that the UK has formally notified the European Council of its decision to withdraw from the economic bloc.
Hosting the EMA could be a huge boon to any country that wins the bid — adding millions of dollars in pharmaceutical and life science investment, and making the new base a hub for drug development overnight. Whichever country hosts will also become the new home to the roughly 900 EMA staffers and their families.
Transplanting such an important institution is no easy decision, involving a wide range of factors ranging from the bid country's political stability to geographic convenience and economic prosperity. Calculations must also account for the needs of staff, such as cost-of-living, school quality and availability of jobs for family members, and for the thousands of visitors that travel to the EMA each year.
"It must be somewhere where the transition can be quick and smooth, and where the authority can recruit," said Anders Lönnberg, the life sciences coordinator for the Swedish government.
A recent survey of EMA staff by the agency made the looming decision's implications all the more stark. For eight countries, more than 70% of employees said they would leave the agency if the EMA was relocated to the country in question — an event that the regulator said would imperil the future of public health in Europe.
Some of the cities bidding to be the EMA's next home are offering quirky inducements. Amsterdam's pitch likens its country to the UK, with a "stylish Queen" and a liking for fish and chips, while Vienna is promoting its wine-growing regions and mountain spring tap water.
While many countries have hired professional public relations firms to craft their bids, others have created videos featuring government leaders.
The European Commission will review bids and submit its assessment to the European Council by the end of September, and a formal vote by the the Council will take place on November 20.
There are currently nineteen bids from cities, from Amsterdam to Zagreb. Here’s a look at some of the top contenders:
Copenhagen is regularly ranked as the happiest city in the world. Among the applications put forward, the Danish city of Copenhagen was tipped the top contender* in a March 2017 KPMG analysis, with 62 points out of a possible 80. The research was commissioned by Novo Nordisk A/S and based on life science clusters, research, infrastructure, current national competent authorities, political stability and quality of life.
(*Paris was rated with 63 points in the analysis, but is not submitting a bid. Instead France is submitting a bid for the city of Lille. Paris is, however, putting a bid in to host the European Banking Authority, which also needs a new home.)
Copenhagen, along with Amsterdam and Stockholm, ranked the highest for the attractiveness of the city to existing EMA staff, as well as the availability of local scientific staff.
Nawal Ouzren, CEO of Sensorion, a French biopharma focusing on therapeutics for inner ear diseases, has her eye on Denmark, Germany, France and Sweden as likely hosts for the new EMA.
"The Nordic countries [Sweden and Denmark] are very open in the way that they provide regulatory advice during development, as rapporteur. it’s also easier and quicker to establish prices there," she said. "What is interesting about the Nordic countries is their leadership in developing new standard guidelines which then become global standards — for example in hemophilia."
Located in the northern part of Europe, Sweden is a beautiful country of islands, coast, fjords, forests and mountains. In the northern parts of the country the sun never sets in the summer and never rises in the winter. A high percentage — around 86% — of Swedes speak English as a foreign language.
Lönnberg, the Swedish government's life sciences coordinator, was enthused about the country's opportunities in an interview with BioPharma Dive.
"The best argument for Sweden is our experience," said Lönnberg. "In 2016, we were responsible for 26 primary rapporteurships, and the U.K. for 22 — together that's almost 60% of the total."
Companies can gain approval of drugs across the whole of the EU through the centralized procedure. A country, selected by the EMA scientific committee, acts as rapporteur and co-ordinates the assessment, preparing draft reports for the CHMP. Sweden’s experience as a rapporteur has provided it with an "inside view" of how the system works, and an in-depth understanding of the needs of both the companies and patients.
Lönnberg also cites Sweden's place in the forefront of life sciences and big data, which he sees as important for the future of the drug approvals process.
"The regulatory process is still a bit old-fashioned, remaining focused on chemistry and biology," he explained. "Drug development needs to move into big data and genomics, with trials using smaller numbers of patients and even Phase 2 data. This would also lower the costs."
Sweden has a long history of science and innovation. The Swedish government prioritizes life sciences, and Stockholm is already a hub for the sciences: Karolinska Institute is likely to be the top European university post-Brexit, and Stockholm is already the home of the European Centre for Disease Prevention and Control.
Amsterdam, The Netherlands
The Netherlands, traditionally known for dykes, windmills, clogs and cheese with holes in it, has put forward an 84-page bid to host the agency in what it describes as the "Amsterdam Metropolitan Area." The Netherlands has the highest percentage of English speakers in the EU, at 90% in 2012, and has a population that is around a fifth foreign nationals and migrants.
This means that it will be welcoming to existing U.K.-based EMA staff, and its bid includes a "personalized expatriation programme ... for the relocation of all EMA staff and their families," according to the bid documents. This would include support for housing, schools, health insurance and partners' jobs.
There is investment promised too, with €16 million (about $19 million) to boost the Dutch Medicines Evaluation Board and put training in place. This will include a similar support level to that currently provided by the National Competent Authorities in the U.K.
Amsterdam was ranked fifth in the KPMG survey, and Lönnberg sees it as one of Sweden's key competitors.
Lille, in the Flanders region of northern France, is dismissed by many as overly-industrial. However, it has a beautiful old town with many 17th century buildings, and is recreating itself as a cultural and commercial hub. It has rapid train links to London, Brussels and Paris, tying it in with the center of EU governance and with the exiting host of the EMA.
Sensorion's Ouzren was upbeat about France's chances — perhaps unsurprising as she heads up a French company. She sees the country's positive points as the size of the French market, and its proximity to the UK, potentially allowing current staff to commute.
"The city of Lille would be a good location," said Dominique Costantini, CEO of OSE Immunotherapeutics, a biotechnology company focusing on immunotherapies. "It is close to the UK by train and it’s easy to access from the rest of Europe. I think this is important for the people that have been working there on the other side of the channel."
Brussels, effectively the capital of the European Union, is the home of a variety of international institutions including the North Atlantic Treaty Organization (NATO) and the World Customs Organization. It's even reported to have more journalists and ambassadors than Washington D.C.
The Brussels Greater Area is pitching a bid with a number of potential locations around the region, including the heart of the European Quarter and near to the airport. The key points in its bid are the availability of premises on time, accessibility, educational provisions, social and medical care, job opportunities and business continuity.
"I think also could be a good solution as there are already a great concentration of EU administrative operations there," said Costantini.
The Irish capital is touting its proximity to London as a key selling point of moving the medical authority to Dublin, which could make the transition easier and allow for continuity in agency practices.
But Dublin isn't stopping there. In its 80-plus page bid for the EMA, it promotes Ireland's fast-growing economy and active life-science community. (Many biopharma companies have already relocated to the country because of its advantageous corporate tax rate).
The Irish government has already said it will commit €78 million to the project, including €15 million in the first year to outfit the premises and reduce rent of the building, as well as another €7 million over the next ten years toward rent and maintenance.
Ireland is also offering "a comprehensive support system" that will help staffers find jobs for their spouses and partners, as well as new living accommodations, and the proper schools for staffer children.
Like Ireland, Milan promises to have the EMA all set up and ready to go on March 1, 2019, the projected transition date. The Italian city, best known for its ties to the fashion industry, has a state-owned building ready to be outfitted to EMA specifications that is centrally located directly in front of the city's main train station.
Milan says it has 69,000 beds available in the city, as well as another 30,000 beds in surrounding areas for staffers and their families. It also broadcasted its 1,000 available hotel rooms in the city. Milan said it will also provide relocation services for staff.
As well as promoting its 18 universities, Milan offers "one of Europe’s best research and business environments," it said in its 52-page bid.