Malta has joined the ever-growing number of countries wanting to host the European Medicines Agency when it relocates from the UK post-Brexit. The European Commission has said new “technical issues” have been raised that will need to be addressed, and industry bodies have outlined the criteria they say need to be met by the future host country.
Malta has become the latest country to say it wants the European Medicines Agency when the agency relocates from London as a result of the UK voting to leave the EU in the June 2016 referendum.
Malta, which currently holds the rotating presidency of the Council of the EU, joins a lengthening queue of member states that would like to have the EMA based on their territory. The countries include Denmark, France, Ireland, Italy, the Netherlands, Spain, Sweden and Portugal.
Announcing the candidature at a March 20 press conference, Maltese health minister Chris Fearne said his island was a suitable location for the EMA because of its free, high-quality healthcare, growing research community, availability of experts, high quality of life, good weather and the fact that English is an official language (the other being Maltese). Other candidates have made much of a having strong local pharmaceutical industry presence. Malta, in contrast, believes that its small pharma sector could actually weigh in its favor.
Fearne “suggested that Malta’s relatively small pharmaceutical community could prove an advantage, in that it wouldn’t exert too much pressure on the Authority’s attempts to design regulations that keep patients at the forefront,” the Malta Today newspaper reported. Quite what that says about the way the EMA operates at present is open to interpretation, but a similar gloss was put on Malta’s bid by Anthony Serracino Inglott, chair of the country’s drug regulator, the Medicines Authority. Serracino Inglott was quoted by the Times of Malta as saying that the country offered “job opportunities in a thriving economy not dominated by the pharmaceutical industry.”
Serracino Inglott is also reported to have said that the Maltese authorities had met with the Malta Enterprise and the Planning authority to discuss options for the premises that would be required to house the EMA, with existing buildings and new construction both under consideration. Any building would need to be around 30,000sq m and able to cater for more than 560 meetings and 4,270 teleconferences a year, Serracino Inglott added.
The EMA in London employs almost 900 people. Malta’s Medicines Authority, one of the smaller regulators in the EU network, had 41 employees at the end of 2015.
The Selection Process
The European Commission is expected to begin the candidate selection process once UK prime minister Theresa May triggers Article 50 on Mar. 29, setting in train two-years of negotiations on the UK’s departure from and its future relationship with the EU.
According to former Novo Nordisk CEO Lars Rebien Sørensen, who is leading Denmark’s bid to bring the agency to Copenhagen, a decision on the agency’s new home is expected to be taken during the second half of this year in order to avoid the decision-making process getting tangled up in the wider Brexit talks. (Also see "EMA’s Post-Brexit Home ‘Could Be Decided This Year’" - Pink Sheet, 27 Feb, 2017.)
EU health commissioner Vytenis Andriukaitis spoke at a press conference in the Maltese capital of Valletta before the Maltese announcement. The Times of Malta reports him as saying that while the EU would follow the 2012 selection criteria in deciding where to locate the EMA, the current situation was “unprecedented” and raised “a number of new technical questions which would be presented to the council immediately”.
Industry Criteria For EMA Location
The criteria that should be used when deciding where to locate the EMA were outlined last month in a joint letter to the European Commission’s director general for health, Xavier Prats Monné, from three industry bodies representing originator, generic and biosimilar firms.
While they made it clear that they did not want to discuss any particular country candidacies, the industry associations said that full consideration had to be given to ensuring a smooth relocation of the EMA,” including the subsequent and ongoing integration of the UK medicines agency into the EU regulatory ecosystem.”
The letter, from the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Association for Bioindustries (EuropaBio) and the generics and biosimilars body, Medicines for Europe, set out the following “essential criteria”:
The capacity of the national regulatory agency to support the EMA’s work, as the UK regulator, the MHRA, currently does.
The need to avoid negatively influencing the ability of the national agency of the host country to deal with non-EMA related activities such as decentralized approval procedures and the maintenance of marketing authorizations.
The size of the local scientific and medical research community and ability to provide experts in different scientific fields.
A central location with easy access to an airport and enough space for the agency’s needs by way of meetings with member state experts, sponsors and other stakeholders.
Good accessibility and connectivity in the form of transport links, hotel capacity and language.
Minimal disruption for agency staff, with relocation support considered such as educational facilities and access to social security and medical care.
The signatories said that the relocation of the EMA “must be carried out in such a way as to minimize disruptions that could affect negatively access to medicines for patients. We call on the EU institutions to take into account the above criteria in the context of the negotiations for the withdrawal agreement with the UK.”
From the editors of Scrip Regulatory Affairs.