Brexit's highest profile Healthcare topic

by Jelena Malinina
Brexit's highest profile healthcare topic is reaching a climax

The Great EU Battle for the European Medicines Agency (EMA): will EMA’s voices be heard?

If the EU had its own statistics of the most frequently asked questions, the question “who will host the European Medicines Agency” would currently seem more important than the role of approving medicines. While the big decision on the next EMA’s location will be taken by the Council of the European Union on 20 November, the EMA 900 staff members have already expressed their assessment and preferences for the 19 Member States’ bids to host the Agency as of March 2019. Although will EMA’s voices be considered as determining factor for the new EMA’s home or it will be purely political decision?

According to the recent EMA internal survey, depending on the chosen location, EMA staff retention would be between 19% and 94%, thus it is likely that in a best-case scenario, EMA could keep up to 81% of its workforce. Staff lost will inevitably result in changes of EMA’s work:

  • in case the staff retention is below 30% it is expected that EMA would not be able to operate and the EU medicines approval system will be permanently damaged;
  • in case the staff retention is more than 65% approval of new medicines and safety monitoring will be largely maintained but with possibility of delays. Depending on the extent of specific staff loss, some initiatives (e.g. EMA cooperation with Health Technology Assessment bodies) will move at a slower pace. The full recovery is expected in 2-3 years after the relocation.

High staff retention is not only crucial to ensure the Agency’s operability but also to avoid a major deficit in EMA’s budget: if operations are delayed, the Agency could experience a dramatic drop in fee income, which would need to be compensated from the Union’s budget.

The technical assessment criteria on relocation included:

  1. The assurance that the agency can be set up on site and take up its functions at the date of the United Kingdom’s withdrawal from the Union
  2. The accessibility of the location
  3. The existence of adequate education facilities for the children of agency staff
  4. Appropriate access to the labour market, social security, and medical care for both children and spouses
  5. Business continuity
  6. Geographical spread

Among highly favoured locations are Amsterdam, Copenhagen, Milan, Vienna and Barcelona. However, the EMA staff survey was conducted before the recent political developments in Catalonia, thus at this point it is not clear whether Barcelona is still considered as a preferred site. Any of the other 14 cities would result in large staff losses: EMA will risk losing more than 70% of its staff if it will be decided to relocate to Athens, Bratislava, Bucharest, Helsinki, Malta, Sofia, Warsaw or Zagreb.

The Great EU Battle for the EMA will soon intensify, although it is unclear to what extent EMA’s staff preferences will be considered or whether political bargaining will dominate the choice. Notably, the top five cities favoured by EMA staff are in the countries that already host at least one EU Agency, and despite the need to fulfill EMA’s business continuity and other technical criteria, the final decision is likely to be influenced by a number of political factors.

For instance, there is an ambition of dispersing Union’s agencies across Europe, particularly to the Eastern European states, however some of the Eastern European candidates to host EMA (e.g. Hungary, Slovakia, Poland) have been most critical of a pan-European approach to migration. For example, after Slovakia’s Prime Minister Robert Fico has publically declared that “Muslims are impossible to integrate in Europe” and “Islam has no place in Slovakia”, it would be incongruent for the EU to reward the countries sceptic of the European values with the EMA.

The Council’s vote on November will take up to three rounds, until a candidate is supported by at least 14 Member States out of remaining 27, thus behind the scenes agreements are already being made by the bidders: Greek Alternate Minister of Foreign Affairs Georgios Katrougalos has suggested Cyprus, France, Italy, Malta, Portugal, and Spain support only each other's bids in the first round of voting. Although the proposal was declined by Italy, such pre-agreed voting coalitions might have a significant effect on the outcome.

It remains to be seen whether fulfillment of technical criteria or pre-determined political agreements will have an outweighing influence during the November’s vote on the relocation of the one of the biggest EU’s Agencies. Either way, the outcome of the vote will further fire up EU discussions and might leave more questions than answers.