EMA relocation - A public health crisis ahead?

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Hogan Lovells

EMA employees are taking precautions to avoid relocating to cities they consider less attractive, according to the results of a recent staff retention survey.

The survey shows that for certain locations staff retention rates could be significantly less than 30%. This would mean that the EMA would move with less than a third of its staff to, for example, Helsinki. This, in turn, means that the EMA would be unable to operate, leading to a public health crisis. According to the EMA, this may result in "Patients exposed to side effects – deaths – litigation", medicines becoming unavailable and the need to rely on third countries for approval and importation. Cities like Amsterdam, Barcelona, Copenhagen, Milan, and Vienna, on the other hand are more popular, and the likelihood of success of compensatory measures is regarded as high, with only 2-3 years needed to full recovery.

In another study, commissioned by the European Federation of Pharmaceuticals Industries and Associations (EFPIA) and released on September 28, 2017, Assessing the impact of the disruption from the relocation of the European Medicines Agency, consider the potential risk to business continuity as a result of the relocation more closely. In particular, the five main functions of the EMA are reviewed. The report comes to the conclusion that the evaluation of applications for marketing authorisation and monitoring the safety of medicines across their lifecycle have the most significant effect on public health; therefore in order to avoid risks for patients, these to functions have to be secured. This report confirms what is at stake when member states start voting in November.

Member states will vote in a Eurovision-style voting in November. Eurovision? Exactly. Each EU member state will have six voting points altogether– three votes for its first preference ("Three votes to Amsterdam"), two for the second choice ("Barcelona, deux points") and one for the third place ("Ein Punkt geht nach Wien"). The city that has received three points from 14 or more member states will be declared the winner.  Should there be no winner, during a second vote, the member states have the choice between the top three cities, according to the points they have accumulated. In a third round, only the top two cities will participate.

So should member states vote according to what the staff retention survey suggest? Does voting for Helsinki automatically lead to "side effects – deaths – litigation"? Or was this just a clever move by EMA's staff, and will EMA employees reconsider their willingness to move to Helsinki (and all the other less attractive cities) once the decision has been made? This remains to be seen.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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