"There's a Divinity That Shapes Our Ends…"

Article

Applied Clinical Trials

The decision of where to move the EMA was determined by a coin toss.

"…rough-hew them how we will." Thus, Hamlet reconciled himself to the supremacy of fate, after all his more famous existential reflections. It's not certain that Beatrice Lorenzin will achieve such resignation. Minutes after the Italian bid to host the European Medicines Agency was crushed by the toss of coin on November 20, she tweeted "Disappointment and bitterness at losing the lottery after coming out ahead in two rounds of voting."

Her reaction is unsurprising given the bizarre outcome of the already bizarre process the EU adopted to choose a new home for EMA after Brexit forces it to move from London. The beauty contest that the selection unleashed was a spectacle in itself-and not just the glossy brochures and slick videos and lavish receptions from the 18 candidate cities and their sponsoring countries. The betting agencies were quick to see the opportunity for relieving punters of their money, and elevated the contest to a high public profile by providing a shifting assortment of odds in the weeks running up to decision-day.

But-as so often in European affairs-the real business was done off-stage. The complex behind-the-scenes horse-trading that went on for months to secure votes in the ballot ranged from reciprocal support in pursuit of other ambitions or appointments, right through to offers of troop reinforcements and naval support. Italy was one of the most generous and energetic in seeking arrangements with potential backers and right up to the last moment it looked as though Milan would take the prize. 

In the event, all that energy and intrigue went for nothing. True, Milan did well in the first round of voting, when the 27 ministers in the European Council finally got together to make the decision (the UK was, of course, excluded). As ministers whittled down the field of pretenders to just three, Milan won 25 points, against 20 for Amsterdam and 20 for Copenhagen. "Our efforts have seen us through to the second round," Lorenzin tweeted triumphantly, promising to follow through with "faith". It also did well in the second round, without securing a clear majority, so the run-off was narrowed to just Milan and Amsterdam. But Milan had failed to win enough support among the other member states, and the run-off resulted in a tie between the two, with 13 votes each.

As the culmination of a day-and indeed half a year-of strange doings, the Estonian minister chairing the meeting then put both names back into the goldfish bowl in which votes had been cast, and pulled one out (it wasn’t actually a toss of a coin-although that makes a better headline!). It was Amsterdam. By pure fortune. And pure misfortune for Milan.

But the fate of Milan is as nothing compared to the fate of the European medicines market, and the Council meeting resolved only a small part of the huge dilemma that Brexit is posing. As EFPIA, the main European drug industry grouping, insisted immediately after the decision was announced, “Now the decision has been made, all authorities and stakeholders need to collaborate to support the agency in making the move to Amsterdam. It is vital to ensure the continuity of the EMA’s critical functions, its ability to retain staff and access expert networks." And it went on: "The location of the EMA is just one of a number of critical medicine issues relating to Brexit where action is needed to protect patient safety and public health"-notably focusing on "securing transitional arrangements and long-term cooperation on medicines regulation between the UK and EU." But that process is still stuck between EU inquiries as to what the UK wants, and UK confusion and obfuscation about what it wants and what it is prepared to do to obtain it.

That is something that is trying the patience of everyone in Europe, and a predicament for which there is little comfort in Hamlet's mature reflections. If the conditions for medicines development and marketing and control in Europe are to be left to the coin-toss of some ill-defined divinity, then God help us all.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

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