Sunday

5th Apr 2020

Analysis

'Think of the patients!' cry EU agency contenders

  • The EMA evaluates if medicines are safe (Photo: Grumpy-Puddin)

Does the future home of the European Medicines Agency matter to patient safety?

The cry '...but think of the children!' has often been used seriously in politics - but also satirically, in TV series like the Simpsons.

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  • Will patients be at risk if the 'wrong' city is chosen to host EMA? (Photo: Helena Spongenberg)

Now, a variation on the theme has been used in earnest in the past few months by European ministers, in the debate about which city is best equipped to host the London-based European Medicines Agency (EMA).

The EMA has to find a new home after Brexit, and nineteen member states have offered to host it.

"Ladies and gentlemen, millions of Europeans depend on the availability of high-quality, effective, safe medicine," said Dutch health minister Edith Schippers last July, when promoting the bid for Amsterdam.

"Think of the many people with chronic diseases, who can live good and productive lives thanks to their medication," she said.

"Think of all those patients with cancer that have an ever-increasing chance of survival, thanks to innovative treatments and medication. The same is true for people with rare diseases. They are looking at us politicians. Can we ensure their access to the treatments they need?"

Spanish health minister Dolors Montserrat said the same thing, when she came to Brussels in May to argue why Barcelona was "the best city" to host the EMA.

She also referred to the argument - made by some EU member states that currently do not host any EU agency - that the offices should be distributed evenly.

Montserrat told EUobserver that whether a member state already has an agency should not be relevant to the decision on where to relocate EMA.

"We have to think of the health of the European patients," she said, noting that some candidate cities "perhaps" did not have the best infrastructure, international schools, or an airport with frequent flights to European capitals.

"So we have to save the health of the European citizens. .. We have to do a smooth relocation," she said.

Unspoken criticism

The phrase 'smooth relocation' has been uttered by most of Montserrat's counterparts from the other competing member states in the past half year.

The unspoken accusation in the words of these health ministers is of course that a relocation to the city of some of the candidates would lead to a potential health risk, maybe even leading to deaths.

So is there such a risk?

Smooth relocation

The EMA is responsible for evaluating the safety of medicines for humans as well as for other animals.

As of last week, the EMA had given 75 positive opinions on new medicines this year, and five negative opinions.

Belgian health minister Maggie De Block told EUobserver earlier this month that there should be no "disruptive effect" during the agency's move from London to the new host city.

"Otherwise this would mean that patients will have access to new medication later than normal," she said. "So for some people that medication will arrive too late. That would be a disaster."

However, De Block would not say if any of the candidate countries, if selected, would lead to such a disastrous scenario.

"We keep it fair," she said. "May the best [candidate] win."

Helsinki mayor Jan Vapaavuori, promoting his city's bid, also declined to answer.

"You asked about the worst case scenario. We do not comment [on] that. We only know what's the best case scenario," he said.

Clinical trials

Health minister Konstanty Radziwill did make an allusion to countries who do not fit the criteria, albeit indirectly.

Radziwill noted in an interview with EUobserver that in Poland between 30,000 and 40,000 citizens are involved in clinical trials annually.

"We have a population of 38 million. If the population is much, much smaller, this is impossible," he said.

But according to a health expert from one of the countries with the smallest populations in the race to host the EMA, that argument is invalid.

"The number of individuals included in clinical trials in the host country has no relevance for the relocation of the EMA," said Sinisa Tomic, head of the Croatian medicines agency.

Croatia has a population of 4.2 million. Its capital Zagreb is a candidate.

"Companies perform clinical trials all over the world and bring their results to the EMA in order to obtain approval for their medicinal products," Tomic told EUobserver via email.

The authorisation of clinical trials takes place at the national level, not the EU level.

Some member states had hoped that the European Commission would make a shortlist, or at least some ranking of the different bids.

However, its assessment of the bids, published last month, was extremely factual.

For example, in the commission's discussion of the criterion "business continuity", the EU's executive refrained from giving a value judgement, or any fact-checking of statements made.

Risk of 'permanent damage'

But the European Medicines Agency itself was much more direct.

Days after the commission had presented its document, the EMA published an assessment of the bids, which did include preferences, and criteria.

It also warned that many staff members were considering leaving the agency, depending on the city chosen.

In the best case scenario – a choice for Amsterdam, Barcelona, Copenhagen, Milan, or Vienna – between 19 percent and 35 percent of staff said they would "likely" or "very likely" quit.

This would lead to the approval of new medicines being "largely maintained", EMA said, although it noted there would still be the "possibility of delays". The agency would then need between two and three years to fully recover from the move.

But if EMA would move to Athens, Bratislava, Bucharest, Helsinki, Malta, Sofia, Warsaw, or Zagreb, between 72 and 94 percent of staff said they would probably leave the agency.

If that were to happen, this would lead to "permanent damage to the system" and an "unravelling of the EU single market for medicines". In that scenario, EMA expects some medicines to become unavailable and a need to import from outside the EU, mainly Japan and the US.

Moreover, in that scenario, EMA expected patients to be "exposed to side effects – deaths – litigation".

Of course, what EMA staff said in the survey they would do, is not necessarily what they will actually do.

Once a decision has been made for a city, personnel will probably make another weighing: do I really want to quit my job, or can I still have a good life in this new city?

The conundrum is that there is no scientific method to determine how many staff will actually leave – the real staff loss will not be known until a city has been chosen, when it will be too late for a minister to change their mind.

On Tuesday (17 October), interior and EU affairs ministers will discuss the bids at a meeting in Luxembourg.

It is unlikely a decision will be made this week.

Rather, it is expected that the next ministerial meeting of that format, now scheduled for 20 November, will see up to three rounds of voting to determine the new seat of the EMA.

Read more on EU agencies in EUobserver's 2017 Regions & Cities Magazine.

Click here to access EUobserver's entire magazine collection.

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