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2 months ago

EU taxpayers in the dark on US corona-drug deal – EUobserver

The European Commission and most EU states recently signed a huge contract with US pharmaceutical firm Gilead for its anti-corona drug Remdesivir.

But the World Health Organisation (WHO) says there is no evidence the medicine works.

  • European Commission was unaware of World Health Organisation report (Photo: European Commission)

The price was sky high – 420 times what it costs to produce the drug.

And there is little transparency for the EU taxpayer on how the Gilead deal came about or how much money might have been wasted.

The WHO recently said that there was no documented effect of Remdesivir on mortality, nor on the recovery time of hospitalised patients.

This was known to Gilead, but not to the EU commission before it signed the final paperwork.

Gilead had been given a secret preview of the WHO’s bombshell report in September.

“We had a contractual obligation to send them [Gilead] the [WHO] manuscript before we published it, since we were testing their molecule. They had a fortnight to give us their replies, during which time we could not send the article to [our] editor,” Marie-Paule Kieny, a research director at Inserm, the French National Institute of Health and Medical Research, who works with the WHO, recalled.

And so, the preliminary WHO report never reached the commission until after the contract was signed.

The European Medicines Agency (EMA) in Amsterdam gave the disputed US medicine conditional approval back in July, based on the results of an American trial.

But the EMA also said it learned about the WHO study in a verbal update by WHO staff on 9 October – the day after the agreement between the EU and Gilead was signed.

The “EMA is not involved in the discussions on the joint procurement framework contract signed by the EC [European Commission] and … Gilead”, it noted in a statement.

But all that still meant that almost 40 European countries are now bound to buy the amount of the drug they ordered earlier in autumn.

That includes all but two EU states – France and Luxembourg, which stayed out of the deal.

And Gilead’s response to the WHO findings was twofold.

On one hand, the US firm said an American clinical trial “was better suited to rigorously assess the recovery time” than the WHO trial had been.

On the other hand, Gilead said the contract “does not oblige the European Commission or any participating country to purchase Remdesivir”.

“The deal allows up to 500,000 treatments to be purchased, but countries control how much they choose to buy,” the US firm said.

The contract, which cannot be renegotiated, was signed on 7 October and announced the day after.

Until then, Gilead had also said that available doses were very limited, which led to a widespread fear of acute shortages.

But one week later, there was no shortage any more.

The World Health Organisation logo on a building in Geneva (Photo: Guilhem Vellut)

Phantom shortage

In an email sent to all the participating countries, released through a freedom of information [FOI] request in Sweden, the so-called ‘Joint-Procurement Agreement [JPA] Team’ suddenly announced, on 14 October, that: “Gilead informed us that it has been able to increase the production of Veklury [a brand name of Remdesivir]”.

“Consequently, there is no longer any need to apply the allocation key [the maximum amount allocated to each country] and the order-timeline that was presented and discussed in the 3rd meeting of the steering committee on 29 September 2020,” it added.

A senior health officer from an EU country, who did not want to be identified, also recounted the close-to-panic situation in some parts of Europe at the beginning of autumn.

“Pharmacists were staying in hospitals until 3AM to 4AM in order to obtain a phial of Remdesivir. This drug was being sent by plane from one hospital to the other, in which patients were more in need. Hospitals and countries were fighting for phials of Remdesivir,” the health officer said.

“So, when Gilead said that the drug had become widely available, the competent authorities immediately made the order,” the officer added.

The feared shortage of Remdesivir is no longer an issue.

Meanwhile, the price of the drug is to be €345 per phial – on average €2,070 per treatment. That is 420 times higher than estimated manufacturing costs.

And it is difficult to get a clear picture of how much of taxpayers’ money has actually been spent on the now WHO-disputed drug.

Boxes of EU-bought Remdesivir (Photo: ec.europa.eu)

Transparency?

A group of collaborating journalists asked 37 European governments how many doses of the medicine they had stockpiled through the EU-agreement.

Some 24 of them declined to answer, citing protection of Gilead’s commercial interests.

In Sweden, the National Board of Health (Socialstyrelsen) even cited national security as a reason.

The Danish Medicines agency (Lægemiddelstyrelsen) did not reply to a formal FOI-request, but answered with a general press release instead.

Out of the 37 governments, 13 did confirmed the number of phials they had ordered, giving a total of 456,483.

This adds up to €159,769.050 spent on Remdesivir.

Besides these national purchases, the European Commission, in July, also signed a contract with Gilead for the treatment of 30,000 patients worth €63 million, later bumped up to €70 million.

This adds up to at least € 229.8 million spent on Remdesivir.

It is still far from the €3.4 billion ceiling in the October agreement with Gilead.

The difference between the two figures is partly due to lack of information on total purchases and partly due to the small print of the deal.

The €3.4 billion indicated covers what may be spent potentially under the contract, if countries choose to place orders. 

It is not money already spent.

And the deal contains up to two renewals for six months each, according to the EU commission.

When asked to comment, Gilead repeated that no government had an obligation to buy Remdesivir and “only official representatives from countries participating in the JPA can confirm the exact quantities of Remdesivir they ordered, per our contractual obligations”.

However, if the general public is not allowed to know how much was spent. It is also being kept in the dark on how the contract was awarded.

The EU commission declined to tell who its negotiators were, or even to name the members of the JPA steering committee – the political body supervising the negotiations, with members appointed by participating European states.

No transparency on who negotiated the contract (Photo: europarl.europa.eu)

Due diligence?

According to the JPA template, members of scientific evaluation committees are asked to sign a conflict-of-interest declaration.

But no such demands are made of members of the steering committees, who have the final say on negotiated contracts.

In July, the European Ombudsman asked the commission to clarify how it had ensured adequate transparency in the JPA.

“How is the Commission ensuring transparency regarding the appointment of the members of the different committees and how does it ensure that they are independent?,” the Ombudsman, Emily O’Reilly, asked.

The commission was requested to answer at the end of October, but it prolonged the deadline for its response to 30 November.

The time’s up. Let’s see what they say.

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