EU Not on the Hook to Pay for Remdesivir Contract

The European Commission (EC) and Gilead Sciences say EU member states aren’t obligated to pay for the up to 500,000 treatment courses of Veklury (remdesivir) negotiated under a joint procurement agreement with the company in October — and the commission says that the European Medicines Agency (EMA) may reconsider the conditional marketing authorization it granted for the drug in July.

The authorization could be taken under consideration again because of the disappointing results from several trials, which prompted the World Health Organization (WHO) on Nov. 20 to recommend against the drug’s use in hospitalized COVID-19 patients and to say “there is currently no evidence that remdesivir improves survival and other outcomes” in hospitalized COVID-19 patients.

The WHO’s findings were based on data from four trials, including the WHO’s Solidarity trial and the ACCT-1 trial sponsored by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). However, Gilead has disputed the WHO’s findings, touting positive data from the ACCT 1 trial, among others.

The EC-Gilead contract has drawn a lot of scrutiny following the WHO’s findings although “the contract between the commission and Gilead is a framework contract,” a commission spokesperson told FDAnews, meaning that individual EU countries could place orders and pay for remdesivir themselves, under the fixed price per dose terms negotiated by the commission. Under the framework agreement, 37 European countries can gain access to the drug, including the 27 EU member states, the UK, six Balkan nations and European Economic Area countries

The deal stipulates a price per vial of approximately $416, with one treatment course usually requiring six vials and the deal’s total value estimated at $1.2 billion. That pricing framework builds upon a contract with Gilead signed in July and expanded in October, worth approximately $84 million, for a total of 33,380 treatment courses.

Gilead confirmed the contract’s framework, saying the agreement “does not obligate the EC or any participating countries to purchase Veklury … countries control the quantities they choose to purchase.” — Jason Scott