Renegotiating with Gilead Sciences in view of the WHO Solidarity trial result

Renegotiating with Gilead Sciences in view of the WHO Solidarity trial result

On 11 November 2020, Belgian Member of the European Parliament (MEP) Marc Botenga of The Left group in the European Parliament – GUE/NGL, posed a written parliamentary question to the European Commission:

“On 23 September 2020, the results of the WHO Solidarity trials were presented to pharmaceutical companies, including Gilead Sciences. These results indicate that remdesivir seemed to have little to no effect on 28-day mortality or the in-hospital course of COVID-19. On 8 October, the Commission concluded negotiations with Gilead on a joint procurement agreement for further deliveries of remdesivir valued at over EUR one billion. Despite the Commission’s statement on 21 October that it will not comment on ‘ongoing negotiations’, in reality negotiations ended before 8 October.

1. Can the Commission now confirm or deny that, during negotiations, it or the European Medicines Agency were informed of the results of the WHO Solidarity trial regarding remdesivir?

2. If relevant, can the Commission now clarify why, unlike Gilead Sciences, it did not have access to the results of the WHO clinical trials?

3. Can the Commission now specify what action it will take to renegotiate the price or conditions of the contract, given that Gilead Sciences was aware of remdesivir’s poor results during the Solidarity trials?”

On 15 February 2021, Health and Food Safety Commissioner Stella Kyriakides responded on behalf of the European Commission stating:           “The Commission was not informed about the interim results of the World Health Organisation Solidarity Trial during the negotiations with Gilead.

The European Medicines Agency (EMA) has requested access to the data from the Solidarity Trial. Once the data are available, EMA will assess the evidence, together with other relevant data, to see if any changes are needed to the marketing authorisation of Veklury (remdesivir) in the EU.

The Commission does not plan to renegotiate the contract as remdesivir continues to have a conditional marketing authorisation.”


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