AstraZeneca to receive preferential treatment for low-cost vaccine sale in EU
European governments will partly pay claims against AstraZeneca due to side effects from its potential COVID-19 vaccine. These terms are different from the terms of the deal entered into with Sanofi. This was announced to Reuters by an EU official..
The heterogeneous nature of transactions reflects different strategies to protect the interests of two of the world’s leading drug manufacturers, as the debate over responsibility for the use of vaccines aimed at ending the pandemic is in full swing.
AstraZeneca Boosts EU Vaccine Supply
AstraZeneca has secured the backing of the European Union in a confidential agreement that fixes a lower price than what the UK drug maker is seeking, the official said..
«If the company asks for a higher price, we do not give the same conditions.», – said an official who was involved in the negotiations but declined to give his name as the contracts are confidential.
Unexpected side effects discovered after the drug got regulatory approval are still rare. The speed at which the COVID-19 vaccine is being developed increases the risks of contingencies.
The deal with AstraZeneca that shifts for taxpayers some of the risks associated with rolling out vaccine use, was concluded in August, and regarding its liability provisions previously not publicly reported.
Under the deal, AstraZeneca will only pay legal costs up to a certain threshold, the official said, declining to clarify how the costs would be split. with individual European governments.
The financial cushion will cover both legal costs and potential compensation, which are less common but could potentially be much more costly in case something goes wrong.
In exchange for a higher price paid for the vaccine, French drug maker Sanofi, which works with GlaxoSmithKline as a partner, received no exemption.
Representatives of AstraZeneca, Sanofi and the European Commission declined to comment on the specifics of the deals.
Asked about the relatively low price of AstraZeneca, a company spokesman reiterated the manufacturer’s promise to promote widespread vaccine distribution and not profit from it during a pandemic..
As part of the deal with AstraZeneca, EU countries agreed to pay € 2.5 (US $ 2.92) per dose, while Sanofi agreed on a price of around € 10, the official said..
As part of the supply contracts, which are currently the only ones concluded by Brussels, the EU also made a non-refundable € 336 million advance payment to AstraZeneca to secure the delivery of 400 million doses, which is proportionately less than the € 324 million that the company paid to Sanofi for the million doses.
An EU spokesman told Reuters that the contract with AstraZeneca includes a narrow definition of side effects that could limit the possibility of claiming compensation, although the company remains responsible for its vaccine..
The deal with AstraZeneca came before the company suspended late trials of its candidate vaccine this month after a British volunteer developed neurological symptoms. Lawsuits resumed in the UK, but not in the US.
EU governments will only share compensation costs if there are unexpected side effects to AstraZeneca vaccine after approval.
EU officials said liability was a key sticking point in negotiations with other COVID-19 vaccine manufacturers, as companies fear they risk higher legal costs than usual when vaccines are developed in much longer trials..
A spokesman for the European Commission said that preliminary procurement transactions «provide that the Member States release the manufacturer from certain obligations arising under certain and stringent conditions», but «responsibility remains with companies».
This means that the firm will have the responsibility to defend its position in court..
Drugmakers have called on EU regulators to create a pan-European compensation scheme, while patient organizations are calling for a pan-European fund, funded by pharmaceutical firms, to offset unexpected side effects.
The EU’s legal regime is one of the least favorable for drug manufacturers in compensation claims, although plaintiffs have rarely been successful as the law requires them to prove a link between the disease and the vaccine that may have caused it..
United States grants manufacturers immunity from regulatory liability for COVID-19 vaccines.
Meanwhile, Russia has said it will bear some of the legal responsibility if something goes wrong with a vaccine developed by the Moscow Gamaleya Institute..