BRUSSELS (Reuters) – European governments will pay claims above the agreed limit against AstraZeneca for side effects from a potential vaccine against COVID-19, under different conditions from the deal with Sanofi, an EU spokesman told Reuters.
The deals reflect different strategies of two of the world’s best drugmakers to defend themselves as the debate rages over vaccine commitments aimed at ending the pandemic.
AstraZeneca AZN.L has secured the European Union̵
“If a company asks for a higher price, we do not give the same conditions,” said the employee who participated in the negotiations, but refused to be identified because the contracts are confidential.
Unexpected side effects after authorization of the drug by regulators are rare, but the speed with which the COVID-19 vaccine is pursued increases the risk of unforeseen conditions.
The deal with AstraZeneca, which transfers some of the risks associated with the introduction of the vaccine to taxpayers, was concluded in August and its liability clauses have not been reported before.
Under the deal, AstraZeneca will only pay court costs up to a certain threshold, the official said, declining to specify how the costs will be shared with individual European governments or the restriction.
The financial shield would cover both legal costs and potential compensation, which is less frequent, but potentially a much larger amount in the event of something wrong.
In exchange for the higher price paid for his vaccine, the French drug manufacturer Sanofi SASY.PA, which works with GlaxoSmithKline as a partner, did not receive a disclaimer.
Speakers from AstraZeneca, Sanofi and the European Commission declined to comment on the specifics of the deals.
Asked about the relatively low price of AstraZeneca, a spokesman confirmed the company’s promise to share the vaccine widely and not profit from it during the pandemic.
Under the AstraZeneca deal, EU countries agreed to pay 2.5 euros ($ 2.92) per dose, while Sanofi negotiated a price of about 10 euros, the official said.
As part of the delivery deals, the only two sealed so far by Brussels, the EU has also made a non-refundable initial payment of € 336 million to AstraZeneca to provide 400 million doses, proportionally lower than the € 324 million it paid to Sanofi provide 300 million doses.
The EU spokesman told Reuters that the agreement with AstraZeneca included a narrow definition of side effects that could limit the possibility of claiming compensation, although the company remained responsible for its vaccine.
The deal with AstraZeneca was negotiated before pausing in the late stages of its vaccine candidate this month after a British volunteer developed neurological symptoms. Trials resumed in Britain, but not in the United States.
EU governments will only share the cost of compensation if unexpected side effects occur after the AstraZeneca vaccine is approved.
Accountability is a major stumbling block in negotiations with other vaccine manufacturers against COVID-19, EU officials said, as companies fear they risk higher legal costs than they normally face when vaccines are developed in much longer experiments.
A spokesman for the European Commission said that the preliminary purchase deals “provide for Member States to compensate the manufacturer for certain obligations under specific and strict conditions”, but “the responsibility still remains with the companies”.
This means that it would be the company’s responsibility to defend its shot in court.
Drug manufacturers are calling on EU regulators to set up a pan-European compensation scheme, while patients’ organizations are calling for a pan-European fund funded by pharmaceutical companies to compensate for unexpected side effects.
The EU legal regime is among the most unfavorable for drug manufacturers in compensation claims, although claimants rarely succeed in winning, as the law requires them to prove the link between a disease and a vaccine that may have caused it.
The United States has granted immunity from liability for COVID-19 vaccines that receive regulatory approval.
Russia, meanwhile, has said it will take some of the legal responsibility if something goes wrong with a vaccine developed by Moscow’s Gamaleya Institute.
Report by Francesco Guaracio @fraguarascio; Additional reports by Ludwig Burger in Frankfurt, Matthias Blamont in Paris and Tom Hals in New York; Edited by Josephine Mason and Alexander Smith