BRUSSELS (Reuters) – The European Union is offering coronavirus vaccine manufacturers only partial protection from the legal risks associated with the potential side effects of their drugs, which hinders deals and contrasts with US policy, European officials say.
During a pandemic, vaccines are being developed at a record pace, which increases the risks of unexpected consequences and the risks associated with the effectiveness of drugs. Financial accountability for these risks is a key issue in negotiations between pharmaceutical companies and governments seeking to secure early access to vaccines.
In such an emergency, EU governments “stand ready to provide companies with financial coverage for some of the risks,” an EU official said. However, he added that the strict rules on liability in force in the EU remain in place.
According to these rules, manufacturers of vaccines and other products are responsible for their products distributed in the EU.
Moreover, a European court of higher jurisdiction ruled in 2017 that vaccine recipients are entitled to compensation if they can prove that the vaccine caused negative side effects, even in the absence of scientific consensus on the matter.
Limiting legal liability for vaccine manufacturers is among the priority issues for the European Union during the pandemic, according to an internal EU document dated May 7, which was at the disposal of Reuters. However, proposals made by governments to vaccine manufacturers have not always met their expectations.
EU sources involved in the negotiations told Reuters in July that the legal liability issue was one of the stumbling blocks in negotiations with US pharmaceutical companies Johnson & Johnson (J&J) and Pfizer (NYSE: PFE), which are developing a COVID-19 vaccine in partnership with Germany. BioNtech.
The European Union later announced that negotiations with J&J are at an advanced stage, but the agreement has not yet been signed.
A European Commission spokesman declined to comment on whether legal liability issues have become an obstacle in negotiations with vaccine manufacturers.
The sample supply agreement with AstraZeneca (LON: AZN) and the University of Oxford provides only partial protection from legal liability. So far, this is the only such agreement reached by Brussels.
“The contract involves the division of obligations and financial costs between the parties,” – said in a statement by the Belgian medical regulator about the deal concluded between the European Commission and AstraZeneca.
“The preliminary procurement agreements stipulate that the EU member states will reimburse the manufacturer” for certain costs associated with the assumed responsibility, said a spokesman for the European Commission, without providing other details.
Meanwhile, in the US, vaccine responsibility is shifted entirely to the government, which protects drug manufacturers.
Congress has committed $ 30 billion to the fight against COVID-19, including funding for vaccine development and any compensation needed. In the EU, similar emergency funding is estimated at around 2 billion euros ($ 2.4 billion), EU officials said.
(Francesco Guaraschio. Translated by Vladimir Sadykov. Editor Marina Bobrova)