COVID-19 vaccine deals with the EU hindered by strict liability rules

Companies would retain liability for unexpected side effects

Deals between vaccine developers and the European Union for a COVID-19 vaccine are being hindered by strict liability rules that offer only partial protection against legal risks for potential shots, according to European officials.

An EU official told Reuters that EU governments “are ready to financially cover certain of the companies’ risks” but strict liability rules remain in place.

Given the speed at which companies are currently developing vaccines for the novel coronavirus, there could be an increased risk of side effects with potential shots.

As a result of these increased risks, companies are placing importance on financial coverage on these liabilities in any government deals for early access to their respective vaccines.

However, the EU is maintaining rules that hold vaccine developers and other manufactures liable for their products, apart from certain rare cases, such as when they did not put the products into circulation.

EU officials involved in the negotiations between the EU and vaccine developers, including Johnson & Johnson and Pfizer, told Reuters that these talks have been hindered by the liability rules.

The EU has currently only reached one supply agreement for a potential COVID-19 vaccine with AstraZeneca and Oxford University. This deal only offers partial liability coverage for developers of the vaccine.

“The contract foresees that liabilities and financial costs are shared among the parties,” the Belgian medicines agency said in a statement about the deal reached by the European Commission with AstraZeneca and Oxford University.

Across the pond, the US has reached a range of deals with a number of companies developing COVID-19. The US system, however, puts the liability for the vaccine completely onto the government, with the company avoiding blame.

The fact that the liability falls on the government in the US could explain why more deals have been reached there than in the EU, which appears to be lagging behind.

Meanwhile, the UK has reached deals with J&J, Novavax, GlaxoSmithKline, Sanofi and AstraZeneca/Oxford University, although the details of the liability rules within these agreements have not been disclosed.