The first pharmaceutical firm to clinch a contract with the EU to supply member states with a coronavirus vaccine will be exempted from a usual product liability clause.
Pharma giant AstraZeneca concluded a deal with the EU Commission mid-August to supply the bloc with at least 300 million doses of a vaccine set to be released by late 2020.
In its current form, the deal allows the multinational drugmaker to pass the hot potato of product liability onto national governments, leaving them exposed to the financial consequences of any potential side-effect claims.
The company said that the upside for governments is that they would be providing their vaccine “at no profit” to EU member states, which will be buying the doses at cost price (€2.9 per dose).
The agreement was announced by the company on 14 August, as late-stage clinical trials on its AZD1222 vaccine were nearing final stages in Brazil and Britain, with mid-stage trials still ongoing in South Africa and others planned in the US, Japan and Russia.
Preliminary reports that the liability clause may be scrapped prompted concerns among Belgian experts, with some admitting to being shocked by the company’s push to get off the hook.
Despite previously stating that Belgium was not in favour of scrapping the liability clause, Federal Health Minister Maggie De Block on Wednesday confirmed that the country would be getting 7.5 million doses of the vaccine.
With two doses required per person, Belgium’s batch will be good to inoculate some 3.75 million Belgians, with citizens belonging to at-risk groups set to be given priority, Het Nieuwsblad reports.
In a statement on 21 August, Belgium’s medicines agency (FAMHP) said that the vaccine still needed to get market approval by the European Medicines Agency (EMA), the bloc’s top drugs regulator, who they said was responsible for carrying out a “deep analysis” of AstraZeneca’s product.
“These vaccines will not be distributed before they are authorised for the European market,” FAMHP said. “This entails a deep analysis by EMA experts and competent national authorities showing [the vaccine] has a favourable safety and efficiency profile.”
After receiving market authorisation, however, the deal will mean that, in the face of any potential claims or complaints from a citizen, it will be up to member states to “guarantee compensation.”