A pharmaceutical firm developing a coronavirus vaccine of which Belgium has already secured millions of doses has made the “exceptional” request to not be held liable for any potential side effects.
As it enters the final stages of human trials in the development of a vaccine against the new coronavirus, drugmaker AstraZeneca has introduced several requests to be protected from future claims of liability.
The request was received with surprise by some observers in Belgium, with, health and medical law experts in Belgium referring to it as exceptional or even shocking.
“In the US it is common for firms to cover for themselves in this way, but, in Europe, it is exceptional,” Stefaan Callens, university professor of medical law at KU Leuven, told HLN.
Thierry Vansweevelt, professor of medical law at the University of Antwerp called the request “very exceptional” and even “slightly shocking,” in light of existing EU regulations on companies’ liability for what they put on the market.
“There is a European directive on product liability,” Vansweevelt said. “Any producer who places a defective product on the market is responsible for that without exceptions. You can’t escape that.”
But, Ruud Dobber, an AstraZeneca executive, told Reuters that most countries with whom it had signed procurement deals had already granted its request, but refused to name the countries in question.
Dobber said that AstraZeneca could “simply not take the risk” of being faced with liability claims if “in four years the vaccine is showing side effects.”
“In the contracts we have in place, we are asking for indemnification. For most countries it is acceptable to take that risk on their shoulders because it is in their national interest,” the added.
Out of the 300 million doses of the vaccine already secured by the EU, some 4 million are set to go to Belgium and used to vaccinate the population groups most vulnerable to the virus.
On Thursday, an advisory body charged with issuing advice on potential coronavirus vaccines to the Belgian government gave the green light to the deal AstraZeneca proposed for its vaccine, Le Soir reports.
The committee’s advice was that it saw no reason for the Belgian government to not accept the terms of the deal as laid out by the pharmaceutical company, with a decision yet to be reached by the federal government.
Federal Health Minister Maggie De Block said so far no agreement had been reached and that negotiations with the company were still ongoing.
“We are being kept informed on a daily basis,” she told HLN. “We don’t want that clause (sic), other member states don’t, and neither does the European Commission.”
Product liability clauses are a central sticking point in negotiations being led by the EU and other pharmaceutical companies, according to statements from EU officials obtained by Reuters this week.