ER Editor: The report below takes as gospel the words of Sandra Gallina, the Deputy Director General of Health and Food Safety for the EU, that Big Pharma companies will be held liable for covid vaccine side effects. The Reuters report, which the article below quotes, begins in the following way. Our emphasis shows that liability will be, to some unspecified degree, shared:
BRUSSELS (Reuters) – The European Union is offering only partial protection to vaccine makers against legal risks from side-effects of their potential COVID-19 shots, European officials said, in a move that is hampering deals and contrasts with U.S. policy.
With vaccines being developed at record speed during the pandemic, there is potentially a greater risk they may have unexpected consequences or may not be effective. The financial coverage of these liabilities is a key feature of drugmakers’ talks with governments keen to secure vaccine shots in advance.
In these extraordinary circumstances, EU governments “are ready to financially cover certain of the companies’ risks”, an EU official told Reuters. The official added, however, that the EU’s strict rules on liability remain in place.
These rules consider vaccine makers and other manufacturers liable for their products on sale in the EU, apart from rare cases when, for instance, they did not put them into circulation.
The EU’s top court increased the burden on drugmakers in 2017 when it ruled vaccine users were entitled to compensation if they could prove a shot caused a negative side-effect, even when there was no scientific consensus on the matter.
Reducing the legal burden for vaccine makers has been an EU priority during the pandemic because it is considered crucial to convincing drugmakers to invest in risky vaccines, an EU internal document dated May 7 and seen by Reuters shows.
The report goes onto say that the one and only deal so far struck with AstraZeneca/Oxford University contains ‘partial liability’ coverage for the manufacturers:
“The contract foresees that liabilities and financial costs are shared among the parties,” the Belgian medicines agency said in a statement about the deal the Commission reached with AstraZeneca on behalf of all 27 EU states, including Belgium.
“Advance purchase agreements provide for member states to indemnify the manufacturer for certain liabilities incurred,” a Commission official said when asked about the deal. The official gave no further details.
Which doesn’t seem to support the hardline optimistically expressed by Sandra Gallina. So what will the fine print say for the other vaccine deals still to be struck?
Of course, the far better and far cheaper option is to avoid vaccines altogether. Just because pharma companies are held 100% responsible (in some fantasy world) doesn’t mean that their products suddenly become less risky to human health.
Readers may also be interested in this report by Commons Dreams from August 27, 2020: As AstraZeneca Signs Deal With EU, Critics Warn Big Pharma Push for Covid Vaccine Liability Protections a ‘Dangerous Precedent’.
Euro Roundup: EU vows to hold COVID vaccine firms liable for side effects
NICK PAUL TAYLOR
Developers of COVID-19 vaccines used in the European Union will be legally liable in the event of hidden defects or other problems with their products, a senior official at the Directorate-General for Health and Food Safety (DG SANTE) has vowed.
Last month, Reuters reported that differing opinions over the level of legal protection that should be afforded to developers of COVID-19 vaccines were hampering efforts to strike deals for the products needed to protect EU citizens against the coronavirus. While the US government has agreed to be liable for the vaccines, the EU has proven less willing to shift responsibility away from manufacturers.
Members of the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) raised the topic in a discussion with DG SANTE Deputy Director-General Sandra Gallina (pictured) earlier this week.
Multiple ENVI members raised concerns about the prospect of deals with vaccine developers shifting legal liability. Gallina was adamant that those concerns are unfounded.
“The companies are fully liable. There is no change. It is the system that we know. We would not be so mad as to change such a system,” Gallina said during the debate in Parliament.
Gallina said the Commission went into the negotiations with COVID-19 vaccine developers including AstraZeneca, Johnson & Johnson and Sanofi with liability and indemnification as red lines. The goal was to ensure that the rights of all European citizens with regards to liability and indemnification are “totally unchanged” by the agreements.
The Commission has retained those red lines throughout the talks, Gallina said. That hard-line stance has put Gallina in a position to strike agreements that allay the concerns of ENVI members but has also held up negotiations.
“The negotiations have been very difficult because we started with the idea that we want to uphold the status quo. As regards both [liability and indemnification], we did not change an iota of what is in the law,” Gallina said.
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