EU Member States to pay compensation for rare Covid vaccine side effects
The Netherlands will join the entire European Union in providing monetary compensation should an approved coronavirus cause serious and unexpected side effects in patients. The provision is part of the agreement made by the European Union and the manufacturers of six potential vaccines against the SARS-CoV-2 coronavirus infection, according to statements from Health Minister Hugo de Jonge in two sets of answers submitted to Members of Parliament earlier this month.
Dutch Health Minister Hugo de Jonge declined to enter into specific discussions about the each deal due to a confidentiality agreement. He did write on 7 October “that Member States will offer financial compensation for claims related to, for example, a hidden deficiency of a vaccine that was not known at the time of its authorization.”
Earlier, he said “Citizens’ rights will remain completely unaffected,” but he followed up on that by saying the agreements indemnify the pharmaceutical companies against third party claims about adverse effects caused by vaccines that were not discovered during testing phases.
That would put the Member States on the hook for what De Jonge described as “rare side effects of a vaccine” which may “only come to light when applied on a wide scale.” He could not estimate the potential cost to the Netherlands in covering financial claims.
At the same time, the businesses will be held liable for production errors and side effects caused by “non-compliance with the rules of European product liability legislation.”
De Jonge’s response angered GroenLinks Member of Parliament Corinne Ellemeet. “Pharmacists are getting away with this too easily. Their business models are fully focused on profit. Why then should governments contribute to any damage claims?” she said, according to newspaper AD. She was prepared to address the issue with Medical Care Minister Tamara van Ark during a debate next week.
“If the lack of clarity persists, the pharmaceutical companies in question can even be summoned for a hearing in the Tweede Kamer,” Ellemeet said, referring to the lower house of Dutch Parliament. “The government is investing millions in the vaccines, and thus we have a right to openness. At the same time, more transparency also creates more confidence among the population.”
The Netherlands has helped represent the European Commission in discussions and negotiations with pharmaceutical companies after first striking a deal with France, Italy and Germany to pre-purchase a vaccine under development at Oxford University and AstraZeneca.
De Jonge continued to refuse to answer questions about the financial terms of the deals, and the cost per vaccine dose. “Broadly speaking, I can further inform the [lower house of Parliament] that accessibility and affordability of a vaccine candidate according to the EU Vaccines Strategy of the European Commission is an important part of the negotiations.”
GroenLinks MP Ellemeet said that the backdoor dealmaking and confidentiality agreements only add fuel to the fire fanned by conspiracy theorists and “vaccine skeptics”.
In a 1 October letter, De Jonge praised the pharmaceutical companies for their financial commitment and hard work into vaccine development. “I have not witnessed the image that pharmaceutical companies mainly want to make money instead of fighting the pandemic,” he stated.