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Regular-article-logo Wednesday, 08 May 2024

Makers to be liable for vaccine side effects

European Commission negotiates conditions with firms for the advance purchase of their potential vaccines

Reuters Brussels Published 23.09.20, 03:16 AM
Officials have said partial legal protection offered by the EU hampered advance purchase deals in past months and prompted vaccine makers to ask for more

Officials have said partial legal protection offered by the EU hampered advance purchase deals in past months and prompted vaccine makers to ask for more Shutterstock

Vaccine makers will be indemnified in Europe if their Covid-19 shots cause unexpected side effects, an industry official said on Tuesday, as nearly 40 firms pursue talks on possible authorisation for shots in development.

The European Commission has confidential liability clauses in contracts signed with AstraZeneca and Sanofi and is negotiating similar conditions with other firms for the advance purchase of their potential vaccines.

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Sue Middleton, president of the Executive Board of Vaccines Europe that represents top vaccine makers, told a European Parliament hearing that in case of unexpected adverse events, which could include unpredicted side effects, she understood that there was indemnification.

“The commission or the member states would essentially indemnify the companies against the cost of legal action that followed those claims,” she said, adding that she had not seen all contracts signed so far.

A spokesman for the European Commission said advance purchase deals “provide for member states to indemnify the manufacturer for certain liabilities incurred under specific and strict conditions”, but “liability still remains with the companies”.

Officials have said partial legal protection offered by the EU hampered advance purchase deals in past months and prompted vaccine makers to ask for more.

Middleton called for no-fault compensation in all 27 EU states for Covid-19 vaccines, which would speed up resolution of legal disputes. Such a system is in place in 11 countries, but its application to Covid-19 vaccine cases is not always clear, she said.

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