(Reuters) – Vaccine manufacturers will be indemnified in Europe if their COVID-19 shots cause unexpected side effects, an industry official said on Tuesday, urging European regulators to set up more predictable systems to compensate potential victims.
The European Commission has confidentiality clauses in agreements signed with AstraZeneca and Sanofi and negotiates similar terms with other companies for the pre-purchase of their potential vaccines.
Sue Middleton, Chair of the Board of Vaccines Europe, which represents the top vaccine. decision-makers, told a hearing in the European Parliament that in the event of unexpected adverse events, which may include unforeseen side effects, she understood that there was redress.
"The Commission or the Member States would mainly harm the companies against the costs of action following these allegations," she said, adding that these incidents were rare and that she had not seen all the contracts
A spokesman for the European Commission declined to comment specifically Ms Middleton's comments, but said that pre-emption agreements "allow Member States to harm the manufacturer for certain debts incurred under specific and strict conditions" but "responsibilities remain with companies."
Officials have said that partial legal protection offered by the EU has hindered pre-purchases in recent months and urged vaccine manufacturers to ask for more.
Consumer organizations and legislators insist that companies be responsible for all potential side effects.
The comments come after Russia told Reuters that they were so sure the vaccine was sure it would take responsibility for everything which would go wrong and leave the state-supported developers open to potentially expensive compensation claims.
The United States also offers full liability coverage to vaccine manufacturers as extensive disease inoculation is considered a bone of contention for society.
Ms. Middleton also demanded flawless compensation in all 27 EU states for COVID-1
The flawless system would reduce legal uncertainty and costs for businesses.
These systems also enable citizens to demand faster payments for damages following vaccinations or treatments, but the compensation is limited and is usually far below what can usually be awarded in a successful product liability case.
The World Health Organization has made it clear to countries interested in joining its COVAX vaccine facility that pharmaceutical companies can apply flawlessly. It has not committed itself to opposing them in negotiations with vaccine manufacturers.
No COVID-19 vaccine has yet been approved in Europe, with clinical trials underway. But contacts between vaccine manufacturers and regulators are ongoing to speed up possible authorizations.
WHO lists 38 candidate vaccines in late-stage trials, including those from China and Russia. Another 149 are under preclinical evaluation.
"Since the beginning of September, the EMA has been in contact with developers of 38 potential COVID-19 vaccines," said Fergus Sweeney, Head of Clinical Studies and Manufacturing Working Group at the European Medicines Agency. , told EU lawmakers.
During a faster "rolling review", vaccine manufacturers can share data with the EMA about their trials as they occur, so that shots can be approved more quickly when all data is available.
No rolling review has yet begun with vaccines, Sweeney said, adding that the agency expected them to begin in the coming weeks. The EMA must approve vaccines before they can be used in the EU.
More news about insurance and risk management about the coronavirus crisis here.