Liability for defects in COVID-19 vaccines

Liability for defects in COVID-19 vaccines

The Financial Times has reported that the European pharmaceutical industry’s vaccines lobby has pushed the EU for exemptions that would protect its members from lawsuits in case of problems with any new COVID-19 vaccines.

On 07 September 2020, the Deputy Director-General of DG SANTE came to answer questions from Parliament’s Committee on Environment, Public Health and Food Safety about the ongoing negotiations of contracts for the purchase of potential vaccines. Several Members of Parliament asked her about the so-called ‘civil liability clauses’ in the contracts. The Commission representative confirmed that pharmaceutical companies would remain civilly liable for any vaccine defects, but could avoid paying indemnification in the event of so-called ‘hidden defects.’ No further details were given on the specific meaning or legal scope of a ‘hidden defect’ in a vaccine.

On 09 September 2020, Members of the European Parliament (MEPs), Katerina Konecna and Marc Botenga of the Group of the European United Left – Nordic Green Left tabled a written parliamentary question to the European Commission. The MEPs asked the Commission “could it specify how and by whom ‘hidden defects’ will be defined for potential COVID-19 vaccines and advance purchase agreements?”

The Parliamentarians also enquired “could the Commission provide specific examples of cases in which pharmaceutical companies involved will be wholly or partially exempted from paying indemnification under this clause?” and “will Member States have to pay the indemnification when manufacturers are exempted from this obligation?”

On 23 November, Commissioner Stella Kyriakides, responsible for Health and Food Safety, responded on behalf of the European Commission. In her answer, she clarified that “as defined by the Product Liability Directive, any defect will need to be established before the competent court with a proof of the damage, the defect and the causal relationship between defect and damage”.

“The Commission assumes that the second question refers to a situation where a company is not held liable due to a hidden defect” stated Commissioner Kyriakides and added “article 7 (e) of the Product Liability Directive provides that ‘the producer shall not be liable as a result of this directive if he proves: that the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered” and “if the company is not held liable, it will not be obliged to pay compensation”.

In closing, Commissioner Kyriakides concluded that “the COVID-19 vaccines advance purchase agreements provide for Member States to indemnify the manufacturer for possible liabilities incurred only under specific conditions set out in the agreement” and “in all other conditions not defined in the agreements, Member States will not be obliged to indemnify the manufacturer”.

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