In spring 2023,Prescrire worked closely with France Assos Santé, an umbrella organisation for patients' rights groups in France, on a proposal to revise the 1985 European directive on "liability for defective products". Under this directive, when a product (in any economic sector) is defective and causes damage to a consumer, the producer may be held liable even without negligence or fault on their part. A product is considered to be defective if it does not provide the safety that the public is entitled to expect (1).

On 27 April 2023, a joint letter signed by Prescrire, France Assos Santé and over forty organisations representing patients, consumers and health professionals was sent to the European Parliament. It was addressed to the members of the European Parliament (MEPs) working on this project within the Committee on Legal Affairs (JURI) and the Committee on Internal Market and Consumer Protection (IMCO) (2).

The purpose of the letter was to urge the MEPs to submit amendments that would ensure the right to compensation for the victims of serious adverse effects linked to pharmaceutical products.

It proposed revisions in several areas:

• changing the definition of a defective product specifically for drugs, since the current definition means that the victims of adverse effects are not eligible for compensation if the risk is mentioned in the patient leaflet;
• removing the "development risk defence", which enables pharmaceutical companies to evade responsibility by hiding behind their ignorance of the risk at the time the damage occurred;
• simplifying the legal procedures and extending the period in which plaintiffs can apply for compensation;
• ensuring that the interests of patients and consumers take precedence over trade secrets, which are used to conceal clinical data;
• enabling member states to adopt measures that give patients and consumers greater protection than the minimum European standard (3).

References 
1- "Defective products: liability". eur-lex.europa.eu accessed 13 July 2023: 4 pages.
2- "Letter to the members of the JURI and the IMCO Committees" 27 April 2023: 2 pages.
3- "Proposal for a Directive on liability for defective products (…) Amendments proposals by France Assos Santé and Prescrire" 10 March 2022: 6 pages.

©Prescrire 1 January 2024

Source: "Defending the right to compensation for the victims of drug-induced harms" Prescrire Int 2024; 33 (255): 26. Free.

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