The Federation of the European Pharmaceutical Industry Associations (EFPIA) and MedTech Europe (representing manufacturers of medical technologies) are among the industrial associations that jointly signed a statement on the Product Liability Directive (PLD) revision proposed by the EU Commission. The PDL directive was originally published in 1985 and revised in 1999; it addresses the product liability regime in order to balance manufacturers’ interest to innovate and consumers’ fair access to compensation.

According to the 11 associations that signed to joint statement, the current proposal might pose a risk for the European competitiveness, as it might result in a increased number of litigations and speculative claims. Instead of just addressing the challenges posed by new technologies such as AI and Internet of Things (IoT) devices, the proposals would involve a complete revision of the current framework. According to the industrial associations, the undergoing discussions by the EU institutions would be too rapid to achieve final satisfactory rules. This may result on a higher burden on national judicial and court systems to accommodate the new and unfamiliar rules, as well as in a low confidence in, or incentivise, manufacturing in Europe.

The statement also highlights six point of attention that should be considered in the revision of the PLD directive, including the liability of software, sufficient protection against malicious mass-claims and third-party litigation funding, the narrowing of key concepts (e.g. the definition of “damage”), safeguards on evidence disclosure orders, limiting the alleviation of the burden of proof, and reinstating monetary upper and lower thresholds.

Source: EFPIA