Twelve European industrial associations, including EFPIA, MedTech Europe and COCIR in the healthcare sector, have published a joint statement to call for a major rethink of the ongoing revision of the Product Liability Directive (PLD). The main concern expressed in the document is the lack of balance in the proposed revision, that according to the associations could undermine European competitiveness and significantly raise litigation risk, legal complexity and uncertainty for European businesses. This might negatively impact on both investment in innovation and consumers. The industrial associations suggest to maintain the current framework, that led to good results for both parties since its entry into force in 1985. Critical parts of the proposed PLD revision, wrote the associations, refer to the expanded scope to include digital products, the de facto reversal of the burden of proof, disproportionate disclosure of evidence provisions and removal of compensation thresholds.
Requests to the Trilogue, now in charged of final negotiations, include limits to the alleviation of the burden of proof, which should be significantly narrowed, and clarified as for what claimants must do and prove before any liability can be presumed. More safeguards would be needed as for the disclosure of evidence, in order to protect businesses against abusive discovery exercises or disclosure of commercially sensitive data or trade secrets. According to the associations, disclosure of evidence should be limited to only what is strictly necessary and proportionate. A greater attention should be also posed in the inclusion of software in a strict liability regime, and how to apply the concept of defectiveness. The associations agree with the EU Parliament proposal of a threshold to prevent frivolous claims.