Press Release: Liability Frameworks in the Life Sciences Sector and their Implications for the EU Single Market

The discussion brought together experts SIMON NEILL, Chair of the Board, European Justice Forum; GRÍMUR JOHANNSSON, Associate Director, EFPIA; JACEK GARSTKA, Legislative Officer, Civil Justice, Directorate-General for Justice and Consumers, European Commission; PABLO ROJAS ABAD, Associate Director and Senior Legal Counsel, MedTech Europe; ALBERT VERDAGUER, Senior Legal Counsel, Legal, Ethics and Business Integrity, Sanofi; and TILL OLAF VOSS, Senior International Counsel, Global Public Affairs, Bayer. The discussion was moderated by AGATA BOUTANOS, CEO, European Justice Forum.

MEP Adam Jarubas, Chair of the SANT Committee, European People's Party stated that SANT Committee is directly responsible for safeguarding the health of European citizens. This responsibility extends to ensuring that the legal frameworks governing essential medical products are fair, predictable and grounded on the rigorous safety systems that Europe has built over the past 40 years or more. The Single Market relies on an effective and robust regulatory environment that protects patients while fostering innovation so that the newest medical technologies can be made quickly and safely available to patients in Europe. The revised Product Liability Directive (PLD) is expected to increase litigation risks, especially in cross-border and mass claims, due to the changes that tilt the balance of risk decisively in favour of claimants, even in cases that are meritless, speculative or based on very weak evidence. The growing role of litigation funding affects how mass claims are initiated, financed and pursued across jurisdictions and the effects on the EU market should be carefully examined.

"The Single Market relies on an effective and robust regulatory environment that protects patients whilst fostering innovation so that the newest medical technologies can be made quickly and safely available to patients in Europe." — MEP Adam Jarubas, Chair of the SANT Committee, European People's Party

MEP Anna Zalewska, European Conservatives and Reformists, called on Europe to prioritise its economy, innovation, industry, and SMEs by ensuring a stable, harmonised, and secure regulatory environment for sustainable growth, recalling the Parliament's 2022 Resolution urging the Commission to establish a harmonised framework for third-party litigation funding. She warned that the revised Product Liability Directive currently being transposed by Member States until December this year risks presuming even fully compliant products to be defective, driving up administrative, insurance, and litigation costs, and creating a fragmented legal landscape through varied national implementation. Mrs Zalewska concluded that maintaining a coherent and predictable legal framework is essential to safeguard consumers while preserving a favourable environment for investment and innovation throughout the Union.

MEP Vytenis Povilas Andriukaitis, Socialists and Democrats (participating virtually) opened by describing the life sciences sector as being at the heart of Europe, contributing nearly €1.5 trillion to the

EU economy and supporting 29 million jobs. Mr Andriukaitis warned that the ambition to make Europe the world's most attractive destination for life sciences by 2030 must not be undermined by unintended risks such as US-style mass litigation driven by offshore hedge funds and commercial lawyers incentivised by profit rather than justice. He called for careful scrutiny of the revised Product Liability Directive, cautioning that even fully compliant products risk being presumed defective under certain conditions, that varied national implementations threaten to fragment the internal market, and that a coherent, predictable framework is urgently needed to safeguard consumers while maintaining a favourable environment for investment and innovation.

Grímur Johannsson, Associate Director, EFPIA, argued that Europe has the talent, infrastructure, and scientific tradition to lead globally in pharmaceutical research and development, but is increasingly lacking the legal and regulatory stability that global investment decisions require. Johannsson underlined that the pharmaceutical sector already operates under one of the most demanding regulatory regimes on earth, with every product undergoing extensive clinical evaluation and safety assessment before reaching patients. He warned that a liability framework capable of presuming such a product to be defective risks undermining the very approval systems that protect patients, while making Europe a less attractive location for the development and launch of next-generation medicines, and called for liability to be anchored to the state of knowledge at the time of market authorisation.

Jacek Garstka, Legislative Officer, Civil Justice, DG JUST, European Commission, reaffirmed that the Product Liability Directive is an instrument intended to ensure that those harmed by defective products can obtain fair redress, and that this objective remains important. However, Garstka acknowledged that the lessons emerging from transposition make clear that ambiguity in key concepts must be addressed through clear and consistent guidance at the European level if the Directive is to function as intended. He noted the Commission's attentiveness to the risk that expanded liability exposure, combined with the rise of third-party litigation funding, could overburden national justice systems and generate disproportionate outcomes, emphasising that protecting access to justice and protecting the integrity of justice systems are two sides of the same coin.

Pablo Rojas Abad, Associate Director and Senior Legal Counsel, MedTech Europe, described medical technology as an industry built on proximity to clinical need and continuous innovation, in which small and medium-sized enterprises play a critical role. Rojas Abad highlighted that the European Medtech sector includes 38.000 medical technology SMEs in Europe, around 90% of which are SMEs, and the majority of which are under 50 employees and these companies do not have at their disposal the legal resources of large multinationals to absorb prolonged litigation. He cautioned that the revised Product Liability Directive, implemented without clear parameters for national judges, could expose these businesses to uncertainty and additional costs that threatens their participation in the supply chain altogether, and called for harmonised guidance that preserves the capacity of SMEs to compete and innovate within the EU Single Market.

Albert Verdaguer, Senior Legal Counsel, Sanofi, noted that the life sciences sector is one of the last high-technology industries that still manufactures at scale within Europe, doing so precisely because of the predictable, science-based regulatory environment the EU has constructed over decades. Verdaguer stressed that medicines are approved according to high standards applicable when they were developed and authorised and therefore a liability regime that effectively reopens that assessment once products are commercialized introduces a degree of legal uncertainty incompatible with long-term investment planning.

Till Olaf Voss, Senior International Counsel, Bayer, drew on Bayer's experience operating across multiple continents to illustrate how differences in liability frameworks shape litigation exposure, insurance costs, market access decisions, and ultimately where companies choose to invest and innovate. Voss pointed to the United States and the decades of mass litigation in the pharmaceutical and agricultural sectors, much of it financed by third-party funders pursuing portfolio strategies rather than justice motives, that offers a cautionary tale that Europe should learn from rather than replicate. He warned that forum shopping is already a feature of the European litigation landscape, and that the revised Product Liability Directive risks accelerating that dynamic, calling on the EU to design safeguards that preserve genuine access to justice while preventing the kind of systemic litigation abuse that ultimately harms the patients and consumers these rules are meant to protect.

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