Liability for defective products

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. Through its direct membership of 37 national associations, 38 leading pharmaceutical companies and a growing number of small and medium-sized enterprises (SMEs), EFPIAs mission is to create a collaborative environment that enables our members to innovate, discover, develop and…

We would like to thank you for the possibility of taking this action and ask you to take our enclosed comments into account. BVMed-Bundesverband Medizintechnologie e.V. represents around 240 manufacturers, distributors and suppliers of the medical technology industry, as well as assistive service providers and homecare suppliers.

Filed in German · English published by the European Commission

The member statutory health insurance funds of the AOK-Bundesverband (Federal Association of the AOK) welcome the European Commission's initiative to modernise product liability law. Particularly due to digitalisation, products and technologies have developed rapidly in recent decades. Modern product liability law must keep pace with this so that no gaps in liability arise.

As per the document attached that provides MedTech Europe more detailed feedback, we welcome the opportunity to provide feedback to the proposed revision of the EU Product Liability Directive (85/374/EEC) (PLD).

To Whom It May Concern, The Regulatory Institute (https://www.howtoregulate.org) is pleased to provide its feedback to the Proposal for a Directive on liability for defective products COM(2022)495. The Regulatory Institute is a non-profit think tank which identifies, develops and promotes best regulatory practices. We aim to improve regulation globally so that regulations benefit us all.

BEUCs preliminary feedback on the PLD proposal: BEUC, the European Consumer Organisation, welcomes the initiative of the European Commission to revise the Product Liability Directive (PLD). However, the European Commission proposal (the proposal) does not sufficiently address fundamental issues like the subsidiary liability of online marketplaces, the burden of proof, the liability exemptions as well as the…

The U.S. Chamber Institute for Legal Reform thanks the European Commission for the possibility to provide feedback on the proposed Product Liability Directive. Please see the attached memo for our detailed comments. Contact: M. Scévole de Cazotte Senior Vice President International Initiatives U.S. Chamber Institute for [name removed]

Developers Alliance welcomes the opportunity to provide feedback on the proposal for a Directive on liability for defective products. The proposal is revising the legal framework provided by the Product Liability Directive (PLD), extending the scope in regard to software, types of damages and changing the burden of proof and conditions for compensation claims.

The Product Liability Directive has proven its value during the past three decades to ensure the victims right to compensation, even without fault on the part of the producer (strict liability). This directive oversees significant aspects of the European Single Market; it complements the safety requirements for placing a product on the Market with the right to compensation in case a product is still defective, i.e.

TomTom wishes to submit feedback on the Product Liability Directive together with fellow location technology provider HERE Technologies. Our position paper gives feedback on both the Product Liability Directive and the AI Liability Directive. Please refer to our position paper for full details.

The European Commissions proposal for a revision of the Product Liability Directive (PLD) intends to adapt the liability regime to the digital economy and the circular economy. The Commission proposes to include software and AI in the scope of the Directive, to ease the burden of proof for claiming liability through some rebuttal presumptions. The Commission also proposes to slightly alter the chain of liability.

France Assureurs would like to stress that the voice of the insurance profession is driven by the willingness to accompany technological changes, while taking into account constraints specific to the insurance operation, which requires legal certainty, indispensable for the proper functioning of the insurance/liability pair.

The Deutscher Anwaltverein (DAV) is the professional association for lawyers in Germany; membership is optional. The DAV brings together more than 61.000 lawyers and notaries of lawyers, organised in 253 local bar associations in Germany and abroad. He represents the interests of the German Bar at national, European and international level.

Filed in German · English published by the European Commission

Below you can find our non-exhaustive feedback to the proposal from September 2022 for a Directive on liability for defective products: VDMA is sceptical of the definition of products - as foreseen in Article 4 - to explicitly include digital manufacturing files and software. The definition of digital manufacturing files is vague and the term software has to be differentiated.

Product liability law in the European Union is based on a 1985 directive. It is outdated and needs to be revised. The Vzbv welcomes the European Commission’s objective of adapting the rules on liability for defective products to the digital age and ensuring that the rules reflect the potential risks of products in the digital age and include the circular economy.

Filed in German · English published by the European Commission

Google welcomes the opportunity to provide feedback on the Commission’s revision of the Product Liability Directive (PLD). Google is happy to answer any additional questions the Commission may have regarding our submission and we also stand ready to continue engaging constructively with the Commission and EU co-legislators over the coming months. Please see the attached document.

Insurance Europe appreciates the European Commissions intention to create a liability regime suitable for the digital age by revising the Product Liability Directive (PLD). However, the proposal, as currently drafted, would negatively impact the availability of insurance and would therefore not meet its intended purpose of enhancing consumer protection while encouraging innovation.

See the full submissions attached. Summary PEOPIL Is disappointed in the draft directive. Whilst the headlines suggest that it is making it easier for victims to bring claims when consumer protection has failed, in reality very few of the changes assist the consumer.

The Bundesarchitektenkammer e.V. (Bundesarchitektenkammer e.V.) (BAK) is a grouping of the 16 regional architects’ chambers in Germany, which are bodies governed by public law which are responsible for the profession. It represents the interests of over 138.000 architects, landscape architects, interior architects and city planners vis-à-vis politics and the public at national and international level.

Filed in German · English published by the European Commission

The PROPOSAL OF THE REVISEE DIRECTIVE NOT GUARANTING LACCES OF VICTIES OF INTERSIONS OF PHARMACEUTICAL PRODUCTS A linCompensation France Assos Santé and the associations which represent (almost one hundred) have always argued that medicinal products are not products like other products and have repeatedly demonstrated that the 1985 Directive is the main obstacle to linetisation of victims of serious undesirable…

Filed in French · English published by the European Commission

SMEunited welcomes the proposal as updated liability rules are necessary to account for the necessities of a digitalised world and a circular economy. Below our main take aways: - The proposal must take into account that an increased liability comes together with higher prices for European products. - Entrepreneurs require clear rules in order to make their business decisions.

The German statutory health insurance scheme (GKV) welcomes the European Commission’s initiative to modernise product liability law. Products and technologies have evolved rapidly in recent decades, in particular as a result of digitalisation. A modern product liability law must keep pace in order to avoid any liability gaps.

Filed in German · English published by the European Commission

The current draft directive shifts the balance between consumers and businesses unilaterally to the detriment of businesses. The proposal for a Directive should therefore be rejected. The proposal only strengthens and extends liability for European companies. This shifts the existing balance between product liability rules unilaterally to the detriment of undertakings.

Filed in German · English published by the European Commission

Please find enclosed our full submission. Software resembles a service rather than a product. A blanket requalification of software as products does not seem justified. A more effective approach would be to establish classifications for software to distinguish and differentiate classes of software, and only extend the PLD to those that already qualify as quasi products because of their inherent potential to cause…

The European Savings and Retail Banking Group (ESBG) supports the protection of consumers as well as adapting liability rules to the digital age, thereby setting out a framework for excellence and trust in Artificial Intelligence. However, we understand from the proposed Directive that the presumption of a causal link in the case of fault is mainly a matter of "non-compliance of due diligence duties".

The proposed amendments of the product liability directive and the introduction of the new AI liability directive cut across the operations of LKQ Europe. In the attached response we focus on four issues: Distributor liability: the importer can be held liable in case of import from outside the EU and the proposed time for the distributor to identify an economic operator Circular economy and remanufacturing: the…

For the sake of appropriate information and possible subsequent dissemination, the EL.T.E. International Association and the Guglielmo Marconi Department of the University of Bologna’s Engineering School have already brought to the attention of both Italian and European Commission heads of government.

Filed in Italian · English published by the European Commission

The Italian Association of Young Lawyers has the honour to take part in the debate on product liability in order to supplement and/or repeal the current European Directive 85/374/EEC. First, the definition of a defective product (in Article 6 of the proposal) appears to be generic, since it does not provide objective parameters for the assessment, or the reference to point (h) of that article.

Filed in Italian · English published by the European Commission

We expect the implementation of AI in services and products to give top priority to the protection of the life, health and privacy of consumers or those that could be harmed by the negative impacts of AI. The question of legal liability in the event of damage needs to be clarified. Research and real-life situations have shown that AI reproduces prejudices and exacerbates discrimination.

Filed in German · English published by the European Commission

The Czech Insurtech Association would like to express its gratitude for the new and modern law on liability for defective products, and is excited about the prospect of it soon becoming a reality. We are very supportive in creating a level playing field for EU operators and those non-EU based, and we welcome the introduction of clear and predictable rules facilitating legal certainty and predictability of the…

Europeans for Safe Connection welcome this activity. However, we see that legal liability rules are being addressed with delay at a time when many services and products already use some form of AI algorithms. We expect that when AI is implemented in services and products, the protection of life, health and privacy of consumers or those harmed by the negative impacts of AI will be prioritised over manufacturers and…

Fujitsu acknowledges the efforts to critically review the legal frameworks that apply to innovative technologies such as AI. It is of high importance that both for developers, manufacturers and providers of such new technologies, as well as for the users or persons otherwise affected by these technologies, legal frameworks exist that take into account the interests of all stakeholders in a balanced and appropriate…

COCIR welcomes the opportunity to provide feedback to the European Commission’s inception impact assessment on adapting liability rules to the digital age and artificial intelligence. Member organisations of COCIR have been at the forefront of bringing innovative health technologies, including Artificial Intelligence applications, to the market and to the patient.

Fujitsu acknowledges the efforts to review the legal frameworks that apply to innovative technologies such as Artificial Intelligence. It is of high importance that both for developers, manufacturers and providers of such new technologies, as well as for the users or persons otherwise affected by these technologies, legal frameworks exist that take into account the interests of all stakeholders in a balanced and…

We support the contribution made by France Assos Santé of which we are both members and appointed on their Board of Directors: We wish to insist on certain points. 1. It is essential that the revision of this Directive with the field of drugs and health products in order to substantially review the methods of assessment, resorting to the balance between the drug companies and the victims of adverse reactions to the…

Filed in French · English published by the European Commission

Attached please find Google's views on the European Commission's inception impact assessment on civil liability - adapting liability rules to the digital age and AI. We thank the Commission for the opportunity to share feedback and look forward to the future discussion on this topic.

Huawei welcomes the debate relating to artificial intelligence and the potential update of the relevant legislative framework. We are generally in favour of a stronger harmonization of the liability framework in the EU as it may help to spur investment in AI and improve Europe’s competitiveness in the global market.

ZVEI welcomes the opportunity to provide input to the European Commission's Inception Impact Assessment on adapting liability rules to the digital age and artificial intelligence (AI). From a ZVEI point of view there is currently no reason for a fundamental revision of the Product Liability Directive (PLD) or the introduction of a new horizontal legislation on liability for AI.

A. Context, Problem definition and Subsidiarity Check: We absolutely agree with the need to adapt the current legal liability regime to the digital age and the circular economy, since artificial intelligence (AI) will certainly contribute decisively in the transition to a circular economy.

Liberty Global welcomes the opportunity to comment on the European Commission (EC)’s IIA of a possible initiative aimed at addressing a number of shortcomings identified in the evaluation of the Product Liability Directive 85/374/EEC (the Directive) and at those challenges posed by the circular economy and new emerging technologies for the application of liability rules.

The Future Society (TFS) is a global nonprofit advancing the responsible adoption of Artificial Intelligence (AI) for the benefit of humanity. With a network of policy researchers and practitioners in the EU, the US and all over the world, we build understanding of AI and its impact, we build bridges between relevant constituents, and we build innovative solutions to help communities and people all over the world…

Siemens Healthineers welcomes the opportunity to provide input to the Commission's plan to adapt the liability rules against the background of new technology developments and artificial intelligence (AI). From a Siemens Healthineers perspective, AI as a technology used in medical devices per se does not pose any danger or harm.

Microsoft appreciates this opportunity to offer feedback on the Commission’s Inception Impact Assessment on Adapting Liability Rules to the Digital Age and Circular Economy (“IIA”), in particular its proposals on new liability rules for artificial intelligence (“AI”) and software. Given the Commission’s proposed AI Act, this is a timely discussion.

GDV welcomes the Commission’s examination of EU legislation on liability and product safety in the context of innovative digital and connected technologies. The PLD and national legislation are suitable and appropriate to address the risks posed by new digital technologies.

Amalyste is the French association for patients with Toxic Epidermal necrolysis (TEN) and Stevens-Johnson syndromes (SJS), which are rare and severe adverse reactions to drugs. They result in a detachment of the skin and mucous membranes, similar to a serious burn.

MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health welcomes the opportunity to provide comments on behalf of the medical technology industry to the European Commission on the Inception Impact Assessment regarding the revision of the Product Liability Framework.

It is important that the complexity of the artificial intelligence (AI) ecosystem is taken into account, while maintaining a balance of commitment between different stakeholders. It will rarely be possible or effective for providers of general AI systems to manage in absolute terms all risks associated with potential applications in high-risk systems, as currently foreseen.

Filed in Lithuanian · English published by the European Commission

Siemens welcomes the opportunity to provide feedback on the European Commission’s Inception Impact Assessment on adapting liability rules to the digital age and artificial intelligence. For many purposes, specifically in the industrial domain, AI is a powerful technology which helps to make our lives and work easier.

DJI, the global leading manufacturer of small drones, welcomes the update of the Product Liability Directive to fit it for the digital age and clarify the liability regime of emerging technologies. DJI firmly supports the Commission’s effort to ensure the same level of protection for emerging digital technologies as for other products and services.

Estonian Land Board welcomes the initiative modernising liability rules to account for new technologies such as AI. In the same time we point out that the scope and content of possible restrictions must be significantly assessed when developing liability framework and solutions as excessive restrictions also mean inhibiting the use of AI.

The Future of Life Institute (FLI) welcomes the opportunity to participate in this consultation on the European Commission’s Inception Impact Assessment on “Civil liability – adapting liability rules to the digital age and artificial intelligence”.

Please find attached the feedback of ACT | The App Association (Transparency Reg. # 72029513877-54) to the European Commission’s Inception Impact Assessment for a legislative procedure to adapt liability rules to the digital age and circular economy. Anna Bosch EU Policy Associate ACT | The App Association (Transparency Reg. # 72029513877-54) Rue de Trèves 45 B-1040 Brussels

Bitkom welcomes the opportunity to provide feedback on the European Commission’s Inception Impact Assessment on adapting liability rules to the digital age and artificial intelligence. Please find our detailed position on this initiative in the document attached.

ACEA welcomes the opportunity to provide feedback on the European Commission’s Inception Impact Assessment on adapting liability rules to the digital age and circular economy. We provide detailed observations on this initiative in the document attached.

France Assos Santé and its member associations – about 100 – especially represent patients and victims of pharmaceutical products. They all welcome the European Commission’s initiative aimed at revising the 1985 “PLD”, the limits of which they have denounced for years.

We thank the Commission for the opportunity to reply to this important Inception Impact Assessment. The regulation on product safety and product liability is one of the key stones in protecting the European Consumers and creating and uphold a level playing field for operators in EU.

CLEPA supports the goal of modernising liability rules to account for new technologies such as AI. However, any liability framework should strike a balance between efficiently protecting victims of damage while also granting leeway for the development of new technologies, services, and products.

BEUC welcomes the possibility to give feedback on the European Commission’s Inception Impact Assessment on “Civil liability – adapting liability rules to the digital age and artificial intelligence”. BEUC recommends a comprehensive upgrade of the EU Product Liability Directive, which was adopted 36 years ago and is therefore no longer adapted to cope with the challenges brought by new technologies.

Artificial Intelligence (AI) is already widely used across all sectors and in all parts of society and it bears a lot of potential for research, innovation, and the economy. Science Europe, the representation of major national research funding and performing organisations, welcomes the fact that the European Commission (EC) intends to update its liability rules for AI.

A. Product Liability Directive – Should the EU product liability regime be revised as a consequence of AI related technological developments The liability of the producer of a product As Bosch, we urge to consider carefully, whether the Product Liability Directive (PLD) needs revision as a consequence of technological developments such as AI.