PLD Article 2. Scope

Liability for defective products should not apply to damage arising from nuclear accidents, in so far as liability for such damage is covered by international conventions ratified by Member States.

Under the national law of Member States, an injured person could have a claim for damages on the basis of contractual liability or on grounds of non-contractual liability that does not involve the manufacturer’s liability for the defectiveness of a product as established in this Directive. This concerns for example liability based on a warranty or on fault or strict liability of operators for damage caused by the properties of an organism resulting from genetic engineering. Such national law provisions, which serve to attain, inter alia, the objective of effective protection of consumers and other natural persons, should remain unaffected by this Directive.

In certain Member States, injured persons are entitled to make claims for damage caused by pharmaceutical products under a special national liability system, with the result that effective protection of natural persons in the pharmaceutical sector is already achieved. The right to make such claims should remain unaffected by this Directive. Furthermore, amendments to such special liability systems should not be precluded as long as they do not undermine the effectiveness of the system of liability provided for in this Directive or its objectives.

Compensation schemes outside the context of liability regimes, such as national health systems, social security schemes or insurance schemes, fall outside the scope of this Directive and should therefore not be precluded. For example, some Member States have schemes in place to provide compensation in respect of pharmaceutical products that cause harm without being defective.

Free and open-source software, whereby the source code is openly shared and users can freely access, use, modify and redistribute the software or modified versions thereof, can contribute to research and innovation on the market. Such software is subject to licences that allow anyone the freedom to run, copy, distribute, study, change and improve the software. In order not to hamper innovation or research, this Directive should not apply to free and open-source software developed or supplied outside the course of a commercial activity, since products so developed or supplied are by definition not placed on the market. Developing or contributing to such software should not be understood as making it available on the market. Providing such software on open repositories should not be considered as making it available on the market, unless that occurs in the course of a commercial activity. In principle, the supply of free and open-source software by non-profit organisations should not be considered as taking place in a business-related context, unless such supply occurs in the course of a commercial activity. However, where software is supplied in exchange for a price, or for personal data used other than exclusively for improving the security, compatibility or interoperability of the software, and is therefore supplied in the course of a commercial activity, this Directive should apply.

Where free and open-source software supplied outside the course of a commercial activity is subsequently integrated by a manufacturer as a component into a product in the course of a commercial activity and is thereby placed on the market, it should be possible to hold that manufacturer liable for damage caused by the defectiveness of such software but not the manufacturer of the software because the manufacturer of the software would not have fulfilled the conditions of placing a product or component on the market.