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Freshfields Risk & Compliance

| 2 minutes read

Commission expert group discusses reform of the EU Product Liability Directive

On 8 June, I was privileged to participate in the first meeting of the "product liability formation" of the European Commission's new expert group on liability and new technologies. I attended on behalf of Freshfields. 

This group of "representatives of Member States and EFTA states, organisations and private experts" has been asked to consider the need for changes to the Product Liability Directive (85/374/EEC) ("PLD"), in order to adapt it to emerging technologies - AI, the internet of things, 3D-printing and so on. 

In the meantime, the expert group will support the Commission in producing guidance on the PLD regime. This is being drafted over the summer. The group will also help with the production of a report, due in mid-2019, on possible gaps in the safety and liability frameworks for new tech.

The Commission has now published the minutes of the July meeting, which are available on its website, here.  Here are some of the key points that were discussed during breakout sessions at the meeting, as noted in those minutes:

  • who should be held liable under the PLD regime in the case of 3D-printed products? Should it be the consumer or business who makes the product, the manufacturer or importer of the 3D-printer, or the supplier of the design that is used? Should there be joint liability in the supply chain, as some at the meeting suggested?
  • more generally, who should be responsible for defects in any product that cannot be foreseen at the time that it is put on the market? Should defendants bear this risk, or should the current development risks/"state of the art" defence - which protects defendants in such cases - continue to apply?
  • the relevance of compliance with safety legislation and standards in determining whether a product is defective or not was discussed...
  • ... as was whether the risk-benefit profile of drugs and medical devices is relevant in that context. For example, if a drug has enormous potential benefits, but also significant side-effects, and receives a marketing authorisation on that basis, shouldn't the potential for patient benefit as well as harm be taken into account when assessing defect?
  • should the types of damage recoverable under the PLD be widened to include pure economic loss and damage to personal data or privacy?
  • should the burden of proof be modified in order to facilitate claims, on the basis that "[c]onsumers are in a weak position to show the requirement of causation between the damage and the defect, consumers have limited information and this problem will worsen with the advancement of new technologies"
  • currently, claims under the PLD may only be brought within ten years of the date that the product at issue was put into circulation. There was discussion as to whether this period needed to be extended for e.g. pharmaceutical products to 20 years.

My own view is that some of the points above go to the heart of the operation of the regime, and to the balance that was struck 33 years ago, when the PLD became law, between consumer interests and the need to protect growth and innovation, and to enable risks to be insured. Changing substantive provisions of the Directive, e.g. as to the burden of proof or the length of the longstop period, would need new legislation, not just guidance.

The draft guidelines will, as the minutes note, be discussed at the next meeting of the expert group on 18 September.

The expert group will support the Commission in producing guidance on the PLD regime. This is being drafted over the summer.


europe, regulatory, employment