Product liability in the life sciences sector

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Product liability in the life sciences sector
  • What is product liability?
  • The EU and UK regulatory framework
  • Product Liability Directive 1985
  • Consumer Protection Act 1987
  • Relationship with the pharmaceutical regulatory framework
  • Liability for defective products
  • What is ‘damage’?
  • What is a ‘product’?
  • What is a ‘defect’ or defective product?
  • More...

Product liability in the life sciences sector

The UK regulatory framework for product liability has mainly originated from EU law. Many principles and requirements derived from EU law have been maintained in UK domestic law, unless specific provisions stipulate otherwise. This Practice Note discusses the EU and UK regimes in parallel: considerations on EU legal requirements can be regarded as applicable to the UK regime unless UK provisions which diverge from EU legislation are explained separately. For information on the extent to which UK courts and tribunals are bound by EU case law after the Brexit implementation period, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit?

What is product liability?

Products sold to consumers must be safe. In the UK, product safety is governed by a wide legal and regulatory framework, with certain high-risk products, such as medicines, being subject to additional regulation.

Failure to comply with these laws can lead to both civil and criminal liability.

Civil product liability can be based on:

  1. strict liability (as a result of a defect in a product rather than any fault on the part of the defendant) under the Consumer Protection Act 1987 (CPA 1987), which implemented Directive 85/374/EEC, the Product Liability Directive, into UK law

  2. negligence (fault-based liability where a duty of care has been breached and resulted

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