Module 5 Presentations

19/07/2024

Legal bases for claims by injured trial subjects

• Strict liability (EU Product Liability Directive/national regimes/UK Consumer Protection Act 1987) • Negligence • Contract (e.g. ABPI Clinical Trial Compensation Guidelines 2014: Phase I Clinical Trial Compensation Guidelines) • Voluntary schemes/provision (e.g. ABPI Clinical Trial Compensation Guidelines 2014: Phases II, III and IV Clinical Trials Compensation Guidelines, Nordic compensation schemes)

The Organisation for Professionals in Regulatory Affairs

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• Imposes liability on the producer of a defective product. • “Producer” is defined as: Strict Liability: EU Product Liability Directive 85/374/EEC – including manufacturer, producer of raw material, manufacturer of component part, person who, by putting his name etc on the product, presents himself as producer – the person who imports the product into the EU – Where the producer cannot be identified, each supplier is treated as producer unless he can identify the person who in turn supplied the product to him. Article 3

The Organisation for Professionals in Regulatory Affairs

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