A brief overview of the situation regarding product liability in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.
1. What types of liability are recognized in your jurisdiction?
The Portuguese legal system provides for two fundamental types of civil liability: liability arising from failure to comply with contractual obligations (contractual liability) and liability resulting from the infringement of fundamental rights or from the practice of certain acts that, although licit, cause harm to another (non-contractual liability).
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
The non-contractual liability includes the objective liability (as opposed to subjective liability based on guilt), based on the risk, which is an exceptional scheme and aims to cover certain activities which by their nature were considered to be dangerous because of an increased risk. There is one specific legal framework which establishes the objective liability for manufacturers of products, including medicinal products and medical devices: the manufacturer’s liability legal framework set forth in Decree-Law 383/89, 6 November 1989, amended by Decree-Law 131/2001 which governs the manufacturer’s liability, regardless of fault, for the damages caused by a defect in his product.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
The general principle governing civil liability of directors and other corporate executives, establishes that, any director that, wilfully or negligently, infringes another person’s right or a legal provision designed to protect the interests of others, is under the obligation to indemnify the aggrieved party for the damages arising from such infringement.
4. How can a liability claim be brought?
A liability claim shall be brought through judicial courts.
5. What defenses are available?
The general rule is that the complainant shall make evidence of the damages caused due to the guilty action of the defendant. However, in the specific case of the manufacturer’s liability, the complainant is exempted from proving the manufacturer’s guilt.
Moreover, in this legal framework the manufacturer may not be liable in case the following claims are evidenced: (i) the manufacturer did not put the product into circulation; or (ii) that, having regard to the circumstances, it is probable that the defect which caused the damage did not exist at the time when the product was put into circulation by him or that this defect came into being afterwards; or (iii) that the product was neither manufactured by the manufacturer for sale or any form of distribution for economic purpose nor manufactured or distributed by him in the course of his business; or (iv) that the defect is due to compliance of the product with mandatory regulations issued by the public authorities; or (v) that the state of scientific and technical knowledge at the time when the manufacturer put the product into circulation was not such as to enable the existence of the defect to be discovered; or (vi) in the case of a manufacturer of a component, that the defect is attributable to the design of the product in which the component has been fitted or to the instructions given by the manufacturer of the product.