Legal & Regulatory > Belgium > Product Liability

The low-down on the situation regarding product liability in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.

1. What types of liability are recognized in your jurisdiction?

Belgian law distinguishes two types of civil liability: contractual liability and tort liability. Where the first arises from a failure to execute, respect or comply with contractual obligations, the latter arises when certain acts cause harm or damage.

In terms of tort liability, a further distinction should be made between ‘fault liability’ and ‘objective liability’. Fault liability requires that a fault has been committed causing the harm or damage. Fault is a broad term encompassing not only the violation of a legal norm but also any act which is considered illicit. In case of objective liability or risk liability, there is no requirement of such a ‘fault’: the liability is based on the (increased) risk certain activities bring about, as a result of which the mere harm or damage resulting from a certain action is sufficient to trigger liability.

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

The manufacturers of medicines and medical devices are subject to the provisions of the Law of 25 February 1991 on product liability. This Law also applies to medicines and medical devices, and establishes a regime of objective liability. This entails that no proof of ‘fault’ must be proven: only the damage, the defect and the causal relationship between those two must be established.

A product is ‘defective’ when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including:

1. the presentation of the product;
2. the use to which it could reasonably be expected that the product would be put;
3. the time when the product was put into circulation.

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

The objective product liability regime of the Law of 25 February 1991 extends not only to the manufacturer, but also to the other participants in the chain from production to sale, including importers, retailers, wholesalers and distributors.

The objective product liability regime does not extend however to corporate executives, employees and representatives. Corporate executives could be held liable for any harmful act that can be qualified as a ‘fault’ that is causally linked to damage of a third party. Employees will, depending on the circumstances, be able to benefit from Article 18 of the Law on the Employment Contracts which provides they are only liable for deceit and grave fault. The employee is only liable for a minor fault if it occurs rather habitually then by chance.

4. How can a liability claim be brought?

A liability claim can be brought before the judicial courts.

5. What defences are available?

In order to escape liability by virtue of the Law of 25 February 1991, the manufacturer must prove that

1. he did not put the product into circulation; or
2. having regard to the circumstances, it is plausible 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
3. the product was neither manufactured by him for sale or any form of distribution for economic purpose nor manufactured or distributed by him in the course of his business; or
4. the defect is due to compliance of the product with mandatory regulations issued by the public authorities; or
5. the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered; or
6. in the case of a manufacturer of a component, 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.