Product liability in Romanian Pharma – a legal guide. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
The failure to comply with the Romanian pharma legislation can trigger disciplinary, civil, material, contraventional or criminal liability, depending on the case.
Additionally, the competent authorities in various fields can apply fines and other sanctions when the breach is related to competition law, consumer protection, misleading and comparative advertising, IP law.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
The Health Law provides a general reference to the legislation applicable for each type of liability. Also, in several cases, the Health Law specifically stipulates the type of liability and sanction applicable to a particular breach or to blocks of breaches.
The civil liability refers to the civil obligation to cover any damage caused either by breach of contract (contractual liability) or by the committing of an illicit action (tort liability).
As a general rule, manufacturers are liable according to Law no. 240/2004 on the liability of manufacturers for damages caused by defective products. Manufacturers have to ensure the security of the manufactured product at a level of consumers’ expectancy considering the presentation of the product, its predictable uses and the date of releasing it on the market. Otherwise, they are liable for the current and future damage caused by the defects of their product. In order to trigger the civil liability of the manufacturer, the injured person must prove the damage, defect and causation between the defect and the damage.
Additionally, the Health Law specifically provides that the manufacturers of medical equipment and medical devices, medicinal substances and sanitary materials are liable according to civil law for the damage caused to patients during prevention, diagnosis and treatment activities, generated directly or indirectly by hidden defects of the products, during the warranty / validity period, in accordance with the legislation in force.
Criminal liability may be applied in several cases to manufacturers of medicines and devices for breaching the Criminal Code or other criminal law related provisions included within other laws.
According to the Health Law, the breach of the regulations on medicines’ good clinical practice and the conduct of clinical studies by unqualified employees are considered criminal offences.
Administrative liability arises from administrative offences, sanctioned by the public authorities. Administrative offences may include: breach of the legislation related to competition or consumer protection, non-compliance with licensing, advertising, manufacturing and distribution requirements, etc.
Disciplinary liability is usually applicable in connection with (i) the disrespect of mandatory provisions on the profession or deontology and of good professional practices and (ii) labour obligations, by the employer to the employee, where a labour or collaboration agreement exists. The Health Law does not specifically detail the applicability of this type of liability in the case of manufacturers of medicines and medical devices.
Material liability is usually connected to labour relationships and it is triggered where a material damage is caused by one of the involved parties.
There is a thin line between the above-mentioned types of liabilities, which can be cumulated depending on the illicit deed causing the prejudice.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
According to the Romanian Civil Code, a legal person is liable for the deeds of its organs if committed in connection with the attributions or with the purpose of the occupied position at the respective company. The liability of the legal person does not exclude the liability of the natural person, regardless of its position in the company. The company is entitled to sue for compensation the natural person responsible for the illicit deed.
Similarly, from a criminal law perspective, the legal person, with the exception of the state and the public authorities, is liable for criminal offenses committed in pursuit of the object of activity or in the interest or on behalf of the legal person. The criminal liability of the legal person does not exclude the criminal liability of the natural person who contributed to the same deed.
4. How can a liability claim be brought?
Claimants can file civil and criminal challenges with the competent courts against a manufacturer, to claim for damage caused by the defect(s) of the product. As a rule, a product liability claim can be brought within three years as of the date the claimant was aware or should have been aware of the damage, the product’s defect and the identity of the manufacturer, but no later than ten years as of the date when the product in question was first placed on the market by the manufacturer.
NAMMD inspectors could apply sanctions (following inspections or complaints) in case of offences in connection with the breach of obligations incumbent to manufacturers.
Additionally, the Romanian legislation provides for different procedures to be carried out by the competent authorities in different fields.
Thus, as a rule, the competent authorities could apply sanctions when finding the applicable legislation is breached, following complaints (e.g., filed by consumers or competitors) following ex officio inspections or other specific procedures. This is the case of the sanctions applied, inter alia, by the Competition Council, National Authority for Consumer Protection, Ministry of Health, Ministry of Finance, National Audiovisual Council.
5. What defenses are available?
According to the Health Law, civil and administrative liability of marketing authorization holders, manufacturers and qualified healthcare professionals is not engaged for the consequences resulting from:
- the use of a medicinal product other than for authorized indications;
- use of an unauthorized medicinal product where such use is recommended or required by a competent national authority in response to a suspicion of spread or confirmed spread of pathogens, toxins, chemical agents or nuclear radiation, liable to produce damage.
Also, the legislation on liability of manufacturers for damages caused by defective products provides that manufacturers of various products are not liable in the following cases:
- the product was not placed on the market by the manufacturer;
- depending on the circumstances, the defect that caused the damage did not exist at the time the product was placed on the market or appeared after the product was placed on the market, due to causes independent of the manufacturer;
- the product was not manufactured for trading or other form of distribution for the manufacturer’s economic purposes, and was not manufactured or distributed during its business activity;
- the defect is due to compliance with mandatory requirements imposed by regulations issued by the competent authorities;
- the state of scientific and technical knowledge at the moment the product was placed on the market did not allow the discovery of the defect;
- the defect is caused by the consumer, due to non-observance of the instructions for use.
Note should be made that, by law, any contractual limitation or exemption from liability of the manufacturer is null and void.
Additionally, in terms of civil law, one common defense is the lack of causation between the illicit deed and the damage. Also, the rules on force majeure or fortuitous case could be applicable.
From a criminal law perspective, the offense is the sole ground of criminal liability. Therefore, no sanction can be applied if the concerned deed does not meet the conditions of an offense.