Legal & Regulatory > Bulgaria > Product Liability

All legal aspects surrounding product liability in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.

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

There are three types of liability recognised in Bulgaria, as follows:

• civil liability;
• administrative liability; and
• criminal liability.

(A) Civil Liability

There are two types of civil liability under Bulgarian law:

• contractual liability, which results from non-performance by the obligor of contractual obligations towards the creditor;
• non-contractual liability (tort), which results from a failure of a person (damaging person) to comply with the general obligation not to cause damage to third parties (damaged person). This liability is not preceded by a contractual relation between the damaging person and the damaged person.

(B) Administrative Liability

Administrative liability results from committing an administrative violation. An administrative violation is such an act (action or omission) that (i) breaches the established order of state government, (ii) has been committed guiltily and (iii) has been declared punishable by an administrative sanction to be imposed following an administrative procedure.

The general rules on administrative violations are set out in the Bulgarian Administrative Violations and Penalties Act. Specific administrative violations and administrative sanctions thereof are regulated in other legislative acts covering different spheres of state government (e.g. tax, customs, etc.).

(C) Criminal Liability

Criminal liability results from committing a crime. All crimes are explicitly regulated in the Bulgarian Criminal Code. Only natural persons can bear criminal liability.

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

(A) Civil Liability

Under the Bulgarian Consumers Protection Act, manufacturers are liable towards consumers for damages caused by defective goods on the basis of tort. In deviation from the general rules of the non-contractual liability, the Bulgarian Consumers Protection Act provides for the following specific rules for this non-contractual liability (product liability):

• only damages resulting from by the following could be compensated:

• • death or injury of a natural person;
  • damage to, or destruction of, any item other than the defective product itself, which item amounts to not less than BGN 1,000 (approximately EUR 510), provided that said item is principally intended for private use and was used by the injured person as intended.
• the manufacturer shall be liable for the damages caused by defective goods, irrespective if the manufacturer is guilty for the respective defect;
• a product is deemed defective when it does not meet the common expectations of customary use, taking all circumstances into account, related to: (i) quality, quantity, name, type, composition, origin, durability, distinctive features, customary and possible use of the product, advertisement of the product and the information provided about it; (ii) the time when the product was put into circulation.

A consumer may claim a compensation of damages caused by defective goods on the grounds of the specific regulation in the Bulgarian Consumers Protection Act or the general rules of non-contractual liability provided in the Bulgarian Obligations and Contracts Act.

In addition, under the general provisions of Bulgarian contract law, in case of a non-performance of its contractual obligations a manufacturer may be liable towards any third party with which the manufacturer has entered into an agreement.

(B) Administrative Liability

An administrative liability of a manufacturer of medicines is provided in the Law on Medicinal Products in Human Medicine (e.g. for manufacturing of medicines without a licence or in non-compliance with the requirements of Bulgarian law).

(C) Criminal Liability

The Bulgarian Criminal Code does not explicitly provide for a specific crime related to the manufacturing of medicines, except in case of manufacturing of veterinary medical products without the required licence. Specific crimes related to manufacturing or trade with narcotic products or substances or manufacturing that is dangerous for the health or the environment may be relevant for manufacturers of medicines and medical devices.

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

In general, product liability under the Bulgarian Consumer Protection Act does not extend to corporate executives, employees and representatives of the manufacturer.

Liability for tort under the general civil liability rules in most cases requires some sort of guilt that is attributable to a natural person. Therefore, in general, only natural persons can be liable for tort. However, certain exceptions exist and legal entities may also be held liable for tort in specific cases.

Contractual liability lies with the manufacturer that is a party to a contract. Administrative liability may extend to corporate executives, employees, and representatives, if they are found responsible for breaching the respective administrative obligations or requirements.

After the manufacturer compensates the third party, it is entitled to seek recovery from its employees who are responsible for the damages.

Since only natural persons can be criminally liable, in case of a crime the liability is usually borne by an employee or another person acting on behalf of the manufacturer.

4. How can a liability claim be brought?

(A) Civil Liability

A civil liability claim can be brought before court or an arbitration institution (if given the specific contractual relation, an arbitration clause is permitted under Bulgarian law and is included in the respective agreement). The claimant must substantiate the claim and prove the elements that trigger the liability.

(B) Administrative Liability

Administrative liability is imposed by the respective administrative authority responsible for the specific sector of state government following an administrative procedure described in detail in the Bulgarian Administrative Violations and Penalties Act.

(C) Criminal Liability

Criminal liability is imposed by the court following a criminal prosecution procedure initiated by the investigative and prosecution authorities and described in detail in the Bulgarian Criminal Procedure Code.

5. What defenses are available?

(A) Civil Liability

Contractual Liability

The plaintiff should prove before the court that the defendant has failed to perform one or more of its contractual obligations and that has caused damages to the claimant. The defendant is not obliged to prove that it has duly performed its obligations but could simply deny the claimant’s assertions.

In addition, the defendant could claim that the limitation period of the claimant’s claim has expired. The limitation period of a contractual claim for compensation of damages is 3 (three) years.

Non-Contractual Liability

In case of a general tort, the guilt of the damaging person is presumed by law. This means that the claimant is not required to prove that the defendant has guiltily caused the damages. Therefore, the defendant could not as in the case of a contractual liability simply deny the claimant’s assertions but should actively prove that it is not guilty for the damages caused to the claimant. Still, the claimant must prove the damages and that they were caused by an act (action or omission) of the defendant.

In addition, the defendant could claim that the limitation period of the plaintiff’s claim has expired. The limitation period for civil claims based on tort is 5 (five) years.

If the claim is brought on the grounds of the Bulgarian Consumers Protection Act for damages caused by defective goods, the manufacturer shall not be responsible for the damages caused to the consumer if the manufacturer proves one or more of the following circumstances:

• the manufacturer has not put the goods into circulation;
• considering all circumstances, it is probable that the defect which caused the damage has not existed at the time when the product was put into circulation by the manufacturer or that this defect became apparent afterwards;
• the manufacturer neither manufactured the product for sale or any form of distribution for economic purposes nor manufactured or distributed said product in the course of the its business activity;
• the defect is due to compliance of the product with mandatory requirements established by the public authorities;
• due to the level of scientific and technical knowledge at the time of placing the product on the market, the deficiency could not have been detected;
• the damage is caused both by the defective product and by the damaged person or by a person for whom the damaged person is responsible.

In addition, the manufacturer could claim that the limitation period of the damaged person’s claim has expired. The limitation period for such claims is 3 (three) years as of the date on which the damaged person has become aware or should have become aware of the damages, the defect and the manufacturer’s identity.