Intro to product liability in Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
In general terms, liability arises from provisions in the Argentine Constitution, the Civil and Commercial National Code, the Criminal Code, and other laws which apply to specific cases such as the Corporate Criminal Liability Law, the Consumer Protection Law, Fair Trade Law, the Law on Medicines, etc. The standards to determine damages are high.
Penalties for non-compliance with the local legal framework vary depending on the type and degree of infringement, for example, potential risk to patients’ health, degree of intentionality, recidivism, unfair competition, and so on. These can be administrative, civil or criminal sanctions.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
There are some specific laws ruling the pharmaceutical and medical device activities such as the Law on Medicines, the Consumer Protection Law, Fair Trade Law and other laws and regulations that set forth obligations and responsibilities to parties involved in the pharmaceutical and medical device business. Besides the general liabilities involving any business or activity, the pharmaceutical and medical device business have additional regulations concerning liability with the aim on protecting the population health, due to the specific risk surrounding the activity.
Infringements to pharmaceutical and devices local regulations follow the penalties or preventive measures provided in the Law on Medicines No. 16,463, and Decree No. 341/92 (and complementary regulations), and would make the company holder of the marketing authorization (jointly with its technical director) liable for such penalties.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
All the parties involved in the manufacturing and commercialization of medicines and devices can be liable in civil claims for damages derived from their acts. The executives, employees and representatives can be liable due to the lack of diligence in their tasks or in case they intentionally seek to breach the law.
According to the Law on Medicines, the holder of the marketing authorization and its technical director are jointly and severally liable for the purity and legitimacy of the products and drugs released into the market.
Furthermore, Consumer Protection Law (CPL) establishes the strict, joint and several liability of the producer, manufacturer, distributor, supplier, retailer and anyone using a brand or trademark on the product or service for damages arising from the risk or defect of products or services. The carrier is responsible for the damages caused to the product as a consequence of or on the occasion of the service. Consumers have the right to take individual actions if their CPL rights are affected or threatened.
4. How can a liability claim be brought?
The claim can be brought by the Government Authority for infringements to the local regulatory framework, by a competitor (for non-compliance with the Fair-trade Law), or by an individual (due to breaches to Consumer Law No. 24,240).
The Argentine Civil and Commercial Code introduced changes to the statute of limitations regime, establishing as a general rule a shorter period (five years). It considers the forfeiture of rights on a separate basis.
The statute of limitations for a civil liability claim is three years, including consumer liability claims, unless any other applicable law provides a more favorable term to the consumer.
The statute of limitation for actions arising from the Law on Medicines is five (5) years. This term is interrupted if another violation to the Law on Medicines or its complementary regulations is committed.
5. What defenses are available?
There are multiple defenses available, depending on the type of infringement and the government agency and/or parties involved in the claim.