The key facts about product liability in Algerian Pharma. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
In Algeria, any product intended for consumption and/or use, under normal or reasonably foreseeable conditions of use, including of duration, must present no risk or only reduced risks at a low level compatible with the use of the product, considered acceptable in respect of a high level of protection for the health and safety of persons (as per Article 3 of Consumer Protection and Fraud Repression Law No 09-03 dated of 25 February 2009, published in the Official Gazette).
When a product causes bodily, material and/or pecuniary damage to consumers, any person involved in all stages of the process of release for consumption (manufacturer, importer, wholesaler or retailer) to whom is attributable the event giving rise to such damage, is deemed responsible. The product liability covers any breach of the obligations provided for in Consumer Protection and Fraud Repression Law No 09-03 related to:
- hygiene and sanitation (Articles 6 and 7);
- product safety (Article 9);
- checking the conformity of the product before it is released for consumption (Article 12);
- testing the product (Article 15);
- information and labeling (respectively Articles 17 and 18).
Depending on the defect and the harm caused by the product to consumers, the person responsible of the bodily, material and/or pecuniary damage incurs:
- administrative penalties (Articles from 53 to 66 within Consumer Protection and Fraud Repression Law No 09-03);
- civil penalties (Article 140 bis of the Civil Code);
- penal sanctions (Articles from 68 to 95 within Consumer Protection and Fraud Repression Law No 09-03).
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
All of the above product liability types apply to drugs and medical devices manufacturers.
Administrative penalties as part of the product liability include:
- seizure of illegal earnings or property;
- order to stop manufacturing activities;
- suspension or withdrawal of licenses;
- administrative detention; and other administrative punishments as stipulated in Consumer Protection and Fraud Repression Law No 09-03 (Articles from 53 to 66).
According to Article 432 of the Penal Code, if a falsified pharmaceutical product resulted for the person who has consumed it or to which it has been administered, an illness or an incapacity for work, the author of the falsification as well as whoever has offered for sale or sold the said product knowingly falsified are punished by imprisonment of five (5) to ten (10) years, and a fine of 500.000 to 1.000.000 DZD (approx. 4.175 to 8.350 USD).
When the aforementioned falsified product causes either incurable disease, loss of use of an organ, or permanent disability, they are punishable by imprisonment for ten (10) to twenty (20) years and a fine of 1.000.000 to 2.000.000 DZD (approx. 8.350 to 16.700 USD), and when it causes the death of a person, the penalty is life imprisonment.
Under provisions of Health Law 18-11 Article 211, “falsified product” means any product with a false presentation of:
- its identity, including its packaging and labeling;
- its name or composition, including excipients and all components amount;
- its source, including its manufacturer, country of manufacture, or country of origin;
- its history, including authorizations, records and documents of the used distribution channels.
Besides that, Article 168 of Insurance Ordinance 95-07 dated of 25 January 1995 published in the Official Gazette, requires that any person who manufactures, imports or distributes pharmaceutical products for consumption or use shall take insurance for professional civil liability towards consumers or users and third parties (product liability insurance).
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Claims could extend to corporate executives, employees, and representatives of the pharmaceutical company, who were deemed responsible of bodily, material and/or pecuniary damage to consumers as consequence of deliberate misconduct, falsification, forgery, fraud, or negligence.
The product liability is also extended to the pharmacist technical director under whose responsibility the technical management of any authorized pharmaceutical establishment (manufacturer, importer or distributer) is put to insure the satisfactory compliance with regulatory requirements.
Without prejudice to civil penalties and penal sanctions incurred, breaches of the obligations set out in the Health Law No 18-11, as well as the rules of medical ethics, expose the pharmacist technical director to disciplinary sanctions too.
4. How can a liability claim be brought?
A product liability claim can be brought by the aggrieved party as plaintiff in civil or criminal courts that have jurisdiction. In addition, administrative claim for investigation could be filled before:
- The Pharmaceutical Products National Agency “ANPP” – “Agence Nationale des Produits Pharmaceutiques”, that is gradually replacing former “DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé” at Ministry of Health.
- The National Center for Pharmacovigilance and Materiovigilance “CNPM” – “Centre National de Pharmacovigilance et de Matériovigilance”), which is a Ministry of Health institution.
- One of the 9 Regional Commerce Directorates “DRC” – “Directions Régionales du Commerce” or one of the 48 Provincial Commerce Directorates “DCW” – “Directions du Commerce de Wilaya”, which are attached to Ministry of Commerce.
5. What defenses are available?
There is no limit to defenses that could be used to demonstrate absence of legal obligations breach, or causation between the product / manufacturer responsibility and damage argued by the plaintiff. Defenses will depend on the case and the object of the claim.