The key facts about product liability in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
There are two types of liabilities in Egypt, Criminal Liability, in case the product caused any injury, permanent disability injury or wrongful death due to negligence or mistake occurred in the preparation process of the medicinal product.
Civil liability, in case the product caused any type of damage to the consumers.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
The Manufacturers of the medicines and devices must notify the Consumer Protection Authority in case of discovering any defects that affects the safety and health of the consumers, this notification shall be within seven days from the date of discovering the defect. Manufacturers and suppliers in the aforementioned case shall publish an announcement to the public refrain them from using the defective products, warning them from the products causes and effects.
In accordance to the Pharmacy Law No. 127 of the year 1955, the MOH will issue a decree for banning the circulation of any substance, or any pharmaceutical preparation which is harmful to the public health, the registration of the preparation shall be deleted from the ledgers of the Ministry, if registered and the remaining quantities thereof shall be administratively confiscated wherever existent, without the owners thereof having the right to have recourse against the Ministry for any possible indemnification.
Either the manufacturer or supplier will face civil and criminal liability in case of the occurrence of any of the aforementioned.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
The marketing authorization holder has control over the medicinal product, including determination of the manufacturer/importer and renewal of the medicinal product registration. Therefore, the marketing authorization holder is liable for the medicinal product, its technical specification and quality control.
However, in practice, the applicant for registration (which could be the scientific office of a foreign marketing authorization holder, or a local manufacturing/agency company) is the entity addressed by the Ministry of Health if any issues arise about the registered medicinal product in Egypt.
Further, under Article 67 of the Commercial Law, the claimant can bring an action against the manufacturer, the distributor, or both without joint liability. If the manufacturer or distributor do not have presence in Egypt, the claimant can bring his case before the Egyptian courts against the manufacturer or agent located in Egypt.
Any individual who intentionally or due to gross negligence causes a defect which results in product liability can be personally liable under both civil and criminal laws.
4. How can a liability claim be brought?
The limitation period for product liability claims is three years from the date the claimant became aware of the damage and the responsible person.
Class actions are not regulated under Egyptian law. A person must have capacity to bring a claim and the claim is limited to damage affecting the claimant. To raise a class action, the claimant must be a legal person representing a class of people affected by the claim.
5. What defenses are available?
The available defenses can only be based on:
- Lack of fault by the manufacturer/supplier.
- Challenging the existence of the damage to the relevant patient.
- Negating the causality between the fault and the damage.
Supervision and approval by the Ministry of Health can be relied on as evidence for lack of fault where applicable.
Liability for defective medicinal products cannot be limited or waived, and any agreement to the contrary is void.
In practice, efforts to limit liability focus on setting out in detail in the medicinal product’s patient information leaflet any possible side effects and damage from using the product.