The legal framework for product liability in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75.
1. What types of liability are recognized in your jurisdiction?
The laws of Thailand provide for civil, criminal, and administrative liabilities.
Fundamentally, product liability is recognized as part of sales and contract law wherein the seller shall be liable to the buyer for a damage caused by deficient goods. This liability may be waived by a contract.
For consumer goods, the Consumer Protection Act and the Unsafe Goods Liability Act limit the seller’s ability to exclude civil liability arising from a product being sold. If it has been established that the product is unsafe, then the seller shall be strictly liable regardless of whether such unsafety was caused by the seller’s negligence or by intentional action or omission.
Specifically, in the context of medical products, the Drug Act and the Medical Device Act set criminal liabilities for selling fake or substandard products, among others. Administrative sanctions, including suspension or termination of a business operation permit, apply as well.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
Because of the territoriality rule, a manufacturer based in Thailand may be enforced for any of the above liabilities.
While a direct enforcement against an overseas manufacturer may be problematic, Thai authorities can effectively block products originating from overseas manufacturers by revoking marketing authorizations, coordinating with the customs authority at the ports of entry, and bringing enforcement actions against the Thai importer who attempted to import such products.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
The abovementioned liabilities (except those concerning operation permits) may extend to individual executives, employees or representatives; however, this is not a strict liability. To hold an individual liable, the complainant is required to prove that such individual’s action/omission caused the injury or the violation of the applicable law.
For civil liability, the standard of proof is “by balance of probabilities;” for criminal liability, the standard of proof is “beyond a reasonable doubt.”
4. How can a liability claim be brought?
The injured consumer may bring their complaint to the competent authority, which includes a civil and commercial court (Consumer Case Procedure Act, B.E. 2551 (2008)) or a consumer protection organization. A class action is also possible.
Specifically, in the context of drugs and medical devices, such competent authority also includes the Thai FDA.
5. What defenses are available?
For civil liability, the Unsafe Goods Liability Act provides several defenses for the defendant. Notable defenses include the following:
- The product was in fact not unsafe.
- The injured party (e.g., the consumer) was aware that the product was unsafe but used it anyway.
- The damage was due to improper use or storage of the product, and the defendant provided reasonably clear and accurate instructions for use and storage.