Key legal info on product liability in Singaporean pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
In Singapore, product liability in relation to medicines can arise under an action in tort, contract and/or breach of relevant statutory provisions.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
An action in tort can arise where the manufacturer has breached its duty of care, such as its duty to ensure adequate quality control measures for medicines or medical devices, or to exercise reasonable care in the marketing and advertisement of such products.
An action for a breach of contract can arise from a breach of express or implied contractual terms, most commonly of an implied term that goods supplied are of satisfactory quality, as supported by section 14 of the Sale of Goods Act (Chapter 393).
Criminal liability can also arise under the Health Products Act. For instance, a person who manufactures, procures or arranges for the manufacture of a medicine or medical device that is adulterated, counterfeit or unwholesome may be liable for an offence for which such person may be subject to fines and/or imprisonment upon conviction.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Potential criminal liability under the Health Products Act can extend to the company’s officers such as its directors, where it is proved that the offence was committed with the consent or connivance of such officer(s), or is attributable to any neglect on the part of such officer(s).
4. How can a liability claim be brought?
To establish the tort of negligence, it must be shown that:
- there was a duty of care owed by the person committing the tort to the consumer;
- the person committing the tort did not meet a reasonable standard of care, as determined by the court; and
- the injury to the consumer is causally linked to the person committing the tortious act and the injury was reasonably foreseeable, as determined by the court.
To establish a breach of contract, certain elements will have to be proved, such as the existence of a contract and a breach of its terms.
Liability for statutory offences differs, depending on the conditions in the relevant statute.
5. What defenses are available?
For actions in tort, some possible defences include that the elements of the tort of negligence are not made out, for instance, that the duty of care was not owed, or the standard of care was not breached, or that there is contributory negligence or a voluntary assumption of risk. For breach of contract cases, possible defences include certain vitiating factors such as frustration, mistake, misrepresentation, illegality and unfairness. In respect of offences under the Health Products Act, statutory defences may be available.