Adverse effects of drugs and vaccines in Singapore

1.1 Which are the main kinds of responsibility (contractual, in tort, criminal) of the following subjects with respect to adverse drugs reactions?

For manufacturers and healthcare professionals, the main types of responsibility with respect to adverse drug reactions would likely be based on the tort of negligence and contract. 

There are also some statutory offences under Singapore legislation (such as the Health Products Act and Medicines Act) which may apply to manufacturers and/or healthcare professionals in the event of adverse drug reactions (e.g. for supplying health/medicinal products without a licence, manufacturing adulterated or counterfeit products, false or misleading advertisements, failure to report defects and adverse effects to the Health Sciences Authority). However, these statutory offences generally do not provide victims with the right to claim compensation.

Where the State is directly involved in the chain of distribution of drugs, the above sources of liability may also apply to the State in cases of adverse drug reactions unless statutory exemptions are passed. While the State Immunity Act provides the State with general immunity from the courts of Singapore, there are statutory exceptions from such immunity which include (i) proceedings relating to a commercial transaction entered into by the State or an obligation of the State which by virtue of a contract falls to be performed wholly or partly in Singapore; and (ii) proceedings in respect of death or personal injury caused by an act or omission in Singapore.

Which are the conditions for claiming compensation (including the burden of proof)?

2.1 In order to be able to claim compensation under the Civil liability regime, the following conditions must be met:

In general, the burden of proof for claiming damages based on tort or contract would lie with the claimant.
To establish and claim damages under the tort of negligence, the claimant must show that (a) there was a duty of care owed by the person committing the tort to the claimant; (b) the person committing the tort did not meet a reasonable standard of care; and (c) the damage suffered by the claimant is causally linked to the acts of the person committing the tort and the damage was reasonably foreseeable. 

In the context of medical negligence of a doctor, the applicable standard of care for diagnosis and treatment is whether a responsible body of medical opinion, that is internally consistent and logical, supported the doctor’s actions or omissions. The applicable standard of care applicable to doctors in respect of medical advice is governed by a three-stage test which places emphasis on whether the doctor has provided the patient with sufficient advice and information to make his/her decision, and whether a doctor is justified in withholding information from the patient is determined according to what an ordinary and reasonable doctor would have done in the circumstances.

To establish and claim damages for a breach of contract, the claim must generally prove (a) the existence of a contract; (b) a breach of its terms; and (c) that the damages claimed is causally linked to the contractual breach and are not too remote.

2.2 Which are the grounds for exclusion of liability?

The grounds for exclusion of liability of manufacturers, healthcare professionals and the State would be those set out in contract. Such contractual exclusions of liability may be subject to restrictions under the Consumer Protection (Fair Trading) Act (CPFTA) and Unfair Contract Terms Act (UCTA).

Where manufacturers, healthcare professionals or the State deals with consumers in Singapore, the CPFTA would apply. The CPFTA prohibits unfair practices, which may include exclusions of liability that are harsh, oppressive or excessively one-sided so as to be unconscionable.

Further, where the UCTA applies to an agreement with a manufacturer, healthcare professional or the State, the UCTA prohibits exclusions of liability for negligence acts causing death or personal injury. For consumer products, the UCTA also prohibits a manufacturer or distributor from relying on a term or notice to exclude liability for product defects or negligent manufacturing or distribution. For exclusions of liability for other loss or damage, such clauses are generally only valid under the UCTA insofar as these are reasonable.

Aside from the above, in the event of a claim based on tort, possible defences which a manufacturer, healthcare professional or the State may raise include contributory negligence or voluntary assumption of risk. In the context of medical negligence, some defences which may be raised by a doctor include waiver by the patient and treatment provided on an emergency basis. For claims based on breach of contract, some vitiating factors (which would invalidate the contract) are frustration, mistake, misrepresentation and illegality. For certain statutory offences, there may be corresponding statutory defences in the relevant legislation.

2.3 Which are the time limits for submitting a claim for compensation?

The limitation period for bringing a claim for negligence causing personal injury is generally (a) 3 years from the date of injury; or (b) 3 years from the date of required knowledge for starting the action, whichever is later. This limitation period is subject to an overriding time limit of 15 years from the date of the act causing the injury.

The limitation period for bringing a claim for negligence causing other damage is generally (a) 6 years from the date of damage; or (b) 3 years from the earliest date on which the claimant had the required knowledge for starting the action and the right to bring such an action, whichever is later. This limitation period is subject to an overriding time limit of 15 years from the date of the act causing the damage.

The limitation period for bringing a claim in contract is 6 years from the date of the breach of contract.

2.4 Which damages can be compensated?

Where negligence is found, the Singapore courts have awarded general damages (for pain and suffering, loss of amenities, and post-trial monetary loss, such as future earnings and future medical expenses) and special damages for pre-trial pecuniary loss (such as medical, nursing and supportive care, transportation and household expenses, and pre-trial loss of earnings or profits).

Where a breach of contract is found, the Singapore courts will award damages to place the aggrieved party, as far as possible, in the position he or she would have been had the contract been performed fully. The award of damages is generally based on pecuniary losses but the courts may take into account non-pecuniary losses (such as mental distress).

2.5 Is it possible to claim compensation directly to the insurance company of the damaging party?

This would depend on the terms in the relevant insurance policy.

Under the Contracts (Rights of Third Parties) Act, third parties may be able to claim compensation directly from the insurance company if (a) the insurance policy expressly enables them to do so, and (b) the insurance policy purports to confer a benefit on them and expressly names them, unless it appears from the policy that the parties did not intend the term to be enforceable by them.

In practice, insurance policies commonly exclude the rights of third parties to claim under the policy.
The Third Parties (Rights Against Insurers) Act also provides an avenue for victims and involuntary creditors of a bankrupt or wound-up party to seek recovery from that party’s insurers, in priority over other claimants against the insolvent estate of that party.

3.1 How would the answers above change if adverse drugs reactions occur within a compassionate use program?

The above answers in relation to the tort of negligence and contract would still apply even if the adverse drug reactions occur within a compassionate use program.

For statutory requirements/offences, the Health Sciences Authority may provide exemptions from certain registration requirements and allow the import or supply of therapeutic products via special access routes in specific situations, which may include the import and supply of unregistered therapeutic products for a compassionate use program. In such cases, requesting doctors remain fully responsible for the use of such products on patients.

4.1 How would the answers above change if the adverse drugs reactions occur as part of an off-label use?

The above answers would still apply even if the adverse drug reactions occur as part of an off-label use. 
While there is currently no specific legislation in Singapore that prohibits the off-label use of drugs, there are restrictions which apply to the advertising of off-label use in the Health Products Act, Medicines Act and subsidiary legislation.

5.1 How would the answers above change if the adverse drugs reactions concern a vaccine?

The above responses would still apply even if the adverse drug reactions concern a vaccine.

5.2 Is any public indemnity/compensation provided in the case of both compulsory and not compulsory vaccination?

Yes, there is a Vaccine Injury Financial Assistance Programme for COVID-19 vaccination (VIFAP) in Singapore that is currently funded by the government. 

The VIFAP provides compensation, subject to specified limits, to Singapore citizens, permanent residents and long-term pass holders recommended to receive the COVID-19 vaccines under the national vaccination programme who experience certain serious side effects that are assessed to be related to COVID-19 vaccines administered in Singapore.

Aside from the VIFAP, eligible claimants may also receive financial support under other applicable government administered healthcare schemes and subsidies.

6.1 Which liabilities can be insured? Is there any compulsory insurance?

In general, the content of insurance policies is not heavily regulated in Singapore, save for some specific content requirements in relation to life policies, marine insurance policies, work injury policies and motor vehicle insurance policies. 

There does not appear to be a compulsory insurance requirement for drug manufacturers or healthcare professionals in Singapore presently.

7.1 Are there particular procedural issues to be highlighted in relation to ADR claims?

There are presently no procedural/litigation issues specific to adverse drug reaction claims. However, insofar as such claims are based on an allegation of medical negligence, the Protocol for Medical Negligence Cases in the practice directions of the Singapore courts should be considered.