Adverse effects of drugs and vaccines in Hong Kong

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

There is no specific legislation governing product liability (generally or in relation to medical products) or consumer protection. 

General

A product liability claim may arise from contractual obligations, tort, or breach of statutory duty. Parties involved in the manufacturing and distribution may be potentially liable. This would include the manufacturer, importer and supplier of the product.

Reporting Requirements

The Department of Health (Drug Office) (“DOH”) has issued guidance for the pharmaceutical industry and healthcare professionals in relation to reporting adverse drug reactions.

Pharmaceutical Industry

Generally, the pharmaceutical industry should submit reports of adverse drug reactions to the DOH as soon as possible. Depending on the type of pharmaceutical product involved, additional reporting requirements and deadlines may be applicable. Follow up reports should also be submitted as required.

Pharmaceutical industry in this context includes licensed wholesale dealers, licensed manufacturers, holders of Certificate of Drug/Product Registration and holders of Certificate for Trial/Medicinal Test.

Healthcare Professionals

According to guidance issued by the DOH, healthcare professionals are encouraged to report adverse drug reaction cases voluntarily to the DOH.

Injuries caused by improper use of drug or device products by healthcare professionals during medical treatment are redressed separately through medical malpractice proceedings.

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:

Contract

Contracts for the sale of goods in Hong Kong are governed by the Sale of Goods Ordinance (Cap. 26) (“SOGO”) and the common law. The SOGO implies certain terms as to quality into contracts for the sale of goods. Where the contract is for the sale of goods by description, there is an implied condition that the contractual goods will correspond with the description. In addition, there is an implied condition that goods supplied under sales contracts are of merchantable quality and that goods supplied under a contract are reasonably fit for a known particular purpose. The burden of proof lies with the claimant.

Tort of negligence

A civil claim under the tort of negligence can be brought for defective products. The burden of proof is on the claimant to prove negligence by establishing the following:

1. The supplier owed a duty of care to the claimant;
2. The supplier breached that duty of care; and
3. The supplier's breach of duty resulted in the claimant's loss or injury.

2.2 Which are the grounds for exclusion of liability?

Contract

Generally, parties are free to enter into contracts of sale subject to statutory requirements and the common law.

Under the SOGO, liability arising from implied terms can be excluded, subject to the Control of Exemption Clauses Ordinance (Cap. 71) (“CECO”)

Negligence

Under the CECO, liability cannot be excluded in a contract for negligence that causes death or personal injury.

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

The limitation period for bringing a product liability claim in contract or tort is 6 years from the date on which the cause of action accrued.

For a personal injury claim involving damages for negligence, nuisance or breach of duty, an action must be brought within 3 years from the date on which the cause of action accrued or the date of the knowledge of the claim (whichever is later).

Representative proceedings (similar to class actions) are permitted in Hong Kong whereby numerous persons having the same interest in any proceedings may bring proceedings by or against any one or more of them as representing all or as representing all except one or more of them. However, we understand that there have been no representative proceedings to date for product liability claims in relation to pharmaceutical products.

2.4 Which damages can be compensated?

A claimant may seek monetary compensation, injunctive and declaratory relief. Losses arising from personal injury, death and damage to property other than the product itself are recoverable.

In very limited and special circumstances, punitive damages may be awarded.

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

No.

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

No change to answers above.

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

No change to answers above.

However, it should be noted that the Hong Kong Association of the Pharmaceutical Industry has previously issued a legislative council paper stating that it does not encourage off-label use of pharmaceuticals as a core principle. Although off-label use is not illegal, it is not encouraged or condoned.

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

No change to answers above.

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

The Hong Kong government has set up an indemnity fund for adverse events following immunization for COVID-19. The fund is public and applies to both compulsory and non-compulsory vaccination.  

The maximum compensation for death and injuries associated with unexpected serious adverse events (“SAE”) is HK$3 million.

An affected individual, who has received at least one dose of the COVID-19 vaccine of any kind under the Hong Kong government’s COVID-19 vaccination programme and has proof of suffering unexpected SAE certified by a registered medical practitioner, is eligible to apply to the fund.

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

Currently, there is no insurance available specifically for adverse drug reactions. There is no compulsory insurance.

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

For representative proceedings, the group or class of persons sought to be represented must be clearly defined in the writ with precision.