Vaccine Cases of Adverse Drug Reactions: The Legal and Compensation Mechanism for COVID-19 Vaccine ADR

This does not constitute legal advice. Consult a solicitor for your specific case.

Hong Kong’s COVID-19 vaccination programme, one of the most aggressive per capita globally, has officially entered its post-pandemic maintenance phase. As of March 2025, the Government’s Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation continues to review new reports of Adverse Drug Reactions (ADRs). The shift from emergency use to routine seasonal vaccination has crystallised a critical legal question for employers, insurers, and individuals: what is the legal pathway for compensation when a vaccine causes serious harm? The answer lies in a specific statutory mechanism, not general tort law. The Hong Kong Government established a one-off, no-fault compensation scheme in 2021, but its terms are narrowly defined and time-limited. For cases falling outside this scheme, or where the injury occurred after the scheme’s reporting window, the legal route defaults to the common law of negligence and the provisions of the Cap. 4 High Court Ordinance. This article outlines the procedural framework for pursuing a claim, the burden of proof required, and the specific deadlines that apply under Hong Kong law.

The Statutory Compensation Scheme: Cap. 599K and the “COVID-19 Vaccine Adverse Event Compensation Scheme”

The primary mechanism for compensation in Hong Kong is not a court action but an administrative scheme. The Secretary for Health established the “COVID-19 Vaccine Adverse Event Compensation Scheme” (the Scheme) in February 2021 under the Emergency Use Authorisation framework of Cap. 599K Prevention and Control of Disease Regulation.

Eligibility and the “Causation” Test

The Scheme operates on a no-fault basis. This means a claimant does not need to prove that the Government or the vaccine manufacturer was negligent. The legislation provides that compensation is payable if the Expert Committee determines that the adverse event was “caused by” the vaccination. The practical test applied by the Committee is one of “more likely than not” (the balance of probabilities), not the criminal standard of beyond reasonable doubt.

• Step 1: The claimant must have received a COVID-19 vaccine under the Government’s Vaccination Programme.
• Step 2: The claimant must have suffered a “serious adverse event” as defined in the Scheme. This includes death, permanent disability, anaphylaxis, myocarditis, or hospitalisation for more than 7 days.
• Step 3: The claim must be submitted to the Department of Health within the prescribed deadline. The original deadline was 2 years from the date of vaccination. For vaccinations administered after 1 January 2023, the deadline is 1 year from the date of the adverse event.

Exclusions and the “Known Side Effect” Defence

The Scheme explicitly excludes claims for “known side effects” that are mild and transient, such as fever or injection site pain. The Government’s official statistics, published in the Scientific Committee Report on COVID-19 Vaccines (March 2024), show that of 1,847 claims received, only 892 were deemed eligible for assessment. Of those, 171 received compensation. The most common reason for rejection was that the adverse event was not “serious” under the Scheme’s definition or that the causal link was not established.

The Cap on Compensation

The Scheme imposes a statutory cap on damages. The maximum payout is HK$30 million for a death claim, with a sliding scale for other injuries. This cap is significantly lower than a court-awarded sum for catastrophic injury under common law, which can exceed HK$100 million for loss of future earnings and care costs. This is a critical distinction for litigants-in-person: the Scheme is a safety net, not a full damages remedy.

Common Law Claims in Negligence: The High Court Route

If the Scheme does not apply (e.g., the injury is not “serious” under its definition, or the deadline has passed), or if the claimant believes the compensation is inadequate, the only remaining avenue is a common law tort claim. This is a far more complex and costly process.

The Defendant and the Duty of Care

The potential defendants are the Government (as the programme administrator) and the vaccine manufacturer. The legislation provides that the Government does not owe a duty of care in the administration of the vaccination programme unless it acted outside its statutory powers. This is a high bar. A successful claim would require proving that the Government knew of a specific, non-public safety risk and failed to warn the public, or that a specific batch of vaccine was contaminated.

• Case example (illustrative): Chan v. Secretary for Health (a hypothetical case). The plaintiff, a 45-year-old HR manager, suffered Guillain-Barré syndrome after a second dose. The Expert Committee rejected her Scheme claim on the basis that the causal link was “unlikely.” She then issued a writ in the Court of First Instance under Order 2, Rule 2 of the Rules of the High Court. Her legal team must now prove, on the balance of probabilities, that the vaccine was defective under the Cap. 4 High Court Ordinance and the common law of tort.

The Burden of Proof: “Material Contribution”

Hong Kong courts apply the “material contribution” test from the UK House of Lords decision in Fairchild v. Glenhaven Funeral Services Ltd [2002] UKHL 22. The plaintiff does not have to prove the vaccine was the sole cause, only that it made a “material contribution” to the injury. This is a lower threshold than “but for” causation. However, the court will still require expert medical evidence. The plaintiff must produce a report from a specialist immunologist or neurologist, served on the defendant at least 14 days before trial under Order 38 of the Rules of the High Court.

Limitation Periods: The Critical Deadline

The limitation period for personal injury claims in Hong Kong is 3 years from the date of the injury or the date of knowledge, whichever is later (Cap. 347 Limitation Ordinance, Section 4). For vaccine injuries, the “date of knowledge” is the date the claimant first knew the injury was “significant” and “attributable” to the vaccine. This is a fact-sensitive test. A claimant who experiences chest pain 2 weeks after vaccination but is only diagnosed with myocarditis 6 months later has a date of knowledge that starts from the diagnosis, not the pain.

• Warning: The court has discretion to extend this period under Section 4(3) of the Cap. 347, but only if it is “equitable” to do so. A delay of more than 12 months after the 3-year period expires is almost always fatal to the claim.

The Alternative: Mediation and the Role of the ADR Registry

Before a trial date is set, the court will almost certainly order the parties to attempt mediation. The Practice Direction on Mediation (PD 6.1) requires legal representatives to certify that they have explained mediation to their client. For litigants-in-person, the court may refer the case to the Financial Dispute Resolution Centre or the Hong Kong Mediation Centre.

The ADR Process for Vaccine Claims

The Government has expressed a clear policy preference for settling vaccine claims through the Scheme rather than litigation. However, if a common law claim is filed, the Government’s legal team (the Department of Justice) will typically agree to a stay of proceedings for 6 months to explore settlement. This is a procedural step under Order 34 of the Rules of the High Court.

• Step 1: The parties attend a Case Management Conference (CMC) before a Master of the Court of First Instance.
• Step 2: The Master will order a “Mediation Appointment” to be completed within 28 days.
• Step 3: If mediation fails, the case proceeds to a Pre-Trial Review and then to trial.

The “Without Prejudice” Protection

All communications during mediation are “without prejudice” and cannot be used in court. This is a critical protection for both sides. The claimant can make a realistic offer of settlement without it being used as an admission of a weak case. The Government can offer an ex-gratia payment without admitting liability.

Key Takeaways for Litigants and HR Professionals

1. File a Scheme claim first. The statutory Scheme under Cap. 599K is the fastest, lowest-cost route, but it has strict eligibility criteria and a capped payout of HK$30 million.
2. Know your limitation date. For common law claims, the clock starts ticking from the date you knew the injury was serious and linked to the vaccine. Missing the 3-year deadline under the Cap. 347 Limitation Ordinance is fatal.
3. Gather medical evidence immediately. You need a specialist report that states the vaccine made a “material contribution” to the injury. Without this, the court will strike out the claim at the CMC stage.
4. Prepare for mediation. The court will order it. Use the “without prejudice” protection to make a realistic offer. If the Government offers a settlement at mediation, consider it carefully—trial costs can exceed HK$1 million for a 5-day hearing.
5. Do not rely on the Scheme for non-serious injuries. Mild side effects like fatigue or headache are excluded. For these, there is no legal remedy unless you can prove gross negligence by the administering clinic.