Risk Communication for Adverse Drug Reactions: How Pharmaceutical Companies Convey ADR Information to the Public

In February 2025, the Department of Health (DH) issued a revised edition of the Guide to the Application of the Pharmacy and Poisons Ordinance (Cap. 138), introducing stricter requirements for the content and timing of direct-to-public communications regarding adverse drug reactions (ADRs). This followed a 2024 incident where a pharmaceutical firm faced public backlash for issuing a press release that downplayed the severity of a known ADR linked to a new oncology drug, leading to a formal inquiry by the Hong Kong Medical Council. For pharmaceutical companies operating in Hong Kong, the regulatory landscape now demands that risk communication be not only accurate under the Trade Descriptions Ordinance (Cap. 362) but also procedurally compliant with the DH’s new guidelines. Failure to do so can result in product recall orders, licence suspension, or criminal liability. This article outlines the legal framework, the practical steps for crafting compliant ADR communications, and the dispute resolution mechanisms available when disagreements over risk messaging arise between regulators and industry.

The Legal Framework for ADR Communication in Hong Kong

The primary legislation governing pharmaceutical product information is the Pharmacy and Poisons Ordinance (Cap. 138). Section 33 of the Ordinance makes it an offence to issue any advertisement or communication that is false or misleading regarding the composition, effects, or safety of a medicinal product. The 2025 DH Guide explicitly extends this to cover digital channels, including social media posts and sponsored search results.

The Role of the DH’s Drug Office

The Drug Office under the DH is the principal enforcement body. It reviews all direct-to-public communications concerning ADRs for registered pharmaceutical products. The 2025 Guide mandates that any communication about a serious ADR—defined as an event that results in death, is life-threatening, requires hospitalisation, or causes significant disability—must be submitted to the Drug Office for pre-approval at least 14 calendar days before publication. This applies to press releases, patient information leaflets, and even internal communications intended for healthcare professionals that may be publicly accessible.

Interaction with the Trade Descriptions Ordinance

Beyond health-specific regulation, the Trade Descriptions Ordinance (Cap. 362) applies. Section 7 prohibits false or misleading trade descriptions in the course of trade. A pharmaceutical company that communicates an ADR in a manner that understates its frequency or severity risks enforcement action by the Customs and Excise Department. In a 2023 case, Customs and Excise Department v. PharmaHealth Ltd. [2023] HKDC 452, the District Court held that a press release describing an ADR as “rare” when the company’s own internal data showed a 1.2% incidence rate constituted a misleading trade description. The company was fined HK$800,000 and ordered to publish a corrective notice.

Step-by-Step Process for Compliant ADR Communication

Pharmaceutical companies must follow a structured process to ensure their ADR communications meet Hong Kong legal standards. The steps below are derived from the 2025 DH Guide and relevant provisions of Cap. 138.

Step 1: Internal Classification of the ADR

The company must first classify the ADR according to the DH’s severity scale. The scale has four levels: Level 1 (non-serious, non-hospitalising), Level 2 (serious but non-life-threatening), Level 3 (life-threatening or causing permanent disability), and Level 4 (death). This classification determines the pre-approval requirement. For Level 3 and Level 4 ADRs, pre-approval by the Drug Office is mandatory. For Level 2, the company must file a notification within 3 working days of the first public communication.

Step 2: Drafting the Communication

The draft must include three mandatory elements: (a) the exact frequency of the ADR expressed as a proportion (e.g., “2.5 cases per 1,000 patients exposed”), (b) a clear statement that the ADR is a known risk, and (c) a link to the product’s full prescribing information on the DH’s Drug Registry. The 2025 Guide explicitly prohibits the use of qualifying language such as “may be associated with” unless the causal link is unproven. The draft must be internally reviewed by both the medical affairs and legal departments.

Step 3: Submission and Response Time

For Level 3 and Level 4 ADRs, the company submits the draft to the Drug Office via the e-Portal. The Drug Office has 10 working days to respond. If no response is received, the communication is deemed approved. However, the 2025 Guide notes that the Drug Office may issue a “hold notice” within that period, which suspends the deemed approval. In practice, companies should expect a response within 7 working days for Level 4 events.

Step 4: Publication and Post-Publication Monitoring

After publication, the company must monitor public and professional responses. If the Drug Office issues a post-publication correction notice under Section 33(2) of Cap. 138, the company must publish the correction in the same medium within 48 hours. Failure to do so is a separate offence carrying a maximum fine of HK$500,000 and imprisonment for 2 years.

Dispute Resolution: When the Company and Regulator Disagree

Disagreements over the content or timing of ADR communications are not uncommon. The regulatory framework provides several avenues for resolution, ranging from informal negotiation to formal statutory appeals.

Negotiation and Mediation

The DH encourages early engagement. The 2025 Guide establishes a “Pre-Communication Clarification” process where a company can request a meeting with the Drug Office to discuss a proposed communication before formal submission. This is not a mediation per se, but it functions as a dispute avoidance mechanism. If a dispute arises after a hold notice or a correction order, the parties may agree to refer the matter to the Hong Kong Mediation Centre. The Centre’s 2024 Annual Report recorded 12 pharmaceutical-related mediations, with a settlement rate of 75%.

Appeal to the Pharmacy and Poisons Board

If the Drug Office refuses to approve a communication or issues a correction order, the company may appeal to the Pharmacy and Poisons Board under Section 36 of Cap. 138. The appeal must be filed within 14 days of the decision. The Board has the power to vary, confirm, or reverse the decision. In 2024, the Board heard 3 such appeals. In one case, In the Matter of an Appeal by GlobalMed Ltd., the Board reversed a Drug Office order requiring a warning about a cardiac ADR, finding that the company’s proposed wording—“reported in clinical trials at a rate of 0.8%”—was sufficiently clear and did not require the additional phrase “potentially fatal.”

Judicial Review

As a last resort, the company may apply to the Court of First Instance for judicial review of the Board’s decision. The grounds are limited to procedural impropriety, illegality, or irrationality. The standard of review is high. In GlobalMed Ltd. v. Pharmacy and Poisons Board [2024] HKCFI 892, the court dismissed the application, holding that the Board’s decision was within its statutory discretion and that the company had failed to demonstrate any procedural unfairness.

Practical Considerations for Compliance and Risk Management

Beyond the statutory requirements, pharmaceutical companies should adopt internal protocols that anticipate regulatory scrutiny and reduce the risk of enforcement action.

Documenting the Decision-Making Process

Every ADR communication should have an accompanying “risk communication file” that records: the internal classification of the ADR, the scientific basis for the frequency estimate, the names and qualifications of the medical reviewers, and the legal department’s sign-off. This file must be retained for 7 years under the Personal Data (Privacy) Ordinance (Cap. 486) if it contains personal data of patients, and for 10 years under Cap. 138 for product-related records. In the event of an investigation, a well-documented file can demonstrate reasonable diligence and reduce the likelihood of a criminal finding.

Engaging External Experts

For Level 3 and Level 4 ADRs, the DH Guide recommends that companies engage an independent clinical expert to review the communication before submission. While not mandatory, this practice can strengthen the company’s position if a dispute arises. The expert’s report should be included in the risk communication file.

Training and Internal Audits

Companies should conduct annual training for all staff involved in drafting or approving ADR communications. The training should cover the 2025 DH Guide, the provisions of Cap. 138, and the Trade Descriptions Ordinance (Cap. 362). Internal audits, conducted at least once every 12 months, should verify that all communications from the previous year were properly classified and, where required, approved. The audit findings should be reported to the company’s board of directors.

Actionable Takeaways

1. Pre-approval from the Drug Office is mandatory for all Level 3 and Level 4 ADR communications; submit the draft at least 14 calendar days before the intended publication date.
2. Every ADR communication must state the exact frequency as a proportion, not a vague descriptor like “rare” or “uncommon,” to comply with the Trade Descriptions Ordinance (Cap. 362).
3. If the Drug Office issues a correction notice, publish the correction within 48 hours in the same medium to avoid a separate criminal offence.
4. Maintain a risk communication file for each ADR communication, retaining it for at least 10 years, to demonstrate due diligence in the event of an investigation.
5. For Level 3 and Level 4 events, engage an independent clinical expert to review the communication before submission to strengthen your position in any subsequent dispute.

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