Who is liable for vaccine adverse events in Malaysia?

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Liability for Vaccine Adverse Events in Malaysia

In Malaysia, there is no specific legislation directly governing adverse events from vaccines. Consequently, product liability is generally determined by existing legal principles rooted in contract law, tort law, and relevant statutory provisions. This means that a patient who experiences an adverse event could pursue legal action based on negligence or breach of contract against any party involved in the drug's distribution chain, including manufacturers, distributors, retailers, or healthcare providers.
Existing Legal Framework for Product Liability

Malaysian law provides several avenues for recourse when a defective medical product causes harm. Patients can initiate civil action under the tort of negligence or breach of contract, seeking remedies such as compensation for pain and suffering and out-of-pocket expenses. Statutes like the Sales of Goods Act 1957, Consumer Protection Act 1999, and Contracts Act 1950 are relevant in these cases. Under the Consumer Protection Act 1999, a patient might be entitled to compensation, a replacement of the defective product, or a refund.
Manufacturer Indemnity and Government Liability

A significant consideration in vaccine liability, particularly during pandemics, is the requirement by manufacturers for government indemnification. Publicly available information suggests that manufacturers like Pfizer have insisted on governments providing them with full indemnity as a condition for vaccine supply, a practice observed in countries such as the United Kingdom and Singapore. If Malaysia agrees to similar terms, the Malaysian government would likely assume primary and independent liability for any adverse effects arising from the vaccine, meaning any awarded damages would be borne by the government.
Criminal Sanctions and Practicalities

While criminal sanctions are a theoretical possibility for side effects from drugs, liability could potentially fall under the Poisons Act 1952 or the Sale of Drugs Act 1952. However, successful criminal prosecutions in such cases are considered unlikely due to the inherent difficulties in securing a conviction. Pharmaceutical manufacturers, in general, aim to avoid financial accountability for vaccine-related adverse events, especially amidst public health crises, a stance supported by industry groups like the International Federation of Pharmaceutical Manufacturers Associations.

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Who is liable for vaccine adverse events in Malaysia?

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