Construction of Consumer Rights and Business Liability for Losses Resulting from Defective or Dangerous Medicines and Medical Devices in Indonesian Positive Law
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Abstract
This study examines the construction of consumer rights and the basis for business actor liability regarding damages arising from defective or hazardous drugs and medical devices within the framework of Indonesian positive law. The primary focus is directed toward two issues: how consumer rights to security, comfort, safety, and information are constructed as standards of protection, and how the basis for compensation claims is formulated through a synthesis of consumer protection regimes, civil law, and health regimes. The analysis is conducted using a normative juridical approach, positioning norms as the primary object, particularly provisions concerning consumer rights, prohibitions on the circulation of goods that do not meet standards, labeling and warning obligations, recovery mechanisms, and causal relationships in evidentiary processes. The results of the study indicate that consumer rights bind the entire supply and distribution chain, allowing accountability to be drawn from producers, importers, and distributors, to service providers distributing the products, according to the relevant point of failure. The classification of design defects, manufacturing defects, and instruction defects serves as a juridical mapping tool to determine standards of care and appropriate forms of compensation. Regarding evidentiary aspects, a layered burden of proof model is considered most adequate: consumers prove the loss and exposure, while business actors demonstrate compliance, quality control, and corrective responses through technical documentation as well as administrative evidence of licensing and oversight. Damage assessment is directed toward adequate recovery through compensation, replacement, and health-related expense financing, including fairly assessed immaterial damages. Multiple forum options are available, through the Consumer Dispute Settlement Agency (BPSK), general courts, class action lawsuits, or alternative dispute resolution, supported by administrative enforcement for corrective actions such as product recalls. This study underscores the importance of harmonizing safety norms, information honesty, and the effectiveness of recovery procedures so that consumer protection for health products is measurable and executable.
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