Regulation and Pharmaceutical Corporate Responsibility: Generic Drug Distribution, Patent Rights, and Their Impact on Equity of Access in the National Health Insurance System
Isi Artikel Utama
Abstrak
The pharmaceutical industry operates at the intersection of intellectual property rights and public health imperatives, creating a fundamental tension between drug innovation and access. This literature study examines the legal framework of corporate responsibility for pharmaceutical companies in distributing branded versus generic drugs in Indonesia, focusing on implications for access, consumer rights, and equity within the National Health Insurance (JKN) system. The analysis reveals that Indonesian law, encompassing patent, health, consumer protection, and competition regulations, establishes a normative foundation that balances exclusive rights with public interest tools like compulsory licensing. However, the strategic use of patent thickets, product hopping, and biased marketing by originator companies can undermine generic drug availability, affordability, and perception, thereby restricting consumer choice and burdening the JKN system. The study concludes that while the legal architecture is conceptually robust, its operationalization is fragmented. Effective realization of access equity requires integrated enforcement, proactive market oversight, and regulatory reforms that explicitly link corporate conduct to the sustainability of the public health insurance system. Strengthening transparency in pricing negotiations, limiting patent evergreening, and empowering the insurance authority are critical steps forward.
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