Jakarta, 2 March 2026 – The Agreement on Reciprocal Trade (ART) between the United States and Indonesia poses serious risks to public health protection. The agreement, signed on 19 February 2026, includes provisions on the recognition of United States Food and Drug Administration (FDA) certificates and the implementation of pharmaceutical data exclusivity, both of which could weaken the authority of Indonesia’s National Agency of Drug and Food Control (BPOM) and restrict public access to generic medicines.
Rahmat Maulana Sidik, Executive Director of Indonesia for Global Justice (IGJ), stated that the Agreement on Reciprocal Trade obliges Indonesia to accept marketing authorizations issued by the FDA. This would allow US pharmaceutical companies to market medicines and health products in Indonesia without undergoing a full evaluation process by BPOM. “This marks a serious shift from BPOM’s sovereign authority over national drug regulation toward reliance on a foreign regulator”, Maulana explained.
Furthermore, he warned that this provision represents a dangerous form of regulatory reliance.
“The Agreement on Reciprocal Trade compels Indonesia to accept FDA-issued approvals. This is not merely cooperation; it amounts to a surrender of sovereignty in protecting public health. BPOM loses control over national drug safety standards, while the public bears the risks, since medicines approved under US standards may not necessarily be suitable for Indonesia’s population,” Maulana emphasized.
He added that the agreement could further entrench the dominance of global pharmaceutical corporations in Indonesia.
“If Indonesia submits to this mechanism, the domestic pharmaceutical industry will face increasing pressure, and dependence on US-based pharmaceutical companies will deepen. In the long term, drug prices could rise significantly, and public access to affordable medicines will become more limited. This is not only a health issue, but also an issue of economic sovereignty,” he continued.
Agung Prakoso, Health Policy Researcher at Indonesia for Global Justice (IGJ), stressed that the issue goes beyond reducing BPOM’s authority, it also concerns public safety. “Drug regulatory authorities in each country operate within different epidemiological contexts. This means that authorization granted by the US FDA may not necessarily align with what BPOM would determine appropriate for Indonesia. The government’s claim that FDA standards are inherently higher is unfounded, as drug approval must be grounded in each country’s specific public health context”, Agung explained.
Agung also highlighted the potential litigation implications. “If marketing authorization is effectively transferred to the FDA, Indonesian citizens will face significant obstacles in pursuing legal action against the licensing authority in cases involving harmful drug effects,” he added.
The Indonesia-US Agreement on Reciprocal Trade also required Indonesia to grant at least five years of data exclusivity for pharmaceutical products. This means that generic manufacturers would be prohibited from relying on existing clinical trial data to obtain marketing approval, even in cases where no patent protection applies.
Agung added that this provision will directly affect access to medicines by delaying the production of generics, “This requirement goes beyond Indonesia’s obligations under the TRIPS Agreement, or more commonly referred to as TRIPS-Plus, and is not mandatory for WTO member states. Numerous studies have shown that data exclusivity can delay the entry of generic medicines and drive up prices. A clear example can be seen in the Jordan-US Free Trade Agreement. Since its implementation in 2001, medicine prices in Jordan reportedly increased by around 20 percent, while overall pharmaceutical expenditures surged up to sixfold. Currently, more than a quarter of Jordan’s Ministry of Health budget is allocated solely to medicine procurement,” stated Agung.
“The Indonesia-US Agreement on Reciprocal Trade demonstrates that Indonesia’s regulatory autonomy over medicine pricing, availability, and safety is becoming increasingly constrained. Dependence on foreign regulatory authorities poses direct risks to public health. Simultaneously, efforts to safeguard access through generic medicines are being undermined,” Maulana concluded.
Related IGJ Publications:
- SIARAN PERS : Indonesia–AS Sepakati Perjanjian Dagang Resiprokal: IGJ Ingatkan Bahaya Penggadaian Mineral dan Pengerukan Alam Indonesia: https://igj.or.id/2025/12/24/siaran-pers-indonesia-as-sepakati-perjanjian-dagang-resiprokal-igj-ingatkan-bahaya-penggadaian-mineral-dan-pengerukan-alam-indonesia/
- Mineral Kritis Dalam Cengkeraman Perjanjian Dagang: Tantangan Kebijakan dan Kedaulatan Ekonomi Indonesia: https://igj.or.id/2025/11/28/mineral-kritis-dalam-cengkeraman-perjanjian-dagang-tantangan-kebijakan-dan-kedaulatan-ekonomi-indonesia/
- Tata Kelola Mineral Kritis Indonesia di Bawah Bayang-Bayang Perjanjian Dagang: https://igj.or.id/2026/01/04/tata-kelola-mineral-kritis-indonesia-di-bawah-bayang-bayang-perjanjian-dagang/.
- Perjanjian Dagang dan Ilusi Kedaulatan Ekonomi Indonesia:
https://igj.or.id/2026/01/26/perjanjian-dagang-dan-ilusi-kedaulatan-ekonomi-indonesia/. - Pernyataan Sikap IGJ terhadap Perjanjian Dagang ART Indonesia – Amerika Serikat: https://igj.or.id/2026/02/21/pernyataan-sikap-indonesia-for-global-justice-igj-menolak-perjanjian-dagang-indonesia-amerika-serikat-neokolonialisme-dan-pelanggaran-konstitusi/
- Siaran Pers IGJ: Perjanjian Dagang ART Indonesia-Amerika Serikat Ancaman Serius Bagi Kedaulatan Bangsa dan Kepentingan Nasional: https://igj.or.id/2026/02/24/siaran-pers-indonesia-for-global-justice-igj-perjanjian-dagang-art-indonesia-amerika-serikat-ancaman-serius-bagi-kedaulatan-bangsa-dan-kepentingan-nasional/.
Contact Person:
Agung Prakoso, Indonesia for Global Justice (IGJ)
P: 085788730007
Indonesia for Global Justice (IGJ) Office
Jalan Rengas Besar No. 35C, Jati Padang, Pasar Minggu, Jakarta Selatan, DKI Jakarta. 12540.
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