Tendering & Market Access

This section is a Vietnam-focused reference for public procurement and market access of medicines, governed by the Ministry of Health (Bộ Y tế) and Vietnam Social Security (Bảo hiểm Xã hội Việt Nam — BHYT). Scope: • Tender group classification — 5 groups for chemical and biological generics, 4 groups for herbal and traditional medicines — based on GMP standard (EU-GMP, PIC/S-GMP, WHO-GMP), origin, bioequivalence data, and reference-biologic status. • Centralized procurement at national level (Trung tâm Mua sắm tập trung thuốc Quốc gia — NCDPC, under MOH), provincial centralized procurement, and individual healthcare-facility tenders. • Inclusion in the BHYT-reimbursable drug list (Circular 20/2022/TT-BYT) and payment ratios/conditions by hospital tier. • Hospital classification (Tier I/II/III/IV and special hospitals) and which tender groups each tier may procure from. • Original brand-name drugs (biệt dược gốc) and reference biologicals — conditions under which public facilities may procure them. • Price negotiation route for selected high-cost medicines. The post-2023 framework — Bidding Law 22/2023/QH15, Decree 24/2024/NĐ-CP, and Circular 40/2025/TT-BYT — replaced the previous regime (Circulars 15/2019 → 07/2024 → 40/2025) to address chronic drug-supply disruptions caused by tender delays and to formalize mid-contract drug substitution.

Procurement law: • Law on Bidding No. 22/2023/QH15 — issued 23 June 2023, effective 1 January 2024. Replaces the 2013 Bidding Law (43/2013/QH13). Article 55 carries provisions specific to drug, chemical, testing-reagent, and medical-equipment procurement. Implementing decree: • Decree 24/2024/NĐ-CP — issued 27 February 2024. Detailed implementation of the Bidding Law on contractor selection, with a dedicated chapter on pharmaceutical procurement. Drug tendering — current authority: • Circular 40/2025/TT-BYT — effective 25 October 2025. Replaces Circular 07/2024/TT-BYT in full. Drug bidding at public medical facilities; aligned with Pharmacy Law 44/2024/QH15. Five tender groups for chemical/biological generics, four for herbal and traditional medicines. Introduces mid-contract drug-substitution rules and updated provisions for traditional medicines and medicinal materials. Drug tendering — historical (superseded): • Circular 07/2024/TT-BYT — issued 17 May 2024; in force only until Circular 40/2025 took effect. • Circular 06/2023/TT-BYT — amended Circular 15/2019; superseded with its parent. • Circular 15/2019/TT-BYT — issued 11 July 2019, effective 1 October 2019; replaced by Circular 07/2024. Health insurance & reimbursement: • Health Insurance Law No. 25/2008/QH12 — original BHYT framework. • Law No. 51/2024/QH15 — amends the Health Insurance Law; passed 27 November 2024, effective 1 July 2025. Notable changes: 100% co-payment relief for participants with 5+ years of continuous coverage, four new categories eligible for state-funded contributions, and formal coverage of home-based treatment. • Circular 20/2022/TT-BYT — issued 31 December 2022, effective 1 March 2023. List, payment ratios, and conditions for BHYT reimbursement of chemical drugs, biologicals, radiopharmaceuticals, and tracers. Replaces Circulars 30/2018, 01/2020, and 20/2020. Note: A draft amendment to Circular 20/2022 has been in public consultation; verify the currently effective version before relying on the appended list for commercial decisions.

2025 — Circular 40/2025/TT-BYT in force: Effective 25 October 2025. Fully replaces Circular 07/2024 and aligns drug tendering with the amended Pharmacy Law (44/2024/QH15). Adds rules for drug substitution when winning bid drugs are withdrawn or otherwise unavailable, and clarifies bidding for traditional medicines and medicinal materials. 2025 — Amended Health Insurance Law in force: Law 51/2024/QH15 took effect on 1 July 2025. Market-access-relevant changes: 100% co-payment relief for long-term participants, four new categories of state-funded contributors, and formal coverage of home-based treatment under BHYT. 2024 — Drug-tendering reform package: Circular 07/2024/TT-BYT (17 May 2024) replaced Circular 15/2019 and its 06/2023 amendment. Issued together with Decree 24/2024/NĐ-CP (27 February 2024), it implemented the 2023 Bidding Law for the pharmaceutical sector and aimed to address persistent drug-supply disruptions caused by tender delays at hospitals. 2024 — Bidding Law in force: Law 22/2023/QH15 took effect on 1 January 2024, replacing the 2013 Bidding Law. Article 55 establishes a specific procurement regime for medicines and medical equipment and gives public facilities greater autonomy in purchasing non-BHYT items and immunization vaccines. 2023 — Stop-gap tendering rules: Circular 06/2023/TT-BYT amended Circular 15/2019 to address acute drug shortages — mainly simplifications around tender package preparation, plan approval, and group changes — pending the full overhaul under Circular 07/2024.