On May 25, 2026, Vietnam’s Ministry of Health issued Circular No. 16/2026/TT-BYT governing free-of-charge medicine support programs for medical establishments (Circular 16). Circular 16 will take effect on July 10, 2026, replacing Circular No. 31/2018/TT-BYT, which currently regulates the same subject matter. Circular 16 introduces several significant changes compared to the existing legal framework.

Removal of Prior Approval Requirement

Under the current regulations, free-of-charge medicine support programs are divided into two categories: (1) entirely free-of-charge provision of medicines for all types of drugs and (2) partially free-of-charge provision applicable only to brand-name drugs under patent protection or drugs whose generic products with identical active ingredients and dosage forms are available in Vietnam. Under the current regulations, partially free-of-charge programs are subject to mandatory registration with the competent authority, while entirely free-of-charge programs could be implemented without prior approval.

A key reform under Circular 16 is that it stipulates only entirely free-of-charge medicine support programs applicable to all types of medicines, thereby eliminating the partially free-of-charge category. In addition, free-of-charge medicine support programs may be carried out solely based on a written agreement between the pharmaceutical company and the medical establishment, without any requirement for prior approval from competent authorities prior to implementation.

Written Agreement Requirements

Circular 16 requires the pharmaceutical company and medical establishment to enter into a written agreement in accordance with a prescribed template. This agreement must include the following compulsory information:

• Information on the supported medicines
• Form of support (entirely free-of-charge provision to patients)
• Quantity of medicines provided
• Target patient groups and applicable indications
• Duration of the program
• Rights and obligations of each party
• Transitional provisions on the protection of patients’ rights upon completion of the program

The agreement may contain other contents as agreed by the parties, provided that these do not contradict applicable laws.

Reporting and Record Retention

Circular 16 proposes a reduction in administrative burden by simplifying reporting requirements.

Under Circular 16, medical establishments are no longer required to submit reports upon completion of each individual program. Instead, results of program implementation must be consolidated into the establishment’s annual report.

All records and documentation must be retained in either electronic or hard-copy format in accordance with Circular No. 33/2025/TT-BYT on record retention in the healthcare sector.

Transitional Provisions

Free-of-charge medicine programs that were approved by the Minister of Health prior to the effective date of Circular 16 and remain valid thereafter can continue to be implemented until the end of their approved duration. However, from the effective date of Circular 16, such programs must comply with the provisions on drug use management, reporting obligations, record retention, and responsibilities of relevant parties as stipulated in the new circular.

In cases where there is a proposal to change the implementing entity or increase the quantity of free-of-charge medicines provided to participating patients in order to reduce treatment costs, the pharmaceutical company and the medical establishment must submit a report and proposal to the Ministry of Health for consideration and resolution.

Outlook

Circular 16 represents a significant shift in Vietnam’s regulatory approach to free-of-charge medicine support programs. By removing program classification and prior approval requirements, and by simplifying reporting obligations, the new framework aims to enhance flexibility, reduce administrative barriers, and promote greater access to essential medicines.

Stakeholders, including pharmaceutical companies and healthcare providers, should closely monitor the effective date of Circular 16 and assess its implications for ongoing and future support programs.