Circular 16/2026/TT-BYT implementation of free drug support programs for patient treatment

CIRCULAR

On implementation of free drug support programs for medical examination and treatment establishments for patient treatment

Pursuant to the Law on Pharmacy No. 105/2016/QH13, amended and supplemented under Law No. 44/2024/QH15;

Pursuant to Decree No. 42/2025/ND-CP defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Department of Health Insurance and the Director of the Drug Administration of Vietnam.

The Minister of Health hereby promulgates the Circular on implementation of free drug support programs for medical examination and treatment establishments for patient treatment.

Article 1. Scope of regulation

1. This Circular provides regulations on implementation of free drug support programs for medical examination and treatment establishments for patient treatment (hereinafter referred to as free drug support programs) in accordance with Point d Clause 1 Article 42 of the Law on Pharmacy.

2. This Circular does not apply to drugs funded from non-refundable aid sources belonging to the state budget revenues.

Article 2. Principles for implementation of free drug support programs

1. Free drug support programs shall be implemented on the basis of written agreements between pharmaceutical business establishments and medical examination and treatment establishments in accordance with Article 3 of this Circular.

2. Free drug support programs shall be implemented subject to the support capacity of pharmaceutical business establishments and shall not constitute an obligation to ensure the full supply of treatment drugs for patients. Such implementation must ensure that no payment is collected from patients and that no commercial conditions binding upon patients are imposed; it must not affect treatment selection or the rational, safe, and effective prescribing and use of drugs for patients.

3. Drugs included in free drug support programs must be lawfully circulated in Vietnam in accordance with pharmaceutical laws.

4. Drug prescribing and indications for drug use must conform to one of the following documents:

a) The package insert approved by the Ministry of Health;

b) Diagnostic and treatment guidelines promulgated or recognized by the Minister of Health;

c) Diagnostic and treatment guidelines developed by medical examination and treatment establishments in accordance with Article 6 of Circular No. 21/2013/TT-BYT prescribing the organization and operation of Medicine and Treatment Councils in hospitals, in case where diagnostic and treatment guidelines of the Ministry of Health are unavailable;

d) The most recent edition of the National Drug Formulary.

5. Medical examination and treatment establishments implementing free drug support programs must maintain a professional scope of practice appropriate to the drug indications included in such programs.

6. Eligible beneficiaries are patients who have received confirmed diagnoses, have been indicated and prescribed drugs consistent with approved indications for drugs included in free drug support programs, and voluntarily participate in such programs.

7. The Health Insurance Fund shall not pay for the free supported drugs already administered to patients holding health insurance cards.

Article 3. Written agreements for implementation of free drug support programs

1. Pharmaceutical business establishments and medical examination and treatment establishments shall enter into a written agreement for implementation of a free drug support program in accordance with Appendix I to this Circular, which include the following principal contents:

a) Information on supported drugs;

b) Support form: Clearly specify that the support mechanism consists of provision of drugs entirely free of charge to medical examination and treatment establishments for patient treatment and is consistent with Clause 2 Article 2 of this Circular;

c) Quantity of supported drugs: Clearly specify the quantity of drugs provided free of charge, by strength and route of administration;

d) Eligible beneficiaries and indications for drug use: Clearly specify eligible beneficiaries and indications for use of drugs under the free drug support program in accordance with Clauses 4 and 6 Article 2 of this Circular. Support is encouraged for persons with meritorious services to the revolution, patients from poor households and near-poor households, ethnic minority populations, the elderly, persons with disabilities, children, pupils, students, social assistance beneficiaries, workers with exceptionally difficult circumstances, and patients with health insurance coverage who continue to bear substantial out-of-pocket treatment costs. Such beneficiary categories must be specified in the written agreement between the two establishments;

dd) Duration of the free drug support program: Clearly specify the commencement date and termination date of the program;

e) Rights and obligations of relevant parties in implementation of the free drug support program;

g) Transitional provisions to safeguard patient rights and interests upon termination of the program.

2. In addition to the contents prescribed in Clause 1 of this Article, the written agreement on implementation of the free drug support program may include other provisions as agreed by the parties, provided that such provisions are not contrary to the law.

Article 4. Management and use of drugs under free drug support programs

1. Drugs shall be used strictly in accordance with indications and solely for eligible beneficiaries under the free drug support program.

2. Where a drug is prescribed or indicated for a patient, the patient’s medical record or prescription must clearly specify that the drug is supplied through the free drug support program.

3. Drugs provided under the free drug support program must be separately maintained and stored and must bear identifying markings indicating that they are drugs supplied under the free drug support program.

4. Disposal of expired drugs, drugs failing to meet quality standards, damaged drugs, broken drugs, and drugs returned by patients or patients’ relatives shall be carried out in accordance with the law on pharmacy. The entity responsible for drug disposal and the costs for drug disposal shall be clearly specified in the written agreement executed between the pharmaceutical business establishment and the medical examination and treatment establishment.

5. Pharmaceutical business establishments shall ensure the lawful origin and quality of drugs supplied to medical examination and treatment establishments. Medical examination and treatment establishments shall ensure that drugs are managed and used in compliance with applicable regulations and in a manner that is fair, appropriate, transparent, and effective.

Article 5. Reporting regime and record retention

1. Reporting regime

On an annual basis, medical examination and treatment establishments shall consolidate results of implementation of free drug support programs for patient treatment into the establishment’s annual summary report.

2. Record retention

Records and documents relating to free drug support programs shall be retained in electronic or paper form by pharmaceutical business establishments and medical examination and treatment establishments in accordance with Circular No. 33/2025/TT-BYT prescribing retention periods for records and documents in the medical sector.

Article 6. Implementation responsibilities

1. The Department of Health Insurance shall act as the focal point and coordinate with the Drug Administration of Vietnam and the Department of Medical Service Administration in organizing implementation of, and providing guidance on, free drug support programs in accordance with this Circular.

2. Health agencies under the People’s Committees of provinces and cities and health management agencies of ministries and sectors shall organize implementation of, and provide guidance on, free drug support programs for medical examination and treatment establishments under their management.

3. Medical examination and treatment establishments implementing free drug support programs shall:

a) Disclose information relating to free drug support programs on their websites (if any) or disclose such information at the establishment for patient access;

b) Issue internal procedures for implementation of free drug support programs at medical examination and treatment establishments to ensure effective and safe drug use and to prevent misuse and waste;

c) Timely provide patients participating in free drug support programs with sufficient information and counseling regarding treatment regimens, treatment effectiveness, adverse drug reactions, drug costs under prescribed regimens, comparative information with alternative drugs and treatment regimens (if any), and program benefits available to participating patients;

d) Based on the quantity of supported drugs, develop specific drug dispensing plans appropriate to the actual number of patients at the establishment and ensure fairness, appropriateness, transparency, and effectiveness.

4. Pharmaceutical business establishments implementing free drug support programs shall:

a) Fully comply with the contents agreed upon in the written agreement executed with medical examination and treatment establishments and comply with this Circular;

b) Ensure adequate and timely supply of drugs in accordance with the quantities and quality under the executed written agreement;

c) Not use free drug support programs for advertising, marketing, or promotional purposes directed toward medical examination and treatment establishments or patients; and not exploit drug support activities to create unlawful competitive advantages in drug supply contrary to law.

5. Patients participating in free drug support programs shall:

a) Comply with program requirements applicable to free drug support programs;

b) Sign the patient voluntary enrollment form for participation in the free drug support program in accordance with the form provided in Appendix II to this Circular.

Article 7. Transitional provisions

For free drug support programs that are approved by the Minister of Health before the effective date of this Circular and remaining valid after the effective date of this Circular:

1. Such programs shall continue through the expiration of their approved implementation period. From the effective date of this Circular, management and use of drugs, reporting regime, record retention, and implementation responsibilities shall comply with Articles 4, 5, and 6 of this Circular.

2. Where a proposal is made to change the implementing establishment or increase the quantity of drugs provided free of charge to patients already enrolled in the program in order to further reduce patients’ treatment cost burdens, pharmaceutical business establishments and medical examination and treatment establishments shall report and submit such proposals to the Ministry of Health for resolution in accordance with Circular No. 31/2018/TT-BYT on implementation of drug support programs for medical examination and treatment establishments for patient treatment, and shall coordinate to ensure continuity of care without interruption of patient treatment.

Article 8. Implementation provisions

1. This Circular takes effect from July 10, 2026.

2. The Minister of Health's Circular No. 31/2018/TT-BYT dated October 30, 2018, on implementation of drug support programs for medical examination and treatment establishments for patient treatment, ceases to be effective from the effective date of this Circular.

Any difficulties arising in the course of implementation should be reported to the Ministry of Health (the Department of Health Insurance) for consideration and settlement./.