Circular No. 16/2026/TT-BYT on free of charge medicine programs for medical establishments

CIRCULAR

ON FREE OF CHARGE MEDICINE PROGRAMS FOR MEDICAL ESTABLISHMENTS

Pursuant to the Law on Pharmacy 105/2016/QH13 amended by Law No. 44/2024/QH15;

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

At the request of Directors of Department of Health Insurance and Drug administration of Vietnam.

The Minister of Health hereby issues a Circular on free of charge medicine programs for medical establishments.

Article 1. Scope

1. This Circular provide for free of charge medicine programs for medical establishments (hereinafter referred to as “free of charge medicine programs”) in accordance with point d of clause 1 of the Law on Pharmacy.

2. This circular does not apply to medicines that are part of non-refundable aid funded by the state budget.

Article 2. Principles for implementing the free of charge medicine program

1. Free of charge medicine program shall be executed based on a written agreement between the pharmacy business establishments and the medical establishments as specified in Article 3 of this Circular.

2. The execution of the free of charge medicine programs shall base on the support capacity of the pharmacy business establishment, and does not obligate them to ensure a sufficient supply of all medications for patients; must ensure that no fees are charged or that no commercial conditions are imposed on patients; and must not affect the patient’s choice of treatment methods or the rational, safe, and effective prescription of medications.

3. Drugs in the free of charge medicine program must be legally circulated in Vietnam in accordance with the laws on pharmacy.

4. Prescriptions and drug instructions must conform to one of the following documents:

a) The patient information leaflet approved by the Ministry of Health;

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

c) Diagnostic and treatment guidelines developed by the medical establishment in accordance with Article 6 of Circular No. 21/2013/TT-BYT on the organization and operation of the Drug and treatment council in hospitals., in cases where Ministry of Health’s guidelines are not yet available;

d) The latest version of the National Pharmacopoeia.

5. Medical establishments executing the free of charge medicine program must have a scope of professional activities consistent with the indications for drug use in such program.

6. The subjects covered by the program are patients who have been diagnosed with diseases whose treatment requires drugs provided free of charge in the program and voluntarily participate in such program.

7. The Health Insurance Fund shall not reimburse the amount of free drugs used for patients with health insurance cards.

Article 3. Written agreement on execution of the free of charge medicine program

1. Pharmacy business establishments and medical establishments shall sign a written agreement to implement the free of charge medicine program as prescribed in Appendix 01 attached hereto, including the following main contents:

a) Information on the provided drugs;

b) Execution method: Clearly state that the pharmacy business establishment shall provide free of charge the entire amount of drugs used to treat patients in accordance with clause 2 of Article 2 hereof;

c) Quantity of provided drugs: Clearly state the quantity of free of charge drugs according to dosage and route of administration;

d) Target and indications for drug use: Clearly state the target groups for support and the indications for drug use under the free of charge medicine program as prescribed in Clauses 4 and 6 of Article 2 hereof; encourage beneficiaries who are people with meritorious service to the revolution, patients from poor and near-poverty households, ethnic minorities, the elderly, people with disabilities, children, students, recipients of social welfare benefits, workers with particularly disadvantaged circumstances, and patients with health insurance cards but still facing significant financial burdens, and this must be stated in the written agreement between the two establishments;

dd) Duration of the free of charge medicine program: Clearly state the start and end dates;

e) Rights and obligations of the parties involved in executing the free of charge medicine program;

g) Transitional provisions on the protection of patients’ rights upon completion of the program.

2. In addition to the contents specified in Clause 1 of this Article, the written agreement for the free of charge medicine program may contain other contents as agreed upon by the parties, but these must not contradict the law.

Article 4. Management and use of drugs under the free of charge medicine program

1. Medications must be used only as indicated and for the correct target within the free of charge medication program.

2. The prescription or medical record must clearly state that the drugs was provided through the free of charge medication program.

3. Drugs must be stored separately and clearly marked as part of the free of charge medication program.

4. The disposal of expired, substandard, damaged, or broken drugs, as well as drugs returned by patients or their relatives, must comply with laws on pharmacy. The unit responsible for the disposal and the associated costs shall be clearly stated in the agreement signed between the pharmacy business establishment and the medical establishment.

5. Pharmacy business establishments must ensure the legal origin and quality of drugs provided to medical establishments. Medical establishments must ensure that the management and use of medicines within the establishments comply with applicable regulations, ensuring fairness, rationality, transparency, and effectiveness.

Article 5. Reporting and record storage

1. Reporting

Annually, medical establishments shall compile the results of the execution of the free of charge medication program in the review report of the unit.

2. Record storage

Records and documents of the free of charge medication program shall be stored in electronic or paper form at pharmacy business establishments and medical establishments in accordance with Circular No. 33/2025/TT-BYT on the storage duration of records and documents in health sector.

Article 6. Responsibilities for implementation

1. The Department of Health Insurance shall take charge and cooperate with the Drug Administration of Vietnam and the Department of Medical Service Administration in organization and providing guidance on the implementation of free of charge medication programs in accordance with this Circular.

2. Health agencies under the People’s Committees of provinces and cities; health regulatory authorities of ministries and central authorities shall organize and provide guidance on the implementation of free of charge medication program for medical establishments under their management.

3. Medical establishments executing free of charge medication programs shall:

a) Publicize information about the free of charge medication program on the medical establishments’ website (if any) or publicly displaying it at the medical establishments so that patients are aware;

b) Issue internal procedures for implementing the free of charge medication program at the medical establishment to ensure effective and safe drug use, avoiding abuse and wastefulness;

c) Fully and promptly provide and advise on treatment protocols, information on treatment effectiveness, unwanted side effects of drugs, and drug costs in the treatment protocol; information for comparing with other drugs and treatment regimens (if any), and the benefits enjoyed by patients participating in the free of charge medication program;

d) Based on the quantity of drugs supported, the medical establishment shall develop a specific drug distribution plan, appropriate to the actual number of patients at the establishment, ensuring fairness, reasonableness, transparency, and effectiveness.

4. The pharmacy business establishments executing the free drug support programs shall:

a) Strictly comply with the content of the agreement signed with the medical establishment and the regulations of this Circular;

b) Provide drugs fully and promptly, ensuring the quantity and quality of drugs as specified in the signed agreement;

c) Not use the free of charge medication program for advertising, marketing, or promotion for the medical establishments or patients; not exploit the free of charge medication program to create a competitive advantage in drug supply contrary to the law.

5. Patients participating in the free of charge medication program shall:

a) Comply with the regulations of the free of charge medication program;

b) Signing the Patient’s voluntary registration form for participation in the free of charge medication program as prescribed in Appendix 02 attached hereto.

Article 7. Transitional clauses

Free of charge medication programs approved by the Minister of Health before the effective date of this Circular and still valid after the effective date of this Circular shall:

1. Continue to be executed until the end of the approved period and must comply with the regulations on drug management and use, reporting, record storage, and implementation responsibilities as specified in Articles 4, 5, and 6 of this Circular from the effective date of this Circular.

2. In case of proposal to change the executing unit or increase the quantity of free of charge drugs for patients participating in the program to help reduce costs for patients, the pharmacy business establishment and medical establishment shall submit report and proposal to the Ministry of Health for resolution based on the regulations of Circular No. 31/2018/TT-BYT on the execution of free of charge medication programs for medical establishments and cooperate in ensuring that patients’ treatment is not interrupted.

Article 8. Implementation clauses

1. This Circular comes into force from July 10, 2026.

2. Circular No. 31/2018/TT-BYT dated October 30, 2018 of the Minister of Health on the execution of free of charge medication programs for medical establishments shall cease to be effective from the date this Circular comes into force.

Shall any difficulties or problems arise during the implementation process, promptly report to the Ministry of Health (Department of Health Insurance) for review and resolution./.