Circular No. 31/2018/TT-BYT on the implementation of the free drug support program for medical examination and treatment facilities to treat patients

CIRCULAR

REGULATIONS ON THE IMPLEMENTATION OF THE FREE MEDICINE SUPPORT PROGRAM

FOR HEALTH CARE AND TREATMENT FACILITIES TO TREAT PATIENTS

Pursuant to the Drug Law No. 105/2016/QH13 dated April 6, 2016;

Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the request of the Director of the Health Insurance Department,

The Minister of Health issues this Circular to regulate the implementation of the free medicine support program for health care and treatment facilities to treat patients carried out by pharmaceutical business establishments. This Circular regulates the implementation of the free medicine support program for health care and treatment facilities to treat patients carried out by pharmaceutical business establishments, including: principles of implementing the free medicine support program, forms of support, procedures for approving the free medicine support program, regulations on management and use of medicines, approval regime, reporting requirements, and responsibilities of the parties involved.

Article 1. Scope of Regulation and Applicability

2. Applicability:

a) Health care and treatment facilities implementing the free medicine support program;

Article 2. The subjects to which this Decision applies include:

b) Patients with and without health insurance cards;

c) Medical staff participating in the free medicine support program;

d) Pharmaceutical business establishments implementing the free medicine support program;

e) Other related units.

The free medicine support program

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. is an activity of providing medicines by pharmaceutical business establishments to patients undergoing treatment at health care and treatment facilities within a specified period of time aimed at reducing financial burdens and supporting patient care and treatment. Treatment cycle, regimen

2. refers to the number of times medication is taken daily, weekly, or monthly and the total number of days of medication use during a treatment course and the total number of treatment courses. Article 3. Principles of Implementing the Free Medicine Support Program

1. The implementation of the free medicine support program must be based on a contract between the pharmaceutical business establishment and the health care and treatment facility and must ensure that no conditions are imposed that would cause the health care and treatment facility or the patient to abandon, refuse, or change the use of medication or alter the treatment method.

2. Health care and treatment facilities participating in the free medicine support program must have appropriate professional scope, meet the human resource and equipment requirements suitable for the prescription and use of supported medications.

3. Pharmaceutical business establishments must comply with legal requirements for pharmaceutical business operations, ensuring the quality and origin of medicines in the free medicine support program.

4. Patients participating in the program must belong to the target group of the free medicine support program and be diagnosed with a disease consistent with the scope of the program's prescription; they must be provided with full information and counseling, agree voluntarily to participate in the free medicine support program according to Form 01 attached to this Circular.

5. Prescribers must comply with legal regulations on prescription writing, program requirements, and must be assigned in writing by the head of the health care and treatment facility to participate in the free medicine support program.

6. Medicines in the free medicine support program must be legally approved for circulation in Vietnam by the Ministry of Health.

7. The free medicine support program providing partial free medicines must be approved by the Ministry of Health regarding the program content before implementation.

8. Management costs for the free medicine support program shall be agreed upon by the pharmaceutical business establishment and the health care and treatment facility.

8. The management funds for the drug support programme shall be agreed upon by pharmaceutical business establishments and medical examination and treatment facilities.

Article 4. Forms of drug support

1. Free drug support in full

a) Scope of application: Applies to all types of drugs;

b) Form: The pharmaceutical business entity provides free support for the entire quantity of drugs used during the treatment process within the scope committed to under the program for patients.

2. Partial free drug support

a) Scope of application: Applies to original brand-name drugs still within the period of exclusive rights protection; or drugs that have not yet been available in Vietnam with the same active ingredient or dosage form as generics;

b) Form: The pharmaceutical business entity provides partial free support for the quantity of drugs within the total amount of drugs that the patient is expected to use during a cycle or course of treatment, or after the patient has completed a certain number of cycles or courses of treatment.

Article 5. Approval dossier for partial free drug support programs not falling under non-governmental foreign aid

The approval dossier for partial free drug support programs includes:

1. A request document for approval of the partial free drug support program from the pharmaceutical business entity.

2. Content of the proposed partial free drug support program (to be implemented according to the model specified in Appendix 02 issued together with this Circular).

3. A certified copy of the valid Pharmaceutical Business License of the pharmaceutical business entity.

4. A certified copy of the Operating Permit with the approved scope of expertise of the participating medical examination and treatment facility.

5. A certified copy of the Registration Certificate for Circulation or Import Permit of the drug in Vietnam.

6. A document agreeing to accept and participate in the drug support program from the medical examination and treatment facility.

7. Draft Contract between the pharmaceutical business entity and the medical examination and treatment facility. The Contract must include the minimum information specified in Appendix 03 issued together with this Circular.

Article 6. Procedures for approving partial free drug support programs not falling under non-governmental foreign aid

1. The pharmaceutical business entity submits the complete dossier as prescribed in Article 5 of this Circular to the Health Insurance Department, Ministry of Health.

2. After receiving the dossier, the Health Insurance Department, Ministry of Health issues a receipt for the dossier to the pharmaceutical business entity according to the model specified in Appendix 04 issued together with this Circular.

3. In case the dossier meets the requirements:

a) Within thirty days from the date recorded on the receipt for the request to approve the drug support program, the Ministry of Health must conduct a review of the dossier and issue a review report;

b) If the review results meet the requirements and there is no need for modification or supplementation of the dossier: Within ten working days from the date of the review report, the Health Insurance Department, Ministry of Health will submit to the leadership of the Ministry of Health for issuance of a document approving the drug support program;

c) If the review results meet the requirements but require modification or supplementation of the dossier: Within ten working days from the date of the review report, the Health Insurance Department, Ministry of Health will submit to the leadership of the Ministry of Health for issuance of a document requesting the pharmaceutical business entity to modify or supplement the dossier according to the requirements noted in the review report;

In case the Ministry of Health has issued a document requesting modification or supplementation of the dossier, if within sixty days from the date the Ministry of Health issued the document requesting modification or supplementation, the pharmaceutical business entity does not supplement or modify the dossier, then the procedure for requesting approval of the Drug Support Program must be restarted from the beginning;

d) Upon receiving the modified and supplemented dossier from the pharmaceutical business entity, the Health Insurance Department, Ministry of Health shall be responsible for reviewing and comparing it with the requirements noted in the review report;

e) Within ten working days from the date of receiving the modified and supplemented dossier from the pharmaceutical business entity that meets the requirements, the Health Insurance Department, Ministry of Health will submit to the leadership of the Ministry of Health for issuance of a document approving the drug support program. In case the program is not approved, a reply document must be issued stating the reasons.

4. In case the dossier does not meet the requirements:

a) Within thirty days from the date recorded on the receipt for the request to approve the drug support program, the Ministry of Health must issue a document requesting the pharmaceutical business entity to modify or supplement the dossier. The document must clearly state the contents that need to be modified or supplemented;

In case the Ministry of Health has issued a document requesting modification or supplementation of the dossier, if within sixty days from the date the Ministry of Health issued the document requesting modification or supplementation, the pharmaceutical business entity does not supplement or modify the dossier, then the procedure for requesting approval of the Drug Support Program must be restarted from the beginning;

b) Upon receiving the modified and supplemented dossier from the pharmaceutical business entity, the Health Insurance Department, Ministry of Health shall be responsible for reviewing and comparing it with the provisions of this Circular;

c) If the dossier meets the requirements, the Health Insurance Department, Ministry of Health shall be responsible for implementing the provisions stipulated in Clause 3 of this Article;

d) If the dossier still does not meet the requirements, the Health Insurance Department, Ministry of Health shall be responsible for issuing a document requesting the pharmaceutical business entity to continue modifying or supplementing the dossier.

Article 7. Documents and Procedures for Approving Programs to Provide Free Medicines Partially from Non-Governmental Foreign Aid

1. In addition to the documents required for approving aid under the laws on managing non-governmental foreign aid, the application documents for approving programs to provide free medicines must include the following additional documents:

a) The content of the program to provide free medicines partially proposed for approval (to be implemented according to the form prescribed in Appendix 02 issued together with this Circular);

b) A certified copy of the Certificate of Eligibility for Pharmaceutical Business of the pharmaceutical business entity;

c) A document agreeing to accept and participate in the program from the medical examination and treatment facility;

d) A draft contract between the pharmaceutical business entity and the medical examination and treatment facility. The content of the contract must include the minimum information prescribed in Appendix 03 issued together with this Circular.

2. The procedures for approval shall be carried out in accordance with the laws on managing non-governmental foreign aid.

3. The pharmaceutical business entity must submit all documents as stipulated in Clause 1 of this Article to the Department of Planning and Finance, Ministry of Health.

Article 8. Management and Use of Medicines at Medical Examination and Treatment Facilities

1. Medicines must be prescribed for use according to their intended purpose and target group, and must be prescribed and distributed by healthcare staff.

2. When prescribing medicines within the support program, it must be clearly recorded that the medicines were obtained from the support medicine source of the pharmaceutical business entity in the medical record or prescription.

3. Medicines distributed within the support program need to be stored in a separate area and marked as medicines in the program.

4. In cases where the allocated medicines are not fully used, the patient or the patient's family is responsible for returning the unused medicines to the medical examination and treatment facility.

5. The destruction of expired medicines, medicines that do not meet quality standards, damaged or broken medicines, and medicines returned by patients or their families shall be carried out in accordance with the regulations of the Ministry of Health. The entity responsible for the destruction of medicines and the cost of destruction shall be determined by the agreement signed between the pharmaceutical business entity and the medical examination and treatment facility.

Article 9. Approval and Reporting System

1. For Programs to Provide Fully Free Medicines

a) During implementation, the medical examination and treatment facility must notify and send the content of the medicine support program according to the form prescribed in Appendix 05 issued together with this Circular to the Department of Health for facilities directly under the Department of Health or health facilities under the Military and Police systems in the locality, and to the Department of Health Insurance, Ministry of Health for facilities directly under the Ministry of Health;

b) After completing the medicine support program, the medical examination and treatment facility must report the results to the Department of Health for facilities directly under the Department of Health or health facilities under the Military and Police systems in the locality, and to the Department of Health Insurance, Ministry of Health for facilities directly under the Ministry of Health. If the program lasts more than one year, then annually before January 15 of the following year, the medical examination and treatment facility must submit a summary report covering the period of implementation, the number of patients supported, the amount of medicines used, the amount of medicines to be continued to be supported, difficulties and obstacles encountered during the implementation of the program.

2. For Programs to Provide Partially Free Medicines

a) Before implementing the program: the pharmaceutical business entity must submit to the Ministry of Health for approval. The documents and procedures shall be carried out in accordance with Articles 5, 6, and 7 of this Circular;

b) After completing the program:

The medical examination and treatment facility must report the results of the partially free medicine support program not included in non-governmental foreign aid to the Department of Health Insurance, Ministry of Health; simultaneously sending to the Department of Health (for units under the Department of Health or health facilities under the Military and Police systems in the locality). If the program lasts more than one year, then annually before January 15 of the following year, the medical examination and treatment facility must submit a summary report.

The medical examination and treatment facility must report the results of the partially free medicine support program included in non-governmental foreign aid to the Department of Planning and Finance, Ministry of Health; simultaneously sending to the Department of Health (for units under the Department of Health or health facilities under the Military and Police systems in the locality). If the program lasts more than one year, then annually before January 15 of the following year, the medical examination and treatment facility must submit a summary report.

The report must cover the period of implementation, the number of patients supported, the amount of medicines used, the amount of medicines to be continued to be supported, difficulties and obstacles encountered during the implementation of the program.

Article 10. Responsibility for Implementation

1. Responsibilities of Units Under the Ministry of Health:

a) Department of Health Insurance:

- The lead unit coordinating with the Department of Planning and Finance, the General Department of Medical Examination and Treatment, the General Department of Medicine Management, and related units to propose to the leadership of the Ministry of Health the establishment of a review board for programs to provide partially free medicines not included in non-governmental foreign aid; compiling and proposing to the leadership of the Ministry of Health for approval.

- Receiving and compiling reports from medical examination and treatment facilities; inspecting and supervising programs to provide fully free medicines and programs to provide partially free medicines not included in non-governmental foreign aid annually or urgently (when necessary);

b) Department of Planning and Finance:

- The lead unit coordinating with the Department of Health Insurance, the General Department of Medical Examination and Treatment, the General Department of Medicine Management, and related units to examine programs to provide partially free medicines included in non-governmental foreign aid; compiling and proposing to the leadership of the Ministry of Health for approval.

- Receiving and compiling reports from medical examination and treatment facilities; inspecting and supervising programs included in non-governmental foreign aid annually or urgently (when necessary).

2. Responsibilities of the Vietnam Social Security:

a) Direct, guide the Health Insurance Examination and Multi-line Payment Center for the Northern region and the Southern region; Social Insurance of provinces and centrally governed cities and units within the sector to implement examination and payment of costs for medical examination and treatment under health insurance for patients in the drug support program;

b) Coordinate with the Ministry of Health to resolve issues in the payment of costs for medical examination and treatment under health insurance for patients in the drug support program.

3. Responsibilities of the Department of Health of provinces and centrally governed cities:

a) Direct and guide healthcare facilities under their management to organize the implementation of the provisions set out in this Circular;

b) Receive and compile reports on the content and results of the drug support program for patients from healthcare facilities under their management.

4. Responsibilities of healthcare facilities implementing the drug support program:

a) Assign a department to manage the program or delegate specific responsibilities to a ward or subordinate unit to manage the program;

b) Fulfill the reporting obligations as stipulated in Article 9 of this Circular.

5. Responsibilities of pharmaceutical business entities implementing the drug support program:

a) Shall not use the drug support program for advertising, marketing, or promotional activities for their products to healthcare facilities or patients;

b) Supply drugs fully, promptly, and ensure quality according to the signed Contract;

c) Directly manage or hire organizations or individuals with appropriate functions and duties to manage the program.

Article 11. Effective Date

1. This Circular takes effect from January 1, 2019.

2. For the partial free drug support programs currently being implemented but not yet approved by the Ministry of Health before the effective date of this Circular, such programs may continue to be implemented but must complete necessary procedures to obtain approval from the Ministry of Health and apply the regulations on drug management and reporting system of this Circular from the date it becomes effective.

During implementation, if there are difficulties or obstacles, please report them to the Ministry of Health for consideration and resolution./.