Proposal on form of free medicine support for patients in Vietnam

 Proposal on form of free medicine support for patients in Vietnam

The Ministry of Health of Vietnam is drafting a circular stipulating the implementation of a free medicine support program for medical examination and treatment establishments to treat patients.

The form of free medicine support for patients is proposed as follows:

1. Forms of free medicine support for patients 

In Article 4 of the draft Circular, the forms of medicine support are as follows:

1.1. Completely free medicine support

- Scope of application: apply to all medicine items;

- Form: Pharmaceutical business establishments provide free support for the entire quantity of medicines used in the course of treatment within the scope of the program's commitment to patients.

1.2. Partial free medicine support

- Scope of application: Applicable to original brand-name medicines or reference biological products still in the exclusive protection period; or medicines without generic medicines (for pharmaco-chemical medicines) or without similar biological products (for biological products) with the same active ingredients and dosage form in Vietnam;

(Compared to Circular 31/2018/TT-BYT, additional biological products do not have similar biological products).

- Form: Pharmaceutical business establishments provide free support for a portion of the total number of medicines that the patient is expected to use during the cycle, course of treatment, or after the patient has completed a number of cycles and course of treatment.

2. Regulations on the management and use of free medicines at medical examination and treatment establishments in Vietnam

In Article 9 of the draft Circular on the management and use of medicines at medical examination and treatment establishments,

- Medicines must be prescribed for use for the right purposes, to the right subjects, and assigned and dispensed by medical staff.

- When specifying the use of medicines in the support program, it is necessary to clearly state that the medicines are received from the support medicine source of the pharmacy business establishment in the medical record or prescription.

- Medicines dispensed in the support program need to be preserved, stored in a separate area, and have a sign that identifies them as medicines in the program.

- In case the dispensed medicines are not used up, the patient or the patient's family is responsible for returning the unused medicine to the medical examination and treatment establishment.

In case of force majeure, the patient or the patient's family cannot return the unused medicine. The medical examination and treatment establishment must make a written confirmation of the reason for the failure to recall the medicine.

- The destruction of expired medicines, inferior quality medicines, damaged or broken medicines, medicines returned by the patient or the patient's family must comply with the regulations of the Ministry of Health.

The unit responsible for medicine destruction and medicine destruction funding shall comply with the agreement signed by the pharmacy business establishment and the medical examination and treatment establishment.

3. Application for approval of free medicine support not within foreign non-governmental aid in Vietnam

3.1. Application for first-time approval of a partial free medicine support program not within foreign non-governmental aid

In Article 5 of the draft Circular, the application for the first approval of a partial free medicine support program includes:

- A written request for approval of the partial free medicine support program of the pharmacy business establishment;

- The content of the free medicine support program is partly proposed for approval, including the minimum information according to Appendix 02, issued together with the draft Circular.

(In contrast to Circular 31/2018/TT-BYT, which also states that the program content must include at least the information listed in Appendix 02).

- A copy of the valid certification of the pharmacy business establishment's Certificate of eligibility for pharmacy business;

- A certified true copy of the operation license of the medical examination and treatment establishment; an extract of the professional scope approved by a competent authority for a medical examination and treatment facility participating in the program related to the prescription and use of medicines (with a hanging seal of the medical examination and treatment establishment);

(Circular 31/2018/TT-BYT stipulates a certified copy of the operation license with the approved professional scope of the medical examination and treatment facility participating in the program)

- A certified true copy of the valid circulation registration certificate or import license of the medicine in Vietnam;

- A written consent to receive and participate in the medicine support program of the medical examination and treatment establishment;

- Draft contract between the pharmacy business establishment and the medical examination and treatment establishment. The contents of the contract must include the minimum information specified in Appendix 03, issued together with the draft Circular.

(New content has been added) 

3.2. Application for approval for the addition or modification of the content of a partial free medicine support program

According to Article 6 of the draft Circular, stipulating that the partial free medicine support program requires additional approval or adjustment when there is a change in at least one of the following cases:

+ Changes in the list of medical examination and treatment establishments implementing the medicine support program;

+ Changes in the subjects of patients participating in the support program;

+ Changes in the scope of indications of medicines in the support program;

+ Change in the form of support: Change the number of supportive medicines in each cycle, or change the form of support according to the cycles, or change the number of supported cycles;

+ Change in information about adjuvant medicines: change in content, dosage form, or packaging form, or registration number, or manufacturing company of the adjuvant medicine;

+ Change the duration of the medicine support program;

+ Other cases not falling under Section 3.1

Note: When there is a change in the program contents, including the cases mentioned above, the application for additional approval of the partial free medicine support program shall comply with Section 3.1 for new arising factors. Dossiers submitted for the first time under Section 3.1 without any new elements are not required to be supplemented.

4. Procedures for approval of a partial free medicine support program not within foreign non-governmental aid in Vietnam

As stipulated in Article 7 of the draft Circular, the procedures for approving the partial free medicine support program that is not part of foreign non-governmental aid are as follows:

Step 1: The pharmacy business establishment submits a complete application according to Section 3.1 and Section 3.2 to the Department of Health Insurance, Ministry of Health.

Step 2: After receiving the dossier, the Department of Health Insurance, the Ministry of Health shall grant the pharmacy business establishment a receipt for the application according to the form specified in Appendix 04 of the draft Circular.

Step 3: Record settlement

- In case the application has met the requirements:

The Ministry of Health must conduct an appraisal of the application and make a written appraisal within 30 days from the date written on the receipt of the application for approval of the medicine support program.

The Health Insurance Department of the Ministry of Health shall submit a written approval of the medicine support program to the Ministry of Health leaders for promulgation within 10 working days of the day on which the appraisal minutes are issued.

+ In case the appraisal result is satisfactory but there is a request to amend and supplement the dossier. 
Within 10 working days from the day on which the appraisal minutes are issued, the Health Insurance Department of the Ministry of Health shall submit to the Leaders of the Ministry of Health for promulgation a written request for the pharmaceutical business establishment to amend and supplement as per the requirements recorded in the appraisal minutes;

If the Ministry of Health has made a written request to amend and supplement the dossier but within 60 days from the date of the Ministry of Health's written request, the pharmacy business establishment fails to supplement or amend the dossier, they must repeat the procedure for requesting approval of the medicine assistance program from the beginning;

+ After receiving the amended and supplemented dossier of the pharmaceutical business establishment, the Department of Health Insurance, the Ministry of Health is responsible for reviewing and comparing it with the request stated in the appraisal minutes.

+ Within 10 working days from the date of receipt of a satisfactory application for amendment and supplementation, the Department of Health Insurance of the Ministry of Health submits to the Leaders of the Ministry of Health for promulgation a document approving the medicine support program. In the event of disapproval of the medicine support program, there must be a written reply clearly stating the reason.

- In case the application does not meet the requirements,

+ Within no more than 30 days from the date indicated on the application for approval of the medicine support program, the Ministry of Health must issue a written request to the pharmacy business establishment to amend and supplement the dossier. The document must clearly state the contents that need to be amended and supplemented.

If the Ministry of Health has made a written request to amend or supplement the dossier but within 60 days from the date of the Ministry of Health's written request, the pharmacy business establishment fails to supplement or amend the dossier, they must repeat the procedure for applying for approval of the medicine support program from the beginning;

+ After receiving the amended and supplemented dossier of the pharmacy business establishment, the Department of Health Insurance, the Ministry of Health is responsible for reviewing and comparing it with the provisions of this Circular.

+ If the dossier meets the requirements, the Ministry of Health's Health Insurance Department is responsible for adhering to the provisions of Clause 3, Article 7 of the ddraft Circular.

The Ministry of Health's Health Insurance Department will issue a written request to the pharmacy business establishment to continue to amend and supplement the dossier.

More details can be found in the draft Circular.

Ngoc Nhi

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