JOINT CIRCULAR No. 12/2007/TTLT-BYT-BTC GUIDING THE FINANCIAL MANAGEMENT MECHANISM FOR MEDICINES AND MEDICAL DEVICES UNDER THE U.S. PRESIDENTIAL EMERGENCY PLAN FOR AIDS RELIEF (PEPFAR) PROGRAM TO PREVENT AND CONTROL HIV/AIDS

JOINT CIRCULAR

GUIDELINES FOR THE FINANCIAL MANAGEMENT MECHANISM FOR MEDICINES AND MEDICAL DEVICES UNDER THE UNITED STATES PRESIDENT'S EMERGENCY PLAN FOR AIDS RELIEF (PEPFAR) FOR PREVENTION AND CONTROL OF HIV/AIDS

Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decree No. 77/2003/NĐ-CP dated July 1, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Finance;
Pursuant to the Regulation on the management and use of non-governmental foreign aid issued together with Decision No. 64/2001/QĐ-TTg dated April 26, 2001 of the Prime Minister;
Pursuant to the Framework Agreement signed on June 22, 2005 between the Government of the Socialist Republic of Vietnam and the Government of the United States of America;
Implementing the guidance of the Prime Minister as stated in Circular No. 2595/VPCP-QHQT dated May 16, 2007 of the Government Office;
Considering the special nature of the transfer, receipt, management, and use of medicines and medical devices under the PEPFAR program, the Joint Circular of the Ministry of Health and the Ministry of Finance provides for the financial management regime for medicines and medical devices under the PEPFAR program as follows:

This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.

1. Non-reimbursable medicines and medical devices provided as part of the emergency assistance program of the President of the United States for HIV/AIDS prevention and control (hereinafter referred to as the PEPFAR program) constitute a source of revenue for the central budget and must be managed in accordance with the provisions of the State Budget Law and the commitments made in the Framework Agreement signed between the Government of the Socialist Republic of Vietnam and the Government of the United States of America.

2. Medicines and medical devices under the PEPFAR program may only be imported into Vietnam upon approval by the competent authority (as stipulated in Article 6 of the Regulation on the Management and Use of Non-Governmental Foreign Aid issued together with Decision No. 64/2001/QĐ-TTG dated April 26, 2001 of the Prime Minister).

3. The project lead agency, the National Center for HIV/AIDS Prevention and Control, is responsible for receiving, managing, and using medicines and medical devices in compliance with current state financial management regulations and the provisions of this circular.

II. PREPARATION OF APPLICATION DOCUMENTS FOR APPROVAL OF AID

Due to the characteristics of the aid grant and the method of transferring aid for medicines and medical devices under the PEPFAR program, the application documents submitted to the competent authority for approval of aid consist of annual supply plans for medicines and medical devices. Annually, the project lead agency is responsible for coordinating with the donor and related units to prepare the supply plan for medicines and medical devices.

1. Basis for building the plan:

a) The supply plan for medicines and medical devices of the PEPFAR program for HIV/AIDS prevention and control in Vietnam is developed and compiled based on information from treatment facilities for people living with AIDS.

b) Annually, the project lead agency coordinates with the donor to develop the supply and distribution plan for medicines and medical devices of the PEPFAR program in Vietnam based on the following criteria:

- The situation and results of medicine and medical device usage in the previous year (importation, exportation, usage, and inventory levels according to Appendix 1 attached to this circular);

- The need for medicines and medical devices in the upcoming year;

- The supply capacity of the donor.

2. Process:

a) Healthcare facilities directly treating people living with AIDS base their monthly and annual needs for medicines and medical devices on patient treatment requirements and the facility's reception capacity;

b) Seek advice from treatment facilities for people living with AIDS under other programs and projects in the region;

c) Provincial Centers for HIV/AIDS Prevention and Control (or provincial preventive healthcare centers/AIDS committees for provinces that have not established HIV/AIDS centers) review, balance, adjust, and compile the needs for medicines and medical devices, which they then send to the provincial health departments, the National Center for HIV/AIDS Prevention and Control, and other projects under the PEPFAR program;

d) The project lead agency collaborates with the representative organization of the donor to compile the needs for medicines and medical devices for HIV/AIDS prevention and control across all provinces and cities under the PEPFAR program to develop the annual supply plan for medicines and medical devices (including an economic, technical analysis and other relevant factors related to the importation and supply of medicines and medical devices).

đ) The National Center for HIV/AIDS Prevention and Control collaborates with the Department of Planning and Finance, the Treatment Department, and the Drug Administration of Vietnam to submit the plan to the Minister of Health for approval in accordance with regulations.

3. Content of the Supply Plan for Medicines:

The supply plan for medicines and medical devices must reflect indicators regarding the quantity, types, and value of actual stock at the beginning of the year; imports during the year; distribution and usage during the year; and necessary reserves for the following year (compiled according to Appendix 2 attached to this circular).

4. Responsibilities of Related Units in Developing the Supply Plan for Medicines and Medical Devices:

The Ministry of Health directs units and healthcare facilities within the healthcare sector to develop supply and distribution plans for medicines and medical devices under the PEPFAR program to sign agreements on aid for the planning year, including:

a) The project lead agency is responsible for:

- Compiling the situation and evaluating the results of receiving, distributing, and using medicines and medical devices in the previous year;

- Leading and coordinating with the designated representative of the donor to guide healthcare facilities under the PEPFAR program to develop the plan for using medicines and medical devices for the planning year, compiling and submitting it to the Ministry of Health as stipulated in Point đ), Clause 2, Section II of this circular;

b) Related units are responsible for:

- Healthcare facilities treating people living with HIV/AIDS, specialized agencies for HIV/AIDS prevention and control, and provincial health departments under the PEPFAR program proactively assign specific responsibilities to determine the needs for medicines and medical devices suitable to the actual conditions of each unit and locality, promptly reporting to the project lead agency.

- The Department of Financial Planning, the Department of Treatment, and the Vietnam Drug Administration within their respective functions and duties shall closely cooperate with the National Center for HIV/AIDS Prevention and Control to analyze and assess the import needs for medicines and medical equipment in accordance with treatment protocols and approved lists of imported medicines to enhance the effectiveness of the assistance program.

5. Procedure for requesting approval of assistance for medicines and medical equipment under the Pepfar program:

a) After the annual plan for medicines and medical equipment of the Pepfar program has been agreed upon by the sponsor and the Ministry of Health, the Ministry of Health shall submit it to the Ministry of Finance for the Ministry of Finance to request the Prime Minister's approval of the assistance for the entire year according to the regulations on the management and use of non-governmental foreign aid issued together with Decision No. 64/2001/QD-TTG dated April 26, 2001 of the Prime Minister.

b) The dossier for requesting approval of assistance includes:

- The assistance agreement signed between the Ministry of Health and the United States side (or a notification letter of assistance from the United States side);

- The supply plan for medicines and medical equipment for the planned year agreed upon between the Ministry of Health and the sponsor;

- A report on the situation and results of using medicines in the previous year of the Pepfar program;

- A list of medicines, unit prices, and total value requested for approval (in USD). It must clearly specify medicines imported for the Pepfar program according to the standards of the U.S. Food and Drug Administration (FDA) or recommended for use by the World Health Organization (WHO).

c) The decision approving assistance of

6. Handling of arising cases:

After the Prime Minister issues the decision approving annual assistance for medicines and medical equipment of the Pepfar program, if actual circumstances arise that differ from those specified, they shall be handled as follows:

a) In case there is a change in the list of medicines and medical equipment, the Ministry of Health must issue a decision to adjust such list. The adjusted list based on the decision of the Ministry of Health serves as the basis for the Ministry of Finance to confirm the assistance and report to the Prime Minister.

b) In case the value of assistance for the planned year increases by more than $200,000 compared to the value of assistance recorded in the Prime Minister's decision approving assistance, the Ministry of Health is responsible for preparing an explanatory document and requesting the Prime Minister's supplementary approval.

c) In case the value of assistance for the planned year increases by less than $200,000 compared to the value of assistance recorded in the Prime Minister's decision approving assistance, the Ministry of Health shall approve the assistance according to the regulations.

III. MANAGEMENT OF THE PROCESS OF RECEIVING, STORING, TRANSPORTING, AND USING MEDICINES AND MEDICAL EQUIPMENT.

In addition to the responsibilities stipulated in Circular No. 82/2007/TT-BTC dated July 12, 2007 of the Ministry of Finance guiding the state financial management regime for non-reimbursable foreign aid from sources of state budget revenue, during the process of receiving, storing, transporting, and using medicines and medical equipment, the project owner and the receiving units shall also have the following responsibilities:

1. Project Owner:

a) Cooperate with the representative of the sponsor to select units with sufficient capacity to provide services for receiving, storing, transporting, and supplying medicines and medical equipment of the Pepfar program.

b) Together with the representative of the sponsor (party a), sign a service provision contract for receiving, storing, transporting, and supplying medicines and medical equipment of the Pepfar program with the selected units (party b).

c) Sign a declaration form for confirming donated goods to complete customs clearance procedures.

d) Supervise and inspect the entire process of receiving, distributing, and using medicines and medical equipment of the Pepfar program.

đ) Regularly compile and report on the progress of implementing the Pepfar program to the Ministry of Health and the Ministry of Finance.

e) Chair the redistribution and handling of ARV medicines.

g) Implement the final settlement of financial assistance for the Pepfar program in accordance with the Accounting Law.

2. Service Provider Units for Receiving, Storing, Transporting, and Supplying Medicines and Medical Equipment of the Pepfar Program:

a) Fully perform the responsibilities of Party B as stipulated in the terms of the contract signed with party a.

b) Provide complete and timely documentation for imported goods to the project owner to prepare the declaration form for requesting confirmation of assistance.

c) Regularly report fully, accurately, and promptly on the situation and results of receiving and supplying medicines and medical equipment to the project owner.

d) Provide complete information and data as required by the project owner to implement the final settlement of financial assistance for the Pepfar program.

đ) Propose to the project owner to handle promptly any issues arising outside the scope of the contract.

3. Healthcare Facilities Treating AIDS Patients:

When healthcare facilities treating AIDS patients receive medicines and medical equipment from the Pepfar program, they shall be responsible for:

a) Properly conducting the handover of medicines and medical equipment according to the procedures for donated goods (with a handover record specifying quantity, quality, type, and value of each medicine and equipment item, as per Appendix 3 attached to this circular).

b) Completing warehouse entry and exit procedures and maintaining detailed inventory accounting records for medicines and medical equipment according to current accounting regulations.

c) Providing free treatment medicines to AIDS patients according to the treatment protocols issued by the Ministry of Health.

d) Maintaining a record of medicine distribution to patients, analyzing and evaluating the effectiveness of treatment protocols, and proposing new treatment protocols for AIDS patients.

đ) Annually and quarterly, settle accounts for medicines and medical equipment and report to the Ministry of Health (for health facilities under the Ministry of Health) or the provincial health department (for health facilities under the provincial health department) according to current accounting regulations.

IV. ACCOUNTING THROUGH THE STATE BUDGET FOR FUNDS FROM ASSISTANCE FOR MEDICINES AND MEDICAL EQUIPMENT OF THE PEPFAR PROGRAM

1. Quarterly, the Ministry of Finance, based on the value of assistance recorded on the confirmation certificate for imported medicines and medical equipment (implemented by the project owner), shall proceed with recording central government revenue and expenditures for the Ministry of Health.

2. At the end of the Pepfar program's planning year, the project owner shall settle the completed project, prepare the final settlement report for the completed project, and the accounting vouchers for the final settlement shall be the final handover certificates regarding medicines and medical equipment between supply units and healthcare facilities treating AIDS patients.

3. The Ministry of Health shall conduct the review, approval, and notify the approval of the final settlement of the completed project to the project owner, including the handling of assets when the project ends as stipulated in Circular No. 116/2005/TT-BTC dated December 19, 2005, guiding the management and disposal of assets of projects using state budget funds upon completion. Based on the results of the approved final settlement of the project and asset disposal, the Ministry of Health issues the decision to transfer assets and funding to healthcare facilities treating AIDS patients.

4. Based on the Ministry of Health's decision to transfer assets and funding to healthcare facilities treating AIDS patients, the project owner shall reduce the assets and aid funding; healthcare facilities treating AIDS patients shall increase their assets and aid funding. On this basis, healthcare facilities treating AIDS patients shall settle the aid of the Pepfar program and consolidate it into the general settlement of the facility, report to the Department of Health and the Department of Finance for the Department of Finance to audit, approve, and notify the approval of the settlement to the Department of Health, while increasing local government revenue. For non-public treatment facilities, they shall record the increase in assets and funding for the unit; implement financial management, accounting, and financial settlement transparently, promptly, and fully in accordance with current regulations on financial management and accounting for non-public facilities.

5. The project owner and aid recipient units must organize project accounting in accordance with current accounting laws.

V. IMPLEMENTATION OF INSPECTION

Periodically or at random, the Ministry of Health shall carry out inspections on the planning, receipt, management, and use of medicines and medical equipment by the project owner, healthcare facilities treating AIDS patients, and service providers receiving, storing, transporting, and supplying for the Pepfar program to ensure compliance with commitments to the donor and effective, strict management in accordance with current laws. The Ministry of Finance shall conduct financial inspections of the program in accordance with current regulations.

VI. EFFECTIVE PROVISIONS

This Circular takes effect fifteen days from the date of publication in the Official Gazette.
During implementation, if there are any difficulties, relevant agencies shall promptly reflect them to the Ministry of Finance and the Ministry of Health for research and appropriate supplementation or amendment.