Thông tư liên tịch 12/2007/TTLT-BYT-BTC của Bộ Y tế và Bộ Tài chính về việc hướng dẫn cơ chế quản lý tài chính đối với thuốc và thiết bị y tế thuộc Chương trình viện trợ khẩn cấp của Tổng thống Hoa Kỳ (PEPFAR) cho phòng, chống HIV/AIDS

JOINT CIRCULAR

GUIDING THE FINANCIAL MANAGEMENT MECHANISM APPLICABLE TO DRUGS AND MEDICAL EQUIPMENT UNDER THE U.S. PRESIDENTS EMERGENCY PLAN FOR AIDS RELIEF (PEPFAR)

Pursuant to the Governments Decree No. 49/2003/ND-CP of May 15, 2003, defining the functions, tasks, powers and organizational structure of the Health Ministry;

Pursuant to the Governments Decree No. 77/2003/ND-CP of JuIy  1, 2003. defining the functions, tasks, powers and organizational structure of the Finance Ministry;

Pursuant to the Regulation on management and use of foreign non-governmental aid, promulgated together with the Prime Ministers Decision No. 64/2001/QD-TTg of April 26, 2001:

Pursuant to the Framework Agreement signed on June 22, 2005, between the Socialist Republic of Vietnam Government and the United States Administration;

In furtherance of the Prime Ministers instructions in the Government Offices Official Letter No. 2595/VPCP-QHQT of May 16, 2007:

Depending on the particularities of the process of transfer, receipt, use management of drugs and medical equipment under the PEPFAR, the Health Ministry and the Finance Ministry jointly guide the financial management regime applicable to drugs and medical equipment under the PEPFAR as follows:

I. GENERAL PROVISIONS

1. Drugs and medical equipment being non-refundable aid under the US Presidents emergency plan for AIDS relief (PEPFAR) constitute a source of central budget revenue, which must be managed in accordance with the State Budget Law and the commitments in the Framework Agreement signed between the Socialist Republic of Vietnam Government and the United States Administration.

2. Drugs and medical equipment under the PEPFAR will be imported into Vietnam only when approving decisions are issued by competent authorities (defined in Article 6 of the Regulation on management and use of foreign non-governmental aid, promulgated together with the Prime Ministers Decision No. 6472001/QD-TTg of April 26, 2001).

3. The Vietnam HIV/AIDS Prevention and Control Department being the project owner shall receive, manage and use dings and medical equipment strictly according to current regulations on state finance management and the provisions of this Circular.

II. PREPARATION OF DOSSIERS REQUESTING APPROVAL OF AID

Due to the characteristics of the aid and the mode of transfer of aid being drugs and medical instruments under the PEPFAR. the dossiers to be submitted to competent authorities for aid approval will be annual plans on supply of drugs and medical equipment. Annually, the project owner shall assume the prime responsibility for coordinating with donors and concerned units in the formulation of plans on drug and medical equipment supply.

1. Grounds for formulation of plans:

a/ Plans on supply of drugs and medical equipment under the PEPFAR for HIV/AIDS prevention and control in Vietnam are formulated and synthesized from establishments hospitalizing HIV/AIDS patients.

b/ Annually, the project owners shall coordinate with donors in formulating plans on supply and distribution of drugs and medical equipment under the PEPFAR in Vietnam, based on the following criteria:

- The situation and results of the use of drugs and medical equipment in the preceding year (the warehousing, delivery, use and stock, made according to Appendix I to this Circular, not primed herein);

- The demand for drugs and medical equipment in the following year;

- The supply capability of donors.

2. Process:

a/ Medical establishments directly hospitalizing AIDS patients shall base themselves on the patients treatment demands and their respective reception capabilities to determine monthly and yearly drug and medical equipment demands:

b/ To consult AIDS patient-hospitalizing establishments under other programs and projects in the region.

c/ Provincial/municipal HIV/AIDS Prevention and Control Agencies (HIV/AIDS Prevention and Control Centers or Preventive Medicine Centers/ AIDS Prevention and Control Committees, for provinces and cities where AIDS Prevention and Control Centers are not yet set up) shall consider, balance, adjust and sum up drug and medical equipment demands and send them to provincial/ municipal Health Services, the Vietnam HIV/AIDS Prevention and Control Department and other projects under the PEPFAR:

d/ The project owner shall coordinate with organizations representing the donors in summing up the HIV/AIDS drug and medical equipment demands of all provinces and cities covered by the PEPFAR in order to work out annual plans on drug and medical equipment supply (enclosed with the written analysis of economic, technical and other elements related to the process of importing and supplying drugs and medical equipment).

dd/ The Vietnam HIV/AIDS Prevention and Control Department shall coordinate with the Planning and Finance Department, the Therapy Department and the Vietnam Drug Administration in submitting them to the Health Minister for aid approval according to regulations.

3. Contents of drug supply plans:

Drug and medical equipment supply plans must reflect the norms on quantity, category and value of actual goods in stock at the beginning of the year; being imported in the year; being distributed and used in the year and the necessary reserves for early use next year pending the new supply (summed up according to Appendix 2 to this Circular, not primed herein).

4. Responsibilities of units involved in the formulation of drug and medical equipment supply plans:

The Health Ministry shall direct units and medical establishments in the health service to formulate plans on supply and distribution of drugs and medical equipment of the PEPFAR in order to sign aid agreements in the plan year, in which:

a/ The project owner has the responsibilities:

- To sum up the situation and evaluate the results of receipt, distribution and use of drugs and medical equipment in the year preceding the plan year;

- To take the initiative in coordinating with donors representatives in guiding medical establishments covered by the PEPFAR to formulate plans on the use of drugs and medical equipment for the plan year, synthesize them for submission to the Health Ministry as provided for at Point e, Clause 2, Section II of this Circular:

b/ Concern units have the responsibilities:

- Medical establishments hospitalizing HIV/AIDS patients, specialized HIV/AIDS Prevention and Control Agencies and Health Services of provinces and cities covered by the PEPFAR shall lake the initiative in defining their responsibilities and identifying their respective drug and medical equipment demands suitable to the practical situation of each unit, locality and sum them up for timely report to the project owner.

The Planning and Finance Department, the Therapy Department and the Vietnam Drug Administration shall, within the ambit of their respective functions and tusks, closely coordinate with the Vietnam HIV/AIDS Prevention and Control Department in analyzing and evaluating the demands for import of drugs and medical equipment suitable to the therapy process and the list of drugs permitted for import in order to enhance the efficiency of the aid program.

5. Process of proposing the approval of aid being drugs and medical equipment under the PEPFAR:

a/ After the annual drug and medical equipment plans under the PEPFAR are agreed upon by the donors and the Health Ministry, the Health Ministry shall send them to the Finance Ministry for submission to the Prime Minister for approval of aid for the whole plan year according to the Regulation on management and use of foreign non-governmental aid. promulgated together with the Prime Ministers Decision No. 64/2001/QD-TTg of April 26, 2001.

b/ A dossier submitted for aid approval comprises:

- The aid agreement signed between the Health Ministry and the U.S. side (or the U.S. sides aid notification letter);

- The plan on drug and medical equipment supply for the plan year, already agreed upon between the Health Ministry and the donors;

- The previous years report on the situation and use of drugs of the PEPFAR;

- The list of drugs, unit prices and total value asked for approval (in USD) It should be clearly stated that drugs are imported for the PEPFAR under the standards of the US Food and Drug Agency (FDA) or recommended for use by the World Health Organization (WHO).

c/ The Prime Ministers decision approving the aid serves as a legal basis for the receipt, distribution and use of drugs and medical equipment of the PEPFAR.

6. Handling of arising circumstances:

Circumstances actually arising after the Prime Minister issues decisions approving the annual aid being drugs and medical equipment of the PEPFAR will be handled as follows:

a/ In case of changes in the list of drugs and medical equipment, the Health Ministry shall issue a decision adjusting such list. The list adjusted under the Health Ministry’s decision serves as a basis for the Finance Ministry to certify the aid and report thereon to the Prime Minister;

b/ If the aid value for the plan year is over USD 200.000 higher than the aid value stated in the Prime Ministers written approval of aid. the Health Ministry shall send a written explanation requesting the Prime Minister to make additional approval.

c/ If the aid value for the plan year is less than USD 200.000 higher than the aid value stated in the Prime Ministers written approval of aid, the Health Ministry shall approve the aid according to regulations.

III. MANAGEMENT OF THE PROCESS OF RECEIPT. PRESERVATION, TRANSPORTATION AND USE OF DRUGS AND MEDICAL EQUIPMENT

In addition to the responsibilities defined in the Finance Ministry’s Circular No. 82/2007HT-BTC of July 12, 2007, guiding the slate finance management regime applicable to foreign non-refundable aid belonging to the state budget revenue sources, in the process of receiving, preserving, transporting and using drugs and medical equipment, the project owner and aid-receiving units also have the following responsibilities:

1. The project owner:

a/ To coordinate with representatives of donors in selecting units fully capable of providing the services of receiving, preserving, transporting and supplying drugs and medical equipment of the PEPFAR

b/ To join the donors representatives (co-Party A) in signing contracts for provision of services on receipt, preservation, transportation and supply of drugs and medical equipment of the PEPFAR with the selected units (Party B).

c/ To sign the written certification of aid goods for completion of customs-clearance procedures.

d/ To supervise and inspect the entire process of receiving, distributing and using drugs and medical equipment of the PEPFAR.

e/ To periodically sum up and report on the progress of implementation of the PEPFAR to the Health Ministry and the Finance Ministry.

f/ To assume the prime responsibility for transfer and handling of ARV drugs.

g/ To conduct financial settlement of the PEPFAR in accordance with the provisions of the Accountancy Law.

2. Units providing services of receiving, preserving, transporting and supplying drugs and medical equipment of the PEPFAR shall:

a/ Fulfill Party Bs responsibilities specified in the contracts signed with Party A.

b/ Fully and promptly supply vouchers on goods import to the project owner for making declaration to request certification of aid.

c/ Periodically report fully, accurately and promptly on the situation and results of drug and medical equipment receipt and supply to the project owner.

d/ To fully supply information and data at request of the project owner for financial settlement of aid of the PEPFAR.

dd/ propose the project owner to handle in time matters arising beyond contracts.

3. Medical establishments hospitalizing AIDS patients

Medical establishments hospitalizing AIDS patients, when receiving drugs and medical equipment of the PEPFAR, have the responsibility

a/ To conduct the hand-over and receipt of drugs and medical equipment in strict accordance with aid hand-over and receipt procedures (with hand-over and receipt records clearly stating the quantity, quality, categories, value of drugs and equipment for each time of hand-over and receipt, made according to the form in Appendix 3 to this Circular, not printed herein).

b/ To carry out w are housing and ex-warehousing procedures and account the supplies storehouses, with detailed accounting books monitoring separately drugs and medical equipment according to current accounting regimes.

c/ To supply treatment drugs free of charge to AIDS patients strictly according to the treatment guidelines promulgated by the Health Ministry.

d/ To open books to monitor the ding supply to patients, to analyze and evaluate the effect of the treatment guidelines and propose various treatment guidelines for treatment of AIDS patients.

dd/ Quarterly and annually, to make the final settlement of drugs and medical equipment and report thereon to the Health Ministry (for medical establishments attached to the Health Ministry) or provincial/municipal Health Services (for medical establishments attached to Health Services) strictly according to current accounting regimes.

IV. VIA-STATE BUDGET ACCOUNTING OF AID CAPITAL SOURCES IN TERMS OF DRUGS AND MEDICAL EQUIPMENT OF THE PEPFAR

1. Quarterly, the Finance Ministry shall base on the aid value stated in aid certification papers in terms of imported drugs and medical equipment (made by the project owner) to carry out procedures for crediting the central budget and debiting the Health Ministry.

2. At the end of a plan year of the PEPFAR, the project owner shall make final settlement of completed projects and reports thereon. Accounting vouchers for making final settlement are the final drug and medical equipment hand-over and receipt records between supplying units and medical establishments hospitalizing AIDS patients.

3. The Health Ministry shall appraise, approve and notify the approval of final settlement of completed projects for the project owner, clearly staling the handling of assets upon project completion according to the Finance Ministry’s Circular No. 116/2005/TT-BTC of December 19, 2005, guiding the management and use of assets of state budget-financed projects upon project completion. Based on the approval of final settlement of completed projects and the handling of assets, the Health Ministry shall issue decisions on hand-over of assets and capital sources to medical establishments hospitalizing AIDS patients.

4. Based on the Health Ministry’s decisions on asset and capital-source hand-over to medical establishments hospitalizing AIDS patients, the project owner shall record asset decrease and capital source decrease; medical establishments hospitalizing AIDS patients shall record asset increase and capital source increase. On that basis, medical establishments hospitalizing AIDS patients shall make final settlement of aid of the PEPFAR and synthesize them into their general final settlement and report thereon to provincial/ municipal Health Services and Finance Services so that the Finance Services verify, approve and notify the approval of final settlement for the Health Services and, at the same lime, credit local budgets. Non-public hospitalizing establishments shall account the increase of assets and carnal sources for their units; make financial management, accounting and final settlement in a transparent, timely and full manner according to current regulations on financial management and accounting regimes applicable to non-public establishments.

5. The project owner and aid-using units shall account projects strictly according to current legal provisions on accounting.

V. INSPECTION

Periodically or extraordinarily, the Health Ministry shall inspect the plan formulation, receipt, management and use of drugs and medical equipment by the project owner, medical establishments hospitalizing AIDS patients, units providing services of receipt, preservation, transportation and supply for the PEPFAR with a view to strictly observing the commitments with the donors and strictly and efficiently manage them in accordance with current provisions of law. The Finance Ministry shall conduct the financial inspection of the Program undercurrent regulations.

VI. IMPLEMENTATION PROVISIONS

This Circular takes effect 15 days after its publication in CONG BAO.

If problems arise in the course of implementation, concerned agencies shall report them in time to the Finance Ministry and the Health Ministry for appropriate supplements or amendments.