Thông tư 05/2024/TT-BYT quy định về danh mục thuốc, thiết bị y tế, vật tư xét nghiệm được áp dụng hình thức đàm phán giá và quy trình, thủ tục lựa chọn nhà thầu đối với các gói thầu áp dụng hình thức đàm phán giá do Bộ trưởng Bộ Y tế ban hành

• Số hiệu: 05/2024/TT-BYT
• Loại văn bản: Thông tư
• Nơi ban hành: Bộ Y tế
• Người ký: Lê Đức Luận
• Ngày ban hành: 14/05/2024

THE MINISTRY OF HEALTH OF VIETNAM -------	THE SOCIALIST REPUBLIC OF VIET NAM Independence-Freedom-Happiness -----------------
No. 05/2024/TT-BYT	Hanoi, May 14, 2024

CIRCULAR

LISTS OF DRUGS, MEDICAL DEVICES AND TEST EQUIPMENT PROCURED THROUGH PRICE NEGOTIATION AND SUPPLIER SELECTION PROCEDURES FOR PACKAGES APPLYING PRICE NEGOTIATION METHOD

Pursuant to the Law on Bidding dated June 23, 2023;

Pursuant to the Government’s Decree No. 24/2024/ND-CP dated February 27, 2024 elaborating and providing guidelines for implementation of the Law on Bidding regarding contractor selection;

Pursuant to the Government’s Decree No. 95/2022/ND-CP dated November 15, 2022 defining functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam;

At the request of the Director of the Department of Planning and Finance, the Director of the Drug Administration of Vietnam, and the Director of the Infrastructure and Medical Device Administration;

The Minister of Health of Vietnam promulgates a Circular prescribing the lists of drugs, medical devices and test equipment procured through price negotiation and supplier selection procedures for packages applying price negotiation method.

Chapter I

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Article 1. Principles and criteria for compiling lists of drugs, medical devices and test equipment procured through price negotiation

1. A drug to be included in the list must meet one of the following principles and criteria:

a) A drug or reference biological must be included in the list of original brand-name drugs and reference biologicals announced by the Ministry of Health of Vietnam;

b) The drug in the requested dosage form is only supplied by 01 - 02 manufacturers (particularly, a vaccine that is used under the Expanded Program on Immunization and contains the requested ingredients/is produced adopting the requested technology is only supplied by 01 - 02 manufacturers).

2. A medical device or test equipment to be included in the list must meet the following principles and criteria:

a) It has been granted a certificate of marketing authorization in Vietnam;

b) The medical device or test equipment produced adopting the requested production principle or technology or for the intended use is only supplied by 01 - 02 manufacturers.

Article 2. Lists of drugs, medical devices and test equipment procured through price negotiation

Lists of drugs, medical devices and test equipment procured through price negotiation are enclosed with this Circular, including:

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2. The list of medical devices and test equipment procured through price negotiation is provided in Appendix II enclosed herewith.

Chapter II

SUPPLIER SELECTION PROCEDURES FOR DRUG, MEDICAL DEVICE AND TEST EQUIPMENT PACKAGES APPLYING PRICE NEGOTIATION METHOD

Section 1. GENERAL PROVISIONS ON PRICE NEGOTIATION

Article 3. Agency in charge of price negotiation

1. Negotiation on prices of drugs, medical devices and test equipment included in the lists of drugs, medical devices and test equipment procured through price negotiation prescribed in Article 2 of this Circular shall be conducted by a unit assigned by the Ministry of Health of Vietnam (hereinafter referred to as “price negotiation unit”)

2. Tasks of the price negotiation unit:

a) Formulate, approve and disclose the plan for organization of price negotiation;

b) Formulate the plan for selection of suppliers of drugs, medical devices and test equipment adopting price negotiation method;

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d) Organize evaluation of proposals;

dd) Formulate and approve price negotiation scenarios;

e) Appraise, approve and disclose the price negotiation result;

g) Enter into a framework agreement or contract with the selected supplier;

h) Supervise and regulate the supply and use of drugs, medical devices and test equipment procured through price negotiation;

i) Participate in all stages of the price negotiation process, and consolidate and provide relevant information during the price negotiation;

k) Perform other tasks assigned by the Minister of Health of Vietnam.

Article 4. Interdisciplinary team in charge of price negotiation

1. The interdisciplinary team in charge of price negotiation is established according to a decision issued by the Minister of Health of Vietnam (hereinafter referred to as “interdisciplinary team”). The interdisciplinary team is composed of:

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b) 02 team deputy leaders, including a person holding the leadership position of the price negotiation unit and a representative holding leadership position of a Department or Board of Vietnam Social Security; and

c) Other members, including:

- Representative of the Ministry of Finance of Vietnam;

- Representatives of Departments/Agencies/Administrations in charge of managing drugs, medical devices, preventive medicine, population or bidding, and other relevant units of the Ministry of Health of Vietnam.

d) The team clerk who is a representative of the price negotiation unit;

dd) Where necessary, the team leader may invite experts to participate in the price negotiation process.

2. Tasks of the interdisciplinary team:

Carry out negotiation on prices of drugs, medical devices and test equipment included in the lists of drugs, medical devices and test equipment procured through price negotiation according to the price negotiation scenario approved as prescribed in Article 5 of this Circular.

Article 5. Price negotiation scenario

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a) Number of marketing authorization certificates granted to Category-1 generic drugs as prescribed in the Circular on bidding for supply of drugs for public health facilities promulgated by the Minister of Health of Vietnam (hereinafter referred to as “Category-1 generic drugs”) or generic drugs of other technical categories (if Category-1 generic drugs are not available);

b) The winning bids of Category-1 generic drugs or generic drugs of other technical categories (if Category-1 generic drugs are not available);

c) The substitution of the drug procured through price negotiation (where necessary);

d) Availability time of the drug in Vietnam;

dd) Information on the value of the used quantity of the drug to be procured through price negotiation which is provided by Vietnam Social Security (if any);

e) The planned value and quantity of the drug to be procured through price negotiation;

g) Reference prices of the drug to be procured through price negotiation in ASEAN Member States (if any). If reference prices in ASEAN Member States are not available, reference prices in other countries may be used (if any);

h) The roadmap for processing or transfer of technology for production of original brand-name drugs or reference biologicals for which the processing or technology transfer in Vietnam is announced by the Ministry of Health of Vietnam;

i) Proposals of suppliers, report on evaluation of proposals and consolidated information on the drug to be procured through price negotiation made by the expert team;

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2. A scenario for negotiation on price of a medical device or test equipment shall be constructed on the basis of one, or some, or all of the following information pieces:

a) The winning bid of the medical device or test equipment to be procured through price negotiation (if any);

b) Availability time of the medical device or test equipment in Vietnam;

c) Information on the value of the used quantity of the medical device or test equipment which is provided by Vietnam Social Security (if any);

d) The planning value and quantity of the medical device or test equipment to be procured through price negotiation;

dd) Reference prices of the medical device or test equipment to be procured through price negotiation in ASEAN Member States (if any). If reference prices in ASEAN Member States are not available, reference prices in other countries may be used (if any);

e) Proposals of suppliers, report on evaluation of proposals and consolidated information on the medical device or test equipment to be procured through price negotiation made by the expert team;

g) Other relevant information (if any).

3. A price negotiation scenario shall, inter alia, include the following contents:

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b) Brief description of the drug, medical device or test equipment to be procured through price negotiation;

c) The expected negotiated price. This is the price which will be negotiated but is not compulsorily arrived at through the price negotiation. It may be:

- The price which is expected to be arrived at through the price negotiation; or

- The price range which includes different prices expected to be arrived at through the price negotiation;

d) Other contents concerning the price negotiation scenario.

Article 6. Notifying plan for organization of price negotiation

1. Based on its capacity to carry out the price negotiation, the price negotiation unit shall develop a plan for organization of price negotiation which shall, inter alia, include the following contents:

a) Number of price negotiations to be conducted in the year;

b) List of drugs, medical devices and test equipment of each price negotiation;

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Regarding the drugs, medical devices or test equipment which are included in the lists of drugs, medical devices and test equipment to be procured through price negotiation and for which price negotiation results have been disclosed, the price negotiation unit shall formulate the plan, determination of use demands and organize the supplier selection through price negotiation for the following period or at least 06 months before the expiration of the signed framework agreement, and must send written notification to relevant units/local governments to organize supplier selection as prescribed in clause 2 of this Article.

2. The price negotiation unit shall give send written notification of the price negotiation plan and the price negotiation status to relevant units and local governments so that they can proactively organize the selection of suppliers of drugs, medical devices and test equipment to be procured through price negotiation as prescribed in clause 1 Article 20 of this Circular in the following cases:

a) The plan for organization of price negotiation shall be notified by March 15 each year as prescribed in clause 1 of this Article;

b) A drug, medical device or test equipment included in the lists of drugs, medical devices and test equipment to be procured through price negotiation does not meet the principles and criteria set out in clause 1 Article 28 of the Law on Bidding and Article 1 of this Circular;

c) The required price negotiation schedule is not met;

d) The regulation prescribed in Article 17 of this Circular cannot be carried out in the following cases:

- Health facilities have used up the quantity of drugs, medical devices or test equipment specified in framework agreements or have unexpected demands for drugs, medical devices or test equipment which are beyond the regulating capacity prescribed in Article 17 of this Circular;

- Health facilities are established after demands for drugs, medical devices or test equipment have been determined, and the increased demands exceed the regulating capacity prescribed in Article 17 of this Circular.

dd) The price negotiation is unsuccessful;

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Section 2. PREPARATION, APPRAISAL AND APPROVAL OF SUPPLIER SELECTION PLAN

Article 7. Determination of demands

1. Units in charge of consolidating demands for drugs, medical devices, and test equipment included in lists of drugs, medical devices, and test equipment to be procured through price negotiation (hereinafter referred to as “units in charge of consolidating demands"):

a) For antiretroviral drugs: The Vietnam Administration of HIV/AIDS Control plays the leading role and cooperates with the price negotiation unit in giving instructions for determining and consolidating demands for such antiretroviral drugs as follows:

- Health facilities under management of the Ministry of Health of Vietnam, health facilities under management of Ministries or central-government authorities located in provinces or central-affiliated cities, and health facilities under management of provincial governments shall determine their demands for antiretroviral drugs in terms of list of antiretroviral drugs, detailed quantities, categories, and supply schedules, and submit reports on their demands to provincial HIV/AIDS Control Agencies;

- Provincial HIV/AIDS Control Agencies shall review, consolidate and assume responsibility for demands for antiretroviral drugs of health facilities in their provinces or cities, and send consolidated reports on such demands to provincial Departments of Health for consideration and decision;

- Provincial Departments of Health shall send their written proposals indicating demands for antiretroviral drugs, which are accompanied with the documents in clause 3 of this Article, to Vietnam Administration of HIV/AIDS Control;

- Vietnam Administration of HIV/AIDS Control shall consolidate received proposals and send its written proposal for procurement of antiretroviral drugs to the price negotiation unit.

b) For tuberculosis treatment drugs: The National Lung Hospital plays the leading role and cooperates with the price negotiation unit in giving instructions for determining and consolidating demands for tuberculosis treatment drugs, and, based on the quantity of tuberculosis treatment drugs actually used by health facilities and suppliers’ capacity in the previous period, and the estimated number of patients, determine and assume responsibility for determined demands for tuberculosis treatment drugs, and sending a written proposal for procurement of tuberculosis treatment drugs to the price negotiation unit;

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d) For contraceptives: The Population Department plays the leading role and cooperates with the price negotiation unit in giving instructions for determining and consolidating demands for contraceptives, and, based on the quantity of contraceptives actually used by health facilities and suppliers’ capacity in the previous period, and the estimated number of users, determine and assume responsibility for determined demands for contraceptives, and sending a written proposal for procurement of contraceptives to the price negotiation unit;

dd) For drugs, medical devices and test equipment to be procured through price negotiation other than those specified in points a, b, c and d of this clause, the price negotiation unit shall give instructions for determining and consolidating demands as follows:

- Health facilities under management of the Ministry of Health of Vietnam shall determine their demands in terms of list of drugs, medical devices and test equipment, detailed quantities, and additional quantities (if any), assume responsibility for their determined demands, and submit reports on their demands to the price negotiation unit;

- Health facilities under management of Ministries or central-government authorities, infirmaries of regulatory authorities, and private health facilities shall determine their demands in terms of list of drugs, medical devices and test equipment, detailed quantities, and additional quantities (if any), and submit reports on their demands to Departments of Health of provinces or cities where the health facility is located; provincial Departments of Health shall consolidate demands and send reports to the price negotiation unit. Health facilities assume responsibility for their determined demands;

- Health facilities under management of provincial Departments of Health shall determine their demands in terms of list of drugs, medical devices and test equipment, detailed quantities, and additional quantities (if any), and submit reports on their demands to provincial centralized procurement units. Provincial centralized procurement units shall consolidate demands and submit consolidated reports to provincial Departments of Health. Provincial Departments of Health shall consider and decide demands, and assume responsibility for their decision, and then send written proposals for procurement of drugs, medical devices and test equipment to the price negotiation unit.

2. Consolidation of demands for drugs, medical devices and test equipment:

a) Demands for drugs, medical devices and test equipment must be submitted by a specific deadline prescribed by the price negotiation unit;

b) If a unit does not send its demand for a drug, medical device or test equipment within 45 days from the day on which the price negotiation unit makes initial request for consolidation of demands, that unit shall be considered to have no demand, and shall itself carry out procurement as prescribed;

c) If a unit in charge of consolidating demands fails to send adequate documents as prescribed in clause 3 of this Article, the price negotiation unit shall request that unit in writing to submit additional documents. Within 05 working days from the date of the request sent by the price negotiation unit, if the unit in charge of consolidating demands still fails to submit the requested documents or submits inadequate documents, the price negotiation unit shall, based on the quantity of the drug used and proposals of health facilities, determine and consolidate demands of such health facilities, provided that the increased quantity does not exceed 30% of the quantity of that drug used in the previous period or in 12 months prior to the date of the request made by the price negotiation unit;

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dd) After consolidating demands submitted by units in charge of consolidating demands, the price negotiation unit shall send a written request to Vietnam Social Security for its opinions on the consolidated demand for the drug, medical device or test equipment to be procured through price negotiation;

Within 10 days from the date of the written request for opinions sent by the price negotiation unit, Vietnam Social Security shall give its written response. If Vietnam Social Security fails to give its response by the abovementioned deadline or gives its response after the abovementioned deadline, Vietnam Social Security shall be considered to have agreed with the consolidated demand presented by the price negotiation unit.

Where Vietnam Social Security disagrees with the consolidated demand presented by the price negotiation unit, the price negotiation unit shall receive and clarify opinions given by Vietnam Social Security.

If the price negotiation unit disagrees with any opinion given by Vietnam Social Security, within 05 working days from the date of receipt of opinions given by Vietnam Social Security, it shall organize a meeting with Vietnam Social Security to reach agreement. Opinions given by the person who attends the meeting as assigned by Vietnam Social Security shall be considered official opinions given by Vietnam Social Security. Any discrepancies which cannot be resolved at the meeting shall be submitted to the Ministry of Health of Vietnam for consideration and decision.

Where Vietnam Social Security does not assign its representative to attend the meeting, it shall be considered to have agreed with the consolidated demand completed by the price negotiation unit after receiving and clarifying opinions given by Vietnam Social Security.

3. When submitting its consolidated report on demands, each unit in charge of consolidating demands must also submit the following documents:

a) A summary report on supplier selection result, use of the drug, medical device or test equipment in the previous period or the previous 12 months, the quantity of drug, medical device or test equipment in stock, and the quantity of drug, medical device or test equipment which is still not yet supplied under the plan as at the date of determination of demands;

b) A brief explanation for the plan for procurement of the proposed drug, medical device or test equipment. In case there is an increase in the quantity by more than 30% of the quantity of the drug, medical device or test equipment used in the previous period of 12 months before the date of determination of demands, detailed explanations are required;

c) Documents used as the basis for the supplier selection plan;

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- The Drug and Treatment Council in respect of the drug included in the list of drugs to be procured through price negotiation of health facilities under the management of the Ministry of Health of Vietnam;

- The science council in respect of the medical device or test equipment included in the list of medical devices and test equipment to be procured through price negotiation of health facilities under the management of the Ministry of Health of Vietnam;

- Provincial Departments of Health in respect of the drug, medical device or test equipment included in the lists of drugs, medical devices and test equipment to be procured through price negotiation of health facilities under the management of Provincial Departments of Health;

When submitting consolidated reports on demands of a new health facility or a health facility that first has demands for the drug, medical device or test equipment, the documents in point a of this clause are not required.

Article 8. Formulation of supplier selection plan

1. Based on lists of drugs, medical devices and test equipment to be procured through price negotiation announced by the Minister of Health of Vietnam and the plan for organization of price negotiation, the price negotiation unit shall formulate an annual plan for supplier selection through price negotiation.

2. In addition to the provisions of Article 39 of the Law on Bidding, a plan for supplier selection through price negotiation shall also meet the following requirements:

a) Name of the package:

A drug, medical device or test equipment package applying price procurement method may contain one or several drugs, medical devices or test equipment. Each drug, medical device or test equipment is considered a part of the package. If a package is divided into smaller parts, each of them must have a suitable name;

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- Specific information on a medical device or test equipment included in the supplier selection plan includes name of the medical device or test equipment, category, unit, quantity, unit price and total value.

b) Value of the package:

The value of the package shall comply with provisions of clause 1 Article 16 of the Government’s Decree No. 24/2024/ND-CP dated February 27, 2024 elaborating and providing guidelines for implementation of the Law on Bidding regarding contractor selection (hereinafter referred to as “Decree No. 24/2024/ND-CP”). If a package is divided into smaller parts, in addition to total value of the package, the unit price and value of each part must also be specified.

The value of the package shall be determined according to provisions of Clause 2 Article 16 of the Decree No. 24/2024/ND-CP. The price negotiation unit shall propose the unit price of the drug, medical device or test equipment in the supplier selection plan, and assume responsibility for its proposal.

c) Specifications of the drug or configurations/technical features of the medical device or test equipment, delivery schedule requirement, and specific purchase conditions of each drug, medical device or test equipment procured through price negotiation;

d) Supplier selection procedure: single-stage one-envelope procedure shall apply.

dd) Supplier selection schedule: the price negotiation unit shall set up the supplier selection schedule and submit it to a competent person for approval.

e) Type of contract: The type of contract must be specified in the supplier selection plan as prescribed in Article 64 of the Law on Bidding and as the basis for preparation of RFPs; conclusion of the framework agreement or contract in case the price negotiation unit directly purchases drugs, medical devices or test equipment.

g) Duration of the framework agreement or package: The duration of the framework agreement or package specified in the supplier selection plan is approved by a competent person and shall not exceed 36 months.

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Article 9. Appraisal and approval of supplier selection plan

1. Appraisal of supplier selection plan:

a) The price negotiation unit shall submit required documents for approval of the supplier selection plan to the Ministry of Health of Vietnam (via the Department of Planning and Finance) that shall play the leading role and cooperate with relevant units in carrying out the appraisal of the supplier selection plan (hereinafter referred to as “appraisal unit”);

b) Within 10 days from the receipt of the documents submitted for approval of the supplier selection plan, the Ministry of Health of Vietnam (via the Department of Planning and Finance) shall send a written request to Vietnam Social Security for its opinions about the supplier selection plan, except the contents of procurement which have unanimously agreed upon as prescribed in point d clause 2 Article 7 of this Circular;

c) Within 10 days from the receipt of the written request for opinions, Vietnam Social Security shall clearly give its opinions on the supplier selection plan. If Vietnam Social Security fails to give its opinions by the abovementioned deadline or gives its opinions after the abovementioned deadline, Vietnam Social Security shall be considered to have agreed with all contents of the supplier selection plan.

Where Vietnam Social Security disagrees with the supplier selection plan presented by the appraisal unit, the appraisal unit shall cooperate with the price negotiation unit in receiving and clarifying opinions given by Vietnam Social Security.

If the appraisal unit disagrees with any opinion given by Vietnam Social Security, within 05 working days from the date of receipt of opinions given by Vietnam Social Security, it shall organize a meeting with Vietnam Social Security to reach an agreement. Opinions given by the person who attends the meeting as assigned by Vietnam Social Security shall be considered official opinions given by Vietnam Social Security. Any discrepancies which cannot be resolved at the meeting shall be submitted to the Ministry of Health of Vietnam for consideration and decision.

Where Vietnam Social Security does not assign its representative to attend the meeting, it shall be considered to have agreed with the supplier selection plan completed by the price negotiation unit after receiving and clarifying opinions given by Vietnam Social Security.

d) The Ministry of Health of Vietnam shall consider approving the supplier selection plan on the basis of the documents submitted for approval of the supplier selection plan by the price negotiation unit, appraisal report and request of the appraisal unit.

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Article 10. Preparation of request for proposals (RFP)

1. Based on the approved plan for selection of suppliers of drugs, medical devices or test equipment through price negotiation, the price negotiation unit shall prepare the RFP in accordance with provisions of the Law on Bidding, its guiding documents, guidelines given by the Ministry of Planning and Investment of Vietnam, and provisions herein.

2. An RFP shall, inter alia, include the following information: the brief information about the package; instructions on preparation and submission of proposals; capacity and experience requirements satisfied by suppliers; criteria for technical evaluation; determination of the package value. A supplier’s responsiveness to capacity, experience and technical requirements shall be evaluated on pass/fail basis. Classification of technical criteria for a drug which is bidded for shall be carried out in accordance with provisions of the Circular prescribing bidding for supply of drugs for public health facilities promulgated by the Ministry of Health of Vietnam.

3. The RFP must also include instructions for suppliers to provide specific information on price and technical criteria to be applied during the negotiation on the price of drug, medical device or test equipment, including:

a) Information on ex-works price (for domestically manufactured drugs), CIF or CIP price (for imported drugs), the selling price at which drugs, medical devices or test equipment are sold to health facilities in manufacturing countries and ASEAN Member States which is provided by the supplier (if any);

b) The selling price at which drugs, medical devices or test equipment are sold to health facilities in Vietnam;

c) Indications and clinical effectiveness evaluation of drugs in treatment; reports on clinical effectiveness evaluation of drugs in treatment in comparison with other standard drugs (if any);

d) Indications, intended use and effectiveness evaluation of medical devices or test equipment; reports on effectiveness evaluation of medical device or test equipment in comparison with other medical devices or test equipment of the same indication or intended use (if any);

dd) Data on healthcare economic analyses of the drug, medical device or test equipment, including: cost – effectiveness, cost – benefit and cost – utility analyses, provided by the supplier (if any);

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Article 11. Appraisal and approval for RFP

The price negotiation unit shall organize appraisal and approval of RFP.

1. Appraisal of RFP:

a) The RFP must be appraised before it is submitted to the head of the price negotiation unit for consideration and approval;

b) The head of the price negotiation unit shall decide the composition of the unit in charge of appraising the RFP.

2. Approval for RFP:

Based on the appraisal report and proposals made by the unit in charge of appraising the RFP, the head of the price negotiation unit shall consider giving approval for the RFP as prescribed.

Section 4. ORGANIZATION OF PRICE NEGOTIATION

Article 12. Issuance of RFP

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Article 13. Preparation and submission of proposals

1. Based on the invitation to supply drug, medical device or test equipment through price negotiation and the RFP, suppliers shall prepare and submit their proposals to the price negotiation unit either directly or by post.

2. Suppliers shall be provided with a minimum period of 18 days beginning on the issue date of the RFP to the deadline for submission of proposals for preparing their proposals. In case the price negotiation result has to be available ahead of the prescribed deadline, the minimum period beginning on the issue date of the RFP to the deadline for submission of proposals which is given to suppliers for preparing their proposals may be reduced to 05 working days, provided that suppliers must be provided with sufficient time to prepare their proposals.

3. The supplier that is invited to the second negotiation shall be required to submit a new quotation by the deadline specified in the invitation to negotiate sent by the price negotiation unit.

Article 14. Evaluation of proposals and formulation of price negotiation scenario

Based on received proposals and report on evaluation of proposals made by the expert team, the price negotiation unit shall consider approving the list of suppliers that meet eligibility requirements set out in points a, b, c, d, e, g, h and i clause 1 Article 5 of the Law on Bidding, meet capacity and experience requirements, and have drugs, medical devices or test equipment meeting technical requirements set out in the RFP.

2. Based on the received proposals and report on evaluation of proposals made by the expert team, the price negotiation unit shall construct the price negotiation scenario as prescribed in Article 5 of this Circular, and present it to the head of the price negotiation unit for approval.

Article 15. Conducting price negotiation

1. The price negotiation may be conducted directly, by correspondence or a combination of these two forms. The interdisciplinary team shall decide to conduct the negotiation directly or by correspondence or a combination of these two forms on a case-by-case basis.

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If the price negotiation by correspondence is conducted, the price negotiation unit shall take charge of drafting and sending notifications indicating opinions given by the interdisciplinary team to the supplier and receiving responses from the supplier during the price negotiation.

2. The interdisciplinary team shall conduct negotiation on price of each product for which an approved price negotiation scenario is available.

3. Based on the approved price negotiation scenario in which a single price is specified, the interdisciplinary team shall conduct the price negotiation with the supplier according to the following principles:

a) If the supplier’s proposed price is lower than or equal to the expected price, the interdisciplinary team shall accept the supplier’s proposed price and terminate the price negotiation;

b) If the supplier’s proposed price is higher than the expected price, the interdisciplinary team shall request the supplier to adjust their proposed price. No more than 03 requests for price adjustment are made.

If the supplier’s proposed price after adjustment is lower than or equal to the expected price, the interdisciplinary team shall accept the supplier’s proposed price and terminate the price negotiation;

If the supplier’s proposed price after adjustment is still higher than the expected price, the interdisciplinary team shall comment on the price negotiation result.

4. Based on the approved price negotiation scenario in which a price range is specified, the interdisciplinary team shall conduct the price negotiation with the supplier according to the following principles:

a) If the supplier’s proposed price is lower than or equal to the lowest price in the expected price range, the interdisciplinary team shall accept the supplier’s proposed price and terminate the price negotiation;

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Based on the supplier’s response, the interdisciplinary team shall accept the supplier’s proposed price and terminate the price negotiation.

c) If the supplier’s proposed price is higher than the highest price in the expected price range, the interdisciplinary team shall request the supplier to consider adjusting their proposed price. No more than 03 requests for price adjustment are made.

If the supplier’s proposed price after adjustment is lower than or equal to the highest price in the expected price range, the interdisciplinary team shall accept the supplier’s proposed price and terminate the price negotiation;

If the supplier’s proposed price after adjustment is still higher than the highest price in the expected price range, the interdisciplinary team shall comment on the price negotiation result.

5. If the supplier’s proposed price is higher than the expected negotiated price, the interdisciplinary team shall request the price negotiation unit to get opinions about the substitution of the drug, medical device or test equipment on the principle that total quantity demanded by the health facilities whose opinions are to be obtained must be accounted for at least 50% of total quantity demanded by all health facilities:

a) If at least 70% of the health facilities whose opinions are obtained affirms that the drug, medical device or test equipment is necessary to meet treatment demands and should not be substituted, the interdisciplinary team shall accept the supplier’s proposed price and terminate the price negotiation;

b) If less than 70% of the health facilities whose opinions are obtained affirms that the drug, medical device or test equipment is necessary to meet treatment demands and should not be substituted, the interdisciplinary team shall terminate the price negotiation.

6. The interdisciplinary team shall decide the price negotiation result and terminate the price negotiation on the basis of affirmative votes from at least two thirds of its members. Based on the price negotiation result given by the interdisciplinary team (in the meeting minutes or consolidated report on received opinions), the price negotiation unit shall notify the price negotiation result.

Section 5. APPRAISAL, APPROVAL, DISCLOSURE AND IMPLEMENTATION OF PRICE NEGOTIATION RESULT

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1. Appraisal and approval of price negotiation result:

The price negotiation unit shall consolidate, appraise and approve the price negotiation result as prescribed.

2. Disclosure of price negotiation result:

a) The price negotiation unit shall publish the result of supplier selection through price negotiation as prescribed in point a clause 1 and clause 4 Article 8 of the Law on Bidding. Written notification of the supplier selection result shall be sent to suppliers within 05 working days from the day on which the supplier selection result is approved;

b) If the price negotiation for a drug, medical device or test equipment included in lists of drugs, medical devices and test equipment to be procured through price negotiation is unsuccessful, within 03 working days, the price negotiation shall, based on the conclusions given by the interdisciplinary team, notify health facilities of the unsuccessful price negotiation, and alternative solution or procurement plan to be applied while the price negotiation result is unavailable.

3. Conclusion of framework agreement, conclusion of contract, payment and finalization of supply contract:

a) The price negotiation unit and the selected supplier shall complete and sign the framework agreement. Contents of the framework agreement shall comply with provisions of Article 90 of the Decree No. 24/2024/ND-CP.

The price negotiation unit shall publish the framework agreement on the web portal of the Ministry of Health of Vietnam and on its website.

Based on the price negotiation result and the quantity of drugs, medical devices and test equipment distributed in the signed framework agreement, health facilities shall enter into contracts with the successful supplier on the condition that the contractual price shall not exceed the price of the drugs, medical devices or test equipment agreed upon through the price negotiation and specified in the framework agreement announced by the price negotiation unit.

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c) The health facility shall promptly inform the price negotiation unit of the event that the selected supplier that has entered into the framework agreement fails to sign the contract or furnish the required performance security;

d) The supplier selected through price negotiation shall supply drugs, medical devices and test equipment according to the agreed quantity and schedule, and terms and conditions of the framework agreement and the contract signed with each health facility. Upon conclusion of the contract, the health facility and the selected supplier may negotiate increases or decreases to the quantities specified in the signed contract according to the issued RFP;

dd) Duration of the framework agreement and duration of the contract are specified in the plan for supplier selection through price negotiation approved by a competent authority but shall not exceed 36 months from the effective date of the price negotiation result and the framework agreement until the day on which the parties fulfill their contractual obligations;

e) Social insurance agencies shall make payments consistently for all health facilities according to the price negotiation result and the framework agreement announced by the price negotiation unit.

4. The head of the health facility and the selected supplier are responsible for execution of the drug, medical device or test equipment supply contract in accordance with relevant regulations of law, and terms and conditions of the signed contract, and ensure that at least 80% of the value of each part in the signed drug or test equipment supply contract or the quantity of medical device requested by that health facility as specified in the consolidated report on demands of health facilities shall be executed. For specially controlled drugs, intravenous fluids and other cases, after reporting to a competent authority, the health facility ensures that at least 50% of the value of each part in the signed contract shall be executed. For emergency treatment drugs, antidotes and rare drugs, the health facility shall take actions appropriate for its actual conditions.

If the health facility fails to complete at least 80% of the value of each part in the signed contract, its head shall be required to provide explanations to a competent person.

Article 17. Supervising and regulating performance of framework agreement

1. Units in charge of consolidating demands shall supervise and regulate the supply and use of drugs, medical devices and test equipment procured through price negotiation under the signed framework agreement or contract.

2. Drugs, medical devices and test equipment may be regulated by additional purchase which is made within the scope of the additional purchase option and transfer between health facilities. Such regulation shall be made following the procedures for regulating drugs, medical devices and test equipment procured through price negotiation announced by the units in charge of consolidating demands (if any). A health facility is only eligible for replenishment of a drug, medical device or test equipment procured through price negotiation after it has fully received the quantity of drug, medical device or test equipment under the framework agreement.

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- The health facility has fully received the quantities of all selected drugs of the same active ingredient, concentration or content;

- Drugs of other categories of the same active ingredient, concentration or content have to be suspended from supply or marketing or removed from the list of drugs of evidenced bioequivalence after they are selected;

- The selected supplier is unable to fully supply the quantity of drugs of a category as specified in the signed contract due to force majeure events. In this case, a written notification enclosed with relevant supporting documents must be provided.

- The original brand-name drug or reference biological is necessary to meet treatment demands. In this case, the health facility is required to provide convincing explanation.

If the demand for a drug, medical device or test equipment of a health facility under the management of a ministry or central-government authority or provincial government exceeds the quantity of that drug, medical device or test equipment supplied under the framework agreement, the provincial centralized procurement unit or the provincial unit in charge of consolidating demands (for antiretroviral drugs, tuberculosis treatment drugs, vaccines and contraceptives) shall be notified to consolidate and regulate quantities between provincial health facilities, provided that total quantity to be supplied to all health facilities in that province or city must not be exceeded. Within 10 days from the receipt of a written request for replenishment of drugs, medical devices or test equipment from a health facility, the provincial centralized procurement unit or the provincial unit in charge of consolidating demands shall give its written response or make regulation.

If demands for drugs, medical devices or test equipment of health facilities under the management of Ministries, central-government authorities or provincial governments exceed the regulating capacity of provincial centralized procurement units or provincial units in charge of consolidating demands (for antiretroviral drugs, tuberculosis treatment drugs, vaccines and contraceptives), or demands for drugs, medical devices or test equipment of health facilities under the management of the Ministry of Health of Vietnam exceed the quantities distributed under the framework agreement, or health facilities’ unexpected demands for drugs, medical devices or test equipment have not been included in the supplier selection plan, provincial centralized procurement units or provincial units in charge of consolidating demands (for antiretroviral drugs, tuberculosis treatment drugs, vaccines, or contraceptives, or demands of health facilities under the management of the Ministry of Health of Vietnam) shall inform such demands to units in charge of consolidating demands to regulate quantities between health facilities.

Within 05 working days from the receipt of the written request for replenishment of drugs, medical devices or test equipment from provincial health facilities, provincial centralized procurement units or provincial units in charge of consolidating demands (for antiretroviral drugs, tuberculosis treatment drugs, vaccines and contraceptives) shall send reports which are made using the forms in Appendix III and Appendix IV enclosed herewith to units in charge of consolidating demands.

Within 15 days from the receipt of the written request from the provincial centralized procurement unit or the provincial unit in charge of consolidating demands (antiretroviral drugs, tuberculosis treatment drugs, vaccines, or contraceptives, or demands of health facilities under the management of the Ministry of Health of Vietnam), units in charge of consolidating demands shall give their written responses or make regulation. If a request is refused, reasons for such refusal must be indicated in the written response.

3. After the quantity of drugs procured under the framework agreement has been fully transferred between health facilities to meet their demands, units in charge of consolidating demands shall make regulation by executing the additional purchase option.

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4. Drugs, medical devices or test equipment are regulated to meet demands of health facilities and ensure the execution of signed contracts as prescribed in clause 4 Article 16 of this Circular.

Article 18. Reporting on implementation of supplier selection result

Selected suppliers and health facilities shall submit reports on execution of contracts for supply of drugs, medical devices or test equipment through price negotiation. To be specific:

1. Reporting on contract execution results:

By the 10^th day of each month and the 10^th day of the first month of each quarter or upon request, selected suppliers shall submit reports on their execution of contracts for supply of drugs, medical devices or test equipment included in lists of drugs, medical devices and test equipment to be procured through price negotiation, which are made using the forms in Appendixes V, VI, VII and VIII enclosed herewith, to units in charge of consolidating demands.

2. Reporting on supplier selection result:

a) By the 10^th day of the first month of each quarter or upon request, health facilities under the management of Ministries, central-government authorities or provincial governments shall submit reports on their execution of contracts for supply of drugs, medical devices or test equipment included in lists of drugs, medical devices and test equipment to be procured through price negotiation, which are made using the forms in Appendixes IX and X enclosed herewith, to provincial centralized procurement units or provincial units in charge of consolidating demands (for antiretroviral drugs, tuberculosis treatment drugs, vaccines and contraceptives);

b) By the 15^th day of the first month of each quarter or upon request, provincial centralized procurement units and provincial units in charge of consolidating demands (for antiretroviral drugs, tuberculosis treatment drugs, vaccines or contraceptives, or demands of health facilities under the management of the Ministry of Health of Vietnam) shall submit reports on the execution of contracts for supply of drugs, medical devices or test equipment included in lists of drugs, medical devices and test equipment to be procured through price negotiation, which are made using the forms in Appendixes IX and X enclosed herewith, to units in charge of consolidating demands.

Article 19. Additional purchase option in price negotiation

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1. The price negotiation unit may purchase an additional amount of drugs which must not exceed the maximum permissible limit under the approved supplier selection plan to additionally supply them for health facilities.

2. If a health facility wants to use an additional amount of a drug under the framework agreement which is beyond the regulating capacity and exceeds the approved quantity, after obtaining a written consent from the price negotiation unit, it may purchase an additional amount of drugs within the scope of the additional purchase option. In this case, the quantity, value and supply schedule of the drug additionally purchased must be clearly specified in the contract appendix.

3. The price negotiation unit or health facility may make multiple additional purchases provided that total amount of drug, medical device or test equipment additionally purchased must not exceed the maximum permissible limit specified in the approved supplier selection plan.

Article 20. Handling certain situations in price negotiation

1. Based on the notification given by the price negotiation unit as prescribed in clause 2 Article 6 of this Circular, health facilities may organize the selection of suppliers applying competitive bidding, limited bidding, direct contracting or direct procurement in the following cases:

a) A drug, medical device or test equipment is included in lists of drugs, medical devices and test equipment to be procured through price negotiation but the price negotiation unit has not yet conducted the price negotiation according to the plan for organization of price negotiation within 12 months from March 15 each year. The maximum duration of a package is 24 months;

b) The plan for selection of supplier for a drug, medical device or test equipment is included in lists of drugs, medical devices and test equipment to be procured through price negotiation has been approved but the supplier selection result is not available or no supplier is selected. The maximum duration of a package is 12 months;

c) The supplier selection result for a drug, medical device or test equipment is included in lists of drugs, medical devices and test equipment to be procured through price negotiation has been approved and the framework agreement or supply contract has been signed but the unit in charge of consolidating demands is unable to make regulation or the selected supplier is unable to supply the drug, medical device or test equipment or the signed framework agreement expires. The maximum duration of a package is 12 months.

2. Regarding a drug, medical device or test equipment which is included in the lists of drugs, medical devices and test equipment to be procured through price negotiation but no longer meets the principles and criteria set out in Article 1 of this Circular:

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b) If the RFP is not yet issued, the price negotiation unit shall:

- notify the termination of price negotiation process and request competent authorities to consider giving permission to implement the provision of clause 5 Article 53 of the Law on Bidding; or

- notify the termination of price negotiation process and request health facilities/provincial governments to proactively organize the selection of supplier for that drug, medical device or test equipment.

3. If the price negotiation for a drug, medical device or test equipment included in lists of drugs, medical devices and test equipment to be procured through price negotiation is unsuccessful, the price negotiation shall notify health facilities of alternative solutions or procurement plans.

If the price negotiation for an original brand-name drug or reference biological is unsuccessful, the following provisions shall apply:

a) Health facilities shall not be allowed to procure these drugs through original brand-name drug or reference biological packages as prescribed in the Circular prescribing bidding for supply of drugs for public health facilities promulgated by the Minister of Health of Vietnam, except the following cases:

- A drug has special indications and is necessary to meet medical examination and treatment demands as affirmed by the health facility;

- A drug is purchased for re-selling to drug retailers located within the precinct of a health facility;

b) If generic drugs which have the same active ingredient, dosage form, concentration or content as the original brand-name drug or reference drug for which the price negotiation is unsuccessful are available, this original brand-name drug or reference drug may be bidded for in generic drug packages as prescribed in the Circular prescribing bidding for supply of drugs for public health facilities promulgated by the Minister of Health of Vietnam.

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a) There are changes in information on an original brand-name drug or reference biological in comparison with the information in the decision to grant marketing authorization:

- If the changes do not involve any contents of the decision to announce the list of original brand-name drugs and reference biologicals, a competent authority's approval for such changes is required or such changes must be disclosed following procedures for registration of changes in the marketing authorization;

- If there are changes in contents of the decision to announce the list of original brand-name drugs and reference biologicals, such changes must be updated and included in the list of original brand-name drugs and reference biologicals;

b) There are any of the following changes in information on a generic drug but the marketing authorization number remains unchanged:

- Changes in name of the drug;

- Changes in name of the manufacturer or method for specifying address of the manufacturer (but the manufacturing factory is unchanged);

- Changes in the manufacturing factory which do not influence on the manufacturer’s compliance with GMP standards.

- Increase in shelf life of the drug;

- Changes in packaging specifications but the content, concentration or volume of the drug specified in the RFP remains unchanged;

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- Changes in quality specifications but new qualification specifications shall not be lower than those of the selected drug or offered in the proposal;

c) There are changes in the marketing authorization number of a generic drug or a new import license is issued but other information remains unchanged;

d) There are changes in the marketing authorization number of a generic drug or a new import license is issued and there is one or some of the following changes:

- Changes in name of the drug;

- Changes in name of the manufacturer or method for specifying address of the manufacturer (but the manufacturing factory is unchanged);

- Changes in the manufacturing factory which do not influence on the manufacturer’s compliance with GMP standards.

- Increase in shelf life of the drug;

- Changes in packaging specifications but the content, concentration or volume of the drug specified in the RFP remains unchanged;

- Changes in quality specifications of the drug as a result of application of new version of Pharmacopoeia as prescribed;

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When supplying a substitute drug in the cases prescribed in this Clause, the supplier shall provide all necessary information for the procuring entity for its evaluation of the substitute drug, including: decisions and official dispatches on approval of the changes issued by competent authorities, and explanations and/or commitments on unchanged quality specifications of the substitute drug.

5. Regarding changes in a medical device or test equipment bidded for during the supplier selection or the supply of medical device or test equipment, including the following cases:

a) There are any of the following changes in information on a medical device or test equipment but the information on category and product code on the unexpired import license or decision to grant marketing authorization number or marketing authorization remains unchanged:

- Changes in the importer or the applicant for marketing authorization;

- Changes in name of the manufacturer but its address remains unchanged;

- Changes in name of the medical device’s owner but its address remains unchanged;

b) The information on the category of a medical device or test equipment remains unchanged but there are changes in the product code, as a result of termination of manufacturing of products of the previous code, on one of the following documents: the unexpired import license or decision to grant marketing authorization number or marketing authorization.

The price negotiation unit may consider allowing the supplier to make changes in information on the medical device or test equipment to ensure that the medical device or test equipment will be adequately and promptly supplied to meet medical examination and treatment demands.

Where there are changes in information on a medical device or test equipment in the cases prescribed in this clause, the supplier shall provide all necessary documents and information for the price negotiation unit for its evaluation of changes, and explanations and/or commitments on unchanged quality specifications of the medical device or test equipment which is bidded for or on which information is changed.

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7. Where more than one supplier participates in the price negotiation for supply of drugs having the same active ingredient, content or concentration, and dosage form, or medical devices or test equipment having the same configuration and technical features, the price negotiation unit shall, based on the price negotiation results, send written request to suppliers to submit new quotations which must indicate the deadline and place for submission of quotations, and date and time for opening quotations, and invite them to the quotation opening session. New quotations submitted by suppliers must be sealed and must not be opened before the prescribed date and time for opening quotations. The price specified in a new quotation must not exceed the previously negotiated price. The supplier that quotes the lowest price shall be awarded the contract.

8. Apart from the cases prescribed in clause 1 through 7 of this Article, the price negotiation unit shall decide to handle any situations that arise from the price negotiation in a manner ensuring competitiveness, fairness, transparency, economic efficiency, and accountability.

Chapter III

IMPLEMENTATION

Article 21. Effect

1. This Circular comes into force from March 15, 2024.

2. From the effective date of this Circular, the following regulations shall cease to have effect:

a) Chapter V of the Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health of Vietnam prescribing bidding for supply of drugs for public health facilities;

b) Provisions on lists of drugs procured through price negotiation in the Circular No. 15/2020/TT-BYT dated August 10, 2020 of the Minister of Health of Vietnam;

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d) Clauses 27, 28 and 29 Article 1 of the Circular No. 06/2023/TT-BYT dated March 12, 2023 of the Minister of Health of Vietnam.

Article 22. Implementation organization

1. Within a maximum duration of 02 years, based on actual conditions and principles and criteria for compiling the lists prescribed in Article 1 of this Circular, the Ministry of Health of Vietnam shall consider modifying lists of drugs, medical devices and test equipment procured through price negotiation.

2. The price negotiation unit shall:

a) determine annual lists of drugs, medical devices and test equipment procured through price negotiation to ensure that the price negotiation shall be conducted for all listed drugs, medical devices and test equipment;

b) allocate funding for covering expenses incurred from the price negotiation using its state budget-derived funding and other lawful financial sources as prescribed by law.

Article 23. Responsibility for implementation

Chief of the Ministry’s Office, Directors of Drug Administration of Vietnam, Infrastructure and Medical Device Administration, Vietnam Administration of HIV/AIDS Control, Population Department, General Department of Preventive Medicine, and Department of Planning and Finance, head of the price negotiation unit, heads of other relevant units, authorities and organizations, and relevant individuals are responsible for the implementation of this Circular.

Difficulties that arise during the implementation should be reported to the Ministry of Health of Vietnam for consideration./.

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PP. MINISTER
DEPUTY MINISTER




Le Duc Luan