Chapter V
PRICE NEGOTIATION
Article 42. General provisions on price negotiation
1. Drug Price Negotiation Council (hereinafter referred to as Council):
a) Council formed by Minister of Health. Minister of Health shall provide guidance on duties and entitlements, organizational structure and operation of Council. Council shall be funded by state budget from the national centralized drug procurement center and other legal fundings.
b) Council shall include:
- A Chairperson is Minister of Health;
- 02 Deputy Chairpersons is Head of Social Insurance of Vietnam and Director of National Centralized Drug Procurement Center.
- Members who are representatives of relevant agencies affiliated to Ministry of Health, Ministry of Finance, Social Insurance Office, and independent experts in relevant fields.
c) Council shall:
- Consider price negotiation plans developed by the national centralized drug procurement center.
- Implement drug price negotiation under the approved plans;
2. The national centralized drug procurement center, a standing unit of Council, shall:
a) Develop detailed price negotiation plans;
b) Develop, appraise and approve proposals;
c) Evaluate proposals;
d) Develop estimated price negotiation plans;
dd) Publish price negotiation results;
e) Supervise and regulate the supply and use of drugs selected by price negotiation;
g) Participate in all stages of drug price negotiation process; aggregate and provide relevant information during price negotiation process;
h) Carry out other tasks at the request of Chairperson of Council.
3. Drug Procurement Consultancy Council shall advise the Minister of Health in all stages of the drug price negotiation process on request.
4. If an offered drug is changed during the contractor selection process, or the drug is supplied but the substitute drug is not offered in the bid, the unit in charge specified in Clause 1 Article 37 of this Circular shall consider approving for drug substitution specified in Clause 6 Article 37 of this Circular.
Article 43. Prepare, appraise and approve price negotiation plans
1. Aggregating demand for using drugs on the list of drugs for procurement through price negotiation:
The national centralized drug procurement center shall aggregate demand for drug use specified in Clause 1 Article 40 of this Circular.
2. Making drug price negotiation plan:
The national centralized drug procurement center shall prepare drug price negotiation plans. Contents of drug price negotiation plan shall be specified in Article 14 of this Circular with the following information:
a) Names and prices of contract packages, total value of contract packages and value of each part of contract packages in contractor selection plans;
b) The estimated price of each drug through price negotiation shall be specified in Clause 4 Article 14 of this Circular;
c) Requirements in terms of quality standards and delivery time, specific purchase conditions of each drug under price negotiation;
d) The expected time for price negotiation for each drug on the list of drugs under price negotiation;
dd) In case of necessity, the national centralized drug procurement center shall consult with Council on the price negotiation plan before submitting to the appraising unit.
3. Appraising drug price negotiation plan:
a) The national centralized drug procurement center shall submit the proposal of contractor selection plan to Planning – Finance Department for appraisal organization;
Planning – Finance Department shall appraise the lists, contract package quantities, estimated unit prices and drug quantities. The appraisal of price negotiation plan shall comply with Clause 2 and Article 16 of this Circular.
4. The Minister of Health shall consider approving the price negotiation plan on the basis of the report submitted by Planning – Finance Department. In case of necessity, Minister of Health shall consult with Drug Procurement Consultancy Council on drug bidding before approving.
Article 44. Prepare, appraise and approve proposals
According to the contractor selection through price negotiation plan approved by Minister of Health, the national centralized drug procurement center shall prepare the bidding documents, appraise and approve the proposals.
1. Preparing the request for proposals:
a) The request for proposals for drugs through price negotiation shall comply with Law on bidding, detailed documents on Law on bidding and the national centralized drug procurement center;
b) A proposal shall contain sufficient information about the contract package; instructions on preparation and submission of approvals; required capacity and experience of contractors; criteria for technical and financial evaluation. Capacity, experience and technical criteria shall be marked by “pass” or “fail”;
c) A proposal for instructions shall contain information about prices, specific economic-technical criteria to be applied during the price negotiation process that has to be provided by contractors in their quotations, such as:
- EX works, CIF, selling prices for health facilities in manufacturing countries and ASEAN countries provided by contractors;
- EX works, CIF, selling prices for health facilities in Vietnamese market.
- Indications and clinical effectiveness evaluation of drugs in treatment; The report on clinical effectiveness evaluation in treatment in comparison with other standard drugs (if any);
- Data for pharmaceutical economic analysis of drugs including: cost – efficacy, cost – benefits and cost – effects provided by the contractor.
- The contractor’s commitments to quantity and quality of drugs supplied as well as supply schedule if awarded the contract;
2. Appraising request for proposals:
a) The request for proposals under price negotiation shall be appraised before submitting to Director of the National Centralized Drug Procurement Center for approval.
b) The appraising unit shall be decided by the Director of the National Centralized Drug Procurement Center.
3. Approving request for proposals:
The Director of the National Centralized Drug Procurement Center shall approve the request for proposals according to the appraising unit’s report.
Article 45. Organizing drug price negotiation
1. Notification of bidding for drug supply under price negotiation and request for proposals shall be publicly issued.
2. Contractors prepare and submit proposals according to request for proposals.
a) Bid security and submission of proposals shall be specified in Article 30 of this Circular;
b) According to the notification of bidding for drug supply and request for proposals under price negotiation in order to prepare and submit the proposal by post or directly to the national centralized drug procurement center.
3. Evaluating proposals and preparing price negotiation plans
a) The national centralized drug procurement center shall evaluate proposals in accordance with regulations of request for proposals. Proposals shall be publicly opened. In the process of evaluation, the procuring entity may invite the contractor to negotiation and amendments to some necessary information of proposals in order to prove the contractor's qualification in terms of capacity, experience, schedule, quantity, quality, technical solutions and measures of implementing the contract package.
b) According to the contractor’s proposal and the experts’ proposal evaluation report, the national centralized drug procurement center shall prepare price negotiation plans. In case of necessity, the center shall invite clinical and pharmaceutical economic experts to participate in developing price negotiation plan for each drug.
The price negotiation plan shall summarize the information on pharmacological effect, the estimated price and successful bid of the drug under price negotiation; drugs having the same active ingredient, content/concentration, dosage form but not in the same group of offered drugs; drugs in the same group of replaceable pharmacological effect (if any), the factors relating to the price negotiation plan and terms of the framework agreement that will be negotiated.
c) Chairperson of Council shall approve the price negotiation plan before price negotiation.
4. Price negotiation and decision:
a) The national centralized drug procurement center shall invite qualified contractors to price negotiation. In case of necessity, the national centralized drug procurement center may invite representative of the drug manufacturing facility or representative of the license holder in Vietnam (including representative office) to make clear the contents relating to the drug under price nogotiation;
b) A contractor shall be invited to price negotiation if having lawful qualification, satisfying requirements of capacity, experience and technical proposal of the request for proposals and providing the estimated price that does not exceed the estimate for the approved contract package;
c) The Council shall decide whether to choose carry out the negotiations directly or by correspondence. The Council's contents shall be based on the contractor’ proposal, the proposal evaluation report, relevant information and the approved price negotiation plan;
d) If more than one contractors participate in the price negotiation of the drugs having the same active ingredient, content/concentration, dosage form, the Council shall request them to submit new quotations which specify the time and location for receiving such quotations and time for opening them, and invite them to attend the opening session. The prices in the new quotations must not exceed the negotiated prices. The contractor whose new bid is lowest shall be awarded the contract.
dd) If the first price negotiation is unsuccessful, the Council shall decide to invite or not to invite the contractor to the second negotiation. The national centralized drug procurement center shall notify the Council's official conclusion to each contractor after the first negotiation;
e) If the contractor is invited to the second price negotiation, the contractor shall submit the new proposal and quotation in accordance with the negotiation letter of the national centralized drug procurement center.
g) Successful bids through price negotiation shall be decided by the Council and contractors. The Council and the contractor shall conclude a framework agreement and other conditions after reaching agreement on price;
h) After the Council and the contractor’s representative conclude price nogotiation contracts, the national centralized drug procurement center shall send a written request for concluded price confirmation within 7 days to the contractor.
Article 46. Appraising, approving and implementing drug price negotiation results
1. Appraising and approving drug price negotiation results:
The national centralized drug procurement center shall aggregate price negotiation results and submit to Planning – Finance Department for appraisal. Time for appraisal is up to 20 days from the receipt of sufficient documents. Minister of Health shall consider approving price negotiation results on the basis of Planning – Finance Department.
- If the Council and the contractor are unable to reach agreement on price after negotiation sessions, the national centralized drug procurement center shall submit a report to Planning – Finance Department and notify the result to the contractor and health facilities nationwide.
2. Publish price negotiation results:
a) The national centralized drug procurement center shall publish contractor selection results through price negotiation and provide guidance on implementation of price negotiation results to health facilities in accordance with law.
b) For drugs on the unsuccessful list of drugs for procurement by price negotiation, according to the Council's opinions, the national centralized drug procurement center shall propose alternative procurement plans and submit them to Minister of Health for consideration and approval. For the proprietary drugs granted many certificates of marketing authorization of Category 1 specified in Article 7 of this Circular promulgated by Ministry of Health, health facilities may carry out contractor selection by themselves through competitive bidding of generic contract packages according to the Ministry of Health’s notice.
3. Payments for drug supply contracts:
a) The national centralized drug procurement center shall complete and conclude framework agreements with successful contractors; publish price negotiation results and framework agreements on the Ministry of Health's website. Responsibility of relevant parties and effect of framework agreements shall comply with Article 39 of this Circular. Selected contractors shall provide guarantee for contract execution specified in Clause 1 Article 39 of this Circular;
b) According to price negotiation results, framework agreements, distributed drug quantities and plan of drug use budget approved by the competent authority, health facilities shall conclude contracts with contractors under the condition that prices in contracts do not exceed successful bids and framework agreements published by the national centralized drug procurement center;
For effective drug supply contracts, health facilities shall regulate drug prices to ensure that they do not exceed published negotiation prices or the effective time of framework agreements.
c) The contractor selected through price negotiation shall supply drugs with the quantity, schedule and other conditions agreed in the framework agreement and the concluded contract with each health facility;
d) Time limit for contract execution shall be specified in the price negotiation plan approved by the competent authority but may not exceed 36 months from the effective date of the price negotiation result and framework agreement until the parties fulfill obligations in accordance with the provisions of the contract.
e) The health insurance authority shall make unanimous payment for all public health facilities according to price negotiation results published by the national centralized drug procurement center.
4. Report on drug price negotiation results:
Contractors through price negotiation and health facilities shall submit reports on drug supply results through price negotiation to the national centralized drug procurement center specified in Clause 12 Article 40 of this Circular.
5. Supervising progress of execution of framework agreements:
The national centralized drug procurement center shall supervise and regulate the supply and use of drugs selected by price negotiation in the concluded framework agreement specified in Clause 13 Article 40 of this Circular.
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Thông tư 15/2019/TT-BYT (Bản Word)
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