Circular 05/2024/TT-BYT stipulating the list of drugs, medical devices, and supplies subject to price negotiation and the process for selecting contractors from May 15, 2024
What are the Principles, Criteria for Establishing the List of Medicines, Medical Equipment, and Testing Supplies Subject to Price Negotiation?
According to Article 1 Circular 05/2024/TT-BYT, the establishment of the list of medicines, medical equipment, and testing supplies subject to price negotiation must ensure the following principles and criteria:
(1) For medicines included in the list, they must meet one of the following principles and criteria:
- Reference drugs, biological products that are part of the proprietary medicines list, reference biological products announced by the Ministry of Health;
- Medicines with only 01 or 02 manufacturers according to the formulation (specifically, vaccines for the Expanded Immunization Program with only 01 or 02 manufacturers according to vaccine components and vaccine production technology).
(2) For medical equipment, testing supplies included in the list, they must meet the following principles and criteria:
- Medical equipment, testing supplies that are legally circulated in Vietnam;
- Medical equipment, testing supplies produced by only 01 or 02 manufacturers according to their principle, technology, or purpose of use.
Thus, the establishment of the list of medicines, medical equipment, and testing supplies subject to price negotiation must ensure the above principles and criteria.
Circular 05/2024/TT-BYT stipulates the list of medicines, medical equipment, and supplies subject to price negotiation and the process of selecting contractors from May 15, 2024.
What are the Responsibilities of the Price Negotiation Unit?
According to Article 3 Circular 05/2024/TT-BYT regulating price negotiation activities for medicines, medical equipment, and testing supplies in the List subject to price negotiation specified in Article 2 Circular 05/2024/TT-BYT, the unit assigned by the Ministry of Health to carry out the tasks (hereinafter referred to as the Price Negotiation Unit) has the following responsibilities:
- Develop, approve, and announce the plan for organizing price negotiations;
- Develop a plan to select contractors to supply medicines, medical equipment, and testing supplies based on price negotiation;
- Develop, appraise, and approve the request dossier;
- Organize the evaluation of proposal dossiers;
- Develop and approve the price negotiation plans;
- Appraise, approve, and publish the results of price negotiations;
- Sign framework agreements or contracts with winning contractors;
- Participate in monitoring and regulating the supply and usage of selected medicines, medical equipment, and testing supplies via price negotiation;
- Participate in all steps of the price negotiation process and compile and provide related information during the price negotiation process;
- Perform other duties as assigned by the Minister of Health.
How Should the Price Negotiation Plan be Ensured to Comply with Regulations?
According to Article 5 Circular 05/2024/TT-BYT, the regulation on price negotiation plans is as follows:
(1) The development of price negotiation plans for medicines is based on one or a combination of the following information:
- The number of registration certificates for circulation of Group 1 generic drugs under the regulation on drug bidding at public medical facilities issued by the Minister of Health (hereinafter referred to as Group 1 generic drugs) or other technical group generic drugs if there are no Group 1 generic drugs;
- The winning bid prices for Group 1 generic drugs or other technical groups if there are no Group 1 generic drugs;
- The replacement capability of the price negotiation drugs (if necessary);
- The period of circulation in Vietnam;
- Information on the value of the price negotiation drugs previously used provided by Vietnam Social Security (if any);
- The value and planned quantity of price negotiation drugs;
- Reference prices of price negotiation drugs in ASEAN countries (if any). If there are no reference prices in ASEAN, reference other countries (if any);
- The plan for processing, technology transfer of proprietary medicines and reference biological products announced for processing and technology transfer in Vietnam by the Ministry of Health;
- Proposal dossiers from contractors, assessment reports of proposal dossiers, and compiled information on price negotiation drugs by the expert group;
- Other related information (if any).
(2) The development of price negotiation plans for medical equipment and testing supplies is based on one or a combination of the following information:
- The winning bid prices for price negotiation medical equipment and testing supplies (if any);
- The period of circulation in Vietnam;
- Information on the value of the price negotiation medical equipment and testing supplies previously used provided by Vietnam Social Security (if any);
- The value and planned quantity of price negotiation medical equipment and testing supplies;
- Reference prices of price negotiation medical equipment and testing supplies in ASEAN countries (if any). If there are no reference prices in ASEAN, reference other countries (if any);
- Proposal dossiers from contractors, assessment reports of proposal dossiers, and compiled information on price negotiation medical equipment and testing supplies by the expert group;
- Other related information (if any).
(3) The price negotiation plan includes the following contents:
- The expected time to conduct price negotiations;
- Summary information on price negotiation medicines, medical equipment, and testing supplies;
- The desired negotiation price, which is used for negotiation and not necessarily the price that must be achieved during the negotiation, includes one of the following cases:
+ The desired price to be achieved in the price negotiation;
+ A price range including multiple desired prices to be achieved in the price negotiation;
- Other factors related to the price negotiation plan.
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