Principles and criteria for compiling lists of drugs, medical devices and test equipment procured through price negotiation in Vietnam

Principles and criteria for compiling lists of drugs, medical devices and test equipment procured through price negotiation in Vietnam (Internet image)

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Principles and criteria for compiling lists of drugs, medical devices and test equipment procured through price negotiation in Vietnam

According to Article 1 of Circular 05/2024/TT-BYT stipulating principles and criteria for compiling lists of drugs, medical devices and test equipment procured through price negotiation:

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

+ 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;

+ 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).

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

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

+ 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.

Price negotiation scenario for drugs, medical devices and test equipment in Vietnam

Price negotiation scenario is specified in Article 5 of Circular 05/2024/TT-BYT as follows:

(1) A scenario for negotiation on price of a drug shall be constructed on the basis of one, or some, or all of the following information pieces:

- 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);

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

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

- Availability time of the drug in Vietnam;

- 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);

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

- 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);

- 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;

- 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;

- Other relevant information (if any).

(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:

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

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

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

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

- 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);

- 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;

- Other relevant information (if any).

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

- The planned date of the price negotiation;

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

- 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;

- Other contents concerning the price negotiation scenario.

Nguyen Ngoc Que Anh

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