When shall the price negotiation be applied in Vietnam? When shall the price negotiation method be applied to drugs in Vietnam?

When shall the price negotiation be applied in Vietnam?

Pursuant to Article 28 of the Law on Bidding in 2023 stipulating price negotiation:

Price negotiation

1. Price negotiation applies to the following packages:

a) Purchase of original brand-name drugs or reference biologicals;

b) Purchase of drugs, medical devices or test equipment of a type which can only be manufactured by 01 or 02 manufacturers.

2. The price negotiation method shall be adopted according to a decision issued by the Minister of Health of Vietnam who shall also issue the list of drugs, medical devices and test equipment to be procured through price negotiation and specific contractor selection procedures and process for packages executed adopting price negotiation method.

Price negotiation in bidding is a procurement method in which the inviting party directly negotiates with selected contractors to reach an agreement on prices and contract terms for the procurement package.

Price negotiation applies to the following packages:

- Purchase of original brand-name drugs or reference biologicals;

- Purchase of drugs, medical devices or test equipment of a type which can only be manufactured by 01 or 02 manufacturers.

When shall the price negotiation be applied in Vietnam? When shall the price negotiation method be applied to drugs in Vietnam? - image from internet

What information are included in the construction of price negotiation scenario for drugs in Vietnam?

Pursuant to Clause 1 Article 5 of the Circular 05/2024/TT-BYT, 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).

When shall the price negotiation method be applied to drugs in Vietnam?

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

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.

As regulated above, 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).

Best regards!