Vietnam: Grounds for price negotiation and performance of price negotiation

General regulations on grounds for price negotiation and performance of price negotiation are specified in Clause 4 Article 5 of the Circular No. 15/2020/TT-BYT of the Ministry of Health of Vietnam as follows:

- If the drug under price negotiation is one of the original brand-name drugs announced by the Ministry of Health, wholly produced in one of SRA countries, and has two (02) or more certificates of marketing authorization of Category 1 generic drug, the price negotiation plan and implementation thereof shall be based on the quantity of certificate of marketing authorization of generic drug, and successful bids for generic drugs manufactured in reference countries. If the successful bids for drugs manufactured in reference countries are not available, the price negotiation plan and implementation thereof shall be based on the successful bids for drugs manufactured in SRA countries and replacement capacity at the time of price negotiation.

- If the drug under price negotiation is one of the original brand-name drugs announced by the Ministry of Health, wholly produced in one of SRA countries, has two (02) or more certificates of marketing authorization of Category 1 generic drug, and is necessary for treatment, is one of the original brand-name drugs announced by the Ministry of Health, wholly produced in one of SRA countries, and has no or one (01) certificate of marketing authorization of Category 1 generic drug, or is produced by one (01) or two (02) manufacturers, apart from the regulations in Point a of this Clause, the price negotiation plan and implementation thereof shall be based on analysis on cost - efficacy, efficacy, cost – benefits, and cost – effects;

- With regard to original brand-name drugs announced by the Ministry of Health, manufactured under processing contracts or technology transfer contracts in Vietnam, the price negotiation plan and implementation thereof shall be carried out according to the processing or technology transfer roadmap.

View more details at the Circular No. 15/2020/TT-BYT of the Ministry of Health of Vietnam, issued on August 10, 2020.

Thuy Tram

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