The Law amending and supplementing a number of articles of the Law on Pharmacy (hereinafter referred to as the "Law on Pharmacy amended 2024") has supplemented regulations on the announcement of expected drug wholesale prices and the re-announcement of expected drug wholesale prices (hereinafter collectively referred to as 'price announcement'). This is a new procedure, completely different from the price declaration procedure specified in the Price Law 2023. The clear distinction between these two procedures is important in ensuring transparency, avoiding legal overlap and enhancing the efficiency of state management of the pharmaceutical market.
1. New regulations on price announcement under the Law on Pharmacy amended 2024
Drug prices are a key factor in public health policy, directly impacting people's access to medicines and the effectiveness of market stabilization activities. In the face of many fluctuations in drug prices and significant price differences in the market, the requirement for the State is to take appropriate, effective and lawful price management measures. In this context, on November 21, 2024, the 15th National Assembly approved the amended Law on Pharmacy 2024, effective from July 1, 2025. One of the key contents of the amended Law on Pharmacy 2024 is the regulation on "announcement of expected drug wholesale prices" and "re-announcement of expected drug wholesale prices". This regulation is issued to replace the measure of drug price declaration specified in Clause 3, Article 107 of the Law on Pharmacy 2016, and at the same time avoid confusion with the price declaration procedures specified in the Law on Prices 2023.
Previously, in the Law on Pharmacy 2016, pharmaceutical business establishments were responsible for listing the wholesale and retail prices of drugs at the place of transaction or sale of drugs. However, this law does not have mandatory regulations on the disclosure of expected selling prices for drug manufacturers and importers. The amended Law on Pharmacy 2024 has overcome this shortcoming by requiring the aforementioned establishments to publish their expected wholesale prices.
This change in the price management mechanism shows the need to clearly distinguish between two forms: price declaration – within the scope of the Price Law 2023, and announcement of expected wholesale prices – which are separately stipulated in the amended Law on Pharmacy 2024. This delimitation contributes to ensuring transparency in drug price management and avoiding overlap between relevant laws.
Source: Facebook Pharmacity
2. Distinguishing between price declaration procedures and announcement of expected prices
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Content |
Price declaration |
Price Announcement |
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Definition |
Organizations and individuals trading in goods and services subject to price declaration shall send notices of prices after price determination or price adjustment to competent state agencies. |
Drug importers or manufacturers shall send notices of expected drug wholesale prices to the Ministry of Health before distributing the first batch of drugs; at the same time, this information will be published on the website of the Ministry of Health. In case there is a change in the expected wholesale price, the business establishment is obliged to re-announce the price as prescribed. |
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Purpose of implementation |
Designed to serve market synthesis, analysis and forecasting. |
In order to strictly control the wholesale price of drugs from the moment the first batch of drugs is put on the market, the amended Law on Pharmacy 2024 has introduced new regulations on the announcement of expected wholesale prices of drugs. The special feature of this regulation is the establishment of a more proactive monitoring and intervention mechanism for state management agencies. Unlike the previous price declaration mechanism, which was only for information reception, the price announcement mechanism allows the Ministry of Health to proactively evaluate and, when necessary, make recommendations to adjust the announced prices. Specifically, the Ministry of Health has the right to request drug manufacturers or importers to re-announce the expected wholesale prices in the following cases, unless the units have explanatory reports enclosed with documents proving price fluctuations:
This regulation shows the specificity of the price announcement mechanism in the pharmaceutical sector. Not only stopping at transparency of drug price information, this mechanism also contributes positively to price stabilization and ensuring people's rights in accessing drugs. |
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Subject of implementation |
Organizations dealing in goods and services include:
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Drug importers and drug manufacturers. These are entities directly involved in the process of supplying drugs to the market, responsible for determining and announcing the expected wholesale price of drugs before the time of official circulation of the first batch of drugs on the market. |
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Subjects of application |
Drugs on the list of essential drugs used at medical examination and treatment establishments are specifically determined according to Circular No. 28/2024/TT-BYT dated November 1, 2024 of the Minister of Health. |
Applies to prescription drugs. Specifically, drug importers and drug manufacturers are only allowed to sell prescription drugs from the time the Ministry of Health receives the dossier of announcement or re-announces the expected wholesale price of drugs. |
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Drug prices |
The declared price is the price of goods and services decided by the business organization itself and notified to the competent state agency. This price is inscribed on the invoice after deducting discounts and discounts (if any) and includes value-added tax (if any) of goods and services. The declaration does not change the right to self-pricing, but business organizations must take responsibility for the truthfulness and reasonableness of the declared prices and contents. |
The expected wholesale price of drugs is the maximum wholesale price determined by drug importers and drug manufacturers before wholesale the first batch of drugs to the market. This is the price of the above limit, according to which drug business establishments are not allowed to wholesale in excess of this price. The expected wholesale price of drugs is not only a tool for transparency of the drug market but also a basis for the Ministry of Health to supervise, evaluate and in certain cases make recommendations for adjustment when the announced price shows signs of irrationality or abnormality. |
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Receiving agency |
The Department of Health (assigned by the provincial-level People's Committee) is the agency that receives and organizes the declaration of drug prices on the list of essential drugs used at medical examination and treatment establishments. |
The Ministry of Health is the agency that receives and handles the procedures for announcing prices. |
The clear distinction between the procedure for declaring prices under the Price Law 2023 and the procedure for announcing the expected wholesale price of drugs under the amended Law on Pharmacy 2024 has practical significance in the management of drug prices. If price declaration is synthetic, serving market analysis and forecasting, price announcement is a tool to control drug input prices in a more proactive, tight and transparent way. With the new regulations, the Ministry of Health not only receives information but is also empowered to evaluate, supervise and propose price adjustments when necessary. This factor contributes to avoiding overlap between laws, and at the same time improving the effectiveness of state management in the pharmaceutical sector, protecting people's interests and stabilizing the drug market in the context of complicated price fluctuations.
