Ministry of Health's guidance on drug price declaration in Vietnam under the Price Law 2023

Ministry of Health's guidance on drug price declaration under the Price Law 2023 (Image from Internet)

On August 1, 2024, the Ministry of Health issued Official Dispatch 4448/BYT-QLD regarding the implementation of drug price declaration regulations pursuant to Price Law 2023.

Ministry of Health's guidance on drug price declaration in Vietnam under the Price Law 2023

To implement the Price Law 2023 and Decree 85/2024/ND-CP concerning the implementation of drug price declaration regulations, the Ministry of Health of Vietnam has provided the following guidelines:

(1) Regulations on price declaration in the Price Law 2023:

- Clause 14 of Article 4 of the Price Law 2023 stipulates, "Price declaration is the action of business organizations dealing in goods and services that fall under the category requiring price declaration as stipulated in Clause 2 Article 28 of this Law, to notify the set price or adjusted price to the competent state authority for the purpose of synthesis, analysis, and forecasting of market prices.”

- Clause 1 of Article 28 of the Price Law 2023 defines, "Declared price is the price level of goods or services decided by the business organization and notified to the competent authorities receiving the declaration,” and in the price declaration form in Appendix VI issued alongside Decree 85/2024/ND-CP, notes, "Declared price is the selling price recorded on the invoice after deducting discounts, price reductions (if any), and including value-added tax (if any) of goods or services.”

Therefore, the regulation on drug price declaration in the Price Law 2023 (which requires the actual wholesale and retail prices to be declared) is different from the regulations in the Pharmaceutical Law (which requires the projected wholesale price to be declared).

(2) Application of the price declaration regulations per the Price Law 2023:

- Clause 1 of Article 3 of the Price Law 2023 states, "In case of different regulations about price between this Price Law and other laws issued before the effective date of this Law, the regulations of the Price Law shall prevail.”

- Points a and c of Clause 10 of Article 27 of Decree 85/2024/ND-CP stipulates, "To repeal, amend, and supplement certain Sections, Articles, and Clauses of Decree No. 54/2017/ND-CP dated May 8, 2017, detailing some articles and measures for implementing the Pharmaceutical Law, as amended and supplemented by Decree No. 155/2018/ND-CP dated November 12, 2018, and Decree No. 88/2023/ND-CP dated December 11, 2023, as follows:

a) To repeal Section 1 of Chapter VIII (Price declaration, price declaration of drugs); ...

c) To repeal Appendix VII (Tables, forms).”

Therefore, as of July 1, 2024, drug price declaration shall comply with the regulations of the Price Law 2023 and Decree 85/2024/ND-CP.

(3) Implementation of the price declaration regulations pursuant to the Price Law 2023:

- Regarding the list of drugs subject to price declaration:

+ According to Section 9 of Appendix I of the Price Law 2023 and Appendix V of Decree 85/2024/ND-CP, the drugs subject to price declaration include those classified as essential drugs used in medical examination and treatment facilities.

+ Point a of Clause 2 of Article 28 and Clause 6 of Article 29 of Decree 85/2024/ND-CP stipulates, "At the latest by October 31, 2024, ministries, ministerial-level agencies, and provincial People's Committees must issue documents stipulating the economic - technical characteristics for goods and services under the price stabilization list and the price declaration list.”

Currently, the Ministry of Health is in the process of drafting a Circular to issue a list of drugs (detailed names, economic - technical characteristics) subject to price declaration as per the Price Law 2023. When this Circular comes into effect, units must declare the prices for drugs listed in the Circular.

- Regarding the agency receiving price declarations:

According to Appendix V of Decree 85/2024/ND-CP and Point b of Clause 10 of Article 27 of Decree 85/2024/ND-CP: "Provincial People's Committees assign the Departments of Health to receive drug price declarations for essential drugs used in medical examination and treatment facilities as stipulated in the Price Law and relevant guiding documents.”

- Regarding entities required to declare prices:

+ Clause 4 of Article 28 of the Price Law 2023 stipulates, "Entities required to declare prices are business organizations dealing in goods and services registered in accordance with enterprise laws and having the authority to determine prices, and listed by the competent authorities as required by Clause 5 of this Article.”

+ According to Clause 2 of Article 16 of Decree 85/2024/ND-CP, the provincial People's Committees assign a competent authority or professional unit to lead and collaborate with relevant agencies and units to comprehensively review and advise on the promulgation of the price declaration list under their jurisdiction (Price Declaration List).

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