Content of the contractor selection plan for supplying drugs at public health facilities in Vietnam

Content of the contractor selection plan for supplying drugs at public health facilities

What does the contractor selection plan for supplying drugs at public health facilities include? – Thu Trang (Binh Phuoc)

Regarding this matter, LawNet responds as follows:

Content of the contractor selection plan for supplying drugs at public health facilities in Vietnam

According to Article 12 Circular 07/2024/TT-BYT, the content of the contractor selection plan is implemented according to the regulations in Article 39 of the Bidding Law 2023, which includes:

(1) Package name:

The package name is recorded according to the division of the package and drug groups in accordance with the regulations from Articles 4 to 10 of Circular 07/2024/TT-BYT. If a package is divided into several parts, the name of each part must match the content of that part. The information about the package in the contractor selection plan must include at least the following information:

- Each part of the generic drug package includes information: active ingredient name; concentration or potency; method of use, dosage form; drug group; unit of measurement; quantity; unit price, and total value of that drug;

- Each part of the original specialty drug package includes information: drug name with the phrase "or equivalent" according to the provisions at Point c, Clause 9, Article 24 of Decree 24/2024/ND-CP detailing a number of provisions and measures for the implementation of the Bidding Law 2023 on contractor selection; active ingredient name; concentration or potency; method of use, dosage form; unit of measurement; quantity; unit price, and total value of that drug. If an active ingredient has multiple original brand names or reference biological products published by the Ministry of Health in the list of original brand names and reference biological products, the drug name must include all the original brand names or reference biological products;

- Each part of the package for traditional medicine, medicine combined with active ingredients and traditional medicine, traditional medicine semifinished products, traditional medicine ingredients standardized in the dosage forms of high, granules, powder, extracts, essential oils, resins, gums, and standardized preparations includes: drug name or semifinished product name or traditional medicine ingredient name in the forms of high, granules, powder, extracts, essential oils, resins, gums, and standardized preparations; method of use, dosage form; unit of measurement; quantity; drug group; unit price. Writing the name of traditional medicine, medicine combined with active ingredients and traditional medicine, traditional medicine semifinished products, traditional medicine ingredients standardized in the dosage forms of high, granules, powder, extracts, essential oils, resins, gums, and standardized preparations in the package must comply with Clause 3, Article 12 of Circular 07/2024/TT-BYT;

- Each part of the herbal medicine package, traditional medicine ingredient package includes information: herbal name or traditional medicine ingredient name; scientific name; quality standards; part used; processing form or processing method; drug group; unit of measurement; quantity; unit price, and total value of that drug.

public health facilities that add additional information about the package as stipulated in this clause must be responsible for explaining the additional information.

(2) Writing the dosage form of drugs in the generic drug package, herbal medicine package, medicine combined with active ingredients and traditional medicine, traditional medicine at the contractor selection plan is carried out according to Appendix I attached to Circular 07/2024/TT-BYT. The dosage forms (marked with (*)) are recorded separately in the contractor selection plan according to the following principles:

- They are recorded separately only if they share the same dosage form and active ingredient, method of use or drug with the original branded drug or reference biological product licensed for circulation in SRA or EMA countries;

- In cases not specified in point a of this clause, the medical facility must clearly explain the necessity, use demand for this dosage form and only use it when other dosage forms cannot be used or other dosage forms do not meet the treatment requirements.

(3) Writing the name of traditional medicine, medicine combined with active ingredients and traditional medicine, traditional medicine semifinished products, traditional medicine ingredients standardized in the dosage forms of high, granules, powder, extracts, essential oils, resins, gums, and standardized preparations in the package is carried out as follows:

- Only recording the components of traditional medicines, medicines combined with active ingredients and traditional medicine, traditional medicine semifinished products, traditional medicine ingredients standardized in the dosage forms of high, granules, powder, extracts, essential oils, resins, gums, and standardized preparations; not recording trade names;

- If traditional medicines, medicines combined with active ingredients and traditional medicine, traditional medicine semifinished products, traditional medicine ingredients standardized in the dosage forms of high, granules, powder, extracts, essential oils, resins, gums, and standardized preparations have the same components and the same dosage form: recording the concentration or potency of the components when differences in concentration or potency lead to differences in dosage, indications for treatment, and must have the opinion of the Advisory Council.

(4) Package price:

- Package price is determined according to Clause 1, Article 16 of Decree 24/2024/ND-CP;

- If the package is divided into several parts, each part must specify the unit price and total value of that part according to Clause 1, Article 12 of Circular 07/2024/TT-BYT. The unit price of the drugs in the contractor selection plan is proposed and responsible by the public medical facility;

- The basis for determining the package price is implemented according to Clause 2, Article 16 of Decree 24/2024/ND-CP. In addition, public health facilities can refer to the information on drug prices, herbal medicine prices, traditional medicine ingredient prices successfully tendered according to the technical criteria group of public health facilities or successfully tendered centrally at the local level within 12 months before the date of submitting the approval plan for contractor selection or successfully tendered centrally at the national level, price negotiations with existing framework agreements on the Ministry of Health’s electronic portal; National-level centralized procurement unit information site; extracted from the national bidding network system or self-collected to serve as a basis for determining package prices;

- Building planned pricing for items with the same active ingredient, concentration or potency, method of use, dosage form at the generic drug package must ensure the following principles:

+ Group 1 planned price shall not exceed the planned price of the original specialty drug or reference biological product;

+ Group 2, Group 3 planned prices shall not exceed the planned price of the original specialty drug or reference biological product and Group 1;

+ Group 4 planned price shall not exceed the planned price of the original specialty drug or reference biological product; Group 1; Group 2 produced in Vietnam and Group 3;

+ Group 5 planned price shall not exceed the planned price of the original specialty drug or reference biological product; Group 1; Group 2; Group 3 and Group 4.

(5) Funding sources: Clearly state the funding sources according to Clause 3, Article 39 of the Bidding Law 2023. For packages with a duration of more than one year, funding sources can be determined based on the procurement estimate of the fiscal year and the expected procurement estimate of subsequent fiscal years.

(6) Forms and methods of selecting contractors:

- Forms of contractor selection: Based on the package price and nature of each package, select one of the following contractor selection forms: open bidding, selective bidding, direct appointment, competitive quotation, direct procurement, online quotation, online procurement;

- Methods of contractor selection: Apply the one-stage one-envelope method according to Article 30 of the Bidding Law 2023. public health facilities may only apply the one-stage two-envelope method with legal guidance on science and technology.

(7) Time for organizing contractor selection: Specify the time to start organising contractor selection and the time for organizing contractor selection according to Clause 5, Article 39 of the Bidding Law 2023.

(8) Type of contract: Specifically determine the type of contract according to Article 64 of the Bidding Law 2023 to serve as a basis for preparing bidding documents, request documents; signing contracts.

(9) Time for package implementation: The implementation time of the package is according to Clause 7, Article 39 of the Bidding Law 2023 but not exceeding 36 months.

(10) Additional purchase options (if any):

- If the package applies additional purchase options, clearly state the quantity and estimated value of the additional option;

- The additional purchase option is implemented when the following conditions are met: the contractor has won the bid through open bidding; the additional purchase quantity does not exceed 30% of the corresponding drug quantity stated in the contract; an approved estimate for the additional quantity; the unit price of the additional drug does not exceed the unit price of the corresponding drug in the contract; applies only during the effective period of the contract.

(11) Supervision of bidding activities (if any).

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