Circular No. 15/2020/TT-BYT promulgates the Circular on the List of Tender Drugs, the List of Centralized Tender Drugs, and the List of Drugs Subject to Negotiated Pricing.

CIRCULAR

ISSUING THE LIST OF DRUGS FOR TENDER, THE LIST OF NATIONAL CONCENTRATED TENDERS, AND THE LIST OF DRUGS TO BE SUBJECT TO PRICE NEGOTIATION FORM

Pursuant to the Drug Law No. 105/2016/QH13 dated April 6, 2016;

Pursuant to the Law on Bidding No. 43/2013/QH13 dated November 26, 2013;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decree No. 63/2014/NĐ-CP dated June 26, 2014 of the Government detailing implementation of certain provisions of the Law on Bidding regarding selection of contractors;

Pursuant to the Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures for implementing the Medicine Law;

At the proposal of the Director of the Drug Administration Department;

The Minister of Health issues the Circular on issuing the List of Drugs for Tender, the List of National Concentrated Tenders, and the List of Drugs to be Subject to Price Negotiation Form.

Article 1. Scope of Regulation

1. This Circular stipulates the principles and criteria for building and issuing the List of Drugs for Tender, the National Concentrated Tenders List, the Local Concentrated Tenders List, and the List of Drugs to be Subject to Price Negotiation (hereinafter referred to as the drug lists).

2. Amending and supplementing some articles of Circular No. 15/2019/TT-BYT dated July 11, 2019, issued by the Minister of Health, on tendering drugs at public health facilities (hereinafter referred to as Circular No. 15/2019/TT-BYT).

Article 2. Principles and Criteria for Building Drug Lists

1. Principles for Building Drug Lists

a) Drugs that have been legally licensed for circulation in Vietnam, except those specified in Clause 1 and Clause 2 of Article 70 of the Medicine Law;

b) The List of Drugs for Tender shall be built based on necessary drugs for use at healthcare facilities purchasing from state funds, health insurance funds, revenue from medical services, and other legitimate sources of public healthcare facilities;

c) The National Concentrated Tenders List must ensure the supply capacity of drugs after winning the tender without affecting domestic pharmaceutical production facilities;

d) The List of Drugs to be Subject to Price Negotiation must ensure economic efficiency and encourage the use of generic drugs with reasonable costs;

đ) Drugs in the lists shall be updated, supplemented, or removed as appropriate to actual conditions and to promptly meet drug needs for disease prevention and treatment at healthcare facilities.

2. Criteria for Building the List of Drugs for Tender

Medicines included in the List of Drugs for Tender must meet one of the following criteria:

a) Drugs listed in the categories issued by the Ministry of Health, including: the List of Chemical Drugs, Vaccines, Biological Products, Radioactive Drugs, and Markers within the scope of health insurance fund reimbursement; the List of Traditional Medicine and Herbal Drugs within the scope of health insurance fund reimbursement; the List of Essential Drugs of Vietnam;

b) Drugs in the categories of chemical drugs, vaccines, biological products, radioactive drugs and markers, herbal drugs, and traditional medicine that have been legally licensed for circulation in Vietnam, except those specified in Clause 1 and Clause 2 of Article 70 of the Medicine Law;

c) Drugs purchased annually to serve treatment activities at healthcare facilities.

3. Criteria for Building the National Concentrated Tenders List

Drugs included in the National Concentrated Tenders List must meet one of the following criteria:

a) Drugs used in national programs, projects, and units;

b) Drugs meeting all the following criteria: Drugs listed in the List of Drugs for Tender and not in the List of Drugs to be Subject to Price Negotiation; Drugs with high usage value or quantity across healthcare facilities nationwide; Drugs having at least three (3) concurrent registration certificates from at least three (3) manufacturing facilities meeting technical criteria specified in Clause 1 and Clause 2 of Article 7 of Circular No. 15/2019/TT-BYT.

4. Criteria for Building the Local Concentrated Tenders List

Drugs included in the Local Concentrated Tenders List must meet all the following criteria:

a) Drugs listed in the List of Drugs for Tender and not in the National Concentrated Tenders List or the List of Drugs to be Subject to Price Negotiation;

b) Drugs listed in the List of Essential Drugs issued by the Ministry of Health;

c) Drugs having at least three (3) registration certificates in Vietnam according to their formulation and manufacturer;

d) Drugs with high usage value or quantity at provincial and city-level healthcare facilities;

đ) Drugs used in multiple facilities and treatment levels in the locality.

5. Criteria for Building the List of Drugs to be Subject to Price Negotiation

Drugs included in the List of Drugs to be Subject to Price Negotiation must meet one of the following criteria:

a) Drugs listed in the List of Original Brand Drugs issued by the Minister of Health;

b) Drugs listed in the List of Rare Drugs issued by the Minister of Health;

c) Drugs produced by only one or two manufacturers.

Article 3. Lists of Medicines

1. The following lists are promulgated together with this Circular:

a) List of medicines for bidding at Appendix I;

b) List of medicines for centralized national bidding at Appendix II;

c) List of medicines for centralized local bidding at Appendix III;

d) List of medicines subject to price negotiation form at Appendix IV.

2. For medicines meeting the criteria set forth in Clause 2, Article 2 of this Circular but not included in the List of medicines for bidding at Appendix I promulgated together with this Circular, medical facilities using state capital, health insurance funds, revenue from outpatient and inpatient services, and other lawful sources must conduct bidding in accordance with regulations when purchasing medicines.

Article 4. Updating Lists of Medicines

1. In cases where it is necessary to update, supplement, or remove medicines from the lists of medicines to ensure compliance with actual circumstances, the Drug Administration Department shall base on the principles and criteria for building the list set forth in Article 2 of this Circular to compile and establish the list of medicines that need updating, supplementation, or removal; seek opinions, consolidate, absorb, and explain opinions from relevant agencies and organizations; and submit for review to the National Advisory Council on Medicine Bidding.

2. Based on the proposed opinions of the National Advisory Council on Medicine Bidding, the Drug Administration Department shall submit to the Minister of Health for issuance of a Decision to update the lists of medicines.

Article 5. Amending and Supplementing Certain Provisions of Circular No. 15/2019/TT-BYT

1. Amend and supplement Points a and c of Clause 1, Article 4 of Circular No. 15/2019/TT-BYT as follows:

“a) For medicines under Section A in the List of medicines for centralized national bidding issued by the Minister of Health which meet the technical criteria specified in Clauses 1 and 2 of Article 7 of this Circular, medicines under Section B in the List of medicines for centralized national bidding issued by the Minister of Health, and medicines in the List of medicines subject to price negotiation form issued by the Minister of Health: The National Centralized Procurement Center for Medicines shall be responsible for developing the plan to select suppliers of medicines. The plan shall be based on the medicine usage needs of medical facilities established according to the notification of the National Centralized Procurement Center for Medicines. The maximum contract duration is thirty-six months, divided into groups of medicines and supply progress quarterly and annually”;

“c) For medicines not centrally bid by the National Centralized Procurement Center, centralized local procurement units bidding as stipulated in Points a and b of this Clause, medical facilities shall organize the selection of suppliers themselves: Medical facilities shall be responsible for developing the plan to select suppliers of medicines. The plan shall be developed periodically or urgently when there is a need. The maximum contract duration is twelve months, divided into groups of medicines.”

2. Amend and supplement Points a and c of Clause 2, Article 4 of Circular No. 15/2019/TT-BYT as follows:

“a) For medicines under Section A in the List of medicines for centralized national bidding issued by the Minister of Health which meet the technical criteria specified in Clauses 1 and 2 of Article 7 of this Circular, medicines under Section B in the List of medicines for centralized national bidding issued by the Minister of Health, and medicines in the List of medicines subject to price negotiation form issued by the Minister of Health: The National Centralized Procurement Center for Medicines shall be responsible for organizing the selection of suppliers of medicines in accordance with Chapters IV and V of this Circular;”

“c) For medicines not centrally bid by the National Centralized Procurement Center, centralized local procurement units bidding as stipulated in Points a and b of this Clause: Medical facilities shall be responsible for organizing the selection of suppliers of medicines in accordance with Chapter III of this Circular.”

3. Supplement Clause 3 of Article 4 of Circular No. 15/2019/TT-BYT as follows:

“3. For medicines used in national programs and projects listed in Section C of the List of medicines for centralized national bidding issued by the Minister of Health, the programs, projects, and implementing units shall develop plans and organize the selection of suppliers in accordance with regulations. In cases where medical facilities have a need to purchase these medicines for outpatient and inpatient services, they may proceed with procurement in accordance with Chapter III of this Circular.”

4. Supplement Clause 5 of Article 42 of Circular No. 15/2019/TT-BYT as follows:

“5. Basis for negotiation and implementation of drug price negotiations:

a) For negotiated medicines, which are original brand-name drugs announced by the Ministry of Health produced entirely in countries on the SRA list with two (02) registration certificates for Generic Group 1 drugs, the negotiation and implementation of drug prices shall be based on the number of registration certificates for Generic Group 1 drugs; the winning bid price of Generic Group 1 drugs produced in reference countries. If there is no winning bid price for drugs produced in reference countries, then the basis shall be the winning bid price of drugs produced in countries on the SRA list; the substitutability at the time of price negotiation.

b) For negotiated medicines, which are original brand-name drugs announced by the Ministry of Health produced entirely in countries on the SRA list with two (02) registration certificates for Generic Group 1 drugs necessary for treatment needs, original brand-name drugs announced by the Ministry of Health produced entirely in countries on the SRA list with less than or equal to one (01) registration certificate for Generic Group 1 drugs, and drugs with one (01) to two (02) manufacturers, in addition to the basis stipulated in Point a of this Clause, the negotiation and implementation of drug prices shall also be based on the assessment of cost-effectiveness, cost-benefit, and cost-utility;

c) For original brand-name drugs announced by the Ministry of Health manufactured through contract manufacturing or technology transfer in Vietnam, the negotiation and implementation of drug prices shall follow the contract manufacturing or technology transfer schedule.”

5. Amend Point b of Clause 2, Article 46 of Circular No. 15/2019/TT-BYT as follows:

"b) For medicines listed under the Negotiated Price Negotiation Failure Formulary (including original branded drugs manufactured through technology transfer in Vietnam), the National Central Medicine Procurement Center shall base on the opinions of the Price Negotiation Council to propose procurement solutions or alternative measures for review and decision by the Ministry's leadership. For original branded drugs produced entirely in countries included in the SRA list, which have two (02) registration certificates for Group 1 generic drugs as stipulated in Article 7 of this Circular but failed price negotiations, healthcare facilities may organize the selection of contractors through open tendering for generic drug tenders as announced by the Ministry of Health."

Article 6. Effectiveness

1. This Circular takes effect from October 6, 2020.

2. Circular No. 09/2016/TT-BYT dated May 5, 2016, issued by the Minister of Health regarding the List of Tendered Medicines, the List of Centralized Tendered Medicines, and the List of Medicines Subject to Negotiated Pricing shall cease to be effective from the date this Circular takes effect.

Article 7. Transitional Provisions

For tender packages that have been approved for contractor selection plans before the date this Circular takes effect, they shall continue to be implemented according to the provisions of Circular No. 09/2016/TT-BYT dated May 5, 2016, issued by the Minister of Health regarding the List of Tendered Medicines, the List of Centralized Tendered Medicines, and the List of Medicines Subject to Negotiated Pricing, except where the entity specified in Article 2 of Circular No. 15/2019/TT-BYT dated July 11, 2019, issued by the Minister of Health voluntarily implements this Circular from the date of issuance.

Article 8. Reference Provisions

In case the referenced documents in this Circular are replaced or amended, they shall be applied according to the replaced or amended documents.

Article 9. Implementation Organization

Before March 15 each year, the National Central Medicine Procurement Center must promptly inform healthcare facilities and localities about the implementation of centralized medicine tenders at the national level and medicine price negotiations for the announcement year and the following year.

Article 10. Responsibility for Implementation

1. The Director of the Ministry’s Office, the Director of the Drug Administration Department, the Director of the Traditional Medicine Management Department, the Director of the Planning and Finance Department, and the heads of related units are responsible for implementing this Circular.

2. During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are requested to promptly report to the Ministry of Health (Drug Administration Department) for consideration and resolution./.