Thông tư 15/2020/TT-BYT

Circular No. 15/2020/TT-BYT dated August 10, 2020 on promulgating List of drugs procured through bidding, List of drugs procured through centralized bidding, and List of drugs procured through price negotiation

Nội dung toàn văn Circular 15/2020/TT-BYT List of drugs procured through centralized bidding


MINISTRY OF HEALTH
-------

THE SOCIALIST REPUBLIC OF VIET NAM
Independence-Freedom-Happiness
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No.: 15/2020/TT-BYT

Hanoi, August 10, 2020

 

CIRCULAR

PROMULGATING LIST OF DRUGS PROCURED THROUGH BIDDING, LIST OF DRUGS PROCURED THROUGH CENTRALIZED BIDDING, LIST OF DRUGS PROCURED THROUGH PRICE NEGOTIATION

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;

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

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

Pursuant to the Government’s Decree No. 63/2014/ND-CP dated June 26, 2014 providing guidelines for the Law on bidding regarding contractor selection;

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on pharmacy;

At the request of Director of the Drug Administration of Vietnam;

The Minister of Health promulgates a Circular promulgating the List of drugs procured through bidding, List of drugs procured through centralized bidding, and List of drugs procured through price negotiation,

Article 1. Scope

1. This Circular provides the rules and criteria for compiling the List of drugs procured through bidding, List of drugs procured through centralized bidding, and List of drugs procured through price negotiation (hereinafter referred to as “drug lists”).

2. Certain Articles of the Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health prescribing bidding for supply of drugs for public health facilities (hereinafter referred to as “Circular No. 15/2019/TT-BYT”).

Article 2. Rules and criteria for compiling drug lists

1. Rules for compiling drug lists

a) Drugs have been granted certificates of marketing authorization in Vietnam, except the drugs specified in Clause 1 and Clause 2 Article 70 of the Law on Pharmacy;

b) The List of drugs procured through bidding consists of drugs which are necessary for health facilities and funded by state budget, health insurance fund, revenues from provision of healthcare services and other lawful funding sources of public health facilities;

c) The List of drugs procured through national centralized bidding must ensure the winning bidder’s ability to supply drugs after winning the bid and do not adversely affect domestic drug manufacturers;

d) The List of drugs procured through price negotiation must ensure economic efficiency and should include generic drugs with reasonable prices;

dd) The drug lists shall be updated and have drugs added or removed in order to meet the reality and ensure the timely supply of goods serving prevention and treatment of diseases at health facilities. 

2. Criteria for compiling the List of drugs procured through bidding

A drug must satisfy one of the following criteria to be added to the List of drugs procured through bidding:

a) The drug is included in the following lists of the Ministry of Health: List of modern drugs, vaccines, biologicals, radiopharmaceuticals and tracers covered by health insurance fund; List of traditional drugs and herbal drugs covered by health insurance fund; List of essential drugs of Vietnam;

b) The drug is included in lists of modern drugs, vaccines, biologicals, radiopharmaceuticals and tracers, traditional drugs and herbal drugs granted certificate of marketing authorization in Vietnam, except the drugs specified in Clause 1 and Clause 2 Article 70 of the Law on Pharmacy;

c) The drug is annually purchased to serve medical treatment at health facilities.

3. Criteria for compiling the List of drugs procured through national centralized bidding

A drug must satisfy one of the following criteria to be added to the List of drugs procured through national centralized bidding:

a) The drug is used in national programs or projects or by national units;

b) The drug satisfies all of the following criteria: It is included in the List of drugs procured through bidding and not included in the List of drugs procured through price negotiation; It is commonly used with high values or in large quantities at health facilities nationwide; It concurrently has at least 03 (three) certificates of marketing authorization of at least 03 (three) manufacturers satisfying technical requirements laid down in Clause 1 and Clause 2 Article 7 of the Circular No. 15/2019/TT-BYT .

4. Criteria for compiling the list of drugs procured through local centralized bidding

A drug must satisfy all of the following criteria to be added to the List of drugs procured through local centralized bidding:

a) It is included in the List of drugs procured through bidding and included in neither List of drugs procured through national centralized bidding nor List of drugs procured through price negotiation;

b) It is included in the List of essential drugs promulgated by the Ministry of Health;

c) It has 03 (three) or more certificates of marketing authorization in Vietnam according to dosage form or manufacturer;

d) It is commonly used with high values or in large quantities at provincial health facilities;

dd) It is used by numerous local treatment facilities.

5. Criteria for compiling the List of drugs procured through price negotiation

A drug must satisfy one of the following criteria to be added to the List of drugs procured through price negotiation:

a) It is included in the List of original brand-name drugs promulgated by the Minister of Health;

b) It is included in the List of rare drugs promulgated by the Minister of Health;

c) It is produced by only one or two manufacturers.

Article 3. Drug lists

1. The following drug lists are enclosed with this Circular:

a) The List of drugs procured through bidding in Appendix I;

b) The List of drugs procured through national centralized bidding in Appendix II;

c) The List of drugs procured through local centralized bidding in Appendix III;

d) The List of drugs procured through price negotiation in Appendix IV.

2. If a health facility wants to purchase a drug which satisfies the criteria in Clause 2 Article 2 hereof but is not yet included in the List of drugs procured through bidding in Appendix I enclosed herewith by using state budget, health insurance fund, revenues from provision of healthcare services and other funding sources, it must carry out the procurement through bidding as prescribed.

Article 4. Updating drug lists

1. If a drug list needs to be updated or have drugs added or removed to meet the reality, Drug Administration of Vietnam shall, based on the rules and criteria for compiling drug lists in Article 2 hereof, consolidate and prepare the list of drugs to be updated, added or removed; get, receive and consolidate opinions and explanations from relevant agencies and organizations; request for opinions from the National drug procurement consultancy council.

2. Based on opinions given by the National drug procurement consultancy council, Drug Administration of Vietnam shall request the Minister of Health to issue the Decision on updated drug lists.

Article 5. Amendments to the Circular No. 15/2019/TT-BYT

1. Point a and Point c Clause 1 Article 4 of Circular No. 15/2019/TT-BYT are amended as follows:

“a) With regard to the drugs included in Section A of the List of drugs procured through national centralized bidding promulgated by the Minister of Health and meeting technical requirements laid down in Clause 1 and Clause 2 Article 7 hereof, drugs included in Section B of the List of drugs procured through national centralized bidding promulgated by the Minister of Health and drugs included in the List of drugs procured through price negotiation promulgated by the Minister of Health: The National centralized drug procurement center shall develop the contractor selection plan.  The plan shall be based on the demand for drugs of health facilities according to the notification of the National centralized drug procurement center. The maximum period of a contract is 36 months and categorized by drug category and supply interval (quarterly, annually)”;

“c) With regard to the drugs which are not procured through bidding organized by the National centralized drug procurement center or local centralized drug procurement units as prescribed in Point a and Point b of this Clause, health facilities shall themselves carry out the contractor selection: Health facilities shall develop their own contractor selection plans.  The plan is made periodically or on request.  The maximum period of a contract is 12 months and categorized by drug category.”

2. Point a and Point c Clause 2 Article 4 of Circular No. 15/2019/TT-BYT are amended as follows:

“a) With regard to the drugs included in Section A of the List of drugs procured through national centralized bidding promulgated by the Minister of Health and meeting technical requirements laid down in Clause 1 and Clause 2 Article 7 hereof, drugs included in Section B of the List of drugs procured through national centralized bidding promulgated by the Minister of Health and drugs included in the List of drugs procured through price negotiation promulgated by the Minister of Health: The National centralized drug procurement center shall organize the contractor selection in accordance with regulations in Chapter IV and Chapter V hereof;”

“c) With regard to the drugs which are not procured through bidding organized by the National centralized drug procurement center or local centralized drug procurement units as prescribed in Point a and Point b of this Clause: Health facilities shall organize the contractor selection in accordance with regulations in Chapter III hereof.”

3. Clause 3 is added to Article 4 of the Circular No. 15/2019/TT-BYT as follows:

“3. With regard to the drugs used in national programs and projects in Section C of the List of drugs procured through national centralized bidding promulgated by the Minister of Health, units in charge of implementing such programs and projects shall develop contractor section plans and organize the contractor selection as prescribed. If health facilities want to procure these drugs to serve medical examination and treatment, they shall carry out the procurement of drugs in accordance with regulations in Chapter III hereof.”

4. Clause 5 is added to Article 42 of the Circular No. 15/2019/TT-BYT as follows:

“5. Grounds for price negotiation and performance of price negotiation:

a) 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.

b) 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;

c) 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.”

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

“b) With regard to the drugs included in the List of drugs procured through price negotiation for which the price negotiation is unsuccessful (including original brand-name drugs manufactured under processing contracts or technology transfer contracts in Vietnam), based on the opinions given by the price negotiation council, the National centralized drug procurement center shall propose an alternative procurement plan or solution to the Minister of Health for consideration and decision. With regard to the original brand-name drugs announced by the Ministry of Health, wholly produced in SRA countries, granted two (02) or more certificates of marketing authorization of Category 1 generic drugs as prescribed in Article 7 hereof for which the price negotiation is unsuccessful, health facilities may organize contractor selection through competitive bidding for generic contract packages according to the Ministry of Health’s notification”.

Article 6. Entry into force

1. This Circular comes into force from October 06, 2020.

2. The Circular No. 09/2016/TT-BYT dated May 05, 2016 of the Minister of Health promulgating the List of drugs procured through bidding, List of drugs procured through centralized bidding, and List of drugs procured through price negotiation shall cease to take effect from the effective date of this Circular.

Article 7. Transition

The contract packages whose contractor selection plans have been approved before the effective date of this Circular shall be executed in accordance with regulations in the Circular No. 09/2016/TT-BYT , unless the facilities mentioned in Article 2 of the Circular No. 15/2019/TT-BYT volunteer to follow regulations of this Circular after it is promulgated.

Article 8. Reference

If any legislative documents referred to in this Circular are superseded or amended, the new ones shall apply.

Article 9. Implementation organization

By March 15 of every year, the National centralized drug procurement center shall punctually notify health facilities and local governments of the procurement of drugs through national centralized bidding and price negotiation in the year of notification and the following year.

Article 10. Responsibility for implementation

1. The Chief of the Ministry Office, Director of Drug Administration of Vietnam, Director of Traditional Medicine Administration, Director of Planning – Finance Department, and heads of relevant units are responsible for the implementation of this Circular.

2. Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health (via Drug Administration of Vietnam) for consideration./.

 

 

PP. MINISTER
DEPUTY MINISTER




Truong Quoc Cuong

 


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This translation is made by THƯ VIỆN PHÁP LUẬT and for reference purposes only. Its copyright is owned by THƯ VIỆN PHÁP LUẬT and protected under Clause 2, Article 14 of the Law on Intellectual Property.Your comments are always welcomed

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