Resolution 30/NQ-CP 2023 on continuing measures to guarantee drugs and medical devices

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Resolution No. 30/NQ-CP dated March 04, 2023 of the Government on continuing the implementation of measures to guarantee drugs and medical devices
Issuing body: GovernmentEffective date:
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Official number:30/NQ-CPSigner:Le Minh Khai
Type:ResolutionExpiry date:Updating
Issuing date:04/03/2023Effect status:
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Fields:Food and drug , Medical - Health , Policy

SUMMARY

Determination of medical device bidding-package price

On March 04, 2023, the Government issues the Resolution No. 30/NQ-CP on continuing the implementation of measures to guarantee drugs and medical devices.

Accordingly, the Government allows the payment of costs of health insurance-covered medical care for technical services using machines provided by contractors after winning bids for supplies and chemicals according to contractor selection results approved by the competent authority in accordance with the Law on Bidding.

Specifically, for contracts signed before November 05, 2022, implement according to the contracts’ term. For contracts signed from November 05, 2022 onwards, including contracts signed in the form of direct procurement, implement until legal documents on such issue. In case of expiration of the contract term, the payment shall continue to be implemented until the purchased supplies and chemicals are used up.

Besides, health establishments are allowed to pilot application of guidance on setting bid package prices in 2023. Specifically, when setting the bidding-package price, for a type of medical device with different manufacturers, a project owners shall consider and decide to assign the unit’s scientific council to formulate technical configuration and features according to professional requirements of the unit. On the basis of technical configuration and features formulated by its scientific council, the unit shall collect price quotations in accordance with regulations.

The project owner shall determine the bidding-package price based on at least one of the following documents: Market price that is referred to from providers’ price quotations by one of the specified methods; The results of valuation provided by a State agency competent to perform the valuation or a valuation enterprise; The winning bid of the bidding package for procurement of similar medical devices within the latest period, but not exceeding 120 days.

This Resolution takes effect on the signing date.

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Effect status: Known

THE GOVERNMENT

________

No. 30/NQ-CP

THE SOCIALIST REPUBLIC OF VIETNAM

Independence – Freedom – Happiness

____________________

Hanoi, March 04, 2023

                                            

RESOLUTION

On continuing the implementation of measures to guarantee drugs and medical devices

_____________________

THE GOVERNMENT

 

Pursuant to the Law on Organization of the Government dated June 19, 2015; Law on Amending and Supplementing a Number of Articles of the Law on Organization of the Government and the Law on Organization of Local Administration dated November 22, 2019;

At the proposal of the Minister of Health.

 

RESOLVES:

 

1. To amend Clause 4 of the Government’s Resolution No. 144/NQ-CP dated November 05, 2022 as follows:

“Allow the payment of costs of health insurance-covered medical care for technical services using machines provided by contractors after winning bids for supplies and chemicals according to contractor selection results approved by the competent authority in accordance with the Law on Bidding:

a) According to the contracts’ term, for contracts signed before November 05, 2022.

b) Until legal documents on such issue, for contracts signed from November 05, 2022 onwards, including contracts signed in the form of direct procurement.

In case of expiration of the contract term specified at Points a and b of this Clause, the payment shall continue to be implemented until the purchased supplies and chemicals are used up.”.

2. If the project owners or the bid solicitors (hereinafter referred to as the project owners) stipulate, in the bidding dossiers, the content that the contractors winning bids for supplies, chemicals shall be responsible for providing medical devices for use of supplies, chemicals, the winning contractors must provide medical devices at the project owners’ request.

Medical examination and treatment expenses for technical services using machines provided by contractors after winning bids for supplies and chemicals as specified in this Clause shall be covered by the health insurance fund. In case of expiration of the contract term, the payment shall continue to be implemented until the purchased supplies and chemicals are used up.

3. Allow health establishments to pilot application of guidance on setting bid package prices in 2023, to be specific:

a) When setting the bidding-package price, for a type of medical device with different manufacturers, a project owners shall consider and decide to assign the unit’s scientific council to formulate technical configuration and features according to professional requirements of the unit. On the basis of technical configuration and features formulated by its scientific council, the unit shall collect price quotations in accordance with Point b of this Clause.

b) The project owner shall determine the bidding-package price based on at least one of the following documents:

- Market price that is referred to from providers’ price quotations by one of the following methods:

+ The project owner posts a notice of invitation for offers with technical requirements on the Ministry of Health’s website or the online public service portal on medical device management (https://dmec.moh.gov.vn) or the unit’s website or other forms as prescribed by law on bidding for at least 10 days. At the end of notification of invitation for offers, the project owner shall use the received quotations as a basis for setting the bidding-package price. In cases only one or two distributors or enterprises (hereinafter referred to as distributors) provide quotation (s), such quotation(s) shall be used as the basis to set the bidding-package price.

+ The project owner is allowed to get a quotation directly from the distributor in cases there is only one distributor or for the purpose of ensuring technological compatibility and copyright which cannot be purchased from other contractors.

The determination of bidding-package price shall be based on technical features, necessity and financial capacity of the project owner.

- The results of valuation provided by a State agency competent to perform the valuation or a valuation enterprise in accordance with the Law on Prices;

- The winning bid of the bidding package for procurement of similar medical devices within the latest period, but not exceeding 120 days.

c) In case the bidding package consists of many separate parts, the value of each part in the bidding-package price must be clearly specified.

4. Allow the health establishments to use medical devices that are given or donated by domestic or foreign individuals or organizations (including medical devices under joint venture contracts which have been expired) but of which procedures for establishment of ownership by the entire people have not yet completed for the purpose of medical examination and treatment. Technical services using such medical devices shall be covered by the health insurance fund. Medical examination and treatment establishments are responsible for their quality and may use their funds to maintain and repair such medical devices.

5. Responsibilities of ministries and sectors:

a) The Ministry of Health shall:

- Formulate and promulgate guidelines on setting prices of medical device bidding packages: Complete in second quarter of 2023;

- Amend and supplement the lists of drugs subject to centralized bidding at the national and local levels in conformity with bidding organization capacity of each level and enterprises’ supply capacity, ensuring timely provision of sufficient drugs for medical examination and treatment: Complete in third quarter of 2023;

- Research and develop a mechanism to ensure rare drugs and drugs with limited supply: Complete in third quarter of 2023;

- Formulate and issue guidance on the form of bidding dossiers for bidding packages of medicinal materials and traditional medicaments for online bidding: Complete in third quarter of 2023;

- Review and evaluate specifically the reception of used machines and medical devices that are given or donated by the individuals and organizations to health establishments for the purpose of medical examination and treatment; and coordinate with the Ministry of Finance and related ministries and agencies to propose specific measures to the competent authority for consideration and decision: Complete in second quarter of 2023.

b) The Ministry of Planning and Investment shall:

- Promptly and specifically guide units and localities to implement legal documents related to bidding for drugs and medical devices according to their competence;

- Coordinate with the Ministry of Health in formulating regulations on bidding for drugs and medical devices in the Bidding Law project, ensuring that such regulations are suitable to the characteristics of the health sector.

c) The Ministry of Finance shall be responsible for expeditiously reviewing, amending, supplementing or issuing documents on management and use of public properties and use of funds from the state budget for procurement of drugs and medical devices according to their competence or submit them to competent authorities for promulgation according to regulations.

6. This Resolution takes effect on the signing date.

The Ministry of Health shall monitor, urge the implementation of the Resolution and synthesize results of the implementation, and report to the Prime Minister for consideration and direction of the implementation of this Resolution at ministries, branches and localities, if necessary./.

 

On behalf of the Government

For the Prime Minister

Deputy Prime Minister

Le Minh Khai

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