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STANDING
COMMITTEE OF NATIONAL ASSEMBLY |
THE SOCIALIST
REPUBLIC OF VIETNAM |
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Resolution No. 12/2021/UBTVQH15 |
Hanoi, December 30, 2021 |
STANDING COMMITTEE OF NATIONAL ASSEMBLY
Pursuant to the Constitution of the Socialist Republic of Vietnam;
Pursuant to the Law on Organization of National Assembly No. 57/2014/QH13 amended by the Law No. 65/2020/QH14;
Pursuant to the Resolution No. 30/2021/QH15 dated July 28, 2021 of 14th National Assembly in the first meeting,
HEREBY RESOLVES:
Article 1. Scope and regulated entities
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a) Mobilize and coordinate people to participate in testing, vaccination, examination and treatment of COVID-19;
b) Funding for current expenditures of public COVID-19 admission and treatment facilities (hereinafter referred to as COVID-10 treatment facilities) and reimbursement of expenses incurred in COVID-19 prevention and control practices;
c) Payment of examination and treatment expenses incurred by the COVID-19 patients;
d) Remote medical examination and treatment for COVID-19 patients and people who cannot access medical examination and treatment facilities (hereinafter referred to as health facilities) due to the COVID-19 pandemic;
dd) Manage medicines and medicinal ingredients in the context of the COVID-19 pandemic;
e) Stabilize prices of medical devices and equipment in service of COVID-19 prevention and control;
g) Policies for people mobilized to participate in the prevention and control of COVID-19 who are infected with COVID-19 or have to undergo isolation after participating in the prevention and control of the COVID-19 pandemic.
2. This Resolution applies to domestic and foreign agencies, organizations and individuals in Vietnam.
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a) Healthcare practitioners in Vietnam (including foreigners) may conduct testing, vaccination, examination and treatment for COVID-19 other than the scope of specialty specified in their practicing certificates;
b) Foreigners and overseas Vietnamese who have been licensed by a foreign competent authority to practice medical examination and treatment may conduct COVID-19 testing, vaccination, examination and treatment at health facilities established to perform or assigned the task of admitting, managing, taking care of and treating people infected with COVID-19 (hereinafter abbreviated as COVID-19 treatment facilities) without requirement of a medical practice certificate issued by the competent Vietnamese authority;
c) Students and trainees of schools in the health sector; persons who are eligible for being granted but have not yet been granted a medical practice certificates may participate in COVID-19 testing, vaccination, examination and treatment.
2. The Government shall elaborate this Article.
1. Current expenditures of public COVID-19 treatment facilities (including salaries, wages, salary-based allowances and contributions as prescribed by law) are funded from the State budget, health insurance fund, payments by service users and other lawful revenue sources as prescribed by law, in which the state budget is implemented according to decentralization as follows:
a) The central budget shall provide funding for COVID-19 treatment facilities established by the central government, excluding the portion of fund that the local budget that has supported COVID-19 treatment facilities;
b) The local budget shall provide funding for COVID-19 treatment facilities established by the local government. If the local budget fails to provide the funding, the central budget shall do so.
2. The state budget shall reimburse expenses incurred in the prevention and control of the COVID-19 pandemic as assigned by a competent agency within the scope of payment according to regulations from the state budget that the public health facilities used their own financial resources in advance (excluding sponsorship and aid).
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Article 4. Payment of examination and treatment expenses incurred by the COVID-19 patients
1. The payment of examination and treatment expenses incurred by COVID-19 patients at public health facilities shall be made as follows:
a) Comply with the provisions of Resolution No. 268/NQ-UBTVQH15 dated August 6, 2021 of the National Assembly Standing Committee on allowing the Government to issue a Resolution with certain matters different from the provisions of law to meet the requirements of COVID-19 prevention and control.
b) In case the COVID-19 treatment facility cannot separate the expenses incurred in examination and treatment of COVID-19 and other diseases to be paid by given sources or fail to collect the expenses that the patients have to pay as prescribed due to force majeure, these expenses shall be covered by the state budget according to regulations of the Government.
2. The payment of COVID-19 examination and treatment expenses at private health facilities assigned by provincial-level authorities to admit, manage, take care of and treat COVID-19 patients shall be made in accordance with Point a, Clause 1 of this Article at the payment rate of the highest-class province-level polyclinic hospital located in the province.
3. The Government shall elaborate this Article.
1. Allow remote medical examination and treatment for COVID-19 patients and people who cannot access health facilities due to the COVID-19 pandemic as follows:
a) Remote medical examination and treatment is carried out by a practitioner at a health facility in collaboration with a practitioner at another health facility to provide examination and treatment for a patient via phone, electronic mean or another IT-based mean;
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2. Remote medical examination and treatment must be performed by a person who has been granted a medical practice certificate, a health facility that has been granted an operation license and meets the requirements pertaining to medical equipment and IT infrastructure.
3. The Minister of Health shall elaborate this Article and the payment of expenses for remote medical examination and treatment.
Article 6. Management of medicines and medicinal ingredients in the context of the COVID-19 pandemic
1. The Minister of Health shall consider and decide the use of pharmaceutical ingredients licensed for import in accordance with the law on pharmacy for other purposes to produce medicines that have been granted marketing authorization certificates and have indications for use in prevention and treatment of COVID-19.
2. In case of shortage of medicines for the prevention and treatment of COVID-19, the Minister of Health shall decide on the free use of a domestically-produced medicine in the batch manufactured to enable the issuance of marketing authorization certificate for the medicine with indications for use in prevention and treatment of COVID-19 if the following conditions are fully met:
a) The medicine is manufactured in accordance with the manufacturing process in the application for marketing authorization, which has been appraised and a marketing authorization certificate has been granted by the Ministry of Health;
b) Meet all the conditions as specified in the application for marketing authorization approved by the Ministry of Health t;
c) Obtain the consent of the drug manufacturer.
3. The issuance of marketing authorization certificates for a new medicine with indications for use in the prevention and treatment of COVID-19 (excluding vaccines) manufactured in a foreign country that obtains a marketing authorization or license for use in emergency or obtain a conditional marketing authorization from one of the stringent regulatory authorities (SRAs) announced by the World Health Organization, is done as follows:
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b) The Ministry of Health shall carry out technical-based inspection of technical document, application for assessment of GMP compliance of the drug manufacturer after a marketing authorization is granted.
4. For a new medicine with indications for use in the prevention and treatment of COVID-19 (excluding vaccines) that is manufactured domestically, if it has the same active ingredients, dosage form and administration as the drug indicated for prevention and treatment of COVID-19 that obtains a marketing authorization or license for use in emergency, or obtains a conditional marketing authorization from a stringent regulatory agency (SRA), the clinical document in an application for a marketing authorization will be exempt.
5. If the validity period of a marketing authorization of medicines and medicinal ingredients expires at a time during the period from the effective date of this Resolution to before December 31, 2022 but it is unable to apply for renewal of the market authorization due to the influence of the COVID-19 pandemic, this marketing authorization may remain valid until the end of December 31, 2022 for medical examination and treatment purpose.
6. The Government shall elaborate clause 1 and clause 2 hereof.
Article 7. Stabilization of medical equipment prices
1. Add given items of medical equipment for the prevention and control of COVID-19 to the List of goods and services eligible for price stabilization.
Based on the actual situation, the Government shall specify items of medical equipment to serve COVID-19 prevention and control practices that are eligible for price stabilization.
2. The application of price stabilization measures for medical equipment serving the prevention and control of the COVID-19 pandemic specified in Clause 1 of this Article must comply with the provisions of the law on prices.
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2. Receive benefits related to COVID-19 prevention and control practices if they have performed COVID-19 prevention and control tasks while they have been treated for COVID-19.
3. The Government shall elaborate this Article.
1. This Resolution comes into force as of the date of signing.
2. Regulations in articles 3, 4 and 8 of this Resolution apply from January 1, 2021.
ON BEHALF OF
STANDING COMMITTEE OF NATIONAL ASSEMBLY
CHAIRPERSON
Vuong Dinh Hue