DECISION

PROMULGATING THE REGULATION ON THE IMPLEMENTATION OF NECESSARY MEASURES FOR SATISFYING THE DEMAND FOR HIV VACCINE IN AN EMERGENCY

THE PRIME MINISTER

Pursuant to the Law on Government organization dated December 25th 2001;

Pursuant to the Law on Prevention and Control of HIV/AIDS dated June 29th 2006;

Pursuant to the Law on Pharmacy dated June 14th 2005;

Pursuant to the Law on Intellectual property dated November 29th 2005;

Pursuant to the Government's Decree No. 108/2007/NĐ-CP dated June 26th 2007, guiding the implementation a number of articles of  the Law on Prevention of HIV/AIDS;

Pursuant to the Government's Decree No. 79/2006/NĐ-CP dated August 09th 2006, detailing the implementation of the Law on Pharmacy;

DECIDES:

Article 1. Promulgating together with this Decision the “Regulation on the implementation of necessary measures for satisfying the demand for HIV vaccine in an emergency".

Article 2. This Decision takes effect after 15 days as from the date of its publication on the Official Gazette.

Article 3. The Minister of Health is responsible for guiding and implementing this Decision.

The Ministers, Heads of ministerial-level agencies, Heads of Governmental agencies, the Presidents of People’s Committees of central-affiliated cities and provinces are responsible for the implementation of this Decision./.

REGULATION

ON THE IMPLEMENTATION OF NECESSARY MEASURES FOR SATISFYING THE DEMAND FOR HIV VACCINE IN AN EMERGENCY
(Promulgated together with the Prime Minister’s Decision No. 173/2008/QĐ-TTg dated December 25th 2008)

Chapter I

GENERAL REGULATIONS

Article 1. Scope of regulation

This Regulation guides the implementation of necessary measures for satisfying the demand for HIV vaccine in an emergency.

Article 2. Subjects of application

1. The organizations and individuals relevant to the implementation of necessary measures for satisfying the demand for HIV vaccine in an emergency.   

2. The facilities that provide examination and treatment for HIV sufferers; the HIV prevention centers of central-affiliated cities and provinces; and other organizations relevant to the provision of medical care and treatment for HIV/AIDS sufferers.

Article 3. Clinical trial exemption

In a necessary, the following medicines will be considered for being exempted from clinical trial:

1. The HIV vaccine produced in Vietnam according to the Decision on the patent transfer of the Ministry of Health;

2. The imported HIV vaccine without a registration number that satisfies the following conditions:

a) Being legally circulated in the home country;

b) Having the indication and usage in Vietnam similar to that in the home country.

Article 4. Labels of HIV vaccine

The labels of HIV vaccine produced, imported, and registered in an emergency must comply with the laws on medicine labels, and bear the text “Not for sale”

Article 5. The provision and distribution of HIV vaccine

The HIV vaccine produced and imported in an emergency shall be complimentarily provided for and distributed to the facilities that provide medical care and treatment for HIV sufferers prescribed in Clause 2 Article 2 of this Regulation.

Chapter II

THE EMERGENCIES AND NECESSARY MEASURES

Article 6. Declaration and termination of the HIV vaccine emergency

1. When HIV spreads over one or multiple cities or provinces, poses the risk of spreading on a massive scale, and seriously threatens the people’s health and social security, but there is not enough HIV vaccine to treat the sufferers, the Prime Minister shall declare the HIV vaccine emergency, and direct the implementation of necessary measures based on the request of the Minister of Health.

2. When the HIV vaccine satisfies the demand for treating HIV sufferers, the Prime Minister shall terminate the emergency.

3. The decision on declaring the emergency or terminating the emergency of the Prime Minister must be announced in the mass media

Article 7. The necessary measures to be taken in an emergency

1. The measures to be taken in an HIV emergency emergencies include:

a) Ordering the production;

b) Importing;

c) Quick issuance of Licenses for circulation;

d) Compelling the patent transfer in order to produce HIV vaccine.

2. Based on the seriousness of the emergency being declared, the Ministry of Health shall request the Prime Minister to decide the implementation of one or some necessary measures prescribed in Clause 1 this Article.

Chapter III

IMPLEMENTING THE NECESSARY MEASURES IN AN EMERGENCY

Article 8. Ordering the production, and importing HIV vaccine in an emergency

1. The Ministry of Health shall determine the quantity and category of HIV vaccine to be ordered and imported in an emergency.

2. The Ministry of Health shall lead and cooperate with the Ministry of Finance in determining the prices of HIV vaccine produced or imported, and the total budget for satisfying the demand for HIV vaccine in an emergency, and request the Prime Minister to make decision.

Section 1. PRODUCING HIV VACCINE IN VIETNAM IN AN EMERGENCY

Article 9. Producing HIV vaccine in Vietnam

1. Based on the Decision of the Prime Minister, the Ministry of Health shall appoint the Vietnamese medicine producers that satisfy the conditions and standards prescribed in Article 10 of this Regulation to produce HIV vaccine of good quality, of which the quantity, category, and prices are appropriate and may satisfy the demand in an emergency.

2. The premises appointed to produce HIV vaccine according to the Decision on compelling the patent transfer of the Ministry of Health must comply with current laws on intellectual property.

3. The premises being compelled to transfer the patent must cooeprate with the Ministry of Health and the premises appointed to produce vaccine in an emergency by the Ministry of Health.

Article 10. The conditions and standards applicable to HIV vaccine producers

The premises appointed to produce HIV vaccine in an emergency must satisfy the following requirements:

1. Having the Certificate of fulfillment of conditions for trading medicines as prescribed by current law;

2. Meet the standards of Good medicine manufacturing practice of the World Health Organization (GMP-WHO);

3. The production line is suitable for the form of preparation and vaccine according to the order of the Ministry of Health. The premises that meet the requirements and standards of the system of pre-appraisal certification of WHO, the US Food and Drug Administration (US-FDA), and the European Medicines Agency (EMEA) are prioritized;

4. Having at least 3 years of experience in producing HIV vaccine for domestic use and for export;

5. Having sufficient financial resources and able to find the sources of ingredients serving the vaccine production ordered by the Ministry of Health.

Section 2. IMPORTING HIV VACCINE IN AN EMERGENCY

Article 11. Importing HIV vaccine

1. The Ministry of Health shall appoint the premises to import HIV medicine, including the vaccine under the intellectual property protection that bear the same proprietary name with the vaccine that has been issued with the circulation registration number in Vietnam; the vaccine without circulation registration number, of which the quality, quantity, and prices may satisfy the demand for HIV vaccine in an emergency.

2. The premises appointed to import HIV vaccine must satisfy the following requirements:

a) Meeting the standards of Good Safety Practice (GSP) and Good distributint practice (GDP);

b) Being appointed by the Ministry of Health to store, circulate, and supply vaccine serving the prevention and resolution of infections and natural disasters.

Article 12. Issuing the License to import finished vaccine, and ingredients for producing HIV vaccine

1. The time limit for licensing the import HIV vaccine serving the vaccine demand in an emergency is within 03 working days as from receiving the valid dossier.

2. The HIV vaccine import dossier (finished vaccine and ingredient) must comply with the current regulations on imported medicines serving the prevention and resolution of infections and natural disasters, and shall be submitted at the Drug administration of Vietnam – The Ministry of Health.

3. The validity period of the License for import is decided by the Ministry of Health based on the seriosness of the emergency, but must not exceed 01 year.          

Section 3. REGISTERING THE CIRCULATION OF HIV VACCINE IN AN EMERGENCY

Article 13. Quick issuance of Licenses for HIV vaccine circulation

1. The submitted HIV vaccine registration dossiers shall be prioritized, especially the vaccine produced in Vietnam in order to quickly issue the License for vaccine circulation in an emergency.  The time limit for considering and issuing the License for HIV vaccine circulation in an emergency is within 10 working days as from receiving the valid dossier of vaccine registration.

2. The dossier of HIV vaccine registration must comply with the current Regulation on medicine registration, and shall be submitted at the Drug administration of Vietnam – the Ministry of Health.

3. The validity period of the License for import is decided by the Ministry of Health based on the seriosness of the emergency.

Article 14. Using confidential data

The Ministry of Health shall use the confidential clinical data about the HIV vaccine registered in Vietnam for assessing and licensing the HIV vaccine produced and registered in Vietnam in and emergency.

Chapter IV

IMPLEMENTATION ORGANIZATION

Article 15. Responsibility of the Minister of Health

1. Determine the demand and capability to provide HIV vaccine, and request the Prime Minister to announce and implement the necessary measures for satisfying the demand for HIV vaccine in an emergency.

2. Formulate a plan for producing, importing, and distributing HIV vaccine in an emergency.

3. Lead and cooperate with the Ministry of Finance in making budget estimate for the the production, import, and distribution of HIV vaccine in an emergency, and submit it to the Prime Minister for decision.

4. Efficiently direct the implementation of necessary measures for satisfying the demand for HIV vaccine in an emergency.

5. Supervise and expedite the implementation; report the results and the difficulties (if any) during the course of implementation to the Prime Minister.

6. Lead and cooperating with the Ministry of Finance and the Ministry of Science and Technology in determining the level and method of compensation for the paten owner or the holder of the exclusive patent in cases of compelling the patent transfer in order to serve the production and import of HIV in an emergency, and submit them to the Prime Minister for decision and implementation.

Article 16. Responsibility of the Ministry of Finance

1. Cooperate with the Ministry of Finance in making and submitting the budget estimate for the the production, import, and distribution of HIV vaccine in an emergency to the Prime Minister; allocate the budget approved by the Prime Minister; supervise the implementation in order to ensure that the budget is properly used according to current regulations.

2. Direct the Customs to quickly conduct the customs procedures for HIV vaccine imported to Vietnam in order to satisfy the vaccine demand in an emergency.

Article 17. Responsibility of the Ministry of Science and Technology  

Promptly provide information and professional advice at the request of the Ministry of Health in order to assess the legitimacy of the industrial property of HIV vaccine in order to ensure the legitimacy of the industrial propery when taking necessary measures in an emergency.

Article 18. Responsibility of relevant Ministries and sectors

The Ministers, Heads of ministerial-level agencies, Heads of Governmental agencies, the Presidents of People’s Committees of central-affiliated cities and provinces are responsible for organizing, inspecting, and guiding the implementation of this Regulation./.