Nội dung toàn văn Decision No. 68/QD-TTg the national strategy on development of the Vietnam pharmaceutical industry up to 2020
THE PRIME MINISTER
SOCIALIST REPUBLIC OF VIET NAM
Hanoi, January 10, 2014
APPROVING THE NATIONAL STRATEGY ON DEVELOPMENT OF THE VIETNAM PHARMACEUTICAL INDUSTRY UP TO 2020, WITH A VISION TOWARD 2030
THE PRIME MINISTER
Pursuant to the December 25, 2001 Law on Organization of the Government;
Pursuant to the June 14, 2005 Pharmacy Law;
At the proposal of Minister of Health,
Article 1. To approve the national strategy on development of Vietnam pharmaceutical industry up to 2020 with a vision toward 2030 (hereinafter abbreviated to Strategy) with the following principal contents:
I. DEVELOPMENT VIEWPOINT
1. Adequately supply preventive and curative drugs for people with ensured quality, rational prices; in line with disease structure, meet timely requirements on security, national defense, natural disasters, epidemics and other emergency demands.
2. To build the pharmaceutical industry, in which concentrate on development investment to produce generic drug with ensured quality, rational prices, gradually replace import medicines; to develop the pharmaco-chemical industry, bring into play the potential and advantages of Vietnam to develop production of vaccines and medicines from materia medica.
3. To develop the pharmaceutical industry in specialization and modernization, with capability to compete with countries in region and the world; develop a modern, professional and standardized system of drug distribution and supply.
4. To use medicines rationally, safely and effectively; to push up operation of clinical pharmacy and pharmacovigilance.
5. To manage strictly, effectively stages from production, export, import, preservation, circulation, distribution to usage of medicines.
1. General objectives
Adequately, timely supply medicines with quality and rational prices according to the disease structure respectively with each socio-economical development stage and ensure medicine usage to be safe and rational. To attach special importance to medicine supply for subjects belonging to social policy, people of ethnic minorities, the poor, residents in remote and isolated regions.
2. Specific objectives up to 2020:
a) Timely supply 100% of preventive and curative drug demand.
b) To strive to produce 20% of raw materials demand for domestic medicine production, drugs produced domestically occupying 80% of total value of drugs consumed in year, in which drugs from materia medica shall occupy 30%; vaccines produced domestically shall meet 100% of demand for expanded vaccination and 30% of demand for service vaccination.
c) To strive to attain 40% generic drugs produced domestically and imported with circulation registration number already assessed bioequivalence and bioavailability.
d) 100% of medicines-trading establishments under the drug distribution system meet good practice standard, 50% of testing establishments and 100% of establishments of examining and verifying medical biological products and vaccines meet good practice standard (GPS).
dd) 50% of central and provincial hospitals have clinical pharmacy divisions, 50% of district-level and private hospitals have clinical pharmacy operation.
e) Attain rate of 2.5 pharmacists / 1 ten thousand people, in which clinical pharmacists shall occupy 30%.
3. Objectives oriented by 2030: drugs produced domestically shall basically meet demand of usage, special-cure drugs may be produced; taking the initiative in production of vaccines and biological products for epidemic prevention, raw materials for preparing drugs may be produced. System of testing, drug distribution, clinical pharmacy, drug information shall be equal to the advanced countries in region.
III. THE PRINCIPAL TASKS AND SOLUTIONS
1. Solutions on formulating law, regime, policy
a) To research to modify and supplement the Pharmacy Law aiming to encourage production and use of domestic drugs, standardize conditions for medicines business, apply the good practice standards, supply, bid, manage strictly drug price and relevant contents in line with socio-economic conditions of Vietnam and international integration.
b) To complete policy to push up the research, production, export, import, supply of essential drugs ensure for people to have conditions for access, selection and use of safe and effective drugs with rational prices.
c) To promulgate incentive policy for production, supply and usage of generic drugs, special-cure drugs, drugs in special preparation form, vaccines, biological products; to limit import of medicine raw materials, generic drugs which may be produced in Vietnam. State shall have priority policy for usage of drugs produced in Vietnam with state budget and medical insurance sources.
d) To further complete and carry out prescription good practice, drugstore good practice standards and policies related to activities of pharmacovigilance, drug information and advertisement.
dd) To promulgate incentive policy for research, production of drugs from Vietnam materia medica bringing national trademark.
2. Solutions on planning
a) The pharmaceutical industry shall be planned to develop the preparation industry, pharmaco-chemical industry, vaccines, and medical biological products; to prioritize measures to merger, purchase and sell, expand scale aiming to improve the competition.
b) The drug distribution system shall be planned in professional, modern and effective direction; 05 drug distribution centers in the North mountainous region, North Central, South Central – Western Highlands, Southeast and Southwest of Vietnam shall be built.
c) System of testing on pharmaceutical products and products directly influencing to human health shall be planned: To build the regional testing centers in North mountainous provinces, North delta and coastal provinces, the Central, Western Highlands and Southeast of Vietnam; to arrange and improve operational efficiency of the remaining testing centers.
d) Centers of medicines bioavailability research and bioequivalence assessment shall be planned; to invest in upgrading the existing centers and building new ones.
dd) To plan materia medica development in direction of goods production with big scale, development of areas planting trees, seedlings for drug preparation, protect, conserve gene source and develop rare and precious and endemic materia medica kinds on the basis of improving investment in advance technology and technique, and combining with traditional experiences.
3. Solutions on inspection, check and completion of organization
a) To wholly manage medicine quality, to strengthen solutions to ensure quality of drugs circulating in the market to meet the registered standard.
b) To strengthen check, supervision on medicine quality, and strictly handle acts of producing, exporting, importing, circulating, distributing and supplying counterfeit drugs, bad-quality drugs in the market.
c) To research the model of pharmaceutical industry organization system in concentrated and entire management direction of pharmaceutical products, food, cosmetics and products directly influencing to human health.
4. Investment solutions
a) To push up calling domestic and foreign organizations and individuals for investment in development of pharmaceutical industry, especially, domestic drug manufacture, franchised drug manufacture, technological transfer, biological product vaccines for curing and antibiotic raw materials, invest in construction of centers of medicine bioavailability research and bioequivalence assessment.
b) State shall invest, support development of medicine supply system for areas in extremely difficult socio-economic conditions, areas of ethnic minority groups, remote and isolated regions, boundary regions and islands; to further invest in upgrading pharmaceutical research institution, improving capability of drug testing and examination system.
To attach special importance to invest in concentrated projects with investment incentives in domains promulgated together with this Decision.
c) To encourage investment in public-private partnership form (PPP) for projects on building, upgrading, newly building the pharmaceutical research establishments; to select investors through bid for projects which use land to build pharmaceutical factories or industrial zones.
5. Solutions on science and technology, human resource and training
a) To push up research and application of advance and modern technologies in preparing medicines; to encourage implementation of some key pharmaceutical science and technology projects aiming to develop pharmaceutical industry.
b) To strengthen the training of pharmacy human resources to meet demand of pharmaceutical industry development, to attach special importance to train clinical pharmacists; to attract and perform preferential treatment for pharmacy officers working in areas in extremely difficult socio-economic conditions, areas of ethnic minority groups, remote and isolated regions, boundary regions and islands.
6. Solutions on cooperation and international integration
a) To strengthen cooperation and international integration in pharmacy; to participate positively and effectively in global pharmaceutical market.
b) To make use of management sources, experiences and capability of countries, World Health Organization (WHO) and international organizations to develop Vietnam pharmaceutical industry; to strengthen cooperation with countries being traditional customers of Vietnam and countries having developed pharmaceutical industry.
c) To take initiative in participate in International treaties, international agreements in pharmacy with countries, regional organizations and world.
Article 2. Organization of implementation
1. The Ministry of Health shall:
a) Elaborate and complete regimes, policies, planning, plans to submit to competent authorities for promulgation or approval or to promulgate and approve them under its competence to carry out tasks and solutions of Strategy;
b) Research and propose with Government to elaborate model of unified, concentrated, entire and effective management agencies of pharmaceutical products, food, cosmetics and products directly influencing to human health under the Ministry of Health.
c) Assume the prime responsibility for, and coordinate with relevant Ministries and sectors in formulating plan on training and using pharmacy human source aiming to overcome situation of pharmacist lack in difficulty-stricken areas, rural areas, mountainous areas, remote or isolated areas, allocating sufficient pharmacy human source in pharmacy state management agencies from the central level to local level, to strengthen capability, ensure efficiency of pharmacy state management agencies nationwide;
d) Organize the effective implementation of program on calling “The Vietnamese prioritizes usage of Vietnam medicines”.
dd) Guide, check, urge implementation of strategic, to conduct periodical preliminary and final reviews; report to the Prime Minister about implementation of Strategy.
2. The Ministry of Finance shall:
a) Formulate the national plan on medicines reserve, research regime, policy to support the medicine reserve and circulation;
b) Allocate funding to perform Scheme under decentralization of Law on state budget.
3. The Ministry of Industry and Trade shall:
a) Organize production of pharmaco-chemical raw materials, and products to support for drug manufacture;
b) To carry out effectively scheme on planning pharmaco-chemical industry and the national key program on pharmaco-chemical industry development to do as premise for development of Vietnam pharmaceutical industry.
4. The Ministry of Agriculture and Rural Development shall coordinate with the Ministry of Health in carrying out planning of regions for planting materia medica.
5. The Ministry of Planning and Investment shall:
a) To allocate and balance investment sources for pharmaceutical industry, to call up ODA capital sources to prioritize for development of pharmaceutical industry;
b) To review and complete the legal document system in foreign investment, policies related to investment incentives and special investment incentives to facilitate for promoting development of domestic pharmaceutical industry.
6. Other Ministries and sectors shall, within their assigned functions and tasks, carry out or coordinate with the Ministry of Health in implementing contents of this Strategy.
7. The provincial/municipal People’s Committees shall:
a) Elaborate and approve plans to carry out the national strategy on pharmaceutical industry development in their localities;
b) Prioritize cleared land fund for building pharmacy factories, industrial parks, prioritize in land and forest allocation and assignment for projects on materia medica development;
c) Apply regimes and policies in line with real conditions aiming to encourage development of local pharmaceutical industry in new stage.
Article 3. This Decision takes effect on the date of its signing.
Article 4. Ministers, heads of ministerial-level agencies and government attached agencies, chairpersons of provincial-level People’s Committees and heads of related agencies shall implement this Decision.
FOR THE PRIME MINISTER
LIST OF CONCENTRATED AND PREFERENTIAL INVESTMENT PROJECTS
(Promulgated together with Decision No. 68/QD-TTg dated January 10, 2014 of the Prime Minister)
A. LIST OF CONCENTRATED INVESTMENT PROJECTS
Project on building and upgrading centers of medicine bioavailability research and bioequivalence assessment that meet standard
To invest, upgrade and modernize 02 center of testing bioavailability and bioequivalence at the central drug-testing institution and the drug-testing institution of Ho Chi Minh city
Project on establishment of regional testing centers
05 centers in 5 regions: The North mountainous areas, North delta and coastal provinces, Central, Western Highland and Southeast of Vietnam. On basis of investment in upgrading the strong testing Centers of 05 provinces and cities in region
Projects on upgrading the national institution of examining and verifying the medical vaccines and biological products that meet international standard
State invest in upgrading and completing the national institution of examining and verifying the medical vaccines and biological products with human source, equipment, infrastructure, machinery, equipment that are advanced, modern and synchronous and meet international standard
Scheme on establishing 02 national research centers of biological technology and biosimilar in pharmacy domain
To invest in construction of 2 national research centers of biological technology and biosimilar in pharmacy domain
Project on building the clinical pharmacology center
To invest in building 01 national center of clinical pharmacology research
Project on upgrading center of information and monitoring adverse effect of medicines
To invest in upgrading 02 centers of information and monitoring adverse effect of medicines
Project on upgrading research and development institution of pharmaceutical industry
To invest in upgrading material facilities and equipment
B. LIST OF PREFERENTIAL INVESTMENT PROJECTS
To elaborate and carry out projects on technological transfer To research production of medicines under essential and generic drug groups, special active ingredients on the chains which have been invested
To be encouraged at all regions, areas in which factories have been built
To elaborate and carry out projects on upgrading production technology of production chains of vaccines and health biological products
Enterprises manufacturing vaccines
To build new centers of bioequivalence testing and assessment
To build new 3 regional centers of bioequivalence testing and assessment in North Central, South Central and Southeastern of Vietnam
Projects on applying technology of producing pharmacy package
To be encouraged at all regions, areas
To elaborate and carry out projects on technology for drug preparation, new drug, technology for producing vaccines, medical biological products which cannot be produced in Vietnam.
Concentrated industrial zones in pharmacy domain
To elaborate and carry out projects on development of auxiliary industries for pharmaceutical industry: Paper, resin, glass packages…
Concentrated industrial zones in pharmacy domain
To elaborate and carry out projects on producing pharmaceutical products with high technology: Multi-price vaccines, products originated from gene technology, recombination, original cell
Concentrated industrial zones in pharmacy domain
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