Decision No. 43/2007/QĐ-TTg On approving the Project "Developing the Pharmaceutical Industry and Building a Drug Supply System Model for Vietnam from 2007 to 2015 with a Vision to 2020"

DECISION OF THE PRIME MINISTER

On approving the Project "Developing the Pharmaceutical Industry and Building a Model for the Drug Supply System in Vietnam for the Period 2007-2015 and Vision to 2020"

On the basis of the Law on Health Care for the People dated July 11, 1989;

___________________

PRIME MINISTER

Pursuant to the Law on Organization of the Government dated December 25, 2001;

On the basis of the Law on Medicines dated June 14, 2005;

Approves the Project "Developing the Pharmaceutical Industry and Building a Model for the Drug Supply System in Vietnam for the Period 2007-2015 and Vision to 2020" with the main contents as follows:

Considering the proposal of the Minister of Health,

DECISION:

Article 1. A. OBJECTIVES

I. GENERAL OBJECTIVE

To develop the Vietnamese pharmaceutical industry into a leading economic and technical sector towards industrialization and modernization; enhance domestic drug production capacity and improve the drug supply system in Vietnam to ensure regular, timely, and sufficient supply of quality drugs at reasonable prices, safe and effective drug use to serve the health protection and improvement of the people, meeting regional and global integration requirements.

II. SPECIFIC OBJECTIVES

1. Regarding the development of the Vietnamese pharmaceutical industry

a) Establish and develop a system of domestic drug manufacturing plants to meet basic needs for disease prevention and treatment drugs for the people; ensure that domestically produced drugs account for 70% of the value of imported drugs by 2015 and 80% by 2020, among which essential medicines and those serving national health programs should meet about 90% of usage needs;

b) Strengthen scientific research capabilities including basic research, applied research, research and development, and experimental production of drug raw materials to serve the development of the pharmaceutical industry and meet domestic drug production needs;

c) Establish and develop chemical drug factories to produce and supply raw materials for drug formulation industries; ensure that these factories meet 20% of the demand for raw materials for drug formulation industries by 2015 and 50% by 2020;

d) Leverage the potential and strengths of traditional medicinal herbs and traditional medicine, intensify planning, cultivation, and processing of medicinal herbs, and build the industry of formulating drugs from medicinal herbs and traditional medicine into an important part of the Vietnamese pharmaceutical industry; ensure that drugs derived from medicinal herbs and traditional medicine account for 30% of domestically produced drugs by 2015 and 40% by 2020.

2. Regarding the construction of a model for the drug supply system

Establish and develop a distribution and supply system for drugs from central to local levels to proactively regulate and stabilize the drug market, better serve health care and protection for the people, ensuring that everyone with a need can access quality drugs at reasonable prices.

B. MAIN TASKS OF THE PROJECT

I. DEVELOPMENT OF THE VIETNAMESE PHARMACEUTICAL INDUSTRY

1. Development of the drug formulation industry

a) Reorganize the domestic drug manufacturing facilities according to specialization based on drug usage needs, Vietnamese disease models, management capabilities, production capacities, and technological levels of enterprises;

b) By the end of 2010, all enterprises operating in the drug production and distribution sectors must meet the Good Practice Standards (GPs) of the World Health Organization; by 2015, join the Pharmaceutical Inspection Co-operation Scheme (PIC/S);

c) Develop the production of generic drugs to ensure quality to meet treatment needs, especially in public healthcare facilities; focus on joint ventures and collaborations in producing generic drugs; promote the application of advanced biotechnology achievements, including genetic technology, in drug production;

d) Promote and encourage the production of drugs listed under essential medicines and those serving national health programs, and produce according to government orders to ensure that by 2020, approximately 90% of the usage needs for these types of drugs are met;

đ) Invest in researching and producing special formulations of drugs, specialized therapeutic drugs, high-tech drugs; research and produce new drugs; focus on applying scientific and technological research results in the pharmaceutical field to large-scale drug production.

2. Development of the chemical drug industry

a) Invest in scientific and technological research to produce drug raw materials to meet domestic drug production needs consistent with Vietnamese disease models, particularly focusing on:

- Implementing the National Key Scientific and Technological Research Program to develop the chemical drug industry until 2020, concentrating on basic research, applied research, research and development, and experimental production to provide raw materials for the Vietnamese pharmaceutical industry, especially antibiotics raw materials;

- Scientific and technological research to produce some raw materials for preventing and treating common diseases in Vietnam.

b) Develop the chemical drug industry, focusing on investing in building and developing some factories producing drug raw materials:

- From now until 2015, invest in building some factories producing inorganic chemical drug raw materials; ordinary and high-grade excipient factories to meet about 80% of the demand for excipients for drug production; antibiotic raw material factories to meet about 40% of the demand for domestic antibiotic raw materials; some factories extracting, synthesizing, and semi-synthesizing active ingredients from natural sources to be used as drug raw materials;

- From 2015 to 2020: focus on enhancing production capacity, expanding the capacity of existing chemical drug raw material factories. Invest in building additional new factories producing new-generation antibiotic raw materials to meet about 60% of domestic raw material needs, anti-cancer, hormone, cardiovascular, diabetes, antipyretic analgesic, and vitamin raw materials; build additional factories producing inorganic and ordinary excipients, herbal extraction and semi-synthesis factories, and high-grade excipient factories.

3. Development of the industry of processing and producing drugs from medicinal herbs

3. Development of the pharmaceutical industry for processing and manufacturing drugs from medicinal herbs

a) Focus on researching and modernizing technology for processing and manufacturing drugs derived from medicinal materials;

b) Plan, construct regions for growing and processing medicinal materials, such that by 2015, key regions must meet the Good Agricultural and Collection Practices (GACP) standards of the World Health Organization (WHO) to ensure sufficient raw materials for drug production. By 2020, industrial regions for growing medicinal materials will be established to guarantee adequate supply of raw materials for domestic processing facilities and for export;

c) Rationally exploit natural medicinal materials, ensuring conservation, regeneration, and development of medicinal plant genetic resources according to the Good Agricultural and Collection Practices (GACP) standards of the World Health Organization (WHO);

d) Vigorously produce drugs derived from medicinal materials to serve medical examination and treatment activities. By the end of 2010, all drug production facilities using medicinal materials as sources must meet the Good Manufacturing Practice (GMP) principles and standards of the World Health Organization (WHO);

đ) Increase investment in developing facilities for extracting pure active ingredients from medicinal materials to serve domestic drug production and export. Establish some facilities for extracting pure active ingredients from medicinal materials to ensure meeting approximately 20% of the demand for active ingredients used in drug production by 2015 and about 30% by 2020;

4. Encourage organizations and individuals to invest in activities including: production, research, transfer, reception, and application of advanced technologies and techniques in production, marketing, and promotion of brand names for chemical raw materials, medicinal materials, finished drugs, and other activities aimed at promoting the development of the domestic chemical pharmaceutical industry and drug formulation industry;

5. Promote research and application of modern biotechnology, including gene technology, in the industries of producing raw materials and drug formulation;

6. Plan and organize domestic pharmaceutical packaging production so that by 2015, 90% of needs are met, and by 2020, basic needs are satisfied;

7. Vigorously apply high technology and information technology in activities related to the development of the Vietnamese pharmaceutical industry;

8. Strengthen international cooperation in the pharmaceutical industry; promote the reception, transfer, application, and effective exploitation of new and advanced production lines and technologies from foreign countries in the pharmaceutical industry;

II. COMPLETE AND DEVELOP THE SYSTEM OF DRUG SUPPLY IN VIETNAM;

1. Organize and arrange the system of circulation, distribution, and supply of drugs from central to local levels;

a) Reorganize and transform Vietnam Pharmaceutical Corporation into a holding company - subsidiary model; by the end of 2008, complete the basic restructuring plan and operate effectively within the production and circulation distribution system, while fulfilling the public service mission of supplying quality drugs at reasonable prices to remote, mountainous, and island areas in accordance with state regulations;

After 2010, based on the organizational structure and resources of the holding company - subsidiary model, pilot the establishment of Vietnam Pharmaceutical Investment and Trading Group when conditions are met;

b) Attract and encourage economic entities of all forms that meet legal requirements to participate effectively in the drug supply network and fulfill public service missions in accordance with state regulations, particularly focusing on retail systems in remote, mountainous, and island areas;

c) Re-plan the national distribution network through the application of Good Supply Practice (GSP), Good Distribution Practice (GDP), and Good Pharmacy Practice (GPP) principles and standards; strictly manage the business and distribution activities of wholesale and retail systems in accordance with state regulations; by the end of 2010, all enterprises operating in the drug circulation, distribution, and supply sectors must meet the GSP, GDP, and GPP standards of the World Health Organization;

d) Study and develop joint venture and collaboration models to establish retail distribution systems that meet Good Pharmacy Practice (GPP) standards;

đ) Reorganize and arrange the drug distribution and supply system in conjunction with improving management mechanisms to ensure timely supply of quality drugs at reasonable prices to meet the medical examination and treatment needs of the people;

2. Vigorously apply scientific management, advanced technologies, and techniques in building and developing the drug circulation, distribution, and supply system in Vietnam;

C. IMPLEMENTATION MEASURES;

1. Develop and perfect the legal framework for drug production and circulation distribution activities in each phase;

a) Conduct reviews, amendments, supplements, and promulgation of legal documents related to drug production, supply, and market management; build and submit detailed regulations and guidance for implementing the Drug Law to competent authorities for approval;

b) Build and submit support mechanisms and policies to encourage investors, research institutes, universities, scientists, and organizations and individuals to participate in activities to develop the chemical pharmaceutical industry and drug formulation industry; encourage participation in drug supply to remote, mountainous, and island areas;

c) Develop plans for producing drugs listed in essential drug lists, drugs serving national health programs, and drugs produced according to government orders;

2. Increase investment and diversify capital sources to accelerate the development of the chemical pharmaceutical industry and drug formulation industry;

a) The State focuses investment in scientific research, particularly emphasizing investment in:

- Building laboratories for scientific research in the pharmaceutical field, including research under the National Key Science and Technology Program for Developing the Chemical Pharmaceutical Industry until 2020, and research supporting the production of drug raw materials;

- Support the transfer of technology for the production of various types of raw materials for drugs and high-tech drug formulations through various forms such as purchasing invention patents, inventions, joint ventures...;

- Train and enhance the professional capacity of staff involved in scientific and technological research in the pharmaceutical field.

b) Mobilize investment capital to implement projects for constructing factories producing chemical raw materials, raw materials derived from medicinal herbs and natural active substances, essential medicines, medicines serving national health programs, and drug supply activities as prescribed by law.

3. Apply scientific and technological research achievements, strengthen the transfer of new and modern production technologies.

a) Review and evaluate scientific and technological topics, encourage the application, transfer, reception, and utilization of new technology and technical progress in production between enterprises and domestic scientists, and purchase foreign technology;

b) Establish and implement preferential mechanisms and policies for the transfer of technology for products from laboratory research that are applied in practical production.

4. Train, nurture, and develop human resources for the pharmaceutical industry, expand international cooperation in specialized training on management and pharmaceutical economic technology.

5. Organize the implementation of market forecasting for the Vietnamese pharmaceutical industry through the establishment of indices regarding total supply and demand as a basis for predicting drug usage needs and supply capabilities of distribution channels up to 2010, 2015, and with a vision to 2020.

6. Strengthen bilateral and multilateral international cooperation, actively seek investment, take advantage of cooperation and assistance from foreign organizations and individuals, especially those from countries with advanced and modern pharmaceutical industries, in the fields of scientific and technological research and drug production.

D. IMPLEMENTATION PLAN

Based on actual conditions, the Ministry of Health and the Ministry of Industry will develop specific plans, Programs, and Projects consistent with the content of this Program to implement in three phases as follows:

1. Phase from 2007 to 2010

a) Develop the Detailed Plan for the Development of the Pharmaceutical Industry, the Plan and Program for Developing the National Drug Circulation and Supply System, submit to the Prime Minister for approval and implementation;

b) Implement the National Key Scientific and Technological Research Program for the Development of Chemical Pharmaceutical Industry until 2020 (Phase I);

c) Establish and perfect the state management system for drug production and supply under the holding company-subcompany model. Implement the Program to transform the Vietnam Pharmaceutical Corporation into a holding company-subcompany model; recruit additional members to participate in effective operations under the holding company-subcompany model;

d) Invest in human and material resources for the drug circulation and supply network, particularly focusing on remote, mountainous, and island areas;

đ) Develop and submit to competent authorities for approval specific projects on building new or upgrading pharmaceutical production plants;

2. Phase from 2011 to 2015

a) Continue to review, amend, supplement, and build new systems of regulatory documents on the development of the pharmaceutical industry and drug supply to meet state management requirements, suitable for the country's socio-economic development conditions and international integration during this period;

b) Continue implementing the National Key Scientific and Technological Research Program for the Development of Chemical Pharmaceutical Industry until 2020 (Phase II);

c) On the basis of applying the results of the National Key Scientific and Technological Research Program for the Development of Chemical Pharmaceutical Industry until 2020, invest in building several antibiotic raw material production plants to meet about 40% of domestic antibiotic needs, inorganic chemical raw materials, common excipients, and high-grade excipients to meet about 80% of excipient needs for drug production; several plants for extracting and semi-synthesizing natural active substances for drug raw material production;

d) Implement projects to build new or upgrade some specialized production plants for high-tech drug formulations and drugs currently not produced in Vietnam such as cancer treatments, hormone therapies, cardiovascular drugs, anti-rejection drugs...;

đ) On the basis of the organizational structure and resources of the holding company-subcompany, establish the Vietnam Pharmaceutical Investment and Trading Group.

3. Vision to 2020

a) Finalize the National Key Scientific and Technological Research Program for the Development of Chemical Pharmaceutical Industry until 2020; apply research results to the industrial production of drug raw materials. Expand production scale and increase capacity for domestic drug raw material production plants to meet 80% of the value of domestically produced drugs by 2020, specifically as follows:

- Invest in building new antibiotic raw material production plants to meet about 60% of domestic antibiotic raw material needs;

- Build plants for producing raw materials for anti-cancer drugs, endocrine diseases, cardiovascular diseases, diabetes, antipyretic analgesics, vitamins, and additional plants for producing inorganic chemical raw materials, common excipients, high-grade excipients, herbal extraction plants, synthesis and semi-synthesis.

b) Continuously consolidate and strongly and sustainably develop the competitive capacity of the Vietnam Pharmaceutical Investment and Trading Group, ensuring regular, timely, and sufficient supply of quality drugs at reasonable prices to serve the protection, care, and improvement of people's health.

Article 2. Implementation

1. The Ministry of Health

a) Take the lead, coordinate with the Ministry of Industry, relevant ministries, sectors, and provincial and municipal people's committees to develop detailed planning and implementation plans for the contents of the Program effectively and on schedule.

b) Chair and coordinate with relevant ministries and sectors to study, develop, and submit for approval by competent authorities or issue within their authority mechanisms and policies aimed at socializing the development of the pharmaceutical industry and regulations on the business of medicinal drugs to ensure strict management in accordance with state regulations while fully utilizing the participation of the entire society;

c) Coordinate with the Ministry of Industry to effectively implement and apply the results of the National Key Scientific and Technological Research Program for the Development of Pharmaceutical Industrialization until 2020;

2. The Ministry of Industry

a) Chair and coordinate with the Ministry of Health to implement the National Key Scientific and Technological Research Program for the Development of Pharmaceutical Industrialization until 2020 to serve the production of raw materials for medicines suitable for Vietnam's disease model;

b) Coordinate with the Ministry of Health to build specific projects to implement planning and plans for the development of the pharmaceutical industry and chemical drug production according to contents approved by the Prime Minister, submit to competent authorities, and implement;

3. Ministry of Finance

Coordinate with the Ministry of Health and the Ministry of Industry to prepare budgets and allocate funds to ensure timely implementation of the contents of the Project; build, issue, or submit for approval by competent authorities mechanisms and policies on finance to create a favorable environment to promote the process of socializing the development of the pharmaceutical industry;

4. The Ministry of Planning and Investment

Chair and coordinate with the Ministry of Health and the Ministry of Industry to review budget estimates for investment in research and production facilities, national testing centers under the investment plan of the state budget annually reported to the Government for submission to the National Assembly in accordance with the State Budget Law; build, issue, or submit for approval by competent authorities mechanisms and policies to mobilize resources for the development of the pharmaceutical industry;

5. The Ministry of Agriculture and Rural Development

Coordinate with the Ministry of Health to develop plans for the development of key medicinal plant cultivation areas;

6. Provincial People's Committees and Municipal People's Committees under the Central Government

a) Invest capital, material infrastructure, technology, implement preferential policies, and reinvestment for local pharmaceutical production and trading enterprises to ensure adequate, timely supply of quality medicines at reasonable prices for the public health system and community in the locality;

Based on state legal normative documents, review, amend, supplement, and issue detailed guidance documents within their authority on the development of the pharmaceutical industry, improve and develop the local pharmaceutical supply network in accordance with legal provisions and actual conditions of the locality;

Article 3. This Decision takes effect fifteen days from the date of publication in the Official Gazette.

Article 4. THE MINISTERS, HEADS OF GOVERNMENT-LEVEL MINISTRIES, HEADS OF GOVERNMENT-LEVEL AGENCIES, AND CHAIRMEN OF PROVINCE AND CITY PEOPLE'S COMMITTEES DIRECTLY UNDER THE CENTRAL GOVERNMENT SHALL BE RESPONSIBLE FOR ENFORCING THIS DECISION./.