Laws of Vietnam

THE PRIME MINISTER

DECIDES:

Article 1.- To approve the Scheme on developing Vietnam's pharmaceutical industry and building a model drug supply system in the 2007- 2015 period, with a vision towards 2020, with the following principal contents:

I. General objectives

To develop Vietnam's pharmaceutical industry into a spearhead techno-economic one along the line of industrialization and modernization; to improve the domestic drug manufacturing capacity and consolidate the drug supply system in order to ensure the constant, timely and sufficient supply at reasonable prices of high-quality drugs as well as the safe and effective use of drugs for the protection of, care for and improvement of, the people's health, meeting the requirements of regional and international integration.

II. Specific objectives

1. On the development of Vietnam's pharmaceutical industry

a/ To build and develop a system of drug plants in the country, striving to basically meet the demand for preventive and curative drugs; to ensure that home-made drugs will account for 70% and 80% of the total value of drugs by 2015 and 2020, respectively, and satisfy 90% of the demand for essential drugs and drugs used for national health programs;

b/ To improve the capacity for scientific research, including basic research, applied research, development research and trial production of drug raw materials to serve the development of the pharmaco-chemical industry and meet the raw material demands of domestic production;

c/ To build and develop pharmaco-chemical plants in order to produce and supply raw materials for the drug-manufacturing industry; to satisfy 20% and 50% of drug raw material demands by 2015 and 2020, respectively;

d/ To bring into full play Vietnam's potential and strengths in materia medica and traditional medicaments, boosting the planning, culture, planting and processing of materia medica and developing the manufacture of drugs from materia medica and traditional medicaments as an important part of the country's pharmaceutical industry; to ensure that drugs manufactured from materia medica and traditional medicaments will account for 30% and 40% of home-made drugs by 2015 and 2020, respectively.

2. On the building of a model drug supply system

To build and develop a system of drug circulation, distribution and supply from the central to grassroots level in order to proactively regulate and stabilize the drug market, well serving the protection of and care for people's health, and ensuring that everyone will have access to reasonably priced high-quality drugs.

I. Developing Vietnam's pharmaceutical industry

1. Developing the drug-manufacturing industry

a/ To rearrange and reorganize the system of drug-manufacturing establishments in the country toward specialization on the basis of drug demands and disease patterns of Vietnamese people as well as these establishments' management capacity, manufacture capacity and technical levels.

b/ By the end of 2010, all enterprises engaged in the manufacture, circulation and distribution of pharmaceutical products shall reach the Good Practice (GPs) standards of the World Health Organization (WHO); and by 2015, they shall participate in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S);

c/ To develop the manufacture of high-quality generic drugs to meet treatment requirements, especially in public medical establishments; to attach importance to the establishment of joint ventures and affiliates for the manufacture of generic drugs; to accelerate the application of modern biotechnologies, including genetic technology, to the manufacture of pharmaceuticals.

d/ To boost and encourage the manufacture of essential drugs and drugs used for national health programs as well as the manufacture of drugs under the State's orders so that by 2020, domestic manufacture will satisfy about 90% of the demand for these drugs.

e/ To invest in the research and manufacture of drugs in special preparation forms, special drugs and drugs with hi-tech requirements; to research into and manufacture new drugs; to attach importance to the application of scientific and technological research results in the pharmaceutical domain to large-scale manufacture of drugs.

2. Developing the pharmaco-chemical industry

a/ To invest in scientific and technological research for the production of drug raw materials in order to meet the demand of domestic drug manufacture in conformity with Vietnam's disease patterns, paying special attention to:

- The national key program on scientific and technological research for development of the pharmaco-chemical industry till 2020, focusing on basic research, applied research, development research and trial production in order to supply drug raw materials and auxiliary materials, especially antibiotic raw materials, for Vietnam's pharmaceutical industry.

- Scientific and technological research for the production of a number of raw materials of drugs used for epidemic prevention and control and treatment of some common diseases in Vietnam.

b/ To develop the pharmaco-chemical industry, concentrating efforts on the building and development of some drug raw materials plants:

- In the period from now to 2015, to invest in the building of plants to produce inorganic pharmaco-chemical raw materials; ordinary excipients and high-class excipients, aiming to satisfy 80% of excipient demands of drug manufacturers; antibiotic raw materials plants to meet about 40% of raw material demands of antibiotic manufacturers and in the building of some plants that extract natural active ingredients for the production of synthetic and semi-synthetic drug raw materials.

- In the 2015-2020 period: To concentrate on raising the production capacity and expanding the output of pharmaco-chemical raw materials plants already built. To invest in the building of several new-generation antibiotic raw materials plants, satisfying about 60% of the domestic demands for raw materials for the manufacture of anti-cancer, endocrinic, cardio-vascular, anti-diabetic, antithermic and analgesic drugs and vitamins, to build more inorganic excipient and ordinary excipient plants, medica materia-extracting and -semi-synthesizing plants and high-class excipient plants.

3. Developing the industry of processing and manufacturing drugs from materia medica

a/ To focus on the research and modernization of technologies for the processing and manufacture of drugs from materia medica;

b/ To plan and build areas for materia medica culture, planting and processing; by 2015, key areas shall reach the WHO's Good Agricultural Collection Practice (GACP) standards. By 2020, to develop specialized industrial areas for materia medica culture and planting, ensuring sufficient raw materials for domestic materia medica processing and export;

c/ To rationally exploit natural materia medica, ensure the conservation, regeneration and development of gene sources of materia medica under the WHO's GACP standards;

d/ To intensify the manufacture of drugs from materia medica for medical examination and treatment. By the end of 2010, all establishments manufacturing drugs from materia medica shall apply the WHO's Good Manufacturing Practice (GMP-WHO) principles and standards;

e/ To increase investment in the development of establishments extracting pure active ingredients from materia medica for domestic drug manufacture and export. To build a number of establishments extracting pure active ingredients from materia medica in order to satisfy about 20% of the demands for active substances for drug manufacture by 2015 and 30% by 2020.

4. Encouraging organizations and individuals to invest in production and research activities, transfer, receipt and application of advanced technologies and techniques to production, marketing and promotion of pharmaco-chemical raw materials, materia medica and finished drugs, and other activities in order to boost the development of the domestic pharmaco-chemical industry and drug-manufacturing industry.

5. Accelerating the research and application of modern biotechnologies, including genetic technologies, to the manufacture of raw materials and drugs.

6. Planning and organizing the domestic production of pharmaceutical product packings so that 90% and 100% of domestic demand for drug packings will be met by 2015 and 2020 respectively.

7. Accelerating the application of high technologies and information technology in various activities for the development of Vietnam's pharmaceutical industry.

8. Enhancing international cooperation in the pharmaceutical industry; accelerating the acquisition, transfer, application and efficient utilization of foreign new and modern production chains and technologies in the pharmaceutical industry.

II. Consolidation and development of Vietnam's drug supply systems

1. Reorganizing and rearranging the drug distribution and supply systems from the central to grassroots level

a/ To reorganize and rearrange the Vietnam Pharmaceutical Corporation after to the parent company-subsidiary company model; by the end of 2008, to basically fulfill the plan on reorganizing the systems of drug manufacture and distribution to ensure their effective operation and the performance of the public task of supplying reasonably priced high-quality drugs to remote, deep-lying and mountainous areas and islands under state regulations. After 2010, on the basis of the organizational structure and resources of the parent company-subsidiary company model, to set up on a trial basis the Vietnam Pharmaceuticals Trading and Investment Group when conditions permit;

b/ To attract and encourage organizations and individuals of all economic sectors that fully satisfy conditions prescribed by law to effectively participate in the drug supply network and perform public tasks in strict accordance with state regulations, paying special attention to retail systems in remote, deep-lying and mountainous areas and islands;

c/ To re-plan domestic wholesale and retail networks in accordance with the principles and standards of the Good Storage Practice, Good Distribution Practice and Good Pharmacy Practice (GSP, GDP, GPP); to strictly manage trading and distribution activities of wholesale and retail systems in accordance with state regulations; by the end of 2010, all enterprises engaged in drug circulation, distribution and supply shall reach the WHO's GSP, GDP and GPP standards;

d/ To study and develop the forms of joint venture and cooperation for building retail distribution systems up to the GPP standards;

e/ To reorganize and rearrange drug distribution and supply systems together with perfecting management mechanisms in order to ensure the sufficient and prompt supply of reasonably priced high-quality drugs for the people's needs for medical examination and treatment.

2. Accelerating the application of management sciences and advanced technologies and techniques to building and developing Vietnam's drug circulation, distribution and supply systems.

1. Building and perfecting the system of legal documents on the development of drug manufacture, circulation and distribution in each period.

a/ To review, amend, supplement existing legal documents and promulgate new ones on drug manufacture and supply as well as drug market management; to elaborate, and propose competent authorities to promulgate, documents detailing and guiding the implementation of the Pharmacy Law;

b/ To elaborate and propose competent authorities to promulgate mechanisms and policies to assist and encourage investors, research institutes and centers, universities, scientists, organizations and individuals to participate in the development of the pharmaco-chemical industry and drug-manufacturing industry; to encourage organizations and individuals to participate in supplying drugs to remote, deep-lying and mountainous areas and islands;

c/ To elaborate a plan on the manufacture of essential drugs and drugs used for national health programs and the manufacture of drugs under the State's orders.

2. Increasing investment and diversifying capital sources for accelerating the development of the pharmaco-chemical industry and drug-manufacturing industry

a/ The State concentrates investment in scientific researches, attaching special importance to:

- Building laboratories for scientific researches in the pharmaceutical domain, covering researches under the national key program on scientific and technological research for the development of the pharmaco-chemical industry up to 2020, and researches in service of the production of drug raw materials;

- Supporting the transfer of technologies for the production of drug raw materials and the manufacture of drugs with hi-tech preparation requirements in such forms as licensing of patents, cooperation, joint-venture, etc.;

- Training scientific and technological researchers in the pharmaceutical domain in order to raise their professional capacity and qualifications.

b/ To mobilize capital sources for the implementation of investment projects on building plants to produce pharmaco-chemical raw materials, raw materials from materia medica and natural active ingredients and plants to manufacture essential drugs and drugs used for national health programs and other drugs in accordance with law.

3. Applying scientific and technological research achievements and enhancing the transfer of new and modern manufacturing technologies

a/ To review and evaluate scientific and technological schemes, encourage the transfer of new technologies and techniques between domestic scientists and enterprises for application to manufacture, and the purchase of foreign technologies;

b/ To elaborate and implement preferential mechanisms and policies for technology transfer in the form of application of laboratory research findings to production;

4. Training, re-training and developing human resources for the pharmaceutical industry, expanding international cooperation on specialized training in pharmaceutical administration and economics

5. Providing reliable forecasts on Vietnam's pharmaceutical market through developing indicators on total demand and total supply as a basis for making forecasts on drug demand and the drug supply capacity of distribution channels in the period up to 2010 and 2015 with a vision towards 2020.

6. Enhancing bilateral and multi-lateral international cooperation, actively calling for investment, making use the experience of foreign organizations and individuals, especially those from countries with an advanced pharmaceutical industry in the domains of scientific and technological research and drug manufacture.

On the basis of the practical situation, the Ministry of Health and the Ministry of Industry shall elaborate specific plans, schemes and projects in conformity with the contents of this scheme to be implemented through three phases as follows:

1. The period from 2007 till the end of 2010

a/ To elaborate a detailed planning on the development of the pharmaco-chemical industry and a plan on the development of the drug circulation, distribution and supply network nationwide and submit them to the Prime Minister for approval before implementation;

b/ To implement the national key program on scientific and technological research for the development of the pharmaco-chemical industry up to 2020 (phase I);

c/ To elaborate and perfect institutions for state management of drug manufacture and supply after the parent company-subsidiary company model. To organize the implementation of the Scheme on transforming the Vietnam Pharmaceutical Corporation after the parent company-subsidiary company model with the admission of new members to ensure their efficient affiliated activities under this model;

d/ To invest capital and human resources in the network of drug circulation, distribution and supply, paying special attention to remote, deep-lying and mountainous areas and islands;

e/ To formulate and submit to competent authorities for approval specific investment projects on building or upgrading plants that produce pharmaceuticals and raw materials for the manufacture of pharmaceuticals.

2. The 2011-2015 period

a/ To continue reviewing, amending and perfecting the system of legal documents on development of the pharmaceutical industry and drug supply systems in accordance with the state management requirements, the national socio-economic development and international integration conditions in this period;

b/ To continue implementing the national key program on scientific and technological research for development of the pharmaco-chemical industry up to 2020 (phase II);

c/ On the basis of applying research results of the national key program on scientific and technological research for development of the pharmaco-chemical industry up to 2020, to invest in building a number of plants to produce drug raw materials, including antibiotic raw materials, inorganic pharmaco-chemical raw materials, ordinary excipients and high-class excipients, in order to satisfy about 40% of the domestic demand for antibiotics and 80% of the demand for excipients for domestic manufacture; and a number of plants extracting natural active ingredients for the production of synthetic and semi-synthetic drug raw materials;

d/ To execute projects on building or upgrading plants to manufacture drugs with hi-tech preparation requirements and drugs which cannot be manufactured in Vietnam such as anti-cancer, endocrinic, cardio-vascular and anti-rejection drugs;

e/ On the basis of the organizational structure and resources of the parent company and subsidiary companies, to set up the Vietnam Pharmaceutical Trading and Investment Group.

3. Vision towards 2020

a/ To take over the national key program on scientific and technological research for the development of the pharmaco-chemical industry up to 2020; to apply its research results to the production of drug raw materials. To expand the production scope and increase the output of drug raw materials plants so that by 2020, home-made drugs will account for 80% of the total value of drugs, specifically as follows:

- Investing in the construction of new-generation antibiotic raw materials plants to meet about 60% of the demands for raw materials for the domestic manufacture of antibiotic;

- Building plants to produce raw materials for anti-cancer, endocrinic, cardio-vascular, anti-diabetic, antithermic and analgesic drugs and vitamins, and some more plants to produce inorganic pharmaco-chemical materials, ordinary and high-class excipients and plants to extract pharmaceutical materials or the production of synthetic and semi-synthetic drugs.

b/ To continue consolidating and strongly and sustainably developing the competitiveness of the Vietnam Pharmaceutical Trading and Investment Corporation in order to ensure a ready supply of reasonably priced high-quality drugs the protection, care and improvement of people's health.

Article 2.- Organization of implementation

1. The Ministry of Health

a/ To assume the prime responsibility for, and coordinate with the Ministry of Industry, concerned ministries, branches and provincial/municipal People’s Committees in, elaborating detailed plannings and plans and implementing this Scheme effectively as scheduled;

b/ To assume the prime responsibility for, and coordinate with concerned ministries and branches in, studying, elaborating and submitting to competent authorities for promulgation or promulgating according to its competence mechanisms and policies on socialization of the development of the pharmaceutical industry and regulations on trading in curative drugs in order to ensure strict administration according to state regulations and, at the same time, promote social participation;

c/ To coordinate with the Ministry of Industry in effectively applying the research results of the national key program on scientific and technological research for development of the pharmaco-chemical industry up to 2020.

2. The Ministry of Industry

a/ To assume the prime responsibility for, and coordinate with the Ministry of Health in, implementing the national key program on scientific and technological research for development of the pharmaco-chemical industry up to 2020 in service of the manufacture of drug raw materials in conformity with disease patterns in Vietnam;

b/ To coordinate with the Ministry of Health in formulating specific projects for implementing the plannings and plans on the development of the pharmaceutical and pharmaco-chemical industries according to the contents approved by the Prime Minister, submitting these plannings and plans to competent authorities for approval and organizing implementation thereof.

3. The Ministry of Finance

To coordinate with the Ministry of Health and the Ministry of Industry in estimating and allocating funds in order to ensure the timely implementation of the contents of the Scheme; to elaborate, promulgate or propose competent authorities to promulgate financial mechanisms and policies to create a favorable environment for socialization of pharmaceutical industry.

4. The Ministry of Planning and Investment

To assume the prime responsibility for, and coordinate with the Ministry of Health and the Ministry of Industry in, appraising the estimated funds for investment in the construction of drug research and manufacture establishments and national laboratories eligible for state budget investment, and incorporating them in the annual state budget estimates to be reported to the Government for submission to the National Assembly in strict accordance with the Law on State Budget; to elaborate, promulgate, or propose competent authorities to promulgate, mechanisms and policies to mobilize sources for investment in the pharmaceutical industry.

5. The Ministry of Agriculture and Rural Development

To coordinate with the Ministry of Health in making plannings on the development of key areas specialized in materia medica culture and planting.

6. Provincial/municipal People's Committees

a/ To invest capital and techno-material foundations in, and apply preferential treatment and re-investment policies to, local drug manufacture and trading enterprises, fulfill the target of adequately and promptly supplying reasonable priced high-quality drugs for the public healthcare system and local communities;

b/ On the basis of the State's legal documents, to review, amend, supplement and promulgate according to their competence documents providing detailed guidance on the development of the pharmaceutical industry as well as the consolidation and development of local drug supply systems in conformity with law and local conditions.

Article 3.- This Decision takes effect 15 days after its publication in "CONG BAO."

Article 4.- Ministers, heads of ministerial-level agencies and Government-attached agencies, presidents of provincial/municipal People's Committees shall implement this Decision.