Decision No. 108/2002/QĐ-TTg On approving the strategy for the development of the pharmaceutical industry until 2010

DECISION OF THE PRIME MINISTER

Regarding the approval of

Strategy for the Development of the Pharmaceutical Industry to 2010

_________________________

PRIME MINISTER 

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

Pursuant to the Public Health Law dated July 30, 1989;

At the request of the Minister of Health in the report No. 3880/TTr-BYT dated May 17, 2002,

DECISION:

Article 1.Approves the "Strategy for the Development of the Pharmaceutical Industry to 2010" with the following main contents:

1. General objectives:

Develop the pharmaceutical industry into a leading economic-technical sector towards industrialization-modernization, actively integrating regionally and globally to ensure a steady supply of quality medicines, ensuring rational and safe drug use, serving the health care and protection of the people's health.

2. Specific objectives By 2010:

a) Invest in modern technology, update equipment and management systems so that the pharmaceutical industry gradually meets raw material needs. By the end of 2010, all production, trading, research, and testing facilities for pharmaceuticals will meet Good Practice (GP) standards.

b) Build industrial bases for antibiotic and chemical drug production, producing raw materials for drugs with strengths, especially from medicinal herbs.

c) Ensure a steady supply of quality medicines without shortages of essential drugs, drugs for national health programs (malaria prevention, tuberculosis prevention, goiter prevention, etc.). Pay special attention to ensuring adequate drug supply services for people in difficult areas.

d) Ensure rational, safe, and effective drug use.

đ) Ensure domestic production of 60% of the society's demand for disease-prevention and treatment drugs; average drug consumption reaches 12-15 USD/person/year; have 1.5 pharmacists with advanced degrees per 10,000 people.

3. Main solutions and policies:

a) Solutions on planning, technological innovation, and scientific research:

Plan the pharmaceutical industry towards industrialization-modernization and international integration. Enhance drug production capacity in scale and quality, invest in high-tech production lines to leapfrog development. Plan and modernize the drug distribution system including import-export, wholesale, and retail. Develop retail networks, focusing on remote, mountainous, and island regions.

Prioritize investment in chemical production facilities and raw material sources. Focus on producing essential drugs, export-oriented drugs, drugs from medicinal herbs, and generic drugs replacing imported ones; research and produce various formulations for children and the elderly. Emphasize investment in developing medicinal herbs.

Develop scientific research on drug formulation technology, biotechnology, medicinal herbs, and drug analysis to serve the production of new drugs. Vigorously apply information technology to management, production control, drug supply, and usage...

Closely integrate human resources and equipment in the pharmaceutical industry with those of other ministries, research institutes, and scientific centers to conduct drug and raw material research, linking research processes with the practical production of pharmaceutical enterprises.

b) Solutions on organization and human resource development:

Strengthen and enhance the state management system for pharmaceuticals: Improve the Vietnam National Pharmaceutical Administration; reorganize and strengthen specialized pharmaceutical inspection; complete the organizational structure of pharmaceutical management departments at provincial health bureaus; plan the pharmaceutical production system.

Emphasize pharmaceutical human resource training: Increase training and retraining of various types of pharmaceutical staff. Develop postgraduate education. Identify and nurture talents, train high-level research personnel. Establish new pharmacy departments at medical universities to train pharmacists for difficult areas.

Train and rationally utilize pharmaceutical human resources, implement dispatch and targeted training to address imbalances in pharmaceutical personnel between regions, particularly ensuring sufficient pharmaceutical staff for mountainous, remote, and rural areas.

c) Solutions on drug quality monitoring:

Modernize the drug quality assurance system.

Reorganize the state drug quality inspection system. Enhance the capacity of drug testing laboratories to test circulating pharmaceutical products.

Create conditions and encourage the establishment of modern external drug testing service facilities outside the state system.

d) Solutions on policy and mechanism building:

Complete the legal system for pharmaceutical management. Draft the Pharmaceutical Law. Amend, supplement, and promulgate new regulatory documents on pharmaceuticals, regulations, technical norms, and standards. Standardize pharmaceutical management, production, and supply activities, moving towards international standards.

Develop preferential policies for businesses investing in research and development, technological innovation, raw material production, and export product manufacturing.

Develop policies to encourage foreign investment in the pharmaceutical industry, prioritizing projects for raw material production, especially those using high-tech and biotechnology. Implement appropriate policies for foreign investment in the drug distribution sector.

Diversify pharmaceutical business models, accelerate the process of shareholding. Encourage businesses to enhance research capabilities to create new products.

Strengthen cooperation with countries in the region and worldwide, with the World Health Organization and other international organizations. Implement an appropriate economic integration roadmap consistent with bilateral and multilateral commitments, gradually harmonizing pharmaceutical regulations with regional and global standards.

Direct and promote rational, safe, and effective drug use as a key and ongoing task of the healthcare sector. Limit and gradually reduce the misuse of drugs, particularly antibiotics, corticosteroids, vitamins, and brand-name drugs. Encourage the use of generic drugs, domestically produced drugs, and traditional medicine.

d) Ensure financial resources:

Maximize and effectively utilize funds from the state budget, bilateral and multilateral cooperation funds from non-governmental organizations, foreign investment, domestic enterprises, and community resources.

The central State budget sources shall be allocated for scientific research needs, human resource training, herbal potential development and raw material pharmaceutical industry development, investment in public enterprises, and enhancing the capacity of State management agencies and testing agencies.

Foreign investment sources shall focus on the pharmaceutical production sector, encouraging investment in modern technology production lines, prioritizing raw material pharmaceutical production.

Investment demands for developing pharmaceutical production and business operations of enterprises shall be mobilized from loan capital, own capital, shareholding...

Based on the implementation plan of the Strategy, the Ministry of Health will prepare a budget estimate to send to the Ministry of Finance, the Ministry of Planning and Investment for review, balance, and inclusion in the annual budget report to the Government for submission to the National Assembly for approval.

e) Implementation period of the Strategy:

From 2002 to 2010, divided into two phases:

Phase 1: from 2002 to 2005

Phase 2: from 2006 to 2010

Based on actual conditions, the Ministry of Health will develop specific plans and targets for each phase, aligning with the contents of this Strategy.

Article 2.The Ministry of Health shall take the lead, coordinate with the Ministry of Planning and Investment, the Ministry of Finance, and relevant ministries and sectors to develop plans, guide inspections, monitor, and compile annual implementation status reports of the Strategy to report to the Prime Minister; organize mid-term reviews of the Strategy in 2005 and final reviews of the Strategy in 2010.

Article 3. This Decision shall take effect fifteen days from the date of signature.

Article 4. Ministers, heads of ministerial-level agencies, heads of government-affiliated agencies, Chairpersons of People's Committees of provinces and centrally governed cities are responsible for implementing this Decision./.