Quyết định 108/2002/QD-TTg

DECISION

APPROVING THE "PHARMACEUTICAL DEVELOPMENT STRATEGY TILL 2010"

THE PRIME MINISTER

Pursuant to the Law on Organization of the Government of December 25, 2001;
Pursuant to the Law on the Protection of People’s Health of July 30, 1989;
At the proposal of the Minister of Health in Report No. 3880/TTr-BYT of May 17, 2002,

DECIDES:

Article 1.- To approve the "Pharmaceutical Development Strategy till 2010" with the following principal contents:

1. Overall objectives:

To develop the pharmaceutical industry into a spearhead econo-technical industry along the industrialization-modernization direction, to take initiative in regional and international integration so as to adequately and regularly supply quality medicines, ensure the rational and safe use of medicines in service of the cause of caring for and protecting the people’s health.

2. Specific objectives till 2010:

a/ To invest in modern technologies, renew equipment and management mode so that the pharmaceutical industry step by step meets the demand for medicine raw material sources. By the end of 2010, all establishments engaged in pharmaceuticals production, trading, research or testing shall reach the Good Practice (GP) standard.

b/ To build industrial establishments for the production of antibiotics and pharmaceutical chemicals, medicine raw materials with competitive edge, especially those from materia medica.

c/ To regularly and adequately supply quality medicines without missing out those on the list of essential medicines and medicines for the national health target programs (medicines for prevention and combat of malaria, tuberculosis, goiter, etc). Special attention shall be paid to fully providing medicine supply services for people in areas meeting with difficulties.

d/ To ensure the rational, safe and efficient use of medicines.

e/ To ensure that home-made preventive and curative medicines meet 60% of the society’s demand therefor; the average medicine spending level reaches USD 12-15/person/year; and that every 10,000 persons shall have 1.5 pharmacists of university degree.

3. Major solutions and policies:

a/ Solutions on plannings, technological renewal and scientific research:

- To plan the pharmaceutical industry along the direction of industrialization, modernization and international integration. To raise the medicine production capacity in scale and quality, to invest hi-tech chains along the direction of taking short cut in order to keep pace with the world level. To elaborate planning on and modernize the medicine distribution system, including import, export, wholesale and retail. To develop the retail network with special attention paid to deep-lying, remote and mountainous areas and islands.

- To focus investment in chemicals- and medicine raw material-manufacturing establishments. To give priority to investment in manufacturing essential medicines, medicines with high competitive egde for export, medicines from materia medica and generic medicines as substitutes for imported medicines; to research into and manufacture assorted medicines prepared for children and the elderly. Special attention shall be given to materia medica development investment.

- To boost scientific research into processing technology and bio-technology, and into materia madica, to analyze and test medicines in service of production of new medicines. To step up the application of information technology to the management of medicine production, supply and use�

- To closely combine human resources and equipment of the pharmaceutical industry with the resources of ministries, branches, research institutes and other scientific research centers in order to conduct research into medicines and medicine raw materials, to link research process to production reality of pharmaceuticals-manufacturing enterprises.

b/ Solutions on human resource organization and development:

- To strengthen and enhance the system of the pharmaceutical State management agencies: to consolidate Vietnam Pharmaceutical Management Department; to re-organize and raise the capability of the specialized pharmaceutical inspectorate; to perfect organization of the pharmaceutical management bureaus under the provincial/municipal Health Services; and to re-elaborate the planning on medicine-manufacturing system.

- To attach importance to training pharmaceutical human resources: to enhance the training and re-training of pharmaceutical workers of all types. To develop post-graduate training. To find and foster talents, train researchers of high qualifications. To set up a number of pharmaceutical faculties in medical universities in order to train pharmacists of university degree for areas meeting with difficulties.

- To train and rationally employ the pharmaceutical human resources, to recruit and train them according to their addresses so as to overcome pharmaceutical human resource imbalance between regions, paying special attention to ensuring adequate pharmaceutical workers for mountainous, deep-lying and remote areas as well as for districts and communes.

c/ Solutions on medicine quality supervision:

- To modernize the medicine quality-securing system.

- To re-organize the system of State inspection of medicine quality. To raise the capability of the medicine-testing laboratories so that they shall be capable of testing medicines circulated on market.

- To create conditions for and encourage the establishment of modern testing service establishments outside the State testing system.

d/ Solutions on mechanism and policy formulation:

- To perfect the legal system on pharmaceutical management. To elaborate the Pharmaceutical Law. To amend, supplement and/or promulgate pharmaceutical legal documents, the system of pharmaceutical regulations, technical norms and standards. To standardize the medicine management, manufacture and supply activities, proceeding to reach the international standards.

- To formulate priority policies for enterprises that make investment in technological development and renewal research, manufacture medicine raw materials, or produce pharmaceutical products for export.

- To formulate policies to promote foreign investment in the pharmaceutical industry with priority given to projects on manufacture of medicine raw materials, especially to projects where hi-technology and bio-technology are applied. To work out appropriate policies on foreign investment in the field of medicine distribution.

- To diversify pharmaceutical business forms and step up the equitization process. To encourage enterprises to raise their research capability in order to turn out new products.

- To enhance cooperation with countries in the region and the world, the World Health Organization and other international organizations. To implement international economic integration schedule in conformity with our country’s commitments in bilateral and multilateral relations, thus step by step harmonizing Vietnam’s pharmaceutical regulations with those of the region and the world.

- To direct and mobilize the rational, safe and efficient use of medicines are the central and regular task of the health service. To limit and step by step repulse the abuse of medicines, especially antibiotics, corticoid, vitamins, special-effect medicines To encourage the use of generic medicines, home-made medicines and traditional medicines.

e/ Financial security:

To mobilize to the utmost and efficiently use the State budget capital sources, bilateral- and multilateral-cooperation capital sources of non-governmental organizations, foreign investment capital, and capital of domestic enterprises and the community.

- The State budget capital sources shall be concentrated on demand for scientific and technological research, training of human resources, development of pharmaceuticals potentials and medicine raw material industry, investment in public-utility enterprises and raising the capability of the State management agencies and testing agencies.

- Foreign investment capital sources shall be concentrated on pharmaceuticals production, to encourage investment in production chains equipped with modern technologies, with priority given to manufacturing medicine raw materials.

- Enterprises investment demand for pharmaceuticals production and business development shall be met by loan capital sources, own capital, equitization, etc.

Basing itself on the Strategy implementation plan, the Ministry of Health shall draft cost estimates and send them to the Ministry of Finance and the Ministry of Planning and Investment for consideration and inclusion into the annual budget, and then report them to the Government for submission to the National Assembly for approval.

f/ Strategy implementation duration:

From 2002 to 2010, divided into two phases:

- Phase 1: From 2002 to 2005

- Phase 2: From 2006 to 2010.

Basing itself on the actual situation, the Ministry of Health shall elaborate specific plans and objectives for each phase in line with this Strategy’s contents.

Article 2.- The Ministry of Health shall assume the prime responsibility and coordinate with the Ministry of Planning and Investment, the Ministry of Finance and the concerned ministries and branches in elaborating plans, guiding inspection, monitoring and summing up the annual situation of implementation of the Strategy in order to report them to the Prime Minister; make preliminary review of the implementation of the Strategy in 2005 and the final review in 2010.

Article 3.- This Decision takes implementation effect 15 days after its signing.

Article 4.- The ministers, the heads of the ministerial-level agencies, the heads of the agencies attached to the Government, and the presidents of the People’s Committees of the provinces and centrally-run cities shall have to implement this Decision.