Decision No. 376/QD-TTg approving the development program for pharmaceuticals industry until 2030

DECISION

Approving the Program on development the pharmaceutical industry and domestically produced medicinal materials to 2030, with a vision to 2045

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THE PRIME MINISTER

Pursuant to the June 19, 2015 Law on Organization of the Government; and the November 22, 2019 Law Amending and Supplementing a Number of Articles of the Law on Organization of the Government and the Law on Organization of Local Administration;

Pursuant to the April 6, 2016 Law on Pharmacy;

Pursuant to the June 17, 2020 Law on Investment;

Pursuant to October 25, 2017 Resolution No. 20-NQ/TW of the Sixth Plenum of the Party Central Committee, the XII^th Term, on intensifying the protection, care and improvement of people's health in the new situation;

Pursuant to the Government's Resolution No. 139/NQ-CP of December 31, 2017, promulgating the Government's Action Program to implement Resolution No. 20-NQ/TW of October 25, 2017, of the 6th Plenum of the Party Central Committee, the XII^th Term, on intensifying the protection, care and improvement of the people's health in the new situation;

At the proposal of the Minister of Health,

DECIDES:

Article 1. To approve the Program on development of the pharmaceutical industry and domestically produced medicinal materials to 2030, with a vision to 2045 (below referred to as the Program) with the following contents:

I. DEVELOPMENT VIEWS

1. To prioritize the development of the pharmaceutical industry and domestic production of drug materials with high-level incentive and support mechanisms and policies in accordance with law.

2. To strongly attract investment resources for the development of the pharmaceutical industry, to attach importance to attracting foreign investment in the production of still patented brand-name drugs, specialty drugs, and generic drugs with high-tech dosage forms, vaccines, reference biological products and similar biological products.

The State shall give priority to investment in scientific research into and production of new drugs and high-quality drugs from medicinal materials, and development of production of national-branded drugs from medicinal materials.

3. To bring into play the advantages of domestic medicinal materials, especially endemic and precious ones of high economic value.

II. OBJECTIVES

1. General objective: To build the domestic pharmaceutical industry to a high level of development, reaching level 4 according to the classification scale of the World Health Organization (WHO), with a market value ranking among the top 3 ASEAN countries, contributing to ensuring adequate and timely supply of quality, safe, effective and affordable drugs.

To develop domestic medicinal materials and products therefrom into high-quality and high-value commodities competitive in the domestic and international markets.

2. Specific goals

a/ By 2025:

- Domestically produced drugs will account for 75% of the used quantity and 60% of the market value, the rate of using medicinal materials of domestic origin and drugs from domestic medicinal materials will increase at least 10% over 2020.

- To build 8 regions for sustainable exploitation of natural medicinal materials. To build 2 - 5 large-scale medicinal plant growing areas, each exploiting area or growing area having 1 - 2 chains of research, growing, processing and production of medicinal materials in compliance with the World Health Organization’s principles and standards of good agricultural and collection practices for medicinal plants (GACP-WHO).

b/ By 2030:

- Domestically produced drugs will account for about 80% of the used quantity and 70% of the market value, the rate of use of medicinal materials of domestic origin and drugs from domestic medicinal materials will increase at least 30% over 2020; to develop 10 - 15 acclimatized medicinal materials to meet domestic demand. To revive, import, acclimatize and develop 10 - 15 varieties of imported medicinal plants of large quantity.

- To transfer technology to produce at least 100 still patented brand-name drugs, vaccines, medical biological products and drugs which cannot be yet produced in Vietnam.

- To become a regional hub for high-value pharmaceutical production. To strive for the export value of domestically produced drugs to reach about USD 1 billion.

c/ By 2045: Vietnam will have brand-name drugs from endemic medicinal materials that have been researched, produced and copyrighted. To strive for the pharmaceutical industry to contribute more than 20 billion USD to GDP.

III. MAJOR TASKS AND SOLUTIONS:

1. Solutions on institutions and laws

a/ Studying and improving current regulations to ensure the provision of incentives and support and special investment incentives for pharmaceutical enterprises, in which:

- To grant enterprises producing brand-name drugs the same incentives as high-tech enterprises; to adopt a roadmap to maintain and reduce prices of brand-name drugs to levels suitable to attract enterprises to transfer technologies producing brand-name drugs in Vietnam; to increase the R&D fund deduction rate for pharmaceutical enterprises investing in research and development of new drugs.

- To regard brand-name drugs, generic drugs with modern dosage forms, and combination vaccines as high-tech products.

- To grant preferential tax, credit and land use policies (land rental price, land lease term) for enterprises and establishments investing in the growing, processing and extraction of medicinal materials, and development of drugs from medicinal materials and traditional drugs.

- To review and supplement the list of high-tech products for products that are drugs with modern dosage forms (lyophilized tablets, controlled release tablets, targeted drugs, lidose hard capsules. ..); vaccines, medical biological products, drug materials of biological origin; drugs from medicinal materials being substances/compounds with standardized effects; domestically produced drugs which do not yet meet requirements on treatment, prices and supply capacity.

b/ Reviewing and improving regulations on bidding and procurement of domestically produced drugs, increasing the percentage and value of domestically produced drugs in the list of drugs covered by health insurance; ensuring incentives for the use of domestic drugs in accordance with law.

- Having a procurement mechanism suitable to domestically produced brand-name drugs, focusing on the application of the price negotiation mechanism based on the level of technology transfer, in accordance with the price reduction roadmap or schedule and values of brand-name drugs produced in Vietnam.

c/ Applying special incentives as prescribed by law to the following activities:

- Investing in research, transfer, and production of drug materials, especially drug materials of biological origin, and drug materials using domestic medicinal materials of high economic value.

- Investing in building and implementing the Center for Bioequivalence Testing and Clinical Testing, the Center for High-Tech Drugs, Drugs from Medicinal Materials and Traditional Drugs, and National Center for Research in Genetic Resources and Medicinal Material Seeds.

d/ Improving regulations to ensure effective protection of intellectual property rights to still patented brand-name drugs in Vietnam.

dd/ Strengthening the capacity of the pharmaceutical management agency to conform with the organizational model, functions and tasks of developed countries in the world and participate in the Pharmaceutical Inspection Cooperation Scheme.

e/ Implementing EU-GMP or equivalent standards in manufacturing high-tech drugs; creating favorable conditions for foreign enterprises to invest in upgrading domestic production facilities to reach EU-GMP or equivalent standards.

g/ Simplifying administrative procedures and reducing business investment conditions. Enhancing the implementation of level-4 public services in pharmaceutical management, first of all GMP assessment, grant of new drug circulation registration numbers, prioritizing the application of rapid licensing appraisal procedure for drugs to be domestically produced through technology transfer.

2. Solutions on investment and competitiveness raising

a/ Continuing to promote investment in drug research, testing and production. Planning and earmarking land areas for construction of industrial parks to attract domestic and foreign investors to produce patented brand-name drugs, specialty drugs, generic drugs with high-tech dosage forms, vaccines and medical biological products to meet domestic and export demands.

b/ Investing in developing Vietnam's regions growing, exploiting and processing drug materials in the direction of large-scale commodity production; increasing investment in programs on conservation and development of genetic resources of precious and endemic medicinal plants on the basis of increasing investment in advanced equipment and technology for assessing the quality of genetic resources and selecting and breeding medicinal plants.

c/ Mobilizing all resources from domestic and foreign organizations and individuals to invest in domestic drug production, franchised drug production, technology transfer, vaccines, medical biological products and products from drug materials. Attaching importance to investment and development of a pharmaceutical chemistry program to produce drug materials for domestic drug production, reducing dependence on imported materials.

d/ Periodically organizing trade promotion activities to attract investment and transfer of manufacturing technology from high-tech drug manufacturers, foreign-invested companies, countries with developed pharmaceutical industry, and multinational pharmaceutical corporations.

dd/ Prioritizing the development of projects to produce drugs under technology transfer contracts, and processed drugs upon the expiration of their patents or relevant exclusive certificates.

e/ Investing in building and rearranging the domestic drug distribution, wholesale, retail and transportation system to become modern, professional and efficient. Encouraging the application of EU-GSDP technical standards, building drug storage warehouses and transport vehicle systems meeting high technical standards.

g/ Issuing together with this Decision a list of key projects calling for investment (attached appendix).

3. Solutions on science and technology, human resources and training

a/ Organizing the implementation of at least two national scientific and technological tasks funded by the state budget in three years; at least five ministerial-level scientific and technological tasks in 1 year on the development of the domestic pharmaceutical industry, focusing on the following activities:

- Researching into, developing and producing combination vaccines.

- Researching in and applying modern pharmaceutical preparation technology, researching into the production of drug materials of high economic value.

- Researching into and extracting high-tech medicinal materials, preparing and producing drugs and drug materials from a number of domestic endemic medicinal materials of high economic value, and developing national products from Vietnamese medicinal materials.

- Isolating and identifying main active ingredients and standardizing typical drugs from medicinal materials of Vietnam. Conducting scientific demonstration of pharmacological effects, clinical trial and therapeutic effect of drugs from domestic medicinal materials.

- Researching into, selecting and creating varieties, cultivation technology and processes for high yield and quality from genetic resources of precious, endemic and advantageous medicinal plants of Vietnam and importing advanced genetic resources and medicinal plant varieties.

b/ Applying incentives, financial grants and supports from the science and technology funds, the National Technology Innovation Fund, the National Science and Technology Development Fund, and National High Technology Venture Capital Fund for research and development, technology transfer and commercialization of domestic drugs and drug materials.

c/ Attaching importance to training high-quality human resources for research into and production of drugs and drug materials; providing specialized training in vaccine and medical biological product production, bioequivalence research, and clinical trial in university pharmacist training programs.

4. Solutions on control of drug and pharmaceutical markets

a/ Implementing synchronous measures to control and post-control drug distribution activities. Completing the online connection of data on drug business activities from production, import-export, wholesale to retail and use, focusing on monitoring of quality, price, information and origin of drugs.

b/ Speeding ​​up the digitization of the pharmacy industry, developing and providing a drug database for pharmaceutical management and business activities. Applying and managing numeric codes and barcodes of drugs and medicinal materials circulated in the market to trace their origin and controlling their quality.

c/ Raising the capacity of the drug testing system, especially the testing of vaccines and medical biological products. Intensifying sampling and quality control, strictly controlling the quality of drugs and medicinal materials circulated in the market, especially imported medicinal materials, pre-controlling imported medicinal materials according to their registered quality.

d/ Conserving genetic resources of endemic and rare medicinal materials of high economic value and bearing national brand names; sustainably exploiting and limiting the export of rare and endangered medicinal materials.

dd/ Stepping up the prevention of smuggling and illegal import and export of medicinal materials, especially medicinal materials and genetic resources of domestic endemic and rare medicinal plants.

e/ Developing mechanisms of close cooperation and connection between farmers, scientists, government agencies and businesses in the transfer of seeds, cultivation techniques, collection and procurement of domestic medicinal materials.

5. Solutions on international cooperation and integration

a/ Actively cooperating with international forums and organizations, diplomatic agencies, pharmaceutical management agencies of developed countries, and international pharmaceutical enterprises and associations to exchange and share  information and cooperate on management, science, training and technical assistance in the pharmaceutical field; attaching importance to promoting cooperation with multinational pharmaceutical corporations in order to research into and develop still patented brand-name drugs in Vietnam, and transferring technologies to produce generic drugs with high-tech dosage forms.

b/ Actively negotiating, joining and implementing treaties and international agreements in the pharmaceutical field. Developing a roadmap for accreditation and gradual mutual recognition of drug registration and GMP assessment dossiers.

c/ Strengthening cooperation, connecting and sharing pharmaceutical management information databases with drug management agencies. Promoting the harmonization of pharmaceutical management-related dossiers, processes and procedures in conformity with international standards.

6. Information and communication solutions

a/ Actively making communicate plans and content on the quality, safety, effectiveness and reasonable prices of domestically produced drugs. Continuing to properly implement the campaign "Vietnamese people give priority to using Vietnamese drugs".

b/ Disseminating knowledge about the origins and effects of medicinal materials, especially endemic ones of Vietnam in the media in order to raise people's awareness and understanding about the conservation, exploitation and use of medicinal materials.

c/ Effectively supporting the promotion of national-brand drugs and medicinal materials.

d/ Creating a mechanism of drug supply combined with provision of drug and clinical pharmacy information to fundamentally transform from mere drug supply to high-quality pharmaceutical service provision.

Article 2. Organization of implementation

1. The Ministry of Health shall:

a/ Review and propose amendments to current regulations to ensure the application of the highest incentives to investment, research and development of the domestic pharmaceutical industry; promulgate according to its competence regulations to implement the Program's tasks and solutions.

b/ Formulate, submit for approval, approve, and organize the implementation of, scientific and technological tasks on development of the domestic pharmaceutical industry in accordance with the Law on Science and Technology.

c/ Assume the prime responsibility for, and coordinate with related ministries and sectors in, formulating plans for training and employing high-quality human resources in the pharmaceutical field to meet demand for drug research and production. Strengthen capacity and ensure effectiveness of state pharmaceutical management agencies across the country.

d/ Establish the Program Steering Committee headed by the Minister of Health and with members including leaders of the Ministries: Science and Technology, Industry and Trade, Agriculture and Rural Development, Finance, and Planning. and Investment.

dd/ Guide, urge and inspect the Program's implementation by related ministries, agencies and localities; organize preliminary reviews by 2025 and 2030 and report on the Program's implementation results to the Prime Minister.

2. The Ministry of Industry and Trade shall assume the prime responsibility for, and coordinate with related ministries and agencies in, elaborating and organizing the implementation of, the program on development of the pharmaceutical chemistry industry, including production of pharmaceutical chemical materials and drug production support products.

3. The Ministry of Agriculture and Rural Development shall assume the prime responsibility for, and coordinate with the Ministry of Health in, directing the development of farming and planting of medicinal materials, concentrating on those in which Vietnam has advantages and having a high economic value.

4. The Ministry of Science and Technology shall:

a/ Assume the prime responsibility for, and coordinate with ministries, ministerial-level agencies and government-attached agencies in, formulating and approving, implementing and examining the performance progress of, national-level scientific tasks.

b/ Assume the prime responsibility for reviewing and proposing amendments to the regulations on support, funding and incentives for hi-tech enterprises and high-tech products, and the use of the national science and technology funds, National Technology Innovation Fund, National Science and Technology Development Fund, and National High-Tech Venture Investment Fund for research and development activities in the pharmaceutical sector in Vietnam.

5. The Ministry of Planning and Investment shall

a/ Assume the prime responsibility for, and coordinate with the Ministry of Finance in, reporting to the Government for determination state budget investment funds to be spent on the country’s development investment in the pharmaceutical field in medium-term and annual public investment plans. Mobilize ODA capital sources to give priority to the development of drug research and production.

b/ Assume the prime responsibility for, and coordinate with the Ministry of Health and related ministries and sectors in, drafting a draft decree guiding the implementation of the 2020 Investment Law, which identifies the forms and subjects eligible for investment incentives and special investment incentives applied to the pharmaceutical industry.

6. The Ministry of Finance shall allocate funding for the Program’s implementation as decentralized by the State Budget Law.

7. Vietnam Social Insurance shall coordinate with the Ministry of Health in reviewing and building a list of drugs covered by health insurance, and proposing mechanisms and policies in drug bidding to give priority to the use of domestically produced drugs.

8. Ministries and sectors shall, according to their assigned functions and tasks, implement or coordinate with the Ministry of Health in implementing the Program's contents.

9. Provincial-level People's Committees shall:

a/ Research into and develop a model for the development of the pharmaceutical industry suitable to local advantages and practical conditions.

b/ Prioritize land areas for construction of pharmaceutical factories, pharmaceutical industrial zones, pharmaceutical research and testing centers, and prioritize the allocation of land and forests to medicinal material development projects.

c/ Review, research, develop, and adjust appropriate mechanisms, policies and legal frameworks in order to attract investment resources for the pharmaceutical industry and medicinal material development in their localities, and focus on strengthening management capacity and exploitation of rare, precious and endemic medicinal materials, attracting public-private partnerships. Pay special attention to building sustainable partnerships with enterprises investing in high technology in the pharmaceutical field and development of drugs from medicinal materials.

Article 3. This Decision takes effect on the date of its signing.

Article 4. Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of provincial-level People's Committees, and heads of related agencies shall implement this Decision.-

For the Prime Minister

Deputy Prime Minister

Vu Duc Dam

APPENDIX

LIST OF KEY PROJECTS CALLING FOR INVESTMENT

(Attached to the Prime Minister's Decision No. 376 QD-TTg of March 17, 2021)