Quyết định 376/QD-TTg

Decision No. 376/QD-TTg dated May 17, 2021 on approving Development program for pharmaceuticals industry and domestically produced herbal ingredient until 2030 and vision to 2045

Nội dung toàn văn Decision 376/QD-TTg 2021 Development program for pharmaceuticals industry until 2030


PRIME MINISTER
-------

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
----------------

No. 376/QD-TTg

Hanoi, May 17, 2021

 

DECISION

APPROVING DEVELOPMENT PROGRAM FOR PHARMACEUTICALS INDUSTRY AND DOMESTICALLY PRODUCED HERBAL INGREDIENT UNTIL 2030 AND VISION TO 2045

PRIME MINISTER

Pursuant to Law on Governmental Organization dated June 19, 2015; Law on amendments to Law on Government Organization and Law on Local Governmental Organization dated November 22, 2019;

Pursuant to the Law on Pharmacy dated April 06, 2016;

Pursuant to Law on Investment dated June 17, 2020;

Pursuant to Resolution No. 20-NQ/TW dated October 25, 2017 of the 6th meeting of the 12th Central Executive Committee of the Communist Party on improving protection, care and public health in modern time;

Pursuant to Resolution No. 139/NQ-CP dated December 31, 2017 of the Government on Action program of the Government in implementation of Resolution No. 20/NQ-TW dated October 25, 2017 of the 6th meeting of the 12th Central Executive Committee of the Communist Party on enhancing people’s health protection, care and improvement in modern time;

At the request of Minister of Health;

HEREBY DECIDES:

Article 1. Approve Development program for pharmaceuticals industry and domestically produced herbal ingredients until 2030 and vision to 2045 (hereinafter referred to as “Development program”) under following clauses:

I. DEVELOPMENT PRINCPLES

1. Prioritize development of pharmaceuticals industry and domestic production of pharmaceutical starting materials with high-level incentive policies and preferential treatment as per the law.

2. Actively attract resources for pharmaceuticals industry development, attract foreign investment in production of innovator drugs with valid trademark, specialized medication for treatment, generic drugs with hi-tech dosage form, vaccine, reference biological and bioequivalent drugs.

The government prioritizes scientific research, production of new drugs, high quality herbal drugs and production of herbal drugs bearing national brand names. 

3. Utilize domestic herbal sources, especially unique, rare, precious herbal ingredients and herbal ingredients with high economic value.

II. OBJECTIVES

1. General objectives: Develop domestic pharmaceuticals industry to achieve high level of progression, achieve level 4 according to classification of World Health Organization (WHO), and be placed in top 3 of ASEAN market value in order to ensure adequate and timely supply of quality, safe, effective and reasonably priced drugs.  

Develop herbal ingredients and domestic herbal ingredient products into quality, valuable and competitive commodity production in domestic and international market.

2. Specific objectives:

a) Until 2025:

- Domestically produced drugs account for 75% of used drugs and 60% of market value, percentage of domestic herbal ingredients and herbal drugs increases by at least 10% compared to 2020.

- Construct 8 zones for sustainable extraction of natural herbal ingredients. Construct 2 - 5 large-scale herbal ingredient cultivation zones, each cultivation zone or extraction zone is connected to 1 – 2 series of facilities for research, cultivation and preparation of herbal ingredients complying with Guidelines on good agricultural and collection practices for medicinal plants of World Health Organization (GACP-WHO). 

b) Until 2030:

- Domestically produced drugs account for 80% of used drugs and 70% of market value, percentage of domestic herbal ingredients and herbal drugs increases by at least 30% compared to 2020, at least 10 – 15 transplanted herbal drugs are developed to meet domestic demand. Reinvigorate, import, transplant and develop 10 – 15 foreign herbal ingredients in large quantity.

- Transfer production technology of at least 100 innovator drugs with valid trademark, vaccines, medical biological and medicine which Vietnam has not been able to produce.

- Become a high quality pharmaceutical production center in the region. Export value of domestically produced drugs achieves approximately USD 1 billion.

c) Until 2045: Vietnam has innovator drugs originating from unique herbal ingredients which are researched, produced and registered for trademark. Total pharmaceuticals industry value contributes more than USD 20 billion to GDP.

III. PRIMARY TASKS AND MEASURES:

1. Measures in terms of regulations and law

a) Research and finalize applicable regulations and law to incentivize, assist and provide preferential treatment for pharmaceutical enterprises, in which:

- Enterprises manufacturing innovator drugs shall receive benefits similar to hi-tech enterprises; develop roadmap for retaining price and discounting price of innovator drugs appropriately to encourage enterprises to transfer manufacturing technology of innovator drugs in Vietnam; increase R&D contributions for enterprises invested for research and development of new drugs. 

- Innovator drugs, generic drugs with modern dosage form and multivalent vaccines are considered hi-tech products.

- Provide preferential treatment in terms of tax, credit and land use policies (land rent, land rent duration) for enterprises and facilities investing in cultivation, processing, extraction of herbal ingredients and development of herbal drugs, traditional drugs.

- Review and revise list of hi-tech products for drugs with modern dosage form (freeze-dried capsules, controlled release capsules, targeted drugs, lidose hard capsules, etc.); vaccine, medical biological, biological pharmaceutical starting materials; herbal drugs produced from substances/compounds that have been standardized; domestically produced drugs that have not satisfied requirements for treatment, price and availability.

b) Review and finalize regulations on bidding and purchase of drugs produced in Vietnam, increase percentage and value of domestically produced drugs under list of drugs covered by health insurance; ensure promotion of domestic drugs is implemented as per the law.

- Develop procurement mechanism suitable for domestically produced innovator drugs, prioritize price negotiation depending on level of technology transfer, scenario, road map for quantity-based discount and value of innovator drugs produced in Vietnam.

c) Adopt special promotions as per the law for:

- Research, transfer, production of pharmaceutical starting materials, especially biological pharmaceutical starting materials and pharmaceutical starting materials that utilize herbal ingredients with high economic value domestically.

- Construction and operation of bioequivalence testing centers, clinical testing centers, research centers for hi-tech drugs, herbal drugs, traditional drugs, national genetic resource and herbal ingredient research centers.

d) Complete regulations on assuring effective protection of intellectual property rights for innovator drugs with valid trademark in Vietnam.

dd) Increase capacity of pharmaceutical authorities with organization model, functions and tasks similar to advanced countries and participate in Pharmaceutical Inspection Co-operation Scheme (PIC/S),  

e) Implement EU-GMP standards or equivalent in production of hi-tech drugs; enable foreign enterprises to invest in upgrading domestic manufacturing facilities to EU-GMP standards or equivalent.

g) Simplify administrative procedures and cut down conditions for business investment.   Increase provision of level 4 public services in pharmaceutical administration and prioritize GMP assessment, issuance of registration number for new drugs, and adoption of procedures for rapid appraisal and issuance of license for drugs subject to technology transfer for domestic production.  

2. Solutions for investment and improvement of competitiveness

a) Continue to promote investment in research, testing and production of drugs. Plan and allocate land fund for construction of industrial parks to attract domestic and international investors for production of innovator drugs with valid trademark, specialized treatment drugs, generic drugs with hi-tech dosage form, vaccine, medical biological satisfying domestic and export demands.

b) Invest in development of large-scale cultivation zones, extraction zones and processing zones for Vietnamese herbal ingredients; increase investment for preservation and development of genetic resources of medicinal herbs, rare, previous and unique herbs on the basis of investment for advanced technology and equipment to enable genetic resource assessment and medicinal herd selection.

c) Mobilize all resources including domestic and international organizations and individuals to invest in developing drugs domestically, producing drugs subject to right transfer, drugs subject to technology transfer, vaccine, medical biologicals and products originating from herbal ingredients.    Prioritize investment and development of pharmaceutical chemistry program to produce pharmaceutical starting materials serving domestic drug production and reduce dependence on imported starting materials.

d) On a periodic basis, organize commercial promotion activities to attract investment and technology transfer from hi-tech drug production facilities, foreign-invested companies, countries with advanced pharmaceuticals industry and multi-national pharmaceutical groups.

dd) Prioritize development of production projects for drugs subject to technology transfer and processed drugs as soon as patents or relevant trademark certificates expire.

e) Invest in construction and rearrangement of domestic drug distribution, sale, retail and transport in a modern, professional and effective manner. Encourage adoption of EU-GSDP standards, develop drug storage and transport vehicles satisfactory to high technical standards.

g) List of primary projects requiring investment (attached annex) is attached to this Decision.

3. Solutions for science, technology, human resource and training

a) Organize implementation of at least 2 national science and technology tasks that utilize state budget in 3 years; at least 5 ministerial science and technology tasks in 1 year regarding developing pharmaceutical industry domestically, prioritizing:

- Research, development and production of multivalent vaccine.

- Research and application of modern processing technology, research and production of pharmaceutical starting materials with high economic value.

- Research, extraction of hi-tech herbal ingredients, processing and production of drugs, pharmaceutical starting materials from unique herbal ingredients with high economic value, and development of national products based on Vietnamese herbal ingredients.

- Isolation, identification of primary active ingredients, and standardization of herbal drugs that are unique in Vietnam. Proving pharmacological effect scientifically, clinical testing and treatment efficacy of domestic herbal drugs.

- Research, selection of breed, cultivation technology and procedures that yield high productivity and quality based on genetic resources of precious, unique and advantageous medicinal herbs in Vietnam and import of genetic resources and breed of advanced medicinal herbs.

b) Adopt preferential treatment, sponsor and assistance from science and technology funds, National Technology Innovation Fund, National Science and Technology Development Fund, national hi-tech venture capital funds for research-development, technology transfer, commercialization of drugs and pharmaceutical starting materials.  

c) Prioritize training of high quality human resources for research and production of drugs and pharmaceutical starting materials; provide specialized training regarding production of vaccine, medical biological, bioequivalence and clinical testing in training program of bachelors of pharmacy.

4. Solutions for administration of drug and herbal ingredient market

a) Implement drug distribution control and post-inspection affairs simultaneously.  Complete online connection of drug sale data from production, import, export, sale, retail and use, prioritize supervising quality, price, drug information and origin.

b) Promote digitalization of pharmaceutical sector, develop and provide drug database for drug administration and sale affairs. Adopt and manage code, barcode of drugs and herbal ingredients circulated on the market to ensure traceability and quality control.

c) Improve capacity of drug inspection systems, especially systems for inspecting vaccine and medical biological. Increase specimen collection, quality control and close control of drug quality and herbal ingredients circulated on the market, especially imported herbal ingredients, and conduct pre-inspection for imported herbal ingredients to ensure conformity to registered quality.

d) Preserve genetic resources of unique, precious herbal ingredients with high economic value bearing national brand names; extract sustainably and restrict export of rare, endangered herbal ingredients.

dd) Increase anti-smuggling affairs and illicit import, export of herbal ingredients, especially unique, rare herbal ingredients and genetic resources of medicinal herbs.

e) Develop mechanisms for cooperating and collaborating among farmers, scientists, the government and enterprises in transferring breeds, cultivation, harvest and purchase techniques for domestic herbal ingredients.

5. Solutions for cooperation and international integration

a) Actively cooperate with international forums, organizations, diplomatic missions, pharmaceutical authorities of advanced countries around the world, international enterprises and enterprise associations in exchanging, sharing information, developing management, science, training and technical support affairs in pharmaceutical sector; prioritize cooperation with multi-national pharmaceutical corporation in researching and developing innovator drugs with valid trademark in Vietnam, transferring technology for production of generic drugs with hi-tech dosage form.   

b) Actively negotiate, participate and implement international agreements in pharmaceutical sector. Develop roadmap for accreditation and moving toward mutual recognition in terms of drug registration and GMP assessment.

c) Increase cooperation, connection and share of pharmaceutical administration database with pharmaceutical authorities. Promote harmonization of documents and procedures related to pharmaceutical administration as close to international standards as possible.

6. Solutions for information and communication

a) Actively develop plans and communication contents regarding quality, safety, efficacy and reasonable price of domestically produced drugs. Effectively conduct “Người Việt Nam ưu tiên dùng thuốc Việt Nam” (Vietnamese nationals prioritize Vietnamese medicine) campaign.

b) Publicize knowledge regarding origin and effect of herbal ingredients, especially herbal ingredients unique to Vietnam on media platforms to raise awareness of the general public in preservation, extraction and use of herbal ingredients.

c) Provide effective support for advertising drugs and herbal ingredients bearing national brand names.

d) Develop mechanisms regarding drug supply and provision of information on drugs and clinical pharmacology to transform simple drug supply service to high quality pharmaceutical supply service.

Article 2. Implementation

1. Ministry of Health

a) Review and propose amendments to applicable laws to guarantee the highest level of promotion and preferential treatment for investment, research-development of domestic pharmaceutical industry; issue regulations within their competence to implement tasks and solutions under the Development program.

b) Develop, request approval, approve and organize implementation of science and technology tasks regarding development of domestic pharmaceutical industry according to Law on Science and Technology.

c) Take charge and cooperate with relevant ministries in developing plans for training and using high quality personnel specialized in pharmaceutical suitable for drug research and production. Increase capacity and guarantee effectiveness of nationwide pharmaceutical regulatory agencies.

d) Establish Board for directing Development program in which Minister of Health acts as the director and members include Ministry of Science and Technology, Ministry of Industry and Trade, Ministry of Agriculture and Rural Development, Ministry of Finance and Ministry of Planning and Investment.

dd) Guide, expedite and inspect implementation of the Development program in ministries, relevant agencies and local administrative divisions; organize preliminary conclusion in 2025, 2030 and submit report to Prime Minister on implementation results.

2. Ministry of Industry and Trade shall take charge and cooperate with relevant ministries, agencies in developing, organizing implementation of Development program for pharmaceutical chemistry industry, which includes production of pharmaceutical chemistry ingredients and products assisting drug production.

3. Ministry of Agriculture and Rural Development shall take charge and cooperate with Ministry of Health in directing development, cultivation of herbal ingredients, focusing on herbal ingredients which Vietnam is having advantage in and yield high economic value.

4. Ministry of Science and Technology

a) Take charge, cooperate with ministries, ministerial agencies and Governmental agencies in developing, approving, implementing and inspecting progress of national science tasks.

b) Actively review and propose amendments to regulations and law on assistance, sponsor and preferential treatment for hi-tech enterprises, hi-tech products, use of national science and technology funds, National Technology Innovation Fund, National Science and Technology Development Fund, national hi-tech venture capital funds for research-development in pharmaceutical sector in Vietnam.

5. Ministry of Planning and Investment:

a) Direct and cooperate with Ministry of Finance in submitting reports to the Government on state budget-based investment capital for national investment and development in pharmaceutical sector within mid-term and annual investment plans.   Mobilize ODA and prioritize drug development, research and production.

b) Take charge and cooperate with Ministry of Health and relevant ministries in developing Draft Decree guiding implementation of Law on Investment in 2020, which identifies forms and beneficiaries of investment preferential treatment, especially investment preferential treatment in pharmaceutical industry.

6. Ministry of Finance shall allocate funding for implementation of Development program according to Law on State Budget.

7. Vietnam Social Security shall cooperate with Ministry of Health in reviewing and developing list of drugs covered by health insurance, proposing mechanisms and policies in drug bidding to prioritize domestically produced drugs.

8. Ministries within their tasks and functions are responsible for implementing or cooperating with Ministry of Health in implementing the Development program.

9. People’s Committees of provinces or central-affiliated cities

a) Conduct research and develop development models for pharmaceutical industry and herbal ingredients suitable for advantages and practical conditions of local administrative divisions.

b) Prioritize land fund for construction of pharmaceutical factories, industrial parks, research and testing centers, prioritize land and forest land for pharmaceutical development projects.

c) Review, research, develop and amend policies and legal framework accordingly to attract investment in pharmaceuticals industry and local development of herbal ingredients, prioritize improving managerial and extraction capability for rare, unique herbal ingredients and attract public, private investment. Prioritize development of sustainable cooperation with hi-tech enterprises engaged in pharmaceutical sector and development of herbal drugs.

Article 3. This Decision comes into effect from the day of signing.

Article 4. Ministers, heads of ministerial agencies, heads of Governmental agencies, Chairpersons of People’s Committees of provinces and central-affiliated cities and relevant agencies, entities are responsible for implementation of this Decision./.

 

 

PP. PRIME MINISTER
DEPUTY PRIME MINISTER




Vu Duc Dam

 

ANNEX

LIST OF PRIORITY PROJECTS REQUESTING INVESTMENT
(Attached to Decision No. 376/QD-TTg dated March 17, 2021 of Prime Minister)

No.

Project

Detail

Investment period

1

Northern industrial park project.

Construct new infrastructure of industrial parks to enable FIE investors to transfer technology of producing innovator drugs, generic drugs with hi-tech dosage form, vaccine, medical biologicals and biological drugs with high economic value.

2021 - 2030

2

Southern or middle industrial park project

Construct new infrastructure of industrial parks to enable FIE investors to transfer technology of producing innovator drugs, generic drugs with hi-tech dosage form, vaccine, medical biologicals and biological drugs with high economic value.

2021 - 2030

3

Investment project for improving genetic resource research capacity and selection, production of herbal ingredient breed

Invest and upgrade facilities and equipment to match national genetic resource and herbal ingredient breed research center

2022 - 2030

4

Value chain construction project in sustainable extraction, processing and sale of herbal ingredients serving domestic demands and export.

Construct 5 value chains in sustainable harvest according to GACP-WHO, process, sale to serve domestic demands and export in 5 ecozones: Spatholobus harmandii Gagnep, Coscinium fenestratum, Drynaria fortune, Eurycoma longifolia Jack, Ciboticum barometz, Smilax glabra, Gynostemma pentaphyllum, etc.

Construct 5 value chains for cultivation, purchase, processing and production of produce of herbal ingredients (Salvia Miltiorrhiza Bunge, Ledebouriella seseloides Wolff, Angelica laxiflora Diels, Platycodon grandiflorus, etc.)

2022 - 2030

5

Project for application of biotechnology for production of multivalent vaccine and vaccine against various diseases (including the COVID-19)

Construct factories for transferring technology of producing 5-in-1 vaccine and 6-in-1 vaccine to stay active in disease prevention, conduct research and transfer technology of producing vaccine against epidemic.

2021 - 2030

6

Construction projects for bioequivalence testing centers, clinical testing centers

Invest in construction of modern clinical testing centers satisfactory to international standards serving research of new drugs and drugs registered in Vietnam for the first time

2021 - 2030

 

 


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This translation is made by THƯ VIỆN PHÁP LUẬT and for reference purposes only. Its copyright is owned by THƯ VIỆN PHÁP LUẬT and protected under Clause 2, Article 14 of the Law on Intellectual Property.Your comments are always welcomed

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