Vietnam aims to produce innovative drugs

In Vietnam, innovative drugs only account for about 3% in quantity but in reality account for 22% in value and are mainly imported drugs. Faced with this situation, the Ministry of Health is proposing a policy to encourage the transfer of new and innovative drugs to create more opportunities for patients to access treatment.

Limited capacity to manufacture innovative drugs

According to the assessment of the Drug Administration of Vietnam (Ministry of Health ), domestically, invented drugs currently account for only about 3% in quantity but in reality account for 22% in value and are mainly imported drugs. Only a few drugs have been researched and produced domestically or have initially transferred production technology. The main reason is that the scale of domestic pharmaceutical production facilities is currently mostly small and medium enterprises (SMEs), which have not focused on investing in research, production, and transfer of the above drugs due to the need for large resources in terms of finance, time, and high-quality human resources. Investment in research and development is also very modest, mainly in conventional drug forms; not focusing on research, production of modern dosage forms, optimizing formulas and production processes.

Vietnam aims to reach level 4 pharmaceutical industry, producing innovative drugs.

PHOTO: TH

Director of the Drug Administration Vu Tuan Cuong said that in the past, we encouraged the production of generic drugs (drugs whose protection has expired) and ensured essential drugs, so businesses have not focused on researching and producing high-tech drugs, new drugs, specialized drugs, and innovative drugs. Therefore, it is necessary to build a mechanism and policies that are strong enough to attract businesses and investors to promote investment in research and development of new technologies to produce drugs that need priority development as proposed in the draft amendment to the Pharmacy Law. According to the Drug Administration, currently, domestic drugs account for 70% of the quantity used, but only reach about 45-50% in value. The draft amended Pharmacy Law has proposed regulations in the direction of encouraging the production of innovative drugs and drugs with high-tech dosage forms, instead of the production of generic drugs that has been focused on in the past.

Target of 1 billion USD in drug exports by 2030

According to the Drug Administration of Vietnam, Vietnam has 230 factories meeting GMP-WHO standards, of which nearly 20 factories meet GMP-EU standards. The World Health Organization (WHO) classifies Vietnam's pharmaceutical industry as level 3, producing generic drugs and being partly self-sufficient in medicines. In 2023 - 2024, the pharmaceutical market size will reach 6.5 - 7 billion USD, of which 3.5 billion USD will be imported. Pharmaceutical exports are still modest, reaching just over 200 million USD; about 90% of pharmaceutical raw materials must be imported. Currently, Vietnam is aiming for the pharmaceutical industry to reach level 4 (the level at which the pharmaceutical industry can produce invented drugs), with specific policies on science and technology, incentives for enterprises developing high-tech drugs, including a number of high technologies and invented drugs in the preferential list, promoting investment, prioritizing domestic use and supporting export enterprises, with the goal of drug exports reaching 1 billion USD by 2030. Regarding the policy expected to create a breakthrough for the domestic pharmaceutical industry, lawyer Bui Van Thanh, Permanent Vice President of the Vietnam Industrial Park Finance Association (VIPFA), analyzed: in the draft amendments to the Law on Pharmacy, the Ministry of Health proposed to amend and supplement Clause 3, Article 7 of the Law on Pharmacy. Specifically, investment incentives, especially investment incentives on tax policies, land lease, loans, incentives, support on administrative procedures related to investment, business, granting of certificates of eligibility for pharmaceutical business, granting of registration certificates for circulation of drugs, pharmaceutical ingredients; and other investment support policies according to the provisions of law for investment activities in the production of pharmaceutical ingredients, production of new drugs, original brand-name drugs, drugs applying high technology in production, specialized drugs with technology transfer for production in Vietnam, essential drugs, biological vaccines, biotech drugs, medicinal drugs and traditional drugs produced from available medicinal materials in the country, rare drugs; incentives for scientific research on pharmaceutical technology, biotechnology to produce new drugs... According to lawyer Thanh, the comprehensive incentive provisions expressed in the draft revised Pharmacy Law are an important foundation to help promote businesses to invest heavily in the pharmaceutical sector, especially for high-value drugs and complex technologies. Thanks to that, Vietnam can create a favorable environment for sustainable development of the pharmaceutical industry and promote the transfer of advanced technology from developed countries.

The Ministry of Health proposes policies to further encourage research and development of domestically produced drugs with new dosage forms.

PHOTO: TH

However, Mr. Thanh believes that it is more important to realize the policies after they are issued. In order for pharmaceutical technology transfer activities in Vietnam to develop rapidly, lawyer Bui Van Thanh emphasized that it is necessary to simultaneously implement 3 groups of issues. In particular, there needs to be effective cooperation between management agencies and enterprises. For pharmaceutical enterprises, especially small and medium enterprises, the process of accessing and implementing technology transfer often faces many challenges in terms of finance, procedures and techniques. However, the supporting role of current state management agencies is still unclear and not timely in resolving these difficulties. In order for technology transfer to be effective, enterprises need close cooperation from management agencies in every step of the process, from technical and financial advice to legal support. This requires the establishment of communication channels and close cooperation mechanisms between the parties, along with the development of programs to support enterprises in implementing new technologies. This accompanying support will be an important lever, helping businesses accelerate the technology transfer process and improve the efficiency of pharmaceutical production activities. Second, relevant ministries and sectors must unanimously implement and synchronously integrate inter-sectoral regulations. The pharmaceutical industry requires coordination between many management agencies such as the Ministry of Health, the Ministry of Science and Technology and the Ministry of Finance . However, currently, regulations related to technology transfer in the pharmaceutical industry are still lacking in synchronization, causing difficulties for businesses in the process of compliance and implementation. Mr. Thanh said that the overlap in quality control standards, financial regulations and technical requirements between agencies leads to a complicated and cumbersome procedure. To solve this problem, it is necessary to build a system of inter-sectoral regulations that are synchronous, easy to understand and highly applicable, helping to simplify the process for businesses. An integrated regulatory system will not only reduce administrative burdens but also promote more effective technology transfer in the pharmaceutical industry, while helping businesses save time and costs. Another issue, according to Mr. Thanh, is the addition of specific guidance documents. "Although the legal framework for technology transfer in the pharmaceutical industry is available, detailed guidance documents are still lacking, making it difficult for businesses to implement in practice. Current regulations are mainly general in nature, not providing complete information on implementation processes, evaluation criteria and specific procedures for each stage of the transfer process. This lack of clarity leads to a situation where businesses do not have a sufficient basis to comply with the correct procedures, causing delays and difficulties in registering technology transfer," Mr. Thanh noted. According to this expert, issuing specific guidance documents, including detailed technical standards, document requirements and procedural instructions, will help businesses easily access and effectively comply with regulations.

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Source: https://thanhnien.vn/viet-nam-huong-den-muc-tieu-san-xuat-thuoc-phat-minh-185241103222911757.htm