Monday, 08:46 12/08/2019
Vietnam emerges as a global pharmaceutical hub
According to experts, the boost in attractiveness of the Vietnamese market comes at a time when the business environment for drugmakers in neighboring countries has not been favorable.
International drugmakers are increasingly cashing in on the potential of the Vietnamese market, helping the country emerge as a global pharmaceutical hub, experts said.
The European Chamber of Commerce in Vietnam (Eurocham) has recently highly valued the potential of Vietnam to become a center for the research-based pharmaceutical industry including production, export and supplies of high-quality healthcare services in the ASEAN region.
Pharma Group (PG) – the Pharmaceutical Sector Committee of EuroCham, which represents the voice of the international research-based pharmaceutical industry in the country – has highlighted that Vietnam has many advantages in the sector thanks to its population of 95 million, stable political climate and trained human resources. In addition, it is the gateway to ASEAN countries.
Vietnam wants to clearly see the transition from production to innovation, research and development, services and e-healthcare, PG said.
Analysts from financial information services provider Fitch Group also said that Vietnam’s positive market outlook coupled with a constantly improving healthcare system and favorable business and legislative environment are the main factors of growing interest from foreign drugmakers, including Pfizer, Taisho Pharmaceuticals and Kimia Pharma.
Favorable conditions
According to experts, the boost in attractiveness of the Vietnamese market comes at a time when the business environment for drugmakers in neighboring countries has not been favorable. In December 2018, Indonesia enacted a regulation for the compulsory licensing of every medical product that is not being made in the country. This is expected to have significant negative consequences for foreign direct investment in the country, with Vietnam being among the beneficiaries of pharmaceutical companies shying away from Indonesia.
“This, combined with the geopolitical position of Vietnam, places the country in a favorable position to become a regional pharmaceutical research and export hub,” Fitch analysts said.
Besides, trade agreements and legislative changes in Vietnam will also enhance positive sentiment among drugmakers.
The Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) requires each of 11 member countries to have a system of pharmaceutical patent linkage, which means that prior to granting marketing approval to any generic drug, Vietnam must notify the original drug’s patent holder of the generic drug's application for approval.
This provides the patent holder with sufficient time to seek judicial or administrative proceedings for the resolution of disputes concerning the validity or infringement of an applicable patent. Vietnam may alternatively adopt a non-judicial regime to preclude the issuance of marketing approval to generic drugs based on the available patent-related information.
Moreover, recent changes in legislation bode well for the presence of global drugmakers in Vietnam. In an effort to further attract pharmaceutical firms, the government brought into effect a law according to which only drug business establishments are allowed to hire medical representatives. Notably, a representative office cannot hire new medical representatives, as the definition of drug business establishments excludes representative offices.
Besides, Deputy Minister of Health Truong Quoc Cuong said governmental Decree No.155/2018/ND-CP has many positive changes towards reducing procedures, thus creating favorable conditions for businesses in tenders, drug imports, and others. The decree provides quicker access to the Vietnamese pharmaceutical market by making the import license procedure clearer and simpler.
Under the decree, to obtain an import license, no full clinical documents on efficacy and safety are required. In the case of drugs that had previously been granted an import license, there is no need to submit clinical documents when requesting a new import license, unless the drug has undergone major changes.
The loosening of the importation criteria and the expected increase in the presence of global drugmakers is likely to further bolster the local pharmaceutical and healthcare market.
Foreign drugmakers have a growing interest in Vietnam’s pharmaceutical market.
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Pharma Group (PG) – the Pharmaceutical Sector Committee of EuroCham, which represents the voice of the international research-based pharmaceutical industry in the country – has highlighted that Vietnam has many advantages in the sector thanks to its population of 95 million, stable political climate and trained human resources. In addition, it is the gateway to ASEAN countries.
Vietnam wants to clearly see the transition from production to innovation, research and development, services and e-healthcare, PG said.
Analysts from financial information services provider Fitch Group also said that Vietnam’s positive market outlook coupled with a constantly improving healthcare system and favorable business and legislative environment are the main factors of growing interest from foreign drugmakers, including Pfizer, Taisho Pharmaceuticals and Kimia Pharma.
Favorable conditions
According to experts, the boost in attractiveness of the Vietnamese market comes at a time when the business environment for drugmakers in neighboring countries has not been favorable. In December 2018, Indonesia enacted a regulation for the compulsory licensing of every medical product that is not being made in the country. This is expected to have significant negative consequences for foreign direct investment in the country, with Vietnam being among the beneficiaries of pharmaceutical companies shying away from Indonesia.
“This, combined with the geopolitical position of Vietnam, places the country in a favorable position to become a regional pharmaceutical research and export hub,” Fitch analysts said.
Besides, trade agreements and legislative changes in Vietnam will also enhance positive sentiment among drugmakers.
The Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) requires each of 11 member countries to have a system of pharmaceutical patent linkage, which means that prior to granting marketing approval to any generic drug, Vietnam must notify the original drug’s patent holder of the generic drug's application for approval.
This provides the patent holder with sufficient time to seek judicial or administrative proceedings for the resolution of disputes concerning the validity or infringement of an applicable patent. Vietnam may alternatively adopt a non-judicial regime to preclude the issuance of marketing approval to generic drugs based on the available patent-related information.
Moreover, recent changes in legislation bode well for the presence of global drugmakers in Vietnam. In an effort to further attract pharmaceutical firms, the government brought into effect a law according to which only drug business establishments are allowed to hire medical representatives. Notably, a representative office cannot hire new medical representatives, as the definition of drug business establishments excludes representative offices.
Besides, Deputy Minister of Health Truong Quoc Cuong said governmental Decree No.155/2018/ND-CP has many positive changes towards reducing procedures, thus creating favorable conditions for businesses in tenders, drug imports, and others. The decree provides quicker access to the Vietnamese pharmaceutical market by making the import license procedure clearer and simpler.
Under the decree, to obtain an import license, no full clinical documents on efficacy and safety are required. In the case of drugs that had previously been granted an import license, there is no need to submit clinical documents when requesting a new import license, unless the drug has undergone major changes.
The loosening of the importation criteria and the expected increase in the presence of global drugmakers is likely to further bolster the local pharmaceutical and healthcare market.
