Officials from Korean and Vietnamese pharmaceutical associations held talks last Tuesday to discuss the recent downgrade of Korean drug exports by the Vietnamese government.

The meeting between the members of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) and of the Vietnam Pharmaceutical Companies Association (VPCA) follows the Vietnamese government revising the bidding criteria for pharmaceutical products in late February that put South Korean exports at a disadvantage.

Vietnam is the third largest importer of Korean goods, with around 65 Korean pharmaceutical companies exporting about 200 billion won ($187 million) worth of products, according to KPBMA. Several domestic pharmaceutical companies have expanded over to Vietnam, with eight establishing local branches and three -- Korea United Pharm, Shinpoong Pharm, and Samil Pharm -- setting up production facilities, it added.

Pharmaceutical officials from Korea (right column) and Vietnam discuss ways to enhance cooperation in Hanoi last Tuesday. Leading their respective delegations at the center was Huh Kyung-hwa, vice chairman of KPMBA, and Leven Kham, insurance director of the Vietnamese Ministry of Health.

The Vietnamese Ministry of Health gives imported products a grade to foreign drugmakers based on the quality certification received from varying inspecting institutions. Under the system, a higher class equals more significant advantages.

Korean drugmakers had, until recently, enjoyed benefits under the system, having been upgraded from a grade 5 to a grade 2 in 2014 after getting certified with Good Manufacturing Practice (GMP) under the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

The Vietnamese government gives the grade 2 designation to drugmakers who have GMP certifications from either the PIC/S or the European Union.

In February, however, the Vietnamese government said that it would downgrade Korea’s imports from grade 2 to a grade 6, placing higher importance on the GMP certification issued by the European Union.

The medical bidding regulations are likely to be enforced starting in July, KPBMA said.

KPBMA officials talked with Levan Kham, insurance director of the Vietnamese Ministry of Health, and high-level officials from the Ministry of Health National Institute of Drug Quality to get detailed information on the changes of the bidding regulations in Vietnam, the status of the country’s health insurance system and drug quality management.

The Korean pharma association said that it would work to keep Korean exports classified as grade 2 products, emphasizing factors such as having PIC/S certification and status as a member state of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Officials from the two countries’ pharmaceutical associations will also sign a memorandum of understanding in mid-April to co-host the 2018 Future Cooperation Forum held in September.

“Korean pharmaceutical companies are planning to expand direct investment in the Vietnamese pharmaceutical market and increase their technology alliances and cooperation projects,” said Huh Kyung-hwa, vice chairman of the KPBMA. “The future cooperation forum will be held as part of mutual understanding and practical exchange and cooperation.”

The forum will focus on mutually understanding drug licensing and quality control systems of the two countries, introducing each side’s insurance and distribution system and sharing cases of industry-academia collaborations, as well as developing cooperation between firms through joint ventures and technology alliances.

"I am always impressed with the industry-academia cooperation and R&D activities of the Korean pharmaceutical industry,” said Chairman Nguyen Van Tuu of the Vietnamese pharmaceutical association. “We will actively participate in the future cooperation forum, which will serve as a platform for further development of the Vietnamese pharmaceutical industry.”

yjc@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>