Foreign drug firms expect further business improvements in Vietnam

Executives of foreign drug companies in Vietnam have proposed to Prime Minister Pham Minh Chinh legal and administrative improvements to make the market more attractive to foreign investors.

The suggestions were made at a business dialog between the government and foreign investors on Saturday.

“In terms of pharmaceuticals, we’re pleased to see continuous improvements and expect Vietnam to speed up the issuance of marketing authorizations for medical devices and pharmaceuticals,” said Nitin Kapoor, co-chairman of the Vietnam Business Forum (VBF) and chairman of AstraZeneca Vietnam.

“We hope Vietnam will have a specific procurement mechanism for medical equipment and consumables in the amended law on bidding and relevant rules.”

Kapoor said the FDI sector applauds Vietnam’s revisions to the Pharmacy Law that aim to address challenges such as warehousing and transportation restrictions for FDI firms and the removal of country-specific requirements to harmonize Vietnamese processes with regional and global standards.

EuroCham chairman Gabor Fluit said his organization emphasizes improvements for access to pharmaceuticals and medical devices through optimized management processes and global best practices. This requires value-based financing and procurement policies to be revised by the Pharmacy Law.

“We highly appreciate the recent implementation of Decree 07 and Resolution 30, which has contributed to overcoming the shortage of medical supplies and ending the interruption of testing, diagnosis and treatment at hospitals.

“We also acknowledge the efforts by the Ministry of Health in approving marketing authorizations for the backlog of Class C and D medical devices and new submissions, contributing to providing better access to high-quality healthcare services at reasonable costs,” he said.

Emin Turan, CEO of Sanofi Vietnam, raised three major issues at the business meeting.

The first is to improve the effectiveness of regulations, he said.

“By 2021, there were 460 globally advanced drugs made across the world but only 9% of them appeared in Vietnam. This rate is low, and lower compared to many countries worldwide and in the Asia-Pacific region."

Turan said the reasons included policy barriers, administrative delays in drug registration, and fast policy changes, which affect the time it takes to get access to medicines, especially new products. “This also hinders investment activities in the pharmaceutical industry.”

Due to these obstacles, a new drug or vaccine will only be available in public hospitals eight years from the time of filing a domestic application. This period is very long and not good for the investment decisions of drug firms, he said.

The Sanofi Vietnam CEO added: “We’d like Vietnam to pay more attention to the following policies.”

The first is Decision 1661 issued in October 2021 by the Prime Minister. “We want this decision to be implemented towards the goal of eliminating administrative barriers, and we hope that amended Decree 54 in 2023 will reflect the improvements in this decision.”

Secondly, it is necessary to speed up the registration time by applying WHO recommendations on the reliability of mechanisms and policies.

Turan also called for a shorter delivery time of new drugs to public hospitals. "We recommend an annual review process for new drugs to be eligible for use in public hospitals instead of the current cycle of four to five years.

"Vietnam should also allow patients to choose at public hospitals’ pharmacies even before the above-mentioned drugs become available."

Greg Testerman, chairman of AmCham Vietnam in Ho Chi Minh City, proposed procedures licensing food and medicine products to be adjusted in line with global standards, including the amendments to the Pharmacy Law.