On 6 November 2024, EuroCham Vietnam’s Vice Chair for Advocacy, Mr. Jean-Jacques Bouflet, led a strategic discussion with Mr. Ulrich Weigl, Minister Counsellor and Head of Trade Section at the EU Delegation to Vietnam, to address opportunities and challenges within Vietnam’s pharmaceutical and medical device sectors. Also in attendance were Mr. Ky-Anh Le, Economic and Trade Specialist at the EU Delegation, along with key representatives from EuroCham’s sector committees, including Mr. Gregory Charitonos, Chairman of the European Standards Medicines Sector Committee (ESM SC); Mr. Attila Molnar, Vice-Chair and Treasurer of ESM SC; Mr. Qadeer Raza, Chairman of the Medical Devices and Diagnostics Sector Committee (MDD SC); and Ms. Thuy Nguyen, Director of Pharma Group. Support from EuroCham’s team included Mrs. Diep Truong, EuroCham Advocacy Manager, and sector coordinators Mr. Khoa Nguyen, Ms. Hanh Nguyen, and Mr. Trung Luong.
The meeting underscored the critical need for regulatory improvements to support Vietnam’s healthcare sector, with a focus on aligning with international standards to drive growth and attract investment. These industries are vital to Vietnam’s export economy and healthcare system, making regulatory alignment essential for sustainable development.
Pharmaceuticals: The sector continues to face delays in marketing authorizations (MAs), with only a small percentage of global new medicines available in Vietnam. Public procurement, which constitutes the majority of the market, remains an essential distribution channel but is hampered by prolonged approval processes. Upcoming legislative updates, including the Pharma Law and revisions to the National Reimbursement Drug List (NRDL), are expected to improve market access. However, transitional challenges are anticipated, including resource shortages and administrative bottlenecks. Simplified procedures and capacity-building support from international partners are seen as critical for smooth implementation.
Stakeholders also highlighted the slow approval process for variations and the lack of incentives for investment in technology transfer and local manufacturing. Despite companies’ efforts to meet compliance standards, regulatory gaps continue to deter high-value investments. Stronger government engagement and more transparent feedback mechanisms were urged to align incentives with global practices.
Medical Devices: Vietnam’s dependence on imports, which account for the vast majority of the sector, remains a key issue. Public procurement practices currently favor volume over value, posing challenges for high-quality international products. Inconsistent price declaration processes and unclear guidelines for new regulations further hinder market growth. Additionally, stakeholders emphasized the critical role of software and AI in medical devices, noting that without proper reimbursement mechanisms, these innovations may struggle to reach their potential.
The current procurement system often places imported products in less favorable tender categories, limiting their competitiveness. Without reforms, including strategic investment in diagnostic tools, Vietnam risks missing opportunities for early detection and better healthcare outcomes.
The Way Forward: The meeting underscored the importance of ongoing regulatory cooperation and capacity building. Leveraging international expertise can help Vietnam align its healthcare standards with global norms. Proposals include technical exchanges, training programs, and regulatory guidance to ease the implementation of new policies.
Both sides recognized the need for clearer regulations and streamlined procedures to enhance predictability and transparency in Vietnam’s regulatory environment. Strengthened collaboration will not only boost Vietnam’s healthcare system but also deepen trade relations, fostering innovation and economic growth. By addressing these regulatory challenges, Vietnam can better position itself as a competitive and sustainable player in the global healthcare market.
