Vietnam New Drug Regulations Improve Access

Vietnam is facing significant health challenges, including high rates of heart disease and cancer, as the country is experiencing a rapidly growing middle class and strong economic development. With over 97 million people, Vietnam’s demand for better healthcare services, including access to advanced drugs, is increasing. In response, Vietnam’s Ministry of Health has proposed changes to the country’s Pharmacy Law to speed up the process of getting innovative drug products into the market while ensuring public safety.

The proposed changes are part of a draft law expected to be reviewed and potentially approved by the National Assembly on October 10, with plans to implement the new regulations starting in late 2024. The goal is to make it easier and faster to bring new drugs into Vietnam, encouraging medical tourism and improving access to treatments for Vietnamese citizens.

According to data from IQVIA MIDAS from early 2022, Vietnam has access to only 42 new drugs, or 9% of the 460 drug types introduced globally over the past decade. This is significantly lower than the 20% average in the Asia-Pacific region. The limited availability of new drugs affects treatment options for serious conditions like cancer. Currently, only three immunotherapy drugs are approved in Vietnam, while many others are utilized internationally.

The difficulty in accessing new medications has led to an estimated 60,000 Vietnamese patients seeking treatment abroad annually. Additionally, the cost of some drugs not covered by Vietnam’s health insurance is a major hurdle, with patients on average paying 40% of their medical expenses out of pocket.

The Ministry of Health’s proposal aims to address these challenges by making it easier to approve and bring new drugs to the Vietnamese market, improving healthcare access, and reducing the need for patients to seek treatments abroad.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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