Pharma law upgrades will improve effectiveness

This time, the Law on Pharmacy is partially revised, aiming to achieve five policy objectives: ensuring adequate supply of quality medicines at reasonable prices; institutionalising orientations to address shortcomings arising from the practical implementation of the current law; developing the pharmaceutical industry; ensuring the rational use of medicines; and reviewing the distribution and supply system of drugs.

Darrell Oh, chairman, Pharma Group

As the voice of the innovative pharmaceutical industry in Vietnam for over 25 years, Pharma Group has actively contributed to the law revision process since its inception. We are excited about the key improvements in the new law and greatly appreciate the drafting committee’s efforts to consult the industry and various stakeholders throughout the revision process.

From the industry’s perspective, the new law introduces positive regulations expected to significantly benefit patients and the pharmaceutical industry. Highlights include streamlining the drug registration process to enhance patient access and prevent supply disruptions and introducing clearer incentives to foster the development of a high-value pharmaceutical industry.

Details of new positive policies are regulations to shorten the timeline for registration of medicines that are in line with global trends, best practices. Specifically, a regulatory reliance mechanism will speed up access to new medicines, vaccines, and biologics.

Based on the industry’s latest estimates, it takes over 4.2 years on average for innovative medicines, vaccines, and biologics to be approved in Vietnam. Thus, with effective implementation of a new regulatory mechanism, it is highly expected that patients in Vietnam can access these in a matter of months, not years, after they are approved and made available in advanced countries.

This will also bring additional scientific expertise from world-leading health authorities to support Vietnam in the regulatory process, while maintaining Vietnam’s independence in decision-making.

This is in line with global trends to shorten the timeline for medicine registration in the context of increasing number of drug registration due to speed of innovation.

The revision also simplifies the marketing authorisation renewal process, allowing companies to maintain validity while awaiting renewal decisions. This change mitigates the risks of supply disruptions and reduces the admin burden for both the health regulator and companies.

The strong commitment and efforts to develop the pharmaceutical sector are evident in the new incentives introduced to encourage clinical trials and the local manufacturing of innovative medicines. We look forward to the effective implementation of these incentives for the pharma sector development, led by the National Steering Committee, for improving the sector’s attractiveness and increasing Vietnam’s competitiveness, especially compared to other ASEAN countries in a long-term vision.

We appreciate the efforts of the drafting team, government, and National Assembly over recent months around the key objectives of this law revision with patient-centric discussions.

This revision brought concrete improvements and provided a solid legal framework for accelerating patient access to innovative medicines, and is also a step in the right direction in strengthening the pharmaceutical sector.

The forthcoming decree, circulars, and joint effort towards effective implementation of the changes will play a vital role in realising the law’s advancements. To ensure the effective implementation of the new pharma law, it is important to expect that capacity-building initiatives for both regulator and the industry will be facilitated.

Further expectations about legal changes for FIEs With legal improvements in the draft amendments to the Law on Pharmacy 2016, foreign-invested enterprises are expected to get thumbs-up for future performance. Darrell Oh, chairman of the Pharma Group, discussed with VIR’s Bich Thuy about what lies ahead.

Pharma Group expects new pharmaceutical law to open up potential Appreciative of the potential of Vietnam's pharma sector Darrell Oh, Pharma Group chairman, spoke with VIR's Nguyen Huong about some of the outstanding development and innovation in the industry.