HM&P lawyers present their contributions at the Workshop on improving the Draft Decree guiding the Pharmaceutical Law

At the invitation of the Vietnam Chamber of Commerce and Industry (VCCI), on February 20, 2025, Lawyer Nguyen Nhat Duong and Lawyer Cao Nguyen Bao Lien from HM&P Law Firm (“HM&P”) participated in and presented their contributions at the workshop titled “Contributing to the Improvement of the Draft Decree Guiding the Amendment and Supplementation of Certain Provisions of the Pharmaceutical Law” held at the Pullman Saigon Centre Hotel, Ho Chi Minh City.

The workshop was organized by VCCI in collaboration with the Drug Administration of Vietnam, Ministry of Health, with the goal of providing a forum for state management agencies, legal experts, and business representatives in the pharmaceutical sector to exchange ideas and contribute suggestions to refine and complete the legal framework for the pharmaceutical industry in Vietnam moving forward.

As a law firm with specialized expertise in the pharmaceutical and cosmetics sectors, HM&P presented key and valuable opinions at the workshop to ensure that the provisions in the Draft Decree are not only comprehensive and up-to-date with global advancements but also practical, feasible, and effective for implementation in practice.

At the workshop, Lawyer Nguyen Nhat Duong and Lawyer Cao Nguyen Bao Lien presented and contributed several important suggestions.

1. Supplementing criteria for the quality control of traditional medicine

One of the prominent issues raised by HM&P was the lack of specific technical criteria for the quality control of traditional medicine in Article 22 of the Draft Decree, particularly concerning imported medicines. This omission could lead to difficulties in inspection and post-market surveillance, resulting in challenges in controlling the quality of medicines in the market. To address this issue, Lawyer Duong proposed:

“In order to ensure the quality of traditional medicines circulating on the market, specific technical criteria and regular monitoring procedures should be added. This not only helps improve the quality of pharmaceuticals but also protects consumers from the risks of substandard medicines.”

Source: VCCI

2. The process for evaluating foreign qualifications needs clarification

Another critical issue raised by HM&P Lawyers at the workshop was the process and criteria for evaluating the equivalency of foreign qualifications and certificates. The Draft Decree requires the legalization and notarization of documents and professional qualifications issued by foreign institutions, but does not clarify the process or criteria for determining equivalency to define the scope of professional practice. Lawyer Duong emphasized that establishing a clear and transparent evaluation process, with both quantitative and qualitative criteria, would facilitate the issuance of professional licenses for businesses, ensuring fairness between individuals holding domestic and foreign qualifications.

3. Improving regulations on pharmaceutical chains to reduce administrative procedures

Currently, pharmaceutical companies must establish each retail pharmacy individually and submit separate registration applications for operating a pharmaceutical chain, regardless of whether they are operating as a chain. Lawyer Duong pointed out that this process incurs significant time and cost, even when the number of pharmacies within the chain is large. To address this, HM&P recommended allowing businesses to register pharmaceutical chains with a single consolidated application and clearly defining the criteria for scale, quality, facilities, and staffing. This approach would help reduce complex administrative procedures and enhance transparency and efficiency in managing pharmaceutical chains.

4. Need for stricter monitoring mechanisms for online pharmaceutical sales

In addition, the issue of selling medicines via e-commerce platforms was a major point of focus for HM&P Lawyers. Although the Draft Decree includes regulations on posting information and verifying customer data in online pharmaceutical sales, it still lacks effective post-market control and monitoring mechanisms. Lawyer Duong emphasized:

“Selling medicines online offers convenience but also presents many risks. Without strict control mechanisms, it is difficult to prevent counterfeit and untraceable medicines from circulating on e-commerce platforms. Therefore, the Draft Decree should clearly define the responsibilities of regulatory authorities and other involved parties.”

Furthermore, Lawyer Cao Nguyen Bao Lien pointed out that e-commerce platforms lack responsibility for verifying information and ensuring the quality of medicines, which increases the risk of counterfeit and substandard products being sold through online marketplaces. To ensure transparency and safety in online pharmaceutical sales, HM&P recommended adding a strong, periodic monitoring system and clear violation handling procedures. This monitoring mechanism would not only help guarantee the quality of medicines but also protect consumers from unsafe products when shopping on e-commerce platforms.

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