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After nearly seven years of implementation, the Law on Pharmacy No. 105/2016/QH13 has made an important contribution to improving the legal framework for Vietnam’s pharmaceutical sector. However, in the context of strong market fluctuations, increasing requirements for international integration, and particularly the practical lessons learned from the COVID-19 pandemic, many existing regulations have revealed shortcomings and are no longer suitable for current management practices as well as pharmaceutical manufacturing and business activities.
This not only creates difficulties for enterprises but also directly affects the ability to ensure a stable drug supply in emergency situations. Therefore, the amendment and supplementation of the 2016 Law on Pharmacy is considered an urgent requirement to remove bottlenecks and promote the development of the pharmaceutical industry in a modern and sustainable direction.
At the workshop “Consultation on Improving the Law on Pharmacy”, According to Mr. Phạm Ngọc Thạch – Deputy Head of the Legal Department of the Vietnam Chamber of Commerce and Industry (VCCI) – stated that amending the Law on Pharmacy will contribute to promoting legal reform in the pharmaceutical sector, creating favorable conditions for domestic production to grow, while also expanding trade and investment opportunities in the healthcare sector between Vietnam and international economies.
I. Clarification of Key Concepts Needed
Theo According to Mr. Phạm Ngọc Thạch, the 2016 Law on Pharmacy serves as an important legal foundation that has enabled the stable development of the pharmaceutical sector and effectively supported public healthcare. However, after many years of implementation, particularly during the COVID-19 pandemic, numerous provisions have revealed legal gaps and a lack of consistency with the practical operations of enterprises as well as the increasingly deepening trend of international integration.
Để khắc phục những tồn tại này, Ministry of Health To address these shortcomings, the Ministry of Health has been assigned to lead the development of a draft Law amending and supplementing several provisions of the Law on Pharmacy. The draft focuses on several key areas such as drug marketing authorization, pharmaceutical ingredients, quality management, drug pricing, and pharmaceutical business activities. These are all issues that have a direct impact on enterprises in the sector.
Although the drafting agency’s efforts have been highly appreciated, many businesses believe that the current draft still contains several issues that need further refinement.
Representing AstraZeneca Vietnam, Ms. Vũ Thị Hiệp proposed adding a definition for “clinical trial drugs.” According to her, although both the current Law on Pharmacy and the draft amendments mention activities related to clinical trial drugs, the absence of a clear definition may lead to disputes in import activities and post-marketing inspection, and create difficulties for companies operating in this field.
Meanwhile, representatives of Traphaco recommended reviewing definitions such as “chemical drugs", “traditional medicines", “herbal medicines", “traditional medicinal ingredients" and “pharmaceutical ingredients". The enterprise noted that it is necessary to assess whether the definition of “traditional medicine” in the draft fully covers all current types of medicines, and also proposed adding a category for drugs combining pharmaceutical active ingredients with herbal components.
From an academic and professional perspective, TS. DS Nguyễn Thị Phương Thúy - Hanoi University of Pharmacy, argued that the concept of “pharmaceutical practice” does not yet fully reflect the reality of the industry. She suggested adding provisions related to pharmaceutical care services at healthcare facilities and retail pharmacy systems. At the same time, she also proposed introducing concepts of pharmacoeconomic evaluation and health technology assessment in the pharmaceutical field to align with international practices and support the development of more effective health insurance policies.
In addition, the Vietnam Pharmaceutical Association has proposed abolishing the requirement for renewal of marketing authorization for drugs and pharmaceutical ingredients that have been stably circulated, proven to be of quality, and have not incurred any violations. According to the Association, maintaining renewal procedures in such cases is not truly necessary.
To balance regulatory requirements with administrative reform, the Association proposed that the Ministry of Health apply a declaration-based renewal mechanism for drugs that fully meet safety, efficacy, and circulation duration requirements. It also suggested assigning the Government to provide detailed regulations on renewal procedures to ensure flexibility in the roadmap for administrative simplification.
II. Consideration of Regulations on Drug Transportation and Storage
One of the issues that received significant attention at the workshop was the regulation related to drug transportation and storage services for foreign-invested enterprises (FDI).
Mr. Nguyễn Văn Quynh – Principal Officer of the Department of Science, Education, Culture and Social Affairs, Government Office – stated that current provisions under Decree 54, which prohibit FDI enterprises from providing drug transportation and storage services, have sparked considerable debate in recent years. According to him, if such provisions are to be included in the law, a comprehensive assessment of the legal basis, practical feasibility, and impact on the pharmaceutical distribution market is necessary.
Mr. Quynh also noted that although Vietnam has not committed to opening its pharmaceutical distribution market under the WTO, CPTPP or EVFTA, it has already opened up logistics services to foreign investment. Therefore, the inclusion of drug transportation and storage services within the scope of pharmaceutical distribution should be carefully considered to avoid overlap or a lack of clear legal grounding.
From this perspective, current practice shows that restrictions on FDI enterprises participating in drug storage and transportation services have not been effectively enforced. At the same time, regulators need to clearly assess the risk of FDI enterprises potentially leveraging logistics activities to influence the pharmaceutical distribution market.
In addition, the issue of protecting domestic enterprises also requires careful analysis. There is currently insufficient practical evidence to conclude that domestic companies are fully capable of independently controlling drug distribution activities in the market.
From the perspective of domestic industry stakeholders, Mr. Nguyễn Thế Tin – Chairman of the Vietnam Pharmaceutical Association – stated that the draft has added drug transportation services to the list of conditional business sectors, as this stage directly affects drug quality.
However, according to Mr. Tin, drug transportation in practice is highly diverse, including road, rail, waterway, and air transport. Therefore, it is necessary to clearly define the scope of the new regulation to avoid complications during implementation.
He also recommended that instead of creating an additional conditional business category, regulators should focus on developing specific technical standards for drug transportation activities. This would both ensure storage quality and maintain the ability to supply drugs to the market in a fast and safe manner.
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