On February 19-20, the Vietnam Federation of Commerce and Industry (VCCI) coordinated with the Department of Drug Administration (Ministry of Health) to organize a workshop to collect business opinions to complete the draft Decree detailing a number of articles and guiding the implementation of the Law on Pharmacy, to be promulgated by the National Assembly in 2024 in Hanoi and Ho Chi Minh City.
The issuance of this Decree aims to promptly remove difficulties and obstacles stipulated in the Decrees guiding the implementation of the 2016 Pharmacy Law.
According to Deputy Secretary General and Head of the Legal Department of VCCI Dau Anh Tuan, many contents have been revised, absorbed and amended in the Law amending and supplementing a number of articles of the Pharmacy Law, which was recently passed by the 15th National Assembly in November 2024, demonstrating the spirit of innovation and reform of administrative procedures, aiming to create favorable conditions and help improve the competitiveness of domestic enterprises in the pharmaceutical industry; the contents on drug quality control have been adjusted to create conditions for people to access safe and effective drugs.
Therefore, the issuance of implementing documents is very important to bring the provisions and spirit of this law into life, contributing to the development of the Vietnamese pharmaceutical industry in a professional and modern direction, improving production capacity, management and quality control of pharmaceuticals.
Representative of the Drug Administration of Vietnam (Ministry of Health), Mr. Chu Dang Trung, Head of the Legal - Integration Department, informed about the purpose, viewpoints on building the Decree, the structure of the draft Decree and the proposed amendments and supplements.
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| Overview of the Workshop to collect opinions from businesses to complete the draft Decree detailing a number of articles and guiding the implementation of the Law on Pharmacy. (Source: VCCI) |
Accordingly, the most prominent issues are the issue of pharmacy practice certificates, pharmaceutical business by e-commerce, regulations on special control drugs, export of special control drugs, criteria for requesting import licenses in some cases, authority to grant import licenses for drugs without circulation registration certificates and on the supply and transfer of drugs without circulation licenses that have been granted import licenses in some cases.... In addition, there are a number of other important contents such as regulations on information, drug advertising, drug price management, investment incentive policies and implementation provisions of the Decree...
Appreciating the efforts of the drafting agency, representatives of enterprises and associations present at the Workshop gave many positive comments to help build and perfect the draft Decree.
Ms. Dao Thu Nga, Sanofi Vietnam Joint Stock Company, said that it is necessary to review the regulations on cases of petitions regarding the expected wholesale prices of drugs that have been announced and re-announced. Specifically, the company recommends amending the direction of considering only referencing prices in the country of origin or ASEAN (if any) to ensure consistency with current regulations being implemented in practice. In addition, the price reference also needs to balance different factors between the referenced countries, avoiding inadequacies in the implementation process, limiting access to new drugs for Vietnamese patients.
Regarding the content of drug information, Mr. Tran Trung Thanh, representative of Pfizer Vietnam, proposed that the Ministry of Health issue a circular or specific guidance document to allow businesses to provide updated scientific information and updated clinical research information (outside of registered drug information) to medical staff quickly and comprehensively.
Similarly, regarding the content of importing drugs without a circulation registration license, Mr. Thanh also said that there are no specific instructions from the Ministry of Health for importing cancer drugs and A-infection drugs that have been licensed by the US FDA and EMA.
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| The issuance of this Decree aims to promptly remove difficulties and obstacles stipulated in the Decrees guiding the implementation of the 2016 Pharmacy Law. (Source: VTV) |
Concerned about the legal issues in the coming time for online pharmaceutical business, Ms. Tran Thi Huyen, Head of Legal Department of FPT Long Chau Pharmaceutical Joint Stock Company commented that Article 45 of the Draft (regulations on posting information when conducting pharmaceutical business by e-commerce method), guides information and documents to be displayed on trading floors, applications and e-commerce websites, but these 3 e-commerce methods have different operating mechanisms. Meanwhile, the unit owning the application and website is the business unit.
Therefore, Ms. Huyen proposed to clarify that the Certificate of Eligibility for Pharmaceutical Business and the Certificate of Practice of the person in charge of the professional are those of the pharmaceutical business unit. In case the business unit on the e-commerce platform/e-commerce service website, e-commerce service application is not the owner of these platforms, websites, applications, it cannot be displayed on the main screen of the homepage as stipulated in Clause 1, Article 45 of the Draft, so "it is necessary to consider detailed regulations to avoid problems arising during implementation".
On the other hand, according to Ms. Huyen, for the business activities of the pharmacy chain organization when doing e-commerce business, "The Certificate of eligibility for pharmaceutical business, the Certificate of practice of the person in charge of the profession must be shown as the Certificate of the chain organization or the Certificate of the pharmacies in the chain".
In addition to the above contents, the business community also expressed interest in a number of other important contents in the Draft Decree such as licensing/confirming import orders for drugs with registration numbers; regulations on importing rare drugs and drugs without registration numbers; preferential policies in drug procurement, price maintenance and discount policies, etc.
Source: https://baoquocte.vn/kip-tho-i-go-vuong-cho-doanh-nghiep-nga-nh-duoc-305111.html
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