Strict control over the sale of medicines through e-commerce.

(CPV) - The draft Law amending and supplementing a number of articles of the Law on Pharmaceuticals proposes adding regulations on the business of pharmacy chains and the business of medicines and pharmaceutical raw materials through e-commerce.

Continuing the agenda of the 32nd session, on the afternoon of April 16th, the Standing Committee of the National Assembly gave its opinion on the draft Law amending and supplementing a number of articles of the Law on Pharmaceuticals.

Reporting at the session, Minister of Health Dao Hong Lan stated that, compared to the current law, the draft Law amends and supplements 43 articles, including: amending 40 articles, adding 3 articles, and abolishing 4 points and 2 clauses.

One of the notable contents of the draft law is the amendment and supplementation of some regulations on the organization and restructuring of the business and distribution system of medicines and pharmaceutical raw materials; and the authority to issue pharmaceutical practice certificates.

The Standing Committee of the National Assembly gives its opinion on the draft Law amending and supplementing a number of articles of the Law on Pharmaceuticals (Photo: National Assembly)

According to Minister Dao Hong Lan, the draft law supplements several regulations related to the drug distribution rights of FIE pharmaceutical businesses, adjusting the distribution rights of these enterprises to ensure they are consistent with practical realities. It also adds several business models and conditions for chain pharmacy businesses, e-commerce drug businesses, and the rights and responsibilities of these businesses; and includes regulations on granting Certificates of Eligibility for Pharmaceutical Business to public service units that collect fees in pharmaceutical activities.

In addition, the draft law amends the regulations on business conditions for drugs requiring special control according to the plan approved in Decision No. 1661/QD-TTg.

On the other hand, the Standing Committee of the Social Affairs Committee proposed adding the authority of the Ministry of Public Security and the Ministry of National Defense to issue, reissue, adjust the content, and revoke pharmaceutical practice certificates for those in charge of clinical pharmacy work at medical examination and treatment facilities under their management. After reviewing this content, the Standing Committee found that this addition is necessary to meet practical requirements, but suggested clarifying the meaning of "pharmacy chain business," specifically the regulations on establishment conditions, operating methods, and management mechanisms to ensure feasibility and consensus. Regarding the e-commerce business of medicines and pharmaceutical raw materials, more specific regulations are needed on the types of medicines allowed, the forms of e-commerce business, and the eligible participants to ensure transparency and user safety. If regulations on e-commerce retail sales are implemented, they should only apply to over-the-counter drugs. In addition, regulations on e-commerce need to be reviewed to ensure compliance with the Law on Electronic Transactions. Speaking at the session, National Assembly Chairman Vuong Dinh Hue assessed that the preparation and drafting of the Law project had made significant progress in terms of thinking regarding pharmaceutical management; the draft law was meticulously and seriously prepared; and the scope of amendments was extensive. He also noted that although only preliminary review was conducted, the opinions of the Social Committee were very insightful and comprehensive. Regarding the specific issue of the draft law adding regulations on new forms and methods of business, the National Assembly Chairman emphasized that medicine is a very special type of commodity, so a balance must be found between facilitating producers and businesses and protecting the health of the people.

“Medicine is a very special commodity, directly affecting people's health, therefore the sale of medicine in general and the sale of medicine through e-commerce must be very strictly controlled, and the specific impact needs to be assessed,” the Chairman of the National Assembly emphasized and requested the Drafting Committee and the Social Affairs Committee to coordinate to regulate this new business method more specifically and strictly. Accordingly, he suggested careful consideration, based on an assessment of the benefits, risks, and consequences for patients when buying medicine online; an assessment of the level of control by state management agencies; and a study of the experiences of other countries around the world on this issue. Referring to the draft law stipulating that retail pharmacies are allowed to sell medicines on the list prescribed by the Ministry of Health through e-commerce in accordance with the scope of business in their business license, the Chairman of the National Assembly raised the question: if a pharmacy is part of a chain of pharmacies sharing a single website, how will people identify where to buy the medicine? Who is selling it? Furthermore, it is necessary to clarify how businesses with retail chains selling medicines to the public will be held accountable in the event of specific incidents. The Chairman of the National Assembly also requested clarification on the degree of freedom and equality in business between individual retailers and retail chains. “Currently in our country, most businesses are small retail stores, while retail chains are very rare. Therefore, it is necessary to assess the impact of policies for retail chains on retail establishments more thoroughly, especially in coordination with the Vietnam Chamber of Commerce and Industry (VCCI) and the Ministry of Planning and Investment to consider the issue of equality and non-discrimination in business,” the Chairman of the National Assembly emphasized. Noting that the most important issue in chain business is legal matters, the Chairman of the National Assembly requested a more thorough review of procedures and legal responsibilities, such as: What procedures should be followed when opening a new retail outlet within a pharmacy chain? Which outlets are allowed to sell directly to customers, or should all pharmacies in the chain sell through e-commerce? If only a limited number of establishments are allowed to sell, how will the responsibility of pharmacies for quality and issues arising that affect customer rights be addressed? At the meeting, members of the National Assembly Standing Committee also discussed the State's policy on pharmaceuticals and industrial development; administrative procedure reform, strengthening decentralization and delegation of authority in pharmaceutical management; and drug price management…/.

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