(TN&MT) – On the morning of October 22, at the plenary session in the hall on some contents with different opinions of the draft Law amending and supplementing a number of articles of the Law on Pharmacy, Minister of Health Dao Hong Lan explained and clarified a number of issues raised by National Assembly deputies.
Emphasizing that medicine is an important commodity for the people, Minister of Health Dao Hong Lan said that thoroughly solving the problem of medicine shortage is a common problem for many countries, especially after the Covid-19 pandemic, not only in Vietnam. To solve this problem, Minister of Health Dao Hong Lan said that it is necessary to ensure many overall factors...
Accordingly, it is necessary to ensure the supply of drugs to the market; develop the domestic pharmaceutical industry; solve difficulties in procurement and bidding; organize implementation from the issue of circulation licensing, procurement, roles and responsibilities of ministries, branches, localities, medical facilities, etc.
Regarding e-commerce, Minister of Health Dao Hong Lan said that in practice there are still legal gaps, especially for specific items such as drugs. Therefore, the draft law only allows trading of drugs and pharmaceutical ingredients through e-commerce trading floors, e-commerce sales applications, and e-commerce sales websites with online ordering functions to clearly identify the legal entity responsible.
In addition, additional regulations are provided on the conditions for trading in drugs, subjects allowed to participate in trading, buyer information security, traceability, quality management, drug price management, consulting, instructions for drug use, drug delivery and transportation processes, and responsibilities of e-commerce business operators. Minister Lan said that this condition is to meet the legal basis in a type of business.
Emphasizing that this is a business type, businesses conducting e-commerce are still businesses that are actually operating, have licenses that fully meet the regulations on pharmaceutical business, not open to all types of drugs, including unregistered drugs. Currently, regulations only apply to businesses that already have licenses, business types can expand to another type but manage and handle violations.
Regarding the proposal to specify more preferential policies for the development of the pharmaceutical industry, Minister of Health Dao Hong Lan said that this is a content related to legislative techniques, because this content is closely related to other economic laws. If all policies are included in this draft Law, there will be a lot of them. "Therefore, during the process, any issues that need to be detailed and specific will be regulated in specialized laws. In this draft Law, we cannot specify the level, but we will refer to it to ensure the consistency and synchronization of the Vietnamese legal system," Minister of Health Dao Hong Lan stated clearly...
Regarding the content of pharmacy chain business, Minister of Health Dao Hong Lan affirmed that this is not new content, this content has been stipulated in the 2016 Pharmacy Law and in practice, many enterprises have implemented pharmacy chain business.
However, based on the assessment of the implementation from 2016 to present and summarizing the existing problems and difficulties to strengthen management and ensure the responsibility of pharmacy chain businesses, drug quality, and arising consequences, Minister of Health Dao Hong Lan said that this draft Law has also added regulations on the rights and responsibilities of pharmacy chain organizations; responsibilities of pharmacies in the chain; as well as specific regulations on pharmacies being responsible for all supply activities. That is, managing the root, not the tip. Thereby, businesses operating pharmacy chains will have to review, rectify, and ensure service quality for the people depending on their conditions and capacity.
Regarding the content of licensing, registration for circulation, and drug renewal, accepting the general guidance and on the basis of the shortcomings of the 2016 Pharmacy Law, Minister of Health Dao Hong Lan said that the draft Law has clearly stipulated the conditions for reference, recognition, and reduction of administrative procedures during the implementation process.
Minister Dao Hong Lan said that this is a very important law, the Drafting Agency and the Review Agency have fully absorbed the opinions of the National Assembly deputies and have received a very high consensus; hoping that the National Assembly deputies will vote to pass it at this Session to ensure compatibility.
It is necessary to create a healthy competitive business environment in pharmaceutical business activities.
Highly appreciating the draft Law on amending and supplementing a number of articles of the Law on Pharmacy, Delegate Tran Khanh Thu - National Assembly Delegation of Thai Binh province said that the draft Law submitted at the 8th Session had been reviewed by the presiding agencies, the drafting agency coordinated with relevant agencies to study, absorb a number of opinions; synthesize and explain the opinions of National Assembly deputies at the 7th Session, 15th National Assembly and the conference of full-time National Assembly deputies.
Commenting on the rights and responsibilities of foreign-invested pharmaceutical establishments (FIEs), delegate Tran Khanh Thu said that Article 32, Clause 1 of the Law on Pharmacy stipulates that the activity of “trading in the preservation of drugs and pharmaceutical ingredients” is an independent pharmaceutical business activity. Establishments providing drug and pharmaceutical ingredient preservation services are also listed in Clause 2, Article 32 as an independent pharmaceutical business establishment from wholesale or retail establishments of drugs and pharmaceutical ingredients. Therefore, when Clause 4, Article 53a stipulates that foreign-invested pharmaceutical establishments are not allowed to conduct drug and pharmaceutical ingredient preservation activities without clearly stating that these activities are related to sales, it inadvertently excludes the business rights of FIE enterprises for an independent business activity unrelated to drug distribution as stipulated in the Law.
The delegate of Thai Binh province emphasized that according to free trade agreements such as WTO, CPTPP, EVFTA, ... Vietnam has not committed to opening up pharmaceutical distribution but does not reserve market access rights for foreign investors in the logistics sector. According to its commitment in the WTO, Vietnam has removed the restriction on the capital contribution ratio of foreign investors in the logistics sector after 07 years since joining - that is, since 2014, Vietnam has no longer restricted foreign investment in this sector.
If FIEs are granted more rights, it will affect the interests of domestic enterprises, especially those that have focused on investing in construction and providing warehouse and logistics services in the distribution of drugs and pharmaceutical ingredients in the past. In addition, most countries in the region and in the world with developed pharmaceutical industries such as India, South Korea, and Singapore have implemented open-door policies in the field of pharmaceutical distribution and logistics, and these policies have had a positive impact on mobilizing and attracting foreign investment to improve the development capacity of domestic enterprises.
Source: https://baotainguyenmoitruong.vn/bo-truong-dao-hong-lan-luat-duoc-quy-dinh-chat-che-ve-dieu-kien-kinh-doai-thuoc-tren-moi-truong-thuong-mai-dien-tu-381975.html
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