Seeking comments on the draft Law amending and supplementing a number of articles of the Law on Pharmacy

To meet urgent needs and adapt to changes in the socio-economic context, it is necessary to develop a draft law amending and supplementing a number of articles of the Law on Pharmacy.

Dr. Phan Xuan Dung delivered the opening speech at the Workshop to collect comments on the draft Law amending and supplementing a number of articles of the Law on Pharmacy. (Photo: Thu Hang)

This morning (October 23), in Hanoi, the Vietnam Union of Science and Technology Associations (Vietnam Union of Associations) in coordination with the National Assembly's Social Committee and the Vietnam Pharmaceutical Association organized a "Workshop to collect comments on the draft Law amending and supplementing a number of articles of the Pharmacy Law".

In his opening speech, Dr. Phan Xuan Dung, Chairman of the Vietnam Union of Science and Technology Associations, affirmed that the Law on Pharmacy passed by the 13th National Assembly in 2016 marked an important step in perfecting the legal system on pharmacy in Vietnam. After 8 years of implementation, the Law is basically consistent with the development of the pharmaceutical industry in the trend of international integration and has made important contributions to the development of our country's pharmaceutical industry.

However, in the face of urgent practical requirements and demands, the pharmaceutical legal system has revealed a number of limitations and inadequacies. Specifically, a number of regulations related to drug and pharmaceutical ingredient registration are not consistent with the administrative reform policy; a number of regulations on drug quality management are not consistent with the policy of decentralization of management.

At the same time, some policies on pharmaceutical industry development have not created a breakthrough for the Vietnamese pharmaceutical industry in the new situation. Regulations on drug price management are not suitable for practice as well as newly issued price laws; some regulations on business and types of pharmaceutical business need to be adjusted to meet the development and integration trend.

In addition, some regulations related to drug information and advertising are not consistent with the administrative reform policy; some regulations on drug registration, production, export, import and supply are not suitable or have not been regulated to be implemented in emergency cases to meet the needs of disease prevention and control, security and national defense.

Therefore, to meet urgent needs and adapt to changes in the socio-economic context, it is necessary to develop a draft law amending and supplementing a number of articles of the Law on Pharmacy.

Sharing his views, Associate Professor, Dr. Le Van Truyen, senior expert in Pharmacy, former Deputy Minister of Health, highly appreciated the draft Law amending and supplementing a number of articles of the Pharmacy Law, which has demonstrated two main goals. That is, ensuring the people's right to access and use drugs reasonably, safely and effectively. At the same time, ensuring effective policies for the development of the pharmaceutical industry, management of drug production and trading activities, drug quality and drug prices so that people can access good drugs at prices appropriate to the country's socio-economic development level and the development of information technology in the 4.0 Industrial Revolution.

In particular, Article 47a in the draft has very specifically stipulated "Rights and responsibilities of the pharmacy chain organization and the pharmacies in the pharmacy chain".

According to Associate Professor, Dr. Le Van Truyen, these regulations meet the practical situation that in the past 10 years, many large-scale pharmacy chains have appeared in Vietnam (FPT Long Chau, Pharma City...) while the 2016 Pharmacy Law does not have regulations on this form of pharmaceutical retail business.

Besides, a very big problem in pharmaceutical management is drug registration, which has been supplemented and amended in Article 56 on "competence, records, procedures, time limit for granting, extending, changing, and supplementing registration certificates for circulation of drugs and pharmaceutical ingredients".

Associate Professor, Dr. Le Van Truyen emphasized that this is a major problem that has existed in the past, leading to a backlog of tens of thousands of drug registration dossiers, causing difficulties and congestion in production, business activities and ensuring drugs to serve people's health care and protection, especially during the Covid-19 pandemic.

However, Mr. Le Van Truyen suggested that the draft have a separate chapter on "Vietnam's Drug Administration" regulating the organization, functions, tasks, and powers. In the context of integration, it is necessary to study the Food and Drug Administration (FDA) model which is very popular in the world such as: US-FDA (United States), K-FDA (Korea), C-FDA (China)...

Speaking at the workshop, Dr. Pham Van Tan, former Vice President and General Secretary of the Vietnam Union of Associations, said that currently in our country, people can go to a pharmacy to buy any type of medicine they need if the pharmacy has it.

To protect consumer rights, Dr. Pham Van Tan proposed to supplement the content of the Draft Law on the sale of drugs at drug stores to consumers with 2 groups. That is, the group with a prescription prescribed by a doctor at a medical examination and treatment facility and the group without a prescription. At the same time, clearly stipulate which types of drugs must be sold to customers with a prescription prescribed by a doctor and which types of drugs customers can buy without a prescription.

Sharing his views on selling drugs via e-commerce, Mr. Nguyen The Tin, Chairman of the Vietnam Pharmaceutical Association, said that this needs to be strictly controlled. The goal is for people to be able to buy drugs easily and safely, with a doctor's prescription and full consultation, right person, right disease, and monitoring of drug reactions...

The draft stipulates that retail establishments are allowed to sell drugs on the list prescribed by the Ministry of Health that are allowed to be sold via e-commerce and in accordance with the scope of business. "If it is a pharmacy in a chain sharing a website, how will people determine where to sell?", Mr. Nguyen The Tin wondered.

In principle, wholesale companies (achieving GDP) are not allowed to retail to people. This issue needs to be clarified when businesses have retail chains selling drugs to people, because it is related to the responsibility of each entity when handling the case.

The problem of counterfeit goods on the Internet is a new front, causing great difficulties for the authorities because it is difficult to handle in reality, and even more difficult to detect and handle violations in cyberspace. From this reality, Mr. Nguyen The Tin proposed that the draft Law have clearer and stricter regulations on this new business method.

At the workshop, experts focused on discussing and contributing opinions on issues such as adequate and timely supply of quality drugs for people's disease prevention and treatment needs; adequate and timely supply of drugs to meet security and defense requirements, overcoming the consequences of natural disasters, and preventing epidemics. Improving the efficiency of management of import and export of drugs and pharmaceutical ingredients; developing the pharmaceutical industry. Developing drugs, pharmaceutical ingredients, and medicinal materials from available domestic medicinal materials. Regarding the system of trading and distributing drugs and pharmaceutical ingredients and the feasibility of the Law.

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