Amendments to the Law on Pharmaceuticals need to be cautious, precise, and consistent.

National Assembly Chairman Tran Thanh Man emphasized that the amendment of the Law on Pharmaceuticals must be carried out cautiously, accurately, and comprehensively, for the legitimate rights of citizens, businesses, and medical facilities, ensuring that the amended law, once enacted, has a long lifespan and contributes to better and higher-quality healthcare for the people.

National Assembly Chairman Tran Thanh Man delivers a speech at the session. (Photo: DUY LINH)

On the morning of August 12th, the program continued. Session In the August legal session, under the chairmanship of Vice Chairwoman of the National Assembly Nguyen Thi Thanh, the Standing Committee of the National Assembly gave its opinion on the explanation, acceptance, and revision of the draft Law amending and supplementing a number of articles of the Pharmacy Law.

Address the legal loophole regarding medical oxygen as soon as possible.

Reporting on several major issues in the process of receiving, explaining, and revising the draft Law, the Chair of the Social Affairs Committee, Nguyen Thuy Anh, stated that some National Assembly deputies suggested adding regulations on the management of functional foods, health supplements, and therapeutic cosmetics. The Standing Committee of the Social Affairs Committee noted that these products are not medicines and therefore proposed not including them in the draft Law.

Regarding the business of pharmaceuticals and pharmaceutical raw materials through e-commerce, in response to delegates' opinions, the draft Law has been revised to: specifically regulate the types of drugs that can be sold retail and wholesale through e-commerce; add several prohibited acts; stipulate the responsibility for maintaining the confidentiality of buyer information; and assign the Minister of Health the authority to regulate the provision of advice and guidance on drug use and the organization of drug delivery to buyers.

Regarding the registration of drugs and drug raw materials, in order to both strictly manage the circulation of drugs and create conditions for drugs that have already been circulating stably and safely in the market, the draft Law is further revised to classify drugs and drug raw materials according to different levels of drug properties and circulation to adjust the steps in the process and procedures for granting, renewing, changing, and supplementing drug and drug raw material registration certificates.

Chairwoman of the Social Affairs Committee Nguyen Thuy Anh reports on several major issues in the process of receiving feedback, providing explanations, and revising the draft Law. (Photo: DUY LINH)

In some cases, new drugs, drugs requiring continued monitoring, or those with warnings regarding quality, safety, or efficacy will require dossier review or consultation with an advisory board; in other cases, the drug registration certificate will be automatically renewed or changes and additions will be self-announced.

Regarding the management of medical oxygen, Ms. Nguyen Thuy Anh stated that in the verification report presented at the 7th Session of the 15th National Assembly, the Social Committee recommended against regulating medical oxygen products in the draft Law because it was inconsistent with the scope of the Pharmaceutical Law. Meanwhile, the Ministry of Health still wishes to include regulations on medical oxygen in this draft Law.

The Standing Committee of the Social Affairs Committee noted that while medical oxygen was previously regulated in decrees on the management of medical equipment, Decree No. 98/2021/ND-CP and Decree No. 07/2023/ND-CP amending Decree No. 98/2021/ND-CP do not regulate this product. Continuing with the opinion stated in the review report, the Social Affairs Committee requests the Government to promptly address this legal gap by issuing or submitting for issuance, within its authority, a legal document to regulate medical oxygen and other gaseous products used in healthcare.

This is an issue where there are differing opinions between the drafting agency and the reviewing agency. The Standing Committee of the Social Affairs Committee reports and submits it to the National Assembly Standing Committee for consideration and guidance. If necessary, it is possible to study the possibility of entrusting the Government with the detailed regulations on medical gases in the Resolution of the next Session or amending the Law on Medical Examination and Treatment using a simplified procedure, which includes one article on medical gases used in medical examination and treatment activities, similar to the regulations on medical equipment used in medical examination and treatment.

Carefully review for any "special interest groups" that need adjustment.

The Standing Committee of the National Assembly highly appreciates the Social Affairs Committee, the Ministry of Health, and other relevant agencies for fully incorporating and explaining the opinions of National Assembly deputies at the 7th Session in order to revise the draft Law. The documents submitted to the Standing Committee of the National Assembly were prepared seriously and with high quality in accordance with regulations.

Speaking at the session, regarding the inclusion of regulations on medical oxygen management in the Pharmaceutical Law, National Assembly Chairman Tran Thanh Man stated that this is a special product introduced into the human body for treatment, and therefore must be regulated by law with fundamental principles.

"While not yet regulated in the laws, consideration could be given to including this content in a Resolution of the National Assembly session or a Resolution of the Standing Committee of the National Assembly," the Speaker of the National Assembly suggested, adding that whether regulated in a law, resolution, or decree, it should encompass all types of gases used in medicine, in examination and treatment, and should not only mention medical oxygen.

The scene at the meeting. (Photo: DUY LINH)

If necessary, two options may be presented at the upcoming Conference of National Assembly Deputies working in specialized fields for delegates to evaluate, discuss, and provide further feedback.

Regarding drug advertising, the Chairman of the National Assembly pointed out that while there is currently a lot of drug advertising on television, the responsibility for ensuring drug quality remains neglected. Therefore, additional regulations on post-market surveillance are needed to ensure the safety of drugs for consumers.

The Chairman of the National Assembly stated that the Politburo has issued Regulation No. 178-QĐ/TW on controlling power and preventing and combating corruption and negative practices in the process of drafting legislation. Therefore, it is necessary to review the draft Law to identify any vested interests and make adjustments with a very high sense of responsibility. At the same time, he requested that the drafting agency, the Ministry of Health, fully incorporate the opinions of National Assembly deputies; and that the reviewing agency maintain a clear, impartial, and objective stance, free from any influence from individuals or organizations during the law's amendment process.

The Speaker of the National Assembly also emphasized the six words "prudence, accuracy, and consistency" for the legitimate interests of citizens, businesses, and medical facilities, so that the amended Law, once enacted, will have a long lifespan and help improve the quality of healthcare for the people.

Concluding this discussion, National Assembly Vice Chairwoman Nguyen Thi Thanh stated that the National Assembly Standing Committee basically agrees with many contents of the draft Law that have been reported and proposed for inclusion and revision by relevant agencies; and requests the Government to officially provide its opinion on the contents that have been included and revised in the draft Law in accordance with the Law on Promulgation of Legal Documents.

The Vice Chairman of the National Assembly also requested the drafting and reviewing agencies to continue reviewing the draft Law to ensure consistency with relevant laws and international treaties to which Vietnam is a signatory; and to review terminology and definitions to clarify the content.

The Standing Committee of the Social Affairs Committee continues to coordinate closely with the Ministry of Health and relevant agencies, seeking opinions from experts and those affected by this draft law, ensuring the feasibility and breakthrough nature of the draft law in the field of pharmaceutical industry development.

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