National Assembly Chairman Tran Thanh Man emphasized that the amendment of the Pharmacy Law must be carried out carefully, accurately, and synchronously, for the legitimate interests of people, businesses, and medical facilities, so that the amended Law, when promulgated, has a long "lifespan", helping to provide better and higher-quality health care for people.
Morning of August 12, continue the program Session In the August legal seminar, chaired by Vice Chairwoman of the National Assembly Nguyen Thi Thanh, the National Assembly Standing Committee gave opinions on explaining, accepting, and revising the draft Law amending and supplementing a number of articles of the Law. Law of Pharmacy.
Closing the legal gap for medical oxygen soon
Reporting on some major issues in receiving, explaining and revising the draft Law, Chairwoman of the Social Committee Nguyen Thuy Anh stated that some opinions of National Assembly deputies suggested adding management regulations for functional foods, health protection foods, and therapeutic cosmetics. The Standing Committee of the Social Committee recognized that these products are not drugs, so it proposed not to regulate them in the draft Law.
Regarding the trading of drugs and pharmaceutical ingredients by e-commerce, taking into account the opinions of delegates, the draft Law has been revised in the direction of: specifying the types of drugs sold retail and the types of drugs sold wholesale by e-commerce; adding a number of prohibited acts; regulating the responsibility of information confidentiality of buyers and assigning the Minister of Health to regulate the consultation, instructions on drug use and organizing the delivery of drugs to buyers.
Regarding the registration of drugs and pharmaceutical ingredients, in order to both strictly manage the circulation of drugs and also create conditions for drugs that have been circulated stably and safely on the market, the draft Law is further revised in the direction of classifying drugs and pharmaceutical ingredients according to different levels of drug properties as well as circulation to regulate the steps in the process and procedures for granting, renewing, changing, and supplementing the registration certificate for circulation of drugs and pharmaceutical ingredients.
In some cases, new drugs, drugs that need to be monitored or have warnings about quality, safety, and effectiveness, will require file appraisal or consultation with the Advisory Council; in other cases, the drug circulation registration certificate will be automatically renewed or changes and supplements will be self-announced.
Regarding the management of medical oxygen, Ms. Nguyen Thuy Anh said that in the review report submitted to the 7th Session of the 15th National Assembly, the Social Committee proposed not to regulate medical oxygen products in the draft Law because it is not consistent with the scope of regulation of the Pharmacy Law. Meanwhile, the Ministry of Health still wants to include regulations on medical oxygen in this draft Law.
The Standing Committee of the Social Committee found that medical oxygen was previously regulated in the Decrees on medical equipment management, but Decree No. 98/2021/ND-CP and Decree No. 07/2023/ND-CP amending Decree No. 98/2021/ND-CP did not regulate this product. Continuing to be consistent with the opinion stated in the review report, the Social Committee proposed that the Government promptly address the legal gap for this product by promulgating or submitting for promulgation under its authority legal documents to manage medical oxygen and other gas products used in medicine.
This is an issue with different 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 direction. If necessary, it is possible to study the regulations assigning the Government to specify details on medical gases in the Resolution of the next Session or amend the Law on Medical Examination and Treatment according to the simplified procedure, which stipulates 1 Article on medical gases used in medical examination and treatment activities, similar to the regulations on medical equipment used in medical examination and treatment.
Check carefully for any "interest groups" to regulate
The National Assembly Standing Committee basically appreciated the Social Affairs Committee, the Ministry of Health and relevant agencies in fully receiving and explaining the opinions of National Assembly deputies at the 7th Session to revise the draft Law. The documents submitted to the National Assembly Standing Committee were seriously prepared and of high quality in accordance with regulations.
Speaking at the meeting, regarding whether or not to include regulations on medical oxygen management in the Pharmacy Law, National Assembly Chairman Tran Thanh Man said that this is a special product introduced into the human body for medical treatment, so it must be regulated by law with principled regulations.
“While it has not been adjusted in the laws, it is possible to consider including this content in the Resolution of the National Assembly session or the Resolution of the National Assembly Standing Committee,” the National Assembly Chairman suggested, saying that whether it is a regulation in a law, resolution or decree, it is necessary to include the types of gases used in medicine, in medical examination and treatment, and should not only mention medical oxygen.
If necessary, two options can be presented at the upcoming Conference of full-time National Assembly deputies for delegates to evaluate, discuss, and give further opinions.
Regarding drug advertising, the National Assembly Chairman pointed out that there are many drug advertisements on television today, but the responsibility for ensuring drug quality is still unclear. Therefore, there should be more regulations on post-inspection to ensure the quality of safe drugs for users.
The National Assembly Chairman said that the Politburo has issued Regulation No. 178-QD/TW on controlling power, preventing and combating corruption and negativity in law-making. Therefore, it is necessary to review the draft Law to see if there are any interest groups in order to make adjustments with a very high sense of responsibility. At the same time, it is requested that the drafting agency, the Ministry of Health, fully absorb the opinions of National Assembly deputies; the reviewing agency must have a clear, impartial, objective opinion, and not be influenced by any individual or organization during the process of amending the Law.
The National Assembly Chairman also emphasized the six words "cautious, accurate, and synchronous" for the legitimate interests of people, businesses, and medical facilities, so that the amended Law, when promulgated, will have a long "lifespan", helping to provide better and higher-quality health care for people.
Concluding this content, Vice Chairwoman of the National Assembly Nguyen Thi Thanh stated that the National Assembly Standing Committee basically agreed with many contents of the draft Law reported and recommended by the agencies to be absorbed and revised; requested the Government to officially give opinions on the contents of the absorption and revision of the draft Law according to the provisions of the Law on Promulgation of Legal Documents.
The Vice Chairman of the National Assembly also requested the drafting agency and the reviewing agency to continue reviewing the draft Law to ensure consistency with relevant laws and international treaties to which Vietnam is a member; review terminology and explain words to clarify the contents.
The Standing Committee of the Social Affairs Committee continues to closely coordinate with the Ministry of Health and relevant agencies to seek opinions from experts and subjects affected by this draft Law, ensuring the feasibility and breakthrough of the draft Law in the field of pharmaceutical industry development.
Source
Comment (0)