This afternoon, April 16, at the 32nd session, the National Assembly Standing Committee gave opinions on the draft Law amending and supplementing a number of articles of the Law on Pharmacy.
Need a breakthrough mechanism to develop the pharmaceutical industry
One of the important contents of the draft law is to amend and supplement regulations on pharmaceutical industry development policies.
Authorized by the Prime Minister to present the report, Minister of Health Dao Hong Lan said that some provisions will be amended to encourage and provide incentives for domestic production facilities, encourage processing and technology transfer in Vietnam for manufacturing pharmaceutical ingredients, generic drugs or new drugs, original brand-name drugs, specialized drugs, vaccines, biological products, high-tech drugs, drugs produced from Vietnamese medicinal materials and shorten the licensing procedures for these drugs; expand the rights of foreign-invested drug production and import facilities.
Along with that, the responsibilities of relevant ministries in presiding over the application of science and technology to develop the pharmaceutical industry and presiding over the development of legal documents to manage the activities of selecting, breeding, cultivating and harvesting medicinal herbs; disseminating techniques for cultivating, preventing and controlling diseases on medicinal plants and medicinal animals.
Reviewing this content, Chairwoman of the Social Committee Nguyen Thuy Anh said that the Standing Committee of the Social Committee found that the policies on incentives for the development of the pharmaceutical industry are still general and principled, therefore, it is recommended that the Government clarify the limitations, obstacles, and inadequacies, promptly have specific and specific solutions and policies, especially in the field of investment incentives to meet the goal of developing the production of medicinal materials, drugs, and vaccines domestically in the coming period and further specify the policy of "creating favorable conditions for registration procedures" and "priority for procedures" in the draft law.
Discussing, Chairman of the Law Committee Hoang Thanh Tung assessed that with a country of more than 100 million people, the demand for medicine is very large, however, we have not yet mastered the pharmaceutical industry, so researching breakthrough policies to develop the pharmaceutical industry is necessary.
However, Mr. Hoang Thanh Tung also expressed concern that the regulations are not very specific, mainly stopping at viewpoints and policies. “What are investment incentives, special incentives for scientific research? It is necessary to add specific policies on what incentives, how to attract investment so that there are conditions for implementation, so that it can be put into practice more easily. If this law is not specific, it will be difficult for the Government's decree to stipulate otherwise. Moreover, if this law stipulates specific incentives different from the Investment Law, there is no problem because the Investment Law allows it” – the Chairman of the Law Committee expressed his opinion.
Giving his opinion on the draft law, National Assembly Chairman Vuong Dinh Hue highly appreciated the careful and serious preparation and construction as well as the great progress in thinking in this draft law.
Pointing out the fact that most common medicines are self-produced in Vietnam, but raw materials for making medicines, and many essential special medicines, must mainly be imported, the National Assembly Chairman affirmed that developing the pharmaceutical industry is very important, both as an economic issue and related to people's health care.
“We need to pay attention and have policies to promote it. Our potential is huge. In fact, the pharmaceutical industry is also good. Almost all common drugs can be produced, with good varieties and reasonable prices,” said Mr. Vuong Dinh Hue.
The National Assembly Chairman requested the drafting and reviewing agency to review Decision No. 376/QD-TTg of the Prime Minister on approving the Program for development of the pharmaceutical and medicinal materials industry produced domestically until 2030, with a vision to 2045, to legalize a number of policies to encourage the development of the pharmaceutical industry, because, among them, there are many very specific goals. At least the law has a framework for the Government to guide later.
Research on drug business regulations and drug price management
Regarding additional regulations on new business forms and methods, the draft law adds regulations on pharmacy chain business and trading of drugs and pharmaceutical ingredients by e-commerce method.
The Standing Committee of the Social Committee considers that this addition is necessary to meet practical requirements, but suggests clarifying the content of "pharmacy chain business", more specifically the regulations on establishment conditions, operation methods, and management mechanisms to have a basis for consideration, ensuring feasibility and consensus.
According to Director Nguyen Thuy Anh, for the trading of drugs and pharmaceutical ingredients through e-commerce, it is necessary to have more specific regulations on the types of drugs that can be traded, the forms of business that can be carried out through e-commerce, and the subjects that can participate in buying and selling to create transparency of regulations and ensure safety for users.
“If regulations are to be put in place for retail sale of drugs via e-commerce, they should only be applied to non-prescription drugs. In addition, regulations on e-commerce need to be reviewed to ensure compliance with the Law on Electronic Transactions,” said Ms. Nguyen Thuy Anh.
Commenting on this content, National Assembly Chairman Vuong Dinh Hue emphasized that medicine is a very special commodity, so it is necessary to research and find a balance point to have a suitable openness to facilitate production, business, trade and protect people's health.
“The sale of drugs in general and sales via e-commerce must be strictly controlled and need to be assessed for very specific impacts,” Mr. Vuong Dinh Hue noted and suggested that the drafting committee and the review agency coordinate to have appropriate regulations on this issue, in which the experiences of other countries are consulted, and rights and responsibilities are clearly defined.
Also in this draft, Minister of Health Dao Hong Lan said that there are amendments and supplements to a number of articles and clauses on drug bidding and drug price management to ensure consistency and synchronization with the provisions of the Bidding Law and the Price Law 2023.
The draft also adds regulations on specific price management for medicinal products (declaring expected wholesale prices before circulation) to ensure compliance with specialized management and effectiveness.
According to Chairwoman of the Social Committee Nguyen Thuy Anh, the draft law is basically consistent with the provisions of the 2023 Law on Prices. However, the provisions on the responsibility of pharmaceutical businesses, which are drug manufacturers and drug importers, in declaring the expected wholesale price of drugs for the first time before putting drugs into circulation on the market, re-declaring when changing the declared selling price and the guidance in the draft Decree attached are not consistent with the Law on Prices.
The inspection agency recommends that the Government clearly stipulate and specifically explain; provide additional information on management measures for other price-stabilized goods (whether they comply with the Law on Prices or not) to have more basis for consideration.
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