Continuing the 8th Session of the 15th National Assembly, on the morning of October 22, Chairman of the National Assembly's Social Committee Nguyen Thuy Anh reported on the explanation, acceptance, and revision of the draft Law amending and supplementing a number of articles of the Law on Pharmacy.
Regarding pharmacy chain business, Ms. Nguyen Thuy Anh said that the National Assembly Standing Committee has directed to supplement the impact assessment report, international experience and regulations on pharmacy chains to create a legal tool to more effectively manage pharmacy chains that have been and are operating as in current practice.
Supplement some regulations to limit potential risks involved in pharmacy chain business activities and assign the Ministry of Health to specify details, as well as pay attention during the implementation of this task.
Accordingly, a number of regulations have been revised, such as the concept of pharmacy chain, regulations on conditions for granting Certificates of eligibility for pharmaceutical business to establishments organizing pharmacy chains, on the rights and responsibilities of establishments organizing pharmacy chains and the rights and responsibilities of pharmacies in pharmacy chains.
Amendments to the conditions and responsibilities of the person in charge of pharmaceutical expertise at the pharmacy chain organization.
Regarding the trading of drugs and pharmaceutical ingredients through e-commerce, Director Nguyen Thuy Anh stated that drugs are special products that directly affect the health and lives of users.
In response to delegates' opinions, the National Assembly Standing Committee directed the revision in the direction of supplementing prohibited acts; regulating the types of drugs, pharmaceutical ingredients, and specific electronic devices that are allowed to be traded in the form of e-commerce.
Stipulate the responsibilities of pharmaceutical business establishments using e-commerce methods, including the responsibility to organize consultation, instructions on drug use and organize drug delivery according to regulations of the Minister of Health.
Regarding drug price management, the regulation only applies this measure to prescription drugs, except for some cases as prescribed by the Government and price recommendation measures when unreasonably high prices are discovered.
The draft law stipulates the responsibilities of state management agencies and pharmaceutical businesses related to implementing drug price management measures.
The National Assembly Standing Committee has directed research and maximum absorption of opinions of delegates, experts and state management agencies, and a number of provisions of the draft law have been revised.
Amending the concepts of medicinal herbs, traditional medicines, traditional medicinal ingredients, and biological products; adding the concepts of pharmaceutical ingredients that do not meet quality standards and high-tech drugs; initially legalizing the national database on pharmaceuticals.
Maintain regulations on toxic drugs, toxic pharmaceutical ingredients, and pharmaceutical substances on the list of substances prohibited from use in a number of industries and fields in the group of drugs and pharmaceutical ingredients subject to special control of the 2016 Pharmacy Law.
Continue to implement the mechanism of "pre-control" combined with "post-control" in drug advertising management; amend regulations on import and export of drugs and pharmaceutical ingredients. In particular, regulations allow the import of pharmaceutical ingredients that have not been registered for circulation in Vietnam to produce semi-finished drugs for export; increase sanctions against the act of renting pharmaceutical practice certificates.
