The National Assembly discussed the draft Law amending and supplementing a number of articles of the Law on Pharmacy.

Vice Chairwoman of the National Assembly Nguyen Thi Thanh chaired the meeting.

Promote the development of pharmaceutical industry

Presenting the Draft Law on amending and supplementing a number of articles of the Law on Pharmacy, Minister of Health Dao Hong Lan said that the development of the draft Law aims to ensure that people have access to quality, timely, and reasonably priced drugs; promptly remove difficulties and obstacles in institutional and legal aspects in drug management activities; including ensuring drugs for disease prevention and control and urgent cases arising in practice; continuing to reform administrative procedures in pharmaceutical activities, ensuring increased access to drugs for people, creating favorable conditions for people and businesses.

Regarding the scope of regulation of the draft Law, Minister Dao Hong Lan said that the draft Law adds "conditions for circulation of medical oxygen" to the scope of regulation and amends and supplements a number of regulations related to the interpretation of terms and State policies in the pharmaceutical field, regulations on pharmaceutical practice, trading of drugs, pharmaceutical ingredients, registration, export, import of drugs, pharmaceutical ingredients, drug recall, information, drug advertising, clinical drug trials, drug quality management and drug price management.

Minister of Health Dao Hong Lan presented the Draft Law on amending and supplementing a number of articles of the Law on Pharmacy.

Regarding some specific contents, the draft Law amends and supplements a number of provisions to promote the development of the pharmaceutical industry. Accordingly, the amended Law provides for attracting investment and promoting the production of drugs and raw materials in the direction of promoting research, technology transfer and production of raw materials for drugs, high-tech drugs, and biotech drugs in the direction of: Clearly defining investment incentives and special investment support according to the provisions of law for research activities, technology transfer, investment in the production of pharmaceutical raw materials, new drugs, original branded drugs, specialized drugs, drugs applying high technology in production, vaccines, biological products, rare drugs, drugs for preventing and combating social diseases, herbal drugs and traditional drugs produced from Vietnamese medicinal materials with national brands; scientific research activities on the development of pharmaceutical technology, biotechnology to produce new drugs, etc.

Determine investment incentives for the production of generic drugs, pharmaceutical ingredients such as excipients and capsule shells; build biological testing facilities, evaluate bioavailability and bioequivalence of drugs; and drug clinical trial facilities. At the same time, supplement regulations on corporate income tax incentives, increase the deduction rate and duration of use of the Science and Technology Development Fund, import tax on pharmaceutical ingredients that Vietnam cannot produce, for the above activities (because the Corporate Income Tax Law does not clearly stipulate incentives for drug production).

Delegates attending the meeting

Facilitate the procedures for registering the circulation of new drugs, generic drugs, specialized drugs, biological products, high-tech drugs, drugs and pharmaceutical ingredients produced on the basis of national science and technology tasks that have been accepted, and biotech drugs with technology transfer produced in Vietnam, generic drugs of new drugs whose patent protection is about to expire... Supplement and amend regulations on preferential output policies (drug purchase, payment by health insurance, price maintenance and price reduction according to the roadmap...) for drugs researched, transferred technology, and produced in Vietnam.

In addition, the draft Law amending and supplementing a number of articles of the Law on Pharmacy also amends and supplements a number of regulations on the organization and rearrangement of the business system, distribution of drugs and pharmaceutical ingredients. According to Minister Dao Hong Lan, the draft Law supplements a number of business types, business conditions for pharmacy chain business, drug business by e-commerce method and the rights and responsibilities of the above business establishments; connecting electronic prescriptions with drug retail establishments, linking data with the national pharmaceutical database system; the authority to grant pharmaceutical practice certificates to persons in charge of clinical pharmacy work of medical examination and treatment facilities under the Ministry of National Defense, the Ministry of Public Security and the number of pharmaceutical practice certificates of these subjects...

The draft Law dossier is prepared seriously and elaborately.

Presenting the Report on the review of the draft Law, Chairwoman of the Social Committee Nguyen Thuy Anh stated that in the context that the Government has not been able to comprehensively amend the current Pharmacy Law to completely resolve all practical problems and shortcomings, the Social Committee basically agreed to only amend and supplement a number of articles of the Pharmacy Law to immediately resolve a number of problems and shortcomings affecting people's access to medicine.

Chairwoman of the Social Committee Nguyen Thuy Anh presented the Report on the review of the draft Law.

The Social Committee finds that the Draft Law dossier has been prepared seriously and elaborately by the Government, with basically complete documents as prescribed by the Law on Promulgation of Legal Documents; the content of the draft Law is generally consistent with the Party's policies and guidelines, constitutional, legal and compatible with relevant international treaties to which the Socialist Republic of Vietnam is a member.

Regarding the State's policy on pharmaceuticals and pharmaceutical industry development, Ms. Nguyen Thuy Anh said that the Social Committee sees that Vietnam has a lot of potential to develop the pharmaceutical industry, but domestic pharmaceutical enterprises have not yet taken advantage of their advantages due to lack of resources and limited technical and technological level. Meanwhile, large foreign investors are willing to invest in large projects, "take over" domestic pharmaceutical enterprises and compete with domestic pharmaceutical products in many different ways.

The Social Committee basically agrees with the policies proposed in this revision. However, because drugs are important commodities that directly affect human health and life and impact health security, they need to be carefully assessed, carefully considered and comprehensively based on a “people-centered” approach; pharmaceutical products need to be strictly managed; there needs to be a policy that harmonizes attracting foreign investment and ensuring the development of domestic enterprises, creating a position and enhancing competitiveness in the pharmaceutical production and supply chain for domestic pharmaceutical enterprises.

Accordingly, it is necessary to exploit the existing strengths and potential of the pharmaceutical industry through breakthrough and feasible mechanisms, policies and support in terms of capital, human resource training, scientific research, technology transfer, and at the same time, continue to attract foreign investment in areas where Vietnam is not yet self-sufficient, such as the production of new drugs, advanced treatment products, and high-value biological drugs.

Regarding new forms and methods of pharmaceutical business, Chairwoman of the Social Affairs Committee Nguyen Thuy Anh emphasized that two new forms and methods of pharmaceutical business are stipulated in the draft Law, which are pharmacy chain business and e-commerce trading of drugs and pharmaceutical ingredients. Timely legalization of these contents is necessary to create a solid, favorable and transparent legal corridor in the context of the Vietnamese pharmaceutical market where the above forms and methods of business are increasingly flourishing.

However, the Social Committee finds that, with the chain business model, there needs to be regulations to distinguish the chain pharmacy business model from the franchise business model; clarify the relationship of ownership, management, and operation between the enterprise organizing the chain of pharmacies and the pharmacies in the chain along with the responsibilities of the entities; specify the order and procedures for granting, re-granting, adjusting, and revoking the Certificate of Eligibility for Pharmaceutical Business for the enterprise organizing the chain of pharmacies and each pharmacy in the chain to create favorable conditions in the process of operating this new model.

Session view

For e-commerce business, it is necessary to have more specific regulations on the types of drugs that can be traded via e-commerce, the subjects that can participate in buying and selling, the methods of consulting and instructing on drug use, the responsibilities of related parties when incidents occur; and the conditions for allowing the organization of electronic trading floors for pharmaceuticals.

The Social Committee proposed to only allow retail sale via e-commerce of non-prescription drugs, drugs that are not restricted in use or used under the supervision of a physician as recommended by a competent state agency; it is necessary to supplement regulations on measures to ensure drug quality and protect consumer rights; at the same time, continue to review to ensure consistency with the law on electronic transactions.

The Government's submission and the Inspection Report also present many other contents such as: On the rights and responsibilities of foreign-invested pharmaceutical businesses; On drug price management; regulations on registration and circulation of drugs and pharmaceutical ingredients; regulations on the application of the set of principles and standards for Good Manufacturing Practices for drugs and pharmaceutical ingredients; regulations on the management of export and import of drugs and pharmaceutical ingredients, etc.

In the afternoon of the same day, the National Assembly discussed in Groups about this draft Law.

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The Draft Law amending and supplementing a number of articles of the Law on Pharmacy consists of 3 articles, of which 44 articles of 8 chapters out of a total of 116 articles of 14 chapters of the Law on Pharmacy 2016 are amended and supplemented.

Source: https://baotainguyenmoitruong.vn/quoc-hoi-thao-luan-ve-du-an-luat-sua-doi-bo-sung-mot-so-dieu-cua-luat-duoc-375627.html