8 new points in the draft revised and supplemented Law on Pharmacy

It is necessary to amend and supplement the Law on Pharmacy.

The 2016 Pharmacy Law basically regulates comprehensively issues related to the pharmaceutical sector, related to the State's policies on pharmacy and pharmaceutical industry development; pharmaceutical practice; pharmaceutical business; registration, circulation, recall of drugs and pharmaceutical ingredients; medicinal herbs and traditional medicines; prescriptions and drug use; drug information, pharmacovigilance and drug advertising; clinical pharmacy; drug management in medical examination and treatment facilities; clinical drug trials and bioequivalence trials of drugs; management of quality, safety, efficacy of drugs, pharmaceutical ingredients and drug price management.

The Draft Law amending and supplementing the 2016 Law on Pharmacy is necessary to develop the domestic pharmaceutical industry. (Illustration photo).

The 2016 Pharmacy Law has contributed to creating an equal and open business investment environment, creating maximum convenience for businesses, basically ensuring adequate supply of quality drugs at reasonable prices, the domestic pharmaceutical industry has reached level 3.5/5 according to the classification scale of the World Health Organization (WHO).

After more than 7 years of implementing the 2016 Pharmacy Law, the pharmaceutical industry has achieved many important achievements. The provisions of the pharmaceutical law have created a legal basis for the development of the pharmaceutical industry in the direction of openness and transparency, demonstrating progress and integration with countries in the region and the world in regulating principles and standards of Good Practice in pharmaceutical activities, from production, export, import, testing, wholesale, retail... ensuring that the quality of drugs reaching consumers is still maintained well, contributing to the work of protecting and taking care of people's health.

However, in the face of urgent requirements and demands from practice, the pharmaceutical legal system has revealed a number of limitations and inappropriate inadequacies related to drug and pharmaceutical ingredient registration; quality management; pharmaceutical industry development policies; drug price management that is not suitable to practice as well as newly issued price laws...

According to the Ministry of Health , to overcome the above limitations and shortcomings, it is necessary to develop a draft law amending and supplementing a number of articles of the Law on Pharmacy.

New points in the draft revised and supplemented Law on Pharmacy

The draft Law amending and supplementing a number of articles of the Law on Pharmacy includes 3 articles, in which 44 articles of 08 chapters are amended and supplemented out of a total of 116 articles of 14 chapters of the Law on Pharmacy 2016 are amended and supplemented, including the following 8 new points:

Firstly, the draft Law amending and supplementing a number of articles of the Law on Pharmacy has institutionalized all special and specific policy mechanisms that the 2016 Law on Pharmacy does not have regulations or has but is not suitable, which have been allowed by the National Assembly, the National Assembly Standing Committee and the Government to promptly handle drugs and vaccines for disease prevention and treatment during the recent Covid-19 pandemic to ensure feasibility and stability in case of a pandemic...

Second , amend and supplement a number of regulations to promote the development of the pharmaceutical industry, adding more appropriate and innovative policies compared to the 2016 Pharmacy Law to attract investment and further promote research and development of pharmaceutical raw material production; research, receive technology transfer for the production of high-tech drugs, biotech drugs, and special treatment specialties, especially research.

Third is to diversify the system and methods of trading and distributing drugs and pharmaceutical ingredients in accordance with economic and social development and increase the supply of drugs for people.

Fourthly , simplify the procedures for granting drug registration certificates, increasing the ability for people to access drugs early while still ensuring quality control, safety and effectiveness as well as compliance with international practices.

Fifthly, the authority to recall drugs is delegated to the Department of Health in the case of mandatory recall of drugs that do not meet quality standards at level 2 or level 3 detected in the area in order to promptly handle and recall drugs that violate quality in the management area, ensuring safe and effective use of drugs and in accordance with regulations on responsibilities and powers of product and goods quality inspection agencies, including product and goods quality inspection agencies under the People's Committees of provinces and cities in the Law on Product and Goods Quality.

Sixth is to expand the recognition, recognition, and application of the principles and standards of Good Manufacturing Practice for drugs and pharmaceutical ingredients of countries around the world as a basis for assessing the compliance with the conditions of drug and pharmaceutical ingredient manufacturing facilities abroad to ensure the supply of raw materials for Vietnamese drug manufacturing plants, avoiding disruptions in the supply of drugs for treatment.

Seventh is to simplify administrative procedures, reduce some business conditions according to the Party and State's policies and guidelines to create favorable conditions, increase proactiveness for businesses and strengthen inspection and supervision of implementation by state management agencies.

The eighth is to strengthen strict management of drug prices to stabilize the drug market according to the provisions of the 2023 Price Law and to ensure the specificity of the drug product, which is an item that people do not have a choice in, through the management of declared drug prices and expected wholesale drug prices to minimize the intermediary level that has been effectively managed according to the provisions of the Pharmacy Law.

With the new points mentioned above in the draft Law amending and supplementing a number of articles of the Law on Pharmacy on the basis of 5 policies approved by the National Assembly, it is hoped that the existing shortcomings and inadequacies in state management of pharmaceuticals will be fundamentally resolved, helping the pharmaceutical industry continue to develop strongly, as well as ensuring timely supply of quality, safe, effective and reasonably priced drugs for people in the coming time.

The Law on Pharmacy was passed by the 13th National Assembly on April 6, 2016, replacing the 2005 Law on Pharmacy, marking an important step in perfecting the legal system on pharmacy in Vietnam, basically in line with the development of the pharmaceutical industry in the trend of international integration.

Source: https://www.baogiaothong.vn/8-diem-moi-trong-du-thao-luat-duoc-sua-doi-va-bo-sung-192240615100926803.htm