This afternoon, June 17, the Ministry of Health met with the press and provided information on health care work, including new points in the draft Pharmacy Law, including proposals on developing new drugs and increasing access for patients.
In the country, medicinal herb areas that meet World Health Organization standards are being developed to serve the production of high-quality pharmaceuticals.
According to the Ministry of Health, the current pharmaceutical legal system has revealed a number of limitations and inadequacies such as: some regulations related to drug and pharmaceutical ingredient registration are not consistent with the administrative reform policy; some pharmaceutical industry development policies have not created a breakthrough for the Vietnamese pharmaceutical industry in the new situation; some regulations on drug registration, production, export, import and supply are not suitable or have not been regulated for implementation in emergency cases, meeting the needs of disease prevention and control, security and national defense.
To overcome the above limitations and shortcomings, the draft revised Law on Pharmacy has added a number of articles to suit reality.
The proposed regulations include criteria to promote the development of the pharmaceutical industry, including prioritizing research, receiving technology transfer and producing innovative drugs, high-tech drugs, biological drugs/pharmaceutical ingredients, standardized medicinal herbs, and raw materials from available medicinal herbs in the country; at the same time, organizing and rearranging the business and distribution system of drugs and pharmaceutical ingredients to meet the socio-economic development situation and international integration.
The main content of the draft is to solve urgent problems that need to be resolved immediately to ensure adequate supply of medicine for medical examination and treatment for the people; strongly innovate administrative processes and procedures in the direction of minimizing administrative procedures for people and businesses, creating maximum conditions for businesses while still ensuring the quality of medicine; promote decentralization and delegation of authority associated with enhancing the responsibility of all levels and sectors.
According to the Drug Administration, pharmaceutical exports are currently modest, reaching just over 200 million USD/year; pharmaceutical raw materials must be imported for over 90%. Currently, domestic drugs account for 70% of the quantity used but only 50% of the value.
Programs such as "Vietnamese people use Vietnamese medicine" in recent years have promoted domestic production, but it is necessary to increase the domestic proportion in the drug market, and to synchronize some solutions. In particular, the revised Pharmacy Law has a separate chapter on the pharmaceutical industry, in the direction of encouraging the production of innovative drugs and drugs with high-tech dosage forms, because in the past we mainly produced generic drugs (drugs whose copyrights had expired).
"The draft revised Pharmacy Law supplements a number of provisions to promote the development of the pharmaceutical industry, adding appropriate and breakthrough policies compared to the 2016 Pharmacy Law to attract investment and further promote research and development of pharmaceutical ingredient production; research, technology transfer for the production of high-tech drugs, biotech drugs, and special treatment drugs; especially research," said a representative of the Department of Drug Administration.
Specifically: special investment support according to the provisions of law for research activities, technology transfer, investment in the production of pharmaceutical substances, new drugs, original branded drugs, specialized drugs; application of high technology in the production of vaccines, biological products, rare drugs, drugs for preventing and combating social diseases, herbal drugs and traditional drugs produced from Vietnamese herbal sources with national brands; scientific research activities on the development of pharmaceutical technology, biotechnology to produce new drugs; research and production of new drugs from domestic endemic herbal sources; research to create new varieties from domestic and transplanted herbal gene sources with high economic value.
In particular, the draft proposes preferential investment policies for the production of generic drugs, pharmaceutical ingredients such as excipients and capsule shells; packaging in direct contact with drugs; construction of biological testing facilities, assessment of bioavailability and bioequivalence of drugs; and facilities for clinical trials of drugs.
The proposed incentives are also an opportunity for domestic patients to access new drugs as soon as possible, at low cost.
Source: https://thanhnien.vn/de-xuat-uu-dai-san-xuat-thuoc-moi-them-co-hoi-cho-nguoi-benh-185240617162310882.htm
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