5 policies in 2019 will affect China’s pharmaceutical market in 2020, which mainly involve China’s national medical insurance payment and pharmaceutical product cost control.
1. Learning the Sanming Model for medical reform
The State Council of China issued the Notice on Further Promoting the Experience of Fujian Province and Sanming City in Deepening the Reform of Medical and Health System on Nov. 15, 2019 to make clear the further promotion of the medical reform experience of Fujian Province and its Sanming City in China.
According to the document, the scope of varieties subject to the procurement with target quantity organized by China will be expanded in 2020; pharmaceutical products not included in the procurement with target quantity organized by China shall be subject to the procurement with target quantity or budget by the end of Sep. 2020, and the centralized procurement of valuable medical consumables by category shall be explored; the monitoring mechanism for key pharmaceutical products shall be comprehensively established by the end of Dec. 2020.
Comment: We can see from the above that the end-point monitoring management of pharmaceutical products and consumables and the reform of the payment side will be the focuses in 2020.
2. Centralized procurement of pharmaceutical products to be gradually settled by China’s national medical insurance
The Leading Group for Deepening Reform of the Medical and Health Care System of the State Council Issuing the Notice on Several Policy Measures for Further Deepening Reform of the Medical and Health Care System by Breaking Through the Centralized Procurement and Use of Pharmaceutical Products (GYG Fa [2019] No. 3) was issued on Nov. 29, 2019.
The official document for the second batch of procurement with target quantity has been released, which is required to be completed by the Chinese New Year in 2020. It seems that China’s national medical insurance department doesn’t want the industry to enjoy the new year.
Besides implementing the results of the procurement with target quantity required by China, provinces in China shall also act on the pharmaceutical products not included in the procurement scope of China. According to the document, "national medical insurance handling agencies are encouraged to directly settle the pharmaceutical product payments with the pharmaceutical producers or circulation enterprises" and "relying on the provincial centralized procurement platform of pharmaceutical products, construct a unified open public procurement market of pharmaceutical products in China, and unify the codes, standards, and functional specifications, to advance the interconnection of related information such as pharmaceutical product prices and resource sharing and promote the linkage of pharmaceutical product prices in the country".
Comment: The frame of the centralized procurement platform of bio pharmaceutical products has been gradually set up in China, and the identity of China’s national medical insurance as the biggest payer is also gradually established.
3. New Drug Administration Law
The newly revised Drug Administration Law of the People’s Republic of China was adopted by the 12th meeting of the Standing Committee of the 13th National People's Congress of the People's Republic of China by vote on Aug. 26, 2019 and has come into force on Dec. 1, 2019.
This revision is a comprehensive revision of the Drug Administration Law by China after 18 years. The new Drug Administration Law is divided into General Provisions, Pharmaceutical Development and Registration, Pharmaceutical Marketing Authorization Holders, Pharmaceutical Production, Pharmaceutical Distribution, Medical Institutions’ Management of Pharmaceutical Affairs, Post-marketing Pharmaceutical Management, Pharmaceutical Prices and Advertising, Pharmaceutical Reserves and Supply, Supervision and Administration, Legal Liability, and Supplementary Provisions, with a total of 155 articles in 12 chapters.
The supporting Provisions for Drug Registration was sought for c...
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