CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
8.2 Price Levels of Pharmaceuticals or Medical Devices PRC law does not require the prices of phar- maceuticals and medical devices to be bench- marked or otherwise set in reference to the prices of the same products in other countries. However, the NHSA does monitor drug prices at home and abroad for the purpose of mak- ing timely warnings of any abnormal changes to drug prices and supply. Prices in other countries might also be used as reference points during negotiations between the NHSA and drug sup- pliers with respect to BMI funds coverage. 8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds Pharmaceuticals The NHSA and the Ministry of Human Resourc- es and Social Security (the “MOHRSS” ) jointly issued the latest version of the National Reim- bursement Drug List (the “NRDL” ) in 2024. Under the NRDL, pharmaceuticals are classi- fied into Class A and Class B, with each class being reimbursed differently by the BMI funds. Patients assume full costs for drugs excluded from the NRDL. The latest effective NRDL, officially implemented on 1 January 2025, reiterates that all provincial authorities will implement the same NRDL with limited exceptions, including ethnic medicines, preparations of medical institutions and Chinese
tive lists of medical consumables that local BMI funds can reimburse. At the end of 2024, the General Office of the State Council issued the Opinions on Compre- hensively Deepening the Reformation of Phar- maceuticals and Medical Devices Supervision and Promoting the High-Quality Development of the Pharmaceutical Industry, providing guid- ance on studying and standardising the lists of medical consumables and medical service for medical insurance, and incorporating eligible innovative drugs and medical devices into the medical insurance coverage. 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices Pharmaco-economic analysis would be employed when assessing which drugs are to be included in the NRDL and the price for NRDL negotiations. Pharmaco-economic materials may be required to be submitted by applicants to add a drug into the NRDL or to adjust its reim- bursement coverage. A cost-benefit analysis would also be consid- ered when assessing which medical consuma- bles are to be covered by BMI funds. 8.5 Regulation of Prescriptions and Dispensing by Pharmacies Physicians and pharmacists must follow the principles of safety, effectiveness and economy when issuing or dispensing prescriptions. A physician may decide what drugs are to be prescribed based on the physician’s profession- al judgement that the prescription is rational and appropriate to a patient’s condition. In no event will the prescription be formulated by artificial intelligence (AI). The quantity of drugs a physi- cian may prescribe is specifically limited for each
medicine tablets. Medical Devices
Medical consumables may be considered “diag- nosis and treatment items” or parts of these items for BMI funds reimbursement purposes. Certain local healthcare security administrations at the provincial level have promulgated effec-
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