Weekend Long Read: The Rise of Generic Drugs in China

The discussion on the differences between imported brand-name medications and domestic generic drugs in China has intensified, highlighting the need for better understanding and regulation of generics to ensure their quality and efficacy matches that of brand-name drugs. [para. 1][para. 2]

Pharmaceuticals fall into two categories: brand-name and generics. Brand-name drugs are original, requiring extensive research, development, clinical trials, and often result in patent-protected commercial benefits for years. Generics, on the other hand, are produced post-patent expiration of brand-name drugs, duplicating their main molecular structure but differing in cost and non-active ingredients. Due to lesser research costs, generics are typically one-fifth to one-tenth the price of brand-name drugs. [para. 3][para. 4]

In 2015, China revamped its drug review system, requiring generics to match brand-name drugs in quality and efficacy through the "consistency evaluation," aligning with international standards. Another reform was simplifying drug approval, reviewing packaging materials and excipients with the drugs themselves. [para. 5][para. 6][para. 8]

The consistency evaluation ensures generics match their brand-name predecessors, tackling legacy issues with drugs approved under previous standards. Significant changes followed, including the judicial classification of falsifying data as a serious offense, closing legal loopholes and promoting genuine competition between multinational and domestic pharmaceutical companies. [para. 9][para. 10][para. 11]

Since the implementation of the evaluation, significant advances have been made. China now meets international quality standards, allowing its pharmaceutical industry to flourish and paving the way for international market entry. The majority of clinically needed drugs are now generics, reducing healthcare costs and improving accessibility. The review system evolved, ending China's isolation from international standards, and enabling centralized bidding by health insurance. More than 1,300 varieties of pharmaceuticals have passed the evaluation, but challenges like the low pricing and the need to match clinical efficacy of all products remain. [para. 13][para. 14][para. 15][para. 17][para. 19]

The presence of generics makes pharmaceuticals more accessible but does not immediately replace brand-name drugs due to preferences and trust issues. A balance is needed, respecting patient and doctor choices, especially in chronic and sensitive cases. Brand-name drugs still introduce competitive pressure, enhancing generic quality. [para. 21][para. 22][para. 23]

To ensure long-term consistency in generic quality, increased public awareness, strengthened production oversight, guaranteed profits, and elimination of local government conflicts of interest are recommended. This includes the potential centralization of drug production supervision to eliminate regional protectionism. [para. 25][para. 26]

The need for continued enhancement of regulatory frameworks is emphasized to establish confidence in generic drugs and ensure they are not just a "one-time" assessment, but an ongoing commitment to quality. [para. 27][para. 28]