The concept of "original medicine" in China should be legalized as soon as possible
During the recent "Two Sessions," Cai Dongchen, a National People's Congress deputy and chairman of the Shijiazhuang Group, submitted a proposal titled "Proposal to Legalize the Concept of 'Original Drugs' in China." This initiative reflects his long-standing focus on drug research and innovation. Over the years, Cai has consistently emphasized the importance of innovation in the pharmaceutical sector during the annual sessions.
According to Cai, the lack of a clear definition for "original drugs" has been a major obstacle in advancing independent innovation. In China, various terms such as "independent innovation drugs," "drugs with independent intellectual property rights," "innovative drugs," and "new research drugs" are used interchangeably, leading to confusion and inefficiencies in policy implementation. This ambiguity hinders the effectiveness of national policies aimed at promoting innovation, resulting in a mismatch between corporate investment and output, and making it difficult for companies to become true innovation leaders.
Cai also pointed out that the unclear concept of "original drugs" could impede the integration of China’s pharmaceutical industry with global standards. Internationally, "original drugs" are typically defined as new chemical entities (NCEs) that represent the highest level of innovation. These drugs are recognized and protected through well-established frameworks, including incentives and regulatory support.
In contrast, China lacks a formal definition or classification system for the level of innovation in pharmaceutical products. Despite over 70 types of new drugs listed and declared since 1985, only a few—such as artemisinin, butylphthalide, and epothilone—are internationally recognized as original drugs. These products have not achieved the expected market success due to pricing policies, bidding processes, and limited insurance coverage, which fail to reflect their true value.
Cai criticized foreign companies for using vague terms like "patent drugs" or "original research drugs" to gain unfair advantages in the Chinese market. He argued that a clearer legal framework is needed to distinguish "original drugs" from other innovations, ensuring policy continuity and fairness.
In his proposal, Cai suggested that relevant authorities should organize experts to define and legally recognize "original drugs" based on scientific and practical considerations. He also proposed establishing a catalog of original drugs and prioritizing their inclusion in government procurement, essential drug lists, and insurance coverage. Additionally, he recommended separate pricing and direct procurement mechanisms to reduce the burden on hospitals and encourage the use of innovative medicines.
Finally, Cai called for special support policies to foster an environment conducive to innovation, enabling enterprises to lead the way in pharmaceutical development and ensuring the sustainable growth of the industry. His proposal aims to bridge the gap between China’s ambitions and its current practices, paving the way for a more competitive and innovative pharmaceutical landscape.
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