Lei Jufang: The development of original, classic prescriptions is fraught with difficulties.

　　“My biggest concern is that in 2016, I hope the tough healthcare insurance reforms will enter deeper waters. Another issue is that public demand is extremely strong, yet the industry faces even tougher challenges than in the past. In 2015, we saw overall growth in the pharmaceutical industry at just over 9 percent, but the traditional Chinese medicine sector experienced a decline. Originally, the growth rate of TCM was higher than that of the overall industry, but in 2015 it actually declined—a situation that remains very serious,” said Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference and Chairwoman of Tibet Qizheng Tibetan Medicine Co., Ltd.

　　This year, Lei Jufang’s proposals have largely focused on the development of traditional Chinese medicine, including a proposal titled “Improve relevant policies and boost the development of China’s independent pharmaceutical industry.” In 2015, China’s pharmaceutical industry achieved sales revenue of 1.3591 trillion yuan, with a growth rate of 9.1%. Among them, the sales revenue of proprietary Chinese medicines reached 345.7 billion yuan, growing at a rate of 5.6%. With China’s population of 1.3 billion, the healthcare reform aimed at benefiting the general public will undoubtedly bring tremendous development opportunities and room for growth to the independent pharmaceutical industry—a sector that is full of confidence. However, we’ve also encountered significant challenges,” said Lei Jufang. First, regarding China’s original classic prescriptions, whether it’s the approval process or secondary innovation, there are numerous hurdles and a long, arduous road ahead, making it simply too burdensome to bear. Second, market access policies fail to adequately support innovation.

　　Meanwhile, neighboring Japan has already brought herbal medicines and health supplements—rooted in traditional Chinese medical texts—onto the global market. The widespread popularity of these products is largely attributable to supportive government policies: In 1972, Japan’s Ministry of Health, Labour and Welfare approved the use of 210 ancient prescriptions from China’s “Shanghan Zabing Lun” and “Jingui Yaolue” to produce Kampo medicines. In 1976, without requiring new drug clinical trials, Japan made an exceptional move by including 146 Kampo medicines in the national pharmacopoeia and adding them to the national health insurance coverage list. Since then, with continuous additions, the number of Kampo preparations covered by the national health insurance system has grown to 233. Japanese citizens can now claim reimbursement for Kampo medicine preparations manufactured by domestic companies, provided they have a doctor’s prescription. In South Korea, the Ministry of Health and Welfare stipulates that prescriptions from 11 classical medical texts do not need to undergo clinical or other types of trials; pharmaceutical companies can proceed directly to production. “Because of its relaxed policy environment, China’s treasured medicinal ingredients have become valuable medical resources abroad, while ancient prescriptions have enriched foreign markets. Yet as the origin of traditional Chinese medicine, our country still faces numerous obstacles in registering classic formulations of both traditional Chinese medicine and ethnic medicines,” said Lei Jufang. Although the state issued regulations in 2007 allowing the production of finished medicines based on ancient prescriptions, requiring only non-clinical safety data and permitting direct application for production approval, no products have yet been approved. As for the secondary development of registered compound traditional Chinese and ethnic medicines, current regulations mandate that all indications must undergo clinical trials, driving costs into the tens of millions of yuan and often taking several years—with little likelihood of yielding significant results.

　　Unless these issues are addressed, China’s valuable resources will remain underutilized. Lei Jufang believes that, in terms of registration and approval, we should relax the clinical trial requirements for classic prescriptions that are exempt from clinical trials—especially for OTC products undergoing formulation or flavor modifications. Clinical studies should be conducted based on the specific requirements submitted by companies rather than solely adhering to all the indications listed in the original product specifications. We should also encourage the secondary development and formulation innovation of traditional prescriptions, thereby enhancing patient compliance with these products and supporting the diversification and richness of China’s domestically developed pharmaceutical industry.

　　In 2015 and the years prior, Lei Jufang primarily put forward proposals advocating for the inclusion of ethnic medicines in the national medical insurance catalog and for reducing restrictions on the development of ethnic medicines. It was only last year that these calls for change in the development of ethnic medicines finally began to receive a response. At the conclusion of the Two Sessions, ethnic medicines were finally mentioned by high-level leaders, who pledged to integrate them into a comprehensive system for protection and development. In fact, the long-standing call for ethnic medicines to be included in the medical insurance system has remained unresolved for many years. The 2000 edition of the medical insurance reimbursement catalog listed 47 ethnic medicines, while the 2009 edition listed 45—two fewer than before. By contrast, both Western medicines and traditional Chinese patent medicines have seen growth: Western medicines grew by 12.91%, and traditional Chinese patent medicines grew by 31.02%, whereas ethnic medicines experienced a decline of 2.15%. This trend has widened the gap and pushed ethnic medicines further toward marginalization. In other words, this issue remains unresolved even this year, and it may well continue to require ongoing advocacy and calls for action.

　　Reporting media: Economic Observer

　　Report link: http://finance.sina.com.cn/roll/2016-03-13/doc-ifxqhmvc2376818.shtml