Committee Member Lei Jufang: Leverage the role of Tibetan medicine and other ethnic medicines, preserving their unique characteristics while promoting development.

　　At the end of December 2016, the promulgation of the "Traditional Chinese Medicine" Law ushered in a period of favorable policies for TCM, including ethnic medicine. On March 3, Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference and Chairperson of Tibet Qizheng Tibetan Medicine Co., Ltd., submitted a series of proposals focusing on leveraging the distinctive features of ethnic medicine and allowing the preservation and development of commonly used dosage forms unique to ethnic medicines.

　　Lei Jufang told Caixin reporters that leveraging the distinctive features of traditional ethnic medicine in health poverty alleviation can help reduce the financial burden on patients and ease the strain on social security safety nets. For instance, in treating rheumatic diseases, a Tibetan medicinal bath therapy involves two courses per year, with each course costing roughly 2,000 to 3,000 yuan, resulting in annual expenses of about 6,000 to 7,000 yuan. When receiving treatment at grassroots medical institutions, the state covers approximately 85% of these costs, leaving patients to pay only around 1,000 yuan themselves. In contrast, if rheumatic diseases are treated at large urban hospitals, patients typically undergo several courses of treatment per year, with each course costing between 20,000 and 30,000 yuan. The state’s reimbursement rate for such treatments is only about 40% to 50%, which not only increases the financial burden on patients but also places greater pressure on the national medical insurance system.

　　The "Traditional Chinese Medicine" Law proposes the development of “compound Chinese medicinal preparations derived from time-honored classic prescriptions.” The implementing rules also stipulate that “specific management measures shall be formulated jointly by the drug regulatory authority under the State Council and the competent authority for traditional Chinese medicine.” Lei Jufang stated that when drafting the technical details for the registration of ethnic classic prescriptions, the National Medical Products Administration and the State Administration of Traditional Chinese Medicine should fully take into account the distinctive features of commonly used dosage forms in ethnic medicines, allow for the preservation of these unique characteristics during development, and avoid adopting a one-size-fits-all approach.

　　“The modernization of Tibetan medicine is far behind that of traditional Chinese medicine; therefore, we cannot use the same standards to evaluate the reform of dosage forms for Tibetan medicine and traditional Chinese medicine,” said Lei Jufang. For instance, since Tibetan medicines are often administered in solid dosage forms such as pills and powders at relatively low doses, it is appropriate—consistent with traditional practices—to formulate them into pills, tablets, capsules, and other dosage forms. Moreover, topical administration is a distinctive feature of Tibetan medicine, and we should encourage the preservation of these classic topical dosage forms to facilitate their inheritance and protection.

　　The history of the modernization of traditional Chinese medicine can be traced back to the 1980s. Particularly from the late 1990s until before 2005, Chinese pharmaceutical companies leveraged modern pharmaceutical technologies to address shortcomings in traditional Chinese medicine, making significant improvements and upgrades. As a result, numerous reformulated products received approval, spurring a boom in the Chinese medicine market. For example, Tasly’s Compound Danshen Dropping Pills and Kangyuan Pharmaceutical’s Guizhi Fuling Capsules are both successful examples of reformulated products.

　　Looking at the modernization history of Tibetan medicine, we see that it has taken less than 10 years. Yet, due to technical and awareness issues within Tibetan pharmaceutical manufacturers, Tibetan medicines have simply not had time to leverage modern pharmaceutical technologies for variety upgrades and reap the benefits of the then-current drug review policies and technological advancements—for instance, despite being eligible for dosage form modifications, they were completely excluded from such policies, a situation that clearly lacks fairness,” said Lei Jufang. Among the 200 varieties included in the Ministry of Health’s standard for Tibetan medicines, only about 10 are available in modern dosage forms such as capsules, tablets, and granules.

　　Due to geographical and historical factors, many standardized formulations in Tibetan medicine are predominantly available as powders. “Among the 200 varieties included in the ‘Tibetan Medicine Standards’ issued by the Chinese government, more than 90 are powder formulations,” said Lei Jufang. These powder formulations represent the crystallization of Tibetan medical wisdom and have been used in Tibetan regions for over a century—or even millennia. They are also an ideal dosage form—simple, convenient, and inexpensive—that perfectly matches the characteristics of the Tibetan region, where economic development levels remain relatively low and nomadic lifestyles predominate. However, powder formulations are now difficult to promote and apply in inland China. In fact, modern formulation techniques such as encapsulation and tablet compression can easily address dosage-form issues without compromising therapeutic efficacy.

　　In addition, Tibetan medicine comes in many forms, including decoctions and powdered preparations. In fact, turning these into granules not only does not alter the essential manufacturing process or compromise the therapeutic efficacy but also makes them more convenient to take. Lei Jufang pointed out that, according to current review and approval requirements, reformulating drug products is not encouraged. Simply improving compliance between different dosage forms is not enough; often, such reforms must also demonstrate superior efficacy. As a result, inadvertently, the path of adapting Tibetan medicines through dosage-form modifications to meet mainland China’s market demands has been blocked.

　　Ethnic medicine has not only accumulated numerous prescriptions and distinctive medicinal products but has also developed a wealth of treatment techniques that are uniquely characteristic of ethnic medical systems—techniques that are simple, effective, and cost-efficient. Examples include the topical application method and medicinal bath therapy in Tibetan medicine, as well as the herbal acupuncture therapy used by the Miao people. In accordance with regulatory review requirements, any changes to dosage forms of topical medications or conversions from oral to topical administration must be accompanied by thorough explanations regarding the scientific basis, rationality, efficacy, and safety of such formulation modifications.

　　“However, these concerns don’t entirely apply to topical medications,” said Lei Jufang. This is because the transdermal absorption theory doesn’t fully hold true for local analgesics—in other words, conventional methods for detecting transdermal drug absorption into the bloodstream aren’t entirely suitable for traditional topical pain relievers. Research has shown that the analgesic effect of locally applied pain relievers is closely linked to the activation of nerve fibers in the local skin, rather than the previously held notion that these drugs exert their effects by first being absorbed through the skin and then producing anti-inflammatory and analgesic actions. Similarly, current methods for evaluating drug efficacy are mostly designed to assess the analgesic effects of systemic administration, rather than to evaluate the relief of localized pain.

　　This review regulation has, to some extent, made the path to reforming topical medications more challenging than that for oral medications. “This is in stark contrast to the current U.S. approach, which adopts a relaxed filing system for topical medications containing active ingredients already listed in the known catalog,” said Lei Jufang. Similarly, the Japanese over-the-counter drug market boasts an impressive array of topical pain relievers, to the point that many Chinese consumers travel to Japan specifically to purchase topical medications—this phenomenon is closely linked to Japan’s policies on topical applications.

　　Lei Jufang believes that topical treatments, a distinctive feature of Tibetan medicine, with time-honored practices such as patch therapy, bath therapy, topical application, and poultice therapy, boast an abundant repertoire of prescriptions, extensive clinical experience, and significant clinical value. These treatments are ideally suited for leveraging modern technologies to further develop and enhance them, transforming them into a variety of safe and effective topical dosage forms that can enrich current clinical treatment options. However, under the existing regulatory framework, this vision is difficult to realize.

　　Reporting Media: Caixin Media

　　Report link: http://topics.caixin.com/2017-03-04/101062109.html