15 Questions About Chinese Medicine and Herbal Drugs — How Should We Think About Them?

The national strategy for developing traditional Chinese medicine keeps moving forward, and old questions and new ones are surfacing at the same time. Here is our thinking.

On July 1, 2017, the Traditional Chinese Medicine Law of the People's Republic of China took effect.

Article 29 of this law — billed as "the country's first comprehensive, systematic law embodying the characteristics of traditional Chinese medicine" — says that manufacturers of compound TCM preparations derived from classic formulas in ancient texts may, if they meet the stated conditions, submit only non-clinical safety research data when applying for a drug approval number. The detailed rules are to be written jointly by the State Council's drug regulator and its department in charge of traditional Chinese medicine.

On November 29, the website of the journal Nature ran a news item saying that "starting early next year, traditional Chinese medicines may no longer need to pass safety and efficacy trials in China."

On December 1, Order No. 14 of the National Health and Family Planning Commission, the Interim Measures for the Filing Administration of Traditional Chinese Medicine Clinics, took effect, shifting the management of TCM clinics from a licensing system to a filing system: no more approval beforehand, tighter oversight during and after.

On December 20, Order No. 15 of the same commission, the Interim Measures for the Assessment, Registration and Administration of the Physician Qualifications of Personnel with Genuine Expertise in Traditional Chinese Medical Skills, took effect. Under it, once a panel of experts signs off, people with genuine expertise in traditional Chinese medical skills receive TCM (specialist) physician qualifications directly, and may practice within the scope they were assessed on.

As the national strategy for developing traditional Chinese medicine advances, a quarrel between Chinese and Western medicine that has run for more than a hundred years has flared up again. Every online discussion of Chinese medicine eventually boils over into another sprawling flame war: both sides move from technical arguments to philosophical ones, produce evidence that barely overlaps, and declare victory by entirely different rules of debate. None of this is new.

But these debates are not as remote from daily life as they look. We have no interest in joining the long argument over which is right, Chinese medicine or Western medicine. What we care about is the lasting effect of these laws, which govern drugs and public health, and the outcomes they may produce.

So we start by pulling out the most important questions raised by this string of news, and ask what they will change in our lives. Then we ask how we should think about those changes.

The rest of the quarrel — the old, seemingly unbridgeable questions about Chinese medicine, herbal drugs, and the standoff between Chinese and Western medicine — we leave to later articles.

1. Set aside the ideology-laden fight over Chinese medicine itself. What are people actually arguing about when it comes to Chinese herbal medicine?

The day after Nature's report, @Juedaishuangjiao — verified on Weibo as a "well-known health blogger" — pulled Nature's reporting together on his WeChat official account, Juejing, and challenged the provision. In his article he wrote, with evident worry, that "this means the bar for admitting old-style traditional medicines has been lowered across the board — it even abandons the basic principles modern medicine has established."

In fact, ever since the Traditional Chinese Medicine Law of the People's Republic of China (Draft) first came up for review on December 21, 2015, it has drawn questions again and again from the medical community and the public.

In August 2016, when the revised draft went through its second review, Southern Weekly published a report, "The Disputed 'Verification Exemption' for Chinese Medicine: Classic Formulas Won't Need Clinical Trials", which laid out the whole question of the "verification exemption," from the difficulty of getting classic formulas approved to the quality of the drugs themselves. Even people inside the TCM world, the article noted, had reservations. "Some worry that if Chinese medicine skips clinical trials, it will drift further and further from precise, scientifically advanced medicine, and its safety will be even less assured."

The gulf between Chinese medicine and "precise, advanced medicine" was always wide. Open any introductory book on Chinese medicine and a third of the table of contents is given over to "the philosophy of Chinese medicine." Modern medicine is built on anatomy, pathology, statistics and experiment; Chinese medicine rests on an entirely different theoretical foundation. "The two traditions explain the causes of disease in completely different ways," a resident physician surnamed Liang, in the Chinese medicine department at West China Hospital in Sichuan, told us. "When you fall ill, we would say it's because of the seven emotions and six desires inside you, and wind, cold, heat or summer-heat outside."

That leads directly to a different way of judging illness. Under the principle of "treatment based on syndrome differentiation," a physician reads the disease straight from its symptoms and prescribes accordingly. The Chinese medicine we are discussing here splits in two: raw herbal materials and herbal preparations. Leaving aside the herbs you can buy over the counter, an ordinary herbal preparation has to be matched to a classic formula, in which the physician sorts the ingredients into four roles — "sovereign, minister, assistant, courier" — and combines two or more substances into a single prescription.

Chinese herbal medicine, which traces its origins to the legend of Shennong tasting a hundred herbs, has long faced questions about safety. In 2017, a cover story in a translational-medicine journal published by Science reported a retrospective study of 1,400 liver cancer tumor samples from patients in Taiwan and mainland China, and concluded that liver cancer in Asia correlates with exposure to aristolochic acid. Records show that two herbs containing aristolochic acid — madouling, the fruit of Aristolochia, and tianxianteng, its vine — were both listed in Volume I of the Chinese Pharmacopoeia in the 2005 and 2010 editions. In 2006, a tally posted on Xiaomuchong, an academic discussion platform, put the number of common patent Chinese medicines on the market containing aristolochic acid at no fewer than 200.

Besides liver and kidney toxicity, many Chinese herbal preparations have been found to exceed heavy-metal limits. In 2013, Beijing Tongrentang was reported to have 40 medicines containing cinnabar, among them Niuhuang Qianjin San and Xiao'er Zhibao Wan, both with mercury above the national standard. Taiwan's Department of Health had banned the medicinal use of cinnabar back in 1994, and Hong Kong's Department of Health lists cinnabar as a toxic Chinese medicine.

It is exactly this tangle and vagueness in Chinese medicine that has bred distaste in many people. In 1923, Lu Xun wrote in the preface to his story collection Call to Arms: "I still remember the pronouncements and prescriptions of the doctors of my youth, and comparing them with what I know now, I gradually came to realize that Chinese medicine is nothing more than a swindle, deliberate or otherwise." The doctor treating his father had prescribed, among other things, reed roots dug up in winter and a pair of crickets that had to be original mates.

Back to the "classic formulas" in the TCM Law. Put simply, these are recipes setting out ratios of herbal ingredients. The law adds that they mean "formulas recorded in ancient Chinese medical texts that remain in wide use today, have a proven effect, and carry a clear, distinctive advantage. The specific catalog is to be drawn up jointly by the State Council's department in charge of traditional Chinese medicine and its drug regulator."

2. So what do clinical and non-clinical safety trials actually solve inside the modern medical system?

The regulation uses another term as well: "drug clinical safety trial." Under the General Principles for the Consideration of Drug Clinical Trials issued by the China Food and Drug Administration (CFDA), that means any systematic study of a drug carried out in humans — patients or healthy volunteers — to confirm or discover the drug's clinical, pharmacological or other pharmacodynamic effects, its adverse reactions, and its absorption, distribution, metabolism and excretion, with the aim of establishing safety and efficacy.

Put simply, before a new drug can go on sale its developers must run four successive phases of clinical trials in humans to establish how well the body tolerates the drug and how it is metabolized (pharmacokinetics), and from there pin down efficacy, safety, dosage and other measures of treatment effect. In the United States, under normal conditions, a single cycle of a clinical safety trial for FDA approval can involve more than a thousand subjects, with follow-up observation running up to six years or more. A new drug can fail at any of the four phases and never reach the market.

A "non-clinical safety trial," by contrast, means the animal-test data used in a safety assessment, from which the drug's real effects are inferred. With no clinical safety trial and no human metabolic data to compare against, the point of such a trial is simply to supply toxicity figures.

Nature's report argued that these compound TCM preparations still have to provide pre-clinical pharmacological testing and toxicity studies, and that without clinical trials it may be hard to guarantee either the potency or the safety of these "drugs."

Take thalidomide, the case cited in many articles on the subject. In the 1960s this drug, which sharply suppressed morning sickness, went on sale in Europe without rigorous clinical safety trials. In 1960 the rate of birth defects among European newborns rose sharply, and many women who had taken thalidomide gave birth to babies with short, flipper-like limbs — "seal-limb babies." In the United States, FDA officials judged the toxicology data from animal testing unreliable and refused to approve it. Later toxicology research found that thalidomide is strongly teratogenic in primates. This is one reason clinical safety trials matter so much.

3. Supporters say classic formulas were tested by dozens of generations and validated by practice, so they need no further testing. What does that argument leave unsolved?

Supporters have their own account of classic formulas. The most representative version comes from TCM scholars, who told Southern Weekly in 2016 that "running clinical trials on classic formulas over and over misses the point. Classic formulas have been used for hundreds or even a thousand years; their efficacy has already been validated on the human body, and any formula that didn't work would have been weeded out long ago, so there is no need for further clinical trials. Western drugs, by contrast, have never been used on people before they are chemically synthesized, so their efficacy and safety in humans have to be verified."

Once you see how complex a "drug clinical safety trial" actually is, this argument falls apart. At the FDA in the United States and at the CFDA in China alike, clinical safety trials before a new drug reaches market follow strict procedures and evaluation criteria. Each of the four phases has its own focus; together they prove not only that a drug works but also how bioavailable it is and what side effects show up when it is used at scale.

More important, a properly designed clinical trial requires a defined sample size and uses randomized, blinded controlled trials (RCTs). It compares the test drug's relevant parameters against a placebo (containing no active ingredient) or an already-marketed drug, reasoning strictly in pharmacological and biological terms to keep outside factors from muddying the result.

Over the "hundreds or a thousand years" a classic formula has circulated, its effect — not "effect" in the modern medical sense — has been partly confirmed. But how it performs against modern diseases, what reactions it produces, even how the body metabolizes it, remain deeply uncertain. Approving a drug on the strength of its age alone leaves a far larger blank in what we know.

4. How did Japan's kampo medicine get past the hurdle of modern medical testing?

Supporters also point to Japanese kampo. "This move by the state is also a case of learning from Japan," Shi Lichen, head of the Beijing Dingchen Pharmaceutical Consulting Management Center, told a People's Daily Online reporter in 2016. Media reports at the time noted that more than a hundred medical kampo prescriptions appear in Japan's official drug price schedule, and that most kampo medicines come from Chinese herbal medicine.

In 1974 Japan finalized its Standards for Approval of General-Use Kampo Preparations, covering 210 kampo formulas. All were drawn from Chinese medical classics such as the Treatise on Cold Damage, the Essential Prescriptions of the Golden Cabinet and the Thousand Golden Prescriptions, with reference to Japanese kampo texts such as the Compilation of Empirical Kampo Prescription Dosages. After several rounds of revision and addition the number grew to 294, each entry specifying composition, dosage and usage, and indications. These formulas are the basis of kampo research and production in Japan: any company may manufacture a formula listed in the standard, decide the finished dosage form, set its own process and quality standards, and apply to produce it.

"Approaches and Methods for the Modernization of Traditional Chinese Medicine", published in World Science and Technology in August 2017, notes that in Japan the kampo preparations listed in the Standards likewise need no clinical evidence.

But the article's authors also looked at where kampo stands today. First, in Japan both medical-use kampo and general-use kampo preparations (roughly, over-the-counter drugs) are prescribed by Western-trained physicians, and their stated functions are usually framed in Western disease names, such as "neurosis." Second, unlike the coexistence of Chinese and Western medicine in China, kampo preparations occupy a small corner of Japan — about 2% of the pharmaceutical market — serving as an adjunct to Western treatment and, to a degree, as a marketing device.

On top of that, after years of development Japan's kampo market has come to be dominated by one company, Tsumura & Co.; no new medical-use kampo preparation has reached market in years, so Japan's drug regulators have moved their oversight of kampo toward post-market monitoring of adverse reactions.

Even so, Japan reported in 1994 that side effects from Xiaochaihu granules (Sho-saiko-to) had caused 188 cases of interstitial pneumonia and 22 deaths. Regulators and manufacturers then added further safety information to the kampo labeling.

5. If we really mean to learn from Japan's kampo system, what else might we need to learn?

The crucial point is that Japan has no formal split between Chinese and Western medicine. All kampo medicines are used inside the modern medical system, and the physicians who prescribe them are Western-trained. In China, once classic formulas are approved, the people who use them and the people who regulate them will both be traditional Chinese medicine practitioners.

A June 2017 issue of Modern Chinese Medicine carried a drug-review article from the CFDA noting that Japanese medical-use kampo labels "describe not only known drug interactions and the adverse reactions and incidence rates detected after market launch, but also possible adverse reactions from a single herbal ingredient based on its pharmacological action, and warnings about combined use." The Xiaochaihu Tang formula, for example, contains licorice, so its medical kampo label warns that "combining it with preparations containing glycyrrhizic acid or its salts can readily trigger pseudoaldosteronism." Safety information on domestic patent Chinese medicine prescription labels, by contrast, rests mainly on adverse reactions already observed, and some labels simply say "not yet clear."

6. Why can't Chinese herbal medicine pass the tests? Why does it need a standard of its own?

Which brings us back, inevitably, to the internal logic of Chinese medicine. In the 1980s the state began promoting clinical trials for Chinese herbal medicines. But the trial process designed for Western drug development turns out to be especially awkward here. A physician surnamed Liu, in the Chinese medicine department of the PLA Rocket Force General Hospital in Beijing, explained that the ratios of ingredients in a Chinese formula are complex, and that different substances in the same prescription check one another to produce a combined effect. "Take cinnabar, which people argued about endlessly two years back. Everyone says cinnabar is mercury, and that eating it means heavy-metal poisoning. But in Zhusha Anshen Wan, cinnabar is there to treat excess heart fire. And we're not having the patient eat cinnabar on its own anyway — it's used together with coptis and other herbs."

The direct result of holding Chinese medicine to the strict approval standard built for Western drugs is that new Chinese herbal medicines have found it harder and harder to reach market. According to the 2016 Annual Drug Review Report from the CFDA's Center for Drug Evaluation, of the 206 drug production (market) registration applications approved in 2016, only 2 were Chinese medicines. In 2014 the figure was 11.

In his book The Clash of Chinese and Western Medical Cultures, Ren Dianlei, a professor at Nanjing University of Chinese Medicine, sums up this results-first philosophy of treatment as a "black box theory" — what the Spiritual Pivot calls "inferring the internal from the external." As the book puts it: "A single decoction contains many chemical components, and complex physical and chemical reactions occur among them. Modern Western drugs are synthetic compounds with well-defined molecular structures, whose toxicity and therapeutic effect can be revealed through clinical trials. Modern medicine still cannot fully reveal the therapeutic mechanism of a Chinese formula, and to assume that a formula's efficacy comes from the action of a single compound within it is to reject Chinese medicine's theory and its distinctive approach of treatment based on syndrome differentiation outright."

So Chinese herbal formulas, which fit so badly into modern clinical trials, began trying to step around the evaluation system and write a separate approval standard of their own. But because Chinese medical theory and its definitions of illness are themselves fuzzy, such a standard is hard to reproduce and hard to unify. "Treating illness in Chinese medicine stresses adapting to the person, the place and the season — the principles of treatment differ from one individual to the next. Treating a disease in summer is not the same as treating it in winter, and sometimes you also have to factor in the solar term, the weather…" Dr. Liu said.

But an official at the Division of Chinese and Ethnic Medicine in the CFDA's Department of Drug Registration says, "This is a misreading by outsiders. Approval of Chinese medicine has never simply followed the chemical-drug approach; it always combines the general with the specific. That said, because of Chinese medicine's own characteristics, there really is a difficulty in getting it approved."

This is, in effect, a problem with no solution. Inside a modern medical system and a standardized drug review, the "adapt to the person, the place and the season" principle Chinese medicine expects cannot survive a reproducible, quantified test — yet apart from applying a drug directly to the human body, Chinese medicine offers no reliable way to establish that its herbal drugs are safe and effective. The stalemate has now lasted nearly 20 years.

7. The road of rigorous clinical trials led nowhere for decades. Why the sudden acceleration?

In April 2008 the State Food and Drug Administration issued a notice on the Supplementary Provisions on the Administration of Chinese Medicine Registration, which stated for the first time that "compound Chinese medicine preparations meeting certain conditions may submit only non-clinical safety research data and apply directly for production." The conditions all pointed to "formulas recorded in medical texts from the Qing dynasty or earlier that remain in wide use, have a proven effect, and carry a clear, distinctive advantage."

The provision drew little attention, though, because it never said which formulas qualified. "Approval of classic formulas needs supporting implementation rules — you can't just say that whoever picks up an old formula has a new drug. How the market should be regulated, and a whole series of other questions, are still open. Earlier regulations already said that the State Council's department in charge of traditional Chinese medicine, together with the CFDA, would define the specific scope, but that list has never appeared," Liu Baoyan, a chief researcher at the China Academy of Chinese Medical Sciences, said in 2016.

Then came 2015. On October 5 that year, Tu Youyou, a researcher at the China Academy of Chinese Medical Sciences and the discoverer of the anti-malarial drugs artemisinin and dihydroartemisinin, shared that year's Nobel Prize in Physiology or Medicine with William C. Campbell and Satoshi Ōmura.

On December 22, Xi Jinping sent a congratulatory letter marking the 60th anniversary of the China Academy of Chinese Medical Sciences, calling for China to "push traditional Chinese medicine out into the world."

That February, Li Keqiang told an executive meeting of the State Council: "Tu Youyou's discovery of artemisinin drew inspiration from classic Chinese medical texts, extracted an active substance from an herb, and ended up widely used in both Chinese and Western treatment. We need to keep the distinctive character of traditional Chinese medicine while, with an open mind, pushing its development further."

From then on, even though the Nobel committee denied that the prize had gone to traditional Chinese medicine, TCM's forward march was under way.

8. The Nobel committee said plainly that the prize was not for Chinese medicine. Where does China's reading of it diverge?

After Tu Youyou won in 2015, an Indian reporter asked the committee at the post-ceremony press conference: does this year's medicine prize mean the way Western science views ancient or alternative medical systems is changing? Is this a form of recognition?

Nobel committee member Hans Forsberg answered no on the spot. People do have long experience exploring different plants, he explained, which can inspire new drug development, "but I don't think we're going to be using those herbs directly." Committee chair Juleen Zierath added: "They obtained an active compound from a natural product, and they also worked out the structure of that active compound. So this is about the active compound, not the plant mixture."

Finally, answering a Chinese reporter, Hans Forsberg confirmed it once more: "We did not award this year's prize to traditional medicine."

For the Nobel committee, Tu Youyou's award rested on her extraction of artemisinin from sweet wormwood by ether extraction. Domestic reporting prefers to dwell on the process by which she and the Beijing Institute of Chinese Materia Medica's Project 523 team "combed through a large body of ancient medical texts, looked into folk remedies, visited veteran Chinese medicine practitioners around the country, picked out roughly 2,000 anti-malarial prescriptions, screened them down to 380 candidate formulas drawn from 200 herbs, and finally settled on extracting an anti-malarial drug from sweet wormwood."

In her Nobel lecture, Tu Youyou even said that the inspiration for ether extraction came from a dosing method in the Handbook of Prescriptions for Emergencies by Ge Hong, of China's Jin dynasty: "Take a handful of sweet wormwood, soak it in two sheng of water, wring out the juice, and drink it all."

That alone shows how differently traditional medicine is understood inside and outside China. Modern medicine does not, in fact, shy away from drugs derived from natural materials; every country's early medical history records raw medicinal materials being used directly. But the Nobel principle of rewarding the isolation and explanation of an active compound has gradually been drowned out here by the refrain that "the motherland's medicine is a great treasure house."

9. So what exactly are the "classic formulas," and why is the list still not out?

In December 2015 the Traditional Chinese Medicine Law of the People's Republic of China (Draft) passed its first review. In February 2016 the State Council issued the Outline of the Strategic Plan for the Development of Traditional Chinese Medicine (2016-2030), which set out that "by 2020, essentially everyone will have basic access to traditional Chinese medicine services, and the TCM industry will become one of the important pillars of the national economy; by 2030, TCM services will achieve full coverage, TCM health-service capacity will be markedly strengthened, and it will contribute more to economic and social development."

Carried along by this run of policy, and despite the controversy, the draft TCM Law passed its second and third readings smoothly and cleared public comment in October 2017.

But the question of "ancient classic formulas" was still unsettled.

In 2009 the China Academy of Chinese Medical Sciences' Research Center for Development of Chinese Medicine took on a State Administration of Traditional Chinese Medicine research project, the "Catalog of Ancient Classic Formulas," and screened out 531 classic formulas. Since then, after removing formulas already on the market or containing highly toxic ingredients, and after two rounds of expert review meetings and one round of written expert review, a first batch of 100 formulas eligible for registration has been chosen.

On April 10, 2017, the Committee for Chinese Medicine Protection and Innovation under the China Association of Traditional Chinese Medicine held a symposium in Beijing on "compound Chinese medicine preparations from ancient classic formulas."

According to an April report in China Medicine News, the principles for picking these formulas included "retaining formulas commonly used for common and frequently occurring diseases" and "clinically common, frequently occurring, with significant market demand," and "the selection experts were all academicians of the two national academies, National Medical Masters, leaders of key disciplines, and university professors — people with rich theoretical and practical experience in Chinese medicine, strong professional ethics, and significant influence."

At the symposium the research team reported on progress in selecting formulas for the registrable Catalog of Ancient Classic Formulas, and attendees discussed the scope and principles for choosing ancient (pre-1911) pediatric classic formulas, and how turning ancient classic formulas into compound preparations relates to the drug marketing authorization holder system now being piloted.

Chen Ronghu, deputy director of the Chinese Medicine Division in the Science and Technology Department of the State Administration of Traditional Chinese Medicine, said: "Selecting the Catalog of Ancient Classic Formulas is an exploration in supply-side reform for Chinese medicine products. Turning an ancient formula into a drug should follow market demand and, while keeping to the original processing methods of Chinese medicine, pick classic formulas that are safe, reliable and effective. The core of it is making a good drug."

After the symposium some commentators expected the Catalog to come out by July at the latest, alongside the TCM Law. Things turned out to be more complicated. Even now the first batch of 100 formulas, drawn from 176 candidates, has not been made public, and screening for the 10 to 20 formulas to be used in demonstration studies has not begun.

10. Safety is still the biggest issue. So approval is a problem in itself — how, and by whom?

Once the Catalog is published, the classic formulas on it can apply directly for market approval, with clinical evidence limited to non-clinical safety trials and toxicity trials. Under the Administrative Provisions on the Simplified Registration and Approval of Compound Preparations from Classic Chinese Medicine Formulas, applicants may be excused from submitting efficacy research and clinical trial data. Beyond that, an applicant must produce a "standard decoction" following the prescription and preparation method published in the Catalog, then study the classic formula preparation against that standard decoction and show the two are consistent in quality. In other words, this class of drugs will be reviewed entirely by Chinese medicine standards, bypassing the modern pharmaceutical-development route altogether.

Compared with the CFDA's strict test of clinical effect, the provisions care more about how different manufacturers control the quality of a "classic formula." Since quality can be affected at every stage — sourcing the raw herbs, processing them into medicinal slices, manufacturing the preparation — the Provisions require quality-profile studies of the raw herbs, the processed slices, the intermediates, the "standard decoction" and the finished preparation. Yang Yue, a professor and doctoral supervisor at the International Center for Food and Drug Policy and Law at Shenyang Pharmaceutical University, suggests that under the pilot marketing authorization holder system, where one drug can have several holders, a uniform minimum manufacturing-quality standard should be set to protect drug quality.

When that happens, the State Administration of Traditional Chinese Medicine, together with the CFDA, will publish the catalog; once applications come in, the materials on the "standard decoction" will be posted for public comment on the website of the CFDA's Center for Drug Evaluation for six months.

11. Back to Chinese medicine itself. How do TCM practitioners treat patients now?

Beyond the herbal and patent-medicine prescriptions handed out at hospitals and pharmacies, the TCM services most people encounter are the Chinese medicine departments of major Class III Grade A hospitals and the Chinese medicine clinics on nearly every street.

A modern TCM clinic usually offers consultation, prescription-writing, dispensing and decoction services; larger ones add acupuncture and tuina massage. At an ordinary TCM clinic in Beijing, a patient who walks in gets a standard consultation and pulse-taking, and the consultation covers any earlier Western medical treatment. After the diagnosis the doctor writes an herbal prescription, the patient has it dispensed at the same clinic, and depending on the course of treatment usually brews and takes the herbs for more than 15 days. A TCM practitioner at one clinic, who asked not to be named, told us that the standard consultation fee in Chinese medicine is low, and that most clinics make most of their money selling medicine. "At a 'high-end TCM club' like Zheng'an Chinese Medicine, the consultation fee is the bulk of the bill — a single visit for a non-member can run 500 to 600 yuan."

Zheng'an Chinese Medicine is a chain of TCM clinics founded by Liang Dong, a former Phoenix TV host.

Things are stranger in the Chinese medicine departments of ordinary hospitals. Health Ministry rules say that to pass review as a Class III Grade A hospital, the TCM department must hold 5% of the hospital's beds. So every large hospital has to put resources into an ordinary TCM department. But because the diagnostic methods and underlying ideas of Chinese and Western medicine differ so much, TCM departments in most hospitals end up doing duty as pain-management or physical-therapy departments. Relatively few TCM physicians in modern hospital departments do traditional consultation work. A resident physician in the Chinese medicine department at Beijing's No. 301 Hospital said that inside the hospital, the TCM department has come to be seen as a roundabout way for patients with chronic illnesses to hold onto a bed.

Because it leans so heavily on transmission from one person to another, many herbal pharmacies and ordinary clinics survive on the reputation of a single doctor. Liang Dong, the TV host, opened his clinic only after formally apprenticing himself to the TCM scholar Deng Tietao, and constantly presents himself as Master Deng's "last disciple." Founders of "high-end clinics" like Zheng'an all call themselves the clinic's "master" or "proprietor," and are eager to explain health knowledge in the public media.

12. So can anyone open a TCM clinic now? What is the difference between licensing and filing?

In December 2017 new rules on TCM clinics took effect. The Interim Measures for the Filing Administration of Traditional Chinese Medicine Clinics moved clinic management from a licensing system to a filing system, scrapping approval beforehand and tightening oversight during and after operation.

Under the Measures, anyone who meets the requirements for opening a TCM clinic now submits the required filing materials to the county-level department in charge of traditional Chinese medicine; once the materials are accepted, that department issues a TCM Clinic Filing Certificate on the spot. With the certificate in hand, the filer can start practicing.

Article 15 of China's Regulations on the Administration of Medical Institutions says a medical institution must register in order to practice and must obtain a Medical Institution Practice License. Before December 2016, that certificate was what decided whether a clinic counted as practicing medicine illegally. To apply for it the person in charge had to supply seven basic documents, including an Approval for the Establishment of a Medical Institution, proof of ownership or use rights for the premises, architectural floor plans and details of the institution's legal representative, along with the medical institution practice registration form issued by the Health and Family Planning Commission.

In practice, a TCM clinic seeking a Filing Certificate from the county-level TCM department still has to fill out a filing information form, and its contents look much like what the old License required. The biggest change the switch brings may simply be that authority over TCM clinics has been taken back by the department in charge of traditional Chinese medicine — that is, the Administration of Traditional Chinese Medicine.

The other change concerns the basic requirements for a clinic's main person in charge. Under the rules, an individual opening a TCM clinic must hold a Physician Qualification Certificate in the Chinese medicine category and, after registering, have practiced for at least three years at a medical, preventive-care or health-maintenance institution, or else hold a TCM (Specialist) Physician Qualification Certificate.

In the past that practice period was five years.

The Measures took effect on December 1, 2017. The National Health and Family Planning Commission and the State Administration of Traditional Chinese Medicine are about to issue supporting documents, such as the Basic Standards for Traditional Chinese Medicine Clinics, to help them run smoothly.

13. Should we worry about a wave of quacks and con artists?

"We have to admit that some clinics in the TCM world are working in gray areas right now, especially small ones built around physical therapy, acupuncture, tuina and cupping — treatments that need no medication. Opening up the filing system can give these small clinics legal standing, but the 'doctors' practicing inside them may still fail even the loosened registration requirements and be unable to obtain a practicing qualification," said Zhang Yongquan, a lawyer at Grandall Law Firm (Tianjin). Such clinics, he said, face a choice between shutting down and operating under someone else's license.

To head off problems the filing system might create, the Measures provide that county-level TCM departments will set up a points system for clinics' misconduct, recording and scoring improper practice, arbitrary fees, and false or exaggerated advertising; those records and scores will be an important basis for supervising TCM clinics.

But how the scoring will be managed, how the criteria will be set in practice, and what penalty a clinic faces once it piles up bad points — these operational questions are still unanswered.

14. How does someone become a qualified TCM physician?

The last argument, and the fiercest, is about people.

On December 20, Order No. 15 of the National Health and Family Planning Commission, the Interim Measures for the Assessment, Registration and Administration of the Physician Qualifications of Personnel with Genuine Expertise in Traditional Chinese Medical Skills, takes effect. It will help people with genuine expertise in TCM skills obtain a TCM qualification certificate.

The argument over standardizing TCM education is an old one. Studying Chinese medicine at an ordinary mainland medical university in fact means studying an integration of Chinese and Western medicine. The undergraduate Chinese medicine curriculum at Beijing University of Chinese Medicine runs to more than a dozen subjects: fundamentals of Chinese medicine, fundamentals of modern medicine, classical TCM texts, TCM diagnostics, herbal pharmacology, formula science, and internal medicine, surgery, gynecology and pediatrics in the Chinese medicine tradition. Every Chinese medicine undergraduate also has to take basic medical science courses.

But a standardized, reproducible modern education system is a poor fit for learning Chinese medicine. In TCM diagnostics, for instance, skills like pulse-taking need one-on-one transmission and simply cannot be taught in a modern university classroom. Wang Lang, a graduate student at Beijing University of Chinese Medicine, told us: "It wasn't until my internship in my fifth year that I really knew what the textbooks' 'choppy pulse' was." His supervising physician had found the pulse point by hand and let him feel it on a patient's wrist for a full minute.

In September 2016 Wang Lang sat the licensing exam for TCM practitioners, which then covered basic TCM theory, TCM diagnostics, herbal pharmacology and formula science, plus a practical test focused on syndrome-differentiation-based treatment and techniques such as acupuncture. On the written paper candidates faced questions like: "Is the function of Yueju Wan to move qi and dissolve stagnation, to move qi and harmonize blood, or to move qi and relieve depression?"

When Wang Lang was a sophomore, a classmate once joked in the dormitory about their major: "With all this rote memorization, we might as well go outside and apprentice ourselves to an old TCM master." At the time, students who learned by apprenticeship were not even eligible to sit the licensing exam.

Now anyone who has studied continuously under a master for five years, whose treatment methods for certain conditions have been judged adequate by that supervising physician, and who is recommended by at least two licensed TCM physicians, can sit the "assessment for personnel with genuine expertise in TCM skills."

"In other words, whatever you know is what we'll test, and whatever we test is what you'll use later on," Zhao Wenhua, deputy director of the Medical Administration Department of the State Administration of Traditional Chinese Medicine, said at a press briefing in November.

The standard for assessing all these varied "people with genuine expertise in TCM skills" will therefore shift from case to case. Leave aside the differences in assessment format that will follow in practice: for patients alone, telling a qualified "TCM physician" from an unqualified one will get far more expensive.

15. All right — and there are still plenty of large, unsettled questions of right and wrong…

From drug admission to personnel admission, China has worked through three pivotal problems in the development of Chinese medicine since 2008, and in doing so has pushed the regulation of TCM and its master-apprentice tradition into territory that runs entirely counter to modern medicine. This is exactly what governments, physicians and the public have argued over again and again since modern Western medicine arrived in China: does Chinese medicine need to be preserved? How? Can it fit the modern medical tradition, and if not, what do we do with it?

Over a hundred years of conflict between Chinese and Western medicine, a few of the sharpest points have been these —

Is Chinese medicine a form of mysticism?

Does traditional medicine contain any element of "scientific validity"?

Does Chinese medicine have any value in the modern era?

Can a "fusion" of Chinese and Western medicine work?

If it is needed, how should Chinese medicine be modernized?

What do "scientizing Chinese medicine" and "abolish the doctors, test the drugs" mean?

How should traditional medicine take part in treatment, health maintenance and prevention within the public healthcare system?

Was the earlier remaking of Chinese medicine too rash and arbitrary because it rode alongside "social revolution"?

What else do we still need to think through about the conflict between Chinese and Western medicine?

……

We may write more articles exploring these questions.

For now, there is a new question to face: will Chinese medicine be carved out of the modern medical system? When we say modern medical system we do not only mean clinical treatment, drug manufacturing and R&D we mean the whole public health administration — how medical qualifications are regulated, the drug management system, medical insurance… It is an enormous, systemic problem.

And it may be the most important question right now.

Cover image from: Zhongyaowang