By Eric Brand

As Europe prepares for unprecedented restrictions on herb sales, the topic of herbs as "prescription only" remedies has surfaced again and again. It appears that many Chinese herbal products will be restricted in the EU, resulting in minimal access by unlicensed professionals. Unfortunately, the EU lacks a harmonized system for licensing and professional recognition of Chinese medicine practitioners, and in many EU countries TCM practitioners are legally in the same boat as laypeople. If a harmonized system could be set up to allow TCM practitioners in Europe to have professional status and licensure across the EU, it would be feasible for Europe to maintain access to Chinese herbs under a model similar to that used for prescription drugs.

Europe’s situation is quite different from the situation in the U.S., but similar issues abound. Both regions have long enjoyed unrestricted access to most herbal products when sold as dietary supplements, but both regions have lost access to a number of important herbs that might have remained available if a prescription-only model existed. However, neither the U.S. nor the E.U. offers a formal, harmonized system of professional regulation for herbal medicine that protects the herbal scope of TCM practice across the entire region. In the E.U., herbal regulation has long varied from country to country, and in the U.S. the inclusion of herbs into the TCM practitioner’s scope of practice varies from state to state.

Within the professional TCM community, a fair number of people would like to see herbs regulated as “prescription only” products (obviously, we want the right to prescribe them ourselves without needing to go through an MD). A fair number of people in the TCM community want the exact opposite and would like to see herbs minimally regulated. What are the pros and cons of a “by prescription only” model for herbs?

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To a certain extent, the desire to see herbs regulated as prescription products that only practitioners can access reflects a desire to distinguish ourselves from the general public. We don’t want misuse of Chinese herbs by the general public to result in bans like the Ma Huang ban. Chinese herbs are not inherently safe for uneducated use, so their availability without a professional gatekeeper makes adverse events more likely, and these adverse events generate bad publicity for Chinese herbs in addition to restrictions in access. Regulation reflects recognition that herbs are potent, potentially therapeutic but also potentially dangerous substances that need to be prescribed by trained individuals.

If we could make Chinese herbs legally available only through licensed practitioners, it would likely decrease adverse events, give herbs more respect as medicines, and focus the vending of Chinese herbs so that practitioners are involved on some level with all sales. American TCM practitioners have fought long and hard to achieve acupuncture regulation, and in many states we enjoy more formal regulatory provisions and academic degrees than our colleagues in Ayurveda or Western herbalism enjoy. It is only natural that some people in our community would prefer to have Chinese herbs restricted to us, because we are the only ones fully trained in their use (similar politics apply with acupuncture needles).

However, despite the potential advantages in a prescription only access model, there are a number of downsides. First and foremost, we would be losing our unity with the rest of the natural products industry. Chinese medicine and Ayurveda have totally different degrees of regulatory maturity in the U.S., yet they often share individual herbs and both systems are comparable in their age, depth, and safety/therapeutic potential. If Chinese herbs were prescription only, could Ayurvedic practitioners still maintain access to Ayurvedic herbs that are also used in Chinese medicine? How could we implement a system that restricts herbs from the public without restricting herbs from practitioners of other medical systems that lack a formal licensing system (like Western herbs or Ayurveda)? How could we ensure that acupuncturists would retain access to prescription only Chinese herbs in states that do not permit herbal medicine to be used within an acupuncturist’s scope of practice?

Beyond considering the needs of other herbal professions and our own ethical imperative to protect herbal access for all (“do unto others as you would have them do unto you” comes to mind) , there are a number of other questions that are important to consider. First, is the public actually in danger from open access to herbal supplements? How many actual adverse events result from misuse of Chinese herbs by the lay public? Is it the job of the government to protect the public from anything that could be potentially misused and harmful? Where do we draw the line to protect the public without turning the country into a nanny state obsessed with protecting people from their own stupidity? Will we try to go out in nature to eradicate all toxic plants to prevent idiots from poisoning themselves by digging up toxic wild roots in the local hills? Will the uneducated consumer who gives themselves aconite poisoning receive a Darwin award, or will aconite be banned to protect the next person from themselves?

Clearly it is unethical to practice herbal medicine without an adequate education. But should it be illegal? Should “buyer beware” be the final law, or should we try to limit the things that can be bought to only those items that can cause no harm? What about herbs like ginseng that are completely safe from a scientific perspective but only indicated in certain cases from a TCM perspective? Should a Western herbalist with 20 years experience using ginseng based on its scientific indications be denied access while a “C” student new graduate with an NCCAOM diploma retains access? Is the training in our schools adequate to ensure the safe practice of herbal medicine by all licensed practitioners? Do we have the political clout and coordination to get herbs into our scope of practice across the country? Do we trust that a more strictly regulated environment would preserve herbal access, or do we fear that it would actually restrict access even more by creating a lot of red tape and unforeseen consequences? Most importantly, do common people deserve the right to purchase any natural product they like for consensual use without prohibition?

Our field needs to start asking these questions, because the topic of prescription only status for Chinese herbs will be coming up again and again. Some people advocate a model wherein safe herbs are available as supplements with no restrictions, while toxic herbs require a licensed practitioner. Others would like to see even common herbs like ginseng become prescription only. Still others favor no regulation at all, caveat emptor, the less government interference, the better. All practitioners will need to think about these issues so that we can join in when the inevitable debate begins.