How Traditional and Complementary Medicine Is Regulated Around the World

A patient in Sydney who sees a Chinese medicine practitioner is seeing a registered health professional, accountable to a national board under the same law that governs doctors and nurses. A patient in many American states seeing someone who uses the same title may be seeing a licensed acupuncturist with graduate training, or someone with no regulated training at all. A patient in Delhi consulting an Ayurvedic doctor is seeing a practitioner of a nationally regulated system of medicine, with a degree and registration of its own. A patient in Berlin may be seeing a Heilpraktiker, a distinctive German category of licensed non medical practitioner. For practitioners working in integrated settings, or advising patients who move between countries, these differences are not academic. They determine what can be assumed about a colleague’s training, how products are controlled and what to check.

3 broad models

The World Health Organization has described national approaches to traditional and complementary medicine in 3 broad categories.

Integrative systems formally recognise traditional medicine and incorporate it into national health care: its practitioners are educated and registered, its products regulated, and its services provided in public facilities and sometimes covered by insurance. China, India, the Republic of Korea and Vietnam are prominent examples.

Inclusive systems recognise some traditional and complementary practices, perhaps regulating certain professions or covering some services, without fully integrating them.

Tolerant systems permit practice under general law but do not formally recognise or regulate it, leaving practitioners largely self governed.

Most countries sit somewhere between these categories, and a single country may treat different practices in different ways.

Regulating practitioners: a range of approaches

2 features of this landscape are worth emphasising. The same title can mean very different things in different places: in the United States, an osteopathic physician holds a medical degree and full prescribing rights, whereas in the United Kingdom and many other countries an osteopath is a manual therapist with a separate professional registration. And statutory regulation assures minimum training and accountability, not the effectiveness of every intervention a profession offers.

Regulating products

Product regulation varies at least as much as practitioner regulation, and it matters more directly for safety.

In the European Union, a simplified registration scheme for traditional herbal medicinal products allows products to be registered on the basis of long standing traditional use, generally at least 30 years including 15 within the Union, together with evidence of quality and safety, without clinical trials of efficacy. Such products carry wording stating that their use is based on tradition.

In the United States, most herbal products are sold as dietary supplements under a framework that does not require approval of safety or efficacy before marketing. Manufacturers must follow good manufacturing practice and may not claim to treat disease, and the regulator can act against unsafe products after they are on the market. Studies of products associated with regulatory warnings have found undeclared pharmaceutical ingredients, particularly in products marketed for weight loss, sexual enhancement and muscle building.

In Australia, complementary medicines are regulated through a tiered system, with most products listed on the basis of permitted low risk ingredients and a smaller number registered after fuller evaluation.

In Canada, natural health products require a product licence, with the level of evidence required depending on the claims made.

In India, Ayurvedic, Siddha, Unani and homoeopathic medicines are regulated under national drug law, with specific provisions for their manufacture and quality.

In China, traditional Chinese medicines are regulated as medicines within the national system.

The practical consequence for practitioners is that a product’s regulatory status depends on where it was made and bought. Products purchased online from other countries may fall outside the regulatory protections of the patient’s own country entirely.

Where regulation protects, and where it does not

Regulation helps in several ways. It sets minimum education standards, provides a route for complaints and discipline, requires practitioners to hold insurance, and for products, sets standards for manufacture, labelling and contaminants.

Regulation does not guarantee effectiveness. A statutorily registered profession may offer interventions with weak evidence, and a traditional herbal product registered on the basis of tradition has not been shown to work in trials. Nor does regulation eliminate risk: contaminated or adulterated products still reach patients, especially through informal supply chains.

What this means for practice

Ask where and how

When a patient mentions a practitioner or product, it is worth asking where the practitioner trained and whether they are registered, and where the product was bought. These 2 questions often determine how much further checking is needed.

Check registers

Where statutory registers exist, they are usually searchable online and confirm whether a practitioner is registered and whether any conditions apply.

Know your own scope

Every practitioner is bound by the rules of their own licence where they practise. In some countries, recommending or supplying certain products, or practising certain techniques, is restricted to specific professions. Cross system prescribing, in which a practitioner of one system prescribes medicines from another, is tightly controlled in several countries, and in some it is prohibited.

Be cautious about online and imported products

Products obtained from overseas sellers, informal markets or relatives abroad deserve particular attention to identity, ingredients and possible contamination.

Refer and coordinate across boundaries

Referral to a registered practitioner in another discipline is a legitimate part of integrated care. Coordination works best when both practitioners understand each other’s scope.

An illustrative case

A family relocates from India to Canada. The father, who has type 2 diabetes, has for years taken an Ayurvedic preparation manufactured by a licensed company in India and prescribed by a registered Ayurvedic doctor. In Canada, he runs out and buys a similar product online from an unfamiliar seller. His new physician, seeing an unexpected rise in his liver enzymes, asks about everything he takes. The product turns out to contain ingredients different from his previous prescription, from a supplier with no evident quality controls in either country. It is stopped, his liver tests return to normal, and his physician and a Canadian naturopathic doctor familiar with Ayurvedic practice help him decide how to proceed. The same kind of product had a very different regulatory status, and risk, in 2 different supply chains.

A shifting landscape

Regulation of traditional and complementary medicine continues to evolve. The World Health Organization has encouraged countries to develop policies that ensure safety, quality and appropriate integration, and new national laws and registers appear regularly. Practitioners do not need to master every country’s rules, but they do need to know the rules where they practise, to ask the right questions about everything else, and to remember that the answers can differ at every border.