Chinese medicine has a long history of providing alternative therapeutic approaches for various health conditions, and over the past few decades, it has experienced growing popularity in the United Kingdom (‘UK’). Patients who are drawn to holistic and time-honoured treatment methods often seek Chinese medicine as a complementary addition to conventional healthcare, particularly for chronic or difficult-to-manage ailments. Despite its appeal, Chinese medicine exists at the crossroads between preserving traditional knowledge and complying with rigorous public health and safety standards. This situation has led to ongoing debates about the adequacy of the current regulatory framework, which relies on voluntary registration schemes, and whether a system of statutory regulation might be more appropriate. The issues at stake are far-reaching, as the regulatory approach adopted by the UK may influence not only the professional standing of Chinese medicine practitioners but also the extent to which patients can access time-tested remedies and practices.
By Charles Mak, Lecturer in Law, Robert Gordon University
The voluntary registration model presents advantages and limitations, reflecting a tension between safeguarding the public and honouring a therapeutic tradition with its own epistemological foundations. This piece will examine the current regulatory system, assess the ongoing push for statutory oversight, and highlight the major factors that may shape future developments.
Current Regulatory Landscape
Under the existing structure in the UK, Chinese medicine practitioners are not subject to compulsory registration, and this means that individuals with varying degrees of training and expertise can label themselves as providers of traditional therapies. Although some professional associations maintain voluntary registers and uphold ethical standards among their members, these schemes do not have legal force. The Register of Chinese Herbal Medicine, established in 1987, represents one notable attempt to foster excellence and patient protection. Still, membership remains optional, and its authority extends only to practitioners who choose to join. Similarly, the Complementary and Natural Healthcare Council offers a voluntary scheme for certain practices, though it too lacks the power to enforce standards universally.
Successive governments have intermittently considered introducing statutory regulation for acupuncturists, herbalists, and those specialising in traditional Chinese medicine, partly in response to concerns about consumer protection and the credibility of these disciplines. In 2008, a Department of Health Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK recommended such a move in its Report to Ministers from The Department of Health Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK, but implementing a mandatory framework has proven to be a slow and intricate process. The continued reliance on voluntary registration reflects the complexity of Chinese medicine and the broader difficulties in establishing criteria that can satisfy the diverse stakeholders involved.
Challenges in Regulating Chinese Medicine
Regulating Chinese medicine poses intricate challenges that stem from the tradition’s unique conceptual framework and the demands of modern healthcare standards. Chinese medicine, grounded in centuries of empirically developed knowledge, emphasises holistic diagnostics, pattern differentiation, and approaches that vary among individuals. These elements can be difficult to reconcile with Western methodologies that rely heavily on randomised controlled trials and standardised protocols. As a result, conventional evaluative procedures may overlook the complicated, personalised aspects that define many practices within the Chinese medical tradition, creating tension about demonstrating efficacy and safety.
Additional complications arose from historical European Union (‘EU’) legislation, such as the European Directive on Traditional Herbal Medicinal Products (Directive 2004/24/EC), which required herbal products to meet standards of quality, safety, and evidence of traditional use within the EU (including 15 years of use in Europe). While the UK transposed this directive into national law via the Traditional Herbal Registration (‘THR’) scheme, post-Brexit regulatory adjustments mean the Medicines and Healthcare Products Regulatory Agency (‘MHRA’) now oversees these requirements independently. The UK’s THR scheme retains the 30-year traditional use criterion but may revise geographic applicability, potentially easing access for non-European remedies while maintaining safety standards.
Potential for a Unified Regulatory Body
One proposal that has generated substantial interest is creating a unified regulatory body responsible for overseeing acupuncture, herbal medicine, and other forms of traditional Chinese practice. Advocates suggest that merging these disciplines under a single authority could promote uniform standards of education, practice, and professional conduct, thereby reducing public confusion and providing clearer pathways for accountability. Theoretically, a consolidated structure would also enable regulators to devise comprehensive guidelines that address the diverse modalities within Chinese medicine, ensuring that practitioners adhere to established ethical codes while allowing room for cultural and philosophical differences.
However, bringing disparate traditions together under a single organisational framework is fraught with practical and conceptual difficulties. Different branches of Chinese medicine place varied emphases on diagnostic techniques and treatment strategies, and some practitioners worry that a homogenous set of regulations may fail to accommodate the subtle distinctions that define their work. There is also a concern that insisting on conformity to Western evidence-based benchmarks could overshadow the experiential wisdom that underpins many longstanding therapeutic methods. Despite these uncertainties, a unified approach still holds considerable appeal for policymakers seeking to streamline the regulatory environment and enhance public trust in complementary healthcare.
Innovative Aspects of the UK’s Regulatory Approach
The UK has implemented novel approaches to regulating complementary and alternative treatments, including herbal medicines. The MHRA established the THR scheme, which allows certain herbal products to be marketed based on their history of traditional use rather than the extensive clinical trial data typically required for pharmaceuticals. This scheme, introduced in response to the European Directive on Traditional Herbal Medicinal Products (Directive 2004/24/EC), acknowledges the long-standing use of many herbal remedies while ensuring safety and quality standards are met. However, it is important to note that the THR scheme addresses product safety and quality but does not regulate practitioners or clinical use. It remains limited to herbal products for minor conditions, leaving broader aspects of Chinese medicine, such as acupuncture or individualised herbal formulations, outside its scope. The scheme originally required 30 years of traditional use, including 15 years within the EU. Post-Brexit, the MHRA may adjust geographic criteria, though current guidelines still reflect the EU-derived framework. Ongoing reviews could shift emphasis toward global traditional use, affecting how Chinese herbal products are evaluated in the UK. While this approach recognises the empirical support for some herbal remedies, it does not equate to proof of efficacy, and registered products must clearly state that their indications are based on traditional use rather than clinical evidence.
From January 2024, the UK’s International Recognition Procedure allows the MHRA to fast-track medicines already approved by trusted regulators (e.g., the Food and Drug Administration in the United States or the European Medicines Agency). While this primarily targets conventional pharmaceuticals, it could indirectly benefit standardised Chinese herbal products if they undergo similar regulatory pathways. However, most traditional Chinese medicines, which rely on historical use rather than clinical trials, may not qualify under this procedure. In addition, new regulations governing point of care manufacturing permit the production of innovative medicines closer to patients, a world-first framework designed to support the development of personalised treatments such as cell and gene therapies. The MHRA has also created the Innovative Licensing and Access Pathway to accelerate the market entry of promising new medicines through a phased, modular review process that provides ongoing regulatory guidance. Furthermore, the UK has entered initiatives like Project Orbis and the Access Consortium, collaborating with international regulators to pool knowledge and streamline regulatory evaluations, particularly for essential products, including cancer therapies. Collectively, these efforts underline the UK’s commitment to fostering a regulatory environment that promotes innovation while upholding stringent safety and efficacy standards for medicinal products.
Impact on Practitioners and Patients
Any move towards stricter or more comprehensive regulation of Chinese medicine will likely affect practitioners in complex ways. On the one hand, statutory oversight or a unified regulatory system could bestow enhanced legitimacy on qualified professionals, potentially increasing public confidence and recognition by mainstream healthcare providers. Such recognition might create new opportunities for collaborative care, greater research funding, and the inclusion of Chinese medicine within broader integrative treatment protocols. Practitioners who meet defined educational and ethical criteria would benefit from a clarified professional identity and the chance to distinguish themselves from less scrupulous operators.
On the other hand, such regulation carries potential drawbacks. Mandatory registration and adherence to specific guidelines may impose administrative, financial, and procedural burdens that strain small practices or those rooted in family-run traditions. Some practitioners also worry that enforcing evidence-based parameters could limit their autonomy or marginalise techniques that do not align with Western research models. Patients, too, face consequences: while a more regulated environment could assure higher standards of care, it might reduce the range of accessible remedies and raise treatment costs. Ultimately, the interplay between enhanced public protection and the preservation of longstanding healing methods will remain a key point of tension.
Future Outlook
The regulatory future for Chinese medicine in the UK could unfold along several possible trajectories, each with distinct implications for practitioners and the public. One scenario is the continued reliance on voluntary schemes, in which professional bodies set standards without state-backed authority. Another possibility involves full statutory recognition, either through creating a new agency or by extending the remit of an existing healthcare regulator. Alternatively, a hybrid model might emerge, blending elements of voluntary membership with certain mandatory provisions.
Any of these routes will profoundly influence how Chinese medicine is practised, studied, and perceived. A move towards statutory oversight could strengthen professional identity and open avenues for greater collaboration with biomedical sectors. However, it may also prompt concerns about standardisation, overshadowing the nuanced practices cherished by seasoned practitioners. Whatever form the regulatory future takes, it remains essential that it protects public safety and honours the integrity of one of the world’s oldest healthcare traditions.
Conclusion
The debate about regulating Chinese medicine in the UK underscores the inherent complexities involved in integrating traditional practices with a healthcare system that prizes empirical validation and consistent standards of public protection. Voluntary registration schemes have offered a partial solution, yet questions linger about whether statutory regulation might better guarantee patient safety, foster professional cohesion, and broaden acceptance among mainstream providers. At the same time, herbal legislation emerging from Europe and elsewhere has restricted access to some longstanding remedies, prompting cultural preservation concerns. Innovative measures such as the THR scheme and international collaborations signal a willingness to accommodate unique healing traditions, but the path forward remains uncertain. Whether through unified oversight, hybrid models, or continued reliance on voluntary frameworks, the challenge lies in crafting regulations that secure the well-being of patients, respect the historical foundations of Chinese medicine, and continuously evolve and adapt within a diverse and ever-shifting global health landscape.
Charles Mak, Lecturer in Law, Robert Gordon University
