Not the right prescription for European regulators

Steps taken by the European Union and the UK government have put a spoke in the wheels of traditional Chinese medicine, the healthcare system fine-tuned by China's scientists and clinicians over more than four millennia.

Having handed sovereignty to the EU on crucial matters such as key aspects of healthcare and trade, the British government is now choosing to jettison or stall actions that could safeguard the future of TCM.

This includes the recently stated intention by the British medicines regulator, the Medicines and Healthcare products Regulatory Agency, to terminate the "sell-through" of unlicensed herbal medicines by the end of this year. This will mark the effective end of an exemption that has allowed the sale of manufactured unlicensed herbal products for more than 40 years.

In a stay of execution, the MHRA allowed unlicensed products legally in the sales pipeline to be "sold through" after May 2011. However, on Dec 31, the door will close. Any unlicensed products will effectively become illegal. The extent of the impact of this change will largely depend on two factors:

On how many existing products the MHRA considers medicinal as opposed to being food supplements;

The intensity and effectiveness of its policing and enforcement efforts.

The EU Directive on the Traditional Herbal Medicinal Products is responsible for burying the UK-specific exemption. The directive essentially provides a drug-licensing scheme that is referred to as "simplified" because it replaces the need for costly clinical trials that prove efficacy with evidence of historical safe use.

However, it still requires that the other two pillars of drug licensing, namely safety and quality control, are met. It is ironic that TCM is a serious casualty of a European law that was originally conceived to allow TCM and other "non-conventional" medicinal systems to be made widely available to the public, without exposing them to unnecessary risks.

In its attempt to prevent a repeat of a tragedy affecting more than 100 women in the early 1990s after they were prescribed a herb-drug cocktail for weight loss by Western medical doctors in a Brussels clinic, the European Parliament conducted a detailed study of TCM and other systems of traditional or "non-conventional" medicine. It published its findings in 1997 and the report effectively triggered the development of the directive to ensure all Chinese and other non-conventional medicinal products provided to the public were safe.

But given that the directive is not intended for products prescribed by practitioners, being intended instead for products sold directly to the end-consumer for minor ailments that do not require medical supervision, its remit in no way covered the type of cocktail dispensed by the doctors in the Brussels clinic.

The directive also contains eligibility criteria that make it very difficult, or even impossible, for most TCM products to be licensed. Among the numerous obstacles posed by the EU directive is the requirement for inclusion of only herbal ingredients or extracts. Accordingly, minerals and animal-derived products are excluded. It also requires stability data suited more for synthetically derived drugs, rather than complex combinations of naturally sourced materials.

The result is that not a single complex, classic TCM formulation has yet to be registered under the scheme. In effect, therefore, the directive has attempted on one hand to protect the public from problems that do not exist while, on the other, failed to deal with genuine issues of public safety, as exposed by the Belgian tragedy, aspects in which TCM or complementary medicine practitioners played no role whatsoever.

The only remaining safeguard for practitioner prescribed products is another exemption, originally also mandated in the 1968 Medicines Act, that allows unlicensed herbal products to be prescribed to patients following a one-to-one consultation, provided the remedy is manufactured, assembled on the clinician's premises.

Just how long this provision will remain is unclear. It does not allow prescription of any finished products, let alone their purchase directly by members of the public without a consultation.

The UK government's promise made in February 2011 by the then secretary of state for health, Andrew Lansley, to bring in a system of statutory regulation of herbalists in 2012, has already been broken. The Department of Health is unable to make any commitment if or when the process to regulate herbalists by statute may be resumed, the risk being that, in time, herbalists, or traditional medicine practitioners, may not be allowed any special privileges irrespective of their experience or qualifications.

While the TCM, Ayurvedic and other communities representing non-European systems of medicine have spent many years in dialogue with British authorities, it is deeply disappointing that, despite huge interest and uptake by the public, the UK is prepared to do little to protect these complex, yet highly effective traditions that have withstood the test of time.

The author is executive director, Alliance for Natural Health International, a non-governmental organization based in the UK.