Thieme Almanac : Legislation Regulation and Professional Developments : Acupuncturists Without Borders

Professional Developments, Legislation, Regulation

Editorial Comment on "The Regulation of Herbal Medicine in the United Kingdom and Europe. An Interview with Michael McIntyre, Chair of the EHPA"

Michael McCarthy, MA (ThB), LAc, DipCHM, Dublin, Ireland

At this stage, some countries have passed legislation to facilitate the process of the implementation of the Traditional Herbal Medicinal Products Directive (THMPD) by 2011. What seems to be extraordinary is that it is a pharmaceutically trained coterie of individuals who sit on the implementation committee—the Herbal Medicinal Products Committee (HMPC)—with no sign of an herbal expert to be seen anywhere. Several groups, both professional and consumer, within the EU have been lobbying to gain such representation without success. One wonders what the real agenda is here.

The original stated objectives of the THMPD were:

Protection of consumer health, providing access to medicines of the consumer�s choice provided safeguards are met.
To facilitate a single market for herbal medicines via harmonized rules.

These objectives were going to be met by:

A simplified registration system for traditional herbal products.
Manufacturing and quality requirements similar to those for existing licensed medicines.
A system enabling applications to be made without the usual information on safety and efficacy, instead with bibliographic review and expert reports, in the case of national authorities concluding that sufficient product knowledge exists.

Thus there is a need for the development of a set of monographs to establish such information "fficially" and for the creation of a positive list of herbal medicines.

Article 16h of Directive 2001/83/EC provides for the establishment of the HMPC. This is effectively the implementation committee of the Directive.

According to Directive 2004/24/EC of the European Parliament and of the Council of March 31, 2004, amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use:

It should be composed of experts in the field of herbal medicinal products.

The role of the HMPC was to

Develop Community herbal monographs and a positive list of herbal substances at Community level, with therapeutic indications, specified strength, route of administration, and relevant safety information.
Ensure that where herbal substances met the criteria set out in the positive list it would not be necessary to demonstrate compliance with the criteria for traditional use and safety.

Articles 16a—i of Directive 2001/83/EC have a direct impact on East Asian medicines and are creating a number of problems. Firstly, East Asian medicinal products that are not purely herbal fall outside of the present Directive (2001/83/EC Articles 16a—i) with regard to the registration of traditional herbal medicinal products. Within the Asian traditions there are many products that contain natural substances or preparations other than just herbal ingredients, which effectively makes it impossible at this time to register such products as traditional herbal medicinal products. Secondly, it is difficult to meet the requirement to provide bibliographical or expert evidence of medicinal use over a period of 15 years within the Community (Article 16c[1][c]). Furthermore, the opinions on the adequacy of the evidence of longstanding use, on quality, and on safety differ from state to state.

There are also problems with current practices within the HMPC. This Committee, which comprises only pharmaceutically trained, non-clinically practicing representatives of the various Medicines Control Agencies in the different EU states, seems to only reach consensus in a very restrictive manner, which has the effect of narrowing the scope of the Directive.

Incredible as it may seem, despite the huge impact this Directive will have on the practice of herbal medicine, this Committee has not been able to appoint a practitioner expert to its panel, leaving interpretation and decisions on the use of these medicines solely in the hands of non-clinically practicing pharmacists. The Committee has taken on itself the making of rules, such as the Guideline on the Clinical Assessment of Fixed Combinations of Herbal Substances / Herbal Preparations EMEA/HMPC/166326/2005, which limits the minerals that can be used in preparations to nutrients as defined in the Food Supplement Directive (2002/46/EC). This is despite the fact that the directive approves an ancillary use of minerals in traditional herbal medicinal products and does not provide a limiting definition of "mineral." Why is this?

Yet another problem arises with regard to certain plant-based active substances where current practice of the HMPC considers them to be not herbal. One such substance is natural d-camphor (Doc. Ref. EMEA/HMPC/151144/2006 corr. from May 24, 2006). Natural d-camphor is a herbal preparation of a relatively high purity with a long history of having been regarded as herbal even by the German Commission E.

Notwithstanding the problems this Committee is creating for the practice of European herbal medicine, the current behavior of the HMPC seems very anti-Asian in its effect. The HMPC needs to immediately nominate experts on Asian herbal medicines and their practice. How is it possible for the HMPC to find appropriate and feasible solutions without expert knowledge in the different traditional medical practices in Europe and East Asia? As cited above, "[the HMPC] should be composed of experts in the field of herbal medicinal products" (Directive 2004/24/EC of the European Parliament and of the Council of March 31, 2004).

Finally, is it really true, as has been reported, that at the current pace of developments within the HMPC in regard to the production of monographs, East Asian medicine will have to wait another 10�20 years to see the first Community monograph for East Asian herbs?

As we approach 2011 (the final date for the implementation of the THMPD), it is apparently becoming increasingly critical for the constituent members of the herbal medicine community to coordinate their efforts to combat what appears to be the policy of the European Medicines Agency (EMEA)—implemented through its Committee, the HMPC—to effectively wipe out the herbal medicines supply chain and ipso facto the practice of genuine herbal medicine in Europe through the operation of an impossible implementation policy.

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