Paper short abstract:

The European directive for traditional herbal medicines was established in 1995. Consequently, some herbs are practically banned despite their potential therapeutic effectiveness. What are the consequences for Asian medicines containing a blend of potent (mostly herbal) ingredients?

Paper long abstract:

The European directive for Traditional Herbal Medicinal Products (THMP) was a breakthrough at the time of its inception in 2005. The directive offers products consisting of herbal substances/preparations with a 15-year period of traditional use within Europe an avenue to be registered as a medicine. The Herbal Medicinal Product Committee (HMPC) at the European Medicines Agency (EMA) has developed guidelines how to register THMPs, especially regarding their quality and safety.

The talk describes the European framework for THMPs. Overall, the present regulatory environment offers many opportunities to register THMPs. Such a registration is a national process, and the figures collected from the national medicines authorities show a steady increase of THMP-registrations.

Within the same framework many restrictions exist regarding the use and development of herbal formulas, which apply even more to those medicines which are derived from traditional Asian medical systems. Only selected herbal ingredients in a certain dosage range are permissible, whereas even simple animal products such as honey or ghee are not allowed, and minerals are only allowed to a certain extent. The therapeutic indications permitted for THMPs are those of minor, self-limiting diseases or ailments. Due to the unfavourable benefit/risk ratio, safety concerns increase. As a consequence, herbs with a high content of active substances (i.e. high potency) are even considered obsolete for medical use and are practically banned despite their potential therapeutic effectiveness.

This leads to the crucial question: is the European lawmaker interested in herbal medicines with a strong therapeutic potency?