At present, the number of ingredients in a composition is limited to four ingredients. A limit of six seems to be under consideration. Even the latter option would leave only 20 % of classical formulas possible. The combination with mineral and animal ingredients is not possible at this point.
Since, apparently, the combined end- product is subject to registration, there is no solution for tailored prescriptions. Personalized modifications and adaptations are common practice in our disciplines.
Even in the alternative approach of registering single ingredients, the total of registration fees is financially completely prohibitive. Moreover, the fees seem to differ substantially in the various member states.
This means that companies carrying a large assortment, combining food ingredients and restricted herbs in large(r) formulas, mostly on customized prescription, have no future at all. Those companies are the same who have , by huge investments in R & D and quality/safety control, achieved the cleanup of the market in the past 20 years.
Referring to the European directives on Food Supplements, the evidence of consumption history as Food and the safety data, our sector claims that the vast majority of used substances are to be categorized as Food Supplements. Nonetheless our sector initially welcomed the prospect of THMPD since the traditional catalogue also includes a significant minority of substances without food history. Those are the herbs that require not only a thorough and batch-specific quality and safety testing, but also need to be appropriately prescribed following the traditional evaluation, which has its own, evidence based safety rules. However, these herbs are very unlikely ever to be registered as a traditional medicine since it would be inconceivable and even irresponsible that such substances would be available over the counter. This, as well by western scientific standards as by traditional safety standards! This truly incredible clause in THMPD regulation means we lose the only added value that THMPD could bring to our sector.
Generally applicable OTC products are systematically denied a Food Supplement status, while specific and justifiably restricted products would be available over the counter.
A majority of safe, well tried and tested herbals, will be subjected to unnecessary quality-safety-control in order to obtain Traditional Medicine status. An important minority for which this thorough control is imperative will probably never attain Traditional Medicine status.
Experts in traditional disciplines fail to understand why the Herbal Working Party at EMEA, who displays painstaking scrutiny in safety matters, would allow the more delicate herbs as OTC, when those are, even within their tradition, subject to differential diagnosis and supervision of a qualified therapist, both for safety and efficacy reasons.
Another area in which principles seem to overrule facts is the introduction of traditional plant monographs into the E.P. In every member state the regulatory refers to those monographs to draw the conclusion that every traditionally used herb is to be considered a “medicine by function”. Apart from the fact that this mentality often leads to unworldly and even derisory conclusions, it systematically denies the existence of Food Supplements and their EU- legislation.
Similar to the THMPD regulation, the monographs fail to do justice to FS and TM alike. What we have seen thus far are mere compilations lacking consistency on every level. Vital data about dosages, preparations and synergy are partial or absent, and, as such, not allowing any serious assessments about safety, quality nor efficacy. Accessment criteria for processed materials are totally absent and the methods to achieve this (e.g. systembiology) are not valued. The parameters for identity, quality and safety tend to be exclusively associated with the quantitative determination of biomarkers and not with the full spectrum of the plant totum.
Meanwhile, invariably referring to the definition of medicine, local authorities leave no stone unturned to style any substance as a medicine by function. Whenever a herb is scheduled for a monograph in the EP, or when a combination is advised in a medical or paramedical practice, or when there is a registration as a medicine anywhere else in the world. All arguments are welcome except the item-by-item, thorough scientific and epidemiological assessment.
The few registrations under THMPD thus far, confirm these anomalies. The registered products are food supplements! (number and type of ingrediënts, OTC, weak claim) As herbal medicinal solutions they have little or no value.
As such, THMPD regulation is an inconsistent catchall, unsuitable for traditional medicinals and denying the existence of food supplements.
Considering the actual and expected differences in approach within member states (fees, forbidden and restricted items, control capacity, prevailing national legislation) one may further ask whether it makes sense to outline a unifying regulation which will be selectively implemented in the different member states. And how all this concords with some general principles of justice in EU (free movement of goods, fair competition, public nature and transparancy of government, the right for legal certainty, adequate motivation on necessity and appropriateness , a.o.)