Herbal Medicines: Italy Seeks Clarification

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Legislation

27 December 2004 - The Italian Ministry of Health has published an outline of recent European legislative changes that will affect supplements, specifically those containing herbs and plant extracts, asking industry to help shape the European discussion intended to clarify the borderline between what is a medicine and what is not.

Reference is made to the European directive on food supplements, a contested piece of EU legislation that seems to be headed - in the name of market harmonization - towards forcing the removal of many vitamin and mineral supplements on the market today. One positive aspect of the supplements directive: it may provide a framework for herbal products otherwise threatened by yet another directive, a recent European piece of legislation which provides for the registration of herbal medicines.

Further, the European pharmaceutical directive is mentioned with its definition of a medicine that seems so all-embracing that some fear they might be buying fruit from their pharmacist instead of in the market. This may seem exaggerated, but Denmark has recently issued a consultation document where much of the same legislation is discussed in a rather more authoritarian manner, leading some activists to say that the country is in the process of practically eliminating the concept of supplements altogether. When health authorities say that a product "is a medicine" they are really talking about taking products off the market. Most of those products could not be registered and sold as medicines for any number of reasons, so the end effect will be - "sorry, no longer available".

The general climate seems to be one of protection of pharmaceutical interests. Such a pattern of pharma-industry friendly interpretation of laws and rules has also emerged on the other side of the Atlantic. The FDA is being criticized for approving and keeping on the market dangerous medicines that kill tens if not hundreds of thousands of patients, while seeking restrictive legislation "to protect US consumers from supplements".

The United Nations' World Health Organization has announced its own program to promote availability of herbal and other traditional medicines, but it appears that the announcement was immediately seized as an opportunity by pharma linked commentators to point to possible dangers and to demand strict controls.

I cannot help but think that there is real interest on the part of most legislators to ensure that both supplements and herbal products should be widely available to a public that demands them, but the devil is in the (legislative) details. Every time legislation does get proposed, it seems to restrict, forbid and undermine, rather than promote the natural health products regulated. And heaven forbid innovation. It is no wonder, because asking pharmaceutical experts to help shape legislation on supplements and herbs s like asking the fox to guard the henhouse - a course of action certain to end in disaster.

So the Italian request for clarification appears to go in the direction of some sanity, giving Italy's thriving herbal industry a chance to be heard. The European discussion of borderline issues certainly will highlight many inconsistencies. For a good one, think only about health spending for pharmaceutical medicines costing billions - now found to kill hundreds of patients daily - on the one side, and restrictive legislation for the only safe products that could help people sustain their health in a natural way, on the other ... is there a name for collective suicide imposed by law?

Anyway, here's an (unofficial) translation of the Italian ministry's circular:

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Official Gazette Nr. 302 of 27 December 2004

MINISTRY OF HEALTH

Circular number 2 of 25 November 2004
Health products containing plants and their derivatives

With circular number 3 of 18 July 2002, the Ministry of Health has extended, essentially for the purpose of obtaining public-health related information, the notification procedure described in article 7 of legislative decree number 111 of 27 January 1992 (dietetic products - translator's note), to also cover non medicinal herbal products already on the market. In practice, this is the same mechanism that has already been applied to nutritional supplements and supplements containing both herbs and nutrients. After that date, a variety of new European and national legislative instruments have been issued which modify the legal situation of supplements and call for attentive evaluation on the part of companies interested in selling these products.

Firstly, the European directive on food supplements has been put into effect with legislative decree number 169 of 21 May 2004. The decree defines "food supplements" as food products intended to integrate the normal diet by providing a concentrated source of nutrients, such as vitamins and minerals or other substances with a nutritional or physiological effect, particularly but not exclusively aminoacids, essential fatty acids, fibers and plant extracts, singly or in combination, in dose form.

Secondly, there is the recently passed directive 2004/27EC which, in its article 1, modifies the definition of a medicinal product as follows: "a medicinal product is

(i) any substance or combination of substances presented as curative or preventive for human illness; or
(ii) any substance or combination of substances which can be used in or administered to humans for the purpose of restoring, correcting or modifying physiological substances by exerting a pharmacological, immunological or metabolic action or [can be used] to make a medical diagnosis.".

Thirdly, there is the recent approval of directive 2004/24/EC which has introduced a new kind of medicinal product called "traditional plant-based medicinal product". This covers "any medicinal product which exclusively contains as active ingredient(s) one or more plant substances or extracts, whether singly or in combination", and which satisfy the conditions of that same directive.

Fourthly, it is important to note that according to article 2 of directive 2004/27/EC, in cases of doubt, where a product, considering all of its characteristics, could fall both under the definition of medicinal product and under the definition of a product regulated by a different European law, the law that applies is the pharmaceutical directive - 2004/27/EC.

The complex legislative situation as shown above obviously calls for a process of clarifying the interpretation of these norms at the European level, to facilitate determination of which law is applicable to plant based products which are not clearly part of any one particular sector (the so-called borderline products) to avoid interference with the internal market and to prevent the emergence of litigation, possibly involving the European court of justice.

The European Commission, which is conscious of that necessity, has already started the needed additional study of this question. Some clarifying mechanisms for the near future are also envisioned in the above cited legislative instruments. Indeed according to article 4, paragraph 8 of directive 2002/46/EC, the European Commission is called upon to produce, by 12 July 2007, a report on whether to establish specific rules, including, where appropriate, the elaboration of positive lists of further vitamins and minerals or of substances with nutritional or physiological effects, and to propose amendments to that same directive. Furthermore, the plant based medicines committee that has been established at the EMEA (European Medicines Evaluation Agency - translator's note) will have to draw up a list of plant substances, plant extracts and combinations of products to use in traditional plant-based medicinal products; this list will contain, for each single plant substance: purpose of use, specific concentration, quantity and method of utilization and any other information necessary for safe use. The committee is also charged with producing community monographies on the herbs that are to be used as plant-based medicines.

Therefore, it is important to note that, because of the above mentioned legislative developments, the procedure of notification per the cited ministerial circular number 3 of 18 July 2002 will have to be repeated in the light of the new legislative framework described. In the meantime, until a specific circular which will describe the modality of notification per the legislative decree number 169 of 21 May 2004 is worked out, producers are encouraged to accurately examine products already on the market in the light of the new legislative framework and to take any necessary steps. All those producers who would like to obtain clarification with regard to any specific product on the market are urged to transmit pertinent data to the ministry's Department of veterinary and food health, office XII, so that, where necessary, specific questions can be transmitted to the European commission in the course of the present process of clarification.

Furthermore, since the sector of food supplements is subject to European legislation and following the current rules, the Ministry of Health has initiated a procedure of establishing a list of plants that should not be used in the formulation of food supplements. A first list that forms the basis of this proposal is available on the Ministry of Health website "www.ministerosalute.it". Companies and whoever else is in possession of data that would suggest changes to this course of action are encouraged to transmit these to the Ministry of Health, Department of veterinary and food health, office XII.

This circular is to be published in the Official Gazette.
Rome, 25 November 2004
The Minister: Sirchia

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