Traditional Plants Medicines

Traditional Plants Medicines European Regulation

2004/24/CE Directive

The medicinal plants had always had a peculiar statute in the collective unconscious. They have stayed, in our spirits and in our hearts, our grandmas’ remedies; as for example, the officinal sage (Salvia officinalis L.) leaves infusion, carefully prepared, that we drink near the fire-place when we catch a chill or the lime-tea flowers one (Tilia cordata Mill.) that we degust with delight when we have trouble sleeping.
However some of them have an important therapeutic activity and non-negligible adverse effects, which must be known. Let’s only cite here the St John’s-wort (Hypericum perforatum L.) known for its photosensitization effects.

In all the countries all around the world, the medicinal plants use is based on the tradition. As said before, we must know them very well to prescribe, to advice and/or to sell plants.
In Europe, according to the countries, they have different statutes; they can be medicines, food supplements, or natural products – sold by herbalists or phytotherapists – to preserve and/or recover health thanks to their efficacy known for millenniums.

Each European country has its own medicinal culture, its ancestral tradition and its specific regulation:
•   In France, the medicinal plants have been present in the French Pharmacopoeia since its first issue in 1918. They can be considered as medicines since 1986 (first “Avis aux fabricants”). Since the herbalist diploma suppression, the sale of non-liberated plants is part of the pharmaceutical monopoly.
Remark : Some of them can be sold as nutritional supplements through the Mutual Recognition.
• In Deutschland, they can be medicines if they receive the authorization from the Bfarm (Bundessinstitut für Arneimittel und Medizinprodukte).
•  In England, the plants products are usually considered as food supplements sold par herbalists. They can be recommended and sold by “Herbal Practitioners”. Since February 16th, 2011, these practitioners benefit from a legal statute approved by the Health Professions Council.
•  In Belgium, the plants can be sold as medicines, under the control of the Agence Fédérale des Médicaments et des Produits de Santé (AFMPS) (Federal Agency for Medicines and Health Products). They can also be considered as food supplements or sold as they are by herbalists.
•   In Italy, the plants can be sold either as medicines or as food supplements.
•    …

Few months ago, an alarmist message concerning medicinal plants was broadcasted. All the media, newspapers, television, Web sites… relayed the information without understanding the ins and outs, without investigating a minimum to evaluate its credibility.
We were witness of an important disinformation, which provokes panic, sustained by Mrs. Heidi Stevenson. Her words weren’t always justified but understandable when considering the regulatory statute of the plants products in her country.

The protagonist of this polemic is the 2004/24/CE Directive of the European Parliament and Council of March 31rst, 2004. Considering the statutory disparities in Europe, we can easily understand that this Directive hadn’t had the same impact in France, in Deutschland, in England… However, it simply describes the registration procedures for the Traditional Plants Medicines.

As said, before this directive of April 31st, 2004, each country of the European Union had its own quality, innocuousness and efficacy criteria and requirements for the plants products. It was imperative to harmonize the registration procedures to restore the industrials’, the therapists’’ and the patient’s equality towards these Traditional Medicines.

The different “polemical” texts written on this subject, point out a confusion between the words “Medicinal Plants” and “Plants Medicines” also called “Phytomedicines”, probably induced by a lack of judgment or some of competences. We must admit that all this is really complex.

Remark: May 1st, 2011 was to be the limit at which all the traditional medicines already on the marketplace before the date of entry into force of the Directive were supposed to be conformed to this directive.

Lots of medicinal plants are indexed and their therapeutic application based on the usage tradition. A plants product can become a medicine if it obtains a Marketing Authorization (M.A.) or a registration from the competent Authorities. Obtaining a Marketing Authorization or a registration is the guarantee of its quality, innocuousness and efficacy, based for traditional medicines, on their long-standing usage.
This opportunity to convert a plant into a medicine is primordial and has an important impact in various fields. A medicine is defined by a pharmaceutical form (capsules, tablet…), an active ingredients dosage and a therapeutic indication. The pharmacist is going to sell it following all these indications.

From another point of view, it seems obvious that the 2004/24/CE Directive has its limits. It doesn’t ease the registration of the plants mix or of the exotic plants used for millenniums in other medicines such as Chinese, African, and Ayurveda...

In its willingness to do it well, the European Union surely lacks of solicitude and open-mind towards the plants or the plants preparations, little or badly known on the old continent which therapeutic efficacy is not to be proven in other lands.

To conclude, we can say that, in Europe, listed medicinal plants keep a level of recognition by benefiting, on one hand, from a medicine statute and on the other hand, from a prescription by health professionals. Hereafter, we have the great conviction that Europe recognizes the medicinal plants interests.
However, it seems important to preserve the three statutes under which they can be commercialized (medicines, nutritional supplements and natural plants) within the EU.
The vegetal substances use is a valuable ancestral science that it is important to preserve. It supposes a good knowledge of the plants, from their botanical identification to their therapeutic interest, in order to avoid any trouble - falsification, overdoses or intoxication – linked to a bad usage.
Since the definition of the July 2d, 1979 circular: « A medicinal plant is a plant presenting drug properties, without having or planning to have any food, seasoning or hygienic usage», the things have changed and the mentalities have evolved.
The plant is a complex gift offered by the nature. It is imperative to strongly protect this fragile and varied patrimony, used for different goals (therapeutic, food, cosmetic…) from time immemorial, all over the world.

To accredit our analysis and better understand the plants drugs environment, we met and interviewed Mrs. Valérie CLEMENT-NGO, Doctor in Pharmacy, and Regulatory Affairs Manager for the Pharmaceutical Laboratories ARKOPHARMA, specialized in phytotherapy.

Remark: Conjointly to medicinal plants European regulation, an European regulation concerning the food supplements plans the possibility to introduce plants in their ingredients.

Dr Pascale IMBERT