Interview concerning the 2004/24/CE Directive

Mrs. Valérie CLÉMENT-NGO Interview

Valérie CLEMENT-NGO is a Pharmacist Doctor, Regulatory Affairs Manager of ARKOPHARMA, a pharmaceutical company specialized in phytotherapy.

1.    Pascale IMBERT: «Good morning Mrs. CLEMENT-NGO, I want to thank you for granting me few minutes of your precious time to answer some questions concerning the complex legislation of medicinal plants in Europe. Could you tell us in few words, what is the goal of the 2004/24/CE Directive? »

Valérie CLEMENT-NGO : «The goal of the 2004/24/CE directive is the harmonization of the registration procedures of the Traditional Plants Medicines.  It plans to institute a simplified registration, warranting the quality, the security and the efficacy of the products. The applicant must prove that the product has been used for 30 years among which at least 15 years of commercialization in the European Union; this constitutes the basis of the efficacy and the innocuousness of the herbal medicinal product.
This directive aims to save public health and to facilitate the free circulation of Traditional Plants Medicines in the European Union. »

2.    PI : «We understand that this directive was conceived to harmonize and to file down the registration of Traditional Plants Medicines in the European Union. Does it have an impact on these products registration and marketing in France? »

VCN : «It’s important to remind that the France was already disposing, before this European directive, of simplified registration for Traditional Plants Medicines, and that since 1986.
However, before its entry into force, the directive imposed to any traditional medicines already on the market, to be in conformity within a delay of 7 years. Indeed, the Laboratories had to update their files and to get them examined once again by the Authorities, considering the new text. The commercialization can be maintained once the conformity to the new regulation demonstrated. »

3.    PI : «We already know that the plants in Europe can have 3 different statutes :
•    Medicaments
•    Food supplements
•    Natural plants sold by pharmacists, herbalists or phytotherapists
Are these three statutes still current in the European Union?
Could you define for us the characteristics of these statutes? What are their advantages and their inconvenience? »

VCN : « Yes these 3 statutes still coexist in Europe.
Before its commercialization, a medicine must have obtained a Marketing Authorization or a registration based on a documented file, proving its quality, its innocuousness and its efficacy  (which may be considered for traditional drugs on their long-standing use). It benefits from a therapeutic indication.
The food supplement is not supposed to cure (it cannot claim properties of prevention, treatment or healing of human disease) but to complement the food by introducing substances such as plants, having a nutritional or physiological effect, inducing a benefit of well-being or health.
The plants commercialized under these two statutes have various administration forms, quite easy such as pills, capsules, phials… or topic forms like gels, creams…, if they are medicaments with local administration.
On the contrary, the sold natural plants must be prepared before use. They are usually employed as infusions, decoctions or macerations. The professional who prescribes them must have a skilled knowledge to correctly recommend them. »

4.    PI : « Actually, in France, could you tell us how many medicinal plants are going to be not dispensed by a licensed pharmacist ? Could you confirm that the not dispensed by a licensed pharmacist plants can be sold out of the pharmacy distribution, on the opposite of the medicinal plants dispensed by a licensed pharmacist?
What is your opinion about a bill, stating that the not dispensed by a licensed pharmacist plants would be sold only by herbalists, whose diploma would be updated ?»

VCN : « Actually, in France, 148 medicinal plants have been not dispensed by a licensed pharmacist by the 2008 decree. These plants can be sold in their current state or as preparations authorized and listed in the law, outside the pharmaceutical monopoly.
Last July, a bill proposal aiming to create a diploma and organizing the herbalists’ profession has been submitted to the senate. We must remember that this diploma was abolished in 1941. However, is creating an Herbalist’s monopoly of interest as it only deals with medicinal plants already not dispensed by a licensed pharmacist ? »
 
5.  PI : « Before the application on the directive on May 1st, 2011, numerous articles were published predicting the “death” of phytotherapy in Europe. Do you agree with these alarmist publications? »

VCN : « The alarmist and confusing declarations, broadcasted by the media, let believe that the European directive application would prohibit numerous medicinal plants. It can’t be true as the directive deals with Traditional Plants Medicines and not with the medicinal plants themselves. »

6.  PI : « How can you explain this outcry, relayed by all the media? »

VCN : « I don’t’ have any explanation but I can only be chocked by the circulating rumors and petitions, which can only raise unfounded fears among the citizens. »

7.  PI : «Do you believe that one day, exotic plants will benefit from a simplified registration procedure? »

VCN : « In theory, some plants, with which we are less familiarized, could benefit from the simplified registration procedure. Nevertheless, the problem is in the demonstration of their long-standing use in Europe. »

8.  PI : « And what about the plants blend in the Traditional Plants Medicines? »

VCN : « Any product composed of plants blend, justifying 30 years of authorization, can be registered as traditional medicine. However, it must present a documented use, which is far less common for plants blend than for individual plant. »

9.  PI : « Mrs. CLEMENT-NGO, one last question. Thanks to your job, you can be aware of what happens outside France. What is the future of phytotherapy, in France and in Europe? Don’t you think that there is a tendency to over standardize this “Art of healing”? »

VCN : « We can be glad to see the interest revival for natural products, reflecting a saner life pursuit, a come back to nature and essential values. This is very positive for the phytotherapy future, as well in France as in Europe.
The regulation on herbal medicinal drugs, required by Europe, originates from a public health protection care, which is fundamental. By the same time, it wants to take into account the plants long lasting use. This harmonization will allow the public to have access to drugs combining tradition and current requirements.»

Thank you so much Mrs. CLEMENT-NGO for your time and your clear answers. This exchange was really interesting and extremely constructive. Hope to see you soon...