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Des sources du savoir aux médicaments du futur

 | 
Jacques Fleurentin
, 
Jean-Marie Pelt
, 
Guy Mazars

3. Médicaments du XXIe siècle

Herbal medicines in the framework of European regulations

Fernand Sauer

Résumé

Résumé
Herbal medicines have experienced renewed interest in Europe. According to recent statistics, the corresponding turnover is about 4 billion euro, half of it for Germany and a quarter for France.
1'400 medicinal plants have been recorded in the various preparations authorized in France. This growing interest is spreading, not only in the public at large, but also among doctors who prescribe more and more of these products though there is no obligation to do so.
However, scientists sometimes disregard the studies mentioned in the literature and documentation for reference and the competent authorities are not prepared to acknowledge the qualities of herbal medicines
The complexity of preparations based on vegetable drugs might be taken as the cause of the ambiguous attitudes displayed by the national authorities in charge of issuing marketing authorizations when it comes to assessing the quality, safety and efficacy of these products.
The wide range of situations in the member states, some dramatic events such as the kidney accidents that occurred in Belgium five years ago or the interaction between St-John's wort and the anti-retroviral medicines, and popular interest had induced the European Agency for the Evaluation of Medicinal Products to address the issue of herbal medicines on request by the Parliament as they were aware that this situation might have negative repercussions on public health.
As this topic is not pivotal in the preoccupations of the Agency whose research is focused on innovative medicines, a taskforce was set up to investigate plant-based medicines.

Texte intégral

General framework for the EU regulations on pharmaceuticals

1The objectives of the EU regulations for pharmaceuticals have been clearly outlined:

  • protection and promotion of public health in Europe;
  • creation of a single market for medicines;
  • reinforcement of the potential for pharmaceutical research and development in Europe through enhanced international cooperation.

2The history of EU regulations dates back to over 30 years, but this basic legislation was complemented with technical contents only in the 80s, and more specifically in the 90s when the EMEA was founded. In 1993 the heads of state of the various nations decided to establish the head office in London. The institution has been active since 1995 and its objective is to protect and promote public health in Europe by focusing on the regulations applying to innovative medicines, or so-called "high tech" drugs produced by biotechnology.

3The scope of activity of the Agency has been extended in the meantime to Norway and Iceland, two countries which are not EU member states. The set of regulations will be submitted to a thorough revision by the body politic next year, parallel to a discussion on the creation of a food safety agency, finally, another issue currently under discussion is the enlargement of the EU to at least 10 nations of Central and Eastern Europe.

4In the past few years, the national authorities and the European Agency for the Evaluation of Medicinal Products apply the same mandatory regulations. These are not only regulations that have near to federal character, similar to that of the Food and Drug Administration in the USA, but also directives meant to be introduced into national legislation, and finally a European pharmacopoeia as a convention promoted by not only the European Union, but also the Council of Europe with some 40 countries of Western, Central and Eastern Europe.

5Next to these regulations having binding character, the Agency issues numerous explanatory memos, documents for the manufacturers and researchers in the form of "guidelines", i.e. texts that are not binding but offer a codified interpretation of the recommendations for manufacturers and national and European authorities. It is not up to them; either to abide to these recommendations, or to validate an alternative approach. It is a tool for debating to avoid any unnecessary cluttering of regulations and pave the way to proper interpretation and updating of scientific and technical knowledge.

6The European Agency is a virtual institution since it is based on a fabric of national authorities. It relies on the expertise of 2'300 experts in all disciplines and deals with human and veterinary drugs. All experts have to publicize a declaration of intent and a scientific profile. 26 national authorities - which sometimes have an agency of their own - are involved in the network. All members are connected by a powerful network called "eudra.net" so that fast communication and continuous exchange are possible. The Agency can rely on this dynamic network; however it has a staff of 200 people, which compares rather poorly with its American equivalent, the "Food and Drug Administration", as the latter institution is much stronger in terms of staffing and the 2000 budget was no less than 50 million euros.

7The European regulation system for pharmaceutical products covers 3 main procedures, two of them being specifically European:

  • the first one is called the centralized procedure i.e. it focuses on "high tech" drugs or drugs produced by biotechnologies; this operation is the prerogative of the Agency. The resulting assessments lead to establishing one authorization valid for the whole of the European Community. It can therefore be considered as a a single federal authorization;
  • the second procedure has the form of a mutual recognition applying to more traditional drugs. The initial step is an nation-wide assessment which should then be validated by all. In the event of disagreement between the countries concerned, the European Agency comes up as an arbitrator;
  • the next step is a national authorization for the products whose scope of application is only one national or local. This applies, for instance, to many medicinal plants used in Germany.

8The European single authorization for the new drugs leads thus results in only one authorization and there is only one prescription mode; however, this regulation does not apply to either social security reimbursements or price control regulations.

9The work of the Agency has led to issuing an authorization for 140 innovative drugs since 1995. The most remarkable aspect of its efficiency is a 6-fold shortening of the time necessary to have a new drug on the European market.

10Quite recently, after prolonged campaigning and lobbying, and under the impetus of the French Presidency at the Council of Ministers, the EU has undertaken to solve the problem of "orphan" drugs. This expression refers to this type of drugs designed for small numbers of patients suffering from rare affections. Some 5'000 rare diseases of this kind have been listed in the European Union and the Agency has just initiated extensive work following the adoption of a regulation applying to these drugs. Among incentives, we should mention a exclusive rights clause for marketing valid for 10 years, assistance for research provided by the European Agency and a reduction of licence fees.

11As we are dealing with innovative but often dangerous drugs, a very elaborate pharmaco-vigilance system has to be set up. For instance, some interaction between St-John's wort (Hypericum perforatum) and antiretroviral drugs has been reported.

The position of herbal medicinal products

12The plant-based drugs are submitted to procedures leading to authorisation that is either strictly national or given by mutual recognition, and not by the central authority since the latter is not empowered for this procedure restricted to "high tech" drugs.

13Products authorized through the mutual recognition procedure are already on the market. However, there are major discrepancies between the various Member States when it comes to assessing the quality, safety and effectiveness of products, in particular concerning the interpretation and the validation of bibliographical data. In this respect, the European Agency endeavours to bridge the gaps between the various points of view.

14Its role consists in clarifying the interpretation of the ordinary texts and to influence the legislator when it comes to adapt them to the particular cases of the drugs containing plants. The tendency in the Member States is to create a derogatory mode under the pressure of the events but without European harmonization.

15The Agency, whose scope of activities does not include dealing with this type of drugs, has nevertheless created in 1997 an ad hoc working group (Working Group on Herbal Medicinal Products) to deal with the issue of plant-based drugs; this committee is currently chaired by Doctor Konstantin Keller of the German Drug Institute (Bipharm). This group is composed of experts and representatives delegated by the Member States, MEPs, members of the European Commission, and observers of the European Pharmacopoeia whose office in Strasbourg (Figure 2).

16In 1999, the Board of directors of EMEA made moves to give permanent character to the activities of this group by giving up ths status of an ordinary working group; they also adopted new members from the Central and Eastern European countries and also experts from Norway and Iceland. In 1999, the group likewise established contacts with Société Européenne d'Ethnopharmacologie, ESCOP and other associations interested.

17The work that has been accomplished since 1997 made it possible to suggest new orientations and requirements relating to quality, safety and the effectiveness of plant-based drugs, from the point of view of manufacturing, and also cultivating and collecting.

18Concerning safety, the group issued a memo with information and explanations about the testing protocols in pharmacology and toxicology. Research is less advanced as far as efficacy is concerned; however, a memo on possible combinations of plant-based drugs has already been published.

19The group is currently working in two areas: on the one hand, examining proposals and leads related to the potential efficacy of drugs as reported in bibliographical data; on the other hand, drafting notes on products specifications, i.e. scientific monographs. But this is the subject of very controversial debating between the traditional scientific committees and the specific group working on plant- based drugs (Figures 3 and 4).

20The legal dimension of the issue is outside the scope of competence of the Agency. All the same, the Agency turns to the working group dealing with herbal medicinal products to make suggestions and table proposals, the European Commission in Brussels has just announced a new initiative in connection with the regulations applying to mineral and vitaminised additives in food products. This will another theme for thought and discussion, closely related to pharmaceutical issues. We hope that this proposal will help us draw clearer borderlines between medicinal products proper and the other products.

21EMEA has developed an Internet site where specialists can have access to reports of general character, assessment reports on new drugs published by public organisations, and also the proceedings of the work group on plant-based drugs.

22Specific quality standards have also been taken up in the Website. They are to be integrated into the series entitled "Regulations applying to Medicinal Products within the European Community" published by the European Commission.

23Other policy papers are still under examination; they are meant to reduce in the short term the uncertainties related to a demonstration of the efficacy of herbal medicinal products, thus ensuring a high level of consumer protection and safety.

Conclusion

24The stock of herbal medicinal products represents a major asset and a heritage for Europe and the rest of the world and it should be preserved with the utmost care.

25For its research and technical work, the Agency relies on the work of ESCOP in Europe and W.H.O. for the rest of the world; it has set up a specific working group for that purpose. The United States - in particular biotech corporations - have recently shown growing interest in herbal medicinal products as these drugs are likely to assume to strengthen their position in the revolution currently developing in the field of life sciences.

26The Website address is as follows:

27http://www.eudra.org/​emea.html

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Auteur

European Agency for the Evaluation of Medicinal Products 7, Westferry Circus Canary Warf El4 4HB London - UK

© IRD Éditions, 2002

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