Escop

The foundation of ESCOP

In order to provide scientifically based assistance for a harmonized assessment of herbal medicinal products, ESCOP, the European Scientific Cooperative on Phytotherapy, was founded in 1989 by six national scientific associations, and over the years a large number of other associations have joined. The main objectives of this European scientific umbrella organization are to establish harmonized criteria for the assessment of herbal medicinal products, to give support to scientific research and to contribute to the acceptance of phytotherapy on a European level (Steinhoff, 1999). The following national associations are members of ESCOP (2000):

Österreichische Gesellschaft für Phytotherapie

Austria

Société Belge de Phytothérapie

Belgium

Dansk Selskab for Fytoterapi

Denmark

Association Française pour le Médicament de Phytothérapie

France

Gesellschaft für Phytotherapie

Germany

Irish Phytotherapy Association

Ireland

Società Italiana di Fitochimica

Italy

Nederlandse Vereniging voor Fytotherapie

The Netherlands

Norwegian Society for Phytotherapy

Norway

Associaçao Nacional de Fitoterapia

Portugal

Svenska Sällskapet för Fytoterapie

Sweden

Schweizerische Medizinische Gesellschaft für Phytotherapie

Switzerland

British Herbal Medicine Association

United Kingdom

The aims of ESCOP are to advance the scientific status of phytomedicines and to assist with the harmonization of their regulatory status at the European level. The objectives are:

• to develop a coordinated scientific framework to assess phytomedicines;

• to promote the acceptance of phytomedicines, especially within general medical practice;

• to support and initiate clinical and experimental research in phytotherapy;

• to improve and extend the international accumulation of scientific and practical knowledge in the field of phytotherapy;

• to support all appropriate measures that will secure optimum protection for those who use phytomedicines;

• to produce reference monographs on the therapeutic use of plant drugs;

• to further cooperation between national associations of phytotherapy to advance these aims and objectives.

Definition of phytomedicines

For ESCOP, phytomedicines, or herbal medicinal products, are 'medicinal products, containing as active ingredients only plants, parts of plants or plant materials, or combinations thereof, whether in the crude or processed state'.

The following notes on the definition of phytomedicines were given (ESCOP, 2000):

• Medicinal products are defined in European Directive 65/65/EEC.

• The production of phytomedicines is formally determined in 'Quality of Herbal Remedies' in 'The rules governing medicinal products in the European Community, Volume III, Guidelines on the quality, safety and efficacy of medicinal products for human use' (ISBN 92-825-9619).

• Plant materials include juices, gums, fixed oils, essential oils, and any other directly derived crude plant product. They do not include chemically defined isolated constituents, either alone or in combination with plant materials.

• Phytomedicines may contain excipients of plant or non-plant derivation.

ESCOP constitution and structure

Members of ESCOP meet formally at Annual General Meetings (AGMs) or Extraordinary General Meetings (EGMs).The Board is constituted by the Honorary Directors appointed at General Meetings, including a Chairman and Treasurer, plus an Honorary Secretary appointed by the Directors.

The Scientific Committee of ESCOP, comprising delegates from each member country, embarked at the outset on a programme of compiling proposals for European Monographs summarizing the medicinal uses of plant drugs (including their safety), an area which ESCOP considers to be of prime importance for scientific harmonization.

The Research Committee comprises at least one Board member and other invited individuals.

The Secretariat is constituted by the Honorary Secretary appointed by the Board, supported by an employed Administrator and other staff as necessary.

The new European marketing authorization system

On 1 January 1995, new Community procedures concerning the authorization and surveillance of medicinal products came into force, superseding various procedures based on voluntary cooperation between the relevant national authorities. The European Agency for the Evaluation of Medicinal Products (EMEA) plays a central role in this system. Its aims include pooling the scientific expertise of member states in order to ensure a high degree of protection for public health, ensuring free movement of pharmaceuticals, and making certain that Europeans have access to new generations of medicinal products.

To achieve free movement of medicines within the common market of the European Union, in addition to a centralized system of marketing authorization, e.g. for new chemical entities on the one hand, and the possibility of an application on a national level only on the other hand, the so-called decentralized procedure has been established. This represents a system of mutual recognition of marketing authorization decisions and provides as a general rule that the assessment by one national authority should be sufficient for subsequent registration in other member states. Within this decentralized procedure, the 'Summary of Product Characteristics (SPC)' approached by the first authority is taken into account. It represents the main characteristics of the product, e.g. active ingredient, indication, dosage, contraindications, side-effects, shelf-life, etc. The SPC is one of the basic elements of the application procedure.

As herbal medicinal products have, in most cases, well-known active ingredients of which much experience exists in several countries, performance of new clinical and pharmacological/toxicological studies does not seem necessary. In these cases an option for a so-called bibliographic application is provided by Article 4.8 (a) (ii) of Directive 65165/EEC: 'The applicant is not required to provide the results of pharmacological and toxicological tests or clinical trials if he can demonstrate by detailed references to published scientific literature that the constituent(s) of the medicinal product have a well-established medicinal use, with recognized efficacy and an acceptable level of safety.' That means that principle data from literature can be used to answer the questions on safety and efficacy when the expert report and dossier are prepared.

ESCOP monographs

In October 1990, the first monographs were presented at a symposium in Brussels and were officially handed over to representatives of the European Community. From the very beginning the ESCOP Scientific Committee has been working on proposals for monographs on individual plant drugs, primarily those for which European or national pharmacopoeial monographs exist.

In preparing drafts, the ESCOP Scientific Committee has the advantage that it can incorporate the views, knowledge and experience, not only of different nationalities, but also of individuals from different scientific and professional backgrounds, such as medical doctors, practising phytotherapists, pharmacognosists, pharmacologists and regulatory affairs specialists. The Committee, operating as two subcommittees, assesses information from published scientific literature on each plant drug with the assistance of leading researchers on specific plants, who are invited to meetings of the Committee for discussion and critical evaluation of the literature.

To be consistent with the requirements laid down in European guidelines, and on the advice of the Committee for Proprietary Medicinal Products (CPMP), the format of SPC was adopted for subsequent documentation as an integral part of an application for marketing authorization. Therefore, the ESCOP Scientific Committee has been working on monographs, structured like SPCs, for individual plant drugs and their preparations (primarily those for which European or national pharmacopoeial monographs exist). An ESCOP monograph describing a medicinal plant and its preparation refers to a pharmacopoeia monograph with respect to quality, and it lists the most important constituents which are possibly able to contribute to the claimed effect. The most important parts of the monographs (as for an SPC) are the therapeutic indication, the dosage and the pharmacological properties. The latter paragraph gives as many details as possible on pharmacodynamic properties, pharmacokinetic properties and preclinical safety data; each statement is supported by references. In the forthcoming edition the clinical session will report the so-called level of evidence. The text is followed by a detailed reference list including all the papers that have been used for the evaluation of safety and efficacy of each medicinal plant and its preparations.

Drafts prepared by the subcommittees are then circulated to an independent Board of Supervising Editors for appraisal. These eminent academic experts in phytotherapy and medicinal plant research are invited to comment on and criticize each draft and, where appropriate, their comments are incorporated into the final version.

Thus, each SPC proposal and ESCOP monograph takes into account the available scientific literature, national viewpoints and the advice of many authorities on the subject.

The first six fascicules, each containing ten ESCOP monographs, have already been published (Table 3.1). The work of the Scientific Committee was also supported by the European Union through its BIOMED programme.

ESCOP monographs represent an overview of the current scientific data on a medicinal plant, but they can replace neither an expert report nor documentation. They can be used as a 'harmonized' scientific background for an application, whereas the questionnaire (i.e. the requirements of the expert report) has to be answered item by item by the applicant. In 1997 the HMPWG (Ad Hoc Working Group on Herbal Medicinal Products) of EMEA (European Agency for the Evaluation of Medicinal Products) was established and in the November 1997 meeting considered drafting of so-called core-SPCs, the most appropriate way to develop general guidance on criteria to assess efficacy data based on bibliographic documentation. General agreement had already been reached during the discussion on a core-SPC for Valerianae radix based upon a proposal submitted by ESCOP. Furthermore, the HMPWP (Herbal Medicinal Products Working Party) which replaced the HMPWG in 1999, has proposed an amendment to Notice to Applicants, Vol. 2A of May 1996, stating that scientific monographs on certain substances, e.g. those drafted by ESCOP and WHO, offer a valuable and updated overview on published scientific literature, which together may be used in support of the demonstration of the safety and efficacy of a medicinal product in a bibliographical application in accordance with Article 4.8 (a) ii of Directive 65/65/EEC.

The ESCOP monographs were regarded as helpful in avoiding duplication of work and in bringing about gradual harmonization in the evaluation of herbal medicinal products. Therefore it was suggested that the Commission and member states recommend that both applicants and competent authorities should make use of these monographs.

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