Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentFOREWORD
Open this folder and view contentsI. INTRODUCTION
Open this folder and view contentsAfrica
Open this folder and view contentsThe Americas
Open this folder and view contentsEastern Mediterranean
Close this folderEurope
View the documentGeneral aspects
View the documentAttempts to Meet the Need for Harmonization
View the documentAustria
View the documentBelgium
View the documentBulgaria
View the documentDenmark
View the documentEstonia
View the documentFinland
View the documentFrance
View the documentGermany
View the documentGreece
View the documentHungary
View the documentIceland
View the documentIreland
View the documentItaly
View the documentNetherlands
View the documentNorway
View the documentPortugal
View the documentSpain
View the documentSweden
View the documentSwitzerland
View the documentTurkey
View the documentUnited Kingdom
Open this folder and view contentsSouth East Asia
Open this folder and view contentsWestern Pacific
View the documentIII. CONCLUSION
View the documentIV. REFERENCES


Market Importance of Herbal Medicines

Herbal remedies represent an important share of the German pharmaceutical market. According to an Institut für Medizinische Statistik (IMS) report [52], presented during an ESCOP Symposium in Brussels in October 1990, the German herbal medicines market was worth US$ 1.7 billion (incl. VAT) in 1989, which was equal to 10% of the total pharmaceutical market in Germany. A representative study carried out by the Allensbach Institute [53] among the German population in June 1989 confirmed that a large number of people use natural medicines. The study showed that 58% of the population had taken such remedies, 44% of them within the previous year. It could also be shown that over the years the number of younger people using natural medicines had increased significantly. According to the study report, natural medicines were generally considered to be more harmless than chemical drugs. A majority among the German population (85%) believed that the experience of physicians, practitioners, and patients should be accepted as a proof for the efficacy of natural medicines [53].

Herbal medicines are distributed through over-the-counter sales in pharmacies and other distribution channels and on medical prescription through pharmacies. They are, in principle, reimbursable by the health insurance system unless special criteria for their exclusion apply, for example, specified indications such as common cold or laxatives, or substances, with a negative assessment by Commission E. Except for a few preparations, herbal medicines are not prescription-bound but can be prescribed by physicians or practitioners for reimbursement.

The total turnover of non-prescription-bound herbal medicines in pharmacies was DM 4.5 billion in 1995 (public price level), which is equal to almost 30% of the total turnover of non-prescription-bound medicines (DM 15.2 billion). Preparations sold on prescription amounted to DM 2.4 billion and those purchased through self-medication to DM 2.1 billion of the total turnover of non-prescription-bound phytomedicines [54]. Herbal medicines can be found among the 2 000 most important drugs prescribed by medical doctors and reimbursed by health insurances [55].

Legal status

In terms of legal status, herbal medicines are fully considered as medicines. This legal position was confirmed by the European Court of Justice in 1992. On 1 January 1978, the Second Medicines Act came into force which set new standards for the granting of marketing authorization in accordance with the European framework for the handling of medicines [56]. Under this new regulation, proof of quality, safety, and efficacy became an essential pre-condition for the registration of medicines. Article 39 para 2 of Council Directive 75/319/EEC [33] directed Member States to check all products on the market at that time, within a deadline of 12 years, to determine whether they were in accordance with the European Directive. These products were allowed to continue being marketed with a so-called "fiction marketing authorization" for this 12-year transitional period, that is until 31 December 1989 (later extended to 30 April 1990) [56]. To meet the requirements of the new Medicines Act, the authorities were obliged to carry out a review process [57]. The review of existing products was a two step procedure. It began in 1978 and was partly stopped by the fifth amendment to the Medicines Act in 1994. The two steps of the procedure were first a review of active principles, which resulted in monographs, and, second a product-specific verification of pharmaceutical quality and conformity with the published monographs [58-65]. Due to the large number of products on the market, the review was focused on active ingredients and not on individual products. The concept underlying the procedure was to establish clear, a priori criteria for active ingredients and to make it transparent to industry which products would have a chance to be authorized. The review of herbal remedies was done by a pluridisciplinary commission of experts, the so-called Commission E, with pharmacists, pharmacologists, toxicologists, clinical pharmacologists, biostatisticians, medical doctors from hospitals, and general medical practitioners [62,66]. This commission was responsible for the evaluation of more than 300 medicinal plants, and the results - the monographs - have been published in the Bundesanzeiger (Federal Gazette) [67] since 1984 [58-65,68]. These monographs cover most of the ingredients of industrially prepared herbal medicines on the market.

All data available to the health authority (data from pharmaceutical companies interested in a particular drug, new data from pharmacological and clinical research, data from the international side-effect monitoring system, publications, etc.) were collected and forwarded to Commission E. Their work was also supported by the "Kooperation Phytopharmaka", which collected scientific information on a large number of important medicinal plants, which was presented in the form of expert reports to Commission E for evaluation. On the basis of this large documentation, the material was screened, discussed in the Commission's meetings, and then pre-published as a draft monograph. Within a certain deadline, companies and other interested parties were allowed to make statements or remarks, often in co-ordination with the pharmaceutical associations. At a later stage, the monograph text was published officially in the Bundesanzeiger, and this scientific evaluation formed the basis for the marketing authorization and review decisions of the Federal Institute for Drugs and Medical Devices (BfArM). An ideal situation is reflected in the so-called "positive monograph" covering all relevant indications for the package leaflet or consumer information such as composition of the drug, form of application, indications, contra-indications, warnings, dosage [57,62,66,68]. Because there was a growing interest to use monographs for applications for new marketing authorization and because the fourth amendment to the Medicines Act in 1990 allowed manufacturers to change completely the composition of herbal medicines on the basis of published monographs, the texts published in 1991-1994 had to be much more detailed than the earlier texts, sometimes focusing only on specific preparations the efficacy of which had been established in clinical studies.

There are also a substantial number of "negative monographs" where there were risks from active ingredients or absence of reasonable proof of efficacy [60]. Marketing authorizations of a number of herbal remedies had to be withdrawn or to be modified because of serious risks to public health. The work of all review commissions, including Commission E, regarding the evaluation of bibliographic data and the preparation of monographs was finalized with the fifth amendment of the Medicines Act [69]. The main reason was that the most relevant active principles were covered by monographs and the remaining products could be assessed more economically on a case by case basis. The commissions will now be advisory boards to the health authority in making decisions on the registration of new drugs, and in the individual assessment of old medicinal products already on the market, as the second step of review process [69]. By 1996, this second step had not been completed, due to an overload of work for the authority to check all the dossiers that had been submitted during the past years by manufacturers [68].

Requirements for Marketing Authorizations for Herbal Remedies

The Federal Institute for Drugs and Medical Devices, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), since 1994 one of the successor institutes of the former Bundesgesundheitsamt (BGA), is responsible for the assessment of medicines and the verification of submitted dossiers with respect to quality, safety and efficacy. Criteria for registration are set out by European directives and guidelines, such as the Note for Guidance on Quality of Herbal Remedies, the European Pharmacopoeia, and national guidelines and directives such as the guidelines for testing of drugs following section 26 of the Medicines Act (Arzneimittel Prüfrichtlinien) [70]. Bibliographic data on the well established use of herbal medicines are accepted. Criteria developed by Commission E and positive monographs are widely used to document safety and efficacy of herbal remedies [58-65]. Monographs can to a large extent replace pharmacological, toxicological and clinical documentation, as can bibliographic data. Earlier monographs often require an update of literature. The quality dossier is checked in each case individually.

Medicines or groups of medicines which do not pose a direct or indirect risk to the health of man or animal can be exempted from the requirement for an individual marketing authorization according to section 36 of the Medicines Act. To ensure their quality, safety and efficacy, each such medicinal product referring to this procedure must comply exactly with a monograph of a standardized marketing authorization published by the Ministry of Health. The monographs include analytical test requirements and also the texts for labels and package leaflets (279 monographs of standardized marketing authorizations have been published, mainly for herbal teas). An applicant referring to such a monograph does not need to present any documentation to the Federal Institute for Drugs and Medical Devices (BfArM) [62].

Fifth Amendment of the German Medicines Act

In August 1994, the fifth amendment of the German Medicines Act became effective. It provides a new procedure with respect to proof of quality, safety and efficacy, widening the scope of existing legislation for products, including herbal medicines, already on the market. Traditional usage instead of reasonable proof of efficacy is accepted for a certain category of products, mostly sold outside pharmacies. This is why many products with a negative assessment by Commission E are included in this regulation. All these products have to be labelled as "traditionally used". In accordance with section 109a of the Medicines Act, the BfArM has compiled lists stating which preparations are allowed to refer to this regulation and which traditional indications can be claimed [71-75]. This new system may offer a legal possibility for a large number of preparations without sufficient scientific documentation as proof of efficacy to be re-registered under such a simplified procedure [76]. On a "higher" level, "non-traditional" indications will be admissible as before, provided that these are based on monographs or on individual clinical studies with defined preparations.

In contrast to herbal medicines, the quality dossiers of "traditional" products are not checked by the health authority. The regulation contrasts with EU requirements for the marketing of medicinal products. This is why the new regulation may offer a legal possibility for herbal and non-herbal preparations to stay on a strictly national market without sufficient documentation as proof of efficacy and safety and without thorough control of pharmaceutical quality.

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