Robert Jütte1, Michael Heinrich2, Axel Helmstädter3, Jost Langhorst4, Günter Meng5, Wilhelm Niebling6, Tanja Pommerening7, Hans J Trampisch8. 1. Institut für Geschichte der Medizin der Robert Bosch Stiftung, Straussweg 17, 70184 Stuttgart, Germany. Electronic address: robert.juette@igm-bosch.de. 2. Pharmacognosy and Phytotherapy/Research Cluster Biodiversity and Medicines, UCL School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, UK. 3. Institut für pharmazeutische Chemie, Goethe Universität Frankfurt, Max-von-Laue-Str. 9, 60438 Frankfurt am Main, Germany. 4. Zentrum für Integrative Gastroenterologie der Klinik für Naturheilkunde und Integrative Medizin der Kliniken Essen-Mitte, Am Deimelsberg 34a, 45276 Essen, Germany. 5. Abteilung Forschung und Entwicklung der Schwabe Gruppe Karlsruhe, Willmar-Schwabe-Str. 4, 76227 Karlsruhe, Germany. 6. Lehrbereich Allgemeinmedizin am Universitätsklinikum Freiburg, Elsässer Str. 2m, 79110 Freiburg, Germany. 7. Institut für Altertumswissenschaften, Johannes Gutenberg-Universität Mainz, Hegelstraße 59, 55122 Mainz, Germany. 8. Abteilung für Medizinische Informatik, Biometrie und Epidemiologie Ruhr-Universität Bochum, Universitätsstraße 105, 44789 Bochum, Germany.
Abstract
BACKGROUND: Aside from the fully licensed herbal medicines there are products on the European pharmaceutical market which are registered by virtue of their longstanding traditional use. The normal registration procedure does not apply to them because presently they do not meet the legal requirements for a full license as set out in the relevant European Union Directive. One of these requirements, "proof of tradition", has so far been dealt with in different ways and fails to meet the criteria of good practice. METHOD: This analysis is based on a selective literature search in PubMed and in databases of medical and pharmaceutical history, interviews with licensing experts, a consensus meeting attended by researchers with a background in general medicine, phytotherapy, medical and pharmaceutical history, biometry, ethnopharmacology, pharmacognosy and the pharmaceutical industry. RESULTS AND DISCUSSION: The 2004 EU Directive, which governs the registration of Traditional Herbal Medicinal Products and demands proof of tradition, is a regulatory construct and, above all, the outcome of a political process that has ended in a pragmatic compromise. The concept of tradition applied in the Directive does not sufficiently reflect the semantic breadth of the term. The only condition defined is that a specific commercial preparation needs to have been on the market for 30 years (15 of them inside the EU). Such an approach does not make full scientific use of the evidence available because the information excerpted from historical sources, if adequately processed, may yield valuable insights. This applies to indications, modes of application, efficacy and product safety (innocuousness). Such criteria should enter in full into the benefit-risk-analysis of applied preparations, in the registration process as well as in the therapeutic practice. CONCLUSION: When registering Traditional Herbal Medicinal Products the criterion of evidence-based medicine will only be met if all the facts available are assessed and evaluated, over and above the formally stipulated regulatory provisions (30 years, product reference). To this end, the scientific methods (from among the natural, life or cultural sciences), which are recognized as authoritative in each case, must be applied.
BACKGROUND: Aside from the fully licensed herbal medicines there are products on the European pharmaceutical market which are registered by virtue of their longstanding traditional use. The normal registration procedure does not apply to them because presently they do not meet the legal requirements for a full license as set out in the relevant European Union Directive. One of these requirements, "proof of tradition", has so far been dealt with in different ways and fails to meet the criteria of good practice. METHOD: This analysis is based on a selective literature search in PubMed and in databases of medical and pharmaceutical history, interviews with licensing experts, a consensus meeting attended by researchers with a background in general medicine, phytotherapy, medical and pharmaceutical history, biometry, ethnopharmacology, pharmacognosy and the pharmaceutical industry. RESULTS AND DISCUSSION: The 2004 EU Directive, which governs the registration of Traditional Herbal Medicinal Products and demands proof of tradition, is a regulatory construct and, above all, the outcome of a political process that has ended in a pragmatic compromise. The concept of tradition applied in the Directive does not sufficiently reflect the semantic breadth of the term. The only condition defined is that a specific commercial preparation needs to have been on the market for 30 years (15 of them inside the EU). Such an approach does not make full scientific use of the evidence available because the information excerpted from historical sources, if adequately processed, may yield valuable insights. This applies to indications, modes of application, efficacy and product safety (innocuousness). Such criteria should enter in full into the benefit-risk-analysis of applied preparations, in the registration process as well as in the therapeutic practice. CONCLUSION: When registering Traditional Herbal Medicinal Products the criterion of evidence-based medicine will only be met if all the facts available are assessed and evaluated, over and above the formally stipulated regulatory provisions (30 years, product reference). To this end, the scientific methods (from among the natural, life or cultural sciences), which are recognized as authoritative in each case, must be applied.
Authors: Zorica Stanojević-Ristić; Isidora Mrkić; Aleksandar Ćorac; Mirjana Dejanović; Radoslav Mitić; Leonida Vitković; Julijana Rašić; Dragana Valjarević; Aleksandar Valjarević Journal: Int J Environ Res Public Health Date: 2022-04-03 Impact factor: 3.390