title: Could EU herbal monographs contribute to Malta's treatment armamentarium?
abstract: Ten years have passed since Directive 2004/24/EC regulating herbal medicinal products across the EU were published. The directive created the Committee on Herbal Medicinal Products within the European Medicines Agency whose remit includes the creation and publishing of official EU monographs on herbal medicinal products. These monographs include the official uses of the products and their evidence for efficacy and safety. To this effect, we are interested in analysing the potential impact herbal product EU monographs could have on the therapeutic treatment options available for prescribers in Malta. Therefore our aim was two-fold. First, to rationalise the spread of indications of the herbal substances listed in the community herbal monograph inventory and subsequently determine if these herbal substances could potentially contribute to the treatment options available in our local scenario (Malta). 128 EU monographs were analysed resulting in a total of 230 indications which subsequently codified into 42 unique ATC codes. The Malta Medicines List contains 1456 unique ATC codes. Comparative analysis of the Malta Medicines List revealed that the 21 therapeutic areas had 4 or less pharmaceutically used substances (5th level ATC codes) registered and therefore in our opinion are areas with limited therapeutic choice. The following 4 therapeutic areas, A05 bile and liver therapy, A13 tonics, A15 appetite stimulants and D03 preparations for treatment of wounds and ulcers, could potentially benefit from the registration of herbal medicinal products according to the EU herbal monographs. If such registration is effected the aforementioned areas would no longer be considered limited because more than 4 therapeutic choices would be available to prescribers. This study is the first study across the EU to analyse the potential impact of published EU herbal monographs on therapeutic coverage in an EU member state and confirms the notion that herbal products could potentially increase the treatment options available in areas where few medical products have been registered due to Malta's small market size.
authors.affiliation: Medicines Authority, 203 Level 3, Rue D'Argens, Gzira, GZR 1368, Malta.
authors.forename: B
authors.initials: B
authors.lastname: Micallef
authors.affiliation: Institute of Earth Systems, University of Malta, Malta.
authors.forename: E
authors.initials: E
authors.lastname: Attard
authors.affiliation: Medicines Authority, 203 Level 3, Rue D'Argens, Gzira, GZR 1368, Malta; Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta.
authors.forename: A
authors.initials: A
authors.lastname: Serracino-Inglott
authors.affiliation: Medicines Authority, 203 Level 3, Rue D'Argens, Gzira, GZR 1368, Malta; Department of Biology, School of Pharmacy, University of Tor Vergata, Rome, Italy. Electronic address: john-joseph.borg@gov.mt.
authors.forename: J J
authors.initials: JJ
authors.lastname: Borg
mesh_terms: D005062:European Union; D029001:Herbal Medicine; D064425:Herbals as Topic; D008319:Malta; D008517:Phytotherapy; D010946:Plants, Medicinal
keywords: ATC classification system; EU herbal monographs; Therapeutic coverage