Could EU herbal monographs contribute to Malta’s treatment armamentarium?
- Received 24 September 2014, Revised 15 December 2014, Accepted 2 January 2015, Available online 26 February 2015
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.
Graphical abstract
Keywords
- EU herbal monographs;
- ATC classification system;
- Therapeutic coverage
- Corresponding author at: Medicines Authority, 203 Level 3, Rue D'Argens, Gzira, GZR 1368, Malta. Tel.:
+356 23439129; fax: +356 23439161.
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