Lege Artis Medicinae

[Legal status and regulation of complementary and alternative medicine in Europe]

HEGYI Gabriella, VINJAR Fønnebø, TORKEL Falkenberg, HÖK Johanna, SOLVEIG Wiesener

AUGUST 20, 2013

Lege Artis Medicinae - 2013;23(07-08)

[OBJECTIVE - This study aims to review the current legal status of complementary and alternative medicine (CAM) in the 27 member states and 12 associated states of the European Union (EU). METHODS - We contacted national Ministries of Health and educational institutions of all participating countries, international, local and regional CAM associations and members of the EU project CAMbrella. Literature search was performed in governmental, scientific and popular science websites as well as the web sites/databases of health ministries and EU and Hungarian law documents. RESULTS - All 39 nations have different legislative frameworks and different regulations of CAM. CAM activities are regulated by health legislation in 17 member states, 11 of which have created a specific CAM law, and 6 of which include sections related to CAM in their general health laws. Some countries only regulate several CAM treatments. Preparations, agents and herbal products used in CAM are subject to similar authorization requirements in all countries, comparably to other medicinal products. One exception is the requirement for documentation of efficacy studies. The Directives, Regulations and Resolutions of the EU will affect the conditions that might influence CAM treatment(s) in Europe. CONCLUSION - We experienced an extraordinary diversity in EU countries with regard to the regulation and practice of CAM, but did not find differences in the regulation of herbal products and medicines used in CAM. This motivates patients, practitioners as well as researchers when crossing the borders of European countries. In the current legislative environment we think that harmonisation of law is possible within the EU: individual states within culturally similar regions should harmonise their CAM legislation and regulation. This would probably safeguard against inadequately justified, over- or underregulated practice at national levels. In Hungary, modifications of the decree regulating on CAM are currently being prepared following professional recommendations. This outdated decree needs to be reconsidered, as 17 years of practice have shown which practices are worthy to be maintainted, taught and applied within the healthcare system and which should be omitted.]

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