Better regulation is a top priority for the European Commission. It was identified as such in the Political Guidelines for the new Commission and the priority was immediately confirmed by the appointment of Frans Timmermans as First Vice President specifically responsible for Better Regulation. On 19 May 2015, the European Commission adopted a comprehensive package of reforms - the Better Regulation Agenda.
This Commission initiative is welcomed by ECHAMP, as implementation and enforcement of European medicines legislation for homeopathic and anthroposophic medicines have been slow and are very incomplete even twenty years after the publication of the first specific legislation for these products. Divergent implementation, interpretation and enforcement policies in the Member States make it extremely difficult for companies to operate across Europe.
Divergent implementation, interpretation and enforcement policies in the Member States make it extremely difficult for companies to operate across Europe.
ECHAMP’s study, The Availability of Homeopathic and Anthroposophic Medicinal Products in the EU, finds modest to high demand for homeopathic and anthroposophic medicinal products in at least two thirds of the EU Member States. At the same time, the slow progress of enforcement of the relevant articles of Directive 2001/83/EC both seriously limits present availability and raises a question mark over sustained future availability of these products as well.
As EU regulation in the field of homeopathic and anthroposophic medicinal products creates an unnecessary administrative burden on both competent authorities and industry at Member State level, it is hoped that the Better Regulation package will constitute a useful policy hook to attract greater attention to the challenges faced by this sector and to ensure future availability of these products.