The European Commission has launched an EU wide stakeholder consultation in relation to a review of the veterinary pharmaceutical legislation (see E-News May 2010). Its declared purpose is to discuss how to put in place a simpler legal framework, safeguarding public and animal health while increasing the competitiveness of companies.

An analysis of the consultation document shows many similarities between the issues listed as shortcomings of the legal veterinary framework and many of the specific issues that ECHAMP identifies as problematic within the current legislative framework for homeopathic medicinal products for human use. This consultation could therefore set a much needed precedent for a detailed review of the existing legislation on pharmaceutical medicinal products for human use – in particular in relation to homeopathic medicinal products.

Specifically, the document lists various reasons for the need to review the current legislation for veterinary pharmaceuticals. It argues that it:

• is too cumbersome, time consuming and costly for the industry, which mostly consists of small and medium-sized enterprises (SMEs)
• raises issues over ‘unnecessary regulatory burden’
• leaves too much room for interpretation and different ways of implementation by Member States
• has not delivered on the availability of and access to products 
• has not been successful in creating a harmonised internal market; the mutual recognition and simplified procedures have led to delays in granting marketing authorisations and backlogs in national approval systems.

The same arguments could be just as easily applied to the need for a review of the current legal and regulatory framework for homeopathic medicinal products, specifically in relation to Article 13.1, Article 14.1, Article 16.1, Article 16.2 and the specific national rules, policies and limitations. Like the review of the veterinary pharmaceutical framework, a review of the framework for medicinal products for human should aim to

•  increase the availability of homeopathic and anthroposophic products 
• decrease the administrative burden for companies
• improve the functioning of the internal market for homeopathic and anthroposophic medicinal products.

ECHAMP has written to Commissioner Dalli, Commissioner for Health and Consumer Polity, underlining that, if the arguments listed call for a review of the veterinary pharmaceuticals legislation, they also call for a review of the human pharmaceuticals legislation. It reiterates its call on the Commission to create a harmonised and workable legal and regulatory environment for homeopathic and anthroposophic medicinal products across the EU in order to comply with the legitimate demand of the citizens, prescribers and patients for these products.

Christine Marking
ECHAMP Public Affairs Consultant