Commission adopts agenda for better regulation

Better regulation is a top priority for the Juncker 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, 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.

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.

So what difference will the Better Regulation package make to this sector?
Its aims are to:

• stimulate openness and transparency in the EU decision-making process
• improve the quality of new laws through better impact assessments of draft legislation and amendments
• promote a consistent review of existing EU laws, to ensure they achieve their objectives.

The proposed measures include assessing the impact of new legislation under development to ensure that political decisions are ‘well-informed and evidence-based’, and reviewing existing laws to identify what can be improved or simplified. Of particular interest to this sector, special emphasis is placed on the impact of legislation on SMEs.

Moreover, the EU legislative process should become more inclusive, open and transparent. The Commission will open a web portal containing information on its ongoing work as well as consultations on existing policies or assessing new proposals. There will be new opportunities for stakeholders to comment throughout the entire policy lifecycle: they will have eight weeks to provide comments and points of view which will feed into the legislative debate.

As part of the Agenda, the Regulatory Fitness and Performance Programme (REFIT), which assesses the existing stock of EU legislation to make it more effective and efficient, will be strengthened to become an integral part of the Commission's annual Work Programme. A platform for dialogue with stakeholders and Member States on how to improve EU laws will also be set up. This will bring together high-level experts from business, civil society, social partners, the Economic and Social Committee, the Committee of Regions and Member States.

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. ECHAMP has already contacted First Vice President Frans Timmermans to outline the difficulties faced by the industry and requested a meeting to discuss these further.

Christine Marking 
ECHAMP Public Affairs consultant