European law on goods, services and persons increasingly regulates our daily life in terms of what we can do or not do, what are our rights and duties, what we can buy or not buy and so on.

The 50 year old European Union moves quickly and needs legislation and regulations in order to progress towards harmonisation, free trade of goods, free circulation of citizens and free exchange of services. The major concerns of the European institutions are to protect health and provide safety for the citizens, to stimulate innovation and employment and to preserve the natural environment. They strive to meet the expectations of 500 million citizens. So modified legislation and regulations and new structures, institutions and expert committees are created for all possible areas of our daily life.

The resulting tendency is towards ‘Over-Regulation’, ‘Burdensome Regulation’ or ‘Red Tape’. As a counterweight to this tendency a new vocabulary is increasingly apparent in a large number of policy documents and position papers: Deregulation, Better Regulation, Co-Regulation, Self-Regulation and Smart Regulation.

In the introduction to a Commission publication, ‘Better Regulation, simply explained’, José Manual Barroso, President of the European Commission, expresses it as follows: ‘We have to ensure that European laws and regulation are well targeted, correctly implemented at the right level, and proportionate to need’. In the same publication he concludes: ‘Public administrations need to be effective, flexible and focussed. This is the standard which the European Commission has set itself, and this is why we have made Better Regulation one of our core priorities’.

In practice this whole exercise should make it possible to reduce bureaucracy, to be cost-effective in the assessment process and to make the whole regulatory environment affordable for all players, authorities, industry and in the end individual citizens.

This applies equally to the field of medicinal products and in particular for homeopathic and anthroposophic medicinal products, where there is still a lot to be done, as demonstrated by the slow progress in the number of registrations and marketing authorisations in most of the Member States.

Martin Terberger, Head of Unit of European Commission General Directory III, Pharmaceuticals, is aware of the difficult situation of the sector for which he is responsible. In Vienna last year he said: ‘The pharmaceutical sector is covered by highly complex rules’ and ‘Simplification should also apply to the guidelines and the notice to applicants framework’.

ECHAMP is currently working on a comprehensive document which aims to present all the problems we have been able to identify in the field of homeopathic and anthroposophic medicinal products, and to propose possible solutions and the justification for them. This document will contain both pharma-legal and a pharma-regulatory parts, both of which will be presented to (and discussed with) the relevant political and regulatory authorities.

In the introduction to this new publication, Max Daege, President of ECHAMP, states: ‘The industry for homeopathic and anthroposophic medicinal products, a traditional European industry and world leader in its field is being prevented from potential growth. Fifteen years of experience demonstrate that the current European regulatory framework, rather than leading towards European harmonisation, is severely restricting this industry’.

He calls on the European Institutions ‘to take political action to allow the more than 100 million European citizens who are users of homeopathic and anthroposophic medicinal products easy and safe access to the medicines they prefer for their health care’.

‘Better Regulation, simply explained’:  http://ec.europa.eu/governance/better_regulation/brochure_en.htm

Nand De Herdt
ECHAMP General Secretary