On 27 April, some 75 participants from 18 countries gathered for a specialist workshop hosted by ECHAMP in Prague, capital city of the Czech Republic, current Presidency country of the EU. The title of the workshop was ‘EU Harmonisation and the Divergent Policies of the Member States for Homeopathic and Anthroposophic Medicinal Products’. The participants included ECHAMP members from around Europe as well as representatives from the European doctors’, practitioners’, patients’ and pharmacists’ associations, and stakeholders from the Czech Republic active in the field of complementary medicine.

The event was opened by Max Daege, President of ECHAMP, who was pleased to welcome Per Thomas Thomassen, from the European Commission DG Industry Pharmaceuticals Unit and Dr Emiel van Galen, chair of the Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agencies.  The first speaker was Dr Gerhardt Peithner who gave a detailed overview of the situation of homeopathic and anthroposophic medicinal products in the Czech Republic and in Slovakia.

Mr Thomassen gave a well-documented presentation on the current status of homeopathic and anthroposophic medicinal products in the EU, and the legal and regulatory opportunities that exist to improve their situation. During the subsequent discussion it became clear that there is some awareness as regards the unclear situation in a number of Member States and that the Commission is ready to take some legal initiatives if it is asked to do so by the European Parliament and the Council of Ministers.  

It is clear that we will need to work at all levels – national and European - in order to bring about the changes needed to improve the legal and regulatory environment for homeopathic and anthroposophic medicinal products. Improved communication with the European Commission and European Parliament will be important to raise these issues higher on the political agenda. In particular, national governments play an essential role in supporting the changes needed to European pharmaceutical legislation through their representatives in the Council of Ministers.

The rest of the day concentrated on discussions on how to improve communication within the Member States to achieve the changes we need. ECHAMP had invited some of its associated members, national manufacturers’ associations, to join the conference and workshop to exchange experience on how a national manufacturers’ association can best function and successfully negotiate with national legal and regulatory authorities.

Presentations were made by representatives of countries with a range of different national structures: Barbara Cieniewska from Poland spoke of the difficulties faced in a market where there is no national association; Alex Castilla represented Spain, where there is an informal coalition of manufacturers; the meeting was attended by four representatives of national manufacturers’ associations in markets where there are more formal structures in place. These included: Penny Viner (British Association of Homeopathic Manufacturers in the UK) and Rudy De Clercq (Regulatory Affairs Society for Homeopathy in Belgium), whose national associations concentrate solely on homeopathic medicinal products; and Thomas Brückner (Bundesverband der Pharmazeutischen Industrie  (BPI), Germany) and Bernard Mauritz (Nederlandse Vereniging van de Farmaceutische Industrie van Zelfzorggeneesmiddelen en Gezondheidsprodcuten (NEPROFARM), Netherlands ), whose associations represent the whole pharmaceutical industry.

The participants split into four working groups to discuss the most effective methods of negotiation with national political and regulatory authorities.

A common theme of the presentations and output of the working groups was the need for and benefits of a joint platform for communication with the competent authorities within a market; this allows manufacturers to rise above competition between themselves for improved communication and provides the opportunity for more innovative solutions to regulatory challenges. In the case of the Dutch and German associations, some examples were given showing that the mainstream pharmaceutical industry faces similar challenges in some cases (for example the introduction of the requirement to put Braille on packaging) and that it is in the interests of all to collaborate to find simple solutions. There is much scope for improved co-ordination between the national and European associations, to help all to make the best of the existing regulations. The national associations are closer to the Council of Ministers than the European association, and this relationship is critical in terms of the ultimate decision making process of the EU. It was also understood that we all need to build allies to advance our cause – not just between different sections of the industry, but also with other stakeholders, including the patients, doctors and practitioners.

Karen Chapman
ECHAMP PR and Communications Consultant