A quick review of European Commission and European Parliament activities over the last 18 months shows clearly that health is an increasingly important topic at European level in all its aspects, despite the fact that the organisation and financing of healthcare is still a competence of the Member States. Borders have to disappear within the European Union, and this applies equally to the field of health products and health services. ECHAMP News provides a round-up of current initiatives, in particular those of relevance to healthcare services and products in the field of homeopathy and anthroposophic medicine.

EU programmes
Calls for applications have been launched for both the EU Health Programme (2008-12) and the Seventh Framework Programme (EU Research Programme 2007-2013). Complementary Medicine (CAM) is included as a theme in both these programmes and it is likely that CAM projects will be included.

Cross-border healthcare
The Commission has issued a proposal on patients’ rights in cross-border healthcare. Although cross-border healthcare represents only a small fragment of total healthcare spending, it is necessary to regulate the rights of those patients who seek healthcare services and products in other countries, mainly as regards quality and safety, responsibilities and reimbursement. Patients and consumers of complementary medicine can obtain their services and products only from those Member States which have put in place appropriate legal provisions. They have to pay for their own travel, services and products because these are unavailable in their own countries. There is an urgent need for EU-health ministers to seriously consider the growing demand of patients from across Europe for complementary medicine (CAM) health services and for homeopathic and anthroposophic medicinal products. Although the new proposals may have only small impact on CAM services, they may lead to increased rights and more freedom of choice for patients.

Communication to patients
Another current discussion as regards medicinal products is that of communication to patients. The first ideas developed by the European Commission show that the general ban on direct advertising for prescription remedies would be maintained, but that there should be some flexibility regarding objective and reliable non-promotional information to the public mainly via the modern media. This item will probably be part of a Commission Communication to the Council of the European Union and the European Parliament on ‘the future of the single market of pharmaceuticals for human use’ which is expected in autumn this year. The communication is a direct result of the Commission’s public consultation on the future of pharmaceuticals in the European Union from mid-July to mid-October 2007.

ECHAMP took part in this consultation, as did a number of members and associated members (ECHAMP News February 2008). This initiative is part of the Commission’s Legislative and Work Program for 2008. The impact assessment accompanying the Commission Communication will outline how all contributions were taken into account (10% came from respondents active in the field of CAM medicinal products).

Pharma package
The communication already announced by Commissioner Verheugen as the ‘Pharma Package’ will focus on three items: A Directive on information concerning pharmaceuticals to patients, a Directive amending the current system and provisions for pharmacovigilance and a legislative proposal to fight against counterfeit medicines for human use. Other topics are also likely to be included in this communication: proposals for minor adaptations to Directive 2001/83/EC and to Regulation EEC/2309/93 on the European authorisation procedures, including Mutual Recognition.

Pharmaceutical Forum
The Pharmaceutical Forum, a group of experts installed jointly in 2005 by the Commissioner for Enterprise and Industry, Günter Verheugen and the Health Commissioner, Marcos Kyprianou, prepared this communication over about three years. Its work included other topics as well, such as clinical trials, pricing, a methodology for relative effectiveness, a standard or intellectual property protection and a suitable European master file system. It is not expected that proposals on all these topics will be made during this legislative term of the European Commission.

Homeopathic and anthroposophic medicinal products are not taken into account in any of these reports, publications and proposals. These medicinal products still have to make the first step to a real European level. Nor have they ever been on the agenda of the Pharmaceutical Forum, which concludes its mandate with the publication of final conclusions and recommendations before the end of this year.

Next legislative term of European Commission* and European Parliament*: Homeopathic and anthroposophic medicinal products should be high on the agenda

Much has been done by Commissioner Verheugen’s team in the field of pharmaceuticals. However, homeopathic and anthroposophic medicinal products have not been on the agenda so far and will not benefit from the initiatives for deregulation and increased harmonisation. Nevertheless we are confident that initiatives for better regulation and more harmonisation in the field of homeopathic and anthroposophic medicinal products will be high on the agenda during the next legislative term of the European Commission and the European Parliament.

Without changes in the basic legislation, that is articles 13, 14, 15, 16, 68 and 69 of Directive 2001/83/EC, the process of registration and marketing authorisation for the large range of existing homeopathic and anthroposophic medicinal products will not be affordable, either for industry or for the competent authorities. But there is hope: just before the summer break (nevertheless four years after the publication of the applicable legislation), the first mutual recognition procedure involving three Member States for a simplified article 14 homeopathic registration was successfully concluded by one of ECHAMP’s member companies.

* On 1 November 2009 a new European Commission team will take office after having been accepted by the new Parliament.

* The European Parliament elections will take place in June 2009 and the newly elected MEPs will start work in September 2009

Nand De Herdt
ECHAMP General Secretary