On 10 December 2008 the European Commission made public its ‘Pharma Package’, sending it to the European Parliament and the Council of Ministers. The Pharma Package consists of a communication dealing with ‘a renewed vision for the pharmaceutical sector’ and three legislative proposals: one on counterfeit medicines, one on information to patients and one on pharmacovigilance. The discussion and the decision-making procedure can now start in the Parliament and the Council.

It came as no surprise that homeopathic and anthroposophic medicinal products were not mentioned in this communication, although the European Commission is aware of the problems faced by these products, problems not for public health but for the manufacturers who cannot register or authorise their medicinal products in all EU Member States within the current regulatory environment of legislation, guidance, infrastructure and capacities.

Concrete figures show that the real outcome in terms of registered or authorised homeopathic and anthroposophic medicinal products is very disappointing in the large majority of EU Member States. It is increasingly difficult for patients to find the products prescribed by their homeopathic or anthroposophic practitioners in their own country.

Despite the best efforts of the Homeopathic Medicinal Products Working Group (HMPWG) the special working group installed by the Heads of Medicines Agencies (HMA), the progress is very slow. In several Member States, manufacturers are obliged to take products off the market because of the high administrative burden and a lack of resources to do the work. Only in a few cases is withdrawal related to the quality or safety of the products. During the Slovenian and French presidencies in 2008, ECHAMP had a good working relationship with members of the HMPWG but we still hope for greater transparency in the work of this group and for more opportunities for exchange and input.

ECHAMP has published a number of reports and documents asking for better regulation, on how to deal with the overregulation that is the daily nightmare of the regulatory staff of all our members. In the meantime we have made this information available to the European Commission and the HMPWG, hoping that it will prompt open dialogue and solution oriented discussions for the benefit of the millions of patients who use these medicinal products.

We very much hope that 2009 will bring solutions to the disproportionate requirements for and efforts by both applicants and competent authorities and that the newly elected EU-Institutions will make a start in revising the legal provisions for homeopathic and anthroposophic medicinal products in Directive 2001/83/EC.

Nand De Herdt, General Secretary
February 2009

HMPWG information session on ‘anthroposophic use’
ECHAMP presented the Paris plenary of the Homeopathic Medicinal Products Working Group of the Heads of Medicines Agencies in December with information to help the assessment work regarding the justification of ‘anthroposophic use’.
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Second EU Homeopathy Day
The second EU Homeopathy Day will be organised on 2 April with a hearing in the European Parliament.
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Developing and implementing health in the EU
The EU Open Health Forum in December offered the opportunity for complementary medicine stakeholders to raise the profile of complementary medicine as a priority for EU health care.
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ECHAMP Membership Assembly 2009
ECHAMP’s 2009 annual Membership Assembly and Workshop will be held in April in Prague, Czech Republic.
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Hecht-Pharma GmbH: medicinal product by function
Hecht-Pharma provides guidance that sharpens the dividing line between medicinal and closely related products such as food supplements, medical devices, and cosmetics. This newly decided case further harmonises the application of pharmaceutical law in Europe.
Johan Hulshof reports….

Editor: Karen Chapman, ECHAMP PR and Communications Consultant