EU fee for homeopathic complex remedies

Complex media manufacturers criticize new European fee

03/02/2014

A comprehensive body of legislation on safety in the pharmaceutical industry is due to come into force in the European Union later this year, against which manufacturers of homeopathic complex remedies are fighting. Affected are only the complex remedies, not the single remedies used in classical homeopathy. Among other things, the law provides for the regular submission of a safety report (PSUR), in which severe adverse reactions must be reported in a summarized form and analyzed.

Basically, this must be done every three years and is associated with a very high processing fee of 19,500 euros per drug. The lead agency is the European Medicines Agency (EMA). The law is not criticized as such, except that it makes no sense to write safety reports for side-effect-free complex agents in which basically nothing stands. „There is a risk that herbal remedies and homeopathic complex remedies will disappear altogether, as manufacturers can not afford to meet these high cost requirements. The manufacturers of these - usually equipped with a low side effect potential - drugs are not able to act like the big pharmaceutical companies, as they have not remotely on their profit margin or budgets“, write the Austrian Society for Homeopathy (ÖGHM), the Medical Association for Homeopathy (ÄKH) and the umbrella organization for physicians for holistic medicine in a joint press release.

Since most complex drug manufacturers also have homeopathic single remedies in their range, there is a risk that individual remedies will become more expensive or no longer available if an establishment can not afford the high administration fees.

Statement on the EMA fee schedule for PSUR safety reports from Heel
The company Biologische Heilmittel Heel is the largest manufacturer of homeopathic complex remedies in Germany. At the request of the DZVhÄ-Pressestelle Heel wrote the following statement: „We welcome the approach taken by the EMA to strengthen patient safety and to pool activities at EU level to this extent. However, the flat fee for the evaluation of the PSUR safety report of 19,500 euros needs improvement. In the case of chemically defined drugs with a high potential for side effects, a PSUR can quickly reach a volume of several thousand pages, so that even the official inspection is costly. Homeopathic medicines, on the other hand, are characterized by very good tolerability; the safety report therefore only consists of a few pages. In this respect, the extremely low side-effect potential and the minimum official examination effort should also be reflected in a correspondingly significantly reduced fee.“ (Pm)