EU fee for homeopathic complex remedies

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Complex agent manufacturers criticize new European fee

A comprehensive body of legislation on safety in the pharmaceutical industry is set to enter into force in the European Union before the end of the day, against which manufacturers of homeopathic complex remedies are fighting back. Only the complex remedies are affected, not the individual remedies used in classic homeopathy. Among other things, the law provides for the regular submission of a safety report (PSUR = periodic safety update report), in which serious side effects have to be reported and analyzed.

Basically, this has to be done every three years and is associated with a very high processing fee of 19,500 euros per medication. The European Medicines Agency (EMA) is responsible. The law as such is not criticized, only that it makes no sense to write safety reports for side-effect-free complex agents, in which there is basically nothing. “There is a risk that herbal medicines and homeopathic complex remedies will completely disappear from the market because the manufacturers cannot afford to meet these high-cost requirements. The manufacturers of these medicines - usually with a low potential for side effects - tend not to be able to act like the large pharmaceutical companies because they do not have their profit margins or budgets in the remotest ”, write the Austrian Society for Homeopathy (ÖGHM), the Medical Association for Homeopathy (ÄKH) and the umbrella association for holistic medicine in a joint press release.

Since most manufacturers of complex remedies also have homeopathic single remedies in their range, there is a risk that individual remedies will become more expensive or no longer available if a company cannot 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 press office, Heel wrote the following statement: “We welcome the approach of the EMA to strengthen patient safety and, in this respect, to bundle activities at EU level. However, the flat fee for evaluating the PSUR safety report of EUR 19,500 needs to be improved. In the case of chemically defined medicinal products with a high potential for side effects, a PSUR can quickly reach several thousand pages, so that the regulatory review is also time-consuming. Homeopathic medicines, on the other hand, are particularly well tolerated; the safety report therefore consists of only a few pages. In this respect, the extremely low potential for side effects and the minimal official examination effort should also be reflected in a correspondingly significantly reduced fee. ”(Pm)

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