Bund Deutscher Heilpraktiker e. V.
BDH e.V.
Der Bund Deutscher Heilpraktiker e.V.
ID: 105601147501-94
Lobbying Activity
Response to Revision of the Union legislation on blood, tissues and cells
5 Sept 2022
The new safety standards are intended to ensure the safety and quality of substances of human origin (hereinafter "SoHO") and thus a high level of health protection for the citizens of the EU. This intent is definitely most welcome!
However, as a result of the language in the current proposal, it would no longer be possible to perform numerous common procedures of a proven method of therapy, namely autohemotherapy.
Autohemotherapy is performed throughout Europe, e.g. in Belgium, Germany, France, Greece, Italy, Austria, Romania, Spain, Poland and Portugal, as well as worldwide. It has been used throughout the EU in many practices of physicians and health practitioners for many decades. This therapeutic method has significant health benefits for patients. It has been shown to be extremely low-risk: There have not been any cases of damage associated with this method for many years. Numerous studies provide scientific evidence of the effectiveness of this method.
In Germany, the methods of autohemotherapy are listed under number 284 in the German Medical Fee Schedule (GOÄ), in the Fee Schedule for State-Registered CAM Practitioners (GebüH) and, even more extensively, in the Hufelandverzeichnis [Hufeland Index] of the umbrella organization of medical societies from the field of naturopathic healing. This is evidence of the importance and effectiveness of this therapy.
It is therefore imperative that the new regulation be worded in such a way that the proven therapeutic methods of autohemotherapy are excluded from the new guideline so that they continue to be available to patients.
Our Application for Amendment therefore proposes to supplement Article 2(2) as follows with the exemption described under letter (d):
(2) In cases of autologous use of SoHO in which
(…)
(d) SoHO preparations for homeopathic purposes or SoHO preparations for immunotherapy are manufactured under the direct professional responsibility of a person authorized to practice medicine on humans for the purpose of personal application for a specific patient, this regulation shall not apply. This also applies in particular to oxygen-ozone therapy.
We refer to the attached legal opinion for the reasons.
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