Association for Natural Medicine in Europe
ANME
Die Association for Natural Medicine in Europe e.V.
ID: 323028947287-20
Lobbying Activity
Response to Revision of the Union legislation on blood, tissues and cells
5 Sept 2022
The reasons and objectives of the proposal refer (source page 1 point 1) to Directives 2002/98/EC and 2004/23/EC. These have contributed to the "safety of millions of patients treated with blood transfusions, transplants, or medically assisted reproduction." The new safety standards are intended to update the blood, tissue and cell regulations, which are outdated after more than 20 years, to achieve a high level of health protection for EU citizens and to ensure that they have access to safe and effective blood, tissue and cell products. This request is absolutely to be welcomed!
However, the formulations in the current proposal would lead to an overall increase in the personnel and organizational effort required in the manufacture of medicinal products. Due to the increased effort, there is a risk that pharmaceutical companies will incur excessive costs. As a result, the stock of some naturopathic preparations, e.g. microbiological medicines, would be endangered. For patients, this would mean that they would no longer be available. Furthermore, the increased expense for patients could lead to a reduction in the therapeutic range and restriction of the freedom of choice of treatment methods.
This would also be an additional burden for health professionals and professional users in Europe, as the practice could be declared a SoHo facility. Common natural therapies, such as all forms of autologous blood treatment, ozone therapy, symbiosis control of the gut, auto-urine application, etc., would be complicated or made impossible. Microbiota of human origin currently represent an indispensable tool in the treatment of many immune disorders.
Unfortunately, the definitions and scope of the current proposal are such that those health care professionals who perform autologous blood treatments would automatically become "SoHO facilities." Practice owners would have to apply for "authorization of SoHO preparations" for each treatment procedure, and therefore for each patient, under Article 40.
Article 51 would make only those health professionals "SoHO facilities" if they have the "formal qualification as a physician" and the "at least two years of practical experience in the relevant fields." For all other professional users, this would be tantamount to a ban on activity with regard to all self-blood treatment variants, since the draft has formulated a physician proviso in Article 51.
With kind regards,
Nora Laubstein, President of the Association for Natural Medicine in Europe/ANME e.V.
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