The Federal Administrative Court of Germany has ruled that a practitioner operating a private practice for naturopathic holistic medicine cannot manufacture a medicinal product in the form of a vaccine for personal use on patients. The decision by the Federal Administrative Court upholds lower court rulings that barred the practice under national pharmaceutical manufacturing regulations.
In Plain English: The Clinical Takeaway
- Therapeutic freedom does not exempt physicians from pharmaceutical manufacturing laws requiring standardized components.
- Custom products made from components intended for research purposes do not meet recognized pharmaceutical rules.
- Regulatory oversight mandates that substances used in the manufacture of medicinal products must comply with recognized pharmaceutical rules.
Federal Court Upholds Manufacturing Ban
The legal battle began in the summer of 2021, when the operator of a private practice for naturopathic holistic medicine notified the Karlsruhe Regional Council (Regierungspräsidium Karlsruhe) about an in-house manufacturing process. The practitioner stated he was producing a medicinal product in the form of a vaccine designed for intramuscular injection to protect against Covid-19. According to court records, the formulation utilized aluminum hydroxide and the peptide AS 319-541 of the RBD from the spike protein of the SARS-CoV-2 virus.
The regional authority prohibited the further production. Officials argued that the starting materials failed to meet recognized pharmaceutical rules. Subsequent challenges by the practitioner through the administrative court system yielded no relief, culminating in the dismissal of his appeal by the Federal Administrative Court.
Under Section 55, Paragraph 8, Sentence 1 of the German Medicinal Products Act (Arzneimittelgesetz – AMG), only substances that comply with recognized pharmaceutical rules may be used in the manufacture of medicinal products. The Federal Administrative Court confirmed that this mandate applies to physicians who prepare a medicinal product for personal application in a specific patient without having to have official authorization.
Regulatory Standards and the Limits of Medical Autonomy
The practitioner argued that medical freedom of treatment and the patient’s right to self-determination did not stand in the way. Both the higher administrative court and the federal judges rejected this defense. The judiciary determined that the starting materials did not comply with recognized pharmaceutical rules because they were not manufactured in a process designed to ensure safe use in humans.
Central to the legal evaluation was the quality and intended use of the raw ingredients. The findings established that the manufacturers of the substances used stated that they were intended only for research purposes and not for use in humans.
References
- Bundesverwaltungsgericht (Federal Administrative Court of Germany) – Ruling on medicinal product manufacturing under § 55 AMG.
- Arzneimittelgesetz (AMG) – Section 55, Paragraph 8: Requirements for starting materials in medicinal product preparation.
- Regierungspräsidium Karlsruhe – Regulatory enforcement actions regarding unauthorized biological preparations.
