Admissibility of Stem Cell Therapy - Case Law Update Austria

In a recent decision (Ra 2015/11/0113), the Austrian Supreme Administrative Court (VwGH) inter alia addressed the question whether the application of stem cell therapy violates Section 49 of the Austrian Act on the Medical Profession (Ärztegesetz, ÄrzteG), which requires physicians to treat patients "… in accordance with state of the art medical science and practice" and to at all times act in the best interest of the patients.

The question arose in the context of (administrative) criminal proceedings against a doctor. The authority had claimed that the application of stem cell therapies for which no clinical trials had been conducted on a number of patients meant the use of an experimental medical therapy as part of regular clinical operations. The authority argued that the therapy lacked sufficient analysis of potential indications and contraindications and that there was no scientific basis on potential effects and side effects. There was also no scientific basis for the age bracket of patients on which the therapies could be applied.

Medical treatment may go beyond established science

In his counterarguments, the doctor focused on the fact that the authority did not establish a threat to a specific patient in any of the cases. While the treatments went beyond state of the art medical science, the limitations set forth by Section 49 ÄrzteG did not mean that only therapies for which clinical trials have been successfully conducted may be applied. The overriding principle was the obligation to always act in the patients' best interest. This means that a physician enjoys therapeutic freedom, subject to the circumstances of the specific case and the overriding goal to improve a patient's condition and do no harm. The stem cell therapies constituted (permissible) "individualised trials" (Heilversuche).

The patients concerned had exhausted all conventional therapy options and – in line with the case law of the German Supreme Court (BGH) – the individualised treatment of a patient without scientifically proven benefit is acceptable if no other therapy is available.

In its decision, the VwGH first made clear that the applicable Austrian regulations do not contain an absolute prohibition of stem cell therapy. It further determined what would constitute an "individualised trial", namely departing from state of the art medical science in a specific case (rather than as part of a clinical research series) either because there is no medical standard or because the available medical standards are of no use.

Patients also must receive clear and sufficient information about the novelty of the treatment and that the potential treatment may objectively be expected to offer a realistic and justifiable improvement of the patient's condition. Finally, the VwGH ruled that the mere fact that a novel therapy was applied to more than only a small number of patients did not mean that it could not still constitute an "individualised trial". To make such a determination would require individual analysis of each patient's case, something the authority had not done.

In summary, the VwGH thus gave the following practically relevant guidance:

• It is permissible for a doctor and in accordance with Section 49 ÄrzteG to apply therapies which go beyond state of the art medical science.
• Each individual treatment requires a cost/benefit analysis. A doctor remains in compliance with Section 49 ÄrzteG if a treatment (i) objectively is in the individual patient's best interests and does not put the individual patient at risk, and (ii) no other (conventional) therapy is available.
• It must be made crystal clear to the patient that the therapy has reached the limits of conventional treatment and what the potential risks are. The doctor must be sure that the patient understands the risks and consequences.
• The mere fact that a novel therapy is applied to more than only a very small number of patients does not automatically mean it cannot still constitute an "individualised trial".

Authors: Florian Kusznier & Andreas Natterer

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