In a recent decision the Austrian Supreme Administrative Court for the first time has set out under which conditions non-conventional treatment that has not been evaluated in clinical studies may constitute permissible named patient use. This is of particular importance for the development of innovative therapies, such as personalized medicine applications.
In the case at issue1, patients that had exploited all conventional means of treatment were treated with autological stem cell therapy even though the risk-benefit balance of such treatment had not previously been assessed in clinical studies. This conduct may violate the Austrian Act on the Medical Profession which governs the principle of safeguarding the well-being of the patients "in accordance with medical science and experience as well as in compliance with the technical quality standards”.2 However, the Austrian Supreme Administrative Court ruled that the treatment constituted permissible named patient use and was thus lawful:
Named patient use is a deviation from standard treatment in an inpidual treatment situation where standard treatment does not cure the patient or standard treatment is not available for the disease. According to the Supreme Administrative Court’s recent decision, named patient use is permissible if such treatment is in the best interest of the patient after a careful balancing of the advantages of the therapy and its potential risks and adverse effects. The Austrian Act on the Medical Profession does not prohibit named patient use where standard treatment is ineffective. Non-conventional treatments, such as autological stem cell therapy, are permissible if cure of the disease is objectively and realistically expected. However, in any case patients’ consent is required after receiving clear and sufficient information about the novelty of the treatment and its potential for unknown risks.
The court also confirmed that it does not make named patient use impermissible if the non-conventional treatment is applied to a larger number of patients. Overall, the decision has broadened the doctor’s freedom of therapy and may be a door opener for innovative, non-conventional treatments in the future. It may be of particular importance for personalized medicine applications that identify the best treatment for a patient based on inpidual factors and therefore very often indicate non-standard treatment options as the ones that are most likely to benefit the patient.
[1] VwGH 24.04.2019, Ra 2015/11/0113.
[2] Section 49 Austrian Act on the Medical Profession.
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