Violation of the pharmacy reservation pursuant to Section 59 of the Austrian Medicines Act (AMG) by a specialist doctor?

The Supreme Court (OGH) dealt with this question in its recently published decision of March 19, 2024 on 4 Ob 42/24s and commented on a few fundamental questions.
The use of Ozempic in people who are not severely obese or do not suffer from diabetes, but want to lose weight easily, has been the subject of much controversy for several months. Only recently there was a dispute between two well-known Hollywood actresses.

In the case in question, a specialist doctor in plastic, aesthetic and reconstructive surgery had given several patients in his two surgeries who were suffering from obesity the drug Ozempic for self-administration at home for the entire duration of the treatment. The defendant doctor had taken a fee for this. One of the preparations, which he had not purchased from an Austrian pharmacy, also turned out to be a counterfeit. After using the counterfeit preparation, the patient using it suffered a seizure and hypoglycemia.
The Austrian Chamber of Pharmacists based its action on Section 1 of the Unfair Competition Act (UWG) and asserted a breach of Sections 57 and 58 of the Austrian Medical Practitioners Act (ÄrzteG – permissible dispensing of medicinal products) and Section 58 of the Austrian Medicinal Products Act (AMG – pharmacy reservation). The courts issued the requested interim injunction against the doctor.

In its decision, the Supreme Court emphasized that the pharmacy reservation anchored in Section 59 para. 1 AMG means that the supply of medicines to the population by public pharmacies has primacy, from which there are only narrow, legally defined exceptions.

It is true that, depending on the nature of their practice and local conditions, all doctors must keep the necessary medicines for first aid in stock. This requirement is interpreted restrictively by the courts, according to which an urgent case of dispensing a medicine to a patient can only ever exist if it is no longer possible to obtain the medicine from a public pharmacy in good time. This exception therefore only applies to medicines that must be administered to patients without delay in order to provide first aid. Under no circumstances does this regulation apply to medicines that are used for further therapy.

Furthermore, a doctor is not prohibited from keeping medicines in stock that are required for the treatment contract. Such use by the doctor also includes the provision of small quantities of a medicine for self-taking if (i) the direct connection with the treatment in the surgery and (ii) medical supervision are ensured.

These requirements were not met here; the defendant doctor unlawfully interfered with the pharmacy reservation by providing patients with not small quantities (namely a whole month’s supply) of the medicinal product, including injection devices, for the purpose of self-injection over several weeks without any medical supervision.
The main proceedings following the interim injunction have not yet been concluded, but the conclusive reasoning of the Supreme Court in the summary proceedings does not suggest a different outcome.

unyer Health Care & Life Science Working Group
Barbara Kuchar
Beatrice Blümel

Barbara Kuchar Beatrice Blümel

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