Individual small scale contract production of medicinal products
European directives relating to medicinal products have to be transposed into national law by the member states. A certain flexibility of this transposition is aimed at the optimal implementation of European requirements into national standards in order to provide for global European interests such as high-quality health care. This relative “legislational freedom” often results in national legal differences, as for example the so-called “Eigenherstellung” or “Individual small scale contract production” of medicinal products by physicians. Which is not allowed in Austria but licit in some states of the European Union like the Federal Republic of Germany.
Regulatory Differences
According to § 13 of the German Pharmaceuticals Act (AMG) physicians are allowed to produce, personally or via a contractor, medicinal products on small scale for the use in a specific patient under their exclusive professional responsibility. Condition precedent is a notification to the respective authority prior to the planned production. An additional manufacturing approval is not needed. This procedure can be compared with the Austrian magistral or officinal preparations. However, all magistral and officinal preparations have to be produced by a pharmacist in a pharmacy; the Austrian legislation makes no provisions for the manufacture of medicinal products by physicians. By establishing a dual control system comprising physicians and pharmacists the legislator aims for an optimized integration of medical and pharmaceutical competences.
Furthermore, the Austrian legislation does not allow the small scale production and subsequent import of medicinal products e.g. from the Federal Republic of Germany by Austrian physicians for two reasons:
Firstly, manufacturers and physicians are not allowed to distribute medicinal products to patients directly. The right to supply end-consumers with medicinal products is exclusively reserved to pharmacies (§ 59 AMG).
Secondly, the importation of medicinal products may be necessary if a certain therapeutical outcome can presumably not be achieved by the administration of a medicinal product that is available and has been approved in Austria. However, the importation of medicinal products intended for retail sale, whether from a country outside the European Economic Area (EEA) (“Einfuhr”) or from an EEA contracting party („Verbringung“), requires an import licence (“Einfuhrbewilligung”) or a notification (“Verbringungsmeldung”), respectively (§ 3 of the Austrian Act on the Import of Medicinal Products [AWEG]). The possibility to apply for an import license or to notify the import of medicinal products with the Austrian authorities, i.e. the “Bundesamt für Sicherheit im Gesundheitswesen” (BASG), is limited to public and hospital pharmacies and companies that are authorized to distribute medicinal products within a member of the EEA.
Conclusion
For reasons of patient safety, the manufacture of medicinal products according to particular instructions of a physician is limited to pharmacies by the Austrian legislation. The individual small scale production of medicinal products as is licit e.g. in the Federal Republic of Germany is not provided by the Austrian legislation. Additionally, the provisions of the AWEG apply to the transportation of medicinal products across the national border.
