[Phage therapeutics and pharmaceutical legislation: classification, manufacture, placing on the market, and application].

Abstract

Currently, most phage therapeutics are individualized, that is, prepared specifically for a single patient. In this case, the preparation is usually decentralized and takes place in the respective hospital pharmacies as extemporaneous preparations. The technical supply of phage medicinal products thus differs from the guiding principle of pharmaceutical law. The assurance of quality, efficacy, and safety of medicinal products is typically adapted to the supply of medicinal products that are centrally manufactured independently of the patient in advance and administered decentrally. Only in legally defined exceptional cases may medicinal products be prepared decentrally by pharmacies or physicians without the need for a manufacturing authorization or a marketing authorization prior to application.The article shows why, from a legal perspective, phage medicinal products based on wild-type phages are simple, non-specifically classified medicinal product by virtue of function. Based on this, the article describes the legal requirements under which individualized and non-individualized phage medicinal products can be manufactured, placed on the market and administered. The article also addresses legal issues relating to phage lysins. Furthermore, the article shows the impact of the legal handling of phage pharmaceuticals on the requirements for the reimbursement of phage pharmaceuticals by health insurance providers. In view of the technical requirements of phage therapy, the article discusses the extent to which the current legal framework enables the translation of phage medicinal products into standard medical care. Finally, the article provides an overview of currently planned legislative changes and their likely impact on the legal handling of phage medicinal products.