Status quo and future developments of combinations of medicinal products

SummaryCombinations of medicinal products were in common use during the 1950s and 1960s. These combinations were rarely a result of a rational development, but rather based on empirical experience. Following the German Drug Law (AMG) in 1976, a rational pharmacological justification for combinations of medicinal products became mandatory. Simultaneously cases of certain fixed combinations were found to possess high health risks, leading to the opinion that an effective and safe therapy requires an individual dosing of each drug. Today with the advanced knowledge about multifactorial causes of diseases, patients and physicians are increasingly confronted with an existing polypharmacotherapy, but the regulatory framework for the authorisation of combination medicinal products is lagging behind. The article describes in concrete examples the present status for the authorisation of combination medicinal products and offers suggestions for future developments based on the recent advancements in science. It further describes the special legal situation for phytopharmaceuticals and the present status for the reimbursability of fixed medicinal product combinations.