Berlin – The associations of the pharmaceutical and biotechnological industry speak out against the automatic substitution of biopharmaceuticals that are prepared in pharmacies for parenteral administration. The Federal Association of Drug Manufacturers (BAH), the Association of the Biotechnology Industry BIO Deutschland, the Federal Association of the Pharmaceutical Industry (BPI), the AG Pro Biosimilars and the Association of Research-Based Drug Manufacturers (vfa) explain their common position in an addendum to a publish position paper in February 2022.
Even if parenteral preparations are intended for medical use, the automatic substitution of biopharmaceuticals is not recommended in these cases. These drugs are used in the treatment of chronic and oncological diseases, so this group of patients in particular requires special sensitivity. Patient safety must always come first. If pharmacies were to be obliged by the Federal Joint Committee (G-BA) to exchange medically prescribed parenteral preparations from finished medicinal products, this would jeopardize patient safety and care without increasing additional economic reserves for the statutory health insurance system (GKV). This change will not be able to increase further savings potential in the biopharmaceutical sector. Because the competition is already in full swing here. In the special case of parenteral biopharmaceutical preparations for direct medical use, the dynamics of the auxiliary tax also have a cost-reducing effect.
The associations of the pharmaceutical and biotechnological industry are therefore appealing to the legislator to refrain entirely from a substitution requirement at the pharmacy level.
As became clear in the hearing of the associations on March 6, 2023, there is still a broad consensus on the part of patient representatives, doctors and pharmacists as well as industry that the automatic substitution of biopharmaceuticals in parenteral preparations should also be rejected. Against this background, the five good reasons formulated by BAH, BIO Deutschland, BPI, AG Pro Biosimilars and vfa against the automatic substitution of biopharmaceuticals are still very topical.
Attached you will find the addendum and the five-page updated position paper with the five good reasons against the automatic substitution of biopharmaceuticals.