BPI fears severe supply shortages of sterile medicines

View through a window front onto the manufacturing area, image: BPI / Steinheisser

From today, tightened legal regulations for the manufacturing of sterile medicines are to be applied. Pharmaceutical manufacturers in Germany will therefore likely be unable to produce several products. According to BPI, serious supply shortages threaten. "In order to prevent the production of essential sterile medicines from coming to a halt, we need quick and courageous solutions from policymakers and the responsible authorities," says BPI Chairman Dr. Hans-Georg Feldmeier. "As the Federal Association of the Pharmaceutical Industry (BPI), we are happy to support this from practical experience."

"Sterile medicines are rightly subject to very strict quality criteria," explains Dr. Feldmeier. "However, the new requirements go far beyond the goal and have been created completely unnecessarily. They are likely to lead to increased supply shortages rather than improved care." For example, filter systems: where filters for sterile production were previously regularly tested and validated for their performance, they are now to be automatically replaced after each batch. "This not only leads to absurd amounts of special waste but also wastes scarce resources and financial means," states Dr. Feldmeier. "Even before the new regulations, there were already supply difficulties with these filters. Now there is a great danger that a number of medicines will no longer be available at all. We are also talking about products that do not generate large margins but are extremely important for supply. It is all the more incomprehensible that our warnings have so far been ignored."

Shortages threaten

To avoid severe shortages in the supply of the population with predominantly life-saving preparations, ranging from electrolyte solutions to radiotherapeutics/radiodiagnostics to albumins, manufacturers now require substantive technical and financial support. "Everywhere in the market, the same conditions are prevailing for all manufacturers supplying the European market, which are no longer feasible," says Dr. Feldmeier. "The often-cited mantra 'The market will take care of it' can no longer work. All manufacturers are equally affected by the mostly pointless tightening of the framework conditions for sterile manufacturing, as well as by the ruinous price moratorium."

Solutions are on the table

"Practical solutions are now needed, with a sensible approach to the application of the so-called Annex 1 of Good Manufacturing Practice (GMP). The basis for this must be the risk analyses of the manufacturers. The price moratorium should be suspended for certain, (life-)essential medicines so that the transition in production is not solely borne by the manufacturers," emphasizes Dr. Feldmeier. "Medicines that are not already subject to the price moratorium, such as 0.9% NaCl infusion solutions, need appropriate reimbursement within the framework of the flat-rate fee to ensure production in Germany and Europe. Since 'GMP Annex 1' is a European regulation, we are calling for European-wide financial support for the affected companies for the necessary technical modifications."