The Federal Government wants to ensure the supply of medicines in Germany. There has been a significant increase in delivery bottlenecks in recent years, in particular for off-patent drugs. The Federal Cabinet has now adopted a draft law for fighting delivery bottlenecks and improving the supply situation for medicinal products.

Focussing on medicines for children

“Children must come first”: Federal Health Minister Karl Lauterbach wants to promote the supply security of medicines for children in particular. Pricing rules for medicines for children are to be relaxed for this purpose, allowing for price increases of up to 50 percent. This would make it “more attractive for pharmaceutical companies to deliver or even produce medicines for children in Germany,” said Lauterbach following the Federal Cabinet’s decision.

Promoting production in Europe

Greater diversity of suppliers of medicines is key when it comes to preventing delivery bottlenecks and diversifying supply chains for medicinal products. To this end, the focus on European producers is to be increased. However, for the time being, this will be the case for antibiotics only. When negotiating discount agreements, health insurance providers are to be required to grant priority consideration to manufacturers whose active ingredients are produced in the EU and the European Economic Area.

Replacement rules, stockpiling and early-warning system

• Planning also provides for simplified replacement rules when medicines are dispensed by pharmacies: if a particular drug is not available, pharmacists may provide a medicine with the same active ingredients. Pharmacies and wholesalers are to be paid additional fees for such replacements.
• In addition, larger stocks of certain important medicines are to be kept in future than has been the case to date. Hospital pharmacies, for example, are to set up a safety buffer for possible bottlenecks. 
• An early-warning system for detecting imminent supply bottlenecks in time is to be set up at the Federal Institute for Drugs and Medical Devices. The Institute is to be granted additional rights to information, for example vis-a-vis manufacturers and hospital pharmacies.

Further details of the draft can be found on the pages of the Federal Ministry of Health. The draft is based on key points drawn up by the Federal Health Minister.