Status: 05.04.2023 2:45 p.m
Certain medicines have become scarce again and again. The Federal Cabinet has now approved a draft law that is intended to prevent this in the future. Above all, the production of medicines should be more profitable.
The Federal Cabinet has approved a draft law with which the Federal Ministry of Health intends to prevent future supply bottlenecks in the supply of certain off-patent medicines. In particular, drugs for the treatment of cancer and antibiotics have become increasingly scarce for years. At the end of last year and at the beginning of the year, some medicines for children were also in short supply in many pharmacies.
In order to avoid such problems as best as possible in the future, the law focuses on one central point in particular: money. Federal Health Minister Karl Lauterbach himself admitted that Germany had “overdone the economization” of the supply of medicines. The federal government now wants to correct this “with a sense of proportion”.
It should become more attractive again for manufacturers of medicines to supply Germany. So far, when purchasing so-called generics, i.e. patent-free medicines, health insurance companies have had to follow criteria that aim to keep costs as low as possible. A fixed amount, for example, sets a maximum value for the reimbursement of certain medicines. Which often meant choosing the cheapest provider for health insurance companies, but low profit margins for manufacturers when selling in Germany.
“kids first”
Looking at the past few months, Lauterbach emphasized the principle of “children first”. “I don’t want to experience again that we can’t look after children,” said the SPD minister. That is “unacceptable” in a “wealthy country” like Germany.
And so, in the future, fixed prices or discount agreements negotiated with manufacturers for the supply of medicines for children will no longer apply. In addition, the law gives pharmaceutical companies the opportunity to raise their sales prices once by up to 50 percent of the last applicable fixed price.
Early warning system and replacement options
In addition to the relaxed price regulations, other measures are also intended to ensure a safer supply of medicines. Impending bottlenecks should be recognized much earlier in the future in order to be able to take countermeasures. The Federal Institute for Drugs and Medical Devices is to develop a kind of early warning system for this.
In order to increase security of supply, it should become mandatory to store certain medicines in stock. According to Lauterbach, the law provides for a “storage” of at least three months.
And should a prescription drug ever be in short supply, pharmacies should be able to fall back more easily on alternatives in the future. The so-called exchange rules should be relaxed for this. If a remedy is not available, a product with the same active ingredients can be issued – without the patient having to visit the doctor again to have a new prescription issued. Pharmacies and wholesalers are to receive a surcharge for the exchange.
More production in the EU
In its law, the Federal Ministry of Health also provides for counteracting an imminent shortage with a growing number of pharmaceutical manufacturers – and they are to produce more in the EU in the future. The law initially focuses on antibiotics, but later the regulations could also be extended to the production of cancer drugs.
In the future, tenders should not only play a role as to which provider offers medicines at the lowest price worldwide. In the future, health insurance companies should give more consideration to companies that produce active ingredients in the EU in tenders.
GKV criticizes the law
In the run-up to the Federal Cabinet’s decision, the Central Association of Statutory Health Insurance Funds (GKV) expressed doubts as to whether the planned law could really counteract possible delivery bottlenecks. The federal government put “everything on one card: more money for the pharmaceutical industry,” criticized Stefanie Stoff-Ahnis, board member of the National Association of Statutory Health Insurance Funds, in an interview with the AFP news agency.
At the same time, the GKV warned that with the abolition of fixed prices and discount agreements as “proven instruments” consumers could face rising prices for medicines and thus a greater financial burden.