INFORMATION - GENERIC MEDICATIONS

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The list of missing medicines is long. Manufacturers and traffic light coalitions are calling for concrete help. They are a long time coming. 

Generics, i.e. cheap copycat medications, represent 80 percent of the medication supply in Germany. 

The year 2022 began with bad news for doctors, pharmacists and cancer patients. In February 2022, the breast cancer drug Tamoxifen was suddenly no longer available. A round, white pill – with no alternative for the more than 100,000 patients. It took months for the situation to improve. 

It shouldn't just be this one bottleneck. In the summer, fever juices containing paracetamol suddenly became scarce for children. In the fall, the manufacturer of the cough reliever ACC Akut reported delivery problems. The stroke drug Actilyse from the manufacturer Boehringer Ingelheim will continue to be in short supply until next year - the only one in the world for the acute treatment of a cerebral infarction. 

There are currently over 300 medications on the Federal Institute for Drugs and Medical Devices (BfArM) list of medications that are not in stock. 

This is only a fraction of the approximately 105,000 approved medications in Germany. And it is not uncommon for there to be a replacement medication. However, every bottleneck can have noticeable consequences. In addition, concerns about further bottlenecks have increased with rising energy and gas prices. “The situation has never been so serious,” said Bork Bretthauer, managing director of the progeneric industry association, to the Handelsblatt. Manufacturers with earnings in the cent range would also have to deal with inflation. “The result: the portfolio is thinned out and certain drugs disappear from the market.” The association is therefore calling, among other things, for inflation to be added to the fixed amounts with which most generic drugs are reimbursed in Germany. In addition, there are dependencies on active ingredients that are primarily produced in countries like China. The calls from generic and other drug manufacturers are also being listened to closely in the federal government. However, there is currently no concrete help in sight. 

In an answer to a parliamentary question from CSU Bundestag member Stephan Pilsinger, the Federal Ministry of Health at least admits that “rising energy prices are also putting manufacturers of generic drugs under additional pressure”. In addition, the “concentration of a few manufacturing sites” and a shortage of raw materials are a cause. 

 “Against this background, the federal government is currently examining measures to ensure the supply of medicines and strengthen the production locations in Germany and the EU,” says the answer, which is available to Handelsblatt. For example, this involves relocating the production of active ingredients and excipients back to Germany. We are talking to associations and manufacturers about this. 

These intentions are not new, but can already be found in the coalition agreement of the traffic light parties. However, the fact that there has been no momentum for the project even after the serious shortage of the cancer drug tamoxifen has led many in the industry to fear that it will be neglected in view of many other reforms in the healthcare system. Already in the summer, the ministry stated at a meeting of the BfArM advisory board that it was examining “possible legal measures” to avoid bottlenecks - without presenting anything concrete. 

Simple medications are often no longer available, says Thomas Fischbach from the medical association. 

One must “quickly get fever juice, certain antibiotics and other preparations for small children that have become rare.” Because a lot of children are sick at the moment, demand is high. 

Due to delivery problems with medicines for small children such as fever syrups, the professional association of pediatricians is calling for the federal government to intervene at short notice. “We now need a procurement campaign pushed by politicians in order to quickly get fever juice, certain antibiotics and other preparations for small children that have become rare in an emergency, as was the case at the beginning of the corona pandemic,” said Association President Thomas Fischbach to the Rheinische Post. The plans for changes to the law presented by Federal Health Minister Karl Lauterbach (SPD) come too late. 

“We are experiencing a very high demand for fever-reducing medications such as ibuprofen or paracetamol because an extremely large number of children are currently ill,” said Fischbach. "It's a disgrace that simple medications like fever juice are often no longer available." Desperate parents come to the practices and the pharmacists have to endure the trouble through no fault of their own. “There are too few providers of such products because the fixed price regulation has led to production moving to low-wage countries such as India and China,” criticized the pediatrician. “There are now supply chain problems there, which in turn leads to delivery bottlenecks.” 

There have also recently been supply bottlenecks for some medications for adults. In response, the federal government wants to change procurement law. The aim is to broaden supply chains so that dependence on individual manufacturers decreases, said a spokesman for the Ministry of Health at the end of November. Despite existing instruments for alternative preparations in the event of shortages, the situation is unsatisfactory. Lauterbach told the ARD capital studio that health insurance companies should no longer be forced to buy medicines and active ingredients where they are cheapest. 

The shortages are a nuisance for pharmacies because they have to find alternatives to medications for patients or sometimes produce them themselves - this is time-consuming and expensive. The President of the Federal Association of German Pharmacists Associations (ABDA), Gabriele Overwiening, therefore called for an additional fee: "For the management of delivery bottlenecks, pharmacies urgently need a fee in order to be able to cope with the high expenditure of time and personnel," she told the Rheinische Post. "In the medium and long term, we need more production capacity for important medicines, such as antibiotics, in Europe."