Berlin The year began with bad news for doctors, pharmacists and cancer patients. In February, the breast cancer drug tamoxifen was suddenly no longer available. A round, white pill – no alternative for the more than 100,000 patients. It took months for the situation to improve.
It shouldn’t stop at this one bottleneck. In the summer, paracetamol-containing fever juices for children suddenly became scarce. In autumn, the manufacturer of the ACC acute cough reliever reported delivery problems. The stroke drug Actilyse from the manufacturer Boehringer Ingelheim is still in short supply into next year – the only one in the world for the acute treatment of a cerebral infarction.
Almost 300 drugs are currently on the list of the Federal Institute for Drugs and Medical Devices (BfArM) for drugs that are not in stock.
This is only a fraction of the approximately 105,000 drugs approved in Germany. And it is not uncommon for there to be a substitute drug. Nevertheless, every bottleneck can have noticeable consequences. In addition, concerns about further bottlenecks have increased with the rising energy and gas prices.
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“The situation has never been so serious,” said Bork Bretthauer, Managing Director of the Progenerics Industry Association, to the Handelsblatt. The manufacturers with earnings in the cent range would also have to deal with inflation. “The result: the portfolio is thinned out, certain drugs disappear from the market.”
The association therefore calls, among other things, for inflation to be added to the fixed amounts with which most generics in Germany are reimbursed. In addition, there are dependencies for active ingredients that are mainly produced in countries like China.
The cries of generics and other drug manufacturers are also being heard very carefully in the federal government. However, there is currently no concrete help in sight.
Box office hit
1.36
euros per bottle
manufacturers of paracetamol-containing fever juices receive from the statutory health insurance companies. The price has been at the same level for ten years.
In an answer to a parliamentary question by the CSU member of the Bundestag Stephan Pilsinger, the Federal Ministry of Health at least concedes that “rising energy prices are also putting manufacturers of generics under additional pressure”. In addition, the “concentration of a few production sites” and scarcity of raw materials are a cause.
“Against this background, the federal government is currently examining measures to ensure the supply of pharmaceuticals and to strengthen the production sites in Germany and the EU,” says the answer that is available to the Handelsblatt. For example, it is about relocating the production of active ingredients and excipients back to Germany. We are in talks with associations and manufacturers for this.
These intentions are not new, but can already be found in the coalition agreement of the traffic light parties. However, the fact that the project has not gained any momentum even after the serious shortage of the cancer drug tamoxifen causes many in the industry to fear that it will be neglected in view of many other reforms in the health care system.
As early as the summer, the ministry stated at a meeting of the BfArM advisory board that it was examining “any legal measures” to avoid bottlenecks – without presenting anything concrete.
Savings law under criticism
Overall, the pharmaceutical industry does not feel valued. Above all, the research-based drug manufacturers see themselves under pressure from a recently passed law that is intended to relieve the statutory health insurance companies in view of their deficit in the billions. Among other things, it provides for a higher manufacturer discount on patent-protected drugs and a price moratorium.
“Instead of doing everything to avoid supply bottlenecks for some essential medicines, the traffic light tames the drug manufacturers through the GKV Financial Stabilization Act with additional savings measures,” said CSU politician Pilsinger. “As if inflation and energy price increases didn’t exist, generic drug manufacturers in particular are being choked off.”
There are also voices in the traffic light group that urge rapid action. “The warnings from generic manufacturers of further supply bottlenecks are not unfounded,” said the health policy spokesman for the Greens, Janosch Dahmen. The delivery bottlenecks are a “serious warning shot”.
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With a view to earnings in the cent range, Dahmen considers, among other things, an “adjusted higher remuneration” to be a possible way for manufacturers to continue to produce reliably, similar to what the Pro Generics Association calls for. “In particular, the current framework conditions such as the high energy and electricity prices must be taken into account,” he said.
Production, on the other hand, cannot easily be relocated to Germany or Europe. This was also shown in the tamoxifen bottleneck.
Few manufacturers in the world market
“The plant in Germany, which jumped in to produce due to the acute bottleneck, then had to be cleaned very laboriously for days and the other production materials burned before the other drugs that were actually planned could be manufactured there again,” said Dahmen.
Despite the warnings, the health expert Nicolas Busch from the management consultancy Boston Consulting Group (BCG) still sees quite comfortable conditions for generic drug manufacturers in Germany. Price adjustments for essential medicines should be possible.
The prices for generics in Germany are still relatively high in an international comparison. At the same time, the volumes sold are extremely high because Germany is not only the largest market, but also has the highest proportion of generics. Health expert Nicolas Busch
“However, the prices for generics in Germany are still relatively high in international comparison,” said Busch. “At the same time, the volumes sold are extremely high because Germany is not only the largest market, but also has the highest proportion of generics.” see world market.
The example of tamoxifen shows that the system can react well in an emergency. The BfArM received the first reports of delivery difficulties in January, and the authority announced the first measures in February. A week later, Lauterbach’s ministry noted an official supply shortage.
Numerous imports were then permitted, for example from Switzerland and the United Kingdom. “The intervention is already happening quite effectively,” said BCG expert Busch. The drug is now available again.
More: Generics industry fears withdrawal from manufacturers – and further drug shortages