Worry about medication shortages
16. Nov. 2022 - Handelsblatt
The list of missing medicines is long. Manufacturers and the traffic light coalition 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.
Austerity law under criticism Overall, the pharmaceutical industry does not feel valued. The research-based drug manufacturers in particular are under pressure from a recently passed law that is intended to relieve the burden on statutory health insurance companies in view of their billion-dollar deficit. Among other things, it provides for a higher manufacturer discount on patent-protected medicines and a price moratorium. “Instead of doing everything possible to avoid delivery bottlenecks for some of the essential medicines, the traffic lights are using the GKV Financial Stabilization Act to punish drug manufacturers with additional savings measures,” said CSU politician Pilsinger. “As if inflation and energy price increases didn’t exist, the generic manufacturers in particular are being squeezed.” There are also voices in the traffic light group that are pushing for quick measures. “The warnings from generic drug manufacturers of further supply bottlenecks are not unfounded,” said the Green Party’s health policy spokesman, Janosch Dahmen. The delivery bottlenecks are a “warning shot that should be taken seriously”.
With a view to earnings in the cent range, Dahmen considers, among other things, “adjusted higher remuneration” to be a possible way that manufacturers can continue to produce reliably, similar to what the Pro Generics Association is calling for. “In particular, the current general conditions such as the high energy and electricity prices must be taken into account,” he said.
Production, on the other hand, could not easily be relocated to Germany or Europe. This was also shown with the tamoxifen shortage.
Few manufacturers in the world market. “The plant in Germany, which stepped in for production due to the acute bottleneck, then had to undergo extensive cleaning for days and the remaining production materials were burned before the other, actually planned medications could be produced there again,” said Dahmen.
Despite the warnings, health expert Nicolas Busch from the management consulting firm Boston Consulting Group (BCG) still sees fairly comfortable conditions for generic drug manufacturers in Germany. Price adjustments for essential medicines should be possible. Health expert Nicolas Busch “However, the prices for generic drugs in Germany are still relatively high compared to international standards,” 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.” This is also pointed out by the statutory health insurance companies, who see the problem not in the German prices, but in the concentration on a few manufacturers See world market.
The Tamoxifen example shows that the system can react well in an emergency. The BfArM received the first reports of delivery problems in January, and the authority announced the first measures in February. A week later, Lauterbach's ministry identified 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 medication is now available again.