There is an ongoing trend: delivery bottlenecks are becoming more common in German pharmacies
Painkillers, antibiotics, cancer drugs – even common medicines are often not available for months. Why is this so – and how can the problem be solved?
"I got a pretty good shot when the pharmacist didn't have my medicine in stock," says Sybille Burmeister. For an epileptic from Ludwigshafen, this can quickly become a big problem. "There are so many types of epilepsy and each one needs a special medicine so that people with epilepsy cannot simply take another manufacturer's medication."
These situations are more common in German pharmacies. According to the German Association of German Pharmacists (Abda), the number of over-the-counter medicines – medicines subject to manufacturer and health insurance contracts – has almost doubled: from 4.7 million packages in 2017 to 9.3 million last year. And with 7.2 million packages in the first half of 2019 alone, the trend continues.
Exciting, but no time?
Narrow delivery points are not a supply shortage
According to the Zentralinstitut für die Kassenärztliche Versorgung in Deutschland (ZI), just under 10 million legally insured persons did not receive an adequate medication or framework contract at least once last year. In terms of quantity, analgesics, antihypertensives and antidepressants are particularly affected. So, there are no new, innovative drugs, but especially the basic supply of older drugs, as CDU health expert Michael Hennrich concludes.
It also causes resentment for pharmacists: More than 90 percent of independent pharmacists consider Abda bottlenecks to be one of the biggest disabilities in their daily working lives. In 2016, it was just under 36 percent.
In the event of a supply shortage, the drug is not available for more than two weeks or is in greater demand than it is offered. In contrast, lack of supply is much less common if there are no alternative medicines for the drug and a large proportion of the population is affected.
"We have had many cases of oncology accident"
Most delivery bottlenecks are short-lived. But even a short gap can pose risks: "We've already had a lot of failures in oncology," Michael Hallek, executive director of the German Society for Hematology and Medical Oncology, said at a recent news conference.
Oncologist Bernhard Wörmann of Berlin-based Charité describes a particularly drastic case: As of October, pentostatin for chemotherapy is no longer available worldwide, so therapy must be completely discontinued and switched to another preparation. The patient will not die while doing so, but "change in the middle of therapy, of course, is not at all what one wants."
Another drug to treat acute myeloid leukemia (AML), cytarabine, had to be imported from the US. Although there are no more bottlenecks, the price of funds has quadrupled, Woermann says.
274 bottlenecks report 103,000 approved drugs
Two institutes cite bottlenecks and supplies in Germany: The Federal Institute for Medicines and Medical Devices (BfArM) maintains a database of unavailable delivery-related drugs, the Paul Ehrlich Institute (PEI) for vaccines. At the end of November, there were 274 bottlenecks reports – with around 103,000 approved medicines in Germany.
While there is a "continuous increase in reports of shortages of deliveries," BfarM explains. However, the data could not be compared with previous years because some reporting criteria were changed. In addition, there is probably a trend towards more willing information.
For now, the report is only mandatory for vaccines. This is what Health Minister Jens Spahn (CDU) wants to change. Plans a general registration request. Accordingly, pharmaceutical companies and wholesalers would have to inform the federal authorities about the supplies and upcoming bottlenecks in delivery-related drugs.
Price pressure is particularly high for generic products
Often, the cause of the supply shortage is not the manufacturer or distributor, but the supplier of the active ingredients, for example in India or China, says Daniel Wosnitzka of the Central Bureau of Health Insurance. About 80 percent of the active substances sold in the EU are produced in non-EU countries, according to Pro Generic estimates. There, manufacturing focuses on only a few companies. Result: If production is temporarily halted or the drug is recalled due to impurity, it is stuck in the supply chain. "Then a few or all of the generic manufacturers are usually hit," Wosnitzka says.
A generic drug is a copy of a drug like drug whose patent has expired. According to Pro Generic information, the price pressure is particularly high here: the average cost of a generic drug in Germany is six cents per day. Generics cover 78 percent of needs, but make up for less than 10 percent of actual pharmaceutical expenses, according to the association. In part, the reason for bottlenecks is that production may not be worth it if the prices of generic products fall. Then the manufacturers withdrew and there may be only one supplier.
Ibuprofen is only manufactured in the US, China and India
This can currently be well noticed in the classic pharmacy classic: ibuprofen. The active ingredient is manufactured in accordance with Zentiva Pharmaceuticals only in a total of six locations. "They can no longer fully meet growing global demand," the company said in a statement. In addition, production of ibuprofen at BASF in Bishop, Texas was discontinued for several months last year due to a technical malfunction. According to BASF, the plant also experienced an "unplanned production loss" this year. So the situation is still "tense," Zentiva said. Except in the US, ibuprofen is only manufactured in China and India.
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They therefore call for the production of medicines to be shifted back to the EU. "Only by strengthening the production of medicines in Europe will we reduce the problem of sensitive supply chains and the dependence on emerging markets," says Anna Steinbach of Pro Generic.
Until now, generic companies have been banned from manufacturing in Europe before the patent expires. It will be the past from 2022 onwards: Companies can already manufacture medicines for Day One after a patent expires in Europe.
How much they will use is open. Advisory management Roland Berger examined last year whether the production of antibiotics in Germany would make economic sense. The answer was clear: For the time being, domestic production is not worth it because of operating and investment costs and higher environmental and safety standards.
Hot deals are discount deals as well
"In order to increase security of supply in Germany through local production, government support is needed," they say. This is confirmed by a study by the US Food and Drug Administration (FDA). Thus, delivery bottlenecks could be prevented if there are more incentives to produce cheap drugs on the market.
Another hot topic in this context is discount contracts. In such a contract, the drug manufacturer grants health insurance a discount on the manufacturer's selling price of the drug. In turn, the manufacturer becomes the exclusive cash register supplier. Critics of the rebate agreement say it will narrow the market. Because for competing companies that don't have a cash deal, the contracts would actually mean stopping delivery, the Federal Association of Pharmaceutical Manufacturers (BAH) said on its website.
Companies would then prefer to manufacture other drugs, it is said. The fewer manufacturers that offer drugs, the more sensitive the supply chain. "If one of the discounted companies fails now, the others cannot normally cover the excess demand that suddenly appears," BAH said.
This particularly affects manufacturers of generic products: Last year, 75 percent of all generic drug prescriptions were reported as discounted, while the number of patented drugs was 26 percent, according to Pro Generika.
"Delivery bottlenecks are not a national problem"
For health insurance companies, however, there is no correlation between bottlenecks and discounts. Instead, rebate agreements prevented delivery bottlenecks, said the Ersatzkassen Association (vdek). As a result of contractual delivery obligations, pharmaceutical manufacturers will receive better planning. This increases security of supply, emphasizes vdek. Other stakeholders do not see discount contracts as the only scapegoat. "Delivery bottlenecks are not a national problem – if we think beyond the discount agreement, we still have no more production," says Hennrich, a CDU health expert.
Also SPD health expert Karl Lauterbach wants to stick to rebate contracts – but under changed conditions. He calls for sanctions for those companies that can't deliver: "In a discount agreement, they can negotiate a penalty that the company itself has to pay if they can't deliver it," he told Deutschlandfunk recently.
Sybille Burmeister solved her problem pragmatically and switched to a German manufacturer. But she remains critical: "There are many reasons for delivery bottlenecks, and it is noticeable that others are always to blame."