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Fever syrups containing paracetamol and ibuprofen are currently only available to children to a limited extent
Photo: Bernd Weissbrod / dpa
Warning messages from the German pharmaceutical industry are received by the Federal Institute for Drugs and Medical Devices (BfArM) almost every day.
Various manufacturers report that from now on they will no longer be able to deliver medicines as usual.
This week alone: On Monday, the Mibe company reported a shortage of a certain emergency and shock drug due to insufficient production capacities;
on Tuesday ITM Medical Isotopes from Munich announced delivery problems with a tumor marker;
on Wednesday, Mundipharma canceled the usual availability of a strong painkiller until the end of January.
In addition, there are several "change notifications" every day, with which individual manufacturers extend the already reported delivery bottlenecks for certain medicines.
All in all, there are currently more than 300 drugs on the BfArM list – and not just expensive special drugs.
This is only a fraction of the approximately 100,000 approved drugs in Germany and the authority also sees "no indications of a general acute deterioration in the supply situation in Germany".
However: If there is a supply bottleneck for a supply-relevant drug and no alternative drugs are available, this can have noticeable consequences.
"The situation is bad," said
Thomas Preis
, the chairman of the North Rhine pharmacists' association, to the dpa.
He has never experienced anything like this in more than 30 years of work.
The industry has been dealing with these problems for a long time.
Only at the beginning of this year did things look critical for drugs containing tamoxifen.
The drug is used to treat breast cancer patients.
The BfArM raised the alarm, the Federal Ministry of Health under
Karl Lauterbach
(59; SPD) then identified a supply shortage in February and allowed imports from Switzerland and the United Kingdom, among others.
The ministry identified the production loss of a manufacturer as the cause, which could not be compensated for by other suppliers in the short term.
According to the Pro Generika association, suppliers had previously withdrawn from production for economic reasons.
In the meantime, the ministry estimates that the situation is stable again, but the supply shortage is officially still there.
At the moment, paracetamol and ibuprofen-containing fever juices for children are only available to a limited extent - even if the ministry emphasizes that the current restrictions are not about a break in supply.
Generics, i.e. patent-free medicines, are particularly affected by the supply bottlenecks.
The list of delivery bottlenecks includes antibiotics, insulins and cancer therapies.
Also included in the list: Actilyse with the active ingredient alteplase, the world's only drug for the acute treatment of a stroke.
In the reports, the BfArM distinguishes between supply-relevant and supply-critical active substances.
In the case of the latter, a supply shortage has already occurred.
According to the dpa, there are currently around ten reports on active ingredients that are critical to supply,
One reason is cost pressure in the healthcare sector
The reasons for the delivery bottlenecks are manifold.
"The cost pressure in the healthcare system as a whole is the main problem," says the Federal Union of German Associations of Pharmacists (ABDA).
The ProGenerika association, which represents generics and biosimilar companies in Germany, takes a similar view.
A spokeswoman emphasizes the economic pressure in particular: the proportion that generics manufacturers receive for their drugs has been falling for years.
"As a result, the production of many generics is no longer economical for the manufacturers. More and more companies have therefore withdrawn from the supply."
This is particularly noticeable when costs rise, as is currently the case due to inflation.
Hubertus Cranz,
Managing Director of the Federal Association of Drug Manufacturers (BDA), refers to the increased costs of energy, packaging materials, logistics, as well as active ingredients and auxiliary substances, which are a heavy burden on manufacturers.
Packaging in particular is currently scarce everywhere, paper, glass and certain plastics are correspondingly more expensive - or not available at all.
Unlike other industries, drug manufacturers cannot simply raise prices.
Statutory price regulations, such as fixed amounts or discount agreements with health insurance companies, would restrict flexibility.
"In contrast to other sectors, increased production costs cannot be compensated, or only partially," says Cranz.
Relocation of drug production to Asia
In addition, many manufacturers now source most of their ingredients and active ingredients from China or India for cost reasons.
According to a study by the Association of Research-Based Pharmaceutical Companies (vfa), Asia is the most important production location for active ingredients destined for Europe.
This increases the risks in times of tight supply chains.
And in addition to delivery problems, there are sometimes quality problems, says a spokesman for the pharmacy lobby: "If a batch in a factory in the Far East does not meet European standards and therefore cannot be released, it can take a long time before the next batch is finished. "
The pharmacists' association ABDA warns of dependencies.
There is a monopoly on the market: "Many manufacturers are sometimes dependent on just one or very few active ingredient suppliers," it says.
If this one supplier fails or has problems in production, this can lead to bottlenecks - with consequences for patients.
Objective: Relocation of pharmaceutical production to Europe
Politicians have recognized the risks.
The federal government's coalition paper states that the bottlenecks should be combated - including by relocating drug production back to Germany or the EU.
At the request of manager magazin, the BMG replied that the authority was already holding talks with manufacturers and associations as well as at EU level.
The manufacturers welcome it, of course.
"However, the production of medicines and active ingredients cannot be brought back to Europe overnight, nor can the problem of supply bottlenecks be solved," says Cranz.
"It is still realistic to relocate the entire production back to the EU."
More warnings will probably be received by the BfArM in the coming days and weeks.