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Berlin – Ahead of the upcoming cold season in winter 2024/25, the Pro Generika association is warning of further supply shortages of children’s medicines. This is because the measures that the federal government introduced last year in the Drug Supply Shortages Control and Supply Improvement Act (ALBVVG) have not led to the desired effects.

“The law was actually intended to help manufacturers of children’s medicines to be better off financially,” said the managing director of Pro Generika, Bork Bretthauer, to the German Medical JournalHowever, the regulations in the pharmaceutical sector are so complicated that in some cases the new regulations have instead led to a financial disadvantage for some manufacturers of children’s medicines.

Among other things, the ALBVVG abolished fixed amounts and discount agreements for children’s medicines. At the same time, manufacturers were able to increase their prices once by 50 percent of the last applicable fixed amount.

“That’s actually a good idea,” Bretthauer stressed. “Since the drugs in question no longer fell into a fixed-price group, other regulations such as the price moratorium came into effect, with the result that the manufacturers received less money for their drugs instead of more.”

Other provisions of the ALBVVG have not yet taken effect as much as they were intended, Bretthauer continued. For example, in the awarding process for discount contracts, health insurance companies must award contracts to manufacturers of antibiotics whose active ingredients are produced in Europe.

“This is also a good measure in principle, but it is not a game changer and will not lead to anyone setting up a new antibiotics factory in Europe,” said Bretthauer, referring to a recent response by the federal government to a minor inquiry by the CDU parliamentary group in the Bundestag.

The first corresponding tenders have now been awarded, writes the Federal Government. However, not all previous tenders have allowed lots to be awarded to manufacturers who source their active ingredients in Europe.

In May, the substitute health insurance funds, under the leadership of the Techniker Krankenkasse, put out a tender for antibiotics for the first time in accordance with the ALBVVG rules. This involved eight antibiotic active ingredients. Three surcharges were planned for each active ingredient, one of which was for manufacturers with European active ingredient production.

However, according to TK, it turned out that an active ingredient from the EU was not offered for all lots. TK CEO Jens Baas explained at the time that the ALBVVG was a first step to strengthen security of supply. However, the health insurance companies needed more flexibility to oblige manufacturers to have more robust and diversified supply chains.

Bretthauer from Pro Generika is also calling on the federal government to take further measures to reduce supply bottlenecks for generic drugs. “The ALBVVG is like a plaster on a gaping wound,” he said. The measures are too weak, too detailed and often too complicated, and they do not provide manufacturers with the planning security they need.

As one measure, he called for the suspension of fixed prices and discount agreements for all generics where shortages are threatened due to suppliers leaving the market, as well as a price increase of 50 percent – but without the price moratorium taking effect at the same time.

In its response to the CDU parliamentary group’s minor inquiry, the federal government assumes that the ALBVVG will have further effects in the future. It refers to the evaluation of the measures required by the law, which is to be completed by the end of next year. © fos/aerzteblatt.de