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Berlin – Ahead of the next cold season in winter 2024/25, the Pro Generika association is warning of further bottlenecks in the supply of children’s medicines. The measures that the federal government introduced last year in the Act for Combating Bottlenecks in the Supply of Medicines and Improving Care (ALBVVG) have not had the desired effect.
“The law was really meant to help manufacturers of children’s medicines get into a better financial situation,” said Pro Generika Managing Director Bork Bretthauer. German medical journal. However, regulations in the pharmaceutical sector are so complicated that in some cases, the new regulations have led to a worse financial situation for some manufacturers of children’s medicines.
The ALBVVG abolished, among other things, fixed amounts and discount agreements for children’s medicines. At the same time, manufacturers were able to increase their prices once by 50% of the last fixed amount.
“This is actually a good idea,” Bretthauer emphasized. “Since the drugs in question no longer fell into a fixed-price group, other regulations such as the price moratorium have now come into force, with the result that manufacturers have received less money for their drugs, rather than more.”
Bretthauer continued that other provisions of the ALBVVG have not yet come into force to the extent that they were planned. In the process of awarding discount contracts, health insurance companies have to be careful about 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 someone setting up a new antibiotic factory in Europe,” Bretthauer said, referring to a current factory. Federal government response to a short question from the CDU parliamentary group in the Bundestag.
The federal government writes that the first corresponding tenders have already been awarded. However, not all previous tenders have succeeded in awarding lots to manufacturers who source their active ingredients in Europe.
In May, the substitute insurance funds, led by the Techniker Krankenkasse, announced antibiotics for the first time in accordance with the rules of the ALBVVG. This concerned eight antibiotic active ingredients. Three surcharges were foreseen for each active ingredient, one of which was for manufacturers with European production of active ingredients.
However, according to TK, it turned out that not all batches contained an EU active ingredient on offer. TK CEO Jens Baas explained at the time that the ALBVVG was a first step towards strengthening security of supply. However, the coffers would need even more leeway to force manufacturers to have more robust and diversified supply chains.
Bretthauer from Pro Generika also calls on the federal government to take further measures to reduce bottlenecks in the supply of generics. “The ALBVVG is like a plaster on an open wound,” he said. The measures are too weak, too detailed and often too complicated, and do not provide manufacturers with the planning they need.
As a measure, it called for the suspension of fixed amounts and discount contracts for all generics for which there is a risk of shortage due to the withdrawal of suppliers, as well as a 50 percent price increase – but without the price moratorium coming into force at the same time.
In its response to the CDU parliamentary group’s short question, the federal government assumes that the ALBVVG will have further effects in the future. It refers to the assessment of the measures required by law, which should be available by the end of next year. © fos/aerzteblatt.de