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Berlin – The federal government will be thinking about cost-cutting measures again next year. This is what the head of the “Medicines, Medical Devices, Biotechnology” department of the Federal Ministry of Health (BMG), Thomas Müller, expects. “Behind the scenes, this is already an issue,” Müller reported today at the members’ meeting of the Pharma Germany Association in Berlin.

The BMG and Federal Health Minister Karl Lauterbach (SPD) are very open to innovation. But the minister must also keep an eye on the budgets. “And for 2025, I see dark clouds gathering over health policy,” said Müller.

The CEO of Pharma Deutschland, Dorothee Brakmann, criticised the fact that politicians want to reflexively implement cost-containment measures in the pharmaceutical sector in financially difficult times.

It would make more sense to talk to the pharmaceutical industry about ways to reduce spending. Pharma Deutschland, for example, has proposed making certain drugs prescription-only. This could save 1.4 billion euros, she said.

However, people would then have to pay out of their own pockets what they would save through statutory and private health insurance. This was not mentioned.

Generic prices expected to continue to rise

At the same time, Müller stressed that the BMG wants to further strengthen the pharmaceutical industry – as initiated last year with the National Pharmaceutical Strategy and the Drug Supply Shortages Control and Supply Improvement Act (ALBVVG). “The federal government has recognized that the level of reimbursement for generics must be carefully increased,” said Müller.

In the area of ​​children’s medicines, this was initiated with the ALBVVG. Since then, fixed amounts and discount agreements for children’s medicines have been abolished and prices can be increased once by 50 percent of the last applicable fixed amount.

“But that is not enough,” said Müller, predicting that the reimbursement of generics would also be taken up by the next federal government. This will also involve how to balance the expenditure on new drugs and generics.

Environmental regulations problematic for medium-sized companies

Müller also stressed that politicians must ensure that pharmaceutical sites in the European Union are not destroyed by excessive environmental requirements. “Large companies can better meet the regulatory requirements,” said Müller.

“But this is very costly for medium-sized companies.” He was referring to the amendment to the EU municipal wastewater directive, which the European Union launched this year and which still has to be implemented into national law.

It is an important goal of the association to support the implementation of the directive into national law, explained Jörg Wieczorek, CEO of Pharma Deutschland. In principle, the most important issues for the association in the coming years are securing the production site and reducing the bureaucratic hurdles for the production, approval and distribution of medicines.

New EU directive will make medicines more expensive

The EU Urban Waste Water Directive provides for the majority of the costs for the Europe-wide introduction of a fourth stage of treatment in sewage treatment plants to be allocated to the pharmaceutical and cosmetics sectors.

Wieczorek announced that the association would inform politicians and the public about the financial consequences for the German health system. “If the directive is implemented into German law in its current form, the construction and operation of the fourth treatment stage in the sewage treatment plants will cost around two billion euros per year,” explained Wieczorek.

“The costs of financing the treatment stage,” Wieczorek continued, “make medicines more expensive. These are primarily antibiotics and analgesics, and thus the medicines that are needed in large quantities and are under high price pressure.” The burden of around two billion euros per year on antibiotics and other generics would further exacerbate the strained situation in the health financing system.

Germany against changes to document protection

Müller also reported from the European Council, which is currently discussing the interaction between incentives for innovation and access to medicines. “We have many member states that are worried that new medicines will only be available in their countries very late after they have been approved,” said Müller. The Commission has proposed linking data protection to the market launch of medicines in all EU countries.

“Germany has spoken out against this,” explained Müller. “We do not want to touch the protection of documents and intellectual property because these are essential tools for bringing innovations to patients.” © fos/aerzteblatt.de