Berlin – Today the Medicines Supply Bottleneck Combating and Supply Improvement Act (ALBVVG) passes the Bundestag. This means that a law will come into force that will not reduce the risk of supply bottlenecks, but increase it. Only three days before the 2nd and 3rd reading in the Bundestag, the Ministry of Health inserted a passage that will push generics manufacturers to the limits of their production and storage capacities, further reduce the profitability of drug production and lead to even more bottlenecks.
The last remaining manufacturers will be charged even more
The law obliges generic manufacturers to stock six months’ worth of drugs if they enter into a rebate agreement. If there were already too few manufacturers and machines to meet the demand, it will be even less possible now. Instead of creating incentives for more companies to return to production, the Ministry of Health is putting even more stress on the already limited capacities of the last remaining manufacturers.
“This regulation is unrealistic and it doesn’t solve the problem,” says Bork Bretthauer. “The recent bottlenecks did not arise because of insufficient supplies. They came about because we have too little production capacity in Germany due to the low reimbursement prices. No one knows where even more capacity is to come from and how production, which was often hardly economical before, is still to pay off. Our companies are stunned that politicians, who initially appeared to have understood the causes of the problem, are now shirk their responsibility, rely on a sham solution and pass the costs on to generic companies.”
From the relief law to the burden law
After children’s medicines had become increasingly scarce in autumn and winter, Federal Health Minister Karl Lauterbach initially signaled that he wanted to combat the causes. We had gone too far with economization, he said, and promised to set incentives so that more medicines would be produced again.
Now not even one percent of medicines are regulated, and even then only half, because the measures hardly bring any relief to the manufacturers. Dependence on China is not being reduced either, or only half-heartedly with a view to antibiotics.
The solution is a cloak thrown over the causes of the problem
“The Ministry of Health cannot or does not want to solve the problem of supply bottlenecks and does not address its causes,” says Bork Bretthauer. “Instead, presumably to cover up the problem, it’s stockpiling, knowing full well that it’s going to massively increase this in the process. “
What does the ALBVVG mean for companies? Why doesn’t it lead to more antibiotics production in Europe? And what would have been efficient measures? The current issue of our newsletter, which you can subscribe to here, provides the answers.
Pro Generika is the association of generic and biosimilar companies in Germany. We represent the interests of its members who develop, manufacture and market generics and biosimilars. The use of generics and biosimilars saves important financial resources in the healthcare system – while maintaining the high quality of drug supply. Generics and biosimilars thus ensure that patients have sustainable access to modern medicines.