German Bundestag, 181st Bundestag session: Federal Minister of Health Karl Lauterbach, SPD, gives a speech in the debate on the Medical Research Act./picture Alliance, dts agency
Berlin – The Bundestag has approved the Medical Research Act (MFG) with the votes of the governing coalition. During the discussion, Federal Health Minister Karl Lauterbach (SPD) had to defend himself against allegations of collusion with the pharmaceutical company Eli Lilly.
With the law, the federal government aims to ensure, in particular, that Germany catches up on its backlog in clinical research, among other things by simplifying and accelerating the approval and implementation of clinical trials.
Patients would benefit directly from this, Lauterbach explained at today’s plenary session. “We currently lack drugs for many serious diseases. Therefore, we need more research,” he said. Germany has not participated sufficiently in this research in recent years.
For example, a woman with untreated breast cancer is ten times more likely to participate in a clinical trial, which is her last hope, in Denmark than in Germany. “It cannot be like this,” he stressed.
The law will improve the chances of survival of these people and, at the same time, contribute to research. In the future, approval of studies will be carried out by the Federal Institute of Drugs and Medical Devices (BfArM) “just walk across a table,” he explained. This will make clinical trials in Germany “significantly better, cheaper and faster.” Germany “will become a giant in medical research.”
When questioned by left-wing MP Ateş Gürpınar, Lauterbach defended himself against accusations that he had actually followed the wishes of a single pharmaceutical company, given widespread criticism of the planned introduction of confidential reimbursement prices for newly introduced drugs.
“This has nothing to do with Eli Lilly,” he insisted. The concept of confidential reimbursement pricing was already developed as part of the federal government’s pharmaceutical strategy. No company was involved.
The real problem is that Germany is the only country in Europe that has so far ensured full transparency of reimbursement prices. This means that the highest reimbursement prices are charged in Germany, since the benchmark effect of the German market forms the basis for discount negotiations in other countries. “Transparency for the benefit of everyone and we pay – that cannot be right,” he stressed.
Gürpınar’s parliamentary group colleague Kathrin Vogler did not want to accept this. In response to a parliamentary question from the left, she accused Lauterbach of having had several telephone or personal contacts with representatives of the group this year.
“You’re not talking about anything here,” she accused him. “It’s a lie that confidential reimbursement prices make drugs cheaper. You don’t believe that yourself, or you wouldn’t have limited the regulation to four years.”
In reality, MFG is purely a localization law, as evidenced by the confidential reimbursement prices. “The left has nothing against economic development — but not at taxpayer expense,” she said. “They want no transparency on drug prices and no transparency on their strategies in creating this law.”
However, Paula Piechotta of the Greens, who also campaigned against the reimbursement price regulation when the law was drafted, was pleased. “We have achieved huge improvements in the parliamentary process,” she explained.
Thanks to improvements such as the automatic nine percent discount for confidentiality, the automatic expiration of the regulation after June 30, 2028, and the participation of test subjects in clinical studies as a prerequisite for the confidentiality option, the regulations are much more targeted. They would not be distributed to all drug manufacturers, as in the first draft, but would only benefit those conducting research at the German location.
The Union faction saw things differently. The improvements made the measure so complicated that it was not practical, criticised Georg Kippels (CDU). “This is not a solution,” he said. “If this were such a good solution, it would not have to be limited to three years.”
There was also disagreement about the weakening of the so-called guardrails in the AMNOG process for setting prices for new drugs. Here, too, preference should be given to companies that have addressed issues in the relevant approval studies in Germany. Exceptions to the guardrail price reduction mechanisms should apply to them.
This creates incentives for new innovations in the German pharmaceutical market and thus improves patient care, explained FDP MP Andrew Ullmann. He rejected criticism from health insurers that this would lead to significant cost increases. The GKV is spreading fantastic figures that cannot be understood.
For CSU MP Emmi Zeulner, this is not enough. “The guardrails were fundamentally a violation of the system,” she criticized. Lauterbach should have been bolder and abolished them completely. Instead of creating reliability, he created a bureaucratic monster. “When we take on government responsibility, we will abolish the guardrails,” she announced.
The plan to set up a Federal Ethics Commission – renamed in the law as the Specialized Ethics Commission for Special Procedures (SEKbV) – is also a wrong approach. “We want to strengthen the state ethics commissions,” he emphasized. The connection to the BfArM, which is the highest federal authority of the Federal Ministry of Health (BMG) is subordinate, it compromises the independence of the Commission. “It cannot be that the Federal Minister of Health determines ethics from above,” criticized Zeulner.
His parliamentary group colleague Hubert Hüppe (CDU) also pointed out that the BMG only had to consult the states when appointing the commission members, which further undermined independence and could not be aligned with the Helsinki Declaration. “The result will be a loss of trust and thus less participation in clinical studies,” he predicted.
However, a motion for a resolution by the Union parliamentary group on the law, which, among other things, provides for the further development of the existing ethics committees instead of a federal ethics committee, did not receive a majority. Only the CDU/CSU and the AfD voted for it. © lau/aerzteblatt.de