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Berlin – The Bundestag has passed the Medical Research Act (MFG) with the votes of the governing coalition. During the debate, Federal Health Minister Karl Lauterbach (SPD) had to defend himself against accusations of collusion with the pharmaceutical company Eli Lilly.

With this law, the Federal Government wants to ensure in particular that Germany catches up on its backlog in clinical research by, among other things, simplifying and accelerating the approval and conduct of clinical trials.

Patients would benefit directly from this, Lauterbach explained in the plenary session today. “We currently have no medicine for many serious illnesses. That’s why we need more research,” he said. Germany has not participated sufficiently in this research in recent years.

For example, for a woman with breast cancer that has not been treated yet, the probability of taking part in a clinical trial, which is her last hope, is ten times higher in Denmark than in Germany. “It cannot stay this way,” he stressed.

The law will improve the survival chances of these people and at the same time do something for research. In future, the approval of studies at the Federal Institute for Drugs and Medical Devices (BfArM) will “just go through one table,” he explained. This will mean that clinical studies in Germany will be “significantly better, cheaper and faster.” Germany will “become a giant in medical research.”

When asked by Left MP Ateş Gürpınar, Lauterbach defended himself against accusations that, in view of the widespread criticism of the planned introduction of confidential reimbursement prices for newly introduced medicines, he had in reality followed the wishes of a single pharmaceutical company.

“This has nothing to do with the company Eli Lilly,” he asserted. The concept of confidential reimbursement prices had already been developed as part of the federal government’s pharmaceutical strategy. No companies were involved.

The real problem is that Germany is the only country in Europe that has so far guaranteed full transparency of reimbursement prices. This means that the highest reimbursement prices are charged in Germany, as the reference effect of the German market forms the basis for discount negotiations in other countries. “Transparency for the benefit of everyone else and we pay – that cannot be right,” he stressed.

Gürpınar’s parliamentary colleague Kathrin Vogler did not want to accept this. Based on a parliamentary question from the Left Party, she accused Lauterbach of having had several telephone or personal contacts with representatives of the company this year.

“You’re talking yourself into trouble here,” she accused him. “It’s a lie that confidential reimbursement prices make medicines cheaper. You don’t believe that yourself, otherwise you wouldn’t have limited the regulation to four years.”

In reality, the MFG is purely a location law, as can be seen from the confidential reimbursement prices. “The Left has nothing against economic development – but not at the expense of the contributors,” she said. “They do not want transparency about drug prices and no transparency about their dealings in the creation of this law.”

Paula Piechotta from the Greens, who had also campaigned against the reimbursement price regulation when the law was being drafted, was satisfied. “We have achieved enormous improvements in the parliamentary process,” she explained.

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 trials as a prerequisite for the confidentiality option make the regulations much more targeted. They would not be spread across all drug manufacturers as in the first draft, but would only benefit those who conduct research at the German location.

The Union faction saw things differently. The improvements had made the measure so complicated that they were not practical, criticised Georg Kippels (CDU). “That is not a solution,” he said. “If that were such a good solution, then it would not have had to be limited to three years.”

There was also disagreement about the softening of the so-called guard rails in the AMNOG procedure for setting prices for new drugs. Here, too, companies that have treated subjects in Germany in the relevant approval studies should be given preference. Exceptions to the guard rails’ 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 insurance companies that this would lead to significant cost increases. The GKV is spreading fantasy figures that cannot be verified.

CSU MP Emmi Zeulner doesn’t think that goes far enough. “The guard rails were a fundamental breach of the system,” she criticised. Lauterbach should have been braver and abolished them completely. Instead of creating reliability, he set in motion a bureaucratic monster. “When we take on government responsibility, we will abolish the guard rails,” 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 the wrong approach. “We want to strengthen the state ethics commissions,” she stressed. The connection to the BfArM, which is the highest federal authority subordinate to the Federal Ministry of Health (BMG), undermines the independence of the commission. “It cannot be the case that the Federal Minister of Health determines ethics from above,” criticized Zeulner.

Her parliamentary colleague Hubert Hüppe (CDU) also pointed out that the BMG only had to consult with the states when appointing the members of the commission, which would further undermine independence and could not be reconciled with the Declaration of Helsinki. “The result will be a loss of trust and thus less participation in clinical trials,” he predicted.

However, a motion for a resolution by the Union faction on the law, which, among other things, provides for a further development of the existing ethics committees instead of a federal ethics committee, did not receive a majority. Only the CDU/CSU and AfD voted for it. © lau/aerzteblatt.de