Medical Research Act: Germany to become a heavyweight in research

The Bundestag has passed the Medical Research Act (Medizinforschungsgesetz) in the second and third readings with the votes of the SPD, Greens and FDP. It is intended to bring investment back to Germany as part of a pharmaceutical strategy. There was criticism in particular due to the possible dependence on the Federal Ethics Commission and "confidential reimbursement prices". In addition, the opposition criticized that there had been prior agreements with a pharmaceutical company.

"We are simplifying and accelerating approval procedures for clinical trials, creating clear, simple responsibilities, harmonizing test specifications and using the possibilities of digitalization. […] As a resurgent heavyweight in research, Germany will make important contributions here," said Health Minister Karl Lauterbach on the Medical Research Act. Martina Stamm-Fibich from the SPD parliamentary group had similar words. The well-being of the patients is important, she said, as this is what matters most in research. When Stamm-Fibich said that a law had rarely "received such broad support from experts", boos were heard.

The Greens' rapporteur for pharmaceuticals and medical devices, Paula Piechotta, had many words of praise for the law, which was both a "pharmaceutical industry location improvement law and a drug price regulation adjustment law".

Agreements with pharmaceutical companies

"It's the confidential reimbursement prices that nobody needs, that only cost money," commented CDU Member of Parliament Georg Kippels on the proposal, which has already been amended several times. Vogler described Lauterbach's promises that medicines would become cheaper through secret reimbursement prices as a "brazen lie". In addition, there had been talks between the Federal Chancellor and the pharmaceutical company Eli Lilly in the run-up to the Medical Research Act.

According to Vogler, Olaf Scholz had spoken to the CEO of Eli Lilly twice at the beginning of the year. When she asked whether "the content of the Federal Government's pharmaceutical strategy was based on agreements with Eli Lilly and what these agreements were", Vogler was told by the Federal Ministry of Health that "the Federal Government's pharmaceutical strategy […] was developed with the involvement of the pharmaceutical industry".

"Again and again, the German Bundestag is trying to bring the exploding pharmaceuticals […] under control, which burden the statutory health insurance funds more and more every year. In 2022, for example, it was almost 50 billion euros. But the traffic light government has now finally capitulated and decided to do the very lucrative business with new drugs even more profitable", says Katrin Vogler from the Left Party. In her view, the Medical Research Act is nothing more than "location policy with health insurance money".

In the run-up to the bill, the statutory health insurance funds, among others, had feared that it would lead to higher prices if doctors did not know how much a drug cost. According to Piechotta, the confidential reimbursement prices are now much more strictly regulated, for example by the fact that manufacturers must guarantee a special discount of nine percent and must actually carry out research and development in Germany.

Much criticism for the Federal Ethics Commission

"The law significantly improves the framework conditions for Germany as a business location. Research, development and production will become more attractive for industry, so that more investment will take place in Germany," said Andrew Ullmann from the FDP. Although he admitted that he was still critical of the Federal Ethics Commission, "with the law we have also strengthened the working group of the German Medical Ethics Commission".

Emmi Zeulner from the CDU/CSU parliamentary group "clearly" rejects the transfer of the Ethics Commission to the Federal Institute for Drugs and Medical Devices and thus to the Federal Ministry of Health. The Federal Minister of Health should not "determine ethics in our country from above".

Janosch Dahmen from the Green Party defended the Ethics Commission: "It is right that the Federal Ethics Commission will be located at the BfArM in the future. But as we know it from the STIKO, the members of the Federal Ethics Commission will in future be appointed by the federal states. And just as the STIKO is independent in our country, the Federal Ethics Commission will also be independent in the future. That's what the law says". Ullmann also praised the promised reduction in bureaucracy and declarations of consent, which "will be more patient-friendly in future and we will be able to implement binding confidentiality clauses. This will put more horsepower on the road – especially more horsepower for faster study implementation".

Hubert Hüppe from the CDU/CSU: "These new special ethics commissions [...] do not create less bureaucracy, as is always said, but they create more bureaucracy. [...] And it is not […] independent in the sense of the Declaration of Helsinki because its members are appointed and dismissed by the Ministry of Health and are only in consultation with the federal states. […] And they remain part of the higher federal authority". This would result in a "loss of trust and therefore less willingness to participate in clinical trials". Hüppe also criticized the sanctions, which he believes are too low, if clinics or practices do not report information on implants to the register set up for this purpose. "You can't set up a sensitive register with this".

(mack)