Hospital.Help

Berlin – The Medical Research Act (MFG) has passed the Federal Council. However, the state chamber spoke out in favor of abolishing the new reporting requirements for hospitals introduced by the law as quickly as possible.

Federal Health Minister Karl Lauterbach (SPD) received criticism of his law at the Federal Council meeting exclusively from party members. Lauterbach came into office with the promise of reducing bureaucracy – but there is not much to be seen of that, explained Lower Saxony’s Health Minister Andreas Philippi (SPD).

The MFG undoubtedly has good approaches to strengthening the pharmaceutical location. “However, shortly before the summer break, regulations were included in the law that do not really have anything to do with the original objectives of this law and rather belong in the Hospital Care Improvement Act (KHVVG), which has yet to be passed, but which, above all, instead of reducing bureaucracy, are another “Redefine and entail very significant requirements for hospitals,” he criticized.

The law stipulates that, in addition to the data deliveries in accordance with Section 21 of the Hospital Fees Act (KHEntG), hospitals should in future submit detailed information on the allocation of medical staff to the individual service groups on a quarterly basis.

In order to achieve this, daily and almost minute-by-minute recordings of all medical professionals working in the clinics would have to be made about their respective activities, explained Philippi. This is the only way to make precise assignment to the performance groups possible.

“In times of an increasingly threatening shortage of skilled workers, this would tie up additional personnel capacity for purely bureaucratic activities and thus take away from patient care,” he objected. “That cannot be seriously wanted.” In addition, the KHVVG draft “doesn’t make any sense at all about reporting this data on a quarterly basis.”

Philippi appealed for more trust in the work of people in the clinics. “More trust means less complexity.” It cannot be the case that more than a third of the working hours of medical and nursing staff are already spent on reports to various departments in the bureaucratic jungle of the healthcare system.

“The doctors and nurses in the hospitals are therefore emphatically resisting this new, senseless bureaucracy, and in my opinion they are completely right to do so,” he said. “The excessive control bureaucracy, from which patients do not really benefit, must urgently be reduced. Instead, this law will build it up through the back door.”

Instead of reducing bureaucracy, the regulation would introduce “additional, incredibly complex and completely unnecessary” recording and reporting requirements for hospitals. “This must be prevented at all costs.”

He therefore urgently recommends approving the health committee’s resolution recommendation. In it, the Federal Council emphatically calls on the federal government to “ensure in the short term as part of a further legislative process” that the regulation in question is repealed.

Lauterbach received further criticism from Rhineland-Palatinate. The law makes a “very central contribution” to strengthening the attractiveness of Germany as a pharmaceutical location and makes it easier for patients to quickly access new therapies, explained Prime Minister Alexander Schweitzer (SPD).

However, the states had already expressed their concerns during the legislative process regarding the establishment of a Specialized Ethics Commission for Special Procedures (SEKbV) at the Federal Institute for Drugs and Medical Devices (BfArM), i.e. a federal ethics commission.

“I believe that despite all the competence that we can assign to this commission, there is a risk of the creation of new and parallel structures that we may not even need at this point,” emphasized Schweitzer. “This seems to contradict the basic idea of ​​the law of simplification and de-bureaucratization.”

The Bundestag had already passed the law before the summer break. It did not require approval in the Federal Council, but it is an objection law. With it, the federal government is implementing key goals of its pharmaceutical strategy, Lauterbach explained today.

“We give researchers and companies the necessary planning security, reduce bureaucracy and speed up procedures and strengthen patient care, especially with innovative medicines. “In this way we are strengthening Germany as a research location,” he said.

The newly created regulatory options would now be implemented quickly. To this end, in addition to setting up the Federal Ethics Commission, the BMG is planning, among other things, to create standard contractual clauses for contracts between sponsors and clinical drug and medical device research institutions.

The radiation protection notification and approval procedures should also be completely revised, reduced in bureaucracy and accelerated, thereby reducing the effort for researchers and authorities alike.

Another central project of the law is to simplify and accelerate clinical trials, among other things by shortening processing times for mononational clinical trials and enabling decentralized clinical trials.

The law also contains two other regulations that received a lot of criticism in the parliamentary process. The so-called guardrails for price reductions in the procedure under the Medicines Market Reorganization Act (AMNOG) should be able to be suspended if a pharmaceutical company can prove that at least five percent of the test subjects took part in the clinical study for the respective drug in Germany.

Even more controversial, even within the government coalition, is the introduction of confidential reimbursement prices. Until June 30, 2028, manufacturers should be given the opportunity to keep the reimbursement prices for a drug negotiated with the National Association of Statutory Health Insurance Funds confidential.

This is intended to increase the scope in the reimbursement amount negotiations by reducing the constraints arising from the reference market effect of the German pharmaceutical market for other markets. In return, however, the companies have to grant a nine percent discount.

Critics fear that the complex reimbursement mechanisms will result in considerable bureaucratic effort on the part of the GKV, but also on the companies themselves, which will not be offset by corresponding savings.

From a medical and health insurance perspective, it has been pointed out since the beginning of the parliamentary procedure that confidential reimbursement prices hinder compliance with the cost-effectiveness requirement. From the perspective of pharmaceutical wholesalers, the regulation leads to uncertainty when calculating surcharges and discounts. © lau/aerzteblatt.de