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Berlin – The draft Medical Research Law (MFG) receives fundamental support from both the opposition and government parties. However, the two included plans to allow confidential reimbursement pricing and to create a Federal Ethics Commission are met with equally unanimous criticism from both sides.
Germany must make up for lost ground in the research and development of new medicines, Federal Health Minister Karl Lauterbach (SPD) said yesterday at the first reading of the draft MFG in the Bundestag. Anyone suffering from cancer is now only one-tenth as likely to be included in a clinical trial in this country as in Denmark.
“It cannot be that an entire generation of innovative medicines in Germany was excluded from development just because we were too far behind,” he emphasized. With the MFG, he wants to strengthen the research site again, make a clear commitment to Germany as a production location for medical devices and pharmaceuticals and improve care.
The law will reduce the duration of testing before approval of a clinical study to 26 days and that of its evaluation to five. “Then we will have a full review of a study in 31 days,” she emphasized. By now, it typically takes twice as long, meaning that a clinical trial is often not even approved in this country, while trial subjects are already being recruited in other countries.
Your company’s policy to improve research and development conditions – which also includes the Digital Law (DigiG) and the Health Data Use Law (GDNG) – is already bearing its first fruits.
“We have a settlement boom that we haven’t had in years,” he explained. Global pharmaceutical companies such as Eli Lilly, Roche, Daiichi Sankyo and Merck have each invested billions in Germany in recent months and this will continue. “We are currently in negotiations with another European supplier who wants to invest more than a billion,” he announced.
Lauterbach was pleased with the excellent response MFG has received so far. He wanted to emphasize again that the opposition has not yet criticized the law.
It has not received any real opposition, at least from the Union faction. The Union also wants Germany and the investigation to regain its former strength, explained Hubert Hüppe (CDU): “The federal government’s draft law actually contains things we will support.”
However, the project contains points that make full approval impossible, in particular the planned creation of a Federal Ethics Commission, officially the Specialized Ethics Commission for Special Procedures (SEKbV).
There are already 33 ethics committees registered for drug studies. “These ethics committees have proven their worth,” Hüppe emphasized. Everyone involved in the German Medical Association (BAK) to the pharmaceutical industry would emphasize that there is no need for a Federal Ethics Commission.
This would not only create an unnecessary parallel bureaucracy. Rather, it is due to its affiliation with the Federal Institute for Drugs and Medical Devices (BfArM) as one from the Federal Ministry of Health (BMG) the subordinate higher federal authority does not sufficiently guarantee its independence. “This does not comply with the Declaration of Helsinki.”
Hüppe’s parliamentary group colleagues Erich Irlstorfer (CSU) and Erwin Rüddel (CDU) supported it. A federal ethics commission creates “dual structures that permanently weaken existing mechanisms and have no added value”, criticized Irlstorfer. With regard to confidential reimbursement prices, Rüddel warned that transparency in drug prices must be maintained for neutral evaluation procedures.
This criticism also came from the Greens. Paula Piechotta explained that she also supports the law in principle. The focus should be even more on the benefits for real medical care: the MFG “ultimately creates the structural conditions so that diseases that still destroy families today can be treated in five to ten years,” she said. “In practical terms, this is how many kilometers patients who have completed treatment have to travel to the nearest study center for their condition.”
However, there are disadvantages, namely the confidential reimbursement price: “It is a slightly strange element in this law”, he emphasized. “This concern attracts opposition from the entire healthcare system”, from legal and private health insurance companies to a large proportion of pharmaceutical companies and even self-administration, “including the medical profession, which no longer knows how much what it prescribes costs ”.
In this case, you will probably have to do as you did in 2016, when confidential reimbursement prices were discussed but were later negotiated in the parliamentary process.
Meanwhile, the left brought in much heavier artillery. “Actually, we shouldn’t make laws for individual businesses here, but the traffic light should. We’re talking about a Lex Lilly here,” explained Kathrin Vogler, referring to confidential reimbursement amounts. “When Health Minister Gröhe suggested this in 2016, a certain Karl Lauterbach still considered it unacceptable.”
Even most pharmaceutical companies are against the plans. “Why is the Lily company so interested in the lack of transparency?” she asked, only to respond immediately: The company wanted to market the same drug as a diabetes reimbursement and as a self-pay weight loss aid.
If reimbursement prices are not known, self-payers may also be charged more “and that makes shareholders happy,” she said. “Even if Lilly creates 1,000 jobs in Alzey – if the Chancellor has to become a lobbyist to achieve that, that price will be too high for us.” © lau/aerzteblatt.de