Statement by BIO Deutschland e. V. on the draft bill for a medical research law (MFG)

(15.02.2024) In line with the German government's strategy paper “Improving the framework conditions for the pharmaceutical sector in Germany - action plans for the research and production location”, the present draft law proposes setting up a federal ethics commission to accelerate the start of research projects. This is to be based at the Federal Institute for Drugs and Medical Devices (BfArM) and, from 2025, will take over the data protection and radiation protection assessment of clinical studies on new drugs that are being tested on humans for the first time, as well as gene and cell therapeutics. In addition, the BfArM and the Paul Ehrlich Institute (PEI) are to be better coordinated in the approval of drugs. The PEI is responsible, among other things, for vaccines and gene therapies, while the BfArM is responsible for conventional drugs. The aim is to better integrate the radiation protection notification and approval procedure with the medical device approval or notification procedures and the procedure for approving clinical trials with drugs. A so-called single-gate approach is being introduced, in which all radiation protection notification or approval procedures are carried out via the same electronic submission portal. The review of the radiation protection notification procedure is to be completely handed over to the ethics commissions. In addition, there are plans to establish registered ethics commissions in the federal states specializing in certain indications. The review periods are also to be significantly shortened and aligned with the deadlines for approving a clinical trial. Furthermore, hurdles for conducting decentralized clinical trials will be reduced by expanding the special distribution channel for investigational and auxiliary medicinal products and enabling electronic consent. The labeling of investigational and auxiliary medicinal products will be simplified and the approval of mononational clinical trials will be accelerated. In addition, the Federal Ministry of Health (BMG) will develop and provide standard contractual clauses for the conduct of clinical trials.

The competent federal and state authorities are to be strengthened by empowering the competent higher federal authority to publish recommendations for the interpretation of the EU principles and guidelines of good manufacturing practice. This is intended to support the competent authorities of the federal states in further harmonizing interpretation practice in the areas of manufacturing and testing of advanced therapy medicinal products, in particular gene and cell therapeutics. At the same time, the competent authorities of the federal states will have the right to submit requests to the competent higher federal authority for clarification of questions regarding the interpretation of the principles and guidelines of good manufacturing practice for advanced therapy medicinal products.

For drugs with new active ingredients, pharmaceutical companies should be given the option of confidentiality of the reimbursement amount, which applies until the document protection lapses. As a result, the reimbursement amount will no longer be made publicly available in the generally used directories, thus preventing external referencing and the associated negative effects.

BIO Deutschland welcomes the efforts of the legislature to make Germany more attractive as a location for health and research. The political failures of recent years have led to Germany losing its attractiveness as a location for studies in international comparison. Accordingly, the measures that have now been taken are, for the most part, very welcome. Nevertheless, these will not lead to Germany becoming the European leader in clinical studies again. To achieve this, further measures are needed for the implementation of decentralized clinical trials. For example, electronic data collection and data management would have to be made possible and a permit requirement would be needed to be able to carry out source data verification digitally. In addition, data protection challenges in the area of clinical trials remain unresolved. Study sponsors continue to be confronted with the task of meeting the widely varying requirements of the local data protection officers of the participating study centers. In addition to the confidentiality of prices, the AMNOG guard rails, the combination discount and the orphan drug threshold must also be put on the political agenda. Only if the conditions for recognizing the value of drugs are right again will more clinical trials come to Germany.
BIO Deutschland therefore demands:

• Better alignment of pharmaceutical and genetic engineering requirements for ATMPs
• Establishing an innovation-friendly environment (revision of AMNOG, GKV-FinStG)
• Pan-European harmonization of data protection requirements for clinical trials
• Binding requirements for (European) study centres that want to participate in European studies
• Mandatory model contract clauses for conducting clinical trials
• Consistent use of the possibilities offered by digitalization for decentralized clinical trials
• Enabling confidential reimbursement amounts for additional indications