A concrete action plan aims to make Germany more attractive again as a research and production location for the pharmaceutical industry. This is the goal of the federal government's pharmaceutical strategy, which the federal cabinet approved on December 13, 2023.
This improves the framework conditions for the production and development of pharmaceuticals, promotes digitalization in the healthcare system, provides incentives for the establishment of production facilities in Germany and promotes innovation projects in the pharmaceutical industry.
The pharmaceutical strategy is supported by the Federal Ministry of Health, the Federal Ministry of Economics and Climate Protection and the Federal Ministry of Education and Research.
The essential components of the pharmaceutical strategy:
1. Accelerate clinical trials
- A new Federal Ethics Commission at the Federal Institute for Drugs and Medical Devices (BfArM) decides on important research applications and bundles application procedures.
- The approval of applications for national studies will be reduced by 19 days to 5 days.
- The radiation protection tests are integrated into the drug approval process.
- Model contractual clauses are being developed for clinical trials.
- Studies should also be able to be carried out beyond university hospitals.
2. Strengthening approval structures
- As the central contact for the pharmaceutical industry, the BfArM will in future be responsible for coordination and process management for approval procedures and applications for clinical trials for almost all drugs.
3. Accelerating digitalization in healthcare
- The Health Data Use Act is intended to enable pharmaceutical companies to conduct research on health data upon request.
- In the future, cross-state research projects will only be supervised and approved by the lead state data protection authority.
4. Incentives for pharmaceutical production
- BMWK and BMG are examining funding instruments for the construction of new production facilities.
- Discount contracts for oncological medicines manufactured in the EU should be given priority in the future.
- The procurement transformation package is intended to simplify, professionalize and accelerate public procurement. This also benefits the pharmaceutical industry.
5. Improving the European framework for R&D
- Germany is committed to stable and attractive framework conditions for the pharmaceutical industry in the EU pharmaceutical package and the International Pandemic Agreement (including no shortening of document protection and protection of intellectual property).
6. Promotion of innovation and research projects
- Research and development of scarce drugs (e.g. antibiotics, drugs for rare diseases) should be further supported, particularly in the early development phase.
- The Growth Opportunities Act provides, among other things, for a comprehensive expansion of tax support for research (research allowance), which will also benefit pharmaceutical companies conducting research in Germany.
- The transfer of academic research results to companies (translation) is encouraged.
- Venture capital is aggregated via the “German Growth Fund” and initiatives from the federal states in order to support small and medium-sized companies in the pharmaceutical market.
- The government program EXIST supports scientific start-ups.
7. Reliable framework conditions for pharmaceutical companies
- The legal rules for the pricing of innovative medicines (AMNOG) are being evaluated.
- Pharmaceutical companies are given confidential reimbursement amounts.
- The federal government intends to stabilize the manufacturer's discount for reimbursable medicines without a fixed amount at the level of 7%.
Federal Minister of Health Prof. Karl Lauterbach, Federal Minister of Economics Robert Habeck and Federal Minister of Research Bettina Stark-Watzinger welcomed the strategy to strengthen “research in medicine”, “substantial improvement” of the location conditions in Germany to make it an “attractive location for research, development and production of Medicines” as well as strengthening “innovation activity” and “accelerating digitalization and increasing planning security for investors”.
The Federal Ministry of Research would like to support the transfer of research results into drug development and application with targeted funding measures, for example for the development of new antibiotics and new drugs for rare diseases and for pandemic prevention. The pharmaceutical strategy also aims to create reliable research and innovation-friendly framework conditions and reduce bureaucratic hurdles so that Germany as a pharmaceutical location remains successful in the long term.
Source: BiographyM Biotech Cluster Development GmbH from December 15.12.2023, XNUMX