Federal government adopts national pharmaceutical strategy: improved framework conditions, incentives, digitalisation and promotion of innovation projects

This will improve the framework conditions for the manufacture and development of medicinal products, promote digitalisation in the healthcare sector, provide incentives for the establishment of production sites in Germany and support 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 main components of the pharmaceutical strategy:

1. Acceleration of clinical trials

• A new Federal Ethics Commission at the Federal Institute for Drugs and Medical Devices (BfArM) decides on important research applications and organises application procedures.
• The approval of applications for national studies is reduced by 19 days to 5 days.
• Radiation protection tests will be integrated into the authorisation procedure for medicinal products.
Model contract clauses will be developed for clinical trials.
• It should also be possible to conduct studies outside of university hospitals.

2. Strengthening of the authorisation structures

1. The BfArM, as the central point of contact for the pharmaceutical industry, will in future be responsible for the coordination and process management of authorisation procedures and applications for clinical trials for almost all medicinal products
.

3. Acceleration of digitalisation in the healthcare sector

• The Health Data Utilisation Act is also intended to enable pharmaceutical companies to conduct research on health data upon request.
In future, cross-state research projects will only be supervised and authorised by the respective state data protection authority in charge.

4. Incentives for pharmaceutical production

• BMWK and BMG are testing funding instruments for the establishment of new production sites
.
• Discount contracts for oncological drugs manufactured in the EU are to be favoured in future.
• The procurement transformation package aims to simplify, professionalise and speed up public procurement. This will also benefit the pharmaceutical industry.

5. Improvement of the European framework conditions for R&D

• Germany is in favour of stable and attractive framework conditions for the pharmaceutical industry in the EU pharmaceutical package and the international pandemic agreement (e.g. 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 promoted, especially in the early development phase.
• The Growth Opportunities Act provides for a comprehensive expansion of tax incentives for research (research allowance), which will also benefit pharmaceutical companies conducting research in Germany.
• The transfer of academic research results to companies (translation) will be promoted.
•  Growth Fund Germany“ and initiatives by the federal states aggregate venture capital to support small and medium-sized companies in the pharmaceutical market as well.
• The EXIST government programme supports start-ups from the world of science
.

7. Reliable framework conditions for pharmaceutical companies

• The legal rules for the pricing of innovative drugs (AMNOG) are being evaluated
.
• Pharmaceutical companies will be enabled to submit confidential reimbursement amounts.
The Federal Government intends to stabilise the manufacturer discount for reimbursable medicines without a reference price at the level of 7%.

Federal Minister of Health Prof. Karl Lauterbach, Federal Economics Minister Robert Habeck and Federal Research Minister Bettina Stark-Watzinger welcomed the strategy to strengthen „research in medicine“, „substantially improve“ the location conditions in Germany towards becoming an „attractive location for research, development and production of pharmaceuticals“ as well as strengthening innovation“ and „accelerating digitalisation and increasing planning security for investors“.

The Federal Ministry of Education and Research wants 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 as well as for pandemic prevention. The pharmaceutical strategy also aims to create reliable, research- and innovation-friendly framework conditions and reduce bureaucratic hurdles so that Germany remains a successful pharmaceutical location in the long term.

Source: Bio^M Biotech Cluster Development GmbH from 15 December 2023