Germany publishes new measures to strengthen research and medical production locally

“Germany should become more attractive again for research and production by pharmaceutical companies.” This is the aim of the Medical Research Act, which Federal Health Minister Prof. Karl Lauterbach presented at the beginning of the month in Berlin. The aim is to simplify and speed up the approval of studies and reduce bureaucracy.

In order to further expand the attractiveness of Germany as a pharmaceutical location and to ensure reliable supply, the Federal Government is committed to improving the framework conditions for a sustainable and internationally competitive pharmaceutical industry in Germany and the European Union.

What is included in this new plan?

The main measures at a glance:

1. Facilitate clinical trials, promote digitalisation and strengthen regulatory authorities

The Federal Ministry of Health (BMG) is developing a draft for a medical research law which would include:

• An interdisciplinary Federal Ethics Commission, established at the Federal Institute for Drugs and Medical Devices ( BfArM ) with a more centralised responsibility regarding the notification, approval procedures, coordination and process management for the clinical trials of all drugs, with the exception of vaccines and blood products. This will also include model contractual clauses for the conduct of clinical studies as well as shorter processing times for clinical trials conducted locally, and the introduction of decentralized clinical trials
• The labelling of investigational and auxiliary medicinal products will be simplified
• Confidential reimbursement amounts will be possible

The medical research law will also allow for a greater digitalisation in healthcare through:

• Further development of the research data centre at the BfArM, with enhanced access to the data from the research data centre for pharmaceutical research
• The reorganisation of data infrastructure of the genome sequencing model project. Data storage will be decentralised instead of centralised with pharmaceutical research allowed to access the data
• The concept of a lead data protection supervisory authority for cross-border research projects to be further developed within the framework of the Health Data Use Act

2. Protection of Intellectual Property

• In the EU and international context , Germany is committed to develop continued attractive framework conditions for the research and development of new medicines, good access for patients to new medicines and the comprehensive maintenance of the system of intellectual property rights
• As part of the negotiations on the EU pharmaceutical package, Germany will simplify the regulatory approval process and make the regulatory framework highly competitive. They also rejected any shortening of patent protection, protecting manufacturers during the period before the loss of exclusivity
• As part of the negotiations on the EU patent package and the International Pandemic Agreement, Germany is committed to ensuring that intellectual property rights are not weakened

3. Strengthening the EU pharmaceutical location and diversifying supply chains

• Together with the Federal Ministry for Economic Affairs and Climate Protection (BMWK), the Ministry of Health will examine targeted funding instruments and incentives to set up production facilities in Germany
• In order to strengthen the EU location , the discount contract regulations for antibiotics set out in the Medicines Supply Bottleneck Combating and Care Improvement Act will be extended to selected other medicines ( or groups), in particular oncological medicines
• In addition, it actively supports the development of an EU Critical Medicine Act to initiate economic policy measures for critical medicines
• As part of the reimbursement amount negotiations, the replacement of the publicly listed reimbursement amount with a confidential reimbursement amount will be introduced
• It intends on stabilising the manufacturer discount for reimbursable medicines without a fixed amount at the level of 7%

With a revision of the mandatory discount, the introduction of confidential reimbursement price and the inclusion of the oncologic medicines into the discount contract regulations, Germany is aiming to attract manufacturers who feared to launch first in Germany in the past years due to increasing regulatory and pricing regulations. Will this be enough for the pharmaceutical industry to come back or will they be cautious with the German promises until proven effective?

Source: https://www.bundesgesundheitsministerium.de/ministerium/meldungen/lauterbach-forschung-und-medizinproduktion-in-deutschland-staerken-01-12-23

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