📢 Germany’s draft Medical Research Act aims to increase the number of clinical trials in the country. The law will remove bureaucratic and legal obstacles, shorten authorization procedures, and recommend model contract clauses to speed up negotiations between study clinics and sponsors. However, industry stakeholders are disappointed as the law falls short of their expectations. Health Minister Karl Lauterbach is optimistic that Germany will see more studies in the coming years.
📢 Germany’s New Law Revolutionizes Clinical Trials
Introduction:
The German government has proposed a new law, called the Medical Research Act, to increase the number of clinical trials conducted in Germany and improve the country’s pharmaceutical industry. The law aims to remove bureaucratic and legal obstacles that currently hinder the start of industry-sponsored and investigator-initiated clinical trials in Germany.
Main points:
- The German government wants to make Germany more attractive as a location for biopharmaceutical production and research and development.
- The Medical Research Act will shorten the authorization procedures for clinical trials and establish a central ethics committee to speed up the start of studies.
- Model contract clauses developed by industry and medical associations are recommended to expedite negotiations between study clinics and sponsors.
- The draft law has received mixed reactions, with some stakeholders expressing disappointment and others optimistic about the increase in clinical trials in Germany.
- Experts believe that the draft law does not go far enough in improving Germany’s position as a study location.
Conclusion:
The proposed Medical Research Act in Germany aims to accelerate the start of clinical trials and make the country a leader in biopharmaceutical production and research. While the law has received some criticism for not going far enough, it is seen as a step towards improving the framework for clinical trials in Germany.
