zeit.de
Boehringer CEO Calls for Faster Drug Approvals in Germany
Médard Schoenmaeckers, new Boehringer Ingelheim Germany CEO, criticizes slow drug approvals in Germany compared to the US, citing a three-year delay for a lung cancer drug currently in fast-track approval in the US. He also notes Germany's fall to seventh place globally in clinical trials and calls for faster, evidence-based processes.
- How does the German pharmaceutical regulatory system compare to those of other leading countries, and what factors contribute to these differences?
- Schoenmaeckers points to competition from countries like France and Spain with faster clinical trials and approvals, and the pressure from the US due to trade disputes and China's growing pharmaceutical presence. He stresses that Germany must become more competitive to retain investments and avoid negative consequences of a potential trade war, impacting industries like pharmaceuticals, automotive, and machinery.
- What are the primary challenges facing pharmaceutical market access and approval processes in Germany, and what are the potential consequences of inaction?
- Boehringer Ingelheim's Germany CEO, Médard Schoenmaeckers, advocates for faster drug approvals in Germany, mirroring the US system. He highlights Germany's fall from the world's second-largest clinical trials site to seventh, emphasizing the need for evidence-based systems and greater agility in market access. A Boehringer lung cancer drug, undergoing fast-track approval in the US, exemplifies the stark contrast; it could take three years longer in Germany.
- What are the long-term implications of Germany's current approach to pharmaceutical pricing and regulation on its healthcare system, its economy, and its global competitiveness in the pharmaceutical sector?
- Schoenmaeckers's concerns extend to Germany's pricing policies for pharmaceuticals, arguing that viewing drugs solely as cost factors undermines innovation. He advocates for recognizing the preventive and economic value of medicines, impacting healthcare costs and workforce productivity. Continued investment in German Boehringer sites depends on a competitive regulatory environment.
Cognitive Concepts
Framing Bias
The narrative frames the issue primarily through the lens of Boehringer Ingelheim's concerns and the potential negative economic consequences for Germany if regulatory hurdles aren't addressed. This focus emphasizes the company's interests and the potential risks, without providing balanced perspectives on the benefits of a more cautious approach to drug approval. The headline (if there were one) would likely reflect this framing.
Language Bias
The language used is largely neutral, although phrases like "agiler werden" (become more agile), and descriptions of the US system as a 'Fast-Track-Verfahren' (fast-track procedure) subtly favor faster approval processes. While not overtly biased, the consistent emphasis on speed and efficiency could subtly sway readers to favor quicker approvals.
Bias by Omission
The article focuses heavily on the perspective of the new Boehringer Ingelheim Deutschland chief, Médard Schoenmaeckers, and his concerns regarding drug approval processes. Counterarguments or perspectives from other stakeholders, such as government officials or representatives of competing pharmaceutical companies, are absent. This omission could limit the reader's ability to form a complete understanding of the complexities involved in drug approvals and market access in Germany and the EU.
False Dichotomy
The article presents a somewhat simplistic dichotomy between the US and German drug approval processes, portraying the US system as significantly faster and more efficient. While differences exist, the analysis lacks nuance regarding the potential benefits and drawbacks of each system. The complexity of factors influencing approval times is not fully explored.
Sustainable Development Goals
The article highlights the need for faster drug approval processes in Germany, which would improve access to potentially life-saving medications and contribute to better health outcomes. Faster approvals would directly impact patients who need timely access to treatments, such as the Boehringer-Ingelheim lung cancer drug mentioned in the article. The faster approval processes in the US are cited as a benchmark, emphasizing the positive impact on patient well-being that such a system would have.