French Plans to Cut Spending Through Off-label Medicines Jeopardizes Patient Safety and Challenges EU Regulatory Standards
The European Confederation of Pharmaceutical Entrepreneurs is very concerned about legislative developments on the use of off-label medicines in France.
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is very concerned about legislative developments on the use of off-label medicines in France. This week, the lower house of the French Parliament, the Assemblée nationale, voted on a draft law which would broaden the use of off-label medicines, even if on-label medicines are available. The proposal, which explicitly aims reducing the health insurance system’s spending, has now to be approved by the upper house of Parliament, the Sénat, before being formally adopted.
While the off-label use of medicines is appropriate for medical reasons – for example in pediatric care when no on-label treatment is available – concerns are growing that European doctors are being pushed to prescribe off-label medicines to reduce spending. Medicines used off-label are not systematically tested to the same stringent standards for the off-label indication that is required for authorized medicines. Member States promoting off-label use purely for economic reasons therefore put patients at unnecessary risk.
Furthermore, the promotion of off-label use for economic reasons undermines the innovative potential of all pharmaceutical companies in Europe and especially in France. In particular, small to medium-sized companies and those developing orphan medicinal products for rare diseases will be impacted by these developments. The French law counteracts ongoing efforts funded by Member States to boost innovation and research in Europe.
EUCOPE Secretary General Alexander Natz said: “The proposed French legislation not only conflicts with EU law and poses a significant impediment to our highly innovative members but most importantly puts patients at risk. We therefore call on the European Commission to stop national developments infringing EU law. We must adhere to the highest standards of patient safety enshrined in the EU’s regulatory framework and have to ensure that the use of medicines is driven by patients’ medical needs rather than budget considerations.”
For questions please contact [email protected]
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
