The regulation of healthcare products is at the heart of public policies aimed at guaranteeing equal and sustainable access to medical innovations. Faced with a surge in expensive, targeted treatments, France is facing major challenges: reconciling public health requirements with financial sustainability and environmental imperatives. Against this backdrop, the mission entrusted by the Prime Minister in August 2023 offers a comprehensive analysis of existing tensions and proposes concrete solutions for a balanced future. This article presents the main findings of the report, and invites healthcare professionals to consult the full study for an in-depth understanding.
Major trends impacting the regulation of healthcare products
The rise of costly, targeted innovations
The development of cutting-edge treatments, particularly biotherapies and personalized medicines, is redefining regulatory paradigms. These innovations, often focused on restricted populations, are driving up unit costs significantly. While these treatments offer revolutionary therapeutic prospects, they also raise questions about their universal accessibility and their impact on the financial sustainability of healthcare systems.
The tension between financial sustainability and equitable access
Regulating the prices of healthcare products is a complex task. On the one hand, it must guarantee access to treatment for all patients, whatever their income or place of residence. On the other, it must preserve public budgets. The report highlights these growing tensions, exacerbated by an ageing population and an increase in chronic pathologies.
Emerging environmental issues
The production and distribution of healthcare products have a significant impact on the environment. From CO2 emissions to impacts on biodiversity, healthcare professionals and regulators must now integrate environmental sustainability into their decisions. This challenge adds to an already complex list of regulatory objectives.
Recommendations for a “New Deal” in healthcare
Faced with these challenges, the report proposes a “New Deal” for the regulation of healthcare products. This concept is based on a balance between health, industrial and ecological priorities, taking into account the specificities of France and Europe.
Rebalancing health, industrial and ecological priorities
The report recommends better alignment of public policies to support innovation while controlling costs. For example, it suggests strengthening price negotiation mechanisms with manufacturers, while supporting the development of generics and biosimilars to reduce budgetary pressure.
Enhancing transparency and cooperation
Better collaboration between regulators, industry and public health players is essential to anticipate future challenges. The report stresses the importance of transparency in pricing and evaluation processes, in order to strengthen public and professional confidence.
Focus on economic regulation and its impact
Tensions over prices of innovative drugs
Innovative medicines, although effective, pose major problems in terms of cost regulation. The report highlights the major discrepancies between the production costs and sales prices of certain treatments, creating pressures on the financing of healthcare systems.
The key role of generics and biosimilars
Generics and biosimilars are strategic solutions for balancing expenditure. They help maintain access to care while reducing costs. However, their uptake remains uneven, requiring more robust incentive policies to stimulate their use.
The environmental dimension of regulation
Towards sustainable production of healthcare products
The report highlights the urgent need to integrate environmental criteria into the regulation of healthcare products. This includes promoting responsible supply chains and reducing the carbon footprint of pharmaceutical production.
Limiting the impact of distribution chains
Distribution chains account for a significant proportion of greenhouse gas emissions in the healthcare sector. The report proposes measures to optimize logistics, reduce distances travelled and promote the use of less polluting modes of transport.
Conclusion
The report of the mission on the regulation of healthcare products offers a comprehensive analysis of the challenges and opportunities facing the sector. By simultaneously tackling the issues of innovation, accessibility and sustainability, it proposes concrete solutions for a balanced future. This “New Deal” in healthcare calls for a rethink of current models to ensure a sustainable, fair and efficient system.
For a detailed view of the recommendations and figures, we invite healthcare professionals to consult the full study. Access the report and explore the avenues for reflection to actively contribute to the transformation of our healthcare system.
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