Economic simplification act: long-awaited reform and positive developments for clinical research in France

Law No. 2026-403 of 26 May 2026 on the simplification of economic activity forms part of a broader effort to enhance France's economic attractiveness. While the law affects a wide range of sectors, several of its provisions are of particular relevance to stakeholders in the life sciences and healthcare research sectors.

The reform comes at a time when France is seeking to strengthen its competitiveness in the conduct of clinical trials and, more broadly, in attracting clinical research projects. For several years, industry stakeholders, particularly pharmaceutical and medical device companies, have pointed to national administrative requirements that are sometimes perceived as more burdensome than those applicable in other European Union Member States.

Against this backdrop, the law seeks to align the French framework with developments already observed at the European level. It aims to eliminate certain procedural rigidities and duplicative requirements for individual research projects, while adapting the regulatory framework to emerging research models, including decentralized clinical trials, studies involving the international transfer of human biological materials, and the growing use of health data for research purposes.

In this context, several developments deserve particular attention.

• A single authorization framework for the import and export of human biological materials for research purposes. Research sponsors may now import and export blood, organs, tissues, cells and their derivatives where such transfers are directly linked to a research project that has been authorized by the competent authority. This reform removes the administrative burden created by the previous dual-authorization process, under which sponsors were required to obtain (i) authorization from the competent authority to conduct an interventional study and (ii) a separate authorization from the ministry of research to import or export human biological materials for scientific purposes in connection with the same research project.
• Extension of biological sample conservation declarations to import and export activities. Organizations that have declared to the Ministry of Research activities involving the conservation and preparation of human biological samples for their own research programs are no longer required to obtain an additional authorization to import or export human body elements and products. Such activities are now covered by the initial declaration relating to the conservation of biological samples.
• Recognition of decentralized clinical trials and creation of “research territories”. The law amends the rules governing research sites by expressly recognizing the possibility of carrying out certain research activities at participants' homes or in appropriate local facilities. In addition, multiple stakeholders may join together within a “research territory” in order to coordinate research activities under a common contractual framework. University hospitals (CHU) may therefore rely on teleconsultations, medical laboratories and self-employed healthcare professionals providing home-based care to create coordinated local networks capable of supporting patient follow-up and treatment activities, while reducing travel requirements for participants, particularly in areas located far from traditional research centres.

These provisions provide a legal basis for developments that have already been emerging in practice for several years. Decentralized and hybrid trial models are increasingly regarded as important tools for improving participant recruitment, reducing travel-related constraints and enhancing patient access to clinical research.

This legislative recognition therefore represents an important step in the modernization of the French clinical research framework, although its effectiveness will largely depend on the practical implementation of these measures and on forthcoming implementing regulations.

• Strengthening the role of hospital pharmacies in clinical trials. The reform expands the responsibilities of hospital pharmacies (pharmacies à usage intérieur – PUI) by allowing them, under certain conditions, to supply non-commercial research sites and, where provided for in the protocol, dispense medicinal products directly to participants at home. These measures naturally complement the development of decentralized clinical trials. They are intended to provide greater legal certainty for supply and distribution channels while offering increased flexibility in the organization of research activities. For sponsors, they may result in significant logistical simplification, particularly in studies involving remote visits or participants located far from investigational sites.
• Streamlining health data research requirements. The law also adapts the framework applicable to the processing of health data for research, study and evaluation purposes by expanding the role of CNIL reference frameworks. These frameworks are now positioned as the primary benchmark for health data processing carried out for research purposes, while individual authorization procedures are intended to become increasingly exceptional. Although this development largely reflects existing practice, the adoption of additional reference frameworks should provide sponsors with greater granularity and legal certainty regarding the rules applicable to their research programs. The law also introduces certain simplifications regarding the reuse of data previously collected in the context of healthcare delivery or earlier studies. In such cases, the legislator favours a framework based on information of the individuals concerned and the exercise of a right to object, rather than requiring the collection of renewed consent. This development may be particularly beneficial for real-world evidence studies, registries and certain retrospective studies relying on pre-existing datasets.

The changes introduced by the Economic Simplification Act have long been awaited by stakeholders in the sector. While they do not address all of the operational and regulatory challenges regularly identified by sponsors seeking to initiate research programs in France, they nevertheless represent a significant step towards a framework that is better aligned with the realities of modern clinical research.

By formally recognizing decentralized clinical trials, facilitating certain transfers of biological materials, strengthening the role of hospital pharmacies and streamlining requirements applicable to health data, the legislator has addressed several issues that have long ranked among the sector's priorities.

Although the practical impact of these reforms will continue to depend on forthcoming implementing measures, future CNIL reference frameworks and the manner in which competent authorities support their implementation, the overall direction is clearly positive. The law sends a strong signal in favour of a more agile, patient-centric clinical research environment that is better integrated into international healthcare innovation ecosystems.

Next steps

Several of the measures introduced by the Act still require implementing regulations to clarify their practical application. The content of these measures will be critical in determining the actual scope of certain reforms, particularly those relating to research territories and the organization of decentralized clinical trials.

Beyond these regulatory developments, the effectiveness of the announced simplifications will also depend on the approach taken by the competent authorities in implementing these new mechanisms. In this regard, the CNIL has already begun modernizing its framework applicable to health research by publishing, on 26 May 2026, updated versions of its Methodologies of Reference (MR-001 and MR-003), whose scope has notably been expanded to reflect evolving research practices and the growing use of digital technologies.

You may also wish to consult our previous article discussing the recent developments to MR-001 and MR-003.

Authored by Mikael Salmela, Joséphine Pour, and Gauthier Zimmer.