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Contributions of the Economic Life Simplification Bill to the Legal Framework for Health-Related Research

The Draft Economic Life Simplification Bill, passed by the French National Assembly on June 17th, 2025, seeks to promote French innovation in the healthcare sector by easing both the practical conditions for conducting researches in France and the administrative formalities that accompany it.

Indeed, the very name of the title - “Simplify to Innovate”- captures this ambition. The key question, of course, is whether it will succeed.

Let us start with the particularly complex rules governing researches that re-use human biological samples.

Currently, only organizations specifically authorised by the French Ministry of Higher Education and Research (MESR) may :

  • import or export, for scientific purposes, human tissues or cells to or from an EU or EEA Member State (Article L. 1245-5-1 I, paragraph 4 of the French Public Health Code) ;
  • import or export, for scientific purposes, those same materials to or from a third country outside the EU/EEA, including any derivatives (Article L. 1245-5-1 II, paragraph 4 of the French Public Health Code).

Many stakeholders regard this authorisation as redundant, because the French Ethics Review Committee (Comité de protection des personnes – CPP) already assesses the scientific and ethical relevance of projects that create biological-sample collections in the course of a human-subjects study (Article L. 1123-7 of the Code).

Article 22 of the draft bill therefore simplifies the formalities for sponsors of research involving human participants by allowing them to import or export the biological samples they need without any additional paperwork.

On June 13th, the French National Assembly adopted two identical amendments (no. 1951 and no. 2559) aiming at eliminating for authorised or declared organizations (Articles L. 1243-3 and L. 1243-4 of the French Public Health Code) to submit import and/or export-authorisation requests for human biological samples.

This regime would partially resolve a long-standing bottleneck that has hampered and slowed research founded on the extraordinarily rich data contained in biological samples.

The bill also opens the way for certain research procedures to be carried out at the participant’s home, in a private office or in any other nearby location, thereby authorising decentralised trials.

In practice, a nurse will be able to collect a sample at home, a follow-up examination may take place in a health setting, and the dispatch of medicinal products from the hospital pharmacy will continue to be covered by a specific logistics agreement (Article L. 1121-1 et seq. of the French Public Health Code).

Monitoring and quality assurance may likewise be performed remotely via secure platforms, which must of course comply with personal data protection principles (encryption, strong authentication, logging, back-ups, etc.). The bill also introduces the concept of a “research territory”—a single contractual framework for bringing together a local network of hospitals, healthcare centres and public actors around a common trial strategy. Such simplified governance should speed up the opening of new sites and encourage regional multicentre studies.

In the post-pandemic climate, these provisions are timely and fall within the context of the work conducted by the CNIL, which on May 16, 2024 published Good practices for remote quality control of clinical-trial data. That guidance reminds us that a quality-control officer may access only the individual data needed for that control and sets out the requisite safety safeguards.

Finally, the draft bill provides that applications for authorisation of studies, evaluations or research not involving human participants that have already received a favourable opinion from a local scientific and ethics committee may be exempted from prior review by the national CESREES committee, under conditions to be laid down by a decree issued after consultation with the CNIL.

All of these measures appear highly effective, and we can only hope that the final version of the Economic Life Simplification Bill retains them. We will, of course, be watching closely to see how they are implemented.

Read the record of the parliamentary debates ➡ here.
Consult the provisional version of the bill as adopted by the French National Assembly ➡ here.