French simplifies regulations applicable to health care activity authorizations; health cooperation groups now entitled to hold healthcare activity authorizations

The French decree outlining the list of healthcare activities for which a health cooperation group (Groupement de Coopération Sanitaire - GCS “de moyens”) may hold authorization was published in the French Official Journal on December 31st, 2024. This decree is part of the broader healthcare activities authorizations reform initiated by Ordinance no. 2021-583 of May 12, 2021, which revised the healthcare activities and heavy equipment (Equipements matériels lourds) authorizations system.

The objective pursued by this reform is to simplify the authorization procedures and provide a better response to evolving patient care needs. Decree No. 2022-1237 of 2022, issued in application of the reform, amended the list of healthcare activities subject to authorization under article L6122-1 of the French public health code. New healthcare activities such as nuclear medicine and interventional radiology now require authorization from the regional health agency (ARS) with territorial jurisdiction. Previously, these activities were only covered under the    authorization procedure for heavy equipment (EML), which required authorization from the relevant ARS. 

The classification of nuclear medicine and interventional radiology as healthcare activities pursues two main objectives:

1. enhancing the safety and quality of care provided in departments offering these rapidly expanding activities. This is achieved by (i) setting minimum structural standards (e.g., the involvement of radiopharmacists and specific insurance requirements), (ii) promoting a patient-centered care pathway approach, and (iii) establishing requirements in terms of quality management, including the use of registers and vigilance indicators; 
2. improving the geographical offer of healthcare services by ensuring a coordinated and equitable spread of nuclear medicine facilities on the French territory. This aims to provide a comprehensive healthcare offering that is tailored to the specific needs of patients within a region.

However, this development directly impacts the ownership of these authorizations. Given that medical radiological equipment (MREs) are often costly, a significant proportion of MRE authorizations for nuclear medicine and interventional radiology are held by health cooperation groups (the so-called “GCS de moyens”). These entities facilitate the pooling of equipment, financial resources, human resources, and technical expertise, while also enabling cost-sharing—an important tool for ensuring collaborations between public and private healthcare operators. However, existing regulations did not allow health cooperation groups to hold authorizations for healthcare activities (with the exception of the authorization for biological activity in medically assisted procreation). The health cooperation group wishing to hold healthcare activity authorizations (except for those related to biological activities in medically assisted procreation). As a result, health cooperation group wishing to obtain any other healthcare activity authorization had to be restructured as healthcare establishments (GCS “établissement de santé”), subject to a more restrictive legal framework than that which applies to health cooperation groups.

Following the reform, the creation of healthcare activities to use EML required health cooperation groups holding EML authorizations to adopt a new legal structure authorized to hold healthcare activity authorizations (such as healthcare establishments, physicians private practice companies). In practice, this change significantly affected healthcare providers, forcing them to reassess their organizational structure in terms of material, technical, administrative, and financial aspects—an often complex process, particularly in cases of cooperation between public and private entities. 

To address this challenge, Article L6133-7 of the French public health code was amended by Law No. 2023-1268, known as the Valletoux Law. This law stipulates that a decree issued by the French Administrative Supreme Court would amend the list of healthcare activities for which a health cooperation group may hold authorization. Over a year after the new healthcare activity authorization regime came into effect, Decree No. 2024-1235, published on December 30, 2024, was adopted, adding nuclear medicine and interventional radiology to the list of healthcare activities that health cooperation group are authorized to undertake. While professionals in the sector had anticipated this inclusion, the lack of legal certainty had caused difficulties, particularly in preparing applications to the ARS for authorization to carry out healthcare activities, some of which were due to be submitted in 2024.

The long-awaited publication of this decree resolves this issue and reflects the legislator's desire to maintain a balance between flexibility for health cooperation groups and improving the overall healthcare offering.

The decree also sets out the conditions under which health cooperation groups may hold healthcare activity authorizations. Health cooperation groups wishing to do so must comply with the following requirements: 

1. drawing up a constitutive agreement that specifies the invoicing arrangements for care provided under the authorization. The agreement must also identify whether invoicing will be done by the group's members or by the group itself;
2. the request for authorization must be accompanied by a proposed scale of charges, which will apply if the group opts to bill for the care provided under the authorization;
3. the General Director of the ARS approves, in a single act, both the constitutive agreement of the health cooperation groups, and grants the healthcare activity authorization;
4. if the group invoices for the care provided under the authorization, it will be financed in accordance with the rules applicable to healthcare establishments. The same rules will apply to the remuneration of individuals or legal entities working on a self-employed basis within the group;
5. on the contrary, if the group does not invoice for the care provided under the authorization, the remuneration of the aforementioned individuals will be governed by the provisions applicable to health cooperation groups.

Should you have any questions regarding this update or the regulations applicable to healthcare structures and healthcare activity authorizations in France, please feel free to contact Mikael Salmela or Joséphine Pour.

Authored by Mikael Salmela, Joséphine Pour, and Léanne Fortuna