France Update: Nuclear medicine reform: what you need to know before June 1, 2023

We alerted you with an article of April 6, 2022 on the changes announced by the nuclear medicine reform.

As a reminder, this reform will enter into force from 1 June 2023 and the 2023-2028 regional health plans, which will take into account these new provisions, must be published no later than 1 November 2023.

In line with the decrees of 30 December 2021 and 1 February 2022, and the decree of 1 February 2022, an instruction relating to the activity of nuclear medicine care was published on 19 December 2022.

This instruction shall describe and specify the modalities for implementing the provisions applicable to the new nuclear medicine care activity.

REMINDER OF THE GRADATION OF ACTIVITY INTO TWO LEVELS AND ITS CONSEQUENCES

The instruction recalls that the use of radiopharmaceuticals (MRP) in the context of nuclear medicine activity entails particular constraints of use and that a gradation into two levels of nuclear medicine activity (grade A or mention B) was introduced by the reform.

The instruction specifies that this gradation is proportionate to the level of risk of the use of MRP used for diagnostic examinations and for the treatment of benign and malignant pathologies, and correlated with appropriate radiopharmaceutical control.

The instruction also provides details on the security of the radiopharmaceutical circuit by specifying the different composition of the teams working on each site marked A or B, and the contractual requirements in this area.

CLARIFICATIONS CONCERNING THE OBLIGATION OF THE AUTHORIZATION HOLDER TO PROVIDE QUALITY ASSURANCE

The instruction recalls that the holder of the authorization is subject to the quality assurance obligation defined in I of Article L. 1333-19 of the CPMP from the justification of the choice of the act, the optimization of the doses delivered to patients until the rendering of the result of this act.

As such, it must implement the following actions:

• A status of quality controls for medical devices provided for in Article R. 5212-25 of the CPMP;
• A status of the recording and analysis of events that may lead to accidental or unintentional exposure of people to ionizing radiation and serious adverse events associated with care mentioned respectively in Articles L. 1333-13 and L. 1413-14 of the CSP;
• Clinical peer audits.

In addition, the authorisation holder shall ensure that designation sites A and B must have equipment connected to an image archiving and sharing system (PACS) and a dose archiving and analysis system. 

FOCUS ON HOW TO OBTAIN THE INITIAL AUTHORIZATION AND ITS UPDATE

INITIAL AUTHORIZATION

The instruction recalls that an implementation of mention A or B must be available for the holder to submit his application file for authorization within the period of opening of the filing window opened by the ARS. This authorization is now issued by geographical site.

If the initial authorisation is issued for a platform of up to 3 pieces of equipment, the authorisation holder must have at least one PET scan or SPECT on the day of the application for authorisation. If he has only one of the two pieces of equipment, an agreement, which will be attached to the file, must be drawn up with another holder with the missing equipment. If the holder has the equipment at another site, an agreement is not required, however the organization between the two sites will be described in the application file.

UPDATING THE INITIAL AUTHORIZATION

The steps to be taken are as follows:

• From 1 to 3 pieces of equipment (base tray):

The following must be the subject of a simple declaration to the ARS:

• The addition of new equipment;
• Replacement with equipment of the same nature;
• The replacement of equipment by equipment of a different nature.
• From 4 to 9 pieces of equipment (which corresponds to the maximum number of pieces of equipment that an authorisation holder can hold at a geographical site):

Must be the subject of an amendment to the initial authorization¹ and an assessment by the Director General of the ARS who decides whether or not the modification calls for a new decision:

• The addition of new equipment;
• Replacement with equipment of the same nature;
• The replacement of equipment by equipment of a different nature;

For the addition of equipment above the threshold (4 to 9 EML), the licensee must justify its request. The DG of the ARS may authorize the said holder if the volume of acts, the specialization of the activity or the territorial situation justify it.

WHAT ABOUT EML AUTHORIZATIONS ALREADY OBTAINED?

When we published our previous article, we pointed out:

• that the reform did not provide for the automatic transfer of an EML authorisation already granted to a holder into a care authorisation;

• that the holders of the EML authorisations currently in force therefore had no guarantee that they would continue after the submission of a new application for authorisation to provide healthcare activities. They were only certain that they would continue to use their EML authorisations until a decision was taken on their new application for authorisation to provide healthcare activities to be submitted during the first filing window opened after the publication of the regional health plan.

These two points are confirmed by the instruction of 19 December 2022.

It specifies that the current PET and SPECT authorizations will be extended until the ARS decides on the new application to be filed during the first filing window opened after the publication of the SRS 2023-2028.

All current authorisation holders of “Scintillation camera with or without coincidence positron emission detector, emission tomograph, positron camera” will, during this first filing window, have to apply for a new authorisation for the nuclear medicine activity, mention A or B. If these holders do not submit a new application for authorisation, their authorisations will de facto fall on the date following the expiry of the first window for the submission of nuclear medicine authorisations.

For the sake of simplification, the instruction also specifies that the DGOS is currently finalizing a single application for dematerialized authorization, common to all ARS. This file will be adapted according to two situations: applicants who wish to continue their activity and applicants who create a nuclear medicine activity ex nihilo.

WHICH STRUCTURES CAN CARRY NUCLEAR MEDICINE AUTHORIZATIONS?

In our previous article, we alerted the current holders of gamma-camera and PET authorizations, structured in GCS of means, GIE or SCM, on the need to reorganize their activity by opting for a legal structure authorized to receive an authorization of care activity.

Indeed, during the preparation of the reform, it had been identified that those legal persons whose object is the pooling of the equipment necessary for the exercise of the activity of their members could not carry authorisations for care activities.

This point was confirmed by the instruction of 19 December 2022 in these terms:

“Professionals who carry out their activity thanks to the resources pooled within the framework of SCM, GIE or GCS of means will therefore, if they wish to continue to exercise their activity by sharing the equipment, group together under a new form of legal structure authorized to receive a care activity (e.g. private practice company [SEL], private limited liability company [SELARL], GCS health establishment, professional civil partnership [SCP])”

The ministerial instruction of 19 December 2022 thus included practice companies (SCP, SEL and SELARL) among the legal persons likely to hold an authorization for care activities, even though the corporate purpose of these practice companies is limited to “the joint practice of the profession”, which is necessarily more restrictive than the operation of a care activity.

The instruction also does not provide any details on other forms of SEL or on doctors’ cooperative societies. The issue of commercial companies is also being avoided, which is regrettable.

Ginestié Magellan Paley-Vincent, France, a Transatlantic Law International Affiliated Firm.  

For further information or for any assistance please contact france@transatlanticlaw.com

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