LEEM DDP 2025, what you need to know from the new updates
November 6, 2025
In June 2025, Leem published the new version of its Dispositions Déontologiques Professionnelles ("DDP"), which includes several improvements for the ethics of the pharmaceutical sector, adding to the June 1, 2021 version, Codeem's responses on the deontological and ethical framework for relations between drug companies and Patients and Patient Associations and on the practice of immersions of drug company employees in healthcare services.
This new version will come into force on January 1, 2026, with the exception of the maximum amount of 70 euros (incl. VAT) for meals granted in France and the prohibition on the person interacting with the Patient or Patient Association to engage in any commercial or promotional activity within the company, which came into force on the date of adoption of the PDDs.
The main changes brought about by the 2025 PDDs :
Theextension of major ethical principles and general rules to Patients and Patient Associations
Immersions of pharmaceutical company employees in care departments
The new RFPs also allow us to update a number of regulatory provisions and modify some terminology that has become obsolete.
Extending the rules to patients and patient associations
Ethical principles" applicable to patients and patient associations (chapter 2, 1.4 of the PDD)
Provisions relating to specific ethical principles applying to relations with patients and patient associations, previously included in chapter 6 of the PDD, have been incorporated into the chapter on major ethical principles. This change enables these provisions to be elevated to the rank of major principles, in the same way as those applicable to healthcare professionals. They include several requirements:
Interactions such as sharing information or setting up a project must have as their sole purpose the search for expertise or the sharing of experience or knowledge.
Relationships must not have as their object or effect the marketing and/or promotion of a drug.
The prohibition of commercial or promotional activities within the company by the person who interacts with the Patient or the Patient Association.
Transparency of the objectives and scope of any collaboration.
Clear and express identification of all financial and non-financial support provided by companies, both on their part and on the part of the Patient or Patient Association.
The prohibition on demanding to be the sole supporter of a Patients' Association or one of its programs because of the independence sought by them.
Respect for the independence of Patients and Patient Associations in terms of opinion, freedom of speech and choice (of policy, strategies and activities, etc.).
Preventing any risk of companies influencing patients and patient associations.
Taking into account the patient's potential vulnerability in all circumstances.
Extending general rules to Patients (chapter 4 of the PDD)
Among these general rules extended to Patients are :
Rules applicable to events and hospitality,
A general ban on gifts to patients,
The definition of who can interact with Patients and Patient Associations, as interaction with a Patient cannot be associated with a commercial or promotional approach,
The possibility of remunerating Patients in compliance with applicable regulations,
Transparency of financial links.
Immersions of pharmaceutical company employees in healthcare departments (Chapter 9 of the DDP)
Located in the new Chapter 9 of the PDDs, these rules govern the immersions of pharmaceutical company employees in hospitals, clinics and GP surgeries.
Please note: Immersion refers to interaction between an employee of a pharmaceutical company and at least one healthcare professional, with or without the presence of the Patient.
This immersion can take place :
Within a care service designed to receive Patients (inpatient clinical departments, consultation departments and offices, etc.).
In a healthcare support department (biology or radiology laboratories, etc.).
The aim is to enable the person immersed to acquire the knowledge or know-how required for his or her professional activity, and to familiarize him or herself with the site and the way the services operate.
Please note! Immersion does not include "normal medical promotional information activities". In immersions, employees of pharmaceutical companies come for training.
Immersions in a department with Patients
Pharmaceutical companies must not carry out immersions in the presence of the Patient in the departments of hospitals, clinics, doctors' surgeries or in any consultation. Patients' rights must be respected (medical confidentiality, patients' wishes, personal data).
Immersions in a care support department
They can only be set up if two cumulative conditions are met:
The company systematically questions the purpose and relevance of this immersion,
The company ensures that, in practice, the only purpose of this immersion is to familiarize employees with the role of these services in the healthcare process. It cannot therefore be carried out in parallel with promotional actions, contacts or the transmission of scientific information.
To find out more...
The new Leem RFPs for June 2025 and the Q&A on these RFPs are available here :