Prohibition of patient benefits, remuneration, digital tools: what the Leem 2025 DDPs are likely to block

While the new Leem 2025 DDPs demonstrate a desire to better regulate interactions with patients and their associations, several provisions raise questions: the risk of blocking digital tools, difficulties in remunerating patients, practical gray areas, etc. Here is an overview of what could hinder, rather than promote, collaboration.

In June 2025, Leem published a new version of the Professional Ethical Standards ("PES"), which came into effect on January 1, 2026.

Among the major developments, greater attention is being paid to patients and patient associations, which are now fully integrated into the field of pharmaceutical ethics (see our article on this point: LEEM 2025 DDP, key points to remember from the new updates).

Extending the rules to patients and patient associations

Until now, DDPs mainly concerned relations with healthcare professionals. They now apply more broadly to relations with patients and patient associations. Certain general rules of DDPs therefore become applicable to them.

Among these general rules extended to patients are:

• Rules applicable to events andhospitality,
• The prohibition of gifts,
• The definition of persons who may interact with patients and patient organizations, outside of any commercial or promotional activity.
• The possibility of remunerating patients in accordance with applicable regulations,
• The requirement for transparency in financial relationships.

While the stated intention is to provide a framework for interactions with patients and their associations by specifying the scope of possibilities, some of these principles raise questions about their real impact on patients.

By seeking to strengthen transparency and ethics, Leem's DDPs paradoxically risk hindering collaboration between laboratories and patients. While case law calls for better information and smoother interaction, particularly in terms of risk management, the current ethical framework appears out of step and at odds with the issues at stake.

‍

The ban on "gifts": implementation that did not incorporate digital information tools

‍

A principle prohibiting the offering of gifts

Gifts, whether direct or indirect, for the personal benefit of patients or representatives of patient associations are therefore now formally prohibited.

So no more courtesy gifts, non-professional assistance, or gift certificates given as compensation for time spent.

Every rule has its exceptions.

However, the DPPs do allow certain benefits. Information materials and medical items intended directly for the patient's care and whose value does not exceed €60 including tax are permitted.  

These may include books, publications, magazines, or subscriptions, provided they meet the above conditions.

Please note that these informational materials and medical devices, while they may bear the company name, must not bear the product brand name, unless this is necessary for their correct use.

Digital tools, the forgotten elements of the system

However, this framework raises the question of financing or co-financing the development and provision of digital information and support tools for patients, the costs of which exceed €60 including tax.

Under these circumstances, should we refrain from such projects?

The development of compliance support applications, digital companions, or patient monitoring tools very often exceeds the thresholds set for development costs. The DDPs do not specify how to reconcile these innovations with the ethical framework, nor how the cost of development and provision to patients should be approached.

It is regrettable that these elements, which are essential to a truly "patient-centered" approach, have not been included. It would be welcome if Leem could provide further clarification on these points.

‍

Patient remuneration: implementation still unclear

‍

Similarly, the DDPs reiterate thatno financial compensation may be paid for the mere presence of a patient or representative of a patient association at an event.

However, a service contract may be concluded between the company and the patient or representative of a patient association, under which they provide services to the company, provided that:

• These services are intended to contribute to healthcare, research, or training, and
• The patient should not be encouraged to recommend and/or prescribe, purchase, supply, sell, or administer medications.

In this context, remuneration must be provided for in the contract, in monetary form, and comply with the applicable regulations.

But in practical terms, how can this be done?

In practice, one question remains: how can a patient who is not an entrepreneur and is not formally structured to bill for services be remunerated or compensated?

With direct financial compensation and gift certificates now prohibited, contractual services appear to be the only recourse, at the risk of complicating patient participation in laboratory projects.

Here too, clarification would be welcome, particularly regarding:

• secure business practices,
• prevent the cumbersome nature of the framework from discouraging patient involvement,
• and enable genuine recognition of their expertise.

‍

By extending the scope of DDPs to patients and their associations, Leem is establishing a necessary ethical framework for interactions between laboratories and patients. However, without sufficient detail on highly operational issues—digital tools, valuing patient time, practical payment arrangements—this framework risks achieving the opposite of the desired effect: hindering collaboration rather than encouraging it.

It is not only pharmaceutical companies that are affected: it is an entire ecosystem—patient associations, start-ups and digital health companies, specialized service providers—whose projects are likely to be challenged, slowed down, or even blocked when it comes to compliance. Faced with legal and ethical uncertainty, laboratories will automatically tend to reduce their funding and support for these forward-looking projects, which are nevertheless at the heart of a truly "patient-centered" approach.

The coming months will therefore be decisive: they must enable Leem, pharmaceutical companies, and patient representatives to clarify these gray areas in order to secure practices without undermining innovation, and to build genuine partnerships that are compliant, sustainable, and truly useful to patients.

‍

‍

‍