Life Sciences and Healthcare

Object: Preventing HCPs from receiving any benefit, in cash or in kind, in any form whatsoever, either directly or indirectly, from HCC.

 
Object: Disclosing publicly links of interest, including advantages, between HCPs/HCOs and HCC.

Purpose: Preventing influence of companies on the way HCPs perform their activities (e.g. prescription, purchasing, etc.).

Purpose: Allowing citizens to appreciate in all objectivity the nature of the relationships that link the health industries to HCPs/HCOs.

Only benefits compliant with the Anti-gift regime can be granted and therefore disclosed under Transparency requirements. Both systems have a slightly different scope of application and different reporting modalities.

• Healthcare professionals, i.e. professionals working in the healthcare sector and whose profession is regulated by the French Public Health Code (“PHC”);
• Students and persons following trainings in the healthcare sector;
• Associations of HCPs and students; and
• Public officials who participate in public health or social security policies and/or have authority to rule in health-related matters.

The French Anti-gift regime only applies to HCPs and HCOs established or exercising their activity in France.

• Companies that produce (even in the context of clinical trials) or market products for human health purposes – e.g. drugs; contraceptive and contragestive products, biomaterials and medical devices; in vitro diagnostic medical devices; tissues, cells and products of human or animal origin; cellular products for therapeutic purposes; software to assist in prescribing and dispensing; etc.
• Companies providing healthcare services such as public and private hospitals as well as biomedical laboratories.

The French Anti-gift regime applies to all HCC, whether or not they are established in France and whether or not their products or services are produced, operated or marketed in France.

It does not apply to companies producing and marketing cosmetic products. However, if a company produces or markets both cosmetics and products for human health purposes, it falls within the scope of the French Anti-gift regime.

Article L.1453-5 of the French PHC prohibits HCCs, as defined here above, from offering or promising benefits in cash or in-kind, in any form whatsoever, directly or indirectly, to HCPs and HCO.

By way of derogation, certain benefits can be offered subject to strict conditions and formalities and if they are in relation with the professional activity of the HCP/ HCO*:

• Fees or payments in relation to research, consulting and, more generally, service agreements, provided that the fees are proportional to the service rendered;
• Benefits, in cash or in kind, for research, research valuation or scientific assessment activities;
• Prizes or competitions to reward scientific research;
• Benefits to HCPs associations, except in case the main purpose is unrelated to the professional activity;
• Hospitality provided during promotional, professional or scientific events, provided that the hospitality is reasonable, limited to the main professional and scientific objective of the event, and is not extended to persons other than HPCs;
• Hospitality cannot be provided to students and associations of students.
• Funding to promote continuing medical education.

* wine bottles, chocolates, art objects, museum tickets, etc. are not considered to be in relation with the professional activity of a HCP and are therefore prohibited.

• Fees, discounts and advantages linked to an employment contract or certain commercial agreements for the supply of goods or services;
• Royalties and IP related payments;
• Benefits of “negligible value”.
   
  Certain in-cash or in-kind benefits are considered as benefits of “negligible value” if they are related to the exercise of the beneficiaries' profession and if their market value is below or equal to an amount which varies depending on the nature and the frequency of the benefits:

€20 up to a maximum of three/calendar year

with some exceptions i.e., the following are authorized with no limit of amount:

1. Medicinal products samples;
2. Health products samples and demonstration products provided for educational or training purposes for HCPs and which cannot be used as part of the patient's care;
3. Health products samples and demonstration products used by HCPs for educational purposes with the patient or provided to the patient exclusively for the purpose of testing or adapting the product and for temporary use
   
   

€20 in total/calendar year

with some exceptions i.e., products whose supply to HCPs is requested by a public authority are authorized with no limit of amount

Granting any of the listed benefits is subject to the conclusion of an agreement between the HCC and the beneficiary.

The agreement must include:

• identification of both parties;
• date and purpose of the agreement. A typology of agreements is defined by ministerial order. For instance, agreements concluded in the context of research activities should be designated as “scientific assessment contract” or “scientific research contract”;
• type and amount of the benefit granted, according to a thematic typology. For example, in the context of a research contract, the typology of benefits is remuneration, compensation, gift, etc.

In specific situations, the agreement shall also include:

• for benefit granted in the context of a scientific event, the program of the event;
• when several benefits are granted at a time, the agreement must contain the individual amount of each benefit and, where appropriate, the cumulative amount of such benefits;
• when a benefit is granted to a public official / a HCP working in a public hospital, the authorization to perform an additional private activity;
• for research or scientific evaluation activities, a summary of the research protocol.

The requirement for prior notification to the relevant professional board is replaced by either (i) a prior declaration or (ii) a prior authorization depending on the amount provided to the beneficiary.

The French PHC sets, for each category of beneficiaries (HCPs, students and associations) and each category of agreements (remunerations, donations, hospitality, etc.), the applicable threshold (i) above which a prior authorization is required and (ii) below which a mere declaration is sufficient.

This prior declaration/authorization's request is made before the relevant ethic board (if any) or the relevant regional health agency (agences régionales de santé, ARS), depending on the beneficiary involved.

It shall include the entire agreement entered into with the HCP / HCO.

The table hereafter summarizes the applicable thresholds. 

 
€200/hour
(up to €800/half-day and up to €2 000 for the entire agreement)

Hospitality offered during scientific/professional events or promotional events

The amounts are all taxes included.

€150/night
€50/meal
€15/snack
and €2 000 for the entire agreement including travel costs. 

Registration fees can be paid in addition. They are subject to authorization if they exceed €1 000.

Submission at least two months before the day the benefit shall effectively be granted.

Three weeks in case of an emergency.

Within one month, if the submission is not complete, the competent authority may put on hold the process of authorization in waiting the communication of the missing documents.

After two months of silence from the competent authority, the agreement is deemed to be authorized.

In the event that the competent authority refuses to approve the agreement, the grantor of the benefit may amend the agreement and submit for a new authorization within three weeks or one week in case of an emergency.

Please note that the decision can be challenged before French courts.

Submission at least eight business days before the day the benefit shall effectively be granted.

The competent authority might issue recommendations to the parties on the definition of benefits, their amount or the content of the agreement itself. The recommendations are not binding but they should be taken into account by the grantor.

Two dedicated on-line systems are currently available:

• IDAHE, for submissions to the Conseil National de l’Ordre des Médecins, “CNOM”, the French Physicians Board;
• Ethique des professionnels de santé, for submissions to the other HCPs’ ethic boards (if any) and the regional health agencies.

In case of non-compliance with the Anti-gift regime, the following criminal sanctions apply for entities or persons that offer illicit benefits:

• Two years of imprisonment;
• a fine of up to €150,000. The amount of the fine can amount up to 50 per cent of the expenses incurred for the grant of the illicit benefit.