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France
transparency obligations overview

Latest update: 7 November 2018 | Important Notes

Report Due Date

Law: Semi-annually. (1 September for payments in first half of the same year; 1 March for payments in second half of the previous year)
Code: Refers to law

Authority

Law: Ministry of Health
Code: LEEM

Who Must Report

All health service and product providers

Covered Recipients

Healthcare professionals (HCPs), HCP students, HCP/HCP student associations, hospitals, foundations/ organisations in the healthcare sector, publishing companies (press, radio, TV, online media), editors of prescription or dispensing software, legal entities contributing to HCP trainings

Pharmaceutical Companies and Medical Device Companies

What is reported:

All agreements concluded, with the benefits (transport, accommodation, meals) procured and remuneration paid to HCPs/associations of HCPs/associations of patients/healthcare institutes.

On the transparency website; the public database “Transparency – Health” specifies, for each type of link of interest, the following information:

  • For conventions (e.g. participation in a congress as a speaker, transport and accommodation, research activity or clinical trials on a health product, participation in a scientific congress, training, etc.): The identity of the parties concerned, the date of the agreement, its precise purpose, the amount and the organizer, the name, date and venue of the event, if any
  • For direct and indirect benefits in kind and in cash (e.g. gift of equipment, meals, transport, accommodation, etc.): The identity of the parties concerned, the amount, the nature and the date of each benefit, provided that the amount of each benefit is greater than or equal to 10 euros inclusive of tax
  • For remuneration (services): The identity of the parties, the date of payment, the amount if it is greater than or equal to 10 euros. Where appropriate, the final beneficiary of the remuneration or benefit is informed by the company.
Important notes:
  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information reflects that most recent changes and is still applicable.
  • Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. (In such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency related to patient organizations (unless the patient organization is considered an HCO)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

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