Regulatory Update: French Transparency Report Template Revisions

By Benoit Racault

On December 30, 2016, the French Ministry of Health released a new decree that significantly impacts French transparency reporting.

France has long been the leader in Europe for increasing transparency in the life sciences sector, and this recent reform furthers the already significant reporting and disclosure obligations of life sciences companies interacting with French healthcare professionals (HCPs) and healthcare organizations (HCOs).

Since 2013, the “Loi Bertrand” has required life sciences companies in France to disclose the existence of agreements with, and direct or indirect monetary “benefits” of 10€ or more given to, HCPs/Os.  The law does not explicitly define “benefit” however an explanatory document provides a list of examples including gifts, free medical equipment, donations (to HCOs), hospitality (e.g., meals, travel, accommodations), rebates, discounts, and reimbursement of costs (excluding those provided in purchase of goods or provision of services agreements).

The new decree significantly expands the scope of reportable spending as it now requires the disclosure of all fees related to agreements with HCPs/Os.  For example, if an HCP is hired to serve on an advisory board the company would previously disclose the value of travel, meals and/or accommodations provided to the HCP if they were 10€ or more.  However, under the new law, life sciences companies will now be required to disclose the fee the HCP received for participating in the advisory board.

More specifically, life sciences companies are required to disclose the following: (1) purpose of the contract if it is not on the official list, (2) total contract amount, (3) date of payments, (4) interim remuneration amount (if any) and (5) the contract ID related to the remuneration.

This new decree will take effect on July 1st, 2017 and will apply to spending since January 1, 2017.  Companies are required to report each March 1st regarding spending from July-December of the previous calendar year, and each September 1st regarding spending from January to June of the same calendar year.  Thus, for 2017 the first reporting date will be September 1st, 2017 (on data from January-June 2017). Veterinarians will soon be required to disclose fees for services, but a separate decree is expected to address this issue soon.

Polaris is updating its STAR (Spend, Tracking, Analytics and Reporting) Solution reports to address these new requirements.

For information on Polaris’ solutions and how they can help you stay compliant with this and all global regulations, contact us.