As a reminder, the “Transparency” scheme, provided for in Articles L. 1453-1 et seq. and R. 1453-4 of the French Public Health Code (“CSP“), requires healthcare manufacturers to declare certain agreements, remuneration and other benefits granted to various actors in the healthcare sector on a single public website (“Health Transparency Database“, which is the translation of “Base Transparence – Santé” in French).
A few weeks after a new version of the Health Transparency Database went online in January 2022, the decree of March 15, 2022, published in the Official Journal of March 26, 2022 and applicable since March 27, 2022, has modified the “Transparency” scheme.
Compliance with the RGPD
Secure transmission of information by the manufacturer
Prior to the entry into force of this decree, manufacturers could send their electronic declarations to the authority responsible for the Health Transparency Database, i.e. the Minister of Health, in one of three ways, as chosen by the companies:
- An online entry on a form available on the Health Transparency Database;
- Online filing of a file on the Health Transparency Database;
- Automatic transmission via a webservice.
From now on, it is no longer possible to submit a file online to the Health Transparency Database.
Rights of the beneficiaries of the benefits on their information transmitted by the manufacturer
Prior to the March 15, 2022 Order,, in the event of a request for access to or rectification of data by the beneficiary of the benefit, the minister of health was required to put the requestor in touch with the company that transmitted the information concerned :
- either by providing the contact details of the operational contact(s) of the company concerned ;
- or by providing a link to the right of access and rectification section on the company’s website when this section exists.
The Order of March 15, 2022 eliminates the second possibility. From now on, in the event of a request for access or rectification of data by the beneficiary of the benefit, the Minister of Health will put the applicant in touch with the company that transmitted the information concerned, indicating the details of the operational contact(s) of the company concerned. The company will be informed of the transmission of this information to the applicant by the Minister.
Harmonization with the “anti-gift” thematic typology
The thematic typology of agreements and benefits initially provided for by the “Transparency” scheme was modified by the Order of March 15, 2022. This modification follows the entry into force of the new “anti-gift” scheme on October 1, 2020, which lists the thematic typology of agreements and benefits that may, under certain conditions, be offered or promised by manufacturers to healthcare professionals, students or associations grouping them together (see our article of September 30, 2020) [1].
In order to ensure consistency between these two schemes:
- the benefits that must be declared on the Health Transparency Database are now listed in a different way from the agreements;
- the thematic typology of agreements and benefits provided for by the “Transparency” scheme uses the headings of the thematic typology provided for by the “Anti-Gift” scheme.
It should be noted that the “scientific evaluation contract”, a category provided for in the “anti-gift” scheme, has just been introduced into the “Transparency” scheme.
The typology set by the Order of March 15, 2022 is not exhaustive. While we recommend that manufacturers respect the different categories as much as possible, it is still possible to provide for a different purpose or type of benefit.
[1] Order of September 24, 2020 on the thematic typology of benefits and agreements pursuant to Article R. 1453-14 of the CSP.
GD Avocats advises manufacturers on issues related to “anti-gift” and “Transparency” schemes. Contact us by e-mail : contact@gd-associes.com
