Have you Notified CNOM of Any Agreements with Healthcare Professionals?
REMINDER – In June 2013 we informed you of new disclosure requirements which were implemented by Decree No. 2013- 414 dated 21 May 2013 lays down the implementation provisions of Article L.1453-1 of the CSP. These new provisions will come into effect on 1st June 2013. At this date, the companies will have to disclose all the agreements signed and advantages granted in 2012.
According to the provisions of new article L.1453-1 CSP, pharmaceutical companies must now disclose the existence of agreements that they concluded with:
- Healthcare professionals,
- Associations of healthcare professionals,
- Students in medicine and odontology,
- Associations of patients,
- Health establishments,
- Press organs for health professionals for all media (press, radio, TV or online communication);
- Medical prescription and deliverance software editors;
- Learned societies.
Each company must disclose the information for each agreement concluded.
Above a limit of 10 euros all taxes includes, the obligation of disclosure also applies to the advantages in nature or in money granted directly or indirectly by pharmaceutical companies to the above listed recipients. Consequently, all advantages granted to persons listed above that are above 10 euros will have to be disclosed.
The said information will be disclosed in French on a unique public website held by an authority to be created by an order of the Ministry of Health.
The companies will have to transmit the above-mentioned information to this authority within 15 days from the execution of the agreement and at least on 1st August of each year for the advantages granted during the 1st semester of the year and at least on 1st February of each year for the advantages granted during the 2nd semester.
The authority must then disclose the information on the website for the 1st semester of the year on 1st October and for the 2nd semester on 1st April.
Before the establishment of the relevant authority, a transitional period is put in place. For the time being, the information will be disclosed on the website of the relevant professional society of the healthcare professional (if a physician, on the website of the Medical Doctor Society) or on the website of the company if no relevant professional society exists. A professional syndicate may also take the responsibility to disclose this information for its members.
Regarding the agreements concluded and the advantages granted in 2012, the companies have to transmit all relevant information before 1st June 2013. The information shall be made available on the website of the professional societies, of the professional syndicates or of the companies at least on 1st October 2013.
This CNOM procedure is described on the CNOM website:
- Paule Drouault-Gardrat and Juliette Peterka, PDG Avocats
- Benedicte Bonnet, Senior CN CRA, inVentiv Health Clinical