Nevertheless, this body of rules might be amended again soon,
with a new draft order released recently by the Ministry of Social
Affairs and Healthcare. In view of the modifications it proposes,
the regulation of these issues seems to be moving in three
Simplification in both the form and substance of the applicable
regulation, which concerns, essentially, the health care providers
(HCPs) whose agreement(s) with a health care company have to be
published: the new text shall simply refer to the current article
L.1453-1 of the French Public Health Code, which provides a list
substantially similar to the existing one. It also plans to remove
some pieces of the information the laboratories are required to
make public (qualification, title, college register number,
event's schedule...). In other words, same substance but less
detail. It is important to keep in mind that the amount of the
payments made to HCPs through these agreements does not
need to be disclosed under French law.
Regarding the website where the declaration of interests should
be made, the Sunshine Act sets forth that personal data of the HCPs
(data that would allow, according to EU regulation, the
identification of HCPs either directly or indirectly) is
to be protected against indexing on search engines. The draft order
reduces the scope of such protection, maintaining only protections
of the "directly identifying data" against this
type of indexing.
Last but not least, the main purpose of the draft is obviously
to change the schedule initially set up to declare the benefits and
the conventions: it removes the existing 15-day deadline after the
signature of the convention, and allows the advent of a biannual
schedule. The draft order goes even further by postponing the
declarations regarding the benefits granted in 2012 and 2013 to
August 2015, and its publication on the unique website to October
2015. In the meantime, rules are drafted to organize a publication
on the personal websites of the companies.
Setting up the new transparency requirements in France obviously
takes more time than expected...
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