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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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Important Legal Update for Life Sciences: Prospective public disclosure platform “Transparence Santé” update
May 04, 2021
The French Ministry of Health (MoH) is currently updating the public disclosure platform “Transparence Santé” to consider HCPs’ Engagement Law changes. According to the first set of elements known, a full redesign of the platform is ongoing. It will impact the data collection scope as well as the ways of submitting transparency reports for all the Companies/Report Submitter.
An official communication from the French Authorities is expected soon (May – June 2021) to provide more details on the timeline for the application of this new tool, currently under development.
In a preliminary communication, French Authorities have indicated their willingness to make the new Transparency platform operational for the submission of the next Transparency Report (i.e. for the next transparency report, to be submitted before the 1st September 2021 on the Transfer of Values provided in the first half of 2021).
Important changes will be implemented in this process:
PLATFORM ACCESS
- New accounts and passwords will have to be required. There should be no continuity or transposition from the old DGS platform
SCOPE OF DATA
- The official data collection template will be in a simplified format. There will probably be only 22 columns to fill in instead of 42 in the current template (other sources suggest a 25-column template)
- A new recipient category type has been added to reflect the extension of the scope of Transparency Law in France: “INF – Influencer”. It concerns the persons who, in the media or on social networks, present one or more health products to influence the public.
These stakeholders will have to be mapped in the next Transparency Report for the S1 2021 Data.
DATA UPLOADING
- There will be two ways of reporting value transfers:
- Copy and paste or fill in line by line in a table available on the platform
- A submission via API/Webservices
Note that documents or forms in CSV format will no longer be accepted
- Expenses type will no longer be filled in “free text” format but will correspond to one of the proposals in the official list proposed.
AUTOMATIC FILLING
- Fields concerning the information of the HCPs/HCOs will be filled in automatically, during the manual entry of data on the platform, after the provision of the identification number of the recipient (RPPS/SIREN).
IMPLICATIONS
- Make sure that you map and monitor all HCP/HCO interactions occurred in 2021 and collect all ToVs in scope
- Prepare your systems & processes to these potential changes: documents, IT systems…
- ITR & AGS Product Managers will share the product change roadmap with clients in due time
IQVIA Commercial Compliance leverages the industry’s leading technologies, consulting, and services teams to deliver streamlined processes and business efficiencies—with embedded compliance. From automating and managing the entire HCP/O engagement lifecycle, to capturing, collecting, and reporting global and local spend; to continually monitoring for regulatory updates—discover how IQVIA’s integrated offerings can help you with your commercial compliance needs. For more information on how we can help navigate the current compliance landscape, visit our website or email us here.