The breakfast event featured several conferences around the theme “See beyond transparency”. The aim was to present a regulatory overview in France and in Europe, as well as the challenges and opportunities it raises.
Simmons & Simmons
Strategy Director, Veeva OpenKey, Veeva Europe
Regulatory Affairs Expert, BMI SYSTEM
Alexandre Regniault, Lawyer at Simmons & Simmons, first introduced the transparency requirements for the healthcare industry in France and in Europe.
Even though the EFPIA enforces disclosure requirements on transfers of value through its Code of Disclosure in order to standardise transparency policies across Europe, local laws and regulations vary from one country to another.
To illustrate the implementation of these regulatory requirements, Anne-Sophie Idée, Compliance Officer at Takeda, presented the implementation of transparency at Takeda in France, the challenges it brought up and the benefits arising from it.
The main problems encountered were on collecting reliable data, which represents an important amount of data to treat, and on identifying the HCPs as well as informing them during and after disclosure.
Internal tools were set up to face these challenges, such as traceability tools, training sessions and audits.
Finally, these regulatory requirements enabled Takeda to improve the accuracy of forecasted and actual data entries as well as its data management.
Indeed, when properly managed, transparency can and must become an asset for healthcare companies, Guillaume Roussel from Veeva Systems and Laurent Clerc from BMI SYSTEM explained.
In France, with a two-year hindsight on disclosure, now is the time to ask ourselves what the next steps are in terms of transparency.
The main issue currently focuses on the quality and reliability of collected data, and in particular, regarding the identification of HCPs and HCOs. A survey conducted by Veeva reveals that the companies surveyed identify this issue as an obstacle to disclosure.
This must come with a cost rationalisation taking an economic approach based only on the information needed for disclosure.
Indeed, a healthcare company uses only about 10% of its HCP database. An “on request” update of this database is therefore more economically valuable than a global update.
Finally, it is crucial to be able to anticipate and prevent risks related to relationships between healthcare companies and HCPs and HCOs:
• Inconsistencies between forecasted and actual expenses
• Conflicts of interest
This breakfast encountered a great success and enabled BMI SYSTEM to meet its clients and prospects in an informal and friendly atmosphere.
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