Successive health crises plus the willingness of governments to reduce health care costs have the effect of strengthening from year to year regulatory pressure.
Two basic trends are emerging, namely a strengthening of pharmacovigilance rules and an enhanced transparency of financial relations between pharmaceutical companies and “stakeholders” (administration and health professionals).
Thus we see the emergence of similar requirements in all countries:
· Sunshine Act law (USA)
· Bribery Act law (UK)
· Increased requirements in Europe.
In these areas, France has set up early strict measures: in 1992 for the transparency of financial relations and in 1995 for safety.
Crises linked to contaminated blood, as well as pharmacovigilance recent accidents in the past few years have led the French and European authorities to strengthen the rules governing the collection, the analysis and the reporting of adverse drug reactions (pharmacovigilance) as well as the identification of the so-called weak warning signs .
Transparency of relationships
The recent questioning of the relationships between health industries and these stakeholders has highlighted the need for better track and documentation of all these relationships and to publish all the benefits of them.
The bill on the modernization of health products is complement and reinforces these measures firstly by introducing a device called the “French Sunshine Act” (new L. 1453 – CSP 1) and secondly, by the implementation of the December 2010 Directive on pharmacovigilance.
This project is expected to be validated in first reading at the National Assembly in late September. Although it is likely that these provisions will be subject to amendments, in particular to clarify the scope and the perimeter, this first project already presents a framework, which in mind, should not be changed.