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New French Transparency Regulations Ruled Valid by French Constitutional Court

29 January 2016
The law on modernisation of the French health system adopted on 17 December 2015 introduced, amongst other things, changes to the existing sunshine regulations which require industry to make public the existence of certain agreements with, and benefits provided to, various stakeholders in the healthcare industry.   By a decision dated 21 January 2016,  the French constitutional court considered that the changes introduced comply with French constitutional rules.   The companies will now have to:

  • disclose fees above a certain threshold (to be established by the government) paid under agreements with HCPs and with other stakeholders;
  • report the purpose of the agreements in a more detailed manner, and not by generic descriptions;
  • "direct" and the "final" beneficiary of the agreements will have to be reported.

The specifics of these changes will be established by an upcoming implementing decree.

EMA to Revise Herbal Medicines Guideline

On 1 September 2016, the European Medicines Agency ("EMA") opened for public consultation a Draft revision to its Guideline on the assessment of clinical safety and efficacy in the...

08 September 2016
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