Description
TRANSPARENCY
of the law, being an indirect change
of the regulation, should be
immediately applicable. However,
the date of application of the new
requirements is still a major
practical issue that needs to be
addressed, as the Court’s decision
does not clarify when the changes
in the implementation of the
French Sunshine Act will apply.
A restrictive interpretation would
be that the new decision that the
provision foreseeing no disclosure
of the remuneration paid in the
framework of agreements with
HCPs being considered null and
void, should be repaired as of the
beginning of the coming into force
of the law, i.e. as of 1 January 2012,
which would mean corrections
over the last three years. A more
conservative approach would be to
consider that no retroactivity is
foreseen and therefore, the
reporting obligations could start as
of 1 January 2015 in order to have
a full year of reporting.
The complexity of the
implementation of such indirect
changes should not be
underestimated as these are key for
the industry: the abovementioned
transparency decree of 21 May
2013 can in that regard be valued
as one of the worst examples of
retroactive implementation.
The text imposed retroactively the disclosure of data back to 1 January 2012. On top of that, such requirement was supposed to be implemented by the industry within a week, on 1 June 2013. The only possible way to circumvent such a rigid framework was to allow some flexibility in its implementation, which is what happened. However, whilst flexibility is welcome, the downside is that there is no clear guidance as to the length of such an ‘adaptation phase’ and the tolerance in that respect.
So again legal uncertainty is created, in particular for international companies that are eHealth Law & Policy - April 2015 These unstable times may continue as another round of changes to the French Sunshine Act are currently under discussion required to navigate through this challenging environment and who may not be that familiar with the French legislative ‘adaptation’ process. These unstable times may continue as another round of changes to the French Sunshine Act are currently under discussion: the issue of territoriality could be revisited after the aforementioned opinion of the DGS, as well as the periodicity of disclosure reporting - it makes no sense to have benefits disclosed every six months whilst agreements have to be disclosed 15 days after their signature. Further concerns Besides the legal instability described above, initial trends can be identified concerning the consequences of the implementation of the transparency regulation. Two trends at least can be identified: First, with regard to the interpretation of the Conseil d’Etat, the French sunshine regime seems now to be aligned with the US sunshine system in terms of the value of the contract. Does this have any consequences for product liability and litigation? In that respect, the terms of the debate are different in France, as (a) class actions have for now a limited scope - however, things are about to change as a bill for the extension of class actions to health related claims is currently being discussed at the French National Assembly, and (b) the liability is based on the defectuosity of the product rather than the negligence of the manufacturer.
However, the crossing of such transparency data, which will now be publicly available, with potential defectuosity concerns could potentially lead to an increase of separate liability/tort claims against HCPs, and perhaps even criminal claims. Just recently, a French investigatory newspaper examined the transparency fillings and found that 75% of the approval committee for two vaccines were bound by a consulting agreement to the vaccine manufacturers. This particular point will certainly be closely monitored in terms of insurance coverage alongside broader ‘reputational screening’ of HCPs if their links to industry could be valued as too close. Another trend of the disclosure of ‘links of interest,’ as they are called in France, between HCPs and the healthcare industry, is that no HCP having been in a contractual relationship with the industry for a period of less than five years can be associated in any form whatsoever with the evaluation of a drug or medical device by the French Agency for Drug Safety and Health Products (‘ANSM’). As a consequence, practitioners who are helping to improve drugs and medical devices cannot be part of this process although it would be very helpful.
This situation could also more directly affect the industry if French HCPs consider that they should be less involved in the improvement of drugs and medical devices because of reputational and insurance concerns now that all payments made to them are to be disclosed. Should this happen, it would be questionable as to whether all this helps the patient in terms of research and development. The French transparency requirements, along with other transparency requirements like the US Sunshine Act, should not only be scrutinised for compliance purposes but also raise important questions in regards to liability that also need to be addressed. Daniel Kadar Partner Reed Smith, Paris dkadar@reedsmith.com 07 .
The text imposed retroactively the disclosure of data back to 1 January 2012. On top of that, such requirement was supposed to be implemented by the industry within a week, on 1 June 2013. The only possible way to circumvent such a rigid framework was to allow some flexibility in its implementation, which is what happened. However, whilst flexibility is welcome, the downside is that there is no clear guidance as to the length of such an ‘adaptation phase’ and the tolerance in that respect.
So again legal uncertainty is created, in particular for international companies that are eHealth Law & Policy - April 2015 These unstable times may continue as another round of changes to the French Sunshine Act are currently under discussion required to navigate through this challenging environment and who may not be that familiar with the French legislative ‘adaptation’ process. These unstable times may continue as another round of changes to the French Sunshine Act are currently under discussion: the issue of territoriality could be revisited after the aforementioned opinion of the DGS, as well as the periodicity of disclosure reporting - it makes no sense to have benefits disclosed every six months whilst agreements have to be disclosed 15 days after their signature. Further concerns Besides the legal instability described above, initial trends can be identified concerning the consequences of the implementation of the transparency regulation. Two trends at least can be identified: First, with regard to the interpretation of the Conseil d’Etat, the French sunshine regime seems now to be aligned with the US sunshine system in terms of the value of the contract. Does this have any consequences for product liability and litigation? In that respect, the terms of the debate are different in France, as (a) class actions have for now a limited scope - however, things are about to change as a bill for the extension of class actions to health related claims is currently being discussed at the French National Assembly, and (b) the liability is based on the defectuosity of the product rather than the negligence of the manufacturer.
However, the crossing of such transparency data, which will now be publicly available, with potential defectuosity concerns could potentially lead to an increase of separate liability/tort claims against HCPs, and perhaps even criminal claims. Just recently, a French investigatory newspaper examined the transparency fillings and found that 75% of the approval committee for two vaccines were bound by a consulting agreement to the vaccine manufacturers. This particular point will certainly be closely monitored in terms of insurance coverage alongside broader ‘reputational screening’ of HCPs if their links to industry could be valued as too close. Another trend of the disclosure of ‘links of interest,’ as they are called in France, between HCPs and the healthcare industry, is that no HCP having been in a contractual relationship with the industry for a period of less than five years can be associated in any form whatsoever with the evaluation of a drug or medical device by the French Agency for Drug Safety and Health Products (‘ANSM’). As a consequence, practitioners who are helping to improve drugs and medical devices cannot be part of this process although it would be very helpful.
This situation could also more directly affect the industry if French HCPs consider that they should be less involved in the improvement of drugs and medical devices because of reputational and insurance concerns now that all payments made to them are to be disclosed. Should this happen, it would be questionable as to whether all this helps the patient in terms of research and development. The French transparency requirements, along with other transparency requirements like the US Sunshine Act, should not only be scrutinised for compliance purposes but also raise important questions in regards to liability that also need to be addressed. Daniel Kadar Partner Reed Smith, Paris dkadar@reedsmith.com 07 .
