Following the "Mediator" scandal, France decided to implement new rules on the transparency between the pharma industry and Health Care Professionals ("HCPs") inspired by the US Physician Payments Sunshine Act. The Loi Bertrand (n° 2011-2012) was adopted on 29 December 2011 and has been complemented by Decree n° 2013-414 of 21 May 2013.
The main features of the so-called "French Sunshine act" are:
- Transparency obligations apply to a very large range of companies (pharmaceutical and medical device industries, cosmetic or tattoo product industries) and to any HCP (surgeon, dentist, student, pharmacist, nurses etc...).
- Further to the transparency obligation, any advantage granted to an HCP, should be published on a public database, as well as conventions entered into with HCPs. The current accessible database can be found on www.transparence.sante.gouv.fr.
- Said "advantages" are defined by an interpretative circular (Memorandum DGS/PP2 no 2013-224 of 29 may 2013). The definition of an "advantage" is broad, encompassing anything "allocated or paid to a beneficiary, including in the scope of the performance of agreements" with a value of more than €10.
In cases of non-compliance with the transparency obligation, manufacturers can be subject to criminal sanctions.
Conseil d’Etat ruling of February 24, 2015
A procedure has been initiated to challenge the legality of a number of provisions of the above mentioned Decree and interpretative circular before the French Conseil d’Etat (Supreme Court of the administrative order). This procedure led to a ruling of February 24, 2015 (No. 369074), the key aspects of which are summarized below.
Types of agreements to declare
The Conseil d’Etat first confirmed that the agreements pursuant to which HCPs purchase from pharmaceutical or other concerned life science companies fall outside the scope of the publication obligation. Thus, discounts awarded in these agreements should not be considered an advantage to be disclosed under the Loi Bertrand regimen. The same exemption applies to advertising agreements with TV, radio and internet companies.
Types of advantages to declare
Until now, according to the above mentioned interpretative circular incomes awarded to physicians in compensation of professional services provided to companies fell outside the scope of the advantages to be declared except if the remuneration was obviously disproportionate.
The Conseil d’Etat invalidated this distinction between incomes paid to HCPs in compensation of professional services and other amounts awarded to HCPs.
This could result in a substantial broadening of the scope of the publication obligation.
The transparency obligation should now encompass consulting fees and salaries of HCPs. The impact of this ruling could be all the more important as it should have a retroactive effect.
Information to declare
The parties that brought the challenge also tried to invalidate the provisions of the Decree which allow certain information in the agreements between HCPs and companies to be kept confidential, in particular to preserve trade secrets.
According to the Decree, information that should be published regarding agreements concluded between the company and the HCP are, notably, the HCP’s identity, his/her professional qualifications, his/her address, the purpose and the date of agreement and the amount of the advantage awarded.
The Conseil d’Etat confirmed that this level of information was sufficient to fulfill the transparency required by the Loi Bertrand while allowing the preservation of trade secrets.
Bill under discussion at the French parliament
On the same topic, an amendment (n° 2505) to a draft law related to public health (n° 2302 of 15 October 2014) has been filed by the Government and adopted by the French National Assembly on 9 April 2015. This bill shall now be submitted to the Senat.
The bill provides for a clarification to be inserted in the French Public Health Code regarding the obligation to make public any relationship of interest between companies and HCPs.
Such relationships encompass wages earned in the course of an employment contract, compensation of temporary consultancy services or also, for example, compensation for the contribution of an HCP to the drafting of a collaborative scientific book written under a company’s direction.
In this context, compliance audits should be conducted regularly by pharmaceutical companies. In particular, it is recommended checking that the following actions are in place:
- All relevant data shall be collected and classified, including a copy of any invoice or bill proving the amount of the advantage granted to an HCP;
- Said advantages and conventions should be published online for at least a period of 5 years;
- The obligation to publish is to be executed twice a year; and
- Appropriate measures should also be taken in order to comply with relevant data protection requirements.
Overall, from the result of the above ruling and bill is that the relationship between companies and HCPs are subject to regulations which are more and more complicated to implement in France. The transparency standards are now very high and could be compared with those of the EFPIA Code. Companies should be really careful with this heavy burden that applies to them.
This article is part of the International Life Sciences Update for July 2015.