Welcome to the second of our updates on countering bribery and corruption in the Life Sciences and Healthcare sector, examining the regulatory regimes from across Europe.
The French Sunshine Act: Public website disclosing financial ties gets off to a timid start
The Mediator scandal saw French pharmaceutical company Servier face significant litigation as a result of the withdrawal of the product amid accusations that Mediator caused the death of 500 to 2000 patients. As a result, on 29 December 2011, France introduced legislation requiring healthcare companies to disclose their financial ties to healthcare professionals. The Transparence Santé website, which collates all the declared financial ties, was launched in 2014 but has, so far, got off to a timid start.
Following the Mediator scandal, French legislators saw the need to restore public trust in the system of regulation for medical products. As a result, on 29 December 2011, French legislators adopted an act to reinforce the safety of health products (the “Act“). The Act introduced, inter alia, new rules aimed at ensuring a greater degree of transparency with respect to financial ties between healthcare companies and healthcare professionals.
The requirements of such disclosure were particularised in an implementation decree called the ‘French Sunshine Act’ which was published on 21 May 2013 (the “Sunshine Act“). The Sunshine Act provided for the creation of a publicly operated website which would collate all the declared financial ties.
The Transparence Santé website was launched in June 2014: a year after the publication of the Sunshine Act.
Who must comply with this disclosure obligation?
It is not only drug companies that must adhere to the disclosure obligation. Organisations including – but not limited to – manufacturers of medical devices, biomaterial manufacturers and manufacturers of cleaning and application products for contact lenses (the “Healthcare Companies“) must also adhere to this disclosure obligation.
Financial ties with whom?
The Act has made it mandatory for the Healthcare Companies to disclose their financial ties with, inter alia, doctors, nurses, pharmacists, opticians and medical students, healthcare facilities, associations of healthcare professionals, learned societies, charities and the trade press (the “Healthcare Professionals“).
What needs to be disclosed?
The Sunshine Act requires Healthcare Companies to disclose:
- The agreements entered into with Healthcare Professionals. This obligation does not include certain types of purchase/distribution agreements and is limited to the identity of the parties, the date of the agreement and the purpose of the agreement.
- Any gifts whether they are in-kind or in cash, direct or indirect, provided that their value exceeds EUR 10 (VAT included). This disclosure obligation is limited to the identity of the beneficiary, the amount and the nature of the gift and the date of the gift.
Conditions of publication
Healthcare Companies are liable for the accuracy of the data they disclose. The information available on the Transparence Santé website is updated twice a year and remains available for 5 years.
What is the current status?
In June 2014, more than 1130 Healthcare Companies had registered on the Transparence Santé website. Despite the significant number of Healthcare Companies providing information on the website, the scope of the disclosure requirements included in the Sunshine Act has been the subject of heavy criticism. For example, the French National Medical Council Association (CNOM) criticised the disclosure requirement as it does not allow the users of the website to identify any benefits received through associations subsidised by the Healthcare Companies.
The CNOM also criticised the fact that while the giving of seemingly inconsequential items (such as pens or key-chains) to doctors or medical students shall be disclosed, the remuneration given to Healthcare Professionals in consideration of services performed for Healthcare Companies such as presentations at symposiums are not subject to this disclosure obligation. It is plain to see that the risk of conflict of interest is much higher in the former than in the latter case.
Why does it matter?
The launch of the website is broadly in line with the pattern observed in a number of countries to boost transparency. It is not only national governments that are involved in this process: professional organisations have also followed suit. For example, the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) disclosure code on disclosure of transfers of value to healthcare professionals and organisations will become effective in 2016 and will capture transfers that occurred in 2015.
Despite the launch of the website, various commentators believe that full transparency is yet to be achieved in France and the fear is that the restrictive scope of the Sunshine Act will lead to only partial transparency.