On 29 December 2011, the French Public Health Code (PHC) introduced the French Sunshine Act to establish transparency in a broad section of the France life sciences industry. The act ensures that life sciences companies provide transparent information about any existing contract with the health care providers. The purpose of the act is to avoid any possible conflict of interest between the Health Care Providers (HCPs) and the life sciences companies during their decision-making process.

The French Sunshine Act is Applicable To:

  1. Companies that manufacture or distribute products regulated under the Agence Nationale de Sécurité du Médicament (ANSM)
  2. Companies operating in France and those that provide associated services (such as technical services or communication/advertising) for life sciences products
  3. Companies acting on behalf of the above mentioned companies

Information to be reported under the French Sunshine Act

Companies are required to report any kind of agreement made with health care providers of any category.

1. Companies are required to submit the following information for any agreement made with the health care providers:

  • Name and address, along with the registration number and qualification (in case of medical students), of the individual HCPs
  • Contract date
  • Purpose of the contract
  • Amount of the contract need not be disclosed

2. Companies that provide benefits to the HCPs are required to submit the following information:

  • Name and address, along with the registration number and qualification (in case of medical students), of the individual HCPs
  • Value and nature of the benefits along with the date on which the benefits were granted
  • Duration throughout which benefits were provided

 

The French Sunshine Act is important to ensure transparency in the life sciences health care system of France. Are you looking for assistance with the French Sunshine Act? Reach out to Freyr at sales@freyrsolutions.com