German Association FSA “Voluntary Self-regulation for the pharmaceutical industry” (“Freiwillige Selbstkontrolle für die Arzneimittelindustrie”) released a new Transparency Code and a revised version of the FSA Code of Conduct on the Collaboration with Healthcare Professionals concerning strict transparency regulations in the pharmaceutical industry, which have been approved by the Federal German Cartel Office and were published in May 2014.

Overview of the FSA

German FSA is a self-regulatory body of the pharmaceutical industry founded in 2004 that monitors the collaboration between pharmaceutical companies, healthcare professionals and patient organizations.

FSA affiliates represent more than 70 percent of the German pharmaceutical market. FSA therefore is the authoritative control and sanctioning institution in the German pharmaceutical industry.

FSA releases its own regulations laid down in different codes binding FSA affiliates in the way of a self-commitment. FSA codes implement effective standards for transparent and ethical behavior supporting cooperative work in the pharmaceutical industry and ensuring fair competition between member companies. FSA provides to its members an arbitration body monitoring compliance with regulations and sanctioning infringements through reprimands, fines and disclosing information about non-compliant members.

Core content of the new Transparency Code

The new Transparency Code is based on the EFPIA Transparency Code (European Federation Of Pharmaceutical Industries and Associations) and implements standards and stricter regulations for disclosure of information, especially concerning any form of sponsoring. With the adoption of the Transparency Code, FSA affiliates commit to comply with the new Code in any form of future cooperation in the health care sector.

“The members of the FSA have decided to complete existing codes of conduct and to realize the next step towards greater transparency, even before national legislation will adapt stricter rules” said Dr. Holger Diener, CEO of the FSA.

FSA´s core approach is Create Trust – Fight Mistrust

For this purpose the Code namely sets out

  • an obligation for FSA member companies to document all direct and indirect payments or any other valuable grants to healthcare professionals or healthcare organizations in the areas of research and development, donations and similar grants, sponsoring and other financial support, invitations to training events as well as service and consulting fees, from beginning of 2015.
  • Disclosure of all documented payments and other valuable grants of FSA member companies on the FSA Website for the respective past year, starting in 2016 for the past year 2015.

Additionally to the release of the Transparency Code a core change of the existing Code of Conduct has been passed by the board of FSA members, implementing a total ban of any form of presents to members of the healthcare sector. This significantly tightens the previous regulation that, up to now, allowed presents of minor value.

The Transparency Code and the revised version of the Code of Conduct, in particular the changed provision regarding the ban of presents have been approved by the Federal German Cartel Office and have both been published in May 2014. Consequently companies in the healthcare sector should carefully consider these new codes and transparency regulations for compliance reasons.