Transparency Reporting Update: Germany

09.26.17 | By Caroline Franco and Veronique Monjardet

Since 2016, Life Sciences companies that are members of the voluntary German FSA (“Freiwillige Selbskontrolle für die Arzneimittelindustrie”)[1] have been required to disclose payments to German HCPs and HCOs.

Now that 2016 transfers have been published, we are taking this opportunity to review and reflect on the data disclosed, and to take a look at what’s next for the industry.

Analysis of Payments[2]

As shown in Figure 1, most of 2016 transfers of value made from the pharmaceutical industry were made towards clinical trials and studies. The remaining payments were made towards other services of HCPs and HCOs: 18% of the 2016 transfers of values were paid to Healthcare Organizations (HCOs) for sponsorship, consulting and events, and 18% to Healthcare Professionals (HCPs) for lectures, trainings and consulting.

Surprisingly, the level of consent for the key pharma stakeholders decreased year over year. Only 25% of HCPs agreed to have the data disclosed on an individual level, representing €24 million, compared to 31% in 2016, representing €33.3 million. It is unclear whether this decrease in the consent rate is a consequence of the importance of data privacy for German HCPs or due to a potential lack of participation by pharmaceutical manufacturers in regard to the requests of consent. Due to privacy laws in Germany, the number of final recipients can only be estimated. Because 25% of consent resulted in individual disclosure for 16,500 HCPs, we evaluate that the total transfers of value of €562 million made by 54 companies went to approximately 66,000 HCPs.

The five companies listed below had the largest transfers of values in 2016 with German HCPs and HCOs:

  • Novartis Pharma with €23.6 million
  • Bayer with €17 million
  • MSD with €12.1 million
  • Berlin-Chemie with €11.7 million
  • Bristol-Meyer-Squibb with €11.2 million

A clear majority of payments to HCPs were made up of fees for services and travel. Meanwhile most of the payments are deemed as reasonable, as exhibited in Figure 2: total payments to HCPs are lower than €1,000 for 70.4% of HCPs on 2016 data and upper than €10,000 for 1.3% with only a handful number of HCPs receiving over €200,000.

The Future of Disclosed Transparency Data

Both voluntary and government enacted transparency initiatives are on the rise globally. We are confident that this trend will continue.

Transparency reporting gives companies the opportunity to ensure various departments and affiliates have a consistent approach regarding HCPs engagements (including approval processes, consent requests, Fair Market Value, contracting, recording of proofs of service, etc.). Therefore, now is an opportune time for Life Sciences companies to prepare for new and upcoming regulations and reporting periods by organizing their cross-functional processes. It is also recommended that they organize internal spend tracking to better understand their relationships with HCPs and HCOs, in both the short and long term. The internal data analytics gathered will allow companies to detect potential breach of codes and to confirm whether payments are consistent and appropriate across their organizations and beyond.

Since 2001, Polaris has helped Life Sciences companies around the world create, implement, manage and automate their transparency reporting. These efforts not only reduce costs and risks, but increase efficiencies across the organizations. Learn more about Polaris’ transparency reporting solutions here or contact us to find out how our experts can help your company.

[1] Note: In addition to the FSA Transparency Code, there are additional transparency requirements set by the AKG Code of Conduct in Germany.

[2] Sources : FSA, Spiegel