The role of the FSA
Since November 2013, Germany has adopted its own National Code of Transparency for interaction with healthcare professionals (HCPs) and healthcare organisations (HCOs) as a result of work of the FSA (Freiwillige Selbstkontrolle für die Arzneimittelindustrie). The FSA is a self-regulatory body of the pharmaceutical industry founded in 2004, which monitors the collaboration between pharmaceutical companies, healthcare professionals and patient organisations. Since then, the FSA has incorporated EFPIA’s Transparency Code and has maintained an active role in communicating the benefits of transparency to all stakeholders. The FSA’s dedicated website to transparency in the pharmaceutical industry ‘pharma-transparenz’ uses the phrase “Transparency creates trust and combats mistrust!” to highlight how important it is for the German pharma industry to be a good role model in this arena.
The hurdle of data protection laws
At the Pharmadisclosure.eu workshop held this January in Rotterdam, Holger Diener, Managing Director of the FSA, explained how Germany has some of the strictest data privacy laws in Europe. In the German system, doctors have to ‘opt in’ to disclosure and can ‘opt out’ at any time. With this in mind, the FSA has been working hard to obtain and maintain consent: they have achieved this by publishing a ‘Q and A’ discussing the issues; drawing up model consent forms; and by launching a dedicated website: http://www.pharma-transparenz.de/.
Previously, members of the FSA were required to disclose the names of doctors and other members of the healthcare field with whom they are collaborating and the nature of the relationship. In addition, since July 2014, the FSA General Assembly voted that gifts of any kind to healthcare professionals are prohibited.
However, from this year, the FSA member companies will also be documenting all direct and indirect payments and benefits in kind made to healthcare professionals, including donations and payments; sponsoring and other forms of financial support; invitations to advanced training events; as well as service and consulting fees. In line with the EFPIA Code, this data will be published in 2016 for public scrutiny. According to the FSA, the disclosures will be made available on the websites of the member companies and updated annually.
A year of adaptation
After the FSA Transparency Code was published in November 2013 and later approved in May 2014 by the German authorities, FSA members began adapting their internal systems in order to record all payment data. Experience from the U.S. Sunshine Act, where there were complaints of inaccurate data reporting, has shown the importance of recording and reporting data correctly.
The past year has given pharmaceutical companies the chance to develop systems that can track the movement of payments from all departments, across all sectors and borders, in order to guarantee the integrity of the data. Since payments occur on a European level, it is also critical that data exchange between all national subsidiaries and affiliates is accurately captured. It is recognised by the FSA that “The disclosure of individual amounts involves sensitive data: once amounts are disclosed on the Internet, they are out there in the world, therefore they must be 100% correct – it’s a big challenge.”
The challenge of accurate data collection can be successfully met by companies that use robust data recording systems, such as those developed by BMI SYSTEM. The NAYA software is a cloud-based solution to meet business and regulatory requirements regarding relationships with HCPs and HCOs with a cost-effective and compliant approach.
Dr Holger Diener, Managing Director of the FSA emphasised the importance of accurate data collection in an article published on the Pharmadisclosure website “That’s been an important message for us. We have got to be sure the data are accurate. This is quite a challenge for companies. Larger multinationals have systems in place in the U.S. and these need to be synchronised with systems in Europe to ensure all the information is correct and complete, with no duplication,” Dr Diener commented.
How to achieve self-regulation
The FSA and German Industry Associations are optimistic that, although legislation may help to overcome some of the issues with the strict German data protection laws, self-regulation is possible if there is a good dialogue between all the relevant groups in the discussion, especially doctors. According to Dr Diener, “We don’t want to wait for legislators; we want to show the outside world we have an open approach.” In particular, the FSA recognises that the support of the German Medical Association is key to leading the project to success.
Ruth Knowles is a freelance science writer who has written articles and press releases on a range of life science and health topics. She received her MSc in Science Communication from the University of the West of England, Bristol.