In Germany, the association “Freiwillige Selbstkontrolle für die Arzneimittelindustrie” (FSA, “Voluntary Self-regulation for the Pharmaceutical Industry”) released its version of the Sunshine Act. The Code is binding on FSA organizations, which represent more than 70 percent of the German pharmaceutical market.
Compliance with the Transparency Code will be monitored by the FSA, which will issue sanctions in case of violations. Starting in 2015, the FSA member companies will be documenting all direct and indirect payments and benefits in kind made to healthcare professionals or healthcare organizations for research and development, donations and payments, sponsoring and other forms of financial support, invitations to educational events, as well as service and consulting fees. In 2016, these transfers of value will be published, based on 2015 data. The disclosures will be made available on the websites of the member companies and updated annually.
Click here for the FSA association webpage, which requires translation.
The new Transparency Code is based on EFPIA (European Federation Of Pharmaceutical Industries and Associations), and implements standards and stricter regulations for disclosure of information, especially concerning any form of sponsoring.
Unlike in the United States, physician payment disclosure is not mandated by law. “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, Managing Director of the FSA.
Dr. Diener recently spoke positively about transparency as a policy, but noted that implementing a disclosure system is tough. (See Pharma Disclosure) “Overall companies are very positive about progress but there is a significant amount of work to do,” he says. Dr. Diener hopes to avoid the data integrity problems the U.S. system faced. “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 US and these need to be synchronised with systems in Europe to ensure all the information is correct and complete, with no duplication,” Dr Diener concluded.
In addition to the Transparency Code, a fundamental change in the Healthcare Professionals Code was promulgated at the FSA General Assembly. In the future, gifts of any kind to healthcare professionals will be prohibited. Among other things, this applies to inexpensive promotional items such as pens or notepads. The new rule came into effect on July 1, 2014.
Germany’s transparency code implicates many legal issues, perhaps most of all privacy and data protection laws. In Germany, it is mandatory to obtain consent from healthcare providers before their personal data can be published. FSA notes that they are hoping the German Medical Association provides its support in helping the transparency project to be successful. We wrote about the privacy implications of international disclosure laws here.
Stay tuned for more updates about transparency initiatives worldwide.