FS Arzneimittelindustrie e.V.

Dr. Holger Diener - Geschäftsführer
Daniela von Arnim - Assistentin

Grolmanstr. 44-45
10623 Berlin

d.arnim@fsa-pharma.de
Tel.: 030 88728-1700
Fax: 030 88728-1705

Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V.

Milestones

The basis for the FSA Transparency Code is found in the standards of the EFPIA Transparency Code: http://transparency.efpia.eu (adoption: end of June 2013), established by the European umbrella association for the research-based pharmaceutical industry (EFPIA). The FSA has transformed the European Transparency Code into a national Transparency Code for Germany. This was adopted on November 27, 2013 by the FSA General Assembly.

From 2015, the FSA member companies will be documenting all payments made to healthcare professionals and organisations of the healthcare system. In 2016, the first disclosure will occur – based on the year 2015.

The information must be available to everyone on the company's website, thus making the cooperation between industry and physicians transparent. As a general rule, the Transparency Code foresees individual disclosure of the recipient and the details of his business address. In cases where individual disclosure is not possible for legal reasons (e.g. on grounds of data protection, i.e. if a payment recipient does not provide his consent to disclosure), the disclosure will be made in summary form.

If it involves payments in connection with research and development, a summary disclosure is made from the beginning, without specifying the name of the individual recipient. This also includes treatment monitoring. Disclosure is made in summary form here in order to prevent competitors from drawing conclusions regarding research projects. In addition, the research and development field is already closely regulated by existing legal provisions: Studies must be approved by the regulatory authorities and the Ethics Commission prior to launch. For treatment monitoring, in addition to public transparency, the companies make individual disclosures (registration at the beginning and disclosure of summary results at the end; each in a public database) of the participating physicians, along with the remuneration they receive, to the Statutory Health Insurance Funds Association, National Association of Statutory Health Insurance Funds, and the Association of Private Health Insurance Funds.

As a flanking measure alongside the transparency rules, the giving of gifts to physicians and other healthcare professionals will be forbidden in the future (exceptions are allowed only under narrow conditions for "scientific information" involving certain information and training material and medical instruction and demonstration items).

 

 

The FSA

Information on the „Freiwillige Selbstkontrolle für die Arzneimittelindustrie e. V.“ (FSA) is available at

www.fsa-pharma.de.

Current News

The International Olympic Committee published its indemnity policy for the first time to increase transparency within the organization

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Allergo Journal "wholeheartedly" supports the transparency initiative of the FSA

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Survey: Most Physicians Report Being Unaffected By Open Payments Database.

more

Disclosure of payments to health professionals: Going Live

more

Press Contact

wbpr_ Kommunikation
Natalie Schneider
Phone: +49 89/99 59 06-25
Email: natalie.schneider@wbpr.de