Event Type: Seminar
The U.S. Sunshine Act was just the tip of the iceberg in terms of tracking healthcare provider payments, and just having systems in place to meet the challenges of U.S. federal and state aggregate spend laws is not enough. In light of the newly minted transparency reporting requirements of the European Federation of Pharmaceutical Industries and Associations (EFPIA), companies with a global reach or designs to have it must swiftly adapt to the new regulatory and compliance environment and be prepared to track and integrate data globally. There is more on the horizon as well, and failing to adhere to the varying nuances of all these regulations can have dire consequences when trying to conduct business abroad.
ACI’s inaugural Summit on International Transparency & Physician Payments will provide in-depth analysis of transparency regulations across the world on a region-by-region basis. Leave the conference with a cheat sheet for coordinating global tracking and a greater understanding of how the laws around the world differ from the U.S. system.
On June 10, Reed Smith's Daniel Kadar will present a session on "Navigating the Currently Established Global Transparency Landscape." This session will survey the world and provide information on countries or regions that have reporting requirements, be they legislative or industry group driven. Topics to be covered include:
- Identifying countries with transparency reporting statutes, such as
- The Netherlands
- United Kingdom
- Introduction to major industry group driven reporting requirements, including
- The Japan Pharmaceutical Manufacturers Association (JPMA)
- The Japan Federation of Medical Devices Associations (JFMDA)
- The European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Medicines Australia
- Groups in Central and South America (e.g., Columbia and Mexico)
- Providing a basic overview of established reporting regimes
- What industries are required to collect and report data (e.g., pharmaceutical, medical device, biotech, device distributor, etc.)?
- Who bears the burden of reporting (i.e., company or provider)?
- Setting forth timeline requirements
- Discussing practice issue with the disputes process
- Highlighting resources for the industry (e.g., guidelines, websites, equivalents of FAQs, pertinent industry associations, etc.)