EFPIA Compliance: What Can We Learn From US Sunshine Act
The EFPIA Transparency Directive is seen as a successor to the US Sunshine ACT also known as PPACA (Patient Protection and Affordable Care Act). The Sunshine Act was first introduced in the US in 2010 with the initial transparency report required by January 2012. The US pharmaceutical organizations embarked upon the PPACA reporting projects as early as 2010 and many programs failed for four primary reasons:
Single packaged software sold as a one shot silver bullet solution.
Setting targets for a perfect transparency report instead of a practical one.
Approaching transparency reporting solution as a project instead of a program.
Treating transparency program as a compliance initiative as against a business initiative.
Starting too late and rushing to finish.
Spending 2X to 10X more than needed.
The rampant Sunshine Act project failures contributed to the CMS (Center for Medicare and Medicaid Services) which is the governing body for the transparency reporting in US to delay the compliance reporting date from January 2012 to mid-2014.
Based on the lessons learned shared above, please see our recommendations on EFPIA compliance best practices. Click on the link below to download a free copy of White Paper on EFPIA Best Practices.
efpia white paper -best practices