What Sponsors Need to Know about the New EFPIA Disclosure Code

What Sponsors Need to Know about the New EFPIA Disclosure Code

The new Disclosure Code from the European Federation of Pharmaceutical Industries and Associations (EFPIA) went into effect on 1 January 2015. Manufacturers should have finalised their plans by now in order to collect the requisite data and avoid potential violations.

EFPIA Disclosure Code Basics
The new EFPIA code requires reporting of transfers of value to healthcare professionals (HCP) and healthcare organisations (HCO.) The code was adopted on 24 June 2013, but required national codes to be amended to ensure unified reporting standards. A final review of the status of transposition into national codes was done by EFPIA in April 2014. EFPIA members must begin tracking these transactions as of 1 January 2015 and post reports on an unrestricted and publically available site, such as the manufacturer’s website or a common website, starting in 2016. These reports are not retrospective, so they will only cover 2015 transactions. The information will be available for three years unless privacy laws require a shorter period or if the recipient’s consent is revoked. France is a notable exception. The French regulation disclosure began in October 2013.

Compared to the US Sunshine Act
The new code is comparable to the physician payment provisions of the Affordable Care Act of 2010, commonly referred to as the Sunshine Act. Both require pharmaceutical companies to disclose payments or “transfers of value” in a publically available forum. While the fundamental goal is the same, each regulation requires slightly different reporting.

What Sponsors Need to Do Now
Pharmaceutical companies acting as sponsors are ultimately responsible for conforming to the code, but they can, and should, leverage their business partners to assist with data compilation. 
UBC has an integrated functional process to collect and collate data, which we report to our clients. Our internal structure and specific processes help ensure a smooth and accurate collection of the payment-related information and timely reporting to the clients for further processing. Our SOPs have been updated to reflect these new requirements and our staff is fully trained on the new code.