With the advent of the The Physician Payments Sunshine Act (PPSA) in 2010 and the final rule being enacted in 2013, the risks to a manufacturer in relation to the promotion of their medical products to health care providers (HCPs) in the United States became even greater than had existed previously. Prior to this legislation, only companies under a Corporate Integrity Agreement (CIA) with Health and Human Services Office of Inspector General (HHS-OIG) were required to post their physician payments to their company websites. Now, any manufacturer is at potential risk if transfers of value (TOV) to HCPs are not reported. Although the penalties for violations of PPSA are not at the same level of penalties under a CIA, the financial risk to manufacturers are still substantive.
Europe is jumping on the transparency bandwagon, too. Beginning this year, in an effort to boost transparency and make patients aware of possible conflicts of interest, manufacturers operating in Europe and subscribing to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Ethics, must disclose payments made to physicians. Prior to 2016, only manufacturers marketing products in France had be concerned about transparency under France’s Loi Bertrand (French Sunshine Act), which has many similarities to the US PPSA and was launched in 2013.
In addition, the Japan Pharmaceutical Manufacturers Association (JPMA) issued its Transparency Guideline for the Relation between Corporate Activities and Medical Institutions in 2011, and although like the EFPIA Code of Ethics it is a voluntary program, the risks to a manufacturer for failure to comply are its political position and public perception.
As global sales of medical products expand beyond traditional geographies into the emerging markets of Asia and Latin America, manufacturers must consider the complex and unique regulatory environments of the countries in these regions, as related to transparency. For example, in the Peoples Republic of China (PRC), anti-bribery concerns and investigations take on an even more serious nature and manufacturers, and their employees, could face serious consequences if corporate compliance programs aren’t monitored and enforced.
Ultimately, to be successful in both traditional and emerging markets, medical product manufacturers must lower their tolerance for risk and increase their ability to mitigate risk associated with TOV to HCPs on a global basis. Since TOV transparency is essentially a data management activity, manufacturers need to have information systems that enable them to collect, store, and report, on TOV data in an effective and efficient manner, in the required formats of the specific regulatory and professional bodies within the geographies in which they operate. The challenge and opportunity is having a single platform for transparency data management, enabling both local market and global compliance analysts to have a consistent, reliable, and comprehensive approach to ensuring that the risk associated with TOV to HCPs are being minimized.
Mike Strassberg, MHA, Sales Director, AHM
Mike has over twenty-years of experience in the life sciences industry, having held positions at several medical communications agencies, consulting firms, an HMO, hospital, and a pharmaceutical manufacturer. He has a Master of Healthcare Administration from Cornell University.