Marcel Syriani, CTOLife sciences organizations have difficulty complying with regulations related to their product promotion, education, and marketing activities. DATABASICS’ expense reporting solution, DATABASICS Expense, relieves much of the burden. Governmental and industry entities, seeking to ensure that physicians and other health care professionals (HCP) always act in their patients’ best interests, have imposed statutory rules and reporting requirements on manufacturers of pharmaceuticals and medical devices and supplies. In the U.S., there is the federally mandated Sunshine Act, but there are also state-by-state regulations. More than a dozen states have their own laws when it comes to HCP spending and reporting. Other states also require that life sciences organizations conform to a Code of Conduct and still more states are considering their own brand of legislation related to HCP spending.
The U.S. is not alone in its concerns about HCP spend. For example, France has instituted its own version of the Sunshine Act, the Loi Bertrand, and the EFPIA, a European industry organization, has established a code of conduct for HCP relations.
The specifics of compliance vary with the regulatory entity, but the underlying requirement is for detailed record-keeping. Take the Sunshine Act. HCP spend needs to be tracked at the level of the unique HCP identification code or National Provider Identifier (NPI) for every instance where the HCP receives a “transfer of value.” All of this data must be maintained and periodically compiled into an electronic, downloadable format. Moreover, in the EU, the special data management protections of the GDPR (coming soon to California!) apply. That’s where the need for a software solution like DATABASICS Expense comes into play.
With DATABASICS Expense, sales and marketing people can record individual HCP expenditures, assign the proper NPI, and extract associated HCP personal information. To select the right NPI, DATABASICS uses an automated look-up function connected to a global NPI database. DATABASICS Expense even allows for allocating single expenditures over a group of attendees as the Sunshine Act requires.
With DATABASICS Expense, sales and marketing people can record individual HCP expenditures, assign the proper NPI, and extract associated HCP personal information
And DATABASICS, as a “Processor” of HCP personal information (as well as that of the report filer), is fully GDPR compliant. “Our vision is to make HCP spend reporting as simple as possible for our customers’ sales representatives,” says Marcel Syriani, CTO, DATABASICS. “Meeting the Sunshine Act and similar regulations without supporting software is really not a practical option for organizations that actively promote their products to HCPs.”
In addition to mandating the reporting of transfers of value above a certain threshold, there is a secondary test for excluded transactions based upon total annual spend upon an HCP. Here DATABASICS also has the answer. DATABASICS Expense provides invaluable reporting tools for aggregating and analyzing spend, as well as exporting data to the exact specification of customers’ Sunshine Act auditors.
For regulatory compliance, change is one of the few constants. With DATABASICS Expense, organizations can be confident that their systems will be able to keep up. “DATABASICS’ solutions have always been about adaptability,” says Syriani. “The rules are always changing, so it is important to us to provide a solution that can quickly accommodate new requirements, and provide the additional data and functionality that our customers may need.”
Regulatory relief regarding HCP spending does not appear to be on the horizon. But it can feel like it with a solution like DATABASICS Expense.