Recently, Colombia’s Ministry of Health and Social Protection issued a draft resolution outlining new measures regarding interactions between health care practitioners and the life sciences industry. Following examples set by the Physicians Payment Sunshine Act in the United States and EFPIA in the EU, Colombia’s goal is to create financial transparency between pharma/device companies and physician interactions. While a relative newcomer in the global transparency arena, Colombia does not appear to be content with adapting legislation Europe and the United States have developed, but rather looks to expand reporting requirements even further.
Naturally, the draft resolution covers cash, cash equivalents and in kind payments to physicians, clinics and hospitals, but Colombia plans on including administrative staff, NGOs, students of professions in the health sector and patient organizations as part of the recording scheme. This represents only a small sample of the differing categories intended for future payment capture. Colombia’s more onerous reporting categories will pose myriad challenges to trans-national businesses who will be required to track disparate and unfamiliar categories of spend.
Ostensibly, the Ministry of Health and Social Protection is developing a reporting tool, for which there is little information currently available. To date, the Ministry has only provided a list of the fields that will be required for each financial transaction (see below). It is unlikely that these interactions will raise any great concern, as they reflect current requirements in the EU and United States.
|a. Consulting fee||f. Food and drink||k. Royalties or licenses|
|b. Compensation for services other than consulting||g. Travel and accommodation||l. Current or prospective ownership or investment interest|
|c. Fees||h. Education||m. Direct compensation for serving on a faculty or as a speaker for a medical education program or academic event|
|d. Gifts||i. Research||n. Donation|
|e. Entertainment||j. Charitable contributions||o. Other|
Other more unusual requirements will create added difficulties in spend capture and transparency reporting in Colombia. Foremost among these is the necessity of minimum wage tracking. The draft resolution states that transfers of value “of less than half (1/2) a monthly legal minimum wage (SMMLV) shall not be registered”, unless they exceed one monthly minimum wage in one year. Similarly, medical samples shall not be registered unless the market value exceeds four monthly minimum wages (SMMLV). An additional complication in spend capture involves promotional materials. Printed materials will not be subject to registration unless they are part of continuing education or a recreational activity.
The need to prepare is essential, as Colombia plans to implement reporting in the very near future. The draft resolution, if formalized in its current iteration, states that voluntary registration will begin January 1, 2015 and mandatory registration will begin January 1, 2016 with reporting required before April 30th of each year.