Health Care Meeting Compliance in South America: Still a Slippery Slope
The global transparency landscape for life sciences companies seems to grow more complex each year. National governments and industry associations continue to enact, update and revise regulatory requirements. Since the U.S. Sunshine Act was enacted in 2013, the number of regulations around the world has grown exponentially. Dozens of countries and organizations, including the EFPIA (European Federation of Pharmaceutical Industries and Associations), have created their own versions of the Sunshine Act, collectively impacting thousands of life science companies around the world.
Although slow to adopt, countries in South America are finally joining this regulatory environment. Brazil, Colombia, and Argentina, specifically, have begun adopting a version of the EFPI Disclosure Code, requiring companies to publicly disclose payments and transfers of value (ToVs) to healthcare professional (HCPs) and healthcare organizations (HCOs).
The last several years have seen a wave of enhanced anti-corruption laws and enforcement efforts across Latin America, including in countries as diverse and dynamic as Mexico, Argentina, Brazil, Colombia, and Peru. The regulatory landscape continues to evolve. The pharmaceutical, biotech, and medical device industries are increasingly facing a more challenging regulatory and enforcement landscape throughout Latin America.
Information on Brazil and Colombia are as follows.
According to recent law, Pharma and Medical Device Companies must report any type of donation or benefit granted to HCPs, whether directly or through third parties, such as gifts, tickets, event registration fees, accommodations, funding for research stages, consultancy and lectures (collectively “ToVs”).
From 2019 onwards, the reporting deadline will be the last working day of January of each year.
Additionally, recent legislation states that companies producing health products are obliged to inform the State Body of Minas Gerais regarding sponsorship funding for scientific events. According to the law, expenses that fall under the scope of sponsorship include: speaker fees, gifts, food, transportation, and/or accommodations provided in the context of a scientific event.
Companies will comply with the law requirements by uploading an electronic file to a central platform by the last working day of January of each year with reference to sponsorships of the previous year.
The next reporting deadline is January 31, 2020 for 2019 sponsorships.
Please note that, under both laws, Companies must upload ToVs to the central platform, “DeclaraSus” (http://declarasus.saude.mg.gov.br/), using a CSV file available in the restricted area of the DeclaraSus website.
According to a recently passed law, pharmaceutical and medical device companies should disclose their payments and in-kind transfers made to physicians, institutions and patient organizations begining January 1, 2020, with reference to data from July-December 2019.
Expenses in the scope of the law include, but are not limited to, food and drinks, fee-for-services, clinical research, registration fees for conferences, travel and accommodation (collectively “ToVs”).
Companies will comply with the reporting requirements by uploading the files requested in Annex 1 of the Law to a central governmental platform twice a year:
- ToVs made January-June must be reported by the end of September of the same year
- ToVs made July-December must be reported by the end of March of the following year.
The first reporting deadline due under the law will be March 31, 2020 for the ToVs made in the 2nd half of 2019.