Health Care Meeting Compliance in South America: Still a Slippery Slope

Navigating the Evolving Transparency Landscape in Latin America: Ensure Compliance Today.

The global transparency landscape for life sciences companies has become increasingly intricate, with numerous regulatory requirements enacted and revised by national governments and industry associations. Since the introduction of the U.S. Sunshine Act in 2013, the number of regulations worldwide has surged exponentially. Various countries and organizations, including the EFPIA, have developed their own versions of the Sunshine Act, impacting thousands of life science companies globally.

In Latin America, the region is witnessing a wave of enhanced anti-corruption laws and enforcement efforts, compelling pharmaceutical, biotech, and medical device industries to face a more challenging regulatory and enforcement environment. Countries like Brazil, Colombia, and Argentina are now adopting versions of the EFPIA Disclosure Code, mandating the public disclosure of payments and transfers of value (ToVs) to healthcare professionals (HCPs) and healthcare organizations (HCOs).

Let's delve into the specific regulations in Brazil and Colombia:

Brazil: Recent legislation in Brazil requires Pharma and Medical Device Companies to report any form of donation or benefit granted to HCPs, directly or through third parties. This includes gifts, tickets, event registration fees, accommodations, funding for research stages, consultancy, and lectures (collectively "ToVs"). The reporting deadline is set as the last working day of January each year.

Additionally, companies producing health products must inform the State Body of Minas Gerais about sponsorship funding for scientific events. Sponsorship expenses encompass speaker fees, gifts, food, transportation, and accommodations provided in the context of a scientific event. Companies must upload the required information to the central platform "DeclaraSus" using a CSV file by the last working day of January each year.

Colombia: According to a recently passed law, pharmaceutical and medical device companies in Colombia must disclose their payments and in-kind transfers made to physicians, institutions, and patient organizations. This reporting should begin on January 1, 2020, with reference to data from July-December 2019. The scope of expenses includes 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 requested files 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 second half of 2019.

Complying with these regulations is essential for life sciences companies operating in Latin America. Ensure your organization stays on the right side of the law and maintains transparency by meeting the reporting requirements in a timely manner.

Conclusion:

As the transparency landscape in Latin America continues to evolve, life sciences companies must navigate these regulatory changes with utmost diligence. Understanding the requirements in Brazil, Colombia, and other countries is crucial to ensuring compliance and maintaining the integrity of your organization's operations. Partner with industry experts to help you navigate these complex regulations and safeguard your company's reputation. Stay ahead in the ever-changing landscape of transparency and compliance in Latin America.

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