Transparency Update: Brazil

03.21.18 | By Giuseppe Saporito and Michael Arbini

On February 23rd, 2018, the Secretary of Health of the State of Minas Gerais, in accordance with the provisions of Law n. 22440 / 2016, issued a Note of Clarification (“Note”) providing some details on the implementation of transparency reporting obligations.

Particular attention should be paid to two (2) key points of the Note:

Law n. 22440 of December 21st, 2016

According to this 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”).

The Note clarifies that ToVs related to 2017 will need to be submitted by Companies by December 31st, 2018.

From 2019 onwards, the reporting deadline will be the last working day of January of each year.

Please note that, under Law n. 22440/2016, 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.

Law n. 22921 of January 12th, 2018

The legislation states that companies producing health products are obliged to inform the State Body of Minas Gerais in regard to 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 first reporting deadline will be January 31st, 2019 for 2018 sponsorships.

The Note clarifies that the DeclaraSus platform will be adapted in order to receive the sponsorship declarations due under Law 22921/2018.

The electronic file to be used for submission is not yet available.

Polaris will be making necessary revisions to the Spend, Tracking, Analytics and Reporting (STAR) solution to ensure it is compliant with the legislation.

To learn how Polaris can help you stay current and compliant with regulations and codes around the world, visit our website or contact us.