The transparency landscape for the life science industry is continuously evolving, with requirements that seem to be increasing by the minute. At Informa’s recent Transparency, Aggregate Spend & HCP Engagement conference, industry professionals discussed the latest regulations impacting both pharmaceutical and medical device companies. Two areas stood out during these discussions: Illinois and Brazil.

Illinois

House Bill 5517 (HB5517) was introduced to the Illinois General Assembly on February 9, 2024. The bill’s requirements align closely with Connecticut’s recent enactment of Public Act 23-171. Under Section 20 of HB5517, all pharmaceutical manufacturers employing individuals to perform the duties of a sales representative must register with the Department of Financial and Professional Regulations (the Department) by October 1, 2025. Registrations will be valid until June 30th of each year, requiring annual renewal. As part of this process, each company must submit a list of all individuals employed as sales representatives to the Department.

Additionally, HB5517 includes annual transparency reporting requirements, with the first due by July 1, 2025. Each company will be required to disclose the following information for each sales representative:

  • The total number of contacts the pharmaceutical sales representative had with prescribing practitioners and pharmacists
  • The specialty of each prescribing practitioner and pharmacist
  • Whether any product samples, materials or gifts of any value were provided to prescribing practitioner, their staff or pharmacists
  • An aggregated report of all free samples provided, categorized by drug name and strength

The Department will review all submissions and publish an annual report by December 1st.  Guidance and report templates are yet to be released.

Brazil

Brazil’s legislators recently introduced Bill No. 1,041/24 to the House of Representatives, proposing national regulations for reporting and publicizing financial relationships between the life sciences industry and healthcare professionals (HCPs). While the state of Minas Gerais has required the disclosure of transfers of value to HCPS, Bill No. 1041 would be the first to implement such regulations across Brazil.

If enacted, this bill will require disclosures for any donations or benefits to HCPs or their families, including gifts, registration fees, travel and accommodation, research and consultancy payments and speaker fees. These disclosures would be due within 90 days following the end of each calendar year. MediSpend will closely monitor developments on this bill to keep you informed.

 

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Lauren Howe
Director, Compliance Solutions

October 7, 2024