Upcoming Hot Topics in the Healthcare Sector: What You Need to Know

By Benny Spiewak, Partner at SPLaw

We are excited to discuss some pivotal topics in the healthcare sector. Our discussions will cover:

1. Hot Topics and Practical Interplays between ESG and Healthcare Products
2. Data Protection, Risk Management, and Securing the Medical Device Sector
3. Public-Private Partnerships, the New Brazilian Public Procurement Law, and Value-Based Healthcare
4. The Brazilian Private Healthcare System and the Reimbursement System Applicable for Medical Devices
5. Legal and Regulatory Aspects Concerning Marketing Initiatives of Medical Devices and Technology

Legislative Updates Affecting the Healthcare Industry

Below are the congressional movements we are closely monitoring:

Draft Bill #7990/2017

This bill aims to set the Brazilian Federal Sunshine Act. The procedure would require companies to disclose payments, benefits, or advantages granted to doctors, healthcare establishments, patient associations, or people in public offices. Currently, only one (1) Brazilian State – out of twenty-six (26) requires the disclosure of payments to healthcare professionals (HCP). The draft bill consolidates seven other (7) similar congressional initiatives. The slow pace of the draft bill may be due to the low support of current Congresspeople and the loud support it has received in the previous congressional tenure (2018-2022) from the Minister of Health from a preceding Government. Despite recent media coverage disputing the relationship between the pharmaceutical industry and HCPs, the draft bill has yet to get traction.

Draft Bill #4436/2020

This bill aims to amend the Brazilian Criminal Code by outlawing private corruption acts, is under consideration. The bill, if approved, will penalize anyone who demands, requests, or receives an undue advantage, as an employee or representative of a company or private institution, to benefit themselves or third parties, with a sentence of 2 to 5 years in prison and a fine. This bill, authored by Senator Marcos, who has played a vocal role in its drafting and promotion, could serve as a strong deterrent against private corruption, underlining the seriousness of such offenses. If approved, compliance practices and codes will need substantive changes.

Draft Bill #2056/2022

This bill aims to (re)introduce the patent term adjustment (PTA) into the Brazilian Patent Law as compensation for the delayed patent review by the Brazilian Patent Office. The Supreme Court of Brazil decided in 2021 that the country's then-existing PTA rule was unconstitutional, i.e., it ensured patents would be valid for at least ten years after they were granted. This decision has significant implications, as according to the Supreme Court's ruling, patents are now suitable for 20 years from the filing date. The draft bill was introduced by an opposition minority caucus member of the House of Representatives and has yet to receive extra attention from Congress. Still on the “compensation mechanism,” we must highlight Yesterday′s debate at the Senate′s Science and Technology Commission on the relevance or adequacy of a legal framework protecting regulatory data, i.e., the one submitted to ANVISA when securing marketing authorizations. Currently, the Brazilian legal framework ensures regulatory data protection for vet and chemical products, excluding the protection for human-oriented pharmaceutical products. Most participants decried plans to regulate human-oriented pharmaceutical products, as it could hinder the development of the Brazilian-born and bred pharma industry and make it more expensive (and challenging) to access generic or subsequent entry products.

Draft Bill #2338/2023

This bill suggests creating rights to safeguard consumers affected by artificial intelligence systems, e.g., algorithm-based recommendations. It also establishes definitions and conditions for AI-based innovation and technological advancement through governance tools and an institutional oversight and supervisory structure. The President of the Senate is the author of the Draft Bill, which is receiving bipartisan steadfast support. Politicians construe the bill as crucial considering the threats that the technology may negatively impact the outcome of the elections for over five thousand five hundred (5500) mayors throughout Brazil by forging deep fakes and propagating fake news. The Senate's first report commending the draft bill, issued on May 2, suggests an expedited Congressional review.

Approved Bill #6007/2023

This bill has turned into a Legislative branched-backed Federal Law on the rules for clinical trials with human beings. The former set of rules was formulated by the Executive branch and labeled as legally insecure. The approved bill updated sixty (60) items vis the Executive branch′s version, including post-trial access rules, biobanks, and biorepositories; rules for clinical trial agreements, monitoring rules for research; definition of information and procedures for ethical analysis by the IRBs; requirements for the design and implementation of a post-study supply program or continuation of the experimental treatment; and specificities of research in the humanities and social sciences. President Lula's executive branch head will likely approve the bill in the coming weeks.

With less than 30 business days of actual Brazilian Congress activity left, these topics are too sensitive for discussion during an election year. If Congress fails to address them now, their assessment is likely to be pushed to Q1 2025.