Brazil Track and Trace Bill Passes Committee Vote Amidst Presidential Upheaval
Earlier this week, PL 4069 — the amended 1-year/8-month/3-year phased serialization and compliance reporting bill — passed by House vote in the Brazil legislature, where it had been debated and refined since February. The bill had already passed in the Brazil Senate in December, so the Committee on Social Security and Family’s (CSSF) vote was the final major hurdle in the legislature.
Next, the bill goes to the Committee on Constitution, Justice, and Citizenship (CCJ) for a final review. Once CCJ receives the bill from the CSSF, it is expected to review and pass it somewhere within a three- to a six-week time frame. Since the bill has widespread support, it is expected to then be signed by the president.
The Presidential Impact
Coincidentally, President Dilma Rousseff was formally impeached by the Senate on Aug. 31 — the day after PL 4069 passed — and interim president Michel Temer was sworn in. This was anticipated and is not expected to hold up the complex track and trace process in Brazil, although we could see some personnel changes at the Brazilian Health Surveillance Agency (ANVISA).
Once signed into law, ANVISA has up to four months to complete the implementation rules (known as RDC) that support the law. Since ANVISA has been working in parallel with the industry on drafting the RDC, this phase could go much quicker.
The one-year pilot phase clock starts with the publication of the RDC rules, which means that this could still happen in Q4 2016.