Proposed Pharma Serialization Regulation Progresses in Brazil

395px-Coat_of_arms_of_Brazil.svgThe government of Brazil is trying to recover from the poor design of their first attempt at a pharma serialization and tracing regulation, RDC-54/2013.  That first regulation was at least partially suspended (see “Brazil Suspends Pharma Serialization And Tracing Requirements” and “The Official Suspension of the Three-Lot Pilot in Brazil”).  Everyone seems to be operating under the assumption that the entire RDC-54-2013 will be replaced with a new regulation.  Legislation to do exactly that has been slowly churning its way through the Legislature for the last 9 months.  Word came last week that it has advanced one more step when PL 4069/2015 was referred to the Commission of Constitution and Justice, a subcommittee of the Senate. 

My understanding of the timeline that the current proposal contains is:

  • 4 months for ANVISA to write regulations and publish, then,
  • 1 year for the same kind of 3-lot pilot that was suspended from RDC 54/2013 last fall, then,
  • 8 months for analysis of the results of the pilots, then,
  • 3 years for all drugs to be serialized and traced.

If this is accurate, this timeline would start when PL 4069/2015 is signed into law by the Brazilian government.  Most people seem to think that will happen near the end of this year.  If this timeline sticks, it will be a little more relaxed schedule than the first try, which would be a good start. 

Another aspect of the current proposed solution is that the government would implement a centralized database where all members of the supply chain would update the status of each package of drugs as them move down the supply chain.  This is an improvement over the previous attempt, but even with this approach, there is no guarantee of success.

Beyond these aspects of the proposed regulation, I don’t think it makes sense to deconstruct the entire proposed law.  If/when PL 4069/2015 is enacted, ANVISA will need to use it to write specific regulations (the first step in the timeline above).  Until that happens, it doesn’t make any sense for companies to do anything to prepare for the requirements because they could change, or maybe they won’t even be enacted.  In that case, those who support serialization and tracing of drugs in Brazil will be forced to go back to the drawing board with a new proposal in the future.  Nobody really knows until something actually makes it through the full legislative process.