The Brazilian Serialization Initiative

Brazil, home of 191M people and the largest drug market in South America (estimated at $17B in 2008), has just implemented a three-year plan to track all of its medicinal prescription products, both human and veterinary, using a 2D datamatrix barcode. The goal is to put in place a thorough method through which all pharmaceutical products can be traced from producer to end-user using safety codes located on the packaging. These so-called Medicine Single Identifier labels will contain unique barcodes that link the medicine to its registration number, lot number, production date, etc. in an official database. Medicine manufacturing companies will be responsible for ensuring that all of their products contain these safety labels, which companies can buy either blank or with codes already printed on them. The national regulatory agency - ANVISA - will supply all pharmacies with scanners in order to verify the authenticity of products at or before the time of purchase. Several of the issues raised by these new rules include questions about the regulation of international medicines: can pharma products produced outside the country use the codes provided by Brazilian national authorities? If so, and assuming that ANVISA will require all serialization codes to be applied within the country/upon product entry into the Brazilian drug market, it seems that international medicines will be significantly less secure despite their secure assurance label. We reckon consumers might also wonder about the system's transparency - if pharmacists are now selling fakes and they will also be doing the checking using special scanners, consumers seem to be left out in the dark in this new process and it may not be as effective as a solution that puts the power of authentication in the hands of the consumer.

Questions have also been raised about whether the national database will be government- or commercially-maintained. Interestingly, Sproxil avoids uncertainty on all of these concerns:

  1. we sell scratch-off codes to pharmaceutical manufacturing companies whose products appear in Nigerian markets, regardless of their production location
  2. we put the power of authentication in the hands of the consumer
  3. we keep a private, encrypted information database in a redundant cloud

In any case, it would seem that even though Brazil is on its way to decreasing the 25% market share that counterfeits currently hold, the country has a bit further to go before its 1 January 2012 timetable deadline. Other countries, such as the USA, have tried to set deadlines on serialization projects to spur industry adoption, but that approach doesn't seem to be effective. We hope to see much more industry collaboration with the authorities in Brazil to make the project successful.