Brazil green lights medicine track-and-trace scheme

Brazil has finalised its plans for a track-and-trace system for medicines, setting the clock ticking on a three-year deadline for full implementation.

The plans have been in gestation since 2009, when national medicines regulatory ANVISA first published proposals to introduce a pedigree-like traceability system for all prescription medicines - from manufacturer to pharmacy - based on serial numbers encoded within 2D datamatrix codes.

Progress with the scheme was stalled by initial plans to require printing of the codes onto security labels printed by the national mint - which were subsequently dropped on feasibility and cost grounds - and the latest version correlates fairly closely with a draft scheme opened up for public comment earlier this year.

The unique medicines identifier (UMI) - which will be applied to each medicine pack - will incorporate a 13-digit, randomised serial number, the product's ANVISA registration number, batch number and expiry date. Earlier plans to include information such as the tax payer numbers of the companies remitting and receiving the product and the transaction date have been dropped.

ANVISA has set a deadline of two years for pharma companies operating in Brazil to submit a comprehensive report on traceability of at least three batches, and says it will form a technical committee to monitor implementation of traceability.

ANVISA director Dirceu Barbano (pictured) said the report would give companies an opportunity to establish whether their serialisation programmes are on track and give them a year to iron out any problems.

The traceability system would also help protect pharmaceutical shipments from theft and discourage smuggling, added Barbano.

Mussolini Nelson, chief executive of Brazilian pharma trade organisation Sindusfarma, says the move "brings certainty to the industry and the consumer." He added it should be possible for industry to meet the deadline established by ANVISA, although noted concerns remain about the cost and the availability of equipment necessary to establish traceability.

With more than 190 million inhabitants, Brazil is the biggest pharmaceutical market in South America - valued at around $27bn last year according to Business Monitor International - and is the tenth largest drug market in the world.

The market has been experiencing buoyant growth despite economic problems, with domestic drugmakers now accounting for around half the national drugs market, but this growth has been accompanied by an increase in drug counterfeiting.