Brazil may swap its serialisation scheme for Turkish model

The government in Brazil may back away from its current plans for implementing a national serialisation system for medicines and adopt one closer to the model which has just gone live in Turkey.

The shift, widely discussed in the industry as SecuringPharma.com went to press but as yet unconfirmed, could also see the demise of Brazil's plan to combine serialisation with a security feature - a measure which has been resisted furiously by the pharmaceutical industry.

Brazil's current traceability proposal as laid out by the national regulatory agency ANVISA is to include a serialised code in 2D datamatrix format - replacing the current linear barcodes - and a security hologram printed by the national mint which would be co-located with the datamatrix code on a self-adhesive label.

The hologram would replace the 'raspadinha' label, which is based on coin-reactive ink and has been widely used on Brazilian pharmaceuticals for a number of years.

A shift towards Turkey's system would signal a dropping of the requirement for government-supplied security label, which according to the current proposals would have to be applied to the product within Brazil. [Although Turkey is experiencing its own problems with serialisation - see 'Teething troubles' hit Turkey's serialisation roll-out - Ed.).

Patricia Blanco, who was formerly head of ETCO, the organisation which carried out a serialisation feasibility study on behalf of ANVISA, told SecuringPharma.com at the European Compliance Academy's Strategies against Counterfeit Medicines conference in Wuerzburg, Germany, recently that pharmaceutical manufacturers have been lobbying hard against the proposals.

"The industry is up in arms because it believes the serialisation system alone is sufficient to guard against illegal medicines and reimbursement fraud," said Blanco, who has since moved on to head up Brazil's Palavra Aberta Institute.

ETCO's feasibility study did not examine the use of a combined security label, and simply applied 2D datamatrix codes to a test sample of around 75,000 medicine packs supplied by seven national and multinational drugmakers including Bayer, Pfizer and Sanofi-Aventis. The GS1-based datamatrix code was linked to conventional linear barcoding on the shipping unit (case).

Blanco said the first ANVISA proposal issued in January 2009 was in keeping with the model used in the pilot, but the safety tag element was added when the proposals were revised in November 2009, with a tamper-evident component added in January of this year.

According to the current proposals, from 1 June the safety label should be applied to all drugs in Brazil, and by 1 January 2011 these labels should be serialised with the 2D datamatrix. ANVISA will allow a year for non-serialised product in warehouses and pharmacy shelves manufactured ahead of the 1 January 2011 deadline to be used up.

Some pharmaceutical manufacturers have been implementing systems to meet the ANVISA requirements, but a larger proportion has been adopting a wait-and-see approach while the debate over the proposals plays out.

Meanwhile, Brazil is suffering major problems with illegal medicines, and ANVISA is fighting a constant battle against unregistered, stolen, counterfeited and smuggled pharmaceutical products, with a lot of illegal imports said to enter the country via the border with Paraguay.

Last year alone, the agency took part in 63 enforcement operations, making more than 200 arrests and inspecting around 500 establishments. 150 facilities were shut down, with more than 300 tonnes of illegal drugs seized, a 40 per cent rise on the prior year.


Related articles:

'Teething troubles' hit Turkey's serialisation roll-out

Safety in numbers: Brazil's medicine serialisation initiative

Cargo theft on the rise in Brazil