Opposition building to Brazil's drug traceability scheme?

Brazil serialisation imageBrazil's implementation of a system for medicines traceability could be threatened if a bill tabled in the country's parliament gains traction.

The bill filed in the Brazilian Senate on June 30 wants to extend the deadline for a 2009 law - updated in 2013 - that is introducing a national drug tracking scheme and has now been backed by Abrafarma, an association representing pharmacies in the country.

The bill wants to extend the current three-year implementation period for the scheme - which is being implemented by national medicines regulator ANVISA - to 10 years. Like many drug traceability approaches around the world Brazil's system is based on the serialization of medicine packs using unique 2D datamatrix codes.

The head of Abrafarma, Sérgio Mena Barreto, maintains the traceability programme is being rushed through and is too complex, raising the risk of medicine shortages if all parties in the supply chain are not ready to comply by the deadline.

Barreto is also concerned about the ownership of the transactional data, arguing it may be visible by pharmaceutical companies and could contravene privacy laws as well as giving drugmakers an opportunity to use it for commercial purposes, potentially leading to price manipulation and unfair competition.

The data should be visible only to the Brazilian government, as is already mandated in Argentina and Turkey and will be implemented in the EU and US, he says.

Brazil is regarded as having one of the most complex track-and-trace regulations in the world, with manufacturers or importers given the responsibility to capture product movements across the supply chain - from the point of manufacture to the pointing the drugs are dispensed to patients.

The tracking requirements apply to both their direct trading partners as well as indirect partners - which means any other organisation that might purchase the product. Meanwhile, distributors must report serialised transaction data back to the manufacturer, which is obligated in turn to report all transactions to ANVISA and provide access to its internal compliance system to the regulator via a secure web platform.

By December 10 pharma manufacturers are required to have serialised and tracked three batches of product through the supply chain, and a year later this will be mandatory for all pharmaceuticals. A big hurdle to overcome is that - unlike Turkey and Argentina for example - it is not possible for manufacturers to re-package or add serialized codes within Brazil. The codes must be traced right from the point of manufacture, even if that is outside Brazil.

Moreover, companies will have to have serialization at the unique item level as well as at the case level, and the aggregation relationship between the two - in other words the identity of individual packs in a case, has to be known and recorded.

It is estimated that pharmaceutical manufacturers have already invested upwards of $50m upgrading packaging lines to handle the coding requirements that underpin the traceability system. The overall aim is to clamp down on medicine counterfeiting and smuggling.

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