Brazil joins forces with Mercosur partners on counterfeit medicines

Brazil has announced a plan to work with partner countries in the Mercosur trading block on the development of a proposed traceability scheme for medicines.

The resolution - announced by Brazil's Ministry of Health earlier this month - would see Brazil work on a coordinated anti-counterfeiting strategy for medicines with its main Mercosur partners Argentina, Paraguay and Uruguay.

In addition to "systems, mechanisms and technologies for traceability of medicines and medical products," the notice indicates that the partners would collaborate on legislative development, information-sharing, development of guidelines for anti-counterfeiting strategies and training programmes. The four countries already operate a customs union.

Other collaborative measures outlined in the document - available to view (in Portuguese) here - include systems to identify fake medicines on the market and to coordinate the investigation of counterfeiting cases.

Brazil has been mulling over a serialisation programme for medicinal products in accordance with the 11.903 law, which was implemented in 2009. However, it delayed its plans earlier this year on the back of industry resistance to the proposals, which involved the printing of GS1-compliant 2D datamatrix codes containing a serial number unique to each medicine pack onto security labels, which would be produced and supplied by the national mint.

In the face of resistance a working group was set up by Brazil's health ministry, the national medicines authority ANVISA and other stakeholders to look into revising the proposals and potentially dropping the security label requirement. An initial 60-day period to review the plans (from March 3) has since been extended by another 60 days.

Meanwhile, Argentina published its own draft proposals in April (Resolution 435/2011) which also calls for a mandatory authentication and traceability systems for medicines to be introduced, from the point of production to the point of dispensing.

The decision to take a Mercosur-wide approach to the problem actually dates back to 2007, when the Health Ministers of the countries agreed to develop an inter-agency strategy to combat counterfeiting, as well as a traceability system for medicines, according to Oswaldo Gabriel Jara, legal manager at Argentinian pharmaceutical equipment specialist OneLite. This was adopted by the Common Market Group the following year.

He told the 6th Global Forum on Pharmaceutical AntiCounterfeiting last month that around 10 per cent of the medicines circulating in Argentina are fake. From a regional perspective, Latin America recorded the second highest number of counterfeit, diverted and stolen medicine incidents (348) in 2009 behind Asia (1,073) and ahead of Europe (327), according to data from the Pharmaceutical Security Institute.

Adoption of a traceability scheme by these four countries could encourage economically-smaller states in the Mercosur block - so-called associate partners such as Bolivia, Chile, Colombia, Ecuador and Peru - to follow a similar path.