Although the medication traceability project has been a federal law for six years, the initiative ‘Two medication RG’ isn’t yet operating in Brazil. In fact, in the face of continuing criticism from different sectors the National Agency for Healthcare Vigilance (Anvisa) is working on a new, less controversial model.
The objective of the system is to prevent the falsification of medications and the distribution of expired batches and to accelerate the recovery of products in the event of problems or adulterations.
In practice, it seeks to monitor the path of the packages throughout the sales chain, i.e.: from the moment they leave the manufacturer and distributor, passing through the pharmacies, until they reach the consumer. Traceability, in this regard, will be possible via the printing of a two dimensional code and an identification number on the package of each product.
However, the industry in Brazil has come out against the system because the way it is currently set up means that the data obtained will be the property of the manufacturers and will allow them to know the location of the products. The sector, especially small companies, claims that there are risks in sharing so much information with other laboratories and there are worries that the system will harm commercial competition.
This is why directors at Anvisa decided to suspend the implementation schedule. The first stage, planned for the end of the year, had involved the different pharmaceutical laboratories presenting three batches of traceable medications in order to carry out a kind of pilot test with formal implementation of traceability beginning next year,
Now, in contrast, the agency will propose its own centralized model to administer the data generated by traceability. In this case, the government will receive the medications data directly from the industry, distributors and sales points, without intermediaries.
Anvisa claims that the Brazilian pharmaceutical market has significant scale issues that make for difficulties in tracing medications in comparison with countries that are more advanced in the issue such as Turkey and Argentina. In Brazil 2014, over six thousand products were sold in around four billion packages distributed across over 71 thousand private pharmacies.
