Author: Jornal do Senado

Source: Ultima Hora, 12/06/2008

Specialists in health and pharmaceutical products were unanimous in stating, during a public hearing in the Senate, that the fight against counterfeiting of medicines requires, necessarily and primarily, an effective inspection in the production chain, especially in distribution, with tracking mechanisms that guarantee the its authenticity.

The hearing took place at the Commission for Science, Technology, Innovation, Communication and Informatics (CCT) and aimed to instruct the processing of the bill (PLS 521/07) authored by Senator Valdir Raupp (PMDB-RO) which determines the mandatory identification of medicines through an electronic system. The request for the debate was made by the rapporteur, Marcelo Crivella (PRB-RJ), and by the chairman of the collegiate, Wellington Salgado (PMDB-MG).

The “insufficiency” in the inspection of the entire drug distribution chain was recalled by the director-president of the Association of National Pharmaceutical Laboratories (Alanac), Carlos Alexandre Geyer. He emphasized that the Ministry of Health has managed to reduce counterfeiting of medicines in Brazil, but that the lack of inspection is still very great.

The president of the Brazilian Institute of Ethics in Competition (ETCO), André Franco Montoro Filho, suggested the implementation of a two-dimensional system in the secondary packaging that enables tracking and authenticity systems and also guarantees access to information in all links of the production chain.

Lauro Moretto, technical regulatory executive director of the Brazilian Federation of the Pharmaceutical Industry (Febrafarma), stressed that the project under examination is convergent with the actions to combat counterfeiting recommended by the World Health Organization (WHO). However, it restricted the period foreseen for the entry into force of the new rules, which is 180 days. The ideal period, in your opinion, should not be less than 60 months.

Cargo theft

The CEO of Anvisa, Dirceu Raposo de Mello, explained that, currently, cargo theft is more worrying than the falsification of medicines. “It was easier to steal cargo than to assemble an entire structure aimed at counterfeiting. I don't mean to say that the counterfeiting is over, but that the theft of cargo has changed the profile [of the sector] that existed a little before, ”he explained.

Among the minimum requirements for the definition of mechanisms for the traceability and authenticity of medicines, Dirceu Raposo suggested the existence of capacity and ease of immediate identification of the authenticity of a product, the presence of a unique medicine identifier (IUM) and the availability of access to information to track a product.

The manager of the Pharmaceutical Research Industry Association (Interfarma), Marcelo Liebhardt, highlighted the damage caused by counterfeiting of medicines worldwide. He cited the occurrence of serious collateral health problems and even death, the loss of confidence in health systems and brands and the evasion of tax revenue.

- It is estimated that in 2010 global sales of counterfeit drugs will reach US $ 75 billion, an increase of more than 90% compared to 2005. This counterfeiting will represent 16% of the global sales of the legitimate industry - revealed Marcelo Liebhardt.