Source: Simepe Notícias, 12/06/2008

Federal Senate Agency

Specialists in health and pharmaceutical products, invited to participate in a public hearing this Wednesday [11] in the Senate, were unanimous in stating that the fight against counterfeiting of medicines must, necessarily, and, above all, for an effective inspection in the productive chain of these products, mainly in distribution, with tracking mechanisms that guarantee the authenticity of medicines.

The hearing took place at the Commission for Science, Technology, Innovation, Communication and Informatics [CCT] and had the objective of instructing the processing of the bill authored by Senator Valdir Raupp [PMDB-RO] which determines the mandatory identification of medicines through of electronic system [PLS 521/07]. The request for holding the debate was made by the reporter of the matter, senator Marcelo Crivella [PRB-RJ], and by the committee chairman, senator Wellington Salgado [PMDB-MG].

The “insufficiency” in the inspection of the entire drug distribution chain was recalled by the president of the Association of National Pharmaceutical Laboratories [Alanac], Carlos Alexandre Geyer, during the debates. 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.

- Before thinking about the implementation of new technologies to track and guarantee the authenticity of products, there needs to be an increasingly active and effective inspection - he said.

The president of the Brazilian Institute of Ethics in Competition [ETCO], André Franco Montoro Filho, highlighted at the meeting that the level of informality in the area "is alarming", providing "relevant damage to the development of the sector and to society as a whole". For him, combating this informality will only be achieved through a set of simultaneous actions. As an example, he suggested the adoption of an efficient tracking system and greater control of medicines distributed in the public health system.

Montoro also suggested, as a technological solution, the implantation, as a bar code in the products, of a two-dimensional system in the secondary packaging that enables tracking and authenticity systems and also guarantees access to information and minimum requirements for aggregating information in all links of the company. productive chain.

The Executive Regulatory Technical Director of the Brazilian Federation of the Pharmaceutical Industry [Febrafarma], Lauro Moretto, highlighted the positive and negative points of the project in progress. He stressed that the proposal is in line with the actions to combat counterfeiting recommended by the World Health Organization [WHO]. On the other hand, he criticized the deadline for the entry into force of the new rules, which is 180 days.

- One hundred and eighty days is a highly unworkable period. The ideal period should not be less than sixty months - he said.

Moretto also suggested that tests be carried out before the standard was published, so that the consistency and effectiveness of the proposed measure can be verified.

Cargo theft

In his presentation, the director-president of the National Health Surveillance Agency [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. This is not 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 presented for the definition of mechanisms for 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 information to track a product.

The manager of Economic Affairs, Foreign Trade and Informatics of the Association of the Pharmaceutical Research Industry [Interfarma], Marcelo Liebhardt, highlighted the losses caused by the counterfeiting of medicines worldwide. Among the main ones, he mentioned the occurrence of serious collateral health problems and even death, the loss of confidence in public health systems and brands, and also the evasion of tax revenue.

- It is estimated that, in 2010, worldwide sales of counterfeit drugs will reach U $ 75 billion, an increase of more than 90% when compared to 2005. This counterfeiting will represent 16% of the global sales of the legitimate industry - he announced.