EU counterfeiting response is far from generic

By Nick Taylor

- Last updated on GMT

Related tags: Fake, Bristol-myers squibb

Continuing in the series analysing the industries response to the
EU's counterfeiting measures in-PharmaTechnologist.com tackles the
generic industry's reply.

The stance taken by the European Generics Association (EGA) sets the sector at odds with vast swathes of the responses on some of the fundamental issues over how to tackle counterfeiting. The EGA's response is perhaps best summarised as: "Technical solutions do not constitute reliable prevention systems; the implementation of such measures will only stimulate counterfeiters to develop new skills and capabilities​." Fear of a counterfeiting arms race is why, unlike the majority of respondents, the EGA is opposed to the use of tamper evident seals. This standpoint is based on the idea that counterfeiters will quickly learn to make fake seals, citing the case of Microsoft's hologram being faked in 2003. If the seal is counterfeited it would cease to offer any benefits and "the costs imposed on the industry from implementing a unique seal will increase inefficiencies at the production lines and will diminish output, increasing production costs in an industry that is highly sensitive to the cost factor​". The EGA believes these costs would be to the detriment of the generics industry and those who purchase its products. It is also concerned about the practicality of updating leaflets in response to changes in safety information if the seal is implemented. In addition the EGA worries that the seal will lead to a false sense of security, creating "additional safety risks to patients​". The implementation of a centrally accessible record to facilitate batch traceability and mass serialisation are similarly dismissed by the EGA. This measure is supported by a number of big pharma companies, albeit with some exceptions such as Bristol-Myers Squibb (BMS). BMS' reasoning differs from the EGA, which is perturbed by the prospect of a record that "would revealincreases and decreases in volumes shipped, show changes in product mix, breadth and depth of product lines, changes in routing, and other specifications​", fearing it will "affect the secrecy of vital strategic company information​". The EGA does not spell out who it fears will gain access to this information but is explicit in its concerns over mass serialisation, regarding the centralisation of data as a "delightfully (from their perspective) easy target for counterfeiters​". Both these concerns are based upon the idea that "the perfectly secure technical IT system does not exist​". Underlying the whole report is the belief that technological measures do not make sense when a cost-benefit analysis is applied. From the EU's proposals the EGA regards subjecting all operators in the supply chain to pharmaceutical legislation currently in place and to tighter, more harmonised inspections as the most significant proposals. There is unlikely to be much disagreement on the worth of these points from any interested party. However, there are more points where the EU, the generics industry and big pharma have positioned themselves at loggerheads, making it unlikely all will be happy with the eventual outcome.

Related topics: Markets & Regulations, QA/QC

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