The answer to the problem of counterfeiting, at least by the European Commission, relies mainly on technology: new unfalsifiable seals, probably holographic, centralized batch tracking systems, ban on repackaging and so on. The hypothesis of complex markings of the single posological units could probably also regain ground. But this approach has not met with unanimous approval. It is true that the majority of multinationals are in favour, but even here there are significant exceptions, for example Bristol Myers Squibb. The US company doesn't like the idea of centralizing information on logistics and storage, considered part of the commercial strategy and, therefore, a sensitive matter. Not to mention that such information, if acquired by malicious people, could also facilitate fraudulent activities. BMS does not say at what point in the chain it fears these data leaks could occur, or who the thieves could be, but it has no doubts about the risk. The arguments of the EGA, the association of European generic manufacturers, are much more concrete.
For the EGA, the starting assumption is questionable, namely that there are unfalsifiable marks and impregnable IT systems. Genericists have a good time remembering that even the famous Microsoft hologram in 2003 was counterfeited. In short, relying on technology only has a positive effect in the short term, as counterfeiters soon manage to bridge the technological gap and, moreover, the false sense of security that these generate must be considered. And in the meantime, however, the costs for producers are rising: not only those for the new seals, but also those, for example, for updating the package inserts, which should be corrected to include those relating to integrity among the indications on safety of the seal. In a sector that is very sensitive to price, such as that of generic drugs, all the burdens, which can inevitably fall on the end user or on the third party payer, make the difference. For the EGA, the answer is to harmonize controls and enforce existing laws, and everyone agrees on this.
Another aspect that has created discontent is the ban on the repackaging of medicines. In truth, this measure, as well as by the European Commission, had been advocated by the European association of producers, EFPIA, and it is understandable why: the main instrument of parallel imports, which hoards the price differentials between the various countries of the 'Union, has often caused some headaches to major companies. According to EFPIA, banning repackaging is the main weapon in the fight against counterfeiting in Europe. The trade association of importers, the European Association of Euro-Pharmaceutical Companies (EAEPC) is obviously of a very different opinion, supported by the Chamber of Small and Medium Enterprises (GRTU) of Malta. Beyond the inevitable declarations on the free movement of goods and on freedom in general, the EAEPC points out that, if anything, parallel importation constitutes an additional security, since the importers check the medicine before proceeding with the new packaging, and underline how in 35 years only one case of penetration of the parallel distribution circuit by a counterfeit medicine has been ascertained. What should the European Commission do then? Increase surveillance at the borders of the EU and deal with the chapter of virtual pharmacies in a much more complete way. George Desillani
Source "PharmaMarketing"
