How big is the problem?
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The nature and extent of the counterfeits threat in Europe was a matter of some discussion.
Dr Domenico Di Giorgio of the Italian medicines agency, AIFA, cited the "unofficial" WHO estimate that the share of counterfeit medicines in well-controlled industrialised markets was less than 1%. "To some people that seems a small figure but I think we should stress the risk profile," commented John Chave, secretary general of the Pharmacists Group of the European Union (PGEU). "So we need to act on the basis of precaution."
Conversely, Hugo Carradinha, senior manager, health economics affairs for the European Generic Medicines Association (EGA), saw the 1% estimate as good reason not to "kill a mouse with a tank". What nobody denied was that counterfeit drugs were a serious matter, whatever the scale of infiltration. As Di Giorgio noted, even 1% was enough "to be a danger to patients".
Jim Thomson, chair of the European Alliance for Access to Safe Medicines, argued that if generics accounted - as Carradinha had stated - for 18% of the European market by value but for nearly 50% by volume, that in itself was a justification for mandatory safety features across the board.
Ultimately, the very nature of counterfeiting makes it a difficult phenomenon to quantify or pin down. Yet definitions are important, as Marisa Matias, the new rapporteur for the proposed directive in Parliament's Committee on the Environment, Public Health and Food Safety (ENVI), made clear. That is something the ENVI committee will be looking at closely as the Commission's proposal moves through the first stage of parliamentary appraisal. On the agenda are issues such as how to classify 'falsified' medicinal products, measures addressing excipients, and whether the proposed directive should extend to the export of medicines.
Given that pharmaceutical manufacturers are already applying security features to "high risk" medicines and the problem has not diminished, it is clear that more must be done. If only a small number of products are protected, the risk profile of the non protected items increases. Furthermore, with a number of blockbuster products that have already been counterfeited coming off patent in the next two years, the risk profile of generics products is also set to increase.