EU publishes responses to anti-counterfeit proposals
proposals for tackling the problem posed by counterfeit medicines.
Responses were received from 100 organisations, giving the views of every sector of the pharmaceutical industry from big pharma to patient groups, excipient manufacturers to parallel importers. There is a colossal amount of information contained in the responses, which in-PharmaTechnologist.com has begun to tease out the pertinent points from. From the active pharmaceutical ingredients (API) industry there were very similar responses from DSM and the European Chemical Industry Council (CEFIC). Although both were in support of the EU's goals they regarded the proposals as being "too vague" with regards to APIs. The documents go on to list 10 legislative points which they regard as "absolute musts" for tackling counterfeit APIs, covering areas including mandatory GMP certification of APIs, worldwide inspections and tougher penalties. Tougher penalties are a theme that runs through numerous responses, with PhRMA in particular calling for tougher sanctions. Out of all of big pharma Pfizer has been hardest hit by the trade in illegitimate pharmaceuticals, with Viagra a favourite of counterfeiters. The pharmaceutical giant is broadly in support of the EU proposals but seeks clarification in several areas and also states the need to tackle purchases over the internet. In addition it highlights the increasing complexity and fragmentation of the supply chain and raises concerns over the rise in parallel trade. It goes on to say that the number of parallel trade licenses "of one Pfizer product alone" has risen from 18 in 2000 to 76 in 2006. The Malta Chamber of Small and Medium Enterprise is one of the bodies to launch a riposte to attacks on parallel trade by big pharma, stating it is necessary for its populace to get access to affordable medicines. Another group whose response stated a desire to maintain the flow of affordable medicines is the European Generics Association (EGA). The EGA document claimed generic medicines are not reported to be subject to counterfeiting in the EU. Nonetheless, it still felt the proposals could impact on generics manufacturers and was keen for the EU to abandon plans to use seals and traceability systems to stop counterfeiters. The EGA believes such measures would not stop counterfeiting but instead provide a false sense of security and substantially increase the cost of manufacturing generic medicines. It instead calls for better enforcement of current legislation and greater international cooperation. The need for greater international cooperation is felt throughout pharmaceutical industry, with excipients being no exception. Consequently the International Pharmaceutical Excipients Council (IPEC) issued a response, although excipients were not directly referred to in the EU's proposal. This is an issue that IPEC seeks clarification on, calling for the Commission to explicitly include or exclude excipients from its proposals. Beyond this IPEC uses the EU proposals regarding APIs to highlight how its own house is in order as its guidelines already cover tamper evident seals and batch traceability. This gives a brief overview of the key points from some of major players in the industry. Over the coming days in-PharmaTechnologist.com will be picking apart the responses from different sections of the industry in greater depth.
