Counterfeit Medicines
This article was originally published in SRA
Executive Summary
European proposals to combat counterfeiters generally welcomed
European proposals to combat counterfeiters generally welcomed
“Urgent and decisive” action is needed to combat counterfeit medicines in Europe, but any changes that are made should not lead to an overhaul of the existing legal systems, should allow plenty of time for implementation and should include stricter enforcement measures. According to the European Commission, public response to anticounterfeiting proposals it issued in March was generally positive, but respondents made it clear that they wanted to see a flexible system that allowed for a multitude of techniques to be used to ensure the safety/authenticity of medicines1,2.
For example, the European Federation of Pharmaceutical Industries and Associations says in its response that it supports the use of overt and covert authentication features (eg holograms, colour shifting inks, taggants), but that the technology choice should be specific to each manufacturer3. In addition, the industry federation says that it “fully supports” the commission's proposals requiring the use of tamper-evident packaging. However, it wants these measures be extended to all prescription drugs rather than implemented on a risk-based basis.
EFPIA maintains its stance that there should be a ban on repackaging, and that only the original full marketing authorisation holder and the end user should have the right to open the outer packaging. Finally, the federation says that it supports the introduction of a harmonised coding standard, but believes this would be best achieved through an end-to-end product verification system of each individual unit at the point of dispensation (ie pharmacy), rather than a full track-and-trace system such as a pedigree. With respect to the implementation of a mandatory notification procedure for manufacturers/importers of active pharmaceutical ingredients, EFPIA says that accountabilities and roles and responsibilities for any such procedure would need to be clearly defined for the different actors in the supply chain, and that agencies would have to co-operate - for example, by sharing inspection reports - to focus resources effectively.
Not surprisingly, the generic medicines industry expresses different views in its response4. The European Generic medicines Association recognises that exchanging and/or opening the outer packaging of a medicine increases the risk of counterfeiting, but it strongly believes that the use of seals and traceability systems are “expensive measures that will not stop the counterfeiting of medicines or prevent a fake medicine from reaching patients”. It adds that “over-reliance on technology will provide a false sense of security”.
Instead, the EGA agrees that the commission's proposals to make all actors of the distribution chain - including brokers, traders and agents - subject to the existing pharmaceutical legislation (Directive 2001/83/EC, as amended) would effectively combat medicines counterfeiting. Contrary to EFPIA, which says it is not clear how more frequent good manufacturing practice audits of API manufacturers would contribute to enhancing product safety, the EGA supports proposals for regular audits.
The EAEPC, which represents Europe's parallel importers, focuses much of its response on explaining why repackaging, a fundamental part of parallel trade, does not contribute to medicines counterfeiting5. Among other things, it argues that repackaging adds a layer of safety in the supply chain due to visual checks under GMP. As for introducing an obligatory product seal, the EAEPC says that it is unrealistic to assume that this would make medicine packages safer. Seals can be faked by counterfeiters and as such are not a strong deterrent, it says.
The group believes that implementation of pedigree requirements and mass-serialisation for pack tracking and authenticity checks are two important elements of the supply safety chain. However, it says any track-and-trace system should be administered by an impartial body to avoid anticompetitive behaviour. A good distribution practices certificate to be given after each wholesaler inspection, it says, would improve sourcing safety.
References
1. European Commission, Summary of Responses to the Public Consultation Document, 19 June 2008, http://ec.europa.eu/enterprise/pharmaceuticals/counterf_par_trade/conterfeit_doc/2008_06_19_summary_of_responses.pdf
2. The Regulatory Affairs Journal - Pharma, 2008, 19(4), 256-258
3. EFPIA response, 9 May 2008, http://ec.europa.eu/enterprise/pharmaceuticals/counterf_par_trade/doc_publ_consult_200803/114_efpia.pdf
4. European Generic medicines Association response, May 2008, http://ec.europa.eu/enterprise/pharmaceuticals/counterf_par_trade/doc_publ_consult_200803/101_european_generics_association.pdf
5. EAEPC response, 9 May 2008, http://ec.europa.eu/enterprise/pharmaceuticals/counterf_par_trade/doc_publ_consult_200803/130_european_association_nof_euro_pharmaceutical_wholesaler_s.pdf