Guaranteeing the safety and security of the pharmaceutical supply chain has become a growing concern for everybody working in the pharmaceutical industry both in the UK and further afield. The risk of counterfeit medicines entering the legitimate supply chain is now greater than ever before and there is growing concern over the capabilities of the present supply chain system to deal with more sophisticated and structured criminal activities. Falsified medicines are a growing threat to public health with 27.4 million doses being seized at European borders over the last five years - that doesn’t even begin to take account of medicines that make it through border controls undetected!
Since 2004, there has been 10 cases of counterfeit medicines reaching patients while seven others have been seized at the wholesale level. Falsified medicines may contain low quality ingredients or the wrong dosage. Their source or identity can be deliberately mislabelled, with fake packaging and the wrong ingredients. All of these factors present a risk to the patient notwithstanding the fact that they are not receiving the medicines intended to treat their medical condition. There is a huge variation in standards, and the more sophisticated copies can look identical to the original pack.
The Falsified Medicines Directive was developed to tackle this increasing problem. The directive aims to stop falsified medicines reaching patients by introducing harmonised pan European safety and control measures. The procedures will enable easier identification of falsified medicines and enhance controls within the EU and its borders. The directive has four elements including: stricter control of active substances being imported into the EU, a tightened control of the supply chain including all agents and brokers, the requirements for safety features on packs of medicines (incorporating unique serialisation codes and tamper evidence) and controls being placed on medicines sold over the internet.
The directive was passed in June 2011 and will be legally enforceable in the UK by 2017. We await clarity on some elements of how it will be implemented and this is expected at the end of 2014. The ABPI and other stakeholders are working together to build the technical solution and call on the Medicines and Healthcare Regulatory Agency (MHRA) to engage in closer collaboration to address UK implementation of the directive. We believe that this directive will make a real difference by tackling a growing problem.
Membership Services Director