The threat of counterfeit medicines is substantive and growing. Counterfeit medicines have been documented in every therapeutic category and in every region of the world. Recent cases of, for example, counterfeit oncology treatments underline the urgent need for action and stringent measures to protect patients worldwide. In its annual report on European Union customs enforcement of intellectual property rights, released on July 24, the European Commission put forward numbers and statistics clearly highlighting the increasing threat of counterfeit medicines entering the bloc – with medicines among the top categories of articles stopped by customs in 2011. 

With figures showing a significant increase in detained postal packages, 36 per cent of them concerning medicines, the commission report confirms the growing trend of counterfeit medicines being ordered over the internet, often from websites that hide their physical identity. According to the European Alliance for Access to Safe Medicines, 60 per cent of medicines purchased online are substandard or counterfeit. During the 2011 Interpol-led Pangea IV annual week of action, which aims to tackle the online sale of counterfeit and illicit medicines, 2.4 million such pills were confiscated and almost 13,500 websites shut down.

As more and more patients look to the Internet for the supply of medicines, the European Federation of Pharmaceutical Industries and Associations – in partnership with our sister organisations – is proactively engaged to protect their safety. Together we are committed to promoting access to safe and efficacious medicines, advocating for robust patient education and awareness, and combating unsafe medicines, including those sold by illicit online pharmacies. We support the individual and cooperative work of public authorities and international organisations, and encourage voluntary and cooperative action taken by private sector stakeholders, such as the Centre for Safe Internet Pharmacies initiative launched on July 23 in the United States. All stakeholders must join forces in order to combat the threat of counterfeit medicines and protect patient safety. 

At EU level EFPIA, together with the European Licensed Parallel Distribution Industry, the Groupement International de la Répartition Pharmaceutique, and the Pharmaceutical Group of the European Union – the respective European organisations of parallel distributors, wholesalers and pharmacists at EU level – has proactively initiated a project to identify concrete options for establishing a system for the verification of pharmaceutical products in Europe to secure the legal supply chain, in compliance with the EU falsified medicines directive, adopted last year. This pan- European product verification system is to be run by stakeholder organisations on a non-profit basis. 

This serialisation project, the European Stakeholder Model, ensures verification of product authenticity by professionals at the point of dispensing and provides a modern technology solution, using 2D barcoding, that will enhance patient safety as well as having the potential to generate additional spillover benefits in the future. Potential advantages include the possibility of allowing for the automated checking of expiry dates, better pharmacovigilance, a reduction in the number of fraudulent reimbursement claims, higher effectiveness in preventing recalled products from being supplied to the patient, more efficient handling of product returns, and improved stock management processes for pharmacies. 

Following our joint submission to the European Commission public consultation on the delegated act for safety features, we are now looking forward to further engaging with interested parties such as patients and national public authorities in order to explore opportunities for further collaboration. Patient safety must come first. Using counterfeit medicine represents a health risk and there is therefore an inherent need to focus on ensuring that the supply chain is as safe as possible and encourage patients to buy from reliable sources. We are proactively engaged in ensuring patients have access to safe medicines.

(Source: Public Service Europe, 30 July 2012 - by Camilla Kent Hansen, Market Access Manager, EFPIA)