Counterfeit Medicines
Counterfeit medicines are any brand (or generic) medicines and active pharmaceutical ingredients (APIs) that are deliberately and fraudulently mislabelled by unauthorised parties with respect to source, and / or composition and / or therapeutic quality. They include products without active ingredients, or with the wrong active ingredients, or with insufficient active ingredients, or with fake packaging. Sometimes they contain substitutes, or are diluted with foreign or toxic bodies, to increase the quantity of the original medicine.
The World Health Organisation (WHO) estimates that 8% to 10% of the medicines in the global medicine supply chain are counterfeit, reaching as high as 25% in some countries. The largest counterfeit market with close proximity to the EU is Russia, where it is estimated that 12% of medicines are counterfeit (1). Counterfeit medicines are entering Europe’s legitimate supply chain in increasing numbers. More than 8.8 million counterfeit medicines packs were seized at Europe’s borders in 2008, a 118% increase on the previous year (2). According to the World Health Organisation, around one percent of medicines in Europe are now counterfeit (3).
To date Ireland has had few incidences of counterfeits attempting to enter the legitimate supply chain however continued vigilance is required. The reality is that as long as repackaging and breaking of seals in the distribution chain is allowed, patient safety will be at risk and the potential for more incidences will only increase.
IPHA encourages patients to purchase prescription medicines through authorised distribution channels only and continues to raise awareness of the dangers of purchasing medicines online. A report published in 2008 revealed that a frightening 62% of medicines purchased on the internet were fake or substandard (4). The pharmaceutical industry spends billions in developing reliable, safe, life-saving and life-enhancing medicines. The system that enables such medicines to reach patients, through the collaboration of regulators, pharmacists, healthcare professionals and the manufacturers of medicines, has protected Irish consumers very successfully.
The European pharmaceutical industry has proposed a European verification system to enhance supply chain security. A pilot project was conducted in Sweden in 2009 (Download the Pilot Project Report). Industry has also called for a ban on repackaging of pharmaceutical products; clearly defined liabilities for all involved in the distribution chain (including brokers, traders and agents); stricter auditing rules and controls of the supply chain; application of penalties for trafficking in counterfeits and for patients to be encouraged to purchase prescription medicines through authorised distribution channels only.
Industry calls for increased Good Manufacturing Practice inspections on a risk basis in non EU countries; the use of tamper evident packaging; strengthening of product verification at individual pack level by using a coding solution and auditing of the entire medicines supply chain. Only when these are implemented will European patients be guaranteed a genuine pharmaceutical product.
Video: Coding Solution Pilot Project
- Association of International Pharmaceutical Manufacturers (AIPM) and the Coalition for Intellectual Property Rights (CIPR) 2002
- Report on EU customs enforcement of intellectual property rights 2008 (page 22) http://europa.eu/rapid/pressReleasesAction.do?reference=IP/09/1106
- Counterfeit Medicines – a New Update on Estimates. Position statement by the International Medical Products Anti-Counterfeiting Taskforce (WHO). November 2006.
- Counterfeiting Superhighway (EAASM) 2007 http://www.eaasm.eu/Media_centre/News/
The_Counterfeiting_Superhighway