Counterfeit medicines rarely reach patients through the regulated supply chain and are more commonly available to consumers via unregulated websites. Although no fatalities have been attributed to counterfeit medicine in the United Kingdom, it is acknowledged that all counterfeit medicines are dangerous and pose a risk to patient health.
In response, the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health with responsibility for regulation of medicines for human use and medical devices, has developed and implemented a comprehensive anti-counterfeiting strategy to combat the threat posed by the infiltration of counterfeit medicines and devices into the UK market.
A number of public awareness campaigns have been delivered, both by MHRA and also by MHRA in conjunction with other stakeholders such as the General Pharmaceutical Council and patient groups.
The MHRA monitors the internet for websites operating within the UK supplying medicines illegally, makes test purchases from these sites and, as a result, has successfully prosecuted a number of individuals. All referrals involving suspected counterfeit medicines are investigated thoroughly and necessary action is taken to protect public health. Enforcement activity is closely co-ordinated with other enforcement authorities around the world and MHRA regularly engages in international initiatives to tackle this issue.
The MHRA also chairs an anti-counterfeit stakeholders group, with representatives from, among others, UK police forces, regulators and industry, where intelligence concerning counterfeit medicines is regularly reviewed and assessed.
New requirements for wholesalers and distributors of medicines will be introduced by the falsified medicines directive in January 2013. Further proposals affecting the pharmaceutical industry are being considered as part of the UK supply chain review.