The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new anticounterfeiting strategy with the aim of curbing the occurrence of falsified medicines in the county’s supply chain. The strategy will focus on prevention, incident management, and investigation of all reports of falsified medicines in the UK.
To help prevent counterfeits from reaching patients, MHRA says it will use a combination of market surveillance and testing, vigilance at UK ports, and pharmacovigilance. In addition, the agency highlighted the importance of establishing networks to facilitate exchange of information and cooperation. The agency also sees communicating the danger of counterfeit medicines as a priority.
When receiving a report of counterfeit medicines, MHRA will take immediate action, which involves quickly conducting an initial assessment with a focus on minimizing the risks to public health. Working relationships with relevant public or private entities will also be important.
All cases involving reports of falsified medical products to MHRA will be investigated, particularly with regards to where the product came from and then tracing payments through bank accounts. MHRA believes that prosecution and confiscation of any financial proceeds from counterfeit medicines is an effective method of making fake medicines a less attractive option for criminals.
This is the second such strategy that MHRA has implemented. The first was launched in 2007, following several incidents of counterfeit products being identified in the legal pharmaceutical supply chain. Since this time, the agency has seized counterfeit medicines worth more than £25 million ($41 million).
“The UK market for medicines is immense and is estimated to be worth around £8000 million [($13 billion)]. Combating the real and present threat posed by counterfeit medical products continues to remain a priority for the MHRA,” explained Nimo Ahmed, MHRA’s acting Head of Enforcement, in a press statement.
According to MHRA, the number of incidents of counterfeit medicines reaching pharmacies and patients via the regulated supply chain has decreased since 2007. During this time, MHRA has also reported on several success stories. In 2010, an international operation resulted in more than 2 million doses of fake medicines being seized, as well as 90 arrests and the closure of 500 websites. More recently in 2011, more than 13,500 illegal websites were taken down or suspended and 2.5 million doses of medicines were seized. In March 2012, 300,000 doses of counterfeit pharmaceuticals were seized in a joint operation across Europe.
Unregulated websites are a significant source of falsified pharmaceuticals. According to MHRA, the UK is used as a transit and fulfillment center for orders placed on websites operated in other countries, which gives the end consumer the impression that the product is supplied from the UK.
See related articles:
Anticounterfeiting Success in the UK (PharmTech Talk blog)
Stepping up the Fight Against Counterfeiters (Pharmaceutical Technology Europe)