MHRA launches new action plan to combat UK counterfeit hub
UK Medicines and Healthcare products Regulatory Agency (MHRA) last
week launching its new three-year action plan to tackle the recent
surge in drug fakes head on.
While drug counterfeiters tend to manufacture their illegitimate wares in locations such as China or India, the UK has become a key hub for drug fakers as they realise that the presence of a British stamp on their packages adds credibility to their operations. This has resulted in a surge in the volume of counterfeit medicines distributed from the UK, as well as an increase in products finding their way into the UK supply chain and potentially reaching patients. In a bid to stem the flow of drug counterfeits in and out of the UK, the MHRA has kicked of its first dedicated anti-counterfeiting strategy, launched last week at an international conference in London. Currently still riding on a wave of success following the overthrow of the largest drug counterfeiting ring in the UK's history, the MHRA has formulated a strategy based on three broad concepts of communication, collaboration and regulation. The agency plans to set up a 24-hour anti-counterfeiting hotline for healthcare professionals and the public to report any counterfeiting suspicions, alongside an online reporting system via its website. While communicating risks to the public is a key issue in the MHRA's anti-counterfeiting campaign, there are some concerns that members of the public may end up with a disproportionate view of the problem, causing them to stop taking their medication or become unduly concerned about a relatively small risk. Communication and collaboration with various stakeholders, however, is of paramount importance, and the MHRA has established links with the World Health Organization (WHO), Interpol, the European Commission and a number of other agencies to ensure that its strategy addresses the global nature of drug counterfeiting. A close working relationship with pharmaceutical manufacturers is also a critical feature of the MHRA's plans. The agency is inviting industry trade associations and law enforcement to participate in Anti-Counterfeit Stakeholders meetings every six months, in order to share intelligence and identify potential threats to the UK pharmaceutical supply chain. The last meeting, for example, identified 14 products that were added to the MHRA watch list representing those counterfeit medicines most likely to be encountered in the UK. Acknowledging the major role that the Internet and online pharmacies now play in the trade of counterfeit drugs, the agency's Intelligence Unit will also be monitoring the web for any drugs identified on the current watch list, and carrying out covert test purchases. Dedicated 'Internet Days of Action' will also continue, focusing on those websites most active in the UK suspected of supplying counterfeit medicines or other breaches of medicines legislation. In terms of regulation, the MHRA's three-year plan centres on continuous 'threat assessment' of the risk of counterfeit medicines and medical devices in the UK. With targeted market surveillance projects and international monitoring of counterfeiting activity, the agency hopes to be able to identify key areas or weaknesses in current legislation. Although the UK may only represent a transit point and distribution hub for drug counterfeiters rather than a manufacturing destination, fake medicines are increasingly finding their way into legitimate supply chains. Incidents have steadily increased over the last few years, with counterfeit meds reaching patient level on nine occasions since 2004, and reaching wholesale level on five occasions. A further worrying trend is the progression of counterfeiters from so-called 'lifestyle' drugs such as erectile dysfunction or weight loss pills, to 'life saving' drugs such as cardiovascular or cancer medicines. The strategy unveiled by the MHRA last week intends to ensure cases of potentially harmful fake drugs entering the supply chain are few and far between, and to make the UK a less attractive market for drug and medical device counterfeiters. More information on the scheme can be found here.