Regulatory Focus™ > News Articles > MHRA Launching New Anti-Counterfeiting Strategy

MHRA Launching New Anti-Counterfeiting Strategy

Posted 08 May 2012 | By Alexander Gaffney, RAC 

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is unveiling a new Falsified Medical Products Strategy it says will improve its existing anti-counterfeiting strategy by enhancing communication, collaboration and regulatory activities between MHRA and stakeholders.

The agency's updated strategy will seek to enhance its original strategy by focusing on preventing counterfeit products, changing how counterfeit products are handled once they are found and how investigations into counterfeit products occur.

MHRA said is hopes better communication and increased collaboration can help it to prevent counterfeit medicines from entering the supply chain, while an incident response plan can help regulatory authorities zero in on if the product represents a threat to public health and where the product came from.

Finally, MHRA said it hopes to enhance its Enforcement Group to go after counterfeiters and partner with international organizations including INTERPOL, Europol and the World Customs Organization to better coordinate its enforcement activities.

The updated strategy advances an earlier one released in 2007, which MHRA said was responsible for "a marked reduction in known incidents of falsified medical products which have penetrated the regulated UK supply chain."

MHRA highlighted a number of factors that could have led to the reduction in pharmaceutical counterfeiting, including a weaker exchange rate for the pound relative to the Euro, a growing awareness of counterfeit medicines, increased vigilance and decreased supply as the result of high-profile prosecutions of counterfeiters.

The 2012 update to the Falsified Medical Products Strategy also comes as multiple instances of fake Avastin (bevacizumab) within the UK pharmaceutical supply chain have highlighted MHRA's lack of resources to adequately oversee wholesalers in the country, which are largely responsible for ensuring the integrity of the supply chain.

Malcolm West of the Association of the British Pharmaceutical Industry told Reuters in April the group is "concerned that the MHRA doesn't have sufficient resources to inspect all the premises that have a wholesale dealer license."

Read more:

MHRA - Falsified Medical Products Strategy

Securing Pharma - UK regulator launches new counterfeit medicine strategy

Anticounterfeiting Strategy Launched in UK

U.K. regulators toughen focus against counterfeit devices and drugs

Regulatory Focus - Report: Second Instance of Fake Avastin Highlights MHRA Troubles

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