(2) what assessment of the risk from counterfeit medicines and devices the Medicines and Healthcare Regulatory Agency has made in each of the last 12 months;
(3) how many instances of counterfeit medicines or devices in the supply chain have been discovered in each of the last four years;
(4) what assessment he has made of the effectiveness of his Department’s anti-counterfeiting strategy.
The supply of counterfeit medicines is a growing problem worldwide and one which the Government are taking very seriously.
The Medicines and Healthcare products Regulatory Agency (MHRA) has therefore introduced a 24-hour anti-counterfeiting hotline in November 2007 as part of the Agency’s Anti-Counterfeiting strategy. The Strategy was launched in November 2007. It sets out a three year plan and contains a commitment to audit activities carried out under it. A review is planned for the end of the three year period. The cost of the designated telephone is currently £65.00 per quarter, which is met from the Agency’s overall telecommunications budget and it is manned by MHRA personnel as part of their normal duties. To date, 64 reports have been received (via e-mail, website, telephone and letter). All were responded to and none have proved to be counterfeit.
The MHRA has analysed in detail all of the cases of counterfeit medicines which have been discovered in the United Kingdom supply chain. This study has also contributed to the European Commission’s proposals to tackle counterfeit medicines which are currently subject to public consultation. It has also contributed to a comprehensive review of the UK supply chain which has also been released for public consultation.
A ‘watch list’ of counterfeit medicines and medical devices which may appear in the supply chain has been established and circulated to Customs, police and other regulators to be aware of, and to deal with, potential threats.
The number of instances that counterfeit medicines and Devices have been found in the supply chain in each of the last four years is in the following table. The figures given are for every individual instance and may feature the same type of medicine or medical device on more than one occasion.
Medicines Devices 2005-06 1 4 2006-07 2 5 2007-08 5 2 2008-09 0 0
There have been no reports of counterfeit medicines discovered in the regulated supply chain since May 2007.