Date lodged: 4 October 2016
To ask the Scottish Government, further to the answer to question S5W-00491 by Shona Robison on 16 June 2016, what communication it has had with the (a) Medicines and Healthcare Products Regulatory Agency and (b) UK Government regarding action that is being taken to ensure that counterfeit medical products and medicines are not being used in the NHS.
Answered by: Shona Robison 1 November 2016
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices in the UK. Any allegations regarding the use of counterfeit material, or any other adverse event, are investigated by the MHRA and device and drug alerts are issued as required.
With reference to the alleged use of counterfeit material in Boston Scientific's trans-vaginal mesh products, I can confirm that the Scottish Government has contacted the MHRA on more than one occasion, most recently at the beginning of October. To date, the alleged use of counterfeit material has not led to any reported adverse events associated with the devices, and the MHRA has not therefore been required to take enforcement action or to issue any device alerts.