MHRA And Govt Must Provide Clarity On Yellow Card Scheme

Legal Experts Make Call As New App For System Is Launched

15.07.2015

Specialist lawyers who represent people injured as a result of defective medical devices and medicines have urged that steps are taken to ensure the effectiveness of the system designed to monitor the safety of drugs, as access to it becomes available via an app.

A free app has been launched for the Yellow Card Scheme, which was first introduced following the Thalidomide scandal in 1964 to act as an early warning system related to adverse reactions related to healthcare products.

The scheme allows patients, carers and healthcare experts to report concerns or side effects linked to drugs to the Medicines and Healthcare products Regulatory Agency (MHRA), while they can also monitor news or alerts related to specific medications.

Specialist product liability lawyers at Irwin Mitchell have welcomed the move in principle, but have also urged that the MHRA and Government provide more clarity around key issues which the launch of the app raises.

Expert Opinion
“While bringing the Yellow Card Scheme into the 21st century has to be commended, the launch of the app raises questions that we feel both the MHRA and the Government should answer.

“We continue to have concerns that despite its best intentions, the scheme may not pick up on all vital issues. On the other hand, there are also concerns of confusion as a result of double reporting by patients and healthcare professionals, so clarification of the systems in place to prevent this would be welcomed.

“Other aspects of concern include how the data gathered will ultimately be used. In addition, there are no indications of the structure or process under which action will be taken by the MHRA – ie. will action only be taken after a specific number of adverse incidents have been reported and how does the body assess these.

“Providing this level of transparency should go some way towards ensuring that patients and others in the healthcare sector fully understand how any concerns raised will be handled – reassuring them that any issues are dealt with promptly and robustly.”
Kevin Timms, Solicitor