The Medicines and Healthcare products Regulatory Agency (MHRA) - the body responsible for ensuring the safety and efficacy of medicines used in the UK has come under repeated fire from MPs for failing patients.
MPs named one medical scandal after another as examples of where the MHRA were too slow to act leading to devastating consequences, including patients left with debilitating pain or children born with physical or learning difficulties.
The debate led by Tatton MP Esther McVey largely focussed on the failing and voluntary Yellow Card Scheme, which allows the suspected adverse reactions to drugs and medical devices to be reported, as well as the funding of the MHRA, 75 per cent of which comes from the pharmaceutical industry they are overseeing leading to calls of conflicts of interests.
MPs said the Yellow Card scheme was not fit for purpose, given there was no legal requirement for medics to report adverse events or reactions and patients also knew very little about it.
Ms McVey said: “This reporting scheme should be a valuable source of information about possible harms to act as an early warning system.
“Under-reporting is a big problem because it makes it difficult to spot safety signals and assign causation. This then translates into unnecessary harm or deaths with devastating side effects from treatment going unnoticed for months, years or even decades.”
Among the scandals were surgical meshes which left thousands of women in agony, along with home based pregnancy test Primodos and anti-epileptic drug Sodium Valporate both linked to physical and learning difficulties in children (born to mothers who had taken the drugs), along with multiple other examples. Scientific papers show concerns over Sodium Valproate as early as the 1980s, yet warnings were not added to packaging until 2016.
Ms McVey wants a mandatory requirement on all healthcare professionals to report suspected adverse reactions to the yellow card system, as is the case in Denmark and Sweden. She hopes the small change will protect patients and highlight issues with drugs or devices much earlier.
