This report, published in April 2023, was intended to widen visibility of MHRA’s regulatory failures to Parliamentarians, the media and the public.

We sent a copy to all MPs & Peers. If you share our concerns we’d be grateful if you would sign the open letter to the Health Secretary here

The report’s findings about systemic failures in MHRA’s regulation of medicines relate principally to the fact that it does not follow any of the safety management processes than exist in other safety critical sectors (eg aviation, defence, nuclear, oil & gas, rail):

• it does not define the tolerable rate of fatal and serious side-effects of new medicines.  If it did, it would have a clear threshold for action if subsequent evidence of reduced benefit or increased risk emerges after Authorisation.  This probably explains MHRA’s slowness to act when subsequent problems emerge, as has happened with many medicines not just the Covid vaccines;
• it does not investigate all Yellow Card reports of fatal/serious adverse events potentially linked to a medicine;
• it does not assess the likelihood of causation – that the medicine caused the death/side-effect or not;
• there is no delegation to individuals of safety responsibility/accountability;
• there is no routine senior management governance of safety risks across all medicines;
• There have been no safety audits of MHRA.

And in relation to the Covid vaccines in particular :

• it licensed the vaccines based on limited short term data and no long term data
• it licensed the novel Covid mRNA therapies as vaccines (which have lower regulatory requirements);
• it failed to identify and address problems with manufacturing and quality control.  This led to batch quality problems;
• it tacitly allowed promotion of the Covid vaccines based on relative percentage benefit (a large number), not absolute benefit (a small change in a very small number).  This compromised informed consent;
• it consults the Commission on Human Medicines about the risk/benefit of all medicines and the minutes are published – all except those relating to the Covid vaccines.  Again, this compromised informed consent;
• it did not act on problems with the AstraZeneca Covid vaccine despite other national Regulators suspending and withdrawing it for certain age groups;
• it did not follow through on its promised ‘4 strand Proactive Vigilance’; and
• it seems to be ignoring ever increasing evidence of Covid vaccine risks, notably blood clotting, heart inflammation, neurological conditions, immune downgrading, and menstrual disorder.

Patrick Vallance summed up the whole problem in 2014 : 

“In the future, medicines will come to market quicker with less data, with more research being conducted in the post-license phase.”

Our view is that there must be a full independent inquiry launched into MHRA’s regulatory processes and performance. Otherwise, the same safety problems as identified by the Cumberlege Report, and evidenced in relation to the Covid vaccines, will just happen again and again.