I’m retired but I worked for 20-plus years in a safety critical sector where I was legally accountable for the safety of hundreds of products which I authorised for use. So I know a robust safety management system when I see it. From what I’ve found out about the MHRA, I don’t think its safety management is as robust as those responsible for it seem to think. Consider two pieces of evidence: safety audits and the processes for investigating reports of adverse events linked to medicines including vaccines.
In the organisation in which I worked, we were subject to safety audits at least once a year. I know it’s similar in other safety critical sectors like aviation, nuclear, oil and gas and transport. But not, it turns out, in the MHRA, the organisation responsible for authorising medicines for public use.
I submitted an FOI request for a copy of MHRA’s last independent safety audit report. I was sent the two pages covering safety management from a 50-page audit report (dated February 2020) by the British Standards Institute against the requirements of ISO9001, a Quality Management standard.
Believe me, there’s a world of difference between a Quality Management audit and a Safety Management audit. First, quality is about compliance; safety is about risk. Here’s a simple example of the difference in another sector. If you’re still not convinced, consider that an ISO9001 auditor requires no knowledge, qualifications or experience in safety management. So the safety extract from the Quality audit report is just saying that the auditor had seen a selection of MHRA safety-related documents or processes, or seen evidence that they existed. The auditor can’t say whether they are the right processes for robust safety management or ask searching questions about safety. I could go on but you get the picture.
There’s another major problem. The Human Medicines Regulations – which are the legislation governing medicines for public use in the U.K. – require (Part 11, Section 180) “audit of MHRA’s pharmacovigilance system every two years”. So, not only has it been meeting that requirement with Quality audits not Safety audits, but the most recent one it sent me in May 2022 was dated February 2020. This means that it is either defaulting against the Human Medicines Regulations or it’s got someone to approve it not doing the statutory audits while it’s busy monitoring the Covid vaccines rollout. Was that the work of the Secretary of State for Health? Was Parliament informed? I’ve got another FOI pending to find out.
But, either way, a cautious person would actually want a safety audit of MHRA during the biggest and fastest vaccination programme in U.K. history.
Turning to the process for investigating individual Yellow Card reports, I asked MHRA for its internal document specifying how its staff follow up individual Yellow Card reports for adverse events from medicines. This is the process which would tell its staff which Yellow Card reports to follow up and which not, as there is obviously a spectrum of severity from sore arm to death. It replied: “The MHRA does not hold a process for investigation of individual Yellow Card reports.” However, in response to someone else’s FOI request (21/1109) MHRA outlined the steps it took to investigate individual Yellow Card reports related to myocarditis. But if, as it told me, there is no documented internal MHRA process, how do staff know what steps to take and how does the Chief Executive, Dr. June Raine, know whether or not they are taking those steps? The answer seems to be that she doesn’t, as that same FOI asked how many Yellow Card reports of deaths linked to myocarditis had been investigated. MHRA invoked a Section 12 exemption – it would take too long to find out. They don’t know. So far as I can tell, they just cooperate with Coroner’s Inquests but they have no set process for this either, so it’s all anybody’s guess.
I’ve raised these concerns with both Dr. June Raine, MHRA’s Chief Executive, and Alison Cave, MHRA’s Chief Safety Officer. But so far, no replies. For me, the lack of response just underlines my concern that MHRA’s safety management does not appear to be as robust as those responsible for it think.
I hope to follow up this article later with some observations about MHRA’s process for signal detection from the accumulation of Yellow Card reports for the Covid vaccines. At face value, it appears that MHRA’s first filter on the data is a weekly review of those types of adverse events which are more common than for other vaccines. That ‘relative’ approach seems a very peculiar way to measure safety and not how it’s done in other safety critical sectors. Then there’s the question of how MHRA rolls into that process the issue that the benefit from the Covid vaccines appears to be significantly less than when it originally authorised them for emergency use. So the risk/benefit balance is likely worse than for other vaccines. Which makes the ‘relative’ approach all the more peculiar. But I’ve got more digging to do first.
One final thought in the meantime: Has anyone else noticed that the Terms of Reference for the Covid Public Inquiry do not even mention the word ‘safety’.
Until Nick retired a few years ago, he was a Senior Civil Servant in a Government Department.
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