The MHRA recently confirmed in a reply to an FOI request submitted be me that they are currently running with 20% vacancies in licensing of medicines, including vaccines. I think that’s a safety management crisis. Let me explain why.
I retired in 2017 from a senior role leading three teams totalling 300 people. We licensed and purchased a wide range of safety critical products and monitored their safety in use. Our role was, essentially, the equivalent of MHRA and NHS Procurement. My rule of thumb for an ‘acceptable’ level of vacancies was 8%: people would stay in post for an average of three years and it would take about three months to recruit and have a replacement in post. Three months as a percentage of 36 is about 8%. Simple.
However, for reasons which are irrelevant here, there were times when my vacancy rate ran to 10-15%. I would have sleepless nights because safety management is a labour-intensive business and I was legally accountable for the safety of the products. Cut corners or miss something and there’s a risk that the products injure or kill people. We had to de-prioritise or defer non-essential tasks (e.g. financial reporting) to maintain safety management standards.
Worse, at one point, the vacancy rate exceeded 15% with all the indications that it would increase. I decided I had no choice but to hand back the safety delegations I had accepted. My rationale was that the organisation was not giving me the manpower which, in my professional opinion, I required to stay safe. To cut a long story short, I gave the Board a choice between withdrawing certain products from use and redeploying that manpower or they had to personally accept the legal consequences of continuing with all products. It doesn’t matter here what happened next – there just comes a point when lack of manpower compromises safety. I considered the ceiling to be a 15% vacancy rate and the Board agreed.
So MHRA’s 20% vacancies represents a safety management crisis in my book. And that’s before you factor in some other things. First, post-Brexit, the MHRA has additional workload because it is now responsible for regulation of all medicines in U.K., not the European Medicines Agency. Secondly, they have a lot of extra work in hand to improve safety management to meet the recommendations of the Cumberlege Report. Thirdly, earlier this year the MHRA stopped being self-funding (a Trading Fund), reverted to being funded by the Department of Health and Social Care, had its funding reduced and had to cut 300 posts. I don’t know how many of those were in medicine Licensing and Pharmacovigilance, but just Google “MHRA funding reduced” and see what other commentators thought about it at the time!
All in all, I think the 20% vacancy rate in MHRA’s licensing of medicines represents a safety management crisis. I would love to know what Dame June Raine, the CEO of the MHRA, thinks about that and what she and the Secretary of State for Health are doing about it.
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