You might have read my previous articles which were critical of MHRA’s safety management under the pseudonym Nick Denim.
It’s time to reveal that I was a Senior Civil Servant in the Ministry of Defence (MOD). I was responsible for the safety and effectiveness of ammunition used by the Armed Forces. The same as MHRA is supposed to do for medicines. I am therefore well qualified to comment on MHRA.
If you haven’t already seen it, have a look at a report I co-authored about MHRA. It’s available on the Perseus Group website. It details a litany of problems with MHRA’s safety management and raises a whole host of questions.
This article covers a couple of further issues which have surfaced since the report was completed.
Who watches the MHRA?
In MOD, there are individuals responsible for managing the safety and effectiveness of all products. I was responsible for ammunition. Others are responsible for the safety and effectiveness of aircraft, ships, submarine nuclear reactors and so on. But there is a separate safety regulator: the Defence Safety Regulator. It writes the rules for managing safety and ensure adherence. This separation seems very healthy to me. MHRA, on the other hand, is both the regulator and manages safety, meaning it makes its own rules and marks its own homework, and no one besides ill-qualified and short-lived Government ministers are responsible for checking it is doing its job competently.
I wrote to the Secretary of State for Health on March 20th 2023 to ask why the approach for medicines is organisationally different to defence equipment. One month later I received the reply that, essentially, they are too busy to answer the question. I shall be pursuing this further.
Batch issues are very important in all safety critical sectors. In MOD, if we received a report of a safety incident with one of our types of ammunition we had to decide quickly what action to take. The first questions we asked and answered as soon as possible included: how long had the product been in use; had something similar happened before; and was it therefore more likely to be a manufacturing problem or a design problem. For example, something in use for 10 years with no similar incidents was more likely to be a manufacturing batch issue, so let’s immediately quarantine the items from the same batch and those in adjacent batches. We would start inspecting the failed and quarantined items looking for physical defects, damaged packaging etc. We would delve into the manufacturing records to look for changes in personnel, quality control, production location, sources of supply of materials and so on. In my experience, batch issues contribute to a significant number of safety issues.