MHRA Compliance Monitoring Scheme: Step in the right direction or first on a slippery slope?

From April 2022, the MHRA will begin a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM) to reduce the significant burden on the agency resources by the current process of supervision of companies at IAG. Primarily this will be achieved by reducing the frequent on-site progress inspections used to assure progress in rectifying the issues of concern, which were determined to have direct impact on the delivery of the statutory, routine, risk-based inspection programme. The process as described in the blog Compliance Monitor Process Part 1 An Introduction  appears remarkably uncomplicated (obviously the result of extensive work behind the scenes).

Speaking with colleagues and peers, opinion seems to vary wildly from the uber sceptical “jobs for the boys” to more supportive “something had to give, let’s suck it and see”

Personally, I can see both sides, the agency, like us all, must do so much with their limited resources, so something has to change, and there are dedicated, experienced people out there available for just this purpose. The scheme may provide just the carrot (or is it stick?) for site QA to get senior management approval for this vital support. In fact, this may lead to even greater patient protection as the CMs may very well adopt ‘belt and braces’ to ensure successful re-inspections to, in turn, make sure their eligibility status remains intact, thus improving practices.

But I do worry that especially considering the loss of many senior members of the agency teams and the added burden that running the Eligible Consultants to act as CMs scheme will obviously warrant, we may end up with our inspectorate being even more hogtied by the inevitable red tape and so even less able to meet the objectives of this scheme. Or even more scarily is this the beginning of privatisation by stealth of the jewel in the crown that is our highly effective and globally respected regulator?

From the industry point of view, it does smack of the US Consent Decree process, which while having the same aims regarding remediation plans utilising independent expert third parties, has in cases been exorbitantly expensive leading to financial ruin and site/company closures. The CMs must also ensure that they fulfil their role, not only in delivering the compliance protocols but ensuring the companies involved are left in better shape going forward by upscaling knowledge and providing mentoring to sites; they cannot be a sticking plaster. In this case, they really should not want repeat business for the same issues.

So maybe the answer to my original question is neither? Perhaps it is more like walking a tightrope! Interesting times? Part two of the blog has much riding on it.

Author: Rhona McAteer, Senior Associate Director at Tower Mains