My virtual meeting with Ian Rees at MHRA—why are gene therapies getting special treatment?

Could it be to clear the way for wall-to-wall mRNA injections?

This is a repost from January 24, 2023

Ian Rees was the Manager for the Inspectorate Strategy and Innovation Unit and MHRA. I had a series of communications with him, and the Senior Regulatory Advisor, Inspection, Enforcement & Standards Division, nearly 18 months ago now.

At the end of the discussions, Ian Rees informed me he was about to retire. This is him today:

EX MHRA GMDP INSPECTOR IAN REES JOINS THE EPIC TEAM

by Epic-Admin Sep 1, 2023 0 Comment

EPiC Auditors are thrilled to announce that Ian Rees, a renowned pharmaceutical compliance expert and former Expert MHRA GMDP Inspector, has joined our team as an independent consultant.

With an impressive career spanning over 40 years, twenty of which were with the MHRA, Ian brings a wealth of invaluable experience to our organisation.

That’s a strange kind of retirement? Game keeper come big Pharma poacher?

Anyway, this is what it was about.

Teams call today

I had a Microsoft Teams call with Ian Rees, MHRA’s Manager for the Inspectorate Strategy and Innovation Unit and David Olszowka, Senior Regulatory Advisor, Inspection, Enforcement & Standards Division.

I first met Ian Rees in 2012 when the MHRA was in London, Victoria. His boss then, Mark Birse, had agreed to meet me and I gave both of them a copy of Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics. It was 75 quid even in those days—that’s how generous I am :O)!

Mark Birse left to become Vice President, Technical, Regulatory Consulting Services with Parexel, a large Contract Research Organisation (CRO).

Note: Pharma companies cannot develop drugs without CROs doing the legwork. Same for development and manufacture, they need Contract Development and Manufacturing Organisations (CDMOs). Check out the latest MHRA escapee joining the world’s largest CDMO as Global Head of Sterility Assurance, Cell and Gene Technologies, David Churchward.

Hopefully, you are beginning to get the direction of migration…

FOI and open letter

Returning to the subject at hand. Some of you will remember the FOI and open letter I submitted to MHRA last November:

Subject: FOI Request—Chapter 8, EU Guidance and UK Guidance on Wholesale Distribution in the 2022 edition (current) of Rules and Guidance: for Pharmaceutical Manufacturers and Distributors 2022

I reported on some shocking news received during an initial exchange of emails, below [Note: this is behind a paywall, but not essential to read]:

MHRA confirms that hospital pharmacies can manufacture, transport and store gene therapy products, and the Care Quality Commission will be responsible, not MHRA

This is an extract:

“The January 2022 change to the regulations, for ATMPs only, allow for a hospital pharmacy to carryout additional processing operations (under the title ‘Reconstitution’, please refer to the original FOI for full details).

However, it is the Marketing Authorisation Holder (MAH) that is responsible for compliance with the contents of the eCTD, and meeting the label claim awarded by the MHRA on the basis of such. Any changes that are made by a hospital pharmacy will not have been included in the eCTD submitted by an MAH during the MAA submission process. This would create a legal nightmare in the event of any serious adverse event (SAE) occurring, with damages sought. Of course, that would pale into insignificance compared with the impact on a patient’s life.

There are, of course, further severe issues. For example, the hospital pharmacy will need to procure, transport, and store licensed medicinal products, with all the associated logistics challenges, and therefore would need to gain a successful Good Distribution Practice (GDP) inspection and award of a Wholesale Distribution Authorisation (WDA(H)) before beginning operations.

On the basis of this, I am calling for an immediate repeal of the 2022 GMDP changes, until there is an industry stakeholder consultation similar to the Falsified Medicines Directive, (FMD) 2011, where there were significant changes applied to the original EU legislation. The FMD current legislation still applies to the UK.

Given the gravity of this information, I would request that you escalate this to the MHRA Chair, Stephen Lightfoot, and the MHRA CEO, Dr June Raine. Alternatively, if you provide their email addresses, I can contact them direct, with you and David in copy.

Kind regards,

Hedley”

How did the meeting go?

After introductions (I had not met David before), I quoted from the Orange Guide, 2022, page 34:

1. Pharmaceutical Quality System:

1.1 Quality management is a wide-ranging concept, which covers all matters that individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal prodcts are of the quality required for their intended use. Quality Management therefore incorporates Good Manufacturing Practice [as well as Good Laboratory Practice, Good Clinical Practice and Good Distribution Practice].

1.2 GMP applies to the lifecycle stages from the manufacture of investigational medicinal products, technology transfer, commercial manufacturing through to product discontinuation.

I then drew their attention to the lifecycle stages: “investigational medicinal products, technology transfer, commercial manufacturing through to product discontinuation.”

If GMP applies through to commercial manufacturing and product discontinuation (supply ceased), how can there be a no man’s land, in a hospital pharmacy or similar, where GMP does not apply during the lifecycle of the medicinal product? Only for advanced therapy medicinal products?!

Asking then, “what is different about gene therapies (and other advanced therapy medicinal products), to other medicinal products” did not actually yield an answer.

By the end of the call, which lasted from 11:00 to 11:51 today, I was none the wiser.

When I had mentioned the Falsified Medicines Directive, (FMD) 2011, aim at keeping patients safe from errors and falsification in the end-to-end supply chain, I was told they had decided it didn’t apply to these therapies. It’s written down somewhere apparently, by these guys:

Committee for Advanced Therapies (CAT)

Check it out…

That’s it for now. I’ve been promised another email to clarify how MHRA will evaluate a licence application if activities in the hospital pharmacy are not included? Will update on that when it comes in, should be interesting!