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

What!!! Yes, it's true, read all about it...

Delighted to report there has been a breakthrough with MHRA

This morning, I received this email from Ian Rees, Manager, Inspectorate Strategy and Innovation Unit”

“Dear Hedley

Many thanks, I had a good break.

Thank you for your reply and I can confirm that I have passed this information on to the Directorate.

To resolve this matter, we now need to have a call with you – please let me know what dates and time are suitable for you and I will send a Team invitation.

Regards

Ian”

This is the latest email exchange over my FOI request outlined below:

MHRAs reply to Hedley's FOI request and open letter—it didn't say anything new...

This is the FOI request.

The email from Ian was in response to my email the day before, see below:

“Dear Ian,

Yes, the break was welcome, hope you enjoyed yours too.

The answer below is very helpful, albeit it does not address the majority of the questions posed [in the FOI]. In spite of that, it has allowed me to establish that any ATMP approved by MHRA under the changed regulations, has the potential to be misbranded. The logic is this. The application from a clinical trial sponsor (CTS) to market an ATMP must follow the MHRA Marketing Authorisation Application (MAA) process on the MHRA website, which says: You should submit your application using the electronic Common Technical Document (eCTD). Since this is an open letter, as well as a FOI request, I will explain the eCTD process below. This is meant for the public at large, and I am not suggesting for one minute that you do not know the process.

When a company applies to MHRA to market a new medicinal product, it is required to prepare and submit what is known as an electronic Common Technical Document (eCTD). The eCTD format has been agreed and adopted globally, with every country providing the same data and information required to evaluate a medicinal product for sale. The global template was produced under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The pyramid structure below shows,  at the bottom, the three modules that must be submitted:

Module 3: Chemistry (full name is Chemistry, Manufacturing and Controls (CMC) or Quality Module).

Module 4: Nonclinical (Safety, Toxicology etc of manufactured product).

Module 5: Clinical (efficacy).

Module 3 is critical to patient safety, as it represents the entire supply chain that will produce the product to be administered to the patients who will receive it. In Module 3, every stage of manufacture, storage and transportation must be described in immense detail. The same applies to determine the methods to test the quality of the product at key stages, until it eventually becomes a finished product. This is all regulated under Good Manufacturing Practice (GMP).

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”

What happens next?

As mentioned above, they want a Teams call with me. I’m not going to do it, as there is nothing to question in what I have said. If there was, it would have been in the email reply, surely.

I’m not sure what happens next, but I will be keeping subscribers updated with everything, except for stuff I can’t share until it’s out in the open. :O)