6. Submissions on Behalf of Clinically Vulnerable Families by Mr Wagner

Mr Wagner: Good afternoon, Chair. I make submissions on behalf of the Clinically Vulnerable Families. I appear with Hayley Douglas, instructed by Kim Harrison and Shane Smith of Slater & Gordon solicitors.

We again thank you for giving us the opportunity to be involved in this important module. As you know, CVF was founded in August 2020 and currently represents those who are clinically vulnerable, clinically extremely vulnerable, and the severely immunosuppressed, as well as their households across all four nations.

This group of vulnerable individuals were and remain at higher risk of severe outcomes from the disease, such as greater mortality and Long Covid, than the wider population, and these individuals not only faced but continue to face greater risks to their lives than any other category of person, and their welfare during the pandemic should be a central focus of this Inquiry and certainly of Module 4.

I will make submissions in four areas: the scope of Module 4, expert evidence and Rule 9s, the timetable for the public hearings, and the approach to the provision of documents.

So, starting with the scope of Module 4.

As you know, Chair, therapeutics and antivirals are issues of critical importance to CVF and their members, and CVF are grateful for your commitment in your ruling following the last preliminary hearing that you will ensure that this issue relating to therapeutics is rigorously and comprehensively examined by the Inquiry.

We also welcome the confirmation in paragraph 13 of CTI’s note that Module 4 will include examination of the decision-making relating to the non-vaccine prophylactic Evusheld.

We note the amendment to paragraph 2 of the provisional outline of scope so that it now reads:

“The development, trials and steps taken to enable the use of new therapeutics and re-purposed medications during the pandemic.”

You may recall I made submissions at the first preliminary hearing on the scope and the intended divide between Modules 3 and 4, and I wish to revisit those issues briefly in light of the amendment to the scope.

So, as we understand it, the Inquiry has now split the consideration of therapeutics across Modules 3 and 4 so that Module 3, which comes first, will examine the use of therapeutics, and Module 4 will examine the steps taken to enable the use of therapeutics.

The Inquiry will be aware that there are potential pitfalls to this approach, as we highlighted in the last hearing. The major one is there will be two different teams in two different modules considering what is effectively one discrete issue. As you pointed out, Chair, at the last hearing, there will of course be some overlap. We’re not aware of any other issue in this Inquiry which is being split across two modules in this way, as opposed to being separately considered from two different perspectives, although we’re not involved in all the modules, so we stand to be corrected on that.

The sequencing is not ideal, because Module 3 will now come before Module 4, meaning that the Inquiry will first consider how therapeutics were used in the real world, as it were, and then consider what steps were taken to enable their use. This seems to be back to front, and we suggest it’s not the order the Inquiry would choose if it was considering therapeutics in one module.

As core participants in both Modules 3 and 4, CVF will continue to try to assist the Inquiry in solving the conundrum of how therapeutics will be rigorously and comprehensively examined whilst also being divided across the two modules.

In this regard, we raised in our written submissions the issue of eligibility to therapeutics, as in which categories of people were entitled to access therapeutics. We submit that the Inquiry must ensure that not only is national decision-making on eligibility examined, but also how this translated to access to therapeutics on the ground, which in CVF’s experience varied greatly. It’s of course one thing being eligible for something and it’s quite another being able to access it.

CVF have referred in their draft Rule 9 statement to serious examples where things went wrong with access to antivirals, and in some cases this had tragic consequences.

We have requested, therefore, that the Inquiry obtains data relating to the number of people who received antivirals as against those who were eligible, according to the national eligibility criteria, and we say that information is critical in assessing whether steps were, in fact, successfully taken to ensure the use of new therapeutics during the pandemic.

We heard Mr Keith KC’s submissions this morning on the point, that you don’t intend to seek specific data in the absence of understanding whether it’s a system failure. We respectfully submit this sounds like it is circular, as it’s not possible to identify a system failure without first obtaining the data.

CVF will highlight individual instances where there was a disconnect between eligibility and access, but whether this reflects a systemic issue is a matter which can only be examined with representative data, and if the Inquiry does not obtain this, the important issue may not be resolved.

CVF are also concerned that the current wording of paragraph 2 of the provisional outline of scope in relation to therapeutics may not allow for or at least does not clearly require a full examination of access to therapeutics and antivirals. It does not appear that this would come under the use of therapeutics in Module 3.

We are reassured to some degree by paragraph 12 of CTI’s note, which refers to approval, eligibility for and access to vaccines and therapeutics. However, we want to emphasise the importance of Module 4 examining the issue of access separate from eligibility, both in order to understand the real lived experience of clinically vulnerable people, but, more importantly, for the Inquiry to make recommendations that can improve the process for accessing antivirals, which is an issue for CVF not just of historic importance but of current importance too.

Taking all that into account, we make two requests, Chair. First, that paragraph 12 of CTI’s note is formally reflected in your ruling and that “approval, eligibility for and access to vaccines and therapeutics” is either included in an amended scope or confirmed to be in the upcoming issues list. And, secondly, we request that the Inquiry set out a plan for investigating therapeutics across two modules, because at present what is proposed is a recipe for confusion, and may lead to therapeutics falling between the cracks.

We propose that this could be by way of a therapeutics-specific issues list which applies to both modules. We appreciate that’s not the Inquiry’s usual practice, but, in relation to an issue which is across two modules, we say it is necessary in order to make sure that the two modules work in tandem on this important issue.

So that’s my point on scope.

The other three issues I’ll take in a shorter way.

First of all, expert witnesses and Rule 9 requests. Two of the requests we made in our written submissions relating to expert evidence considering children and the clinically vulnerable have been accepted, and we’re grateful for the indications Mr Keith KC made earlier.

We make two further requests, the first of which was in our written submissions and has not been answered, and the second arises from Mr Keith KC’s oral submissions.

Now, the Inquiry, as you will be very aware, Chair, has consistently said it won’t disclose Rule 9 requests to core participants, but this does sometimes mean that it’s not possible for core participants to understand exactly what is being asked, and in relation to the issue of children, which is very close to CVF’s heart, we simply ask that if key witnesses haven’t been asked about the impact of therapeutics and vaccines on children, that they are asked that question in the same way that the experts will be asked.

The second point is CTI said earlier that it may be necessary to recall the experts that were instructed in Module 2 in relation to structural inequalities if, in the preparation of Module 4, it becomes clear there is a lacuna, a gap, in relation to expert evidence on inequalities and structural discrimination.

We have raised before, I think in the last two preliminary hearings in Modules 3 and 4, that the clinically vulnerable should be included as a specific group that suffered structural inequalities. Of course the clinically vulnerable was a group that, in the context of Covid, emerged during the Covid pandemic because they were the definition of the people who were the most vulnerable to Covid-19. They cross over into a number of other inequality groups, but we submit – and have submitted before – that it’s a helpful lens to understand structural inequality to consider the clinically vulnerable and the clinically extremely vulnerable and immunosuppressed as a separate group, because they were undoubtedly disadvantaged in a very specific way.

We ask that the Inquiry use the opportunity in Module 4, and perhaps even in Module 3, to revisit the inequalities expert evidence and include the clinically vulnerable.

Finishing with two short issues. Timetable for public hearings. A number of other core participants have raised the point, if there’s only going to be 10 or 11 days of evidence in this module, we are concerned that it will impact particularly on the consideration of therapeutics, which is extremely important but risks being overwhelmed by the evidence relating to vaccines, which obtained a very significant public interest during the pandemic but are of no more importance than therapeutics.

So we would be grateful if the Inquiry could set out at an early stage, and perhaps even as part of the plan that we have requested across Modules 3 and 4 on therapeutics, that the Inquiry sets out how it intends to give sufficient billing to therapeutics in Module 4 by way of a timetable.

The final issue is the approach to the provision of documents. CVF noted the indication in paragraphs 26 and 27 of CTI’s note, the targeted approach that the Inquiry is adopting in relation to some document providers, and of course there is a practical reason for that, that there will be many, many tens of thousands of documents and the Inquiry needs to get through them somehow, and is therefore going to request themed document disclosure.

We note and we submit that that may lead to some skewing of the documents that the Inquiry receives, and gives quite a lot of discretion to the individuals and organisations that are being requested for the documents. So simply we ask that there is further clarification from the Inquiry as to how that proposed framework will ensure relevant documents are obtained, and also we do ask for a rough date at the least for when the final disclosure is likely to be received, not least because the autumn will be dominated, for CVF, by Module 3 and it’s important that we are able to plan. But that will be gratefully received.

Unless I can assist you further, those are my submissions on behalf of CVF.

Lady Hallett: Thank you, Mr Wagner.

Mr Wagner: Thank you.

Lady Hallett: Ms Morris.