My Lords, I am glad to have the opportunity of contributing to this debate. If I may, I shall say something about each of the two regulations we are looking at. Before I go down that path, I should declare an interest as vice-chair of the All-Party Parliamentary Group on Vulnerable Groups to Pandemics.
The first regulation is, in a sense, the product of success: we have made a great step forward in the vaccination programme. For the very first time, I tested positive for Covid 10 or 11 days ago—I am negative now, I promise—but it was not remotely worrying and had no serious impact on my health because I had had two vaccinations and a booster. The
process in this country, not least the use of pop-up locations, has been rightly envied in many countries around the world. I got my second vaccination in Poets Corner in Westminster Abbey, a particularly pleasant experience.
The point is, however, that we have now arrived at a position where we are living with Covid, which is a tricky thing to do because the numbers of cases are not small. I was just one of them last week, and not in the least bit surprised when the Office for National Statistics said that there was an increasing number of cases because so many people who I knew of were going down with a case of it. Living with Covid is going to be tricky and I suspect we will, from time to time, find ourselves having to resort to a booster programme—perhaps not for everybody, but certainly among the most vulnerable.
The point I make to the Committee today is that, as we move into this very significant new phase of living with Covid, I do not want us to leave behind—or leave out—the small proportion of people who, by reason of being severely immunocompromised, cannot live with Covid. They cannot access or tolerate the vaccines, as they cannot produce the necessary antibodies. If we do nothing about that we will end up with a very small but significant number of people, maybe somewhere between 100,000 or 150,000, for whom the severity of their lack of immune system means that they literally cannot go out and expose themselves to Covid.
I have been asking questions of my noble friend the Minister and I fear there is a bit of confusion here. The Government are in the process of promoting clinical trials for post-exposure prophylaxis as treatments so that, if somebody has the symptoms of Covid, there are antiviral treatments available for them which have significant efficacy. But the trials are all on the basis that their symptoms are detected within three to five days; if they are not, there is a serious risk of severe harm, hospitalisation or even death for this small group of people.
The case I want to put is that the Government should, as other Governments are doing, look at the emergency-use authorisation of pre-exposure prophylaxis. In this instance, it is a drug with the brand name Evusheld. This is an AstraZeneca combination of monoclonal antibodies, the purpose of which is to give protection to people who are severely immunocompromised. I hope it will be apparent to noble Lords that there is the world of difference between pre-exposure and post-exposure prophylactic treatments. The difference is that a sense of confidence is created in the people to whom the pre-exposure prophylaxis has been provided, such that they too stand some chance of living with Covid and of no longer being subject to the isolation and shielding which has otherwise been their unfortunate experience now for two years.
In the data presently available, the efficacy of Evusheld results in an 83% reduced risk of symptomatic disease over a six-month period. That is a very good potential level of efficacy. If we do not do this in the position we are in, many of these people will not feel confident about leaving isolation and not being shielded. They will not rely on the assumption that they would get access to treatments within the time required.
I am hoping that the Medicines and Healthcare products Regulatory Agency is just about to produce a positive, emergency-use authorisation assessment for Evusheld. If my noble friend has any information, that would be very welcome. While I entirely accept that the Government need to have that in place, why are they not negotiating with AstraZeneca to get access to it in a contract that depends, of course, on the availability of the authorisation?
Many countries are doing this. For example, the United States has ordered 1.7 million doses. The French have around 150,000, which is broadly comparable to us and the number we would expect to need; indeed, in France, they have administered 15,000 doses of Evusheld. I notice other countries entering into these contracts almost every day. On Friday, it was Switzerland. As we move into living with Covid, which these regulations support, can we have some confidence that we can supply Evusheld and pre-exposure prophylaxis for this very vulnerable group? That is my first point.
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My second point concerns the second set of regulations. Again, we are talking about what I regard as a success and the consequences of success. In the past several years, we have gone a long way towards giving additional access to medicines at an early stage in this country. I want to make a small number of points to my noble friend the Minister. I just want to put them on the record; I do not expect him to reply to them all today as it would be tedious for him to have to do so. If my noble friend wants to reply subsequently, I would be grateful.
When we took the Medicines and Medical Devices Bill through the House, we said that a number of things would be important. We are now making progress on some of them. We have the innovative medicines fund; the commitment of resources to it is terrific. I asked for the medtech funding mandate to be expanded, and it is being. I saw that the latest data suggested seven further technologies in the course of this year. They are anticipated to deliver something like £46 million in savings following the four technologies in the previous year, which saved £25 million. These are good steps in the right direction. I hope that we will eventually get to a point where the medtech funding mandate is applied to all medical devices with a positive NICE assessment, in the same way as it is for medicines.
Today’s regulations on the early access to medicines scheme are based on a number of straightforward principles: that manufacturers should not have to work under a specials licence to produce these medicines and make them available; and that we should access the real-world data that is potentially available as these medicines are provided. This is important because the innovative medicines fund is absolutely about getting real-world data from the NHS when new medicines are made available to a population. However, I am slightly surprised that we do not have something a little more wide-ranging in these regulations because we now have a landscape of access to medicines. The time has come for the Government, with the advice of the Accelerated Access Collaborative, to set out more of a strategy about how these various aspects are to be brought together.
For example, those who bring their medicines forward under the early access to medicines scheme are increasingly doing so as part of the Innovative Licensing and Access Pathway—indeed, they are encouraged to do so. When it was a set up last year, a lot of the industry reacted to it. We had 71 applications, probably 40-plus of which have gone forward. Why are we dealing today with just the early access to medicines scheme? Why do we not have regulations that set out how the Innovative Licensing and Access Pathway gives one access to the same kind of regulatory benefits? It is through this that the targeted development profile is set up. It is how the road map is set out. It is what the industry is being encouraged to use as a mechanism for planning access to new medicines in this country.
I also wish to mention Project Orbis. Working with other regulatory jurisdictions, in this instance on cancer and led by the Food and Drug Administration, is absolutely the right way for us to go. It is really important for us to work with them but where is the link in regulatory terms between Project Orbis, the authorisation granted by the FDA and our ability to bring through a new medicine or cancer drug and treat it as something that also has authorisation here and access to the same benefits that the EAMS would deliver? We need these to be put together.
My noble friend might say that this is about the regulatory structure and not about reimbursement, but let us not go too far and assume too much about the ability of the industry to provide medicines free to the NHS in this country in order to demonstrate real-world data, which is essentially what it does under the EAMS. There are inevitable limitations about that. What the industry needs—I always thought that the innovative medicines fund was intended to fill this need—at a relatively early point when the real-world data support it, is for these medicines to be reimbursed.
This problem emerges most obviously for genomic treatments, which may be curative. If you have a relatively small population—these are increasingly treatments for relatively small populations with specific gene characteristics—and you are a company that has produced a gene therapy that can cure this, there will be real limitations in how far you can go to make that available to the NHS for free. The net result is that the patient population is getting smaller and the prospects for reimbursement diminish all the time. Gene-based therapies do not fit into this regulatory structure as readily as some of the other treatments.
All this demonstrates the critical importance of linking the regulatory structure to the reimbursement structure. I am looking for that to be demonstrated to the industry as soon as possible, using the innovative medicines fund and being linked to the NICE assessments and the medicines funding mandate that is derived from them. Even the MHRA, in its response to the consultation leading to this, made it clear that it thought that more streamlining could be done on the scientific opinion and how it leads to authorisation. Through the Accelerated Access Collaborative, we increasingly see that the MHRA, NICE and NHS England should be working together not only at the stage when a medicine is being mainstreamed into
NHS use but right at beginning of this process to understand the potential of new medicines and, in NHS England’s case, by using horizon scanning to understand the benefits and implications in financial terms. Through that mechanism, we can give the industry much more confidence about their reimbursement potential.
Why now? There is a possibility—this year and next—for the industry, the Accelerated Access Collaborative and all the organisations that participate in it to work together and devise a scheme that is about not only streamlining regulation but using real-world data to trigger reimbursement. That reimbursement structure can then be put into the negotiation for the new voluntary pricing and access scheme, which starts from the beginning of 2024. My pitch to noble Lords and my noble friend is this: let us see that happen this year. I am taking this opportunity to ask if the Government will make it happen, through the AAC, during the course of this year.