UK Parliament / Open data

Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022

I begin by thanking all noble Lords who took part in the discussions today for their detailed questions. I will try to answer as many as I can, but I hope noble Lords will understand that I will write to them if I do not have the answer to hand.

To start with a few of the general remarks made, I thank all noble Lords for welcoming these SIs as well as some of the innovation that we have seen throughout the pandemic and how we have seen the NHS work closely with the department and industry to make sure that we develop suitable vaccines and therapeutics as quickly as possible. My noble friend Lord Lansley was absolutely right to refer to the living with Covid strategy. The reason we have that is to make sure that we are not complacent: it is to remind people that the pandemic is not over. Sometimes people say that we have returned to life before the pandemic, but it is still there and, as noble Lords have rightly expressed, there are new variants that we are keeping an eye on, such as the BA.2 and deltacron variants. The important thing to note is that, compared with the beginning of the pandemic, we have weakened the links between infection

and hospitalisation and between hospitalisation and death. Indeed, a number of noble Lords are testament to this fact: they have survived testing positive for coronavirus.

I will try to address some of the specific issues. My noble friend Lord Lansley and the noble Baronesses, Lady Brinton and Lady Thornton, brought up the issue of Evusheld; they are right that it is not currently authorised for use in the United Kingdom. As noble Lords have said, it has been developed as a potential preventive treatment, with AstraZeneca announcing positive interim trial data. However, worldwide, omicron is still the dominant variant, and this trial took place before it emerged, so the therapeutics task force is engaging with AstraZeneca on emerging data and its impact on omicron. This work is ongoing.

A number of people identified previously as clinically extremely vulnerable are well protected after receiving their primary and booster vaccination doses. I am not sure that I have an answer about the fifth dose, but I will find that out and write to noble Lords. Most people who were considered CEV are no longer at substantially greater risk than the general population and are advised to follow the same guidance. In previous meetings that I have had with the noble Baroness, Lady Brinton, I have asked for her to be in direct contact with my officials and others, and I hope that those discussions are helpful. If they are not, I hope that the noble Baroness will let me know so I can intervene to see what more can be done. There remains a small number of people whose immune systems mean that they are at higher risk of serious illness from Covid-19, and enhanced protections, such as those offered by some of these treatments, are being looked at.

My noble friend Lord Lansley also asked about other schemes. As he will be aware, we have the innovative medicines fund and the cancer drugs fund—these are other paths we are looking at. NHS England, NHS Improvement and NICE recently consulted on proposals for the innovative medicines fund and we hope to have an announcement soon. On the Accelerated Access Review and the Accelerated Access Collaborative, we are committed to supporting patient access to these drugs. We created it for this reason and we remain committed to it. In fact, it was part of the Life Sciences Vision that we published in July 2021, and we see it as a crucial part. I understand that some medicine products are expensive to manufacture, and this may limit the schemes’ accessibility in some areas. If my noble friend has specific examples, I am very happy to have further discussions.

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My noble friend Lord Lansley also mentioned cell and gene therapies. The scheme is open for any company to apply for any product that meets the criteria—that is, an area of unmet medical need where there are no alternative treatment options. This could include a cell or gene therapy. UK patients have been among the first in the world to benefit from access to these therapies, including CAR-T therapies for cancer patients and gene therapies for babies with spinal muscular atrophy. We see the scheme as one of the tools in ILAP, as my noble friend mentioned, but it is also a

stand-alone opportunity for patients. We see it as an opportunity to access medicines early, separately to ILAP. The criteria for EAMS is also different from ILAP: the EAMS requires a medicine to demonstrate a major advantage over existing medicines in order to preserve the prescribing hierarchy. This means that prescribers should not prescribe an unlicensed EAMS medicine unless there is a clear clinical advantage in doing so.

The noble Viscount, Lord Stansgate, asked about the impact assessment. In line with government guidance, a regulatory triage assessment was undertaken in place of a full impact assessment service, since the impact is below the £5 million threshold. The EAMS has been in operation on a non-statutory basis since 2014, and the legislation will not involve any significant changes to the requirements for businesses that utilise the scheme.

The noble Baronesses, Lady Brinton and Lady Thornton, raised the issue of inequality. We are very much aware of this. In fact, when I talk to my colleague who is responsible, Maggie Throup, we talk about making sure that we reach those communities that have been hesitant so far. We are continuing to work with a number of different schemes, with communities, with faith organisations and local community champions—people who know these communities far better than we ever would if we were trying to do this from afar. We are taking advice from local people and communities and we also have some funding available to increase uptake and to counter some of the negative sentiments expressed about the vaccines. We are also making sure that there is a quality assurance framework to support vaccination centres and pop-up centres. Making sure we have enough people, increasing the vaccination workforce or task force means that these people are sometimes better trusted than others would be. We are very aware of that and are looking at completely different ways of approaching it. When I first got this job as a Minister, I made an appeal to noble Lords for their direct experience or suggestions of ways to reach some of the harder-to-reach communities and I was very grateful to noble Lords at that time.

The noble Baroness, Lady Brinton, mentioned advice to pregnant women. We have been clear about looking at where pregnant women go—to the doctor’s, the hospital, NCT classes, et cetera—and making sure that information is available at as many places as possible where pregnant women will be going, to inform them of what is appropriate and what is safe.

I am very pleased that the noble Baroness, Lady Thornton, mentioned Orbis. It is really important, as she said, that we continue to have international co-operation and collaboration. We are very pleased with Orbis, and we are talking to Australia, Canada, Singapore, Switzerland and Brazil. As noble Lords will be aware, there are also a number of different research projects where different universities here are co-operating with universities across the world and the life sciences industry. We want to continue to be a global hub for life sciences.

I am trying to see whether I can answer any more questions. I was asked about the nasal spray. I had some details on that, but I am afraid that I have lost them among my papers so, if the noble Baroness, Lady Brinton, will allow me, I will write to her.

I thank noble Lords for taking part in this discussion. We have to learn to live with Covid in the same way that we have learned to live with the flu. We are in a better place thanks to the vaccination programme, but we are clear that it is not all over. People should still take the appropriate precautions, such as washing their hands and ventilating built-up places, and some transport companies are still asking passengers to wear face masks. Vaccines are the linchpin, however. When appropriate, we will look at the longer term and the best ways to address some of these issues. We hope that the EAMS provisions will give patients safe and timely access to life-changing medicines. This instrument will provide legal clarity. A specific statutory basis for EAMS will improve the visibility of this, we hope, but I take noble Lords’ point that it is important that we make sure that more of the public are aware of these schemes, including the other schemes.

I thank noble Lords for supporting us today by assenting to these SIs to help us keep this going and protect the incredible progress we have made. However, there is still more work to be done. We recognise, as the noble Baroness, Lady Thornton, said, that a number of people still have not been vaccinated yet. The recent statistics show that 82% of eligible adults aged 18 and over in England have had a booster; for those aged 50 and over, it is about 93%. There are now 1,800 sites on the Grab a Jab website and more than 1,000 walk-in sites are open on any given day. We are quite clear that this is not just for boosters; it is also available for people who still have not had their first or second vaccine to come forward. We continue to look at different ways to reach these hard-to-reach communities, such as via community centres and faith organisations.

I thank noble Lords for taking part today.

Type
Proceeding contribution
Reference
820 cc11-4GC 
Session
2021-22
Chamber / Committee
House of Lords Grand Committee
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