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

Baroness Thornton Excerpts

Monday 14th March 2022 Grand Committee

Finally, this SI, along with the one that I started with, is very welcome, but it is a key issue. The recommendation from the independent review in 2016 said that it was vital that industry, the NHS and government worked closely together to make this whole transition process much smoother. Can the Minister assure the Committee that this will happen?

[Baroness Thornton (Lab)]

My Lords, as we know, the Covid-19 pandemic has been the most serious domestic challenge that we have had to face in the post-war era. We know that more than 150,000 people have been lost and we know about the impact on our lives and liberties. It felt to me, having been on these Benches in this position from right at the beginning of it all, that we might never get to this point. A lot has changed in the last few months, however. Thanks to our NHS, our incredible scientists and the British public who have been vaccinated in their millions, we now have several highly effective Covid-19 vaccines and the entire population has been offered the third booster jab. While the virus is still with us—we will discuss that in our next debate—we are without a doubt in a much stronger position than we were back in March 2020. The impact of the vaccination programme cannot be overstated. It has allowed us to reclaim liberties that we were forced to forfeit in 2020, driven down hospitalisations and saved lives.

This statutory instrument continues this good work. It will surprise no one that we do not find it contentious; in fact, it is wholly necessary that the amendments made the human medicines regulations are continued. This SI enables us to continue with mass vaccination campaigns for Covid-19 and influenza, and extends the temporary provisions relating to the manufacturing licences and marketing authorisation. It permanently broadens the healthcare groups that are entitled to administer parenteral vaccines in an NHS or local authority, and enables community pharmacists to deliver flu and Covid vaccines outside their normal premises. These changes are sensible and will ensure that, in any future mass-vaccination rollout, the resources will be available to administer those vaccines.

As I said, Covid has not disappeared. We need to be prepared and ensure that the population remains protected against rising case numbers and possible mutations. We know that one of the issues and challenges we face is how to reduce the health inequalities of vaccine uptake. The under-30s, some of our BAME communities and pregnant women disproportionately make up the 8.5%, I think, of the adult population who remain unvaccinated. I do not think that we can be complacent. I would therefore like the Minister to say what further action the department will take to reduce the inequalities in vaccine uptake, as well as how extending these provisions will enable his department to better tackle vaccine hesitancy. As the noble Lord, Lord Lansley, and the noble Baroness, Lady Brinton, said, we cannot pass by without reference to the clinically vulnerable, clinically extremely vulnerable and immunosuppressed. They continue to seek clarity on vaccination in this extremely concerning time.

We have discussed these issues in the House on several occasions and continue to do so, because those who come into these categories need access to the full weight of what our science can deliver for them, as the noble Lord, Lord Lansley, said. However, they also continue to need access to free tests and appropriate treatment. So facilitating continued access to vaccination is a key pillar of Labour’s “living well with Covid” plan, but we oppose the short-sighted sell-off of our Vaccine Manufacturing and Innovation Centre. I would be grateful if the Minister could outline any further discussions that have taken place with his colleagues on VMIC and whether our vaccine manufacturing capability will be impeded by the ongoing negotiations. However, the message from this side of the Committee is that vaccines are safe and effective, and we must continue to ensure that they are widely and freely available. Only by doing so can we continue to build a world beyond Covid.

Turning to the second statutory instrument in this group, the early access to medicines scheme, managed by the MHRA, has been in place for almost eight years. As we know, it aims to provide patients who have life-threatening or seriously debilitating conditions with access to medicines that are not authorised generally or for the specific clinical use proposed. It provides the necessary regulatory flexibility for medicines that can often be a matter of life and death. As the Minister said, more than 100 medicines have been granted promising innovative medicine status; more than 40 scientific opinions have been awarded in areas with unmet patient need; and 1,600 patients have benefited from EAMS medicine since the scheme’s initial implementation. So we on these Benches absolutely support this SI.

Some pharmaceutical companies have raised the concern that EAMS is not delivering an attractive proposition for industry or the scale of early patient access originally envisaged. Furthermore, concerns have been expressed about a lack of clarity on how to apply for EAMS and how it works in practice. These areas for improvement are outlined in the EAMS independent review, which was published in 2016; I think at least one or two noble Lords have already mentioned it. Although the statutory instrument addresses some of those concerns, there are still a few areas on which we need to seek clarification from the Minister in due course. Placing the scheme on a statutory footing will give pharmaceutical companies and patients the necessary legal clarity. It is good that this SI is clear about the need to continue to protect patient safety and aims to simplify EAMS requirements where feasible. Most notably, this legislation will support the collection of real-world data, which will no doubt incentivise medical innovation. It is also important that the SI makes it clear that patient consent to data collection is not a condition of EAMS supply.

My Labour colleagues in the Commons have been engaging with various charities regarding the antiviral drug Evusheld, which is a preventive antibody treatment for the benefit of people with compromised immune systems who cannot get sufficient antibody boost from vaccines. There seems to have been an awful lot of dither and delay regarding this medication, which has left the previously mentioned CV, CEV and immunocompromised people feeling ignored and very anxious. I would be very grateful if the Minister could clarify this issue, if not now then perhaps in writing. I would also be grateful if he could set out what further actions the DHSC will take to improve knowledge of EAMS within both the health sector and the pharmaceutical industry.

Additionally, there is the wider issue of a complex research to clinical care pathway that the Government need to address. We need to ensure that we remove unnecessary barriers in research and medical innovation. I completely agreed with the noble Lord, Lord Lansley, when he talked about Orbis. He and I are veterans of the Brexit discussions of the past five years, which focused on the importance of having the right kind of access to patients, in the right numbers, to develop genetic and other medicine. I would be grateful if the Minister could talk about that.

I also echo the matter raised by the noble Baroness, Lady Brinton, which she called a “lull”; I have called it a “black hole”. It has been reported that for some pharmaceutical companies there is a black hole in the system once marketing authorisation is granted and EAMS designation falls away, which can leave a gap of several months when no further patients can access a drug as it goes through the NICE financial assessment. Again, this was recognised in the independent review and by pharmaceutical companies and charities, so I would be grateful if the Minister could provide his assessment of this issue and whether the department is considering means to ensure a smoother transition from EAMS to full HTC and NICE approval.

EAMS is a great illustration of the work that can be done when industry works alongside healthcare agencies with patient interests at heart, but we must not take our foot off the pedal. We need to keep working to ensure that cutting-edge research is properly supported and puts the needs of patients first.

[Lord Kamall (Con)]

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.