Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022
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Lord Kamall
That the Grand Committee do consider the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022.
Relevant document: 31st Report from the Secondary Legislation Scrutiny Committee
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Kamall) (Con)
My Lords, we are here this afternoon to debate two important statutory instruments which will amend provisions in the Human Medicines Regulations 2012 and support our work to ensure continued access to critical vaccines and medicines across the country. The first SI will maintain vital arrangements which have underpinned our vaccination campaigns against flu and Covid-19. The second SI will support our ambitions to ensure that patients with unmet clinical needs can access the innovative treatments they need. I am grateful to be able to debate such important provisions today.
The purpose of the provisions I have laid in the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations—which I will refer to as “the regulations”—is to amend the temporary provisions that cease to have effect on 1 April this year. They support the continued deployment of safe and effective Covid-19 and flu vaccinations at the pace and scale required both now and in the future as part of the pandemic response. This SI amends provisions in the Human Medicines Regulations 2012, SI 2012/1916, originally amended by the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020, SI 2020/1125, and the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020, SI 2020/1594, either to make permanent or extend by a further two years these key regulatory flexibilities.
There are five provisions before us today, three of which we are seeking to make permanent. The first will enable injectable prescription-only medicines, which includes vaccines, to be given under a patient group direction commissioned by the NHS or a local authority, which effectively expands the workforce of vaccinators. The second will enable pharmacy-led Covid and flu vaccination services to operate outside their registered premises. This has enabled, for example, “pop-up” vaccination clinics to be run by pharmacists at convenient locations for patients, and these have been very successful. The third will add several additional groups of healthcare professionals to those who can administer vaccines under occupational health schemes, thereby expanding the workforce to vaccinate health and care staff. The final two provisions relate to a further temporary extension of easements to licensing requirements for assembly and preparation of vaccines prior to use and sharing of vaccines between sites.
Why do we need this SI? The success of the mass vaccination rollout on the scale and pace that has been possible to date will not continue if the SI is not approved, and the Covid-19 and flu vaccination programmes will not be able to continue running as they currently do. Nor would they be able to be re-established at the pace and scale which has been so vital to our success—for example, in response to the emergence of a new variant, leading to recommendations for an urgent booster campaign.
Approval has been sought and agreed both in the other place and in the Northern Ireland Assembly, and I will now provide the rationale in support of these important provisions in this place. We are debating these provisions today against a completely different backdrop to that which was in place when the key regulatory flexibilities were first made in late 2020. We are now in a position that we should welcome, but we should also be aware that vaccines remain our best line of defence against the virus and to help us to live with Covid. This is the very reason why it is vital to make permanent or temporarily extend these provisions.
The provisions have already proved invaluable by enabling mass vaccination against both Covid-19 and flu to be done as quickly as possible while safeguarding patients and limiting disruption to other NHS services. Patient safety has to be at the heart of any vaccination programme, and it is at the forefront of these provisions.
To improve uptake in areas with low vaccination uptake we have used places of worship as vaccination centres, with many more acting as pop-up venues; provided £22.5 million to fund the community vaccine champions scheme, targeting the 60 local authorities with the lowest vaccine uptake and using local networks to promote accurate health advice; established an army of vaccine ambassadors, speaking 33 languages between them, promoting uptake across the country; and taken the vaccines into the hearts of local communities through initiatives such as vaccination buses and taxis. It is vital that we continue to protect and vaccinate those in our society who are hard to reach and it is really important that we continue to reduce health inequality in vaccine uptake. Making these provisions permanent will enable us to achieve this goal. Indeed, the National Audit Office’s recent report on the rollout of the vaccination programme in England highlighted the balance between central command and control structures and wider empowerment locally. It saw this as a success factor in achieving more than 139 million vaccinations in the 15 months since the programme began.
I turn to the second instrument before us today. We are committed to making sure that individuals suffering from life-threatening or serious debilitating conditions and facing unmet clinical need are able to access the therapies they need. The early access to medicines scheme is a vital tool in supporting such patients to receive innovative new medicines. EAMS, as it is commonly referred to, provides a route for patients to be prescribed medicines that either do not yet have a marketing authorisation or licence, or do not have a marketing authorisation for the medicine to be used for that particular illness. Since 2014, the scheme has benefited hundreds of patients across the country. In England alone, over 1,600 patients have received EAMS medicines since the scheme launched. Their lives have been transformed by the chance to receive vital therapeutics for conditions ranging from cancer to sickle cell disease or severe dermatitis. Putting the scheme on a statutory footing allows us to maximise the benefits it offers to patients, as well as supporting the early development of medicines by innovative manufacturers in the UK.
The provisions we are debating today will deliver three key benefits. First, they will reaffirm in legislation the importance of patient safety within the scheme, putting specific provisions on safety monitoring and risk management on a statutory footing. Secondly, they will reduce the regulatory burden on manufacturers supplying EAMS medicines, making the scheme more visible and easier to use. Thirdly, they will help ensure that information on the real-world use of EAMS medicines can be collected. This will help provide more evidence and more data that can support future decisions about patient access to novel medicines. To summarise, we have the opportunity before us to deliver greater access to safe medicines, as well as supporting the innovation of our life sciences industry for the benefits of patients.
I am bringing forward the first instruments using the powers in the Medicines and Medical Devices Act, allowing us to use effective regulation to provide patients and the public with timely access to critical medicines and vaccines. The provisions in these instruments are incredibly important. They will be in force if mass vaccination campaigns against Covid-19 and flu are necessary again to protect the public and our freedoms. They will also ensure that patients with serious conditions and unmet clinical needs can be offered new, life-changing treatment options.
Lord Lansley (Con)
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.
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.