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

Lord Lansley Excerpts

Monday 14th March 2022 Grand 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.