Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024.

My Lords, this draft statutory instrument proposes amendments to the Human Medicines Regulations 2012, which will expand access to naloxone, a life-saving medication that prevents death from opioid overdose. In addition, this draft statutory instrument makes amendments to keep the regulations current by updating references to Public Health England and the Health and Social Care Board, following the dissolution of those bodies.

We know the devastating impact that illicit drugs cause. Drugs destroy lives, tear families apart and make our streets less safe. Drug misuse deaths have doubled in number over the past 10 years, and we know that people who die from drug misuse often do so at a tragically young age, often in their 40s. Almost half of drug misuse deaths in 2022 involved opiates such as heroin. These deaths are avoidable. Dedicated drug treatment services provide the path to recovery and this Government are continuing to ensure that treatment is available and of high quality.

However, we also know that over half of people struggling with opiate addiction are not engaged in treatment. These are incredibly vulnerable people who often have multiple and complex needs; they are at increased risk of accidentally overdosing and dying. Tackling this issue supports the Government’s health mission. It will ensure that people can live longer, happier and healthier lives, and it chimes in with our collective efforts to break down barriers to opportunity and create a fairer society.

Naloxone is a highly effective antidote to opiate overdose. It can already be administered quickly and safely by anyone in an emergency, but current regulations specifically enable only drug and alcohol treatment services to supply it for future use without a prescription. That limits the reach of this life-saving medicine.

The draft instrument that we are debating today proposes two key UK-wide changes to existing regulations: first, to expand the list of services and professionals named in the regulations who can give out naloxone without a prescription. That means that professionals such as registered nurses and probation officers will be able to provide take-home supplies of naloxone where appropriate, should they wish to do so.

Secondly, it proposes to establish national registration services across the whole UK. This will enable other services and professionals who are not able to be named in the legislation but who come into contact with people at risk of overdose, including housing and homelessness services, to register and procure naloxone.

There is a positive background to these changes. The Department of Health and Social Care consulted on them at the beginning of this year and received over 300 responses spanning a range of organisations and professionals from across all four nations of the UK. Of these responses, approximately 95% agreed with the proposals that are set out. This demonstrates the level of interest in this important issue and the breadth of support for the changes we are seeking to achieve.

I thank the Minister for setting out the rationale for this draft statutory instrument so well. I agree that this is a step forward in the ongoing battle against the devastating impacts of opioid overdoses. As she said, opioid overdoses have reached alarming levels, claiming thousands of lives every year. According to the latest statistics, opioid-related deaths have surged alarmingly in most regions. This is not merely a statistic. This is about the loss of lives, families shattered and far too many left to grieve, so it is important to take further action that is effective and wrapped in compassion. The temporary measures taken in Scotland show that the changes outlined in these regulations work and will save lives.

Naloxone, when used in the right place at the right time, is a life-saving medication. This draft statutory instrument will facilitate local supply networks, ensuring a broader distribution system and therefore more effective use of naloxone, empowering, among others, healthcare professionals, the police, prison and probation staff, and people in the youth justice system to facilitate the supply of this life-saving drug.

In response to one of the issues that the noble Baroness raised, a question occurred to me. As this will not be a mandatory provision across the country, how will the Government monitor lives that could be saved but that may not be saved because of a lack of take-up of this in certain towns, cities or regions? It could end up that a life will be saved if one body decides to do this, while a life could be lost in a neighbouring county, city or town if that does not take place.

One of the key provisions in this draft statutory instrument is the move to enable the friends and family of those at risk to administer this drug. Allowing those closest to individuals at risk to carry and administer naloxone creates a lifeline that will, literally, make the difference between life and death.

My Lords, I thank the Minister for setting out the provisions in the regulations before us so well. This debate touches on a vital aspect of this country’s public health. Opioids are a pernicious threat to our society, a destroyer of lives and a menace to our streets. The ONS reported that 2022 was the deadliest year since records began for drug-related deaths in England and Wales. Of those, opioids accounted for the largest number of mortalities, at 46%. That is 2,261 people dying every year from opioid toxicity. In Scotland, the statistics make for even starker reading. According to the National Records of Scotland, in 2023, opioids were implicated in 80% of all drug deaths.

So we have a problem, but we also have a solution. As noble Lords will be aware, naloxone is a highly effective treatment for opioid intoxication and has been successfully deployed to prevent death from opioid overdose. I am immensely proud that it was a Conservative Government who launched the consultation on proposals to expand access to this life-saving medication, which concluded in March. The regulations laid before your Lordships are the outcome of that process, and I welcome their positive measures.

I will take this opportunity to ensure that the Government have taken all the necessary considerations. As the second report of the Secondary Legislation Scrutiny Committee pointed out, there is no indication of the costs associated with the instrument. The Department of Health and Social Care told the scrutiny committee that services that wish to widen the availability of naloxone would have to do so out of their own pocket, which, given the financial pressures already faced by such providers, may limit the efficacy of the provisions laid before us.

For these regulations to have the desired effect—that is, of course, to reduce opioid-related deaths—access to naloxone products must also be expanded. What is the point of increasing the number of people who can administer the drug if they are unable to procure enough of the medication? Furthermore, will service providers be able to afford the necessary training for the administration and storage of the drug? Would this not somewhat undermine the efforts of the regulations? In the light of these concerns, can the Minister confirm that funding will not impact the rollout of these provisions?

My Lords, I am grateful to the noble Lord, Lord Scriven, who I do not believe I have had the opportunity of welcoming formally to his new Front-Bench role. I am delighted to do that today; he is most welcome. I very much look forward to working with him and hope that he enjoys his role. I am also grateful to the noble Lord, Lord Evans, as ever, for his contribution.

I am pleased that both noble Lords, on behalf of their Front Benches, have been so positive in welcoming these regulations. I certainly agree with the closing words of the noble Lord, Lord Scriven: in doing this today, we are standing with those who struggle with drug use and with those around them—the communities, their families and their friends. It is with that motivation in mind that we are doing this.

I will of course write to noble Lords if there are any points that I do not manage to cover adequately. To pick up some of the points, however, the noble Lord, Lord Scriven, asked who will regulate. As part of the legislation, as I said in my introduction, there will be training and data-reporting requirements attached to both routes for new providers. Those new providers could be the emergency services, for example, and they will have to report on levels of prescribing so that effectiveness and safety can be monitored. That will absolutely be required of them.

The Minister might not still welcome me to my place now but although I understand that, my point was: what powers do those whom they report to have in ensuring compliance? That is the bit I did not get from reading the regulations.

That is understood. I am sure that the noble Lord will be delighted to know that this is to be established, but he is certainly quite right to raise that point. I will ensure that, once that detail is established, it is made known.

On the point about a potential additional burden on services, which the noble Lord, Lord Evans, raised, we certainly recognise the fact that there are challenges in the scope of these regulations. Our intention—I stress intention—is not to create any additional burden. I think I was quite clear in mentioning that these are enabling, not compulsory, requirements. That is important, because it means that no service or individual professional will actually be required to give out take-home naloxone as a result of these regulations. That potentially allows a more gradual introduction of this.

For example, I know that the noble Lord, Lord Scriven, mentioned that there may be differences in the level of take-up across the country. I suspect that may well be the case. It will be our job not just to encourage it to be taken up but to work out why it is not being taken up. We will not just bring in this instrument; we will seek to actively promote it. As I said, we are confident that there is a high level of support for these changes and we will continue to work closely with services and professionals to support them with provision.

The noble Lord, Lord Evans, rightly said that the previous Government undertook the consultation. I am most grateful for that because it has informed where we are today. That consultation under the previous Government received significant positive support from the sector, with the overwhelming majority of respondents agreeing with the set-up of the changes.

The noble Lord, Lord Evans, raised a question about costs. There is no direct cost to the Government associated with these changes since, as the noble Lord will understand, this is only an enabling provision. It will be for services to determine whether they use this power and give out take-home naloxone. At the moment, local authorities provide funding for naloxone, which is supplied through drug treatment services based on their assessment of local need. Although local authority public health services will want to support the wider provision of naloxone, I recognise that their resources are limited; I am sure that many of them will tell me that. This will potentially mean that there is an additional call on their resources and they may need to pay for it through their own funding streams. However, we will monitor demand and engage with services and local areas to understand where any pressures may be.

I thank the Minister for her responses. In Australia, Canada and some states in the United States the nasal spray is available over the counter. Does the Minister have any knowledge of any plans to administer it via our pharmacies?

I am waiting for inspiration, as the noble Lord will realise. In fact, I would rather write to him, as he has made an important point and I want to be quite clear on it. I thank him for reiterating the point.

Motion agreed.