Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024
(2 months ago)
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Baroness Merron
That the Grand Committee do consider the Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024.
Relevant document: 2nd Report by the Secondary Legislation Scrutiny Committee. Special attention drawn to the instrument.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)
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.
These changes have also been called for by experts in the sector such as the Advisory Council on the Misuse of Drugs in its review of naloxone in the UK. In addition, Dame Carol Black recommended naloxone provision as an important harm reduction measure in her two-part independent review of drugs.
Allowing more services and professionals to supply naloxone will mean easier access to it for people at risk, which in turn will mean lives saved. With the growing threat posed by synthetic opioids, which are often more potent and more deadly, the importance of this work only continues to increase as time goes on.
I want to provide reassurance that, with these changes, there is no compromise on safety. Naloxone is very safe and effective, even when administered by a layperson with no prior experience. It has an effect only if the person has been taking opioids and it is already widely used across the UK and internationally.
We are taking steps to mitigate against any very limited risks associated with wider access. We will provide updated guidance for services in scope, and we will set out robust requirements for training and safeguarding. I reassure the Committee that the intention of these changes is not to create additional burdens for services, particularly as we are aware that many of those in scope will already be facing pressures. These new powers are enabling, not mandatory. They provide an opportunity for increased provision, based on local need, but they do not make any requirements.
Finally, addiction is not a choice. It is often fuelled by wider issues, such as trauma and housing instability. This is a complex public health issue and must be tackled as such. We must change the narrative on addiction to one that is about the prevention of drug use, the reduction of harm and enabling recovery. The changes we are discussing here will save lives. On this basis, I beg to move.
Lord Scriven (LD)
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.
I listened to what the Minister said about setting up local naloxone providers and supply co-ordinators, and I have read the draft statutory instrument and the explanation—but I am still not clear about what regulatory oversight of these bodies will be in place. Who will be the regulator and what powers will they have to deal with the improvement or, indeed, withdrawal of such a service if it is deemed that the local provider is not carrying out the rules laid down in the draft statutory instrument?
Clearly, the broader implications of these amendments are not merely about the use naloxone but about standing with those who struggle with addiction, and their families. These amendments are an essential evidence-based response to the dramatic increase in opioid use and overdoses. By enabling greater access to naloxone, they will help to save lives.
Lord Evans of Rainow (Con)
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?
Although Regulation 8 does make provision for training, clarification is required. Naloxone can be administered by three different routes: intravenously, intramuscularly and by intranasal spray. Obviously, the first two require injection, which is a medical procedure for which specific training is required. The NHS, rightly, sets stringent guidelines on who is permitted to provide such services, so I think noble Lords could benefit from assurances that the IV and IM methods of administration are permitted only by medical professionals with full phlebotomy training.
Further to this point, I highlight that intranasal spray administration is, of course, the most effective method of widening access to the drug. Intranasal applicators can be used by the full range of providers specified in these regulations and can be easily distributed into the community. They therefore allow for a rapid response to an individual experiencing an opioid overdose and, I hope, should have a greater impact in reducing mortality rates. Can the Minister confirm that the Government will pursue greater distribution of the intranasal spray to complement this regulation?
I conclude by saying that we are pleased that His Majesty’s Government have continued the policy initiated by the previous Conservative Government by laying these regulations before us. I look forward to the Minister’s response to the questions I have laid out.
Baroness Merron (Lab)
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.
Lord Scriven (LD)
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.
Baroness Merron (Lab)
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.
Another point here is that this is not a neutral act. There will be benefits, in relation not just to personal health and saving lives but to costs associated with dealing with overdoses. I hope that will be seen.
The noble Lord, Lord Evans, also asked whether the methods of administration are permitted only by medical professionals. It is already the case under current regulations that naloxone can be administered by anyone. I emphasise the point about high levels of safety and that it can be administered by a lay person.
I think I have picked up most of the points raised, but as I said, if I have not I shall be very pleased to look further into any other points and to write.
To summarise, the changes we are proposing will allow more services and more professionals to give out take-home supplies of naloxone without a prescription. As I said, it can already be administered by anyone but having more services with the ability to supply it will mean easier access for the people who are at risk of overdose. It will support them and those around them, as has been generously welcomed and acknowledged by the noble Lords, Lord Scriven and Lord Evans.
In short, these changes will widen access to a life-saving medicine. I am sure we can all agree that any death from an illicit drug is tragic and preventable, and we should take every step we can to reduce drug-related deaths; that is what we are doing today. On this basis, I hope that noble Lords will join me in supporting these important regulatory changes. I commend these draft regulations to the Committee.
Lord Evans of Rainow (Con)
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?
Baroness Merron (Lab)
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.