Official Report: Minutes of Evidence

The Chairperson (Ms Kimmins): The Department of Health is proposing to make a statutory rule (SR) that will increase the number of services, professionals or organisations that can supply naloxone without a prescription or written instruction. The rule will also remove remaining references in the Human Medicines Regulations 2012 to the now dissolved Public Health England (PHE) and the Regional Health and Social Care Board (RHSCB) in Northern Ireland. The statutory rule will be subject to the draft affirmative procedure.

I welcome from the Department Gary Maxwell, the head of the health development policy branch; Canice Ward, head of the medicines regulatory group; and Karen Simpson, head of the medicines legislation unit. Thank you for coming to the Committee today. I invite you to make some opening remarks, and we will then move to questions.

Ms Karen Simpson (Department of Health): Thank you for the opportunity to brief the Health Committee. My colleagues who have accompanied me today can assist in providing any further clarification of the proposals that is required.

We propose to amend the Human Medicines Regulations 2012 to expand access to naloxone, which is a life-saving medication that reverses the effects of an overdose of opioid drugs. We are also proposing some technical amendments to the regulations on the transfer of functions following the dissolution of Public Health England and the Regional Health and Social Care Board in Northern Ireland.

I will start with naloxone, however. Anyone can administer naloxone in an emergency, and it is considered a very safe medicine for the recipient and the person administering it. It is already widely used in the UK and worldwide. Current legislation allows only drug and alcohol treatment services to supply it to individuals for future use — usually called take-home naloxone — which limits the reach of that life-saving medicine.

Two key changes are therefore being proposed. First, it is proposed to expand the list of services and professionals named in the regulations who are able to 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 is proposed to establish national registration services across the United Kingdom to enable all other services and professionals who cannot be named in the legislation, including housing and homelessness services, to register and procure naloxone.

It will not be a mandatory requirement for the services and professionals listed in the legislation to supply naloxone. The powers in the draft legislation are enabling; they simply allow the supply of naloxone without a prescription.

There are also safeguards in the proposals, which include the establishing of mandatory training requirements for new services and professionals that wish to take on the role. That training would give participants an understanding of appropriate practices for storing and supplying naloxone and how to support an individual who is being supplied with it.

The proposals are being considered as a matter of public health and safety in the UK. Drug misuse deaths have doubled since 2012, and the impact of synthetic opioids on opioid-related deaths is yet to be fully understood. In 2022, opioids were involved in 60% of drug misuse deaths in Northern Ireland. Through their substance use strategy, 'Preventing Harm, Empowering Recovery', the Northern Ireland Executive have prioritised reducing alcohol- and drug-related deaths. The Committee will be assured to note that the infrastructure is already in place in Northern Ireland to deal with the expansion of those who can supply naloxone.

Since 2012, the Public Health Agency (PHA) has operated a take-home naloxone programme. Naloxone was supplied 1,861 times in 2023-24. The take-home naloxone scheme has successfully reversed an overdose in over 1,765 cases during the time it has been in place. The PHA has mandatory training in opioid overdose awareness and basic life-saving skills and provides naloxone administration training for trainers, which all naloxone suppliers must complete initially and then refresh every two years. In preparation for the expansion of the scheme, the Public Health Agency will be transferring that training online to target larger numbers.

There are also technical amendments in the statutory instrument (SI), outlined in the SL1, in relation to the transfer of functions following the dissolution of Public Health England in 2020 and the Regional Health and Social Care Board in 2022. In Northern Ireland, as part of our programme of work to transform our health and social care system, the Regional Health and Social Care Board closed on 31 March 2022, and its functions migrated to a newly formed strategic planning and performance group in the Department. Many of Public Health England's functions have been transferred to the UK's Health Security Agency, which is also an executive agency of the Department of Health and Social Care (DHSC). The proposed amendments will ensure that the legislation reflects recent changes in the healthcare systems in England and Northern Ireland.

The human meds regulations are made under powers contained in the Medicines and Medical Devices Act 2021 The Department of Health in Northern Ireland is named in the Act as the appropriate authority in recognition that the regulation of medicines in Northern Ireland is a devolved matter. UK-wide consultations on the proposals have taken place and received significant support. In Northern Ireland, 100% strongly agreed or agreed with the proposed list of named services and professionals that can supply naloxone without a prescription, with 91% strongly agreeing or agreeing that training requirements for named services and professionals should include the storage and supply of naloxone. The importance of staff training on the administration of naloxone, along with advice and signposting on additional support, was consistently highlighted.

The regulations will be subject to the draft affirmative procedure and will be laid before, and approved by resolution of, the Northern Ireland Assembly. Therefore, an Assembly debate on the regulations will be required. As the Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 is a joint SI with the Department of Health and Social Care, it must be laid for debate and approval in both Houses of Parliament. The SI was laid in Westminster at the end of July, with the debate in the House of Commons on Monday 9 September. The House of Commons supported the amendments. The House of Lords debate is still to be scheduled.

If the Health Committee is content, following its consideration of the SL1, with the policy intent of the amendments, the Department will seek to lay the legislation next week, which is the week commencing 16 September, and provisionally schedule the necessary Assembly debate for mid-October 2024 to allow the Committee the opportunity for further consideration of the legislation alongside any views of the Examiner of Statutory Rules.

I am happy to take questions.

The Chairperson (Ms Kimmins): Thank you, Karen. Over the summer, I met pharmacies, other organisations and professionals, and naloxone was something that came up. I was shocked to hear how often it has to be used in the centre of Belfast. We have heard a lot about that in the media as well. Anything that enables its supply is certainly welcome. It is sad that it has to happen, but, essentially, it saves lives. Thank you for that.

Mr Donnelly: I agree with the Chair. It is sad that we have such levels of overdose and drug addiction in our society. Órlaithí and I have met families who have, sadly, lost people to overdose. The loss is incredible. The drug was used 1,861 times in 2023-24, reversing an overdose in 1,765 cases. Those number really surprised me: 1,700 lives have been saved. That is absolutely phenomenal and shows how useful and life-saving the drug is. The more people who have it in the community, the more lives can be saved. The legislation has to be supported, and I am glad to see it coming through.

I have a wee question. I know that there are two ways to give naloxone: an injection and a nasal spray. Is there a split in how the drug is administered? Are people trained to administer either the nasal spray or the injection? Does it matter?

Mr Gary Maxwell (Department of Health): It is primarily done by intramuscular injection. That has long been used by people in drug treatment services, and those who administer it are well used to doing so. As we roll naloxone out to other professionals and providers, we will see an increasing use of the nasal spray, because people are obviously more comfortable with putting a spray up the nose than they are with injecting somebody. Both are safe. The intramuscular injection is probably more effective, because that way more naloxone is taken into the body and it acts more quickly. If more people carry the nasal spray, it will outweigh the risk. There is a slight cost difference between the two. As we seek to roll it out, we will look at which one provides the best value for money. It has primarily been administered by intramuscular injection so far.

Mr Donnelly: I am glad to see the move to a harm-reduction model for people who use drugs. That policy is absolutely the right way to go. However, I would like to see it go further and include the provision of safe injection sites, particularly in Belfast, where we know there are issues with people injecting drugs. In order to reduce harm to those people, there should be provision of a site where they can inject in a safe environment under the care of medically trained staff, who can prevent or reverse overdose and save lives, provide clean needles, dispose of needles and provide medical advice to those who need it. That would be a really good step forward, and it is something that we should move towards. Thank you very much for your contribution; it is much appreciated.

Ms Flynn: I have two quick questions. I am also delighted to see the SI being brought forward. The figures that you quoted, which Danny mentioned, speak for themselves. Those are lives that have been saved through the use of this drug. Increasing its availability increases the potential to save more lives. It is desperately sad how people end up in that situation. However, the important thing is that we can, hopefully, save a life when someone, sadly, reaches that point.

The Assembly will debate the motion in mid-October, and, if the legislation has been through the House of Commons, it will go to the House of Lords. Do you have a timeline for when it will come into effect for the organisations that have registered? Is the registration process open to other organisations that have not registered? Will it continue to be open if further organisations want to join the scheme?

Ms Simpson: The legislation will come into operation 28 days after the House of Lords passes it. We assume that it will be operational around January. The Public Health Agency will be involved in the implementation, so Gary's side will be involved in that.

Mr Maxwell: The professionals and services named under route one will be able to supply it from that date. We will manage that through the Public Health Agency, which runs the regional scheme here. That is really useful in managing the roll-out. As for route two, we are having ongoing discussions with our colleagues in DHSC to make sure that we are consistent and follow the same procedures in setting up the scheme and the registration process. The PHA will probably target the specific groups that those who are most at risk of overdose go to and then push it that way. People can apply for registration, and the Public Health Agency will consider that as part of the process. It is planning to take a proactive approach where it says, "We now need to look at more provision in homeless hostels", or "We now need to look at those sites, providers and other professionals whom we have seen deal with some of those issues and be proactive around that". They can start doing that as and when the process comes into place and once we agree on what the registration will look like, ensuring that it is consistent across the UK. It will be a managed process, because, obviously, the demand for naloxone will increase. That will have an impact on available supplies, and we want to manage that by rolling it out in an effective and cost-effective way.

Mr Canice Ward (Department of Health): Training requirements are embedded in the legislation, which means that the process has to be managed as opposed to having a free-for-all. It is a staged process, which PHA is managing.

Mr Maxwell: And PHA is planning it from now on. It has been involved in the discussions to date.

Ms Flynn: Very good. That is great work. Thank you.

The Chairperson (Ms Kimmins): That has been useful. Thanks a million for that.

I have no other questions. Are members content with the merits of the policy and for the Department to make the statutory rule?