Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024
Debate between Lord Scriven and Lord Evans of Rainow(1 month, 1 week ago)
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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.
Health Data: Research and Analysis
Debate between Lord Scriven and Lord Evans of Rainow
Lord Evans of Rainow (Con)
I am not aware that GPs are withholding such important data. If the noble Lord knows of any evidence, I ask him to let me know. I reassure the noble Lord, and indeed the House, that the Department of Health and Social Care and the NHS in England have committed to transforming how NHS health and social care data is made available for secondary uses. Secure data environments allow data to be accessed for research in secure systems without people’s identifiable information being seen or the data having to be sent between individuals. If the noble Lord has any specific cases, I ask him please to write to me.
Lord Scriven (LD)
My Lords, the NHS dataset has been allocated to raise over £5 billion per annum by commercial organisations, if used appropriately. What provision are the Government making to ensure that the public also benefit from this £5 billion by potentially setting something up that is equivalent to a sovereign wealth fund to be invested for public use, particularly for health?
Lord Evans of Rainow (Con)
The noble Lord knows how to run a hospital, and I pay tribute to the work that he has done. On the point about a sovereign wealth fund, I shall take it back to the department—but this strategy will give the public greater access to and control over their own records. Healthcare staff will have easy access to the right information, and social care leaders and policymakers will have data to make effective decisions —so the noble Lord will know that the strategy will benefit all those who work in the NHS, but particularly it benefits patients in the United Kingdom.
Community Pharmacies
Debate between Lord Scriven and Lord Evans of Rainow
Lord Evans of Rainow (Con)
I thank my noble friend for that important question regarding pharmacies. Although we are yet to label our service offer as “pharmacy first”, we have already introduced and funded a range of services in community pharmacy that make use of the clinical skills of pharmacy teams and take the pressure off GPs and other parts of the NHS. We continue to discuss with the Pharmaceutical Services Negotiating Committee how the Government can best support community pharmacies and the sector to provide services to patients.
Lord Scriven (LD)
Due to government policy, primary care networks are recruiting pharmacists from community settings. In January 2023, it was confirmed that about 4,100 pharmacies have been recruited into PCNs, with a large proportion of those being recruited from community pharmacy. Community pharmacy owners are now becoming more dependent on locum pharmacists to fill vacancies, and the fees have gone up by 80%. What will the Government do to deal with this problem as a matter of urgency to support local community pharmacists?
Lord Evans of Rainow (Con)
Health Education England’s 2021 community pharmacy workforce survey identified an increase in the number of pharmacists from 23,284 in 2017 to 27,406. From 2026, all newly graduated pharmacists will have a prescription qualification, and we will upskill the existing workforce. This will provide further opportunity for the community pharmacy sector to better support the delivery of primary care.