Considered in Grand Committee
My Lords, I am grateful to the Advisory Council on the Misuse of Drugs for its advice, which has helped to inform the draft order before us. The order was first laid before Parliament on 17 October and will control pregabalin and gabapentin as class C drugs under the Misuse of Drugs Act 1971. Should the order be made, pregabalin and gabapentin will be subject to permanent control under Schedule 2 to the Misuse of Drugs Act 1971 through an amendment to Part 3, which specifies the drugs that are subject to control under the 1971 Act as class C drugs.
The order follows the recommendation from the ACMD to control the two drugs under class C of the 1971 Act, as their harms are comparable with those of other substances controlled as class C drugs. To help those with a legitimate medical need access these drugs, and subject to Parliament’s approval of the order before the Committee now, we will schedule both drugs under Schedule 3 to the Misuse of Drugs Regulations 2001 through regulations.
Pregabalin and gabapentin are prescription medicines which are used to manage a number of disabling long-term conditions, including epilepsy. They are also licensed for the treatment of general anxiety disorders. In its advice, the ACMD identified a number of harms—in particular, it drew attention to the dangers that can arise when the drugs are used in combination with other central nervous system depressants. In these circumstances, they can cause drowsiness, sedation, respiratory failure and death.
The ACMD also highlighted the risk of addiction that pregabalin and gabapentin presented, as well as the potential for illegal diversion and medicinal misuse. Its advice also drew attention to the concerns of health staff in prisons who reported a high number of prisoners being prescribed the drugs without a thorough assessment of their needs.
Across the United Kingdom, there have been significant increases in the prescription of both drugs: pregabalin prescriptions have increased from 2.7 million in 2012 to 6.25 million in 2017, while gabapentin prescriptions have risen from 3.5 million in 2012 to over 7 million in 2017. In tandem, there has been an increase in the number of deaths related to pregabalin and gabapentin since 2009. In the last five years there have been 408 deaths where pregabalin was mentioned on the death certificate, and 203 in the case of gabapentin. This compares with four and one for pregabalin and gabapentin respectively in 2009.
By controlling the two drugs, we will restrict the potential for misuse by making diversion and their illicit supply more difficult but without compromising access for those who have a legitimate need to access the drugs for healthcare purposes. Parliament’s approval of this order will enable UK law enforcement to take action against those who illegally supply these drugs and against those who illegally possess them. Possession of a class C drug is an offence resulting in up to two years in prison or an unlimited fine, and the supply or production of a class C drug is an offence resulting in up to 14 years in prison or an unlimited fine.
If approved, the order will send a clear message to the public that the drugs should only be in the possession of those who have been legitimately prescribed them. We hope that the significant supply offences for class C drugs will make people think twice before they consider diverting pregabalin and gabapentin into the illegal market.
The measure to control these drugs is scheduled to come into force in April 2019. Given the widespread use of the two medicines, this will help to provide the healthcare sector with sufficient time to implement the new requirements. I can assure Members that all relevant information will be communicated to other stakeholders and the wider public. The Home Office will issue a circular with legislative guidance for the police and the courts. Guidance will also be published following engagement with interested parties about the effect of the legislation in preparation for it coming into force in April. In addition, the Government will continue to update its messaging on the harms of these substances.
I hope I have made the case to control these harmful drugs and I commend the order to the Committee.
My Lords, I am very grateful to the Minister for explaining the order to us. As she has said, this puts two substances into class C of the Misuse of Drugs Act 1971, on the recommendation of the Advisory Council on the Misuse of Drugs.
We support any evidence-based scientific approach to reducing the harm caused by drugs, legal or illegal. My question is very simple. The noble Baroness talked about a very clear message being sent to the public, but why do the Government not always act on the scientific, evidence-based assessment of the ACMD?
The problem with drugs classification under the Misuse of Drugs Act is threefold. First, based on independent scientific assessment, drugs are not classified according to the potential harm that they cause. For example, GHB—gamma-hydroxybutyrate—is believed to cause a significant number of deaths—perhaps as many as several a week in the UK alone. Yet it is classified as a class C drug. Cannabis which, to my knowledge has not been the direct cause of any drug-related death, is a class B drug. Because of this, and several other misclassifications of which I could give examples, the classification of drugs under the Misuse of Drugs Act has fallen into disrepute among those who might arguably be helped most if they knew that the classification of drugs was based on how dangerous they were.
At this stage, I should point out an interest to the Committee. A former partner, who then became my best friend and who was very experienced in the use of recreational drugs, died from an accidental overdose of GHB.
Secondly, because the classification system does not reflect potential harm, only potential sentence, it has become irrelevant to most drug users. They quite simply work on the basis that the penalty is irrelevant to them as they have no intention of getting caught.
Thirdly, any drug classified under the Misuse of Drugs Act carries a heavier penalty than a new psychoactive substance covered by the Psychoactive Substances Act 2016 in that possession of a new psychoactive substance is not an offence, whereas possession of any drug classified under the Misuse of Drugs Act is an offence. This is even though some of the new psychoactive substances are more harmful than drugs classified under the Misuse of Drugs Act.
Our drugs laws are a mess, the Government’s drugs strategy is ineffective and, if we are to stop our young people dying, we need a fundamental rethink. We called for a scientific, evidence-based review of our drugs laws when we debated the Psychoactive Substances Bill—a proposition both the Conservative and Labour Benches refused to support. Therefore, I note with interest the comments of the Parliamentary Under-Secretary of State at the Home Office, Victoria Atkins, in the other place, when this order was discussed by the Tenth Delegated Legislation Committee on 12 November this year, at 6.05 pm, where she said that the Government have announced,
“an independent review of the misuse of drugs in the 21st century”. —[Official Report, Commons, Tenth Delegated Legislation Committee, 12/11/18; col. 4.]
Can the Minister provide the Committee with further details of who will be conducting this review, what their terms of reference are, and any other details that may be of interest?
My Lords, I thank the Minister for explaining the purpose of the order and its provisions. We support it but I have some points that I would like to raise. As has been said, the order controls pregabalin and gabapentin as class C drugs under the Misuse of Drugs Act 1971. Currently these two substances are subject to the Psychoactive Substances Act 2016.
The two substances are used, as the Minister has said, to manage a number of disabling long-term conditions including epilepsy and general anxiety disorders. Although they have legitimate medicinal uses for which they can continue to be used, the two substances in question, when taken with other central nervous system depressants, can be the cause of serious harm including respiratory failure and, at worst, death. The Advisory Council on the Misuse of Drugs has said the two substances in question can be addictive, with the potential for illegal diversion and supply and medicinal misuse. Prescription rates have soared—the Minister gave the figures—while the number of deaths related to the two substances have also increased: just over 400 from pregabalin over the last five years and just over 200 from gabapentin.
Concerns were raised in 2014 by the Health and Social Care Board about the potential misuse of pregabalin. Apparently, in February 2015 Her Majesty’s Inspectorate of Prisons reported concerns of health staff in prisons that a high number of prisoners were being prescribed the drugs without a thorough assessment of their needs, and in a way that did not meet best-practice guidelines. Does that mean prisoners in prison being prescribed the drugs without a thorough assessment of their needs or prisoners prior to their coming into prisons being prescribed the drugs in the wrong way? Either way, the question must be how that has been allowed to happen. What will the planned guidance and communication say to address the issue of drugs of this kind being prescribed without a thorough assessment of the patient’s needs?
For how many years have these two substances been available? What is it that starts the procedure for the control of such substances as class C drugs as per this order? With concerns being raised in 2014, it does not seem to be a particularly quick process. Who or what organisation makes the initial move, and what is then the procedure for getting the matter before the Advisory Council on the Misuse of Drugs? Or is it the advisory council that has to take the initiative in the first instance?
Paragraph 12.2 of the Explanatory Memorandum states:
“Enforcement of offences in relation to drugs controlled by the Order will be subsumed into the overall enforcement response to controlled drugs”.
That statement is in marked contrast to the impact of the order on pharmacies, GPs and the NHS as a whole, for which precise figures have been given in the Explanatory Memorandum with regard to the additional cost. So what will the additional cost be of implementing this order to the police, the court system and the Prison and Probation Service of enforcing these new offences? What is the estimated number of new offences that will be committed each year as a result of controlling these two substances as class C drugs? Is the reality for our overstretched police that either they will not arrest many people for offences related to those two substances or, if they do, it will be at the expense of investigating, enforcing and arresting people for other offences? Is that what,
“subsumed into the overall enforcement response to controlled drugs”,
really means? If not, what does that phrase mean?
Paragraph 13.3 of the Explanatory Memorandum states:
“Exemption from the 1973 Regulation requirements will also ensure that small business should not incur additional cost, e.g., for providing new safes within their premises”.
What are the implications of not providing safes within premises? How many businesses will be exempt from the 1973 regulations? What businesses are they? Against what criteria is a judgment made on whether to make an exemption from the 1973 regulations? What would be the cost of providing new safes or cabinets? Paragraph 16 of the impact assessment refers to,
“the excessive cost to medical suppliers of the drugs that the 1973 Regulations require”.
It is therefore clear that an estimate of the cost has been done, since, without it, nobody could refer to “excessive cost”.
I am sure that the Minister will correct me if I am wrong, but, as I understand it, the exemption was not recommended by the Advisory Council on the Misuse of Drugs, which thought that the regulations should apply.
I thank both noble Lords for their points. The noble Lord, Lord Paddick, asked about the review of drugs. As he said, the Home Secretary announced on 2 October a major, independently led review of drug misuse. While the review will obviously not cover prescription drugs, it will look at a wide range of issues, including the system of support and enforcement around drug misuse, to inform our thinking about what more can be done to tackle drug harms. It will make sure that we know as much as possible about who drug users are, what they are taking and how often, so that law enforcement agencies and the police are able effectively to target and prevent the drug-related causes of violent crime. We will shortly set out the terms of reference and the name of the reviewer, which I cannot give at this point. The review will inform our thinking and help shape what more we can do to tackle drugs and drug harms.
The noble Lord, Lord Rosser, asked whether the drugs are prescribed before people come into prisons or while they are there. I do not have that answer now, but whether the drugs are used before prison or while in prison, it is a problem in the prison estate. I will provide him with a breakdown of where we think the prescribing occurs.
The noble Lord asked whether the Government had asked the ACMD or vice versa. The Government can ask the ACMD for its advice, but the ACMD can also ask the Government to instigate an assessment of drug scheduling. On the additional cost, the financial implications are set out in the impact assessment. The cost in year 1 to pharmacies is estimated to be about £97,000 and the cost to the CPS £172,000. There is an additional dispensing cost to the NHS which is estimated at present value to be £53.7 million over 10 years. That has obvious implications for GPs. Officials will meet the necessary bodies to outline the effect on GPs’ practices of the rescheduling of both drugs.
The issue was not that I was not aware of the costs on GPs, pharmacies and the NHS, because they are spelled out in great detail in the document, even telling us what is the average pay per hour, working out that it would require five minutes for people to find out how to operate the new system and working out the cost of five minutes at £20 or £30 per hour—whatever the figure is. My point is that there is no reference to the cost of the order on the police, the criminal justice service, the probation service or the Prison Service—people can be sent to prison for up to two years. It just says that the cost will be subsumed into the overall cost of dealing with controlled drugs. I find it odd that the Government can set out the calculations in enormous detail of what it will cost pharmacies, GPs and the NHS but remain utterly silent on what the cost will be to the criminal justice system.
I outlined the projected costs to the CPS in year one, but the noble Lord asks a reasonable question and I will try to get him an answer. As he says, the number of organisations affected is stated in the impact assessment.
The noble Lord, Lord Paddick, asked me about the exemption from the 1971 regulations. If I may, I shall write to him. Oh, it was the noble Lord, Lord Rosser.
My point was that small businesses appear to have been exempt from the 1973 regulations in relation to the provision of a safe or appropriate cabinet. I shall stand corrected if I have got it wrong, but I understand that that was not what the advisory committee recommended. Why has the advisory committee’s recommendation been ignored in this case and what are the implications of not applying the 1973 regulations in relation to storage in safes and cabinets?
But am I nevertheless correct in saying that the ACMD did not say that the 1973 regulations should not apply? I am well aware that there is consultation; the document says that small businesses were dead against the regulations being applied, which may not be a surprise. I am asking about the implications of not applying those 1973 regulations, bearing in mind that, as I understand it, the ACMD did not say that they should not apply?
I go back to the consultation. Following the provisions of this option will mean that, although the drugs will be subject to auditing requirements, there will be no requirement to store them in controlled drugs safes—as the noble Lord said. Apparently, a significant number of respondents did not think that organisations could accommodate the drugs in existing safes, and expressed concern that this would result in substantial additional costs associated with buying and installing such safes.
I thank the noble Baroness for her promise to write to me, but these regulations about storage were drawn up with a purpose, to prevent something happening. It is now being said that they will not apply, although, as I understand it, that is not what the ACMD recommended. What is the downside of not applying the regulations, which were presumably made with a purpose? Clearly, the people most against them being applied were the small businesses that would be affected. Can I be told what the downside of not applying them is? Why was the recommendation of the ACMD not followed? I understand that there was consultation, I understand that there were groups which were against that, but perhaps they had a vested interest.