Misuse of Drugs Act 1971 (Amendment) Order 2011
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Earl Attlee
That the Grand Committee do report to the House that it has considered the Misuse of Drugs Act 1971 (Amendment) Order 2011.
Relevant Documents: 13th Report from the Joint Committee on Statutory Instruments
Earl Attlee
My Lords, I beg to move that the Committee considers the draft Misuse of Drugs Act 1971 (Amendment) Order 2011, which was laid before Parliament on 10 January. If it is made, this order in council will bring two new drugs, tapentadol and amineptine, under the control of the 1971 Act and clarify the legislation on mephedrone. Tapentadol is a recently developed, centrally acting analgesic or painkiller, which is likely to be marketed in the UK in the near future following licensing by the Medicines and Healthcare Products Regulatory Agency, or MHRA.
The effects and risks associated with tapentadol are similar to those of other opioid analgesics, including hydromorphone and morphine, which are both controlled as class A drugs under the 1971 Act. Tapentadol presents a risk of addiction, diversion from legitimate sources and potential medicinal misuse. The risks associated with an overdose of tapentadol are constriction of the pupils, vomiting, loss of consciousness, seizures, difficulty in breathing and a risk of serious complications likely to lead to death.
Amineptine, on the other hand, is a powerful and fast acting antidepressant whose misuse has been reported mainly in Asia and Europe. In 2003, the Commission on Narcotic Drugs, on the recommendation of the World Health Organisation, decided to include amineptine in Schedule II to the Convention on Psychotropic Substances of 1971. As a signatory to the 1971 convention, the UK has to schedule amineptine under the 1971 Act to meet its international obligations.
Clinical studies indicate that amineptine has the potential for both dependence and misuse, predominantly in patients with a previous history of substance misuse. The withdrawal symptoms associated with amineptine include anxiety, psychomotor agitation and insomnia. Instances of dependence have been reported in Asia and Europe. The Government have consulted the advisory council as required by statute for both drugs, and in July last year it provided advice on tapentadol and amineptine following consideration of their harms. The advisory council reports that there is no evidence of licit or illicit use of tapentadol or amineptine in the UK. However, it supports the control of both drugs due to the potential harm associated with them. The advisory council also recommends that tapentadol and amineptine are controlled under the Misuse of Drugs Act—in class A and class C respectively—and Schedule 2 to the Misuse of Drugs Regulations 2001. The Government have accepted its recommendations.
The Committee will recollect that mephedrone and other cathinone derivatives—a group of so-called legal highs—were brought under the control of the Misuse of Drugs Act 1971 as class B drugs from 16 April 2010, with cross-party agreement in the final days of the last Parliament. If it is made, the latest Order in Council will also clarify the legislation on mephedrone, subsuming it within the generic definition used to control other cathinone derivatives at the time. Under current drafting, there can be uncertainty surrounding whether Article 2(a) or 2(b) of the 2010 order amending the 1971 Act is applicable to a given sample when preparing a charge for offences relating to mephedrone. The amendment will remove that uncertainty and ensure clarity and consistency for prosecutors, enabling all charges for the possession, supply and production of mephedrone to be prepared under the generic definition in paragraph 1(aa) of the 1971 Act.
This Order in Council, if it is made, will ensure that while honouring its obligations as a signatory to the 1971 UN convention, the UK will also be taking precautionary measures, based on the assessment of harms and the potential for misuse highlighted by the advisory council, by controlling tapentadol and amineptine under the 1971 Act.
There will be no designation order in the case of the two new drugs we seek to control through this Order in Council, as both drugs have legitimate medicinal uses. However, it is intended to make two further related statutory instruments which will be subject to the negative resolution procedure. The misuse of drugs designation amendment order 2011 will amend the Misuse of Drugs (Designation) Order 2001, subsuming mephedrone within the generic definition in the order. The misuse of drugs amendment regulations 2011 will similarly amend the Misuse of Drugs Regulations 2001, bringing mephedrone within the generic definition in the 2001 regulations and including tapentadol and amineptine in Schedule 2 to the 2001 regulations. Those instruments will be laid so as to come into force at the same time as the Order in Council, if it comes into force as proposed.
The Government will publicise the approved law changes on tapentadol and amineptine and the clarification of the legislation on mephedrone through a Home Office circular.
Lord Hunt of Kings Heath
My Lords, I am sure we are all grateful to the noble Earl for his remarks in introducing this order. The scientific evidence and advice on which the Government have acted is very clear and I welcome the Government’s action. The first two provisions in the order follow advice from the Advisory Council on the Misuse of Drugs. A letter about tapentadol from Professor Les Iversen of the Advisory Council on the Misuse of Drugs in July 2010 concludes that the abuse liability of the drug would be substantial and has the potential to cause social harm through diversion and addiction. Measures for amineptine were also on the recommendation of the advisory committee, which supports that drug being controlled under the Misuse of Drugs Act 1971.
The Explanatory Memorandum discloses that no consultation has taken place on this and that the Minister’s department has concluded that it is not necessary or beneficial so to do. The noble Earl will be aware that the Merits Select Committee has suggested that this Committee should satisfy itself that the review processes for the changes are sufficiently robust. I invite the noble Earl to respond to that comment of the Merits Select Committee.
In relation to these first two drugs, I take this opportunity to thank Professor Iversen and his advisory committee for the extremely valuable work that they do. The Minister has also explained that the changes in the draft order about mephedrone will not affect its classification. It is, and will remain, a class B controlled drug. The proposed clarification is simply a technical change in the legislation to make it more straightforward for prosecuting authorities to prepare charges. That seems extremely sensible and the Official Opposition are glad to support the proposal.
It is only a few months ago that mephedrone was brought under the control of the Misuse of Drugs Act 1971 as a class B drug. As has been explained, the paperwork accompanying the order makes it very clear that these drugs are harmful and dangerous and, in addition to legislative controls, a series of actions is required going beyond law enforcement and embracing prevention, public health and education. I would be grateful if the noble Earl could say something about what progress has been made on these fronts since the drug received the classification last April.
I would also like to ask the Minister about the impact of the proposed changes to the National Health Service on public health programmes in relation to this and other drugs. In so doing, I should refer to my declaration of a number of interests of mine in healthcare, declared in the House of Lords register of interests.
I understand that many useful public health programmes in relation to drugs are organised and funded locally by primary care trusts. The noble Earl will be aware that, under legislation now in the other place, primary care trusts are due to be abolished, with most of their public health functions being transferred to local authorities, alongside ring-fenced funding. Perhaps the noble Earl—if not today, but in writing—can assure me that his department will work very closely with the Department of Health and CLG to ensure that the budgets for drug prevention work, which are currently held locally, will be protected and that local authorities will be strongly encouraged to be proactive in that area.
Baroness Hamwee
I, too, am happy to support this order. I would like to follow up the questions asked by the noble Lord, Lord Hunt of Kings Heath, on consultation. The Merits of Statutory Instruments Committee referred in its report to amineptine having been dealt with by the Commission on Narcotic Drugs as long ago as 2003. That is quite startling. I am sure that the noble Earl will have been briefed as to the reason for the delay.
I also want to ask about the reference in the Explanatory Memorandum to consultation not being necessary. One might say that it is or is not, but at least one would understand it. I simply do not understand why consultation may not be “beneficial”, which is the term used in paragraph 8.1 of the Explanatory Memorandum. When is consultation not beneficial? I hope that the noble Earl can find an answer to that perhaps more philosophical question.
Earl Attlee
I am grateful for the helpful response from all noble Lords in this short debate. I think that the most important point to be made is about consultation, which, of course, is necessary. But it is achieved in a variety of ways, including the Advisory Council on the Misuse of Drugs talking to the manufacturers of drugs, particularly of tapentadol, and to the medical health care regulatory agency. Of course, we keep all these matters under review.
The noble Lord, Lord Hunt of Kings Heath, asked me some NHS questions which I think he would agree were rather wider than this order, which is concerned with avoiding harm from therapeutic and recreational drugs. But I will draw our debate to the attention of my noble friend Lord Howe.
As regards mephedrone, there are frank website discussions about its dangers. Ministers have written to organisers of summer music festivals. There is also the student campaign promoting the message that just because something is legal, that does not make it safe. There are ongoing campaigns to educate people of the danger of so-called legal drugs.
Approval of this order will ensure that the UK continues to meet its international obligations and that our drug laws are effective in relation to newly developed pharmaceutical drugs entering the UK market. Controlling these drugs will ensure that the necessary regulatory framework is in place to protect the public from the potential harms associated with these drugs. We will continue to highlight that mephedrone is harmful and that it remains a class B drug, monitor the trends and the misuse of the drugs being proposed for control, and assess the impact of the controls introduced by this order.
Baroness Hamwee
Perhaps I may come back to two points that I made, which may have sounded a little flippant but were serious. The first concerns the delay since 2003, and the other the reference to consultation not being beneficial. If my noble friend Lord Attlee cannot answer these now, I should be grateful if he would write to me with a copy circulated to other Members of the Committee.
Earl Attlee
My Lords, I never said that the consultation would not be beneficial. I said that it would be beneficial, but that the impact assessment—to which I think my noble friend referred—or the Explanatory Memorandum said that it would not be necessary. It was not necessary or beneficial because of the ACMD process, the activities of the MRHA and consultation with the manufacturer.
I did not answer her question about why it has taken so long for the UK to control amineptine when it was scheduled under the UN convention. Amineptine came to light following an audit carried out to ensure that the UK was fulfilling its international obligations. As soon as this came to light, the Government consulted the ACMD, as required under the Misuse of Drugs Act 1971, and, following its advice, have moved swiftly to bring amineptine on to the 1971 Act. However, at no time during this period were the public exposed to any risks from this drug, as amineptine has never been available or licensed in the UK. The ACMD has confirmed that there was no evidence of illicit use of amineptine in the UK. I hope that that answers my noble friend’s questions.
Lord Hunt of Kings Heath
My Lords, as regards consultation, the noble Earl, Lord Attlee, has been helpful. I think he is saying that the advisory committee and the MHRA have gone through their own public consultation procedures and that therefore it is not necessary to do so again. Perhaps he could confirm that. In an otherwise very clear Explanatory Memorandum, it would have been helpful if that point had been raised.
Earl Attlee
I am obliged to the noble Lord, Lord Hunt of Kings Heath. He is absolutely right.