Misuse of Drugs Act 1971 (Amendment) Order 2011

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.