ࡱ> QSNOP)` PbjbjUU B,??Ǖb&POPOPO@O0OOOO8LFO Pf"LԆԆnvr$"hOOOԆԆ4vOԆOԆNOOWԆ )yViV0 ,,`WW,OC\<~v OOP-}OOOF}OOOOOOOOO  INCLUDEPICTURE "http://transnet.dft.gsi.gov.uk/pictures/470xAny/3/7/8/20378_DfT-Logo-green.jpg" \* MERGEFORMATINET  Specifying a limit for amphetamine in Regulations for the new offence of driving with a specified controlled drug in the body above the specified limit A Consultation Document Proposed limit for amphetamine to be specified in Regulations using the power in section 5A of the Road Traffic Act 1988 (as inserted by the Crime and Courts Act 2013). December 2013 The Department for Transport has actively considered the needs of blind and partially sighted people in accessing this document. The text will be made available in full on the Departments website. The text may be freely downloaded and translated by individuals or organisations for conversion into other accessible formats. If you have other needs in this regard please contact the Department. Department for Transport Great Minster House 33 Horseferry Road London SW1P 4DR Telephone 0300 330 3000 Website HYPERLINK "http://www.gov.uk/dft"www.gov.uk/dft General email enquiries HYPERLINK "mailto:FAX9643@dft.gsi.gov.uk"FAX9643@dft.gsi.gov.uk Crown copyright 2013 Copyright in the typographical arrangement rests with the Crown. You may re-use this information (not including logos or third-party material) free of charge in any format or medium, under the terms of the Open Government Licence. To view this licence, visit  HYPERLINK "http://www.nationalarchives.gov.uk/doc/open-government-licence/" www.nationalarchives.gov.uk/doc/open-government-licence/ or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or e-mail: HYPERLINK "mailto:psi@nationalarchives.gsi.gov.uk"psi@nationalarchives.gsi.gov.uk. Contents TOC \o "1-2"  Executive summary  PAGEREF _Toc374088788 \h 4 Duration of consultation  PAGEREF _Toc374088789 \h 7 The devolved administrations  PAGEREF _Toc374088790 \h 7 How to respond  PAGEREF _Toc374088791 \h 7 Freedom of Information Act 2000  PAGEREF _Toc374088792 \h 8 What will happen next?  PAGEREF _Toc374088793 \h 9 1. Introduction to the proposal  PAGEREF _Toc374088794 \h 10 Expert Panel recommendation  PAGEREF _Toc374088795 \h 10 Issues set out in the earlier consultation  PAGEREF _Toc374088796 \h 10 Consideration of the responses on a limit for amphetamine  PAGEREF _Toc374088797 \h 11 2. The proposed amphetamine limit  PAGEREF _Toc374088798 \h 14 3. The draft regulations  PAGEREF _Toc374088799 \h 19 4. Impact assessment  PAGEREF _Toc374088800 \h 20 5. Consultation questions  PAGEREF _Toc374088801 \h 21 Annex A: Consultation principles  PAGEREF _Toc374088802 \h 22 Annex B: List of those consulted  PAGEREF _Toc374088804 \h 23 Annex C: Draft Regulations  PAGEREF _Toc374088805 \h 26  Executive summary The Review of Drink and Drug Driving Law by Sir Peter North, published in June 2010, concluded that there was a significant drug driving problem with an estimated 200 drug driving-related deaths a year in Great Britain. However, in 2011, around 41% of the prosecutions in magistrates courts for driving whilst impaired through drugs were withdrawn or dismissed. The comparable figure for exceeding the drink drive limit is just 3%. Drug driving remains a primary concern for the public with 34% of people agreeing that drug driving is in the top three road safety issues most important to address. This is why the Government included in a Bill in May 2012 a new offence of driving with a specified controlled drug in the body above the specified limit for that drug. The Bill, which is now the Crime and Courts Act 2013 ( HYPERLINK "http://www.legislation.gov.uk/ukpga/2013/22/contents/enacted" \o "blocked::http://www.legislation.gov.uk/ukpga/2013/22/contents/enacted" http://www.legislation.gov.uk/ukpga/2013/22/contents/enacted), received Royal Assent on 25 April 2013. Section 56 of the Crime and Courts Act 2013 inserted a new section 5A into the Road Traffic Act 1988. Section 5A(8) includes a regulation-making power, exercisable by the Secretary of State in relation to England and Wales and by Scottish Ministers in relation to Scotland, to specify the controlled drugs to be covered by the new offence and the corresponding limit for each. A previous consultation that ran from 9 July 2013 to 17 September proposed 17 controlled drugs including amphetamine to be specified in regulations. It also proposed limits to be specified in the regulations for 16 of those controlled drugs but asked what a suitable limit might be for amphetamine. We have now considered those responses and further evidence and propose a limit of 50g/L for amphetamine. The previous consultation was extended to Scotland at the request of the Scottish Government but this consultation only relates to the proposed limit for amphetamine for England and Wales. The Scottish Government has informed us that they intend to consult on a proposed limit for amphetamine early in 2014. Any final policy proposal on the specific issue of drug driving in Scotland will be for the Scottish Government and will be taken within the wider context of Scotlands national drugs strategy. The cost and benefit analysis set out in the impact assessment of the earlier consultation still applies and relates to England and Wales and is available at  HYPERLINK "http://www.gov.uk/government/consultations/drug-driving-proposed-regulations" \o "http://www.gov.uk/government/consultations/drug-driving-proposed-regulations" www.gov.uk/government/consultations/drug-driving-proposed-regulations. In spring 2012 the Department for Transport asked a panel of medical and scientific experts to provide advice on what controlled drugs impair driving and what limits (as a concentration in blood) should be specified for each. The Expert Panel produced their final report Driving Under the Influence of Drugs, which we published on 7 March 2013. The panel proposed a limit of 600g/L for amphetamine. We received a number of responses to the publication of the Expert Panels report, all of which welcomed the report. However, some questioned whether the recommended limit for amphetamine was too high, expressing the view that drivers may not exceed the limit proposed by the panel but still pose a very significant risk to the public. The Government also has a concern as to the extent that the drug is used illegally as to whether a risk based approach to the drug was appropriate. In considering what approach to propose for amphetamine and what limit to set, we have weighed up the evidence about the use of the drug when driving; wider drugs policy; whether the drug is used medicinally; whether patients taking the drug are likely to be in a condition where they might drive; the findings and recommendations from the Expert Panel; the responses to the publication of the Expert Panels report; plus the responses to the previous consultation where we specifically asked for views. After considering all of the above we propose to set a limit at 50g/L for amphetamine. This is close to a zero tolerance approach but slightly higher in order to take account of the level at which a pharmacological effect is likely to take place, which is most likely to impair driving. A full consideration of how the limit was determined is at pages 11-18. The proposed limit for amphetamine does not catch someone who has consumed a very small amount of the drug in question inadvertently. A reliable analytical result can still therefore be obtained, yet be above the level at which issues such as passive consumption or inhalation can be ruled out. This consultation therefore seeks views on the Governments proposed limit of 50g/L for amphetamine. Duration of consultation The consultation period will last 6 weeks, beginning on 19 December 2013 and running until 30 January 2014. In deciding on the length of time for which to consult, we have considered the Consultation principles guidance at Annex A. We have concluded that, as we recently consulted upon the proposed controlled drugs and their limits where the approach to amphetamine was discussed and thus stakeholders are aware of the relevant issues, 6 weeks should be a sufficient period in which to consider the single proposed limit and respond, even taking account of the Christmas holiday period. The devolved administrations Regulation-making power to specify limits for the offence is exercisable by the Secretary of State in relation to England and Wales. This is provided for in section 5A(8)(a) of the Road Traffic Act 1988 (as inserted by the Crime and Courts Act 2013). As set out in the Executive Summary, this consultation has not been extended to cover Scotland. The Scottish Government intends to conduct its own consultation on a proposed limit for amphetamine early in 2014. The regulation-making power to specify limits for the offence is exercisable by Scottish Ministers in relation to Scotland by virtue of section 5A(8)(b) of the Road Traffic Act 1988 (as inserted by the Crime and Courts Act 2013). Any final policy proposal on the specific issue of drug driving in Scotland will be for the Scottish Government in line with the Crime and Courts Act 2013, and will be taken within the wider context of Scotlands national drugs strategy. The Road Traffic Act 1988 (with minor exceptions which are not relevant for present purposes) does not extend to Northern Ireland. How to respond The consultation period will run until 30 January 2014. Please ensure that your response reaches us before the closing date. If you would like further copies of this consultation document, it can be found at  HYPERLINK "https://www.gov.uk/government/consultations/drug-driving-amphetamine-limit" https://www.gov.uk/government/consultations/drug-driving-amphetamine-limit or you can contact Martin Ellis at the Department for Transport (contact details below) if you need alternative formats (Braille, audio CD, etc). Please use the link  HYPERLINK "https://www.surveymonkey.com/s/PXRLQCG" https://www.surveymonkey.com/s/PXRLQCG to access the response form in order to send consultation responses. If you have any further queries about the consultation, please address them to: Martin Ellis Road User Licensing, Insurance & Safety Department for Transport Zone 3/29, Great Minster House 33 Horseferry Road London SW1P 4DR Tel: 020 7944 6945 E-mail:  HYPERLINK "mailto:roadsafetyenforcement@dft.gsi.gov.uk" roadsafetyenforcement@dft.gsi.gov.uk A list of those consulted can be found at Annex B. We do not intend to acknowledge individual responses unless by request. Freedom of Information Act 2000 Information provided in response to this consultation, including personal information, may be subject to publication or disclosure in accordance with the Freedom of Information Act 2000 (FOIA) or the Environmental Information Regulations 2004. If you want information that you provide to be treated as confidential, please be aware that, under the FOIA, there is a statutory Code of Practice with which public authorities must comply and which deals, amongst other things, with obligations of confidence. In view of this it would be helpful if you could explain to us why you regard the information you have provided as confidential. If we receive a request for disclosure of the information we will take full account of your explanation, but we cannot give an assurance that confidentiality can be maintained in all circumstances. An automatic confidentiality disclaimer generated by your IT system will not, of itself, be regarded as binding on the Department. The Department will process your personal data in accordance with the Data Protection Act 1998 and in the majority of circumstances this will mean that your personal data will not be disclosed to third parties. What will happen next? We will carefully consider the responses to this consultation and finalise our considerations of the earlier consultation on the other proposed 16 drugs and their limits with a view to whether any changes are required to the draft regulations before they are laid before Parliament. We will then publish the summary of responses to both consultations, including next steps in 2014 soon after the close of this consultation at  HYPERLINK "http://www.gov.uk/government/organisations/department-for-transport" www.gov.uk/government/organisations/department-for-transport. Paper copies will be available on request. 1. Introduction to the proposal Expert Panel recommendation The Expert Panel recommended a limit of 600g/L for amphetamine based upon the blood concentrations observed in apprehended drivers suspected of or proven to have been driving under its influence. The range of means from different studies varied from 456g/l to 651g/L. However, the panel also acknowledged that amphetamine is a long standing member of the drug scene and is widely available in the UK with much of it manufactured illegally. Issues set out in the earlier consultation The original consultation explained that the approach to take in proposing a limit for amphetamine is less clear than for the other drugs. As the panel acknowledged, drugs containing amphetamine are commonly used illicitly but also includes medicines used to treat conditions such as Attention Deficit Hyperactivity Disorder (ADHD) and also sometimes used to treat hypersomnia (excessive sleepiness) and narcolepsy. A response to that earlier consultation brought our attention to the medication selegiline, which is used in the treatment of those suffering from Parkinsons disease. The metabolic pathway may cause persons taking selegiline to test positive for amphetamine and or methamphetamine on drug screening tests. There is therefore a question as to whether to take a zero tolerance approach in line with drugs such as cannabis and cocaine or whether to specify a limit at which a road safety risk becomes unacceptable to ensure that patients are not unduly penalised. Whilst ADHD is generally not found in the driving population because it is a condition associated with children and adolescents, diagnoses of adult ADHD is becoming more common. ADHD, narcolepsy and Parkinsons disease are conditions that are required to be reported to DVLA if the person wishes to drive. A medical opinion must then be provided on whether the person is safe to drive. Adult ADHD is a developing branch of medicine and we set out in the earlier consultation that there was a lack of available research evidence to determine either the road safety risk of prescribed drugs containing amphetamine on drivers with ADHD or the appropriate blood threshold limits for adults taking properly prescribed drugs containing amphetamine in accordance with the advice of a healthcare professional. The Department of Health has provided data on the amount of prescriptions issued for dexamphetamine which is the amphetamine based medicine prescribed for the above conditions. 3,555 prescriptions were issued between May 2012 and May 2013 and has remained roughly constant over the last 4 years. However, the majority of these are likely to be for treatment of ADHD patients below the driving age. The Department received a number of responses after publishing the Expert Panels report Driving under the influence of drugs, some of which expressed a view that the limit of 600g/L was too high, typically expressing a view that the limit was very significantly higher than those used in other countries. France, Netherlands and Poland have set the limit at 50g/L while Norway, Belgium, Germany and Finland have set it even lower. We set out in the previous consultation that there were potentially 4 different limits which could be set in relation to amphetamine: the limit recommended by the Expert Panel (600g/L), a lower limit of 100g/L that would still not catch most people on standard dosages for the treatment of ADHD; a limit of 50g/L in line with some other European countries; finally, a lowest accidental exposure limit, which the Expert Advisory Committee that is advising the Department recommended at 10g/L. We therefore asked for views on the most suitable approach to take for amphetamine. Consideration of the responses on a limit for amphetamine In the earlier consultation on all 17 controlled drugs proposed we had 18 responses suggesting a limit for amphetamine. These were as follows: Zero tolerance approach (lowest accidental exposure limit, i.e. 10g/L) = 6 50g/L = 5 100g/L = 2 300g/L = 1 600g/L (Expert Panel recommendation) = 4 For the 6 who suggested a zero tolerance approach the overriding view was that it is an illegal drug that is widely abused and given that it is a relatively small number being prescribed amphetamine who are likely to be driving then the medical defence was open to them. Others suggested that as ADHD is a notifiable condition then they should be on the DVLA database and ADHD patients can therefore be informed of the new offence and advised to be prepared to provide evidence of their prescriptions in the same way as Multiple Sclerosis patients are in relation to Sativex. Those that suggested a zero tolerance approach included one police force, a road safety charity, a sustainable travel charity, a driving instructor, a toxicologist and the Chief Fire Officers Association. At the other end of the scale, those who proposed 600g/L did so on the basis that they agreed with the recommendation of the Expert Panel. One of the 4 responses also argued to accept the recommendations of the Expert Panel in full so consequently agreed with 600g/L. Those that suggested a limit of 600g/L included 2 charities concerned with safety, a medical professional body and the DVLA. We also received one response from a toxicologist proposing 300g/L, but the same respondents overall response suggested a zero tolerance approach (Policy Option 3), so the suggested limit for amphetamine conflicted with its response to the earlier question. We had 2 responses proposing a limit of 100g/L. One forensic laboratory suggested that whilst some recreational users may be less than 100g/L this limit would catch chronic users. ACPO England recommended 100g/L because 50g/L might catch those on prescriptions whilst 600g/L might miss a considerable amount of illegal use. ACPO England also suggested that a level of 100g/L is unlikely to include most prescribed use, and would seem to best meet the needs of operational policing and the road safety gains from the prevention of drug driving. For the 5 respondents who suggested 50g/L the common theme was to be in line with several other countries. An equal theme was a 50g/L limit was likely to only catch a small number of patients and that the same approach as to those taking Sativex should be taken. This is discussed in the next chapter. Of the 5 respondents who agreed with this approach one was from a Road Safety Partnership who wanted to see a limit towards the lower end, one was from a medical professional body, a further one from a private organisation and one was from the Welsh Government who suggested 50g/L after taking professional advice. The final respondent was from a toxicology laboratory but suggested a cumulative approach to all amphetamine type drugs as in France. This would result in a tougher approach as other amphetamine drugs such as the presence of MDMA would be added to the presence of amphetamine. We therefore conclude that of those who responded the suggested limit was towards the lower end, i.e. between zero tolerance and 100g/L and that a limit of 50g/L or less is most acceptable to the respondents in the consultation. 2. The proposed amphetamine limit After considering the above along with the Governments wider drug strategy, and consideration of further academic evidence the Government has concluded that a limit of 50g/L is appropriate. In coming to our conclusion we also re-examined the European research project, Driving Under the Influence of Drink, Drugs and Medicines (DRUID) and other evidence based studies. The DRUID project identified that amphetamine was the third most prevalent illicit drug amongst drivers killed or seriously injured behind cannabis and cocaine. It was also more prevalent in northern Europe. In addition, data predominantly from England and Wales presented to the Expert Panel by the Centre for Applied Science and Technology from a forensic laboratory showed that amphetamine type compounds were in the top five of the most prevalent drugs amongst drug drivers. It is clearly important that a limit is set which errs towards a zero tolerance approach given the extent of its illicit use. However, none of the DRUID studies investigating the effects of stimulants such as amphetamine and dexamphetamine found that the consumption alone resulted in increased impairment or risk-taking. In general, low doses of stimulant drugs produce neutral or even stimulating effects on a range of psychomotor functions. Indeed ADHD sufferers taking low doses of amphetamine can improve their driving skills. Some studies found that stimulants may have detrimental effects on specific cognitive functions and increase risk-taking behaviours. Considering the likely drug use setting, the stimulant effects of amphetamine were not sufficient to overcome or compensate for driving impairments resulting from alcohol use or a nights sleep deprivation, which often accompany illicit amphetamine use. Moreover, users of stimulant drugs were not aware of post-acute fatigue effects (the comedown). One night of sleep deprivation alone caused impairments comparable to those observed under the influence of 80mg/100ml Blood Alcohol Concentration. DRUID quotes a case study of killed and seriously injured drivers in 9 European countries and found that the risk for amphetamine was higher than in the studies conducted in the DRUID project. When amphetamine was found in drivers injured or killed in road traffic accidents, the median concentrations were very high compared with the concentrations of subjects in the DRUID experiments. The study concluded that these may have detrimental effects on self-perception, critical judgement and risk-taking, and while the stimulating effects are wearing off the driver may suffer fatigue, anxiety and irritability. It is also likely that drivers who choose to drive when positive for (large concentrations of) amphetamines are more prone to taking risks than the average road user. The DRUID Deliverable 1.2.1 Effects of stimulants on actual and simulated driving found that experimental studies conducted according to a uniform study design (road tracking tests, car-following scenario and risk-taking scenario) designed to assess the effects of dexamphetamine doses on actual or simulated driving performance gave impairment effects of dexamphetamine at doses of 10mg and 40mg. The study suggested that a 10mg dose would be equivalent to a likely concentration in blood of between 0 to 40g/L and a 40mg dose equivalent to a likely blood concentration of 20 to140g/L. More than half of the participants had difficulties falling asleep the day after taking the high dose (40mg). Some felt drowsy for a couple of days following the test, mainly after having taken the higher dose. Where sleep deprivation led to impaired driving there was no evidence in the data that the resulting impaired driving was compensated for by taking a dose of dexamphetamine. A further Norwegian study (Gustavsen et al., 2004), of 878 motorists who tested positive for amphetamines/ methamphetamines only, found a positive correlation between blood amphetamine concentrations and impairment between a blood concentration range of 2753g/L. Furthermore, although 73% of subjects were judged to be impaired using clinical tests, the mean concentration of amphetamine did not differ from those judged not to be impaired (on average, 53g/L = impaired; 50g/L = not impaired) (Gustavsen, 2006; cited by Jones, 2007). In conclusion these studies demonstrate that whilst low doses of amphetamines can improve performance in some simple tasks and increase alertness and focus soon after consumed, it can still lead to increased risk taking. Whilst the later phase of use (the comedown), particularly when taking higher doses can lead to disoriented behaviour, distorted perception, fatigue and poor judgement. We also sought views of experts in the field of ADHD and were advised that many consultants in the UK monitor the research undertaken in the USA, where it has been more extensive, and kindly pointed us to some of these studies. The advice provided suggests that typical doses of amphetamine equate to 20-50g/L in blood, though some prescriptions can equate up to 200g/L. DRUID quotes the analytical cut off at 20g/L (lowest detectable level) whilst the Expert Advisory Committee advised 10g/L. Given the context in which illicit amphetamine use is often taken, i.e. suffering post consumption fatigue we believe an approach should be taken that is close to the zero tolerance approach but which reflects the levels at which impairment has seemed to be most apparent in the various studies and which is above most therapeutic ranges. That level appears to be at 50g/L and is one that is common in several European countries. Of those who responded to the specific question on what a suitable limit for amphetamine might be 13 were zero tolerance to 100g/L, whilst 5 were 300-600g/L. This would indicate that a limit between zero and 100g/L would be more in line with the views of those who specifically responded on a limit for amphetamine than the higher range. Question 1. Do you agree with the Governments proposed limit for amphetamine? If not please provide your reason(s). By proposing a limit of 50g/L we are aware that there may be some ADHD sufferers or those who have a recognised sleep disorder such as narcolepsy that may be prescribed dexamphetamine that in some less common cases may be above the proposed 50g/L limit. Equally this may apply to those in the early stages of Parkinsons disease who may be taking selegiline. However, as these conditions are required to be notified to the DVLA we propose to offer the same solution as we have proposed for Sativex in the earlier consultation. If a patients doctor provides an opinion to the DVLA that the patient is safe to drive then the DVLA would notify the patient that a short-term driving licence will be issued for up to three years. In the notification letter the DVLA proposes to provide the following advice: If you are currently being treated with or start being treated with (Selegiline/Dexamphetamine) please be aware that if you are tested by police for drugs or accused of drug driving and, specifically, if you are asked by police if you are taking any medication, you should declare your use of prescribed (Selegiline/Dexamphetamine). You may also need to provide the Police with anything you have that would confirm this, such as the medication if you have it with you or a prescription, counterfoil or any medical letter, report or advice. The above will of course be sent separately to those with the condition, i.e. those suffering from Parkinsons disease will only get a letter referring to selegiline. We also propose to write to the Association of Chief Police Officers (ACPO) to make them aware of the above situation. It will be for ACPO to disseminate the information as they see fit to ensure that police officers are aware that some ADHD, recognised sleep disorder sufferers and Parkinsons disease sufferers who are taking dexamphetamine or selegiline may be driving legitimately. Drivers taking dexamphetamine or selegiline will of course be able to seek to rely on the statutory medical defence. If in the view of the police officer their driving was not impaired, then we propose that these drivers should not be arrested nor any further action be taken against them. Changes to medicines information must be made through the marketing authorisation via the Medicines Healthcare products Regulatory Agency (MHRA) and should be in line with the provisions of Title V of Council Directive 2001/83/EC. We believe this approach to dexamphetamine and selegiline users is reasonable and will not deter them from taking their medicine in order to continue driving provided it is safe to do so. Question 2. Is the approach we are proposing to take when specifying the limit for amphetamine reasonable for those who are driving and being prescribed with dexamphetamine (which is used to treat ADHD, certain sleep disorders such as narcolepsy and Parkinsons disease)? If not what is the evidence to support your view? Question 3. Are there any other medicines that we have not taken account of that would be caught by the limit we propose for amphetamine and the conditions they treat? This may include medicines that metabolise in the body to amphetamine. If so please give your reason(s). We are currently considering the responses to the earlier consultation on whether there is an impact on business. We would also be interested to know if the proposed limit of 50g/L for amphetamine will have any impact on business. Question 4. Does any business have a view on whether the Governments proposed limit will have any impact on them, directly or indirectly? If so please give your reason(s). 3. The draft regulations The draft regulations are set out at Annex C and include the proposed limit for amphetamine. We have included the limits for the other drugs proposed in the original consultation and no consideration of the responses to that consultation has been taken into account here. The limits for all drugs may therefore change once we have fully considered the responses to both that consultation and this one. We will then publish a summary of the responses to both consultations and our final conclusions in 2014 soon after the close of this consultation. 4. Impact assessment The impact assessment produced for the initial consultation on the other drugs and their limits is still valid for this consultation and is available at Annex D of the initial consultation at:  HYPERLINK "https://www.gov.uk/government/consultations/drug-driving-proposed-regulations" https://www.gov.uk/government/consultations/drug-driving-proposed-regulations We will consider all the responses to both this and the earlier consultation and if necessary amend the impact assessment and publish it when we lay the final regulations before Parliament. 5. Consultation questions The consultation asks respondents to formulate their responses specifically to the following questions: Question 1. Do you agree with the Governments proposed limit for amphetamine? If not please provide your reason(s). Question 2. Is the approach we are proposing to take when specifying a limit for amphetamine reasonable for those who are driving and being prescribed with dexamphetamine (which is used to treat ADHD and certain sleep disorders such as narcolepsy) and selegiline (which is used to treat Parkinsons disease)? If not what is the evidence to support your view? Question 3. Are there any other medicines that we have not taken account of that would be caught by the limit we propose for amphetamine and the conditions they treat? This may include medicines that metabolise in the body to amphetamine. If so please give your reason(s). Question 4. Does any business have a view on whether the Governments proposed limit will have any impact on them, directly or indirectly? If so please give your reason(s). Annex A: Consultation principles The consultation is being conducted in line with the Government's key consultation principles which are listed below. Further information is available at HYPERLINK "https://www.gov.uk/government/publications/consultation-principles-guidance"https://www.gov.uk/government/publications/consultation-principles-guidance If you have any comments about the consultation process please contact: Consultation Co-ordinator Department for Transport Zone 1/14 Great Minster House London SW1P 4DR Email HYPERLINK "C:\\Users\\trollod\\AppData\\Local\\Microsoft\\Windows\\Temporary Internet Files\\Content.Outlook\\MDQLHA6Y\\consultation@dft.gsi.gov.uk"consultation@dft.gsi.gov.uk Consultation principles departments will follow a range of timescales rather than defaulting to a 12-week period, particularly where extensive engagement has occurred before; departments will need to give more thought to how they engage with and consult with those who are affected; consultation should be digital by default, but other forms should be used where these are needed to reach the groups affected by a policy; and the principles of the Compact between government and the voluntary and community sector will continue to be respected. Annex B: List of those consulted Action on Addiction Add Action Advisory Council on the Misuse of Drugs Age UK Alcohol Concern Cymru Association of British Insurers Association of Chief Police Officers (ACPO) (Wales & England) Association of Directors of Environment, Economy, Planning & Transport (ADEPT) Association of Independent Multiple Pharmacies Association of the British Pharmaceutical Industry Automobile Association BRAKE British Generic Manufacturers Association British Medical Association British Pain Society Chief Fire Officers Chief Police Officers Chronic Pain Policy Coalition College of Mental Health Pharmacists Crown Prosecution Service Driving Standard Agency Driver Vehicle & Licence Authority (DVLA) Drug Equality Alliance Drugscope D. Tec International European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) Focal Point General Pharmaceutical Council General Practitioners Committee Highways Agency Independent Healthcare Advisory Services Independent Pharmacy Federation Independent Scientific Committee on Drugs Institute of Advanced Motorists LGC Forensics Liberty Living Streets Mayors Office for Policing And Crime (MOPAC)(London) Medicines & Health Products Regulatory Agency (MHRA) Mental Health Foundation MIND MS Society MS Trust Napp Pharmaceuticals National Attention Deficit Disorder Information and Support Service National Pharmacy Association National Pharmaceutical Association National Rheumatoid Arthritis Society Pain UK Parkinsons UK Parliamentary Advisory Council for Transport Safety (PACTS) Parliamentary Office of Science and technology Pharmaceutical Services Negotiating Committee Pharmacy Substance Misuse Advisory Group Pharmacy Voice Policy Connect RAC Foundation Reckitt Benckiser Pharmaceuticals Release RoadPeace RoadSafe Road Safety GB (Association of local authority road safety officers) ROAR Forensics Royal College of Anaesthetists Royal College of Nurses Royal College of Physicians Royal College of Practitioners Royal College of Psychiatrists Royal College of Psychiatrists in Wales Royal Pharmaceutical Society of Great Britain Royal Society for the Prevention of Accidents Sickle Cell Society The Alliance The Alliance of British Drivers The Company Chemists Association The Law Society The Patients Association Transport for London TTP Counselling Turning Point UK Adult ADHD Network UK Clinical Pharmacy Association UK Psychiatric Pharmacy Group Welsh Government Young Minds Annex C: Draft Regulations Draft Regulations laid before Parliament under section 195(4) of the Road Traffic Act 1988, for approval by resolution of each House of Parliament. DRAFT STATUTORY INSTRUMENTS [2014] No. 0000 road traffic, england and wales The Drug Driving (Specified Limits) (England and Wales) Regulations [2014] Made - - - - *** Coming into force - - *** The Secretary of State makes the following Regulations in exercise of the power conferred by section 5A of the Road Traffic Act 1988() and after consultation with representative organisations in accordance with section 195(2) of that Act. A draft of these Regulations was laid before Parliament in accordance with section 195(4) of the Road Traffic Act 1988 and approved by a resolution of each House of Parliament. Citation, commencement and extent  LISTNUM "SEQ1" \l 2 These Regulations may be cited as the Drug Driving (Specified Limits) (England and Wales) Regulations [2014] and come into force on [..]. These Regulations extend to England and Wales. Specified controlled drugs and specified limits for the purposes of section 5A of the Road Traffic Act 1988 The table below specifies the controlled drugs() and, in each case, the limit in blood for the purposes of the offence in section 5A of the Road Traffic Act 1988. Table Controlled drugLimit [microgrammes per litre of blood]Amphetamine50Benzoylecgonine50Clonazepam50Cocaine10Delta-9-Tetrahydrocannabinol2Diazepam550Flunitrazepam300Ketamine20Lorazepam100Lysergic Acid Diethylamide1Methadone500Methamphetamine10Methylenedioxymethamphetamine106-Monoacetylmorphine 5Morphine80Oxazepam300Temazepam1000 Signed by authority of the Secretary of State for Transport Name Parliamentary Under Secretary of State Date Department for Transport EXPLANATORY NOTE (This note is not part of the Regulations) Section 5A(1) and (2) of the Road Traffic Act 1988 makes it an offence for a person (D) to drive, attempt to drive, or be in charge of a motor vehicle on a road or other public place with a specified controlled drug in the body, if the proportion of the drug in Ds blood or urine exceeds the specified limit for that drug. These Regulations specify the controlled drugs for this purpose and the limit for each expressed as a concentration in blood. An impact assessment on the effect that the offence will have on the costs of business, the voluntary sector and the public sector is available from the Road User Licensing, Insurance and Safety Division, Department for Transport, Great Minster House, 33 Horseferry Road, London SW1P 4DR (telephone 020 7944 6945). It is annexed to the Explanatory Memorandum which is available alongside this instrument on the UK legislation website at http://www.legislation.gov.uk. (It concluded that there will be no effect on business and the voluntary sector.)  TNS British Market Research Bureau 2011  Controlled drugs are defined in the Misuse of Drugs Act 1971 (which extends to the whole of the UK) as being either a Class A, B, C or a temporary class drug. The Road Traffic Act 1988 (as amended by the Crime and Courts Act 2013) provides that, for the purposes of sections 3A to 10 of that Act, the term controlled drug has the meaning given by section 2 of the Misuse of Drugs Act 1971.  Available at:  HYPERLINK "https://www.gov.uk/government/publications/driving-under-the-influence-of-drugs--2" \o "https://www.gov.uk/government/publications/driving-under-the-influence-of-drugs--2" https://www.gov.uk/government/publications/driving-under-the-influence-of-drugs--2  What We Know About ADHD and Driving Risk: A Literature Review, Meta-Analysis and Critique looked at a range of studies in North America, see  HYPERLINK "http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2277254/" http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2277254/  Pages 24-25 of the Findings of the DRUID project 2012   HYPERLINK "http://www.bast.de/nn_107548/Druid/EN/deliverales-list/downloads/Deliverable__1__2__1,templateId=raw,property=publicationFile.pdf/Deliverable_1_2_1.pdf" http://www.bast.de/nn_107548/Druid/EN/deliverales-list/downloads/Deliverable__1__2__1,templateId=raw,property=publicationFile.pdf/Deliverable_1_2_1.pdf  University of Rochester Medical Center in the USA provides reliable therapeutic ranges, see  HYPERLINK "http://www.urmc.rochester.edu/encyclopedia/content.aspx?ContentTypeID=167&ContentID=amphetamine_blood_screen" http://www.urmc.rochester.edu/encyclopedia/content.aspx?ContentTypeID=167&ContentID=amphetamine_blood_screen.  Page 51 of the Findings of the DRUID project 2012 () 1988 (c.52); section 5A was inserted by section 56(1) of the Crime and Courts Act 2013 (c.22). () Section 11(2) of the Road Traffic Act 1988 provides that the term controlled drug has the meaning given by section 2 of the Misuse of Drugs Act 1971 (c.38). The definition of controlled drug was inserted into the Road Traffic Act 1988 by section 56(2) of the Crime and Courts Act 2013.     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