Psychoactive Substances Bill

Written evidence submitted by DrugScience (PSB 03)

The Psychoactive Substances Bill

The core purpose of the Psychoactive Substances Bill is to outlaw the unauthorised production, supply, importation and exportation of ALL "psychoactive substances" (other than some such as alcohol, tobacco and caffeine that will be exempted).

DrugScience is a charity supported by independent scientific and other experts that reviews significant issues relating to drugs and the harms they cause http://www.drugscience.org.uk The DrugScience experts have now review ed the proposed Bill and found it flawed in many respects. The major problems fall into five specific headings as discussed below

1 Issues of fact -

1.1 The evidence used to pursue the ban – a supposed increase in deaths from legal highs to 129 last year [2014] is fundamentally fl awed . Most of the substances reported in these death claims are ALREADY ILLEGAL http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736%2814%2960479-7.pdf . The latest data from ONS survey suggests about 18 at the most in which legal highs are involved http://www.ons.gov.uk/ons/publications/re-reference-tables.html?edition=tcm%3A77-406863 , DrugScience experts have estimated that there are less than 5 deaths solely from truly "legal" legal highs each year

1.2 T he new psychoactive substances (NPS) leading to the recent increase in deaths are not sold in "head shops". In fact it is possible that "head shops", which tend to sell relatively low risk substances, have contributed to the current situation where there are very few deaths from legal highs .

1.3 The Iris h experience shows 9% of their y outh have used N PS – the highest rate in Europe . Expert opinion in the UK and current Irish experience suggests the ban of "head shops" will drive the market underground into the arms of dealers and the internet. This will result in more harms and deaths as seen in Ireland. This is a result of quality control drop ping ("head shops" need to ensure their clients are not harmed so they return for more purchases ) and the underground use of more dangerous drugs such as heroin that will be sold alongside NPS. Moreover the closure of "head shops" means there will be no source of education on responsible use. 

1.4 The main purpose of this new law would appear to be to ban "head shops" for social reasons.  Such ends could easily (and have already in some towns) been achieved by other mechanisms such as local trading regulations.

1.5 The proposed penalties are potentially draconian and disproportionate to the real harms of legal highs. 

1.6 The Act will force individuals who wish to legally enjoy the recreational effects of drugs to use alcohol or nicotine . We know that at least 85% of the population like to use recreational substances since that proportion drink alcohol.  Alcohol is responsible for 22,000 premature deaths per year, and is the leading cause of death in men aged 16-50 www.nwph.net/nwpho/publications/alcoholattributablefractions.pdf so is more harmful than almost all illegal drugs.  As well as presenting this major moral dilemma of driving use to alcohol, the proposed law will preclude the development of new safer alternatives to alcohol and other recreational drugs.

1.7 Despite the claims of the Local Government Association that this Bill follows the recommendation of the expert group on NPS https://www.gov.uk/government/publications/new-psychoactive-substances-review-report-of-the-expert-panel in fact it goes much further than their report. This recommended that substances that are not harmful or have minimal harm are NOT drawn into this bill. Not all psychoactive substances are harmful, and some have clear benefits.

2. Issues of principle

2 .1     The implementation of a new law with such wide-ranging impact is disproportionate to the challenge of new psychoactive substances, which is a health issue, and a lesser one relative to other drug-related problems. It will surely be a major concern to many citizens.

2. 2     The principle of banning any psychoactive substances that might become available in future, with no evidence of their harmfulness, is a fundamental change in the way the UK law works. This sets and extremely worrying precedent for future legislation.

2 .3     This Bill makes no discrimination between drugs carrying very different capacities to harm. People will be equally threatened by prosecution in relation to substances with risks equivalent to that of coffee or heroin. This undermines the basic principle of proportionality in UK law.

2 .4     We already have the Misuse of Drugs Act 1971 (MDAct1971) that can deal with this issue – and indeed has done so successfully in the past decade as indicated by the fall in deaths from truly "legal" drugs in this period to now probably less than 5 per year at present [see1.1] .

2. 5     Another set of regulations will be needed that will become conflicted with the Misuse of Drugs Act 1971, leading to confusion in the minds of the public and the police as well as being wasteful of public resources.

2 . 6     The proposed ban on nitrous oxide (laughing gas) is particularly perverse as it driven by media hysteria . Laughing gas has been used for several centuries by some of the greatest scientists ( Priestly, Davy) philosophers (James) and poets (Southey, Coleridge).  The ACMD earlier this year reported there is minimal evidence of har m from the recreational use of nitrous oxide balloons https://www.gov.uk/government/publications/acmd-advice-on-nitrous-oxide-abuse The media- generated term "hippy crack" is deliberately pejorative and used for scaremongering purposes, so should not be taken to suggest any true simi larity to the risks of cocaine! It is doubtful if nitrous oxide is responsible for the deaths attributed to it though continuous repeated use could cause harms through oxygen deprivation , just as can occur with helium balloons .

 

3. Specific concerns - Problems with definitions

The Bill, as currently drafted, sweepingly defines a "psychoactive effect" as one that is produced if "….by stimulating or depressing the person’s central nervous system, it affects the person’s mental functioning or emotional state". That describes a huge range of substances we regularly use in medicine or would want to test.

3.1.      What does psychoactive cover ? W ill it include new potential antidepressant and antipsychotic drugs?  Will negative psy choactive effects also be caught? ( eg opioid receptor antagonists such as naltrexone that are useful medic ines but can produce anhedonia and dysphoria ).

3.2     How will the exempted substances be defined? e.g . Will alcohol be all ethanol solutions – will coffee be based on chemical caffeine content – tea on having theophylline?  ( in which case what about herbal teas?). Many popular products contain guarana or ginseng both of which may have mild psychoactive effects. Many other widely-sold drinks contain potentially psychoactive substances, e.g. energy drinks such as Red Bull have taurine along with caffeine. Tonic water has quinine. The amendment tabled by Baroness Meacher to limit the scope of the Bill to "synthetic" psychoactive substances has much merit in removing a vast number of traditional herbal products from control.

3.3     Who will decide whether a drug is psychoactive? At present the Bill makes this the police making the prosecution.  And where will the expert guidance come from? The Irish experience tells us that there have been no prosecutions under their Act because proof of psychoactivity of specific compounds has not been possible.

3.4     It is critical that the definition of psychoactive be based on the effects in living humans. Many useful medicines resemble abused psychoactive drugs in the "test tube" but do not have psychoactive activity (e.g. loperamide , a potent opioid agonist that was developed for pain but didn’t work as it didn’t enter the brain so is now used to treat diarrhoea ).  Some cathinone preparations are effective antidepressant, anti-smoking and anti-obesity agents, despite not having immediate psychoactive activity. But innovation using newer cathinones has been stifled by the recent control of many new and as-yet –to be –made under the recent cathinone amendments to the MDAct1971. Similar and potentially worse impediments to innovation can be expected if this new bill is passed.

3.5     Will dosage influence illegality? Will low ( non psychoactive ) doses be exempt from any controls to allow forensic and other labs to hold standards for assay purposes?

 

4.     Likely perverse and unplanned negative effects of the proposed law

4.1 We welcome the plan to exempt doctors and medicines – but the bill needs modifying to ensure that ALL medicines in the pharmacopeia are exempt – not just those with Marketing Authorisations (MA) as presently construed.  Drugs with MA are not the totality of medicines that doctors prescribe (note; a Marketing Authorisation (license) is given by the MHRA to companies to allow them to market (sell, advertise, market) their products, it does not define the use of such drugs, just what claims can be made by the company as part of their marketing. Any doctor working for the benefit of their patients and with adequate knowledge of the efficacy of a drug can use drugs outside their MA. This is because many drugs with established uses are too old to have been through modern testing but are still useful medicines and because this sort of exploratory testing has historically led to much medical innovation). Perusal of one hospital formulary found 16 such substances

http://www.nottinghamshireformulary.nhs.uk/chaptersSubDetails.asp?FormularySectionID=20&SubSectionRef=20&SubSectionID=A100#3114

4.2 One DrugScience member has identified at least 10 non-medicine psychoactive substances he has used in used in his own human brain research. These are largely experimental products or potential new medicines, that work on different brain neurotransmitter systems [noradrenaline, GABA-A, imidazoline, 5HT2A, NK1 and dopamine) but also some brain-active amino-acids and the gas carbon dioxide.

4.3 Experience with other drug laws and associated regulations [e.g. the MDAct1971] tells us they have a significant negative impact on research and development activities in universities and pharmaceutical sites [Nutt King Nichols 2013] .  It is therefore imperative that ALL research establishments , and suppliers of research chemicals to these , are exempted from this Act.

4. 4 Although following pressure from academic societies https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/441400/2-7-15-_ACMD_advice_on_PS_Bill.pdf the government has accepted they will need to make an exemption for bona-fide research but has yet to say how this will be achieved.

5     Recommendations  

5.1     Delay the Bill until there is good evidence that this approach can work by reviewing the Irish data . In the meantime continue to use the MDAct1971 that has successfully controlled the availability of legal highs in recent years.

5.2     The PS Bill be cut down to what it was intended to achieve i.e. control the IMPORTATION and SUPPLY of NEW HARMFUL psychoactive substances by professional drug suppliers and dealers who are set to make large amounts of money from this trade 

5.3     if the Bill does progress then there should be specific exemptions for

5.3.1     all medicines whether they have an Marketing Autho risation or not (see section 4.1 for explanation)

5.3.2     all research pharmaceuticals being used to developed new medicines or progress neuroscience research 

5.3.3     all doctors

5.3.4     all bone-fide research scientists

5.3.5     Low ( non psychoactive doses) should be exempt from any controls to allow forensic and other labs to hold standards for assay purposes.

5.4     Decisions on whether a drug meets the criteria for being significantly psychoactive to be controlled under a new Act be made by either the ACMD or a new committee comprising experts nominated by the Royal College of Psychiatry, the British Pharmacological Society and the Academy of Medical Sciences.

5.5     Systematic evidence gathering of the effects of the new law be made part of the Bill. This must include monitoring deaths and other harms from ALL drugs, not just NPS to endure that any diversion of use into other substances is rapidly detected.

5.6     The impact on British research and productivity must be formally and annually monitored via appropriate bodies, e.g. the British Pharmacological Society and the Academy of Medical Sciences working alongside BIS.

5.7     Entertainment premises should be exempt from liability from their customers’ use of psychoactive substances. If the owners or directors of premises are liable under this Bill - this could have a severe and negative impact on many venues crucial to the night-time and social economy in the UK including: clubs, pubs, bars, and music festivals.

5.8     This Bill as drafted could also have a severe and detrimental impact on all those providing services for people who have multiple vulnerable needs and are more likely to take substances - leading to a situation where Directors of Services are liable for any instances of psychoactive substance use or supply on their premises including: prisons and mental health wards.   

Reference

Nutt DJ, King LA, Nichols DE (2013) Effects of Schedule I drug laws on neuroscience research and treatment innovation. Nat Rev Neurosci. Aug;14(8):577-85. doi: 10.1038/nrn3530

October 2015

Prepared 27th October 2015