Psychoactive Substances Bill

Written evidence submitted by KTR Environmental Solutions Ltd (PSB 11)

I have pleasure in submitting my comments and concerns on a number of issues regarding this Bill with the view to achieving its core objectives in a robust and effective manner. I have for a number of years invested in and collaborated with registered phytoceutrical companies in the research and development of new products in the medical, food suppliments and health and wellness sectors using a number of plant species previously underutilized but show significant and proven potential to improve one’s general health and wellbeing. This Bill, as currently defined will have unintended consequences as some of the plant species will be prohibited whereas they are internationally available with limited or no restrictions. I am a member of the British Herbal Medicines Association and subscribe to the ethical and safe use of all substances for human consumption.

Submission with Respect to the Psychoactive Substance Bill (the Bill)

SUMMARY:

a) The Bill exceeds the stated aims and objectives of the Governments Manifesto.

b) Clauses 6,7,8 and 9 of Schedule 1 should be deleted as they are superceded by Clauses 3(3) of the Bill.

c) Clauses 7 and 8 of Schedule 1 are controlled by the Tobacco Products Directive (TPD2) of the EU and regulations being implemented by the Department of Health. The Poisons Act 1972 and the Poisons Rules 1982 require that the sale of nicotine is only possible through pharmacies or registered sellers.

d) References to and reliance on the New Psychoactive Substance Review - Report of the Expert Panel are inappropriate in terms of Clause 2 of the Bill.

e) In terms of Clause 3(3) of the Bill the issue of the definition of "novel", "harm" or "relative harm" pose no impediment to the consideration of alternative definitions.

f) The Home Secretary confirmed to the ACMD that the Misuse of Drugs Act 1971 remains at the apex of the regulatory framework and through the powers granted to the ACMD [including that of Clause 3(3)] of the Bill they are best placed to determine the Clause 2 definition and its implementation.

g) The Bill undermines the application of the Nagoya Protocol (Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union) signed by the UK.

h) Clause 8 of the Bill is disproportionate and prevents free trade and movement of goods within the EU.

i) The purpose of this Bill is to regulate and control the use of substances for recreational purposes only.

j) There is no provision for individuals or business entities to apply for an exemption or a ruling. This underlines the prohibition nature and thus unworkability of the Bill.

EXPLANATORY NOTES

DEFINITIONS

1.1. Since the Expert Panels report in September 2014 to the present day at least 8 definitions of "NPS" have been presented. It is apparent that the Home Office is unwaivering in this regard. The backbone to the NPS Bill rests on its definition and the outcomes are reliant on the definitions interpretation. It is acknowledged that the ACMD had no part in its drafting.The Goverments manifesto states "We will create a blanket ban on all new psychoactive substances, protecting young people from exposure to so-called ‘legal highs" and this was based on one of the five options considered in the Expert Panel Report (i.e. General Prohibition).

1.2 The Terms of Reference (ToR) for the Expert Panel were clearly stated, quote:

"For the purpose of its deliberations, the Panel adopted the definition of NPS as follows: ‘Psychoactive drugs, newly available in the UK, which are not prohibited by the United Nations Drug Conventions but which may pose a public health threat comparable to that posed by substances listed in these conventions.’

The key features are that NPS are psychoactive i.e. ones that stimulate, or depress the central nervous system, or cause a state of dependence; have a comparable level of potential harm to internationally controlled drugs; and are newly available, rather than newly invented."

DEFINITION 1

1.3 The Bill as currently presented and being deliberated by this committee reverts back to the initial definition contained in the first drafted Bill as presented to the House of Lords, namely:

"(1) In this Act "psychoactive substance" means any substance which-

(a) is capable of producing a psychoactive effect in a person who consumes it, and

(b) is not an exempted substance.

(2) For the purposes of this Act a substance produces a psychoactive effect in a person if, by stimulating or depressing the person’s central nervous system, it affects the person’s mental functioning or emotional state; and references to a substance’s psychoactive effects are to be read accordingly.

(3) For the purposes of this Act a person consumes a substance if the person causes or allows the substance, or fumes given off by the substance, to enter the person’s body in any way". DEFINITION 2

1.4 Had the Expert Panel adopted this definition in their deliberations the outcomes could foreseeably have been quite different, in particular to the Opportunities and Risks contained in Annex D: Model Impact Framework. The Expert Panel have not been given an opportunity to affirm or otherwise the validity of their report on the basis of a totally different definition to that in their ToR. The effect of this is that their report has been poached and inappropriately applied. This might well raise ethical and/or legal questions.

1.5 The UN Office of Drugs and Crime (UNODC) definition of NPS is "New psychoactive substances are substances of abuse, either in a pure form or a preparation, that are not controlled by the 1961 Single Convention on Narcotic Drugs or the 1971 Convention on Psychotropic Substances, but which may pose a public health threat. In this context, the term ‘new’ does not necessarily refer to new inventions but to substances that have been recently become available". DEFINITION 3

1.6 On the 23rd October 2015 further amendments to Clause 2 of the Bill were tabled.

Either:

Stuart C. McDonald

Owen Thompson

Angela Crawley

"In this Act ‘psychoactive substance’ means any substance which is capable of producing a psychoactive effect in a person who consumes it, and-

(a) is not prohibited by the United Nations Drug Conventions of 1961 and 1971, or by the Misuse of Drugs Act 1971, but which may pose a public health threat comparable to that posed by substances listed in these conventions and

(b) is not an exempted substance (see section 3)". DEFINITION 4

Or:

Lyn Brown

Andrew Gwynne

Grahame Morris

"(a) is a compound capable of producing a pharmacological response on the central nervous system or which produces a chemical response in vitro, identical or pharmacologically similar to substances controlled under the Misuse of Drugs Act 1971, and

"(2) For the purpose of this Act "substance" means any compound, irrespective of chemical state, produced by synthesis, or metabolites of those compounds.

"synthesis" means the process of producing a compound by human instigation of at least one chemical reaction. "compound" means any chemical species that is formed when two or more atoms join together chemically." DEFINITION 5

1.7 The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) uses the following definition for NPS:

"A new psychoactive substance is defined as a new narcotic or psychotropic drug, in pure form or in preparation, that is not controlled by the United Nations drug conventions, but which may pose a public health threat comparable to that posed by substances listed in these conventions". DEFINITION 6

1.8 Definition 4 comes closer to Definition 1 (Expert Panel); Definition 2 (UNODC) and Definition 6 (EMCDDA). If included definition 5 provides further scope to all of the aforementioned. In addition to the Misuse of Drugs Act 1971 and the United Nations Drug Conventions of 1961 and 1971, the International Narcotics Control Board (Green List) and The International Drug Control Conventions Schedules of the Convention on Psychotropic Substances could further strengthen the scope and breadth of undesirable substances.

1.9 The ACMD, due to the powers confered upon them under Clause 3(3), should be the final adjudicator in the choice of definitions. In this regard the following amendment tabled on 23rd October could have merit:

Lyn Brown

Andrew Gwynne

Grahame Morris

"(3A) The Home Secretary must consider making regulations under subsection (2) if she receives a recommendation from the Advisory Council of Misuse of Drugs to bring forward such a regulation in respect of a psychoactive substance." [Member’s explanatory statement: This would enable the ACMD to proactively request that the Home Secretary consider regulations].

1.10 The definitions of both the UNDOC and EMCDDA are internationally recognized definitions, have legal clarity and business entities who wish to trade substances which are essentially legal will not be disproportionately penalized particularly within the EU, as will be the case should the current definition (Definition 2) be adopted. Furthermore, this definition echoes that of one of the ACMD’s recommendations, that of the Expert Panels and gives added credibility to their report.

2.0 Schedule 1 – Exemptions

2.1 The Expert Panels Review states:

"In considering the general prohibition on distribution of NPS approach, the Panel was mindful that the approach would capture a very wide range of current and potential future psychoactive substances and there was potential for unintended consequences. With that in mind, the Panel recommends that the Government puts in place a schedule of exemptions for substances it wishes to permit when bringing the general prohibition into force (e.g. alcohol, tobacco, caffeine, energy drinks). Furthermore, in designing the legislation the Government should ensure that provision is made for newly emerging substances to secure exemptions (for example, by a power to add new exemptions by statutory instrument) where the risks of health and social harms can be adequately assessed. A regime is already in place for medicines but the Government needs to be mindful of the emergence of new markets."

The Expert Panel give mere examples of exempted substances "alcohol, tobacco, caffeine, energy drinks".

2.2 Section 3(3) states "Before making any regulations under this section the Secretary of State must consult- (a) the Advisory Council on the Misuse of Drugs". Is not the inclusion of these "exempted" substances premature and not in accordance with the provisions in the Bill?

2.3 The drafters of this Bill has for whatever reason taken out energy drinks and most worryingly introduced "nicotine". Tobacco and nicotine are already regulated elsewhere, both within the UK and under EU instruments. With reference to the Governments own Statutory Instrument on age restrictions for "electronic cigarettes" it is stated:

"It has long been established that nicotine is highly addictive. Nicotine is a potent and powerfully addictive drug, which is five to ten times more potent than cocaine or morphine in producing behavioural and psychic effects associated with addiction potential in humans".

2.4 It is widely believed within the "e-Cig" industry is that the eventual aim is to see consolidation to a handful of suppliers primarily Big Tobacco (who by nature are oligarchs), which will lead to a nicotine tax at source, perhaps the intended consequence of nicotine’s inclusion as exempted substances.

3.0 HARM AND BLANKET BAN

3.1 "Questions are also being asked about whether scheduling substances under the criminal law has any impact on usage, whether ‘drugs of misuse’ might have benefits to the user, to what extent penalties should reflect the harm caused to individuals and society and whether some controls do more harm than good… The European Court has made it clear that the pharmacological properties of a product must be demonstrated by national medicines agencies if a substance is to qualify as a medicinal product, and that the onus in cases of classification is on the medicines agencies to prove that a product has such an effect, not for the supplier to show that it does not.". Leslie A. King - Former part-time advisor to the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), Lisbon, Portugal.

3.2 This Bill aims to address the recreational use of substances. Substances so consumed in general make no claims as to prevent, cure or treat any disease nor in terms of both limbs of the MHRA definitions (i.e. presentation and function) can be considered medicinal. This has legal precedence as has been demonstrated under EU law with respect to electronic cigarettes and the MHRA’s failed bid to classify the product and devices "medicinal".

3.3 The guiding principles of the ACDM includes that to "Provide a proportionate response supported by the evidence base which also minimises unintended negative consequences including legitimate development of medicines and other products". The Bill is disproprtionate and many beneficial substances prohibited.

4.0 NAGOYA PROTOCOL

4.1 The EU Nagoya Protocol, now written into law (and the UK is a signatory), has at its core values Access Benefit Sharing (ABS), recognises the rights of traditional knowledge and to provide plant species trading protection. This protocol promotes the important development of hitherto unaccessible plant species for medicinal, functional foods and health and wellness (et al) applications, many of which will be prohibited.

4.2 The Canadian Governments Agriculture Department state "O ver 20,000 medicinal pl ants has been published and very likely a much larger number of the world's flowering plant species have been used medicinally. Sometimes the figure of 70,000 medicinal plant species is cited, but this includes many algae, fungi, and micro-organisms that are not really plants as the word is understood by botanists " .

See: http://www.agr.gc.ca/eng/science-and-innovation/science-publications-and-resources/resources/canadian-medicinal-crops/introduction-to-medicinal-plants/?id=1300832855227#a2

4.3 In the letter of 2nd July 2015 the ACMD wrote "the ACMD can envisage situations whereby the supplier of benign or beneficial substances could be prosecuted under the Bill". This prosecution also extends to import and export. The Bill as it stands is manifestly inappropriate to the objective of removing barriers to intra-state trade and thus contrary to the principle of proportionality with respect to this particular issue.

5.0 COGNITIVE ENHANCERS

Cognitive enhancers will be prohibitted.

5.1 " One important set of concerns is that social or global inequality might be exacerbated by cognitive enhancement, further marginalizing the poor. In this context, it is necessary both to consider whether future cognitive enhancements would be expensive or relatively cheap (like caffeine) and to establish criteria whereby society might have an obligation to ensure universal access to enhancers. Access to enhancement, especially in education, may be a key element in enabling participation of developing countries in the global economy. Furthermore, enhancement might lead to dramatic social  benefits  by reducing natural inequality and promoting social justice (Savulescu 2009) . Widespread population level increases in cognitive ability could have profound social and economic benefits. Some studies estimate that a 3% population wide increase in IQ would reduce poverty rates by 25% ( Weiss 1998), leading to an annual economic gain of US $165-195 billion and 1.2- 1.5% GDP ( Schwartz 1994; Salkever 1995) " . The Oxford Centre for Neuroethics , University of Oxford

See: http://www.neuroethics.ox.ac.uk/research/area_1

October 2015

REFERENCES:

1. Legal Classification of Novel Psychoactive Substances. Former part-time advisor to the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), Lisbon, Portugal An International Comparison Leslie A. King

2. Law Environment and Development Journal Volume 9/2: Traditional Knowledge and Benefit Sharing after the Nagoya Protocol: Three Cases from South Africa.

3. Functional foods: the Food and Drug Administration perspective1–3 Sharon Ross

4. Identifying emerging trends in recreational drug use; outcomes from the Psychonaut Web Mapping Project.FabrizionSchifano Paolo Deluca et al Progress in Neuro-Psychopharmacology & Biological Psychiatry. journal homepage: www.elsevier.com/locate/pnp

5. Novel psychoactive substances of interest for psychiatry. FABRIZIO SCHIFANO LAURA ORSOLINI et al. (World Psychiatry 2015;14:15–26)

6. SCIENTIFIC REPORT OF EFSA. Compendium of botanicals reported to contain naturally occuring substances of possible concern for human health when used in food and food supplements. European Food Safety Authority (EFSA), Parma, Italy.

7. World Health Organization: General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine. WHO/EDM/TRM/2000.1

8. The challenge of new psychoactive substances. A Report from the Global SMART Programme March 2013. United Nations Office on Drugs and Crime.

9. EMCDDA–Europol 2014 Annual Report on the implementation of Council Decision 2005/387/JHA.

10. A review of plants used in divination in southern Africa and their psychoactive effects J. F. Sobiecki Department of Anthropology & Development Studies, University of Johannesburg.

11. Psychoactive plants and southern African hunter-gatherers: a review of the evidence. Peter Mitchell and Andrew Hudson (School of Archaeology, University of Oxford: correspondence – St Hugh’s College, Oxford, UK.

12. Pharmacology and Treatments. Foresight Brain Science, Addiction and Drugs project Leslie Iversen, Kelly Morris, David Nutt.

13. ‘ Legal Highs’ – novel and emerging psychoactive drugs: a chemical overview for the toxicologist SIMON GIBBONS. Department of Pharmaceutical and Biological Chemistry, UCL School of Pharmacy, London, UK.

14. Assessing African medicinal plants for efficacy and safety: pharmacological screening and toxicology C.W. Fennell, K.L. Lindsey et al. Journal of Ethno-Pharmacology. July 2004.

15. Psychoactive natural products: overview of recent developments. iKem BT, Budapest, Hungary. Ann Ist Super Sanita 2014 | Vol. 50, No. 1: 12-27

16. Neuroscience of psychoactive substance use and dependence WORLD HEALTH ORGANIZATION GENEVA

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Prepared 27th October 2015