Psychoactive Substances Bill

Written evidence submitted by Dr Ornella Corazza and Dr Andres Roman Urrestarazu (PSB 17)

The Psychoactive Substance Bill 2015-16

Summary:

This evidence argues about the importance to give further consideration to Performance and Image Enhancing Drugs (PIEDs) in the Bill. It presents some preliminary results on the rapid diffusion and motivations behind PIEDs use in society, which is alarming. It argues that more attention should be given in the Bill to the similarities between Novel Psychoactive Substances (NPSs) and PIEDs in terms of marketing, access, consumption and distribution, while encouraging research into their safety and toxicity. The provided evidence will also refer to the necessity to strengthen prevention, harm reduction and public health safety within an international context. In conclusion, it reflects on the need to cross country harmonization of the Bill to include EU regulations in order to avoid parallel imports of psychoactive substances from other EU Member States. 

Authors:

Ornella Corazza, PhD, Reader in Substance Addictions and Behaviours, University of Hertfordshire, Hatfield, United Kingdom.

Andres Roman-Urrestarazu, MD, PhD, Research Officer in Health Economics and Health Policy, London School of Economics and Political Science, LSE Health and Social Care, London, United Kingdom; Director of Studies in Psychology and Behavioral Science Trinity Hall, University of Cambridge. Cambridge, United Kingdom.

To the Members of the House of Commons Public Bill Committee

Dear Madam/Sir,

In response to your invitation, we welcome the opportunity to provide evidence in regards to New Psychoactive Substances (NPSs). The recent appearance on the illicit drug market of a variety of NPS s , misleadingly as ‘legal highs’, combined with the ability of the Internet to act as a marketplace and disseminate information quickly, represents a challenge for public health, drug policies , service provision and publ ic safety ( Griffith et al 2013; Corazza et al. 2013 ) . NPSs, an umbrella term for products intended to mimic the psychoactive effects of controlled drugs, has been formally defined by the European Union as "a new narcotic or psychotropic drug, in pure form or in a preparation, that is not scheduled under the Single Convention on Narcotic Drugs of 1961 or the Convention on Psychotropic Substances of 1971, but which may pose a public health threat comparable to that posed by substances listed in those conventions (Council of the European Union decision 2005/387/JHA)". As also outlined in the Bill, the ‘legal highs’ market is characterized by the speed with which suppliers circumvent drug controls by offering new alternatives to restricted products and advertise them with captivating and sophisticated online marketing strategies (as "air fresheners", "herbal incenses", "bath salts", "plant fertilizers", "collectors’ items", etc.), using usually web based platforms for ordering them while at the same time offering distribution chains of their products that link to a mail distribution system. The term ‘legal high’ has also been crafted as a dubious and successful marketing instrument in and of itself, as it implies that these substances are not as dangerous as controlled drugs, thus boosting their popularity and sales among certain groups of people that, as we have observed, have very particular characteristics and do not fit the profile of the usual illegal drug user (ACMD 2011).

1. The diffusion of Performance and Image Enhancing Drugs in society

According to our most recent studies (e.g. Corazza et al 2014; Bersani et al 2015 ; Cinosi et al 2015 ), the latest development of this fast growing phenomenon, is the diffusion of websites selling a wide range of Performance and Image Enhancing Drugs (PIEDs), including medicine without prescriptions or medical supervision. Such a new substance-use trend could be linked to the change of legislation on NPSs in various countries, which has made this market even more profitable for illicit retailers and manufacturers, and we believe that it deserves mention in the Bill. PIEDs, sometimes classifiable as a sub-group of NPSs, is an umbrella term to indicate a wide range of products, which have the apparent potential to improve human abilities and attributes. PIEDs include: (a) anabolic drugs used to enhance structure and function of muscles; (b) drugs taken for weight-loss purposes; (c) Image-enhancing drugs taken to modify ageing processes, beauty and cosmetic appearance; (d) ‘Sex drugs’ and aphrodisiacs; (e) cognitive enhancers; (f) drugs taken to improve mood and social behaviours.

The main problem about this is that although PIEDs share some similarities with NPSs, they usually attract the attention of individuals who do not necessarily perceive themselves as ‘drug users’ but are vulnerable to cultural/media pressures to improve their bodies and minds and find a quick ‘fix’ to look and feel better. PIEDs have been marketed in the same way as NPSs, using the same channels and distribution chains that we have described, but their market is far more extended as targeting the wider population.

2. Preliminary evidence on the access, motivat ions and risks associated with PIED s use

In ord er to provide a better understanding on the availability, motivations, and possible risks associated with the diffusion of PIEDs in society, we initiated "Keep fit", a cross-sectional study on lifestyle, body-image and the use of PIEDs as amongst an adult population who engage in physical activities in collaboration with colleagues based in four different countries across the EU.

More information on the project can be found here : http://humanenhancementdrugs.org/ .

Although the study is ongoing, we are able to share here for the first time som e preliminary data, which mainly reflect the UK situation. So far we have obta ined 433 responses . 51% of the sample was male and 49% female. Participants were mainly engaging with walking (69%), jogging and running (47%) and weight-lifting (69%).  83% claimed to care a lot about their physical appearances. 44% followed a diet; 31% used products to lose weight, while 47% used products to reach their fitness goals. The Internet played an important part in the supply and information gathering about the best products to buy. Approximately, 40% of participants who used products purchased them online, and 43% discovered them through online fitness fora/blogs. The most common products bought for weight loss were proteins (58%), herbal products (34%), such as teas/infusions, Guarana, Ginseng. Interestingly, we also recorded the alarming usage of amphetamine (17%), thyroid hormones (17%) and diuretics (15%). Additional studies from Internet fora, allowed us to provide evidence for cannabis use (Bersani et al 2015). 36% of the participants felt often bothered by feeling down, depressed, or hopeless during the past month; 28% experienced side-effects such as skin problems, change in mood, headache, diarrh o ea, digestion problems, fast heart rate, irritability, sweating, among others. Overall, from this preliminary analysis emerges a tendency to use PIEDs among the studied population; the "perceived" reliability of the Internet as a source of information; the choice of the Internet as the favorite "market place" to buy PIEDs; the self-reported emergence of side-effects from PIEDs use; a high level of concern for physical appearance.

Based on this preliminary evidence, one should address the following questions:

· How does the Bill respond to the PIEDs phenomenon?

· Can the Bill better clarify the relation between NPSs and PIEDs?

· What are key the objectives of the Bill on this regard? Harm reduction? Public health safety?

3. The need for an international policy framework

NPSs have been regulated by new legislations for drug control internationally trying to curve the growing demand, while safeguarding the public’s best interest and health in different ways. Although we recognise the Bill as an important piece of legislation, we believe the main focus of the Bill has been misplaced in substance control and banning, while licensing, regulation of trade and market strategies and distribution have not been affected. This is mostly so because the current Bill does not have:

· a defined impact on how it will affect the current market structure on which NPSs, PIEDs and other drugs are being sold and further more;

· a plan on how it might affect distribution chains that can be seen as harmful as the substances as they allow easy and anonymous access to a series of NPSs, PIEDs, counterfeit and other restricted substances.

As we have tried to demonstrate with the provided evidence, this is specially the case of PIEDs and a variety of other drugs sold over the web without any licensing and sometimes without any regulation. The production of counterfeit drugs, PIEDs and NPSs has led to the sophisticated development strategies of organized crime seeing a new profitable market without any prompt regulation in regards to the distribution over the web. So far the Bill has only introduced regulation on the chemical components that it is aiming to control and ban but not including in its scope the sources of the illicit business behind it, which employ novel market strategies that are an inherent part of the surge in NPSs and PIEDs. Overall, the development of such markets is difficult to follow as they are not currently under international law control. Since there is much uncertainty about these issues, the EU’s drug policy 2013-2020 follows for NPSs the same guidelines and pursues the same aims as for traditional abuse drugs, i.e., the reduction of demand and supply, simultaneously encouraging the involvement of citizens, youths, but also drug users and addicts, in both self-management of health and anti-drug policy development. As a result, investigations and policy recommendations remain mainly focused on recreational users ("clubbers’), when in fact the phenomenon as we are trying to demonstrate reaches a much wider population. Further, the fact that these products are available online makes their market not easy to trace and very difficult to regulate at both national and international level. This is one of the reasons why we believe the Bill should encompass distribution as one of its main points in the attempt to regulate not only NPSs but also PIEDs, including medicines sold illicitly without prescription as this bypasses any form of safety control.

It is also crucial to ask how does the Bill harmonize with current EU directives with regard to drug control and the surge of the NPSs and PIEDs markets. The focus here should be how the UK can be aligned to a supranational drug strategy. The questions should be:

· What is the case of parallel imports?

· How would the UK be able to control imports from other EU Member States that have different laws?

These questions clearly expose the urgent need to harmonize the Bill with EU drug policy. This is specially so considering that identifying policy gaps that have facilitated the emergence of NPSs market is crucial to define a new Bill that will be effective in its scope and aims. We believe that the focus should be on regulation at the European Level. This is because the production and distribution has become cross national and hence implementing unilateral policy frameworks is short sighted and might produce important internal consequences such as one can see in the PIEDs market that tends to swiftly move around as legislation becomes harder in different countries.

Further, serious concerns about the safety profile of NPSs have been discussed in the Bill but with no serious effects in the online NPSs market. A better understanding of the online illicit market of NPSs/PIEDs is necessary in order to contribute towards the development of a new regulatory policy framework aimed at reducing harm and preventing initiation in society by affecting both the substances, distribution and marketing spheres of the NPSs market. We will therefore try and recommend comparative policy analysis. Besides, the Polish and Irish models, we believe that further consideration should be given to New Zealand, which provides the first regulated legal market for NPSs. This new regulatory framework is going through a transitional and implementation phase by adding a range of different trade restrictions and a provisional licensing regime for NPSs while at the same time introducing different operators. This policy regime is unique in its nature and might be used as a reference to inform a renewed policy framework across the UK and the EU.

References

Advisory Council on Misuse of Drugs (ACMD) (2011). Consideration of the Novel Psychoactive Substances (‘Legal Highs’).

Bersani, FS., Santacroce, R., Coviello, M., Imperatori, C., Francesconi, M., Vicinanza, R., Minichino, A., Corazza, O. (2015) Cannabis: a "self-medication" drug for weight management? The never ending story. Drug Testing and Analysis. DOI: 10.1002/dta.1891.

Cinosi, E, Martinotti, G., Simonato, P., Singh, D., Demetrovics, Z., Roman-Urrestarazu, A., Bersani, FS., Vicknasingam, B., Piazzon, G., Li, J., Yu, W., Kapitány-Fövény, M., Farkas, J., Di Giannantonio, M., Corazza, O. (2015) Following "the roots" of Kratom (Mitragyna speciosa): the evolution of an enhancer from a traditional use to increase work and productivity in South-East Asia to a recreational psychoactive drug in Western Countries. Bio Med Research International (in press).

Corazza, O., Demetrovics, Z., van den Brink, W., Schifano, F. (2013) ‘ ‘Legal highs’ an inappropriate term for ‘Novel Psychoactive Drugs’ in drug prevention and scientific debate’, International Journal of Drug Policy, 24 (1): 82-3.

Corazza, O., Bersani, FS., Brunoro, R., Martinotti, G., Schifano, F. Performance and Image Enhancing Drugs: the abuse of cognitive enhancer Piracetam. Substance Use and Misuse, May 2014, Early Online: 1-8, doi : 10.3109/10826084.2014.912232.

Evans-Brown, M., McVeigh, J., Perkins, C., & Bellis, M. (2012). Human enhancement drugs: The emerging challenges to public health. Centre for Public Health, Liverpool John Moores University.

Griffith, P., Evans Brown, M., Sedefov, R., (2013). Getting up to speed with the public health and regulatory challenges posed by new psychoactive substances in the information age Addiction doi:10.1111/add.12287.

United Nations Office on Drugs and Crime UNODC (1971). The Convention on Psychotropic Substances of 1971. United Nations Office on Drugs and Crime.

About the authors:

Dr Ornella Corazza is a Reader in Substance Addictions and Behaviours at the Department of Pharmacy, Pharmacology and Postgraduate Medicine at the University of Hertfordshire in the UK. She has contributed to the generation of original data on over 700 novel psychoactive substances (NPSs​) presented in more than 60 peer-reviewed publications. She managed ReDNet, an EU-wide research project funded by the European Union, which aimed to develop innovative forms of drug prevention among vulnerable individuals and was awarded the 2013 Health Award. Dr Corazza is currently leading "Keep Fit", a project on lifestyles, body image and the use of performance and image enhancing drugs in society. She works in close co-operation with national policy makers as well as various international agencies (European Commission; United Nation Office on Drugs and Crime; World Anti-Doping Agency). Considering her multidisciplinary experience in the combined field of health, culture and legislation, Dr Corazza also plays a major role in drug education internationally assisting schools, charities and the metropolitan police with information on new drugs and trends. The basic theme of her research is to find out new strategies to understand drug use and enhance lifestyles. 

Dr Andres Roman-Urrestarazu is a Research Officer in Health Economics and Health Policy in LSE Health and Director of Studies in Psychological and Behavioral Science at Trinity Hall, University of Cambridge. He specialises in psychiatry and health economics, holds a PhD in Psychiatry from the University of Cambridge, and a Medical Doctorate from the University of Santiago de Chile and an MSc in International Health Policy from the London School of Economics. He has worked for NICE in the Centre for Health Technology Evaluation, LSE Health and the PSSRU, while also working extensively as a clinician in mental health facilities both in the UK and South America. Dr Roman-Urrestarazu has also developed a teaching career in Trinity Hall, Cambridge as Director of Studies in Psychology and Behavioral Science. His clinical research experience has been mainly related to the epidemiology of neurodevelopmental disorders such as schizophrenia and ADHD. Prior to joining LSE Health, he worked extensively in the 1986 Northern Finland Birth Cohort where he was interested in longitudinal analyses of mental health and mental health outcomes. Currently he is contributing to the design of the Qatar Health Survey 2015 and the links between NCD's and the utilization of health care services. He has also developed a research agenda in addiction studies merging clinical, policy and health economics in order to understand the impact of the development of the drug market.

October 2015