Medicinal Cannabis Policies and Practices Around the World by Sofía Aguilar1, Víctor Gutiérrez,2 Lisa Sánchez3 and Marie Nougier4
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Briefing paper April 2018 Medicinal cannabis policies and practices around the world By Sofía Aguilar1, Víctor Gutiérrez,2 Lisa Sánchez3 and Marie Nougier4 Abstract digm in the area of drugs, the adoption of alternative policies at local level – sometimes at the expense of The global debate about the regulation of cannabis the international legal framework – and the growing has intensified in recent years, and jurisdictions have perception that the costs of the ‘war on drugs’ far out- increasingly amended their legislation to allow for weigh its benefits. the medicinal or therapeutic use of the plant. Various countries in the Americas have enacted policies that Unfortunately, and despite the growing number of enable patients to access certain types of preparations regulatory experiences, the world has not yet reached to alleviate symptoms, reduce pain or improve their a consensus on how to proceed, and continues to quality of life. However, although all these experienc- resist any possibility of activating the legal and insti- es can be considered as progress, not all regulatory tutional mechanisms within the scope of the United regimes are equal, and not all reforms will have the Nations to adapt the current treaty framework to this same impact. This paper aims to enhance our under- new situation. The United Nations General Assembly standing of the state of reforms and their potential, Special Session (UNGASS) on the ‘world drug prob- as well as offer some general recommendations in an lem’ in 2016 was the clearest example of the reluc- 5 effort to improve public policies where legislation has tance to openly discuss cannabis and its regulation. already changed and inform decision-making process- Although it occurred at a historic moment – when the es where the reform is still pending. legalisation of medicinal cannabis was already a real- ity in 16 countries (or 40 jurisdictions if US states are counted individually) – the Outcome Document of the Introduction global summit6 made no mention of the issue, or even Although cannabis remains a prohibited substance acknowledge its existence. worldwide, in recent decades a series of political, leg- It is in the midst of this contradiction that the legal islative and judicial processes in various parts of the regulation of medicinal cannabis is currently moving world have given rise to various forms of legal regu- ahead. However, as with all innovative approaches, latory regimes for the medical and therapeutic use of the plant. This trend seems to be consolidating in the major obstacles remain in terms of its acceptance Americas, in particular in Latin America and the Carib- and of the restrictions imposed by the rigid interna- bean, where the largest number of available experienc- tional legal framework. Indeed, although medicinal es is concentrated, and where the regulatory changes cannabis per se is not prohibited under the UN drug are occurring successively, in a sort of domino effect. control conventions, the inclusion of the substance in Schedule IV of the 1961 Single Convention on Nar- Although this progress is not exclusive to Latin Amer- cotic Drugs restricts medical research and strict rules ica, and is still far from being a won battle, there is a must be followed to allow the medicinal and scientific clear shift in the global drug policy debate, particularly use of the substance. The lack of internationally sanc- on cannabis. A variety of factors played a role here, in- tioned scientific consensus on medicinal cannabis is cluding the growing availability of scientific evidence, also a major issue, with no standardised or consistent the inability of the international drug control regime products being used worldwide. These and addition- to accommodate and respond appropriately to new al factors which will be described in this paper have evidence, the emergence of a new public health para- resulted in wide-ranging policies, requiring a certain 1 Figure 1 Map of countries in which medicinal cannabis is available Medicinal cannabis regulated Nabiximols (Sativex) authorised Argentina, Australia, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Austria, Belgium, Brazil, Denmark, Finland, Hungary, Iceland, Ireland, Italy, Finland, France, Germany, Greece, Israel, Italy, Jamaica, Macedonia, Mexico, Kuwait, Liechtenstein, Luxemburg, Malta, New Zealand, Norway, Portugal, the Netherlands, New Zealand, Peru, the Philippines, Poland, Puerto Rico, Slovakia, Spain, Sweden, United Arab Emirates, United Kingdom Romania, Spain, Switzerland, United Kingdom, United States, Uruguay Pilot projects on medical cannabis Denmark,7 Ireland degree of compromise (when done at the sub-nation- Canada and the United States are now at the vanguard al level, for example), and governed by a diversity of of scientific innovation, while also meeting clear- rev norms and institutions. Inevitably, the scope and im- enue-collection goals, and providing a solid basis to pact of these policies vary greatly. expand recreational and industrial systems. As will be discussed below, all experiences are differ- This report precisely highlights this diversity of ex- ent, and no international or regional standards cur- periences, approaches and directions. The purpose rently exist. While the regulation of medicinal canna- of this analysis is to enhance our understanding of bis in Uruguay resulted from government policy and the current state of reforms and the lessons to be coexists with licit recreational use in a clear effort to learned from them. Although the authors have done improve public health, in countries like Argentina, Bra- their utmost to gather as much information as pos- zil and Mexico, timid legislative reforms responded to sible, this paper does not claim to be comprehen- citizen initiatives which, for lack of political support, sive review but rather a selection of key models of only managed to open the minimum space necessary medicinal cannabis being developed around the to comply with court orders and allow the importation world as of March 2018. Based on the findings, we of pharmacological preparations produced abroad. offer general recommendations, in an effort to im- Meanwhile, North America is silently consolidating prove public policies in areas where legislation has industrial-commercial models of regulation. Although already changed, and inform decision-making pro- not immune to political backlash and court decisions, cesses in countries where reform is still pending. 2 Definitions stance used, designed or approved for the follow- ing medical purposes: (a) Improving health and Cannabis well-being; (b) Preventing and treating disease Before describing the various regulatory models, and (including the alleviation of symptoms of that dis- the differences between them, it is important to re- ease); (c) Acting as a diagnostic aid; (d) Aiding con- call the basic definitions of ‘cannabis’ enshrined in the ception or providing contraception; (e) Providing international drug control regime, in particular in the general anaesthesia’. 1961 Single Convention on Narcotic Drugs:8 • Scientific purposes: ‘The designation of the use 1. Cannabis: ‘the flowering or fruiting tops of the of a drug for “scientific purposes” is appropriate cannabis plant (excluding the seeds and leaves when it is used as a tool for investigating mecha- when not accompanied by the tops) from which nisms of health or disease or when investigating the resin has not been extracted, by whatever the use of a product as a medicine. In patients, name they may be designated’ the investigation would be done as part of a clin- ical trial, which requires prior approval from the 2. Cannabis plant: ‘any plant of the genus Cannabis’ research ethics committee’. 3. Cannabis resin: ‘the separated resin, whether crude or purified, obtained from the cannabis plant’. Returning to the treaty framework, and adding anoth- er layer of complexity, it should be recalled that the Based on these definitions, different controls were therapeutic properties of a substance are a decisive established over the plant and its components and factor in permitting – or not – its medicinal use. Ther- for determining the various behaviours to be prohib- apeutic potential is therefore used as a criterion for ited. These definitions also laid the grounds for the differentiating the types of controls established for gradual stiffening of prohibition – transcending the a substance, depending on the schedule in which it original meaning of ‘cannabis’, ‘cannabis plant’ and is classified. That said, according to the conventions, ‘cannabis resin’ to also include their main psychoac- ‘therapeutic’ use is not synonymous with ‘medicinal’ tive component, tetrahydrocannabinols (THC). As will use; and resolving what would appear to be a false di- be explained below, these definitions also serve to chotomy – since all medical usage is, in principle, ther- understand why the use of cannabis was historical- apeutic – has not been easy. Indeed, the international ly strictly limited to scientific purposes – even to the community continues to resist discussing ‘therapeu- detriment of its legitimate use for medicinal purposes tic’ uses as these would entail the existence of specific – and how, even today, the arbitrary invalidation of requirements for the control of pharmaceuticals (i.e. its therapeutic properties continues to determine the products for medical use). scientific evidence and regulatory possibilities availa- ble to UN member states.9 This semantic distinction affects