Allen & Overy | Cannabis Legal & Regulatory Update View this email in your browser Cannabis Legal & Regulatory Update January ­ March 2019 PDF version The A&O view In the last couple of months, the WHO Expert Committee on Drug Dependence (ECDD)’s recommendations on rescheduling cannabis and its derivatives in the international drug conventions have filled the cannabis industry with hope. Removing cannabis from the strictest Schedule IV (also including heroin and cocaine) is a logical – and overdue – step given the well­established medical use of the plant. However, in particular a vote in favour of removing cannabis “extracts and tinctures” from Schedule I (as recommended by the ECDD) may open up new possibilities for the CBD industry, which often faces legal hurdles on this basis given that CBD is not a scheduled substance in itself. We may soon expect approval of the first EU­wide approved cannabis­based medicine (Epidyolex®), and the European Parliament Resolution on the use of cannabis for medical purposes, which clearly recognises its medical use and specifically calls on the EU Commission and Member States for more research and innovation in this respect, will likely make us see more of these in the future. Many EU member states and other countries have recently authorised medical cannabis (e.g. UK) or are in the process of doing so (e.g. France), in order to provide access to patients but simultaneously being aware of the extra source of state income such authorisation represents. These positive recent developments in the medical sphere could nevertheless reinforce the idea of only two categories of cannabis – licit medical use vs. illicit recreational use – without taking into account the broad category of hemp­derived products (e.g. in the paper and construction industry, but also in cosmetics, food supplements, etc.) sold legally throughout Europe. It is more than time that EU authorities clarify their interpretation of the rules with respect to such “well­being” products, but the recent (non­binding) Novel Food Catalogue update – suggesting an overly restrictive rather than tailored approach – will provide the emerging CBD industry with food for thought for at least the months to come… Enjoy the newsletter! CONTENT __1. HIGHLIGHTS __2. LATEST LAWS, REGULATORY GUIDANCE AND ENFORCEMENT ACTIONS ___2.1. Medical Cannabis ___2.2. Well­Being Cannabis ___2.3. Recreational Cannabis __3. SELECTED INDUSTRY AND MARKET NEWS _1. HIGHLIGHTS UNITED NATIONS – WHO Expert Committee on Drug Dependence (ECDD) releases recommendations on rescheduling cannabis and derivatives under International Law On 24 January 2019, the WHO Expert Committee on Drug Dependence (ECDD) published its letter addressed to the Secretary­General of the United Nations summarising the recommendations of its 41st meeting. The ECCD advocates inter alia, for the deletion of cannabis and cannabis resin from Schedule IV and the deletion of extracts and tinctures of cannabis from Schedule I of the Single Convention on Narcotic Drugs (1961). However, the United Nations Commission on Narcotic Drugs (CND) vote, which is required to approve the ECDD recommendations and was originally scheduled on 7 March 2019, has been postponed. The ECDD letter is available here, an extract from the ECDD report here and a related article here EUROPEAN UNION – European Parliament adopts a motion for a resolution calling for more research and innovation regarding medical cannabis On 13 February 2019, the European Parliament adopted a motion for a resolution related to the use of cannabis for medical purposes. The motion clearly recognises the medical use of cannabis and calls for more research and innovation regarding medical cannabis. MEPs also call on the Commission and national authorities to draw a clearer distinction between medical cannabis and other uses of cannabis. The amended draft resolution is available here and the Parliament press release here EUROPEAN UNION – European authorities clarify cannabinoid status under Novel Foods Regulation In January 2019, European authorities updated the Novel Food Catalogue in an attempt to clarify the status of products derived from the Cannabis Sativa L. plant and cannabinoids under the Novel Foods Regulation. The “Cannabis Sativa L” entry was updated, and specifically recognises that certain parts of the plant (e.g. seeds) are not novel. In contrast, the “Cannabidiol (CBD)” entry was deleted and replaced by a more general “cannabinoid” entry, which now states that products containing cannabinoids are considered novel foods. The Novel Foods Regulation is available here and the Novel Food Catalogue here _2. LATEST LAWS, REGULATORY GUIDANCE AND ENFORCEMENT ACTIONS 2.1. MEDICAL CANNABIS ARGENTINA – National Security Ministry approves first cultivation project for medical cannabis On 4 February 2019, the National Security Ministry authorised the first company (in history!) to cultivate cannabis for medical purposes in Argentina by approving the security protocol proposed by Cannabis Avãtara State Society (together with its partner Players Network – Green Leaf Farms International). The resolution is available here (ES) and a related article here BELGIUM – House of Representatives approves motion for resolution in favour of medical cannabis On 27 February 2019, the Belgian House of Representatives’ Health Committee approved the motion for a resolution in favour of cannabis for medical use. The motion aims to create a Cannabis Office (under control of the Belgian State) which would supervise medical cannabis cultivation and trade. It also seeks to enlarge the scope of prescribing cannabis for medical purposes. The motion is available here (FR and NL) and a related article here CYPRUS – Legislators pass a bill authorising medical cannabis under specific conditions On 15 February 2019, legislators adopted an amendment to the Narcotic Drugs and Psychotropic Substances Law which permits, under certain conditions and subject to a specific licence, the cultivation of medical cannabis and regulates its import/export, production and distribution, as well as its use for scientific research. A related article is available here DENMARK – Denmark implements measures to allow reimbursement and export of medical cannabis On 1 January, 2019, a special reimbursement scheme for medical cannabis entered into force which allows Danish citizens to obtain reimbursement for medical cannabis that has been prescribed in the context of the four­year pilot programme. This reimbursement scheme will apply retroactively to purchases made in 2018. The explanatory note of the Danish Medicines Agency is available here On the same date, an executive order of the Danish Government on cultivation, manufacture and distribution of cannabis entered into force and now authorises bulk exports of medical cannabis (subject to requisite permits), whereas previously only single­dosage medical cannabis exports were allowed. The executive order is available here (DA) and a related article here FRANCE – Health Agency alerts epileptic patients on the risks related to the use of (unauthorised) cannabidiol (CBD) products sold online On 22 January 2019, the National Agency for Medicines and Health Products Safety (ANSM) published an information note reminding patients suffering from epilepsy of the potential health risks related to purchasing CBD products outside the legal circuit, in particular on unauthorised websites. The ANSM information note is available here (FR) FRANCE – Health Agency’s Temporary Specialised Scientific Committee (CSST) pursues its activities regarding the authorisation of medical cannabis in France On 30 January 2019, the ANSM announced, after having endorsed the CSST’s recommendation to authorise medical cannabis, that the committee will pursue its work on the modalities of making cannabis available for therapeutic purposes in France. In a first phase, the CSST will focus on possible methods of administration, and in a second phase, on the prescription and dispensing modalities of medical cannabis. The ANSM press release is available here (FR) and the CSST meetings are available here (FR) GERMANY – Health Agency will grant first medical cannabis cultivation contract in Q2 of 2019 On 28 January 2019, The German Federal Institute for Drugs and Medical Devices (BfArM), after having received 79 bids for the cultivation of medical cannabis in Germany, announced that the contract will be awarded in the second quarter of 2019 for a total medical cannabis procurement volume of 10,400 kg over four years. Germany’s first home­grown harvest could take place in late 2020. The press release is available here (DE) and a related article here IRELAND – Medical cannabis legally prescribed for 16 patients On 19 February 2019, the Minister of Health, when questioned on the progress of medical cannabis access in Ireland answered that, inter alia, 29 licences to prescribe medical cannabis had been already granted for 16 different patients. He also indicated that clinical guidance for healthcare professionals had been drawn up but that the full operation of the Access Programme was still pending. The Minister’s written answer is available here ISRAEL – Israeli Government approves law allowing medical cannabis export On 27 January 2019, the Israeli Government approved the bill passed by Parliament on 25 December 2018, which will allow Israeli medical cannabis production to be exported worldwide. The government expects to boost the agricultural sector and generate new tax income from such