NEWSLETTER Cannabis Legal & Regulatory Update September ­ December 2019 PDF version 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 The A&O View 2019 was a momentous year for the cannabis industry – this emerging industry is so fast­ moving that it is said to live in dog years. The medical benefits of cannabis and its derivatives have received green light from the international community. During the last quarter of 2019, the first EU­wide marketing authorisation for a cannabis­derived medicinal product was granted by the European Medicines Agency, France continued gearing up for the implementation of its medical cannabis pilot programme, and an increasing number of countries started reimbursing patients for cannabis­based products. National courts (in the UK) have started showing lenience for home­growing cannabis for medical purposes. Meanwhile Big Pharma is – not only – watching and swiftly expanding its cannabis patent portfolio. The CBD landscape, on the other hand, is still characterised by fifty shades of grey. While CBD­based edibles have become a hot commodity on the EU market, the first national regulators and courts (in Finland, Germany…) have now officially banned such products for lack of novel foods authorisation. Will EFSA finally break the deafening silence, and provide some much needed practical guidance, now that a second novel food application – for synthesised CBD – has been filed? If it depends on the European Commission, the EU will unfortunately not wholeheartedly support the – scientifically sensible – WHO recommendations at the next meeting of the Commission on Narcotic Drugs. But make sure to mark 31 March 2020 in your calendars, when the EU Court’s Advocate General is set to provide an important sneak preview into the EU stance towards harmonisation of the CBD well­being market. Indeed, 2020 is gearing up to be an even more critical (dog) year. Cannabis 2.0, bring it on. Wishing you all a flourishing 2020! 1. HIGHLIGHTS EU – European Medicines Agency (EMA) grants first EU­wide marketing authorisation to CBD­based medicine On 19 September 2019, EMA has granted a marketing authorisation to Epidyolex®, a cannabidiol­based orphan medicine indicated for use as adjunctive therapy of seizures associated with Lennox­Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with Clobazam, for patients two years of age and older. The EMA’s Epidyolex detail page is available here EU – EFSA requested to evaluate new novel food application related to synthetic CBD On 26 November 2019, a new application was submitted, after being considered valid by the European Commission, to the European Food Safety Authority (EFSA) requesting a scientific opinion on synthesised trans­cannabidiol as a novel food. EFSA should adopt its opinion within the next nine months. The application is available here EU – European Commission disagrees with WHO ECDD’s recommendations to remove cannabis extracts and tinctures, and preparations containing less than 0,2% from international control regime On 12 December 2019, the European Commission published its proposal for a Council Decision on the position to be taken on behalf of the EU in the 63rd session of the Commission on Narcotic Drugs (CND) during which the vote on ECDD’s recommendations (of January 2019) should take place. The EU only has observer status in the CND and it is necessary for the Council to authorise Member States to express the position of the EU. The Commission agrees with the recommended removal of cannabis and cannabis resin from Schedule IV, but does not support the ECDD’s recommendations (i) to remove “cannabis extracts and tinctures” from Schedule I nor (ii) to clarify that preparations containing less than 0,2% THC are not under international control, and instead requests further assessment by the WHO. The proposal is available here 2. LATEST LAWS, REGULATORY GUIDANCE AND ENFORCEMENT ACTIONS 2.1. MEDICAL CANNABIS AUSTRALIA – Federal Government announces substantial funding for research into medical cannabis benefits On 6 October 2019, The Minister for Health announced that the Australian Government is investing AUS$3 million from the Medical Research Future Fund (MRFF) to examine the benefits of medical cannabis for pain, symptom and side effect management for cancer patients. The Minister for Health press release is available here On 13 November 2019, the Senate inquired the Community Affairs References Committee to examine the degree of patient access of medical cannabis. The committee is to report its findings by 12 February 2020 and should cover in particular the status of the domestic regulated medical cannabis industry, significant financial barriers to accessing medical cannabis treatment, interactions between state and territory authorities and the Commonwealth, and appropriateness of the current regulatory regimes The Senate’s motion is available here and a related article here BARBADOS – Government makes access to medical cannabis possible On 29 November 2019, Barbados adopted a law which regulates the cultivation, licensing and distribution of medicinal cannabis. The law establishes a competent Cannabis Agency, Board and a Medicinal Cannabis Appeals Tribunal and determines the conditions for issuing licences for the handling of medicinal cannabis. In August, the Barbados Drug Service had issued a public tender to supply approved medical cannabinoid products (e.g. dronabinol) starting April 2020 (as such products are currently not available in Barbados). The bill is available here, the call for tender here and a related article here BELGIUM – National Health Agency specifies prescription conditions of CBD products On 16 July 2019, the Belgian Federal Agency for Medicines and Health Products (FAMHP) issued a circular interpreting the Royal Decree of June 2015 on the regulation of products containing one or more tetrahydrocannabinols with regards to raw materials for pharmaceutical compounding. The circular specifies that pharmacists are allowed to dispense some CBD products upon a medical prescription under certain circumstances. Raw material (CBD powder) can be supplied to pharmacies in order to be processed (and then dispensed) with a THC content limited to one microgram per kilogram body weight of a patient per day. The FAMHP circular is available here (FR) BRAZIL – National Health Agency approves medical cannabis pilot but rejects domestic cultivation On 3 December 2019, the Brazilian National Health Agency (ANVISA) rejected a proposal to allow domestic cultivation of medical cannabis but created transitional rules to facilitate the commercialisation of medical cannabis products that have not completed clinical trials. According to ANVISA’s resolution, the new products will only be available in pharmacies and on special medical prescription. The scheme is temporary (similar to medical cannabis pilot programmes in Europe) and will be reviewed in three years. ANVISA’s press release is available here (PT) and a related article here CYPRUS – Government delays bidding process for medical cannabis cultivation On 22 November 2019, the opening of the bidding process for the cultivation of medical cannabis in Cyprus was delayed after government authorities requested a review of the licensing fees. The delay is due to concerns that the licence fees are too low given the revenue growers are expected to generate. A related article is available here CZECH REPUBLIC – Government plans to subsidise the cost of medical cannabis up to 90% On 8 October 2019, the Czech government announced the adoption of a bill that plans to subsidise the cost of medical cannabis from public health insurance funds and that will allow patients to be reimbursed for up to 90% of the cost of their prescription. The Minister of Health’s announcement is available here (CZ) and a related article here DENMARK – Government willing to extend medical cannabis pilot deadlines On 9 December 2019, the Danish Health Minister indicated that the four­year medical cannabis pilot, which is on­going since 1 January 2018, might be extended due to a number of initial difficulties that make it hard to evaluate the results thereof. The evaluation is set to begin in 2020 to help the legislator decide whether to turn this pilot programme into a permanent regime. Related articles are available here (DA) and here ECUADOR – National Assembly allows the medical use of cannabis On 18 September 2019, the National Assembly of Ecuador approved the reform of the Criminal code, the text of which now allows the production, marketing, distribution and use of cannabis for medical purposes in the country. A related article is available here EU – European Medicines Agency (EMA) grants first EU­wide marketing authorisation to CBD­based medicine On 19 September 2019, EMA has granted a marketing authorisation to Epidyolex®, a cannabidiol­based orphan medicine indicated for use as adjunctive therapy of seizures associated with Lennox­Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with Clobazam, for patients two years of age and older. The EMA’s Epidyolex detail page is available here FRANCE – Implementation of national medical cannabis pilot programme underway On 25 October 2019, the French National Assembly adopted the amendment to the 2020 Social Security Financing Bill providing a clear legal basis for the medical cannabis pilot programme. The adopted amendment