Cannabis Legal & Regulatory Update - October-December 2018
14 January 2019
CANADA – [Recreational Cannabis] ‒ Canadian Cannabis Act legalises recreational cannabis
On 17 October 2018, Canada became the first country in the G7 and the second country in the world (after Uruguay) to legalise the marketing of recreational cannabis.
The Canadian Cannabis Act is available here.
FRANCE – [WellBeing Cannabis] – Court of Appeals asks EU Court of Justice to rule on (non compliance with EU law of French regulations restricting the marketing of hemp based products
On 23 October 2018, the Court of Appeals of AixenProvence referred a preliminary question to the Court of Justice of the European Union (CJEU) requesting the CJEU to confirm that the French regulations restricting the cultivation and marketing of hemp based products to products derived from specific parts of the plant (seeds and fibre) only is not compliant with EU law.
A related article (FR) is available here.
UK – [Medical Cannabis] – UK authorises the supply of unlicensed cannabis-based products for medical use and MHRA publishes related guidance
Since 1 November 2018, the rescheduling of cannabis under the Misuse of Drugs legislation enables unlicensed cannabis-based products for medicinal use in humans to be available under the provisions for “Specials” under the Human Medicines Regulations 2012. The Medicines and Healthcare Products Regulatory Agency (MHRA) published relevant guidance on 31 October 2018.
US – [Well-Being Cannabis] – US Farm Bill authorising hemp first real step towards cannabis legalisation in the US in almost 50 years
On 12 December 2018, the House of Representative passed the 2018 Farm Bill, signed into law by President Trump on 20 December 2018. The Bill legally defines “hemp” as any Cannabis sativa plant with THC below 0,3%, and legalises the production thereof. It also removes hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under US federal law. The US Food and Drug Administration (FDA) issued a related statement on the regulation of cannabis-derived products on 20 December, announcing “new steps” to better define its public health obligation in this area.
2. LATEST LAWS, REGULATORY GUIDANCE AND ENFORCEMENT ACTIONS
2.1. MEDICAL CANNABIS
BRAZIL – Senate takes steps towards the legalisation of home production of cannabis for medical use
On 28 November 2018, Brazil’s Senate Social Affairs Committee approved a draft bill to legalise cannabis cultivation for personal medical use. However, the bill still faces several legislative hurdles and Brazil’s president-elect is unlikely to approve the bill due to his strong opposition to drug legalisation.
ECUADOR – Key legislative committee brings Ecuador one step closer to legalising medical cannabis
On 3 October 2018, Ecuador’s National Assembly’s standing commission on health unanimously approved comprehensive health reform (Libro II del Codigo de la Salud) that could lead to the legal cultivation, manufacture and prescribing of medical cannabis. The bill is expected to be enacted in the next 68 months.
EUROPEAN UNION – Parliamentary question for oral answer on medical cannabis on behalf of the Committee on the Environment, Public Health and Food Safety (ENVI)
On 12 November 2018, certain members of the European Parliament, on behalf of the ENVI Committee, submitted a question for oral answer to the European Commission. The question aims at receiving more insights into the actions and position of the Commission with respect to medical cannabis, and specifically inquires about the appropriate THC limit in such products.
The question for oral answer O000122/2018 is available here.
EUROPEAN UNION – EMCDDA publishes first report on medical use of cannabis and cannabinoids
On 4 December 2018, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) published its first report on medical use of cannabis and cannabinoids: questions and answers for policymaking. The report is accompanied by a background paper which summarises reviews of evidence on the effectiveness and safety of cannabis and cannabinoids when used to treat medical conditions.
FRANCE ‒ Health Agency recommends authorising the medical use of cannabis
On 27 December 2018, the French National Agency for Medicines and Health Products Safety (ANSM) recommended allowing the use of medical cannabis under certain conditions, thus following the recommendations of its Temporary Specialised Scientific Committee (CSST). Before summer 2019, the CSST is expected to provide recommendations on practicalities such as the distribution and dispensing system, and medical cannabis will then be made accessible to patients by means of a pilot project first.
GERMANY – Medical cannabis cultivation plan once again delayed
On 15 November 2018, the German Federal Institute for Drugs and Medical Devices (BfArM) announced another modification to the deadline in the application process for the authorisation of the cultivation, processing, storage, packaging and delivery of cannabis for medical purposes.
The BfArM notice is available here (DE).
GREECE – First authorisations for the cultivation of medical cannabis
On 19 November 2018, Greece issued the first two authorisations for the cultivation and production of medical cannabis and cannabis-derived pharmaceutical products following the legalisation of cannabis on 1 March 2018. Another 12 licenses are expected to be issued by the end of the year.
ISRAEL – Israeli Parliament passes bill allowing medical cannabis export
On 25 December 2018, the Israeli Parliament (the “Knesset”) passed the 16th amendment to the Dangerous Drugs Ordinance that concerns the governance and regulatory aspects of exporting medical cannabis from Israel. The amended bill allows provisions for future medical cannabis export. A government resolution is required to authorise export.
A related article is available here.
NEW ZEALAND – Access to medical cannabis improved after adoption of amendment bill
On 11 December 2018, the Misuse of Drugs (Medicinal Cannabis) Amendment Bill was adopted by the NZ Parliament. The Bill amends the Misuse of Drugs Act 1975 to improve access to medicinal cannabis for patients suffering from terminal illness and ensures that cannabidiol (CBD) and CBD products are no longer classified as controlled drugs.
POLAND ‒ First non-governmental company authorised to import medical cannabis into the country
On 25 October 2018, The Polish Ministry of Health granted Aurora Deutschland GmbH approval for its first shipment of medical cannabis to Poland. This is believed to be the first time a nongovernment run business has been granted approval to supply medical cannabis products in the country.
The Aurora press release is available here.
SOUTH KOREA – First Asian country to legalise medical cannabis
On 23 November 2018, the Korean National Assembly passed an amendment to the Narcotics Control Act to allow the medical use of cannabis under strict conditions (prior approval will be necessary and granted on a case-by-case
basis). The Ministry of Food and Drug Safety (MFDS) will need to establish specific implementing regulations setting out a.o. the procedure patients must follow to qualify.
THAILAND ‒ First country in Southeast Asia to approve the use of medical cannabis
On 25 December 2018, the Thai National Legislative Assembly approved a bill to legalise the medical use of cannabis on the condition that the legislation is reviewed after five years. This makes Thailand the first country in Southeast Asia to allow the use of medical cannabis.
A related article is available here.
UK – NHS Department of Health and Social Care sends information letter to clinicians regarding cannabisbased
products for medicinal use
On 31 October 2018, the NHS sent a letter providing support and guidance following the rescheduling
of certain cannabis-based products for medical use to clinicians in the UK. In particular, the letter sets out their expectations of what this regulatory change will mean in practice for clinicians working in the NHS and in private practice in England.
The information letter is available here.
UK – Health and Social Care Committee launches medicinal cannabis inquiry
On 7 December 2018, the Health and Social Care Committee opened a new inquiry on medicinal cannabis through which it is seeking evidence on the usage of medicinal cannabis products as the first part of a wider inquiry into the impact of drugs policy on public health. Written submissions are expected before 8 February 2019 and shall answer several points as detailed on the Committee’s page.
The inquiry details are available here.
US ‒ Epidiolex®, the first FDA-approved plant-derived cannabinoid medicinal product, available on prescription in the US
On 1 November 2018, GW Pharmaceuticals announced that its cannabis-based medicine Epidiolex became available in the US (50 states) following the rescheduling of FDA-approved medicines containing plant-derived CBD (with no more than 0.1% THC) in schedule V of the US Controlled Substance Act (i.e., including substances with the lowest potential for abuse).
US – Cannabis among ballot measures for 2018 midterm elections
The legalisation of medical or recreational cannabis figured within the ballot measures in four US states in the US midterm elections of 6 November 2018. Whereas Utah and Missouri voted for the legalisation of medical cannabis, Michigan became the first Midwestern state to legalise recreational cannabis.
A related article is available here.
2.2. WELLBEING CANNABIS
AUSTRIA – Government decree bans CBD in food and cosmetics
On 9 December 2018, the Austrian Ministry of Social Affairs confirmed that a Government Decree of 4 December 2018 sets forth that the sale of CBD-containing food and cosmetics is not permitted in Austria.
BELGIUM – Authorities release Q&As on use of cannabinoids in food and other products
In November 2018, the Belgian Federal Public Service for Health, Food Chain Safety and Environment and the Federal Agency for the Safety of the Food Chain published a Q&A on the use of cannabinoids (such as CBD) within foodstuffs. The Q&A states that foodstuffs based on CBD extracts, including CBD oil, are considered as novel foods and not currently authorised in Belgium. Similarly, the Federal Agency for Medicines and Health Products published a Q&A on the use of cannabinoids in other products such as cosmetics and consumer products.
CANADA – Proposed amendments to Cannabis Act and Regulations authorising the sale of new classes of cannabis products
On 22 December 2018, the Government of Canada (Department of Health) proposed to amend Schedule 4 to the Cannabis Act and the Cannabis Regulations to add three new classes of cannabis that could be legally sold by federal licence holders and provincially and territorially authorised distributors and retailers (“edible cannabis”, “cannabis extracts”, and “cannabis topicals”). The proposal is subject to a public comment period ending 60 days following its publication.
DENMARK – Danish Veterinary and Food Administration (DVFA) issues guidance on regulations for food containing cannabidiol (CBD)
On 30 October 2018, the DVFA issued guidance on regulations for food containing CBD. The guidance states that pure CBD as well as hemp products with concentrated levels of CBD are considered novel foods but also lists products which should not be considered as novel foods e.g. hemp seeds, seed flour, protein powder from seeds and seed oil from authorised hemp varieties.
The DVFA guidance is available here.
GERMANY The German Federal Institute for Risk Assessment recommends minimising the level of THC in hemp-containing foods
On 8 November 2018, the German Federal Institute for Risk Assessment (BfR), after assessing the risk of psychogenic and pharmacological effects through the consumption of hemp-containing foods with customary levels of THC, concluded that this consumption could lead to a level of THC absorbed in excess in comparison with the acute reference dose (ARfD) proposed by the European Food Safety Authority (EFSA) and therefore has recommended to
minimise the level of THC in hemp-containing foods.
ITALY – Italian Government notifies draft regulation defining maximum THC levels in food
On 30 October 2018, the Italian Government notified a draft regulation laying down maximum levels of THC in food to the European Commission through the Technical Regulation Information System (TRIS). The limits are defined for foodstuffs derived from hemp (seeds, flour obtained from seeds, oil obtained from seeds) and for supplements containing hemp-derived foodstuffs.
The TRIS notification and draft regulation are available here.
LUXEMBOURG – Health Ministry publishes note on cannabis and hemp derived products
On 2 October 2018, the Health Ministry published a note on cannabis and hemp-derived products to clarify the regulations applicable to those products. The note covers a wide range of products (including natural and chemical raw materials, extracts for cosmetic use, food-related use, smoking and other industrial purposes).
The note is available here (FR).
MEXICO – COFEPRIS authorises the first 38 non-prescription cannabis products in Mexico
On 21 November 2018, the Ministry of Health, through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), announced the authorisation of the first 38 cannabis products, including food products, food supplements and cosmetics, following guidelines published by the Commission on 30 October 2018. All these products contain less than 1% THC, but contain other cannabinoids such as CBD.
US – WASHINGTON – State regulators approve new rules for marijuana edibles
On 12 December 2018, the Washington State Liquor and Cannabis Board issued a new interim policy regarding the packaging and labelling requirements for cannabis infused edible products. This interim policy has been taken in order to clarify the rules for licensees, protect the public and to reduce risk of accidental exposure to cannabis derived products by youth and children.
2.3. RECREATIONAL CANNABIS CANADA – Canadian Securities Administrators publish guidance on good disclosure practices for issuers in the cannabis industry
On 10 October 2018, the Canadian Securities Administrators (CSA) published guidance on good disclosure practices for issuers in the cannabis industry so that investors are provided with transparent information about financial performance and risks and uncertainties, to support informed investing decisions. The guidance follows the review of disclosures of 70 reporting operating issuers, and identified specific areas where issuers are expected to improve their disclosure.
The guidance (staff review) is available here.
CANADA – Unequal treatment for cannabis retailers across Canada
On 19 November 2018, one month after Canada legalised recreational cannabis, Alberta issued nearly 70 private retail licences, while British Columbia issued only one to a public retailer and another to a private store. Businesses in British Columbia remain in the dark about when their applications will be approved.
FRANCE – France introduces lumpsum fine of EUR 200 for unauthorised cannabis use
On 23 November 2018, the French Parliament voted in favour of the introduction of a EUR 200 lumpsum fine for (illegal) cannabis users. Earlier in October, the Senate also voted in favour of the new measure. Until now, illegal cannabis use could only be sanctioned by imprisonment and a higher fine of EUR 3750, but these sanctions are rarely imposed. The bill is still going through the legislative procedure.
The pending bill is available here (FR).
LUXEMBOURG – Luxembourg set to become first EU country to authorise recreational cannabis?
A coalition agreement dated 3 December 2018, signed for the purpose of the formation of the new Luxembourg Government (20182023), proposes the legalisation of recreational cannabis use by adult residents. No specific timetable is set for the adoption of such measure. The agreement also establishes a two-year evaluation period for Luxembourg’s medical cannabis program (legalised earlier this year).
MEXICO – Supreme Court declares ban on recreational cannabis use unconstitutional
On 31 October 2018, Mexico’s Supreme Court ruled that an absolute ban on recreational use of cannabis was unconstitutional in the latest two of five similar rulings on the matter, effectively leaving it to lawmakers to regulate consumption of cannabis in Mexico. The Court ordered federal health regulator COFEPRIS to authorise people seeking the right to use cannabis to do so personally.
MEXICO – Mexico introduces bill to legalise recreational cannabis use
On 8 November 2018, and following two rulings by the Supreme Court holding Mexico’s ban on recreational cannabis use unconstitutional, Interior Minister Olga Sanchez Cordero proposed a bill to legalise cannabis. If it passes, each person will be allowed to have up to 20 plants at a time for personal consumption. The bill would also include regulating and monitoring production, sales, and consumption.
NEW ZEALAND – Government confirms recreational cannabis referendum in 2020
On 18 December 2018, the Minister of Justice of New Zealand confirmed that a referendum on recreational cannabis use will be held at the 2020 election, and that the outcome there-of will be binding.
A related article is available here.
SOUTH AFRICA ‒ Constitutional Court gives green light to private cannabis use
In September 2018, the Constitutional Court decriminalised the possession, consumption and cultivation of cannabis by adults in private places. The ruling also approved growing cannabis for personal consumption. The Court gave parliament 24 months to change the law to reflect its ruling.
UNITED NATIONS – WHO postpones recommendations on the international scheduling of cannabis
Following the WHO’s Expert Committee on Drug Dependence (ECDD) meeting from 1216 November 2018, the ECDD’s recommendations on the international scheduling of cannabis were expected to be released on 7 December at the Commission on Narcotic Drugs (CND) session in Vienna. However, the WHO indicated to need more time to complete the evaluation process. No new date was provided for the release, but member states are expected to vote
on the issue in March 2019.
3. SELECTED INDUSTRY AND MARKET NEWS
- Business News
2018 International Cannabis Business Year in Review – 28-12-2018 – Marijuana Business Daily
Cannabis continued to make headlines around the globe in 2018, from the historic legalization of recreational use in Canada to passage of medical marijuana legislation in traditionally conservative countries. 2018 International Cannabis Business Year in Review is a post from: Marijuana Business Daily: Financial, Legal & Cannabusiness news for cannabis entrepreneurs…
Pot Producer Aphria Rejects $2.1 Billion Green Growth Hostile Bid – 28-12-2018 – Bloomberg
Canadian marijuana producer Aphria Inc. rejected a planned C$2.8 billion ($2.1 billion) hostile offer by U.S. cannabis retailer Green Growth Brands...
Growth slows for German medical cannabis market in third quarter – 27-12-2018 – Marijuana Business Daily
Demand for medical marijuana in Germany continued to increase in the third quarter, albeit at a slower pace than the previous quarter. Total cannabis sales covered by statutory health insurance surpassed 50 million euros ($56.8 million) in the first nine months of 2018, with all categories of allowed medical cannabis posting gains between the second…
Brewer AB InBev partners with Tilray to tap cannabis drink market – 19-12-2018 Reuters
AnheuserBusch InBev (ABI.BR), the world’s largest brewer, and Canadian pot producer Tilray Inc (TLRY.O) are partnering in a $100million joint venture to research cannabis-infused non-alcoholic drinks for the Canadian market, the companies said Wednesday…
Tilray Goes Global With Novartis Marijuana Sales Partnership – 18-12-2018 – Bloomberg
Tilray Inc. has signed a global partnership with a division of Swiss drug giant Novartis AG to develop and distribute its medical marijuana in legal jurisdictions around the world…
Altria to marry pot with big tobacco in $1.8 billion Cronos deal – 07-12-2018 – Reuters
Marlboro cigarette maker Altria Group Inc announced a $1.8 billion investment in Cronos Group Inc on Friday, which could give it up to 55-percent ownership of the Canadian cannabis producer. The deal represents by far the biggest investment by a major tobacco conglomerate in a cannabis company…
Israel's Cannbit eyes medical cannabis growth, export in Portugal – 03/12/2018 – Reuters
Cannbit (CPHO.TA), an Israeli grower of medical cannabis, said on Monday it was examining the possibility of establishing a cannabis farm in Portugal as part of its strategy to expand outside of Israel. Cannbit said it was possible to grow medical cannabis in Portugal and export it from there, with the necessary licenses and permits required by authorities in the country
Neal Brothers and Newstrike partner on cannabis edibles – 28-11-2018 – The Globe And Mail
Food entrepreneurs Chris and Peter Neal, best known for Neal Brothers chips and salsa, have teamed up with Newstrike Brands Ltd. in the first publicly announced deal between an established Canadian food company and a cannabis grower. The joint venture will see Neal Brothers Brands Inc. and Newstrike cooking up cannabisinfused
goodies in a kitchen in Newstrike’s facility in Grimsby, Ont…
Pernod Ricard eyes 12-18 months to assess cannabis legislation impact – 21-11-2018 – Reuters
The head of Pernod Ricard said on Thursday it will take 12-18 months before the French spirits group can assess whether the legalisation of cannabis will impact the consumption of premium spirits…
Canopy Growth Corp., one of the world’s biggest medical cannabis companies, is planning a major investment in Europe. The marijuana grower will spend more than 100 million euros ($115 million) to expand production in the EU over the next two years, according to Pierre Debs, managing director at Canopy’s Spectrum Cannabis Europe division…
Molson stands at ready position for edibles; Estimates suggest the cannabis-infused-drinks segment could be worth at least $1.5billion ‒ 01-11-2018 ‒ The Globe and Mail (Globeinvestor)
Molson Coors Brewing Co. expects to “secure a meaningful share” of the cannabis-infused beverage market when edibles are legalized in Canada, the company's chief executive said. “We will be in a ready-to-go position and, you know, one of the first on the playing field as the market opens up,” Mark Hunter said in a conference call with analysts after the company released its third-quarter...
Constellation to sell off wine brands to focus on cannabis, beer ‒ 23-10-2018 ‒ Marijuana Business Daily
One of the world’s largest alcohol producers, Constellation Brands, plans to shed some of its U.S.based wine portfolio as part of a strategic shift to beer and marijuana products, according to an exclusive report by Reuters. Constellation increased its ownership in Canadian licensed cannabis producer Canopy Growth in August with an industryrecord
investment […] Constellation to sell...
RBC capital markets will start doing deals for pot companies – 18-12-2018 – Bloomberg
RBC Capital Markets has decided to begin doing deals in the cannabis industry. […] “Under certain circumstances with certain customers, we’ll participate,” RBC Capital Markets head Doug McGregor said Tuesday in an interview. “We’re going to be selective in our approach, frankly, but within the bank we’ve established a policy that we’re comfortable with.”…
Infused cannabis product maker Dixie Brands posts $2.4 million loss in third quarter – 10-12-2018 – Marijuana Business Daily
Denver-based Dixie Brands reported a net loss of $2.4 million in its fiscal third quarter, even though revenues more than doubled. The maker of infused marijuana beverages and products posted revenue for the quarter of $2.43 million – up nearly 110% from the year-ago quarter…
Cresco Labs Begins Trading on the Canadian Securities Exchange Under Ticker Symbol ‘CL’ – 03-12-2018 – Market Watch
Cresco Labs Inc., one of the largest vertically integrated multistate cannabis operators in the United States, begins trading today on the Canadian Securities Exchange ("CSE") under the ticker symbol "CL."
Leading U.S. marijuana firms list shares on Canadian stock exchange ‒ 17-11-2018 ‒ Marijuana Business Daily
Three top American cannabis firms made their trading debuts on the Canadian Securities Exchange (CSE) this week, continuing the frenzy of U.S.based marijuana companies turning to Canada's public markets to raise capital. Here’s a quick rundown of what investors need to know: Multistate cannabis operator Acreage Holdings listed its shares under the ticker symbol ACRG…
Canadian marijuana firm Canopy Growth posts bigger net loss as expenses rise ‒ 14-11-2018 – Reuters
Canopy Growth on Wednesday posted a bigger quarterly net loss as the Canadian marijuana producer spent more in the weeks before full legalisation of recreational use in mid-October…
Cannabis firm Tilray shares pull back on bigger-than-expected loss ‒ 13-11-2018 – Reuters
TORONTO, 13 November : Canadian cannabis producer Tilray Inc reported an 86 percent jump in third-quarter revenue on Tuesday, but a wider-than-expected loss weighed on shares in after-hours trading…
Banks pass on marijuana loans, for now ‒ 02-11-2018 ‒ Reuters
NEW YORK, Nov 2 (LPC): Wall Street is warming up to the idea of financing marijuana producers as the sector blossoms, but concerns with regulation and reputational damage could stop banks from lending in the short term…
- Regulatory and Enforcement News
Mascara containing cannabis oil seized; CNB also orders Singapore company to stop import, sale of product created by US firm – 21-12-2018 – The Straits Times (Singapore)
The Central Narcotics Bureau (CNB) has seized cannabis oil-infused mascara from a local skincare shop. Officers from CNB went to Skinx in Amoy Street on Wednesday morning and seized the product, a Skinx spokesman told The Straits Times. The mascara in question is Kush High Volume Mascara, created by Milk Makeup, a cosmetics company based in New York City. A CNB spokesman told The Straits ...
Battelle and Canopy Growth Announce Strategic Collaboration to Advance Cannabis Research – 27-11-2018 – Batelle Press Release
Battelle, the world’s largest non-profit research and development organization, and Canopy Growth Corporation, the world’s largest diversified cannabis company, today announced the completion of multiple fully legal cannabis imports from Canada to the United States. Battelle and Canopy Growth will work together to advance knowledge surrounding cannabis in support of medical research and novel product development…
Uses of illicit psychoactive substances in France: results of the health barometer 2017 – 26-11-2018 Santé Publique France
Experimentation: in 2017, cannabis remains by far the most experienced illicit product in France. Nearly half of adults (45%) have already used it (42% in 2014).The proportion of “yearly” users (11%, i.e. one adult in ten) has not changed compared to 2014 and the proportion of regular users (at least 10 times in the month) has increased from 3.1% to 3.6%. In addition, 2.2% of 1864 year olds report daily use (1.7% in 2014)…
Columbia Care LLC, the leading medical cannabis company in the United States (U.S.), announced today that it received notification that its application for licensure in Malta has been approved by Malta Enterprise, the country’s economic development agency. Upon completion of the final regulatory steps, Columbia Care will be able to import, export, cultivate…
The largest supplier of medical marijuana in Israel is not distributing or selling products from its facility in Biriya after the Ministry of Health raised questions over a new drying process ‒ but the company expects the facility to be up and running in a matter of days. Tikun Olam CEO Aharon Lutzky said the […] Israeli medical cannabis pioneer hit with ‘temporary closure’ is a post from...
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