NEWSLETTER Cannabis Legal & Regulatory Update September December 2019
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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 seeks to ensure that the pilot programme is adequately financed and can be launched as foreseen.
The amendment is available here (FR) and our A&O Life Sciences Hub post here
On 15 October 2019, the French National Agency for Medical and Health Products (ANSM) issued two decisions in order to pursue the necessary work to set up the medical cannabis pilot programme in France. The decisions (i) create a new French specialised scientific committee (CSST) and define its attributed tasks, and (ii) nominate the members thereof. The new CSST will need to draft (i) recommendations on the scope of work (type of medical cannabis, training for prescribers, content of patient monitoring register) and (ii) recommendations for prescribers. The decisions mark the official start of the implementation of the medical cannabis pilot programme in France which is expected to last two years.
The decisions are available here (FR) and here (FR) and our A&O Life Sciences Hub post here
In January 2020 the ANSM published a Q&A on medical cannabis and the pilot programme. The ANSM clarified that (i) the “cahier des charges” on the specifications and expected product quality (setting out the conditions of participation for cannabis companies) will be published on the ANSM website early 2020 and (ii) that the pilot is expected to begin in the second half of 2020. The ANSM also specified that parallel research projects on cannabis and cannabisrelated products could be authorised (after evaluation) by the ANSM.
The ANSM Q&A is available here
FRANCE – Parliamentary Office publishes scientific note on health effects of cannabis use
On 7 November 2019, the Parliamentary Office for Assessment of Scientific and Technological Choices published a new scientific note on the benefit of medical cannabis as well as the possible adverse health effects associated with the recreational consumption of the plant. The note concludes that (i) there is enough scientific evidence to legitimise the medical use of cannabis and its derivatives while further research is necessary; but (ii) its nonmedical uses create health risks which justify better prevention for young people and pregnant women.
The note is available here (FR) and the parliamentary press release here (FR)
GERMANY – New law improves patient access to medical cannabis
On 9 August 2019, a new Law for More Safety in the Supply of Pharmaceuticals (GSAV) was adopted in order to facilitate access to medical cannabis for patients who are already on prescription or who have been hospitalised. The law will, inter alia, enable patients to switch between cannabis products without having to wait for approval.
The law is available here and our A&O Life Sciences Hub post here
ISRAEL – Ministry report on medical cannabis ecosystem aims at attracting foreign investments
In November 2019, the Ministry of Economy and Industry released a white paper on the opportunity and benefit that investing in Israel’s unique medical cannabis ecosystem may represent and shows the clear intention from the government to back up the burgeoning sector. The white paper maps out the industry’s framework (i.e. key players, leading start ups, breakthrough research, regulations and opportunities etc.).
The white paper is available here and a related article here
ISRAEL – Medical Cannabis Agency releases transitional guidelines to approve medical cannabis exports on casebycase basis
On 19 November 2019, Israel’s Medical Cannabis Agency published guidelines that seek to approve medical cannabis exports on a casebycase basis provided local supplies are sufficient to meet patient demand. The guidelines address the laboratory testing during the growth and production processes, the amount of cannabis that can be grown, post harvest processing, approval of batches for export and local supply ahead of export approval. They are issued for a transitional period of six months following which the Health Ministry will determine whether to extend, abolish or adopt them as permanent regulations.
The guideline is available here (HE) and a related article here ISRAEL – High Court overturns Israel’s medical cannabis price reform
On 5 December 2019, Israel’s High Court ordered medical cannabis companies to sell their products at considerably lower prices, similar to the ones offered before the reform was implemented. The reform intended to increase competition by introducing higher quality control but instead created supply issues and higher prices. The Health Minister announced that it will respect the Court’s decision.
A related article is available here
MACEDONIA – Bill to change medical cannabis regulations withdrawn
On 3 October 2019, the Macedonian government submitted a bill to Parliament to substantially change the medical cannabis framework. The bill proposed to allow the export of cannabis flowers but increased the licence requirements. It also introduced the creation of an independent cannabis regulatory agency. However the bill has meanwhile been removed from Parliament’s agenda.
The bill is available here (MK) and related articles here and here
NEW ZEALAND – Government passes regulations to enable medicinal cannabis scheme
On 18 December 2019, regulations enabling a medical cannabis scheme were passed and will come into effect on 1 April 2020. A Medicinal Cannabis Agency will be established to administer the scheme. The Medicinal Cannabis Scheme intends to increase access to medicinal cannabis products, through increasing the supply of products by establishing a licencing regime enabling the cultivating of cannabis in New Zealand and the manufacture and supply of medicinal cannabis products made to quality standards. The Scheme covers cannabis products originating from the cannabis plant for medicinal use.
The regulations are available here and the Ministry of Health’s press release here
PARAGUAY – Government plans to open up the application process for medical cannabis production
On 12 September 2019, the Health Minister announced the opening of an application process for medical cannabis production. Five licences are to be granted that cover cultivation and manufacture of medical cannabis products. The first licences are expected to be awarded early December with the first batch of medical cannabis arriving six months later.
The Government’s press release is available here (ES) and a related article here
PERU – Health Ministry adopts technical guidelines on medical cannabis use
On 9 December 2019, the Health Ministry (MINSA) adopted a Ministerial Resolution which approved a technical guideline on the medical use of cannabis and cannabis derivatives. The resolution sets up the protocol for medical cannabis prescriptions (indications, information, registry etc.). The Resolution also approves the use of four cannabisderived medicinal products.
The resolution is available here (ES) and a related article here
PORTUGAL – First cannabisbased medicinal product reimbursed
On 25 July 2019, the Portuguese government agreed to apply to Sativex a 37% subsidy following the guidelines adopted when the law approving the medical use of cannabis passed. Sativex® will be the first cannabis medicine to be marketed and reimbursed in Portugal but only for patients affected by multiple sclerosis who suffer from spasms and who have not had satisfactory results with traditional medicines.
A related article is available here (ES) and here (ES)
SINGAPORE – Government authorises first case of cannabisderived medication On 1 December 2019, the Singaporean press reported the first and only approval in the country of a cannabisderived treatment. The patient is an epileptic girl who failed to respond to therapies and had exhausted all currently registered medications for treatment.
A related article is available here
THE NETHERLANDS – Office of Medicinal Cannabis opens medical cannabis supply to competition
On 7 November 2019, the Dutch Office of Medicinal Cannabis issued a tender ‘Supply of medicinal cannabis of pharmaceutical and consistent quality 2019’ the purpose of which is to conclude a Framework Agreement with a maximum of two suppliers for the supply of medical cannabis of pharmaceutical and consistent quality. The end date of the tender is 20 January 2020, and the starting date of the framework agreement is 1 April 2021, for an initial duration of four years (with possible extensions).
The tender is available here (NL)
UK – Authorities issue prescribing recommendations for medical and medicinal cannabis
On 6 September 2019, the Government published its response to the conclusions and recommendations made in the Health and Social Care Select Committee’s report on Drugs Policy: Medicinal Cannabis which was published on 3 July 2019. The Committee as the first part of a wider inquiry into the impact of drugs policy on public health sought evidence on the usage of medical cannabis products.
The Committee’s report is available here and the Government’s response here
On 11 November 2019, the National Institute for Health and Care Excellence (NICE) published a guideline on cannabisbased medicinal products. The guideline makes recommendations regarding prescribing cannabisbased medicines for people with intractable nausea and vomiting, chronic pain, spasticity and severe treatmentresistant epilepsy, and will replace the interim clinical guidance.
The NICE guideline is available here
The same day, NICE published two final appraisal documents related to the recommended use of cannabidiol (Epidyolex) with clobazam for treating seizures associated with both Lennox–Gastaut and Dravet syndromes in people aged two years and older. The recommendations are subject to two conditions: (i) treatment is stopped if the frequency of seizures has not fallen by at least 30% compared with the six months before starting treatment; and (ii) the company provides cannabidiol (Epidyolex®) according to the defined commercial arrangements.
The NICE final appraisal documents are available here and here
On 21 December 2019, the NHS (i) announced that Epidyolex® had been fasttracked and would be available from 6 January 2020 and (ii) published a letter highlighting some new resources to help clarify the process for prescribing cannabisbased products for medicinal use (CBPMs).
The NHS press release is available here and the letter here
UK – Drugs advisory committee launches first national pilot study for medical cannabis
In July 2019, Drug Science, an independent scientific body on drugs, launched “Project Twenty21” aiming to enrol 20,000 patients into the pilot before the end of 2021. This pilot aims at gathering data on medical cannabis by using a real world data patient registry to assess efficacy, safety, qualityadjusted life years (QALYs) and patientreported outcomes in those prescribed medical cannabis. Related article are available here and here
UK – Court acquits a multiple sclerosis (MS) patient of cannabis homegrowing
On 6 January 2020, the Carlisle Court acquitted an MS patient of cannabis homegrowing deciding it was not in the public interest to prosecute patients who have no option but to use medical cannabis to alleviate their symptoms. Despite being in line with the softening of cannabis prosecution in the UK, the ruling does not set a binding precedent which can be relied on by others in court and it remains an offence for people to use cannabis to treat their illnesses.
Related articles are available here
URUGUAY – Senate approves a new bill on promotion and access to medical cannabis
On 10 December 2019, the Uruguayan Senate unanimously approved a bill regulating access to and promotion of medical cannabis. The Institute for Regulation and Control of Cannabis (IRCCA – Instituto de Regulación y Control del Cannabis) will establish a certification and quality control system, while the Ministry of Public Health will implement a Medicinal Cannabis and Therapeutic Use programme with the objective of including these treatments.
A related article here
US – Drug Enforcement Administration (DEA) announces its plan to improve cannabis research
On 26 August 2019, the DEA announced its plan to move forward to facilitate and expand scientific and medical research for cannabis in the US. The DEA is providing notice of pending applications from entities applying to be registered to manufacture cannabis for researchers and anticipates that registering additional growers will increase the variety of cannabis available for these purposes.
The DEA’s press release is available here and the notice for applications here
US – FDA allows evaluation of a cannabisbased drug/device combination
On 3 October 2019, the US Food and Drug Administration (FDA) allowed the evaluation of the CAUMZ kit as a combination drug/device product, providing clarity on the regulatory approval pathway. The kit is composed of a vaporiser (Mighty Medic vaporiser), a medicinal product, CAUMZ which is cannabinoidderived (synthetic THC and CBD) and a nonopioid alternative in Phase 3 development for the treatment of pain and inflammation.
The company’s press release is available here
2.2. WELLBEING CANNABIS
BRAZIL – Court for the first time authorises hemp cultivation and trade
On 3 December 2019, the Civil Federal Court of the Federal District authorised on an emergency basis the import and cultivation of seeds of industrial hemp under the supervision of the Ministry of Agriculture and ANVISA, the Brazilian National Sanitary Surveillance Agency, thus for the first time allowing a company to grow hemp commercially. The judge specified that only seeds of varieties with a THC concentration below 0.3% can be used. The decision can be appealed.
Related articles are available here (PT) and 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
EU – Cannabis sativa leaf extracts (re) enter the European cosmetic database
In November 2019, a modification was made to the CosIng, the European Commission database for information on cosmetic substances and ingredients, to include “Cannabis Sativa Leaf Extracts”. Such extracts are associated with emollient and skin conditioning functions and are, at the moment, not subject to any restriction associated with other Cannabis Sativa extracts already included in the database.
The CosIng entry 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 – General Court of the European Union rejects cannabis trademark as contrary to public policy
On 12 December 2019, the General Court of the European Union dismissed an action seeking annulment of the decision of the European Union Intellectual Property Office (EUIPO) and confirmed that a sign referring to cannabis may not, as the law currently stands, be registered as an EU trademark. EUIPO and the Court concluded this sign was contrary to public policy.
The General Court’s decision is available here and our A&O Life Sciences Hub post here
EU – First CJEU case regarding hempderived consumer products proceeds to oral hearing
On 23 October 2019, exactly one year after the Court of Appeals of AixenProvence referred a preliminary question to the Court of Justice of the European Union (CJEU) in the Kanavape case, the interested parties presented their oral arguments to the CJEU. The pending question is whether French regulations restricting the marketing of hemp based products are compliant with EU law. Apart from France, all parties present (including the European Commission) agreed that French regulations restrict the free movement of hempderived products in the EU and that the “cautionary principle” should not apply as there is little scientific uncertainty about the effects of CBD on human health. The Advocate General will deliver his opinion in the case on 31 March 2020. The Court’s judgment is expected a couple of months thereafter.
The reference to the case is available here and a related article here (FR)
FRANCE – French public prosecutor for the first time does not appeal CBD retailer’s acquittal
On 6 September 2019, the first instance criminal court of Bordeaux acquitted the managers of a tobacco kiosk that had been prosecuted for the sale of (nonpsychotropic) CBDbased products, and specifically ruled that the French regulations (in essence prohibiting all CBDbased products if these are not derived from hemp fibre/seeds) do not comply with EU law. This case is remarkable as it is the first time that the prosecutor chose not to appeal an acquittal decision from a lower court, and the ruling is therefore definitive.
A related article is available here (FR)
FINLAND – Food Agency requires CBDbased food products to be withdrawn from the market
On 10 December 2019, the Finnish Food Agency (Ruokavirasto) published an update on CBD products stating that such products are marketed without a novel food application and therefore have to be withdrawn from the market as CBD is considered as a non approved novel food.
The Finnish Food Agency publication is available here (FI) and a related article here
GERMANY – German government and courts confirm novel food status of CBD based food products confirm sale bans imposed by district administrations
On 25 July 2019, the Federal Government replied to written questions of the Opposition Party on the novel food (NF) status of CBDbased products and confirmed that “cannabinoids” had recently been included in the NF Catalogue as cannabinoid–containing products are increasingly appearing on the market. The Government stated then that the European Commission made it clear that such products are novel foods within the meaning of the NF regulation and require authorisation
The questions are available here (DE) and a related article here
Several German district administrations have imposed sales bans on CBDcontaining foods and dietary supplements, which have recently been confirmed in summary proceedings by certain administrative courts. The decisions have been issued by the Administrative Courts of Düsseldorf, Hannover and Gießen in September, November and December 2019. To our knowledge, Germany is therefore one of the first EU member states to actively enforce the novel food provisions for CBDbased food products.
The Court decisions are available here, here and here (DE) and our A&O Life Sciences Hub post here
INTERNATIONAL – World AntiDoping Agency excludes CBD from list of prohibited substances
On 30 September 2019, the World AntiDoping Agency (WADA) published its 2020 List of Prohibited Substances and Methods that will come into force on 1 January 2020. This list designates what substances and methods are prohibited both in and outofcompetition and which substances are banned in particular sports, including all cannabinoids except for cannabidiol.
The WADA press release is available here, the list here and the summary of explanatory notes here
ITALY – Legislative proposal aims to regulate sale and extraction of hemp biomass
On 24 September 2019, a political party submitted a resolution to the Agriculture Commission of the Deputy Chamber to regulate the sale of biomass of hemp (raw material composed of vegetative aerial parts) for extractive purposes for companies that meet the necessary legal requirements, and for all other uses permitted by applicable law. The resolution also invites the Italian Government to adopt a decree to set limits for THC in foodstuffs, to include hemp in the list of officinal plants and to incentive the experimentation of new hemp varieties.
The resolution is available here (IT)
ITALY – Remaining uncertainty on sale of cannabis “light”
On 13 December 2019, the Italian Parliament adopted an amendment to the 2020 draft budget legalising the production and sale of cannabis “light”, i.e. with a THC content below 0.5%. However, the provision that was aiming at ending months of uncertainty for farmers and the industry was removed by the Italian Senate on 16 December as it was deemed “inadmissible” due to “extraneousness of matter”.
A related article is available here
LUXEMBOURG – Government clarifies legal status of smokable hempderived products
On 22 November 2019, following its neighbouring country Belgium, the Customs and Excise Administration clarified the custom status of hempderived products intended to be smoked or vaporised or which may be used for that purpose (hemp flower or other plant parts, resin or hemp cigarette). The note covers the classification, import, authorisation, declaration obligation, tax signs and excise/VAT duties for such hempderived products.
The administration’s note is available here (FR)
SLOVAKIA – Slovak Parliament rejects draft law which would soften regulation of CBD
In November 2019, the Slovak Parliament rejected the government’s proposal to remove cannabidiol (CBD) from the list of psychotropic substances and to render CBD a non regulated substance. Hence, CBD will – erroneously – remain classified in Act No. 139/1998 Coll. (the Narcotics Act), i.e., in the same category as THC, amphetamine, cocaine and morphine.
The proposal is available here (SK) and our A&O Life Sciences Hub post here
THAILAND – Government removes low THC cannabis extracts from narcotic schedule
On 2 September 2019, the Thai Government removed cannabis and hemp extracts (with a content of less than 0.2% THC) from its narcotics schedule. According to the Thai Food and Drug Administration (FDA), the descheduling intends to allow such extracts to be used in medicine, cosmetics and food and support hemp as a cash crop.
A related article is available here
UK – Centre for Medicinal Cannabis launches Quality Charter to ensure CBD industry compliance
On 20 August 2019, the Centre for Medicinal Cannabis (CMC) announced the release of a new Cannabinoid Industry Quality Charter to help foster a legally compliant, socially responsible and innovative CBD industry in the UK. The Charter was launched for consultation and in order to collect sufficient signatories before undertaking further steps.
The Charter’s detailed overview is available here
UK – National Pharmacy Association demands clearer CBD regulations
In December 2019, the head of the advice and support service of the National Pharmacy Association expressed the need for clear and authoritative guidance that would make it easier for manufacturers, health care professionals, retailers and consumers to make informed choices, keeping everyone on the right side of the law. The newly created Association for the Cannabinoid Industry (ACI) welcomed this statement. A related article is available here
UN – Commission on Narcotic Drugs (CND) publishes Q&A related to WHO’s recommendation on cannabis and related substances
On 10 October 2019, the UN CND published Questions and Answers (Q&A) in relation to the WHO recommendations on cannabis and related substances. The Q&A, which includes questions from member states and organisations as well as WHO answers, was part of the procedure for the rescheduling of cannabis and related substances.
The Q&A is available here
US – USPTO issues first patent for a hemp cultivar
On 2 July 2019, the US Patent and Trademark Office granted the first plant patent concerning a hemp cultivar, the variety “CW2A”. The company CWB Holding, which filed the application in May 2018, had developed a high CBDcontent hemp cultivar while maintaining a low (less than 0.3%) THCcontent.
The patent is available here and a related article here
US – Department of Agriculture releases a draft version of the domestic hemp production programme
On 28 October 2019, the US Department of Agriculture (USDA) released a draft interim final rule with a request for comments. The draft introduces a new part specifying the rules and regulations to produce hemp and a programme which includes provisions for maintaining information on the land where hemp is produced, testing THC levels, disposing of plants not meeting necessary requirements, licensing requirements, etc.
The USDA’s draft is available here
US – FDA publishes a revised Consumer Update on CBD products
On 25 November 2019, the US Food and Drug Administration (FDA) published a revised version of the Consumer Update on products containing cannabis or cannabisderived compounds, including CBD. The FDA states that only limited data about CBD safety are available and these data point to real risks that need to be considered before taking CBD for any reason.
The FDA’s consumer update is available here
US – FDA and FTC publically warn companies marketing unapproved CBD products with unsubstantiated health claims
On 22 October 2019, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) posted a joint warning letter warning a company marketing unapproved CBD products with unsubstantiated health claims. These actions aim at sending a message to the broader market about complying with FDA requirements.
The FDA release is available here and the joint letter here
2.3. RECREATIONAL CANNABIS
AUSTRALIA – First Australian province (ACT) allows recreational cannabis
On 25 September 2019, the legislative assembly for the Australian Capital Territory (ACT) voted the “Drugs of Dependence (Personal Cannabis Use) Amendment Act 2019” allowing possessing and growing cannabis for personal use to a maximum of 50g provided that the person is 18 years old or older. The ACT amendment is available here and the EMCDDA update here
CANADA – Public consumption of federally authorised recreational cannabis (e.g. in edibles, vaping products) being banned in some Canadian provinces
On 4 October 2019, Manitoba’s prime minister announced that the consumption of edibles will not be allowed in public despite the fact that cannabisbased edibles were federally set to be legally sold this December. This announcement echoes a previous declaration from Quebec authorities which planned to ban any edibles that are “attractive to minors”.
Related articles are available here and here
On 1 November 2019, the Act to tighten the control of cannabis, amending the Cannabis Regulation Act, was adopted. This law introduces the prohibition of smoking or vaporising cannabis in any public place (inside or outside). As of 1 January 2020, the minimum legal age for possessing and purchasing cannabis and access to the premises of the Société québécoise du cannabis will also be raised to the age of 21 years.
The government update is available here
On 20 November 2019, the Quebec Cannabis Company (Société Québécoise du cannabis – SQDC) declared that it will not sell vaping products following the opinion of the National Director of Public Health which stated that “by virtue of its mission of sale of cannabis in a perspective of protection of health”, it should not sell any liquid of vaping cannabis until further order.
A related article is available here
FRANCE – Parliamentary factfinding mission on cannabis use in all its dimensions ongoing
On 11 July 2019, four commission chairs of the French National Assembly announced the creation of a factfinding mission on cannabis. The parliamentary mission will focus on the cannabis plant in all its dimensions, i.e., for medical, wellbeing but also recreational use. The specific goal of this longterm parliamentary mission is to provide all stakeholders with the opportunity and time to examine the different dimensions and issues related to the use of the cannabis plant in order to support further public debate and possible future legislation. At the end of the mission, a parliamentary report will be published and, if appropriate, serve as a basis for a draft bill or specific recommendations.
A related article is available here (FR) and our A&O Life Sciences Hub post here
On 20 December 2019, the French National Assembly announced the composition and first meeting agenda (14 January 2020) of the factfinding mission. The mission will be composed of 30 parliamentarians from the majority and various opposition groups.
The mission’s detail page is available here (FR)
GERMANY – Federal Drug Commissioner calls for uniform federal decriminalisation standard
On 17 December 2019, the Federal Drug Commissioner called for a nationwide standard for the amount of cannabis allowed for personal possession. Cannabis is currently illegal in Germany, but each state has different regulations on how much is allowed for personal possession. Possession of “a small amount” of the drug is generally not prosecuted, but until now, the interpretation of “small amount” varies at regional level from 5g to 15g of cannabis.
A related article is available here
GERMANY – Federal Drug Commissioner calls for uniform federal decriminalisation standard
On 19 December 2019, the Italian Supreme Court ruled that home cannabis growing for personal use is not a crime according to Presidential Decree No. 309/1990 (the Consolidated Text of Narcotics). The Court specified that “small amounts grown domestically for the exclusive use of the grower” are not subject to the application of criminal sanctions without providing details on the limit of “smallscale” cultivation.
A related article is available here
MEXICO – Mexico initiates cannabis legalisation reform following 2018 Supreme Court judgment
In October 2019, the United Commissions of Justice, Health and Legislative Studies initiated specific actions aimed at proper regulation of cannabis use. The Commissions agreed on the need to move from prohibitionist regulations towards a regulation with a focus on human rights, public health, sustainable development and peace and security.
The webpage of the initiative is available here (ES)
Meanwhile, the Mexican Government released a bill for cannabis legalisation which was presented to the Commissions. The bill aims at improving the living conditions of Mexican residents, combat the consequences of problematic cannabis use and reduce drug related crime while promoting peace, security and the wellbeing of individuals.
The bill is available here (ES) and a related article here
On 29 October 2019, just before the oneyear anniversary of the Supreme Court ruling that deemed the prohibition of personal use or cultivation of cannabis unconstitutional, Mexican lawmakers submitted a request for extension of the Supreme Court deadline (set on 31 October). The Court approved the request and extended the deadline to 30 April 2020. Mexican legislators are thus granted some additional time to consider and debate the aforementioned legalisation bill.
The Court approval is available here (ES) and a related article here
NEW ZEALAND – Government releases cannabis legalisation policy positions
On 3 December 2019, the government released its cannabis policy positions for the legalisation of recreational cannabis. The policy sets regulatory conditions for purchase and use such as minimum age, limits the consumption to private homes and also sets up parameters whereby small amounts of cannabis may be legally shared socially with those over the legal purchase age.
The summary of current policy positions is available here
THE NETHERLANDS – Government opens consultation on regulation of cannabis experiment
On 1 October 2019, the Dutch government submitted for consultation the ministerial regulation of its “closed coffee shop chain” experiment. The regulation sets the requirements for the quality of hemp/cannabis and determines the packaging requirements. The consultation ended on 12 November 2019.
The government’s press release is available here (NL) and the timeline of the experiment here
UN – INCB warns Australia that cannabis legalisation contravenes international legal obligations
On 3 October 2019, the United Nations International Narcotics Control Board (INCB) sent a letter to the Australian Government recalling that the legalisation and regulation of cannabis for nonmedical use, including small quantities, would be inconsistent with the provisions of the 1961 Convention and therefore with Australia’s international legal obligations thereunder.
The INCB’s letter is available here
UK – Amendment to the Misuse of Drugs Act reduces the range of controlled synthetic cannabinoids
On 8 October 2019, the UK Parliament approved an amendment to the Misuse of Drugs Act 1971 which reduces the scope of the generic definition for a range of synthetic cannabinoids controlled as Class B and continues to exclude compounds otherwise controlled and compounds with legitimate medical use.
The amendment is available here and the explanatory memorandum here
URUGUAY – Cannabis institute grants production and distribution licences for recreational cannabis to new companies
On 28 October 2019, the Institute for the Regulation and Control of Cannabis (IRCCA – Instituto de Regulacion y Control del Cannabis) granted production and distribution licences to three new companies. The three companies will be able to produce and distribute up to two tons of dried flowers per year for an initial period of five years.
The Institute’s press release is available here (ES)
US – Supreme Court declines to hear a case on cannabis companies’ tax deductions
On 7 October 2019, the US Supreme Court declined to hear a case by a cannabis business company arguing that state laws allowing cannabis sale should not be overridden by a federal law prohibiting business tax deductions for the sale of illegal substances. The petitioners were held liable for unpaid taxes.
A related article is available here
US – SAFE Banking Act passes the vote of the US House of Representatives
On 25 September 2019, the US House of Representatives voted to advance legislation that would allow banks to provide services to cannabis companies in states where it is legal. The bill will now head to the Senate. However, the SAFE Banking Act faces opposition from the Senate Banking Committee Chairman.
The bill is available here and related articles here and here
US – Government submits a bill to the Senate for cannabis decriminalisation
On 20 November 2019, the Bill submitted on 23 July 2019 by Democratic White House hopeful Kamala Harris passed the House Judiciary Committee and will now head to the full House. The bill would decriminalise cannabis at federal level and deschedule cannabis, provide for reinvestment in certain persons adversely impacted by the War on Drugs and provide for the expungement of certain cannabis offences.
The bill is available here and a related article here
3. INDUSTRY AND MARKET NEWS
BUSINESS NEWS
Analysis: Germany’s medical cannabis market loses momentum but on pace to surpass 100 million euros – 18/12/2019 – Marijuana Business Daily: Insurance reimbursements for medical cannabis in Germany reached a new high during the July September period, according to recently published data by the German National Association of Statutory Health Insurance Funds (GKVSpitzenverband).
Italy to nearly triple domestic medical cannabis production in 2020 – 17/12/2019 – Marijuana Business Daily: The Italian Ministry of Health plans to almost triple the quantity of medical marijuana to be produced domestically in the coming year.
Canada sold $908 million of legal cannabis in one year – 16/12/2019 – GreenCamp: Statistics Canada is reporting nearly $1 billion in nonmedical cannabis sales across the country in the first year of legalization in its latest report.
Europe: the cannabis industry’s Eldorado – 28/11/2019 – Pharmacy Business: After North America, the cannabis industry dreams of conquering the European market — Britain in particular — and is banking on changing the image of the psychoactive plant, despite regulatory constraints and ethical debates…
Germany reveals wholesale medical cannabis price at 2.3 euros per gram, signaling no windfall for suppliers – 22/11/2019 – Marijuana Business Daily: The German federal government will buy at least 650 kilograms (1,433 pounds) of medical cannabis flower from domestic producers for approximately 1.5 million euros ($1.66 million) per quarter, which sets the average wholesale price at 2.3 euros per gram…
England’s health insurance has covered only 18 ‘unlicensed’ cannabis prescriptions – 19/11/2019 – Marijuana Business Daily: Since a new law took effect a year ago, England’s National Health Service (NHS) has reimbursed patients on only 18 occasions for “unlicensed” cannabisbased products that have not undergone clinical trials, according to government data…
Medical Marijuana Market to Register Favorable Growth by 2026 – 14/11/2019 – Pharmiweb: Marijuana refers to the dried leaves, flowers, stems, and seeds from the hemp plant Cannabis sativa. There are 2 main active chemicals in Marijuana cannabidiol (CBD) and tetrahydocannabinol (THC), which impact the brain and relieve the pain, respectively…
Analysis: German sales of insured medical cannabis soar in second quarter – 09/10/2019 – Marijuana Business Daily: Sales of medical cannabis covered by insurance continue to increase in Germany, reaching new highs in the second quarter, according to newly released data…
Hundreds of patients turn to private cannabis clinics in UK – 16/08/2019 – Pharmafile: While medicinal cannabis was made legal in Britain in November 2018, few patients have been able to access the drug on the NHS. Patients are thus turning to private clinics, and paying as much as £800 a month, to get legal medicinal cannabis…
Approval of public health insurance could boost medical cannabis sales in Czech Republic – 16/08/2019 – Marijuana Business Daily: The Czech Republic has one of the oldest medical cannabis programmes in Europe and was the second country on the continent to authorise a domestic grow – after the Netherlands – yet, after several years, the market has been unable to gain traction…
Brazil’s Medical Marijuana Market Projected to Reach US$ 1.1 Billion per Year – 30/09/2019 – Folha de S. Paulo: Entrepreneurs continue to invest in Brazil’s medical marijuana market, despite a lack of support from Brazil’s government. There is no legislation in favour of legalising medical marijuana in Brazil…
FINANCIAL MARKETS
High demand prompts launch of Europe’s first cannabis ETF – 06/01/2020 – Financial Time: European savers will soon be offered their first opportunity to invest in an exchange traded fund focused on the fastgrowing legal marijuana industry
Pot Stocks End 2019 on a Dismal Note as ETF Falls to Record Low – 30/12/2019 – Bloomberg: A gloomy year for pot stocks is ending on a dismal note, with the industry’s first exchangetraded fund falling to a record low on Monday.
CIBC: ‘Indiscriminate’ cannabis selloff should start to shift in 2020 – 11/12/2019 – Marijuana Business Daily: The cannabis stock meltdown that erased $49 billion in enterprise value this year should begin to shift in 2020 as the industry leaders separate themselves, one of Canada’s largest investment banks forecasts…
Hemp Industry Is Cleared to Do Business With Banks – 03/12/2019 – The New York Times: United States regulators say hemp businesses should not be treated with any more suspicion than other bank customers. The number of banks in the United States willing to lend to hemp producers can be counted on one hand. That is about to change…
Wave of European Cannabis firms to list in 2020, analyst says – 28/11/2019 – Reuters: Up to five companies active in the cannabis industry could go public in 2020 in Europe, a continent whose stock markets have largely missed out on the NorthAmerican “pot stocks” frenzy, a leading industry analyst said on Thursday…
The cannabis conundrum risks causing investors to be accused of money laundering – 27/11/2019 – CITY A.M.: The overseas legalised cannabis industry is growing fast — estimates suggest that the US cannabis industry will be worth over $75bn by 2030. Investment firms in the UK are keen to take full advantage of this growing market, but have found unexpected hurdles in their way…
‘It’s confounding’: Former Nova Scotia premier wants Ottawa to fix cannabis banking problems – 11/10/2019 – Marijuana Business Daily: Former Nova Scotia Premier Darrell Dexter is calling on the federal government to address banking issues stymieing legal marijuana businesses across Canada…
SEC green light prompts rush into marijuana ETFs – 07/10/2019 – Financial Times: Marijuana ETFs are rushing to list on US exchanges after getting a green light from the Securities and Exchange Commission…
REGULATORY AND ENFORCEMENT NEWS
Federal Marijuana Prosecutions Keep Declining In Era Of Legalization, Chief Justice Reports – 31/12/2019 – Marijuana Moment: While federal prosecutions of drug related crimes increased in 2019, cases involving marijuana dropped by more than a quarter, according to an endofyear report released by Supreme Court Chief Justice John Roberts on Tuesday...
Tilray® Receives Additional GMP Certification at EU Campus Allowing for International Export of Finished Medical Cannabis Products – 11/12/2019 – Yahoo Finance: Licensing expands company’s international export capacity with the authorized manufacture of medical cannabis flower and oil products to be exported from Portugal as finished product to Germany and other European and international markets...
Zenabis facility failed inspection for EU quality certification last year – 05/12/2019 – BNN Bloomberg: A facility operated by Vancouverbased Zenabis Global Inc. failed an inspection to receive a key European Union certification last year, hindering the cannabis producer’s ability to ship medical cannabis to the continent…
Crackdown looms for cannabis snacks – 01/12/2019 – The Times: The Food Standards Agency is alarmed by the boom in drinks and sweets containing CBD, many of which breach regulations…
FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns – 2511/2019 – FDA: Today, the U.S. Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act)…
Italy cancels one of Aurora’s three cannabis supply lots– 01/11/2019 – Marijuana Business Daily: One of the three lots Canada’s Aurora Cannabis won in July to supply the Italian market has been cancelled, Italy’s minister of health explained in a parliamentary inquiry this week, citing noncompliance with European Union Good Manufacturing Practice (GMP) standards…
OSC alleges three executives committed fraud in Canadian Cannabis case – 16/09/2019 – The Globe and Mail: The Ontario Securities Commission alleges that three men, including the former CEO of publicly traded cannabis seller Wayland Group Corp., committed fraud at a separate pot company. In the regulator’s first fraud case in the cannabis industry…
CannTrust’s cannabis licenses suspended by Health Canada – 17/09/2019 – Marijuana Business Daily: Citing noncompliance with Canada’s federal cannabis law and regulations, embattled producer CannTrust says it has received a Notice of License Suspension from Health Canada…
Health Canada suspends British Columbia cannabis producer Evergreen’s licenses – 16/09/2019 – Marijuana Business Daily: Another cannabis company has been penalised by Health Canada for alleged regulatory violations. British Columbiabased Evergreen Medicinal Supply was sanctioned 9 August over noncompliance with federal law and regulations, according to Health Canada, which did not list the licences as “suspended” on its website…
U.S. tells cannabis companies not to advertise disease treatments without science – 09/09/2019 – Reuters: The top U.S. consumer and trade regulator said on Tuesday it had warned three companies selling products infused with cannabidiol that it was illegal to advertise that such products could fight disease without providing credible scientific evidence…
Linneo Health, the first Spanish manufacturing company for medical Cannabis under GMP accreditation – 02/09/2019 – Linneo Health: It is a milestone of extraordinary relevance in the medicinal cannabis industry, because the GMP (Good Manufacturing Practice) is the quality standard of the pharmaceutical industry…
In case you have any queries on our Cannabis Practive or this newsletter, please contact [email protected].
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Eveline Van Keymeulen
Cannabis Sector Lead Head of the Life Sciences Regulatory Practice
Tel +33 1 40 06 54 00 [email protected]
Link to web bio here → A&O Cannabis A&O Life Sciences A&O Life Sciences Practice Practice Hub
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