Cannabis practice 2019 - Allen & Overy
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2 Cannabis practice | 2019 Cannabis markets According to UN estimates, the global cannabis market is currently worth approximately USD150 billion annually. At present, much of this market is illegal, but what is most interesting is the rate at which new products are being developed for the growing sections of the medicinal and recreational market that are legal (or anticipated to be authorised in the near future). Many companies, from industries as diverse as beverages, food, pharmaceuticals, cosmetics and tobacco, are actively investing in this market which, in recent research, Barclays suggests could almost double to USD272bn by 2028. For example, we recently advised. We advised Imperial Brands Ventures Ltd, a subsidiary of Imperial Brands PLC on its equity stake in Oxford Cannabinoid Technologies (OCT). OCT is a biopharmaceutical company focused on researching, developing, and licensing cannabinoid-based compounds and therapies. Its activities are licensed for operation by the UK Home Office. Imperial is just one of the companies making a mark in the sector by taking stakes in innovative companies. A number of joint venture and collaborations are also happening – for example Novartis’ strategic alliance between its subsidiary Sandoz and Tilray, a Canadian company developing cannabis-based medications. Allen & Overy LLP’s ‘top tier’ multidisciplinary team is ‘responsive, extremely knowledgeable about the healthcare industry, the client’s needs and the relevant technolog y’ Legal 500 EMEA, Health and Life Sciences 2017 Strong European offering with noted expertise in IP and patent litigation matters. Well regarded for its impressive client portfolio, which spans the pharmaceutical, biotechechnolog y, medtech, diagnostics and healthcare industries. Chambers Global guide 2018 Global-wide: Life Sciences Allen & Overy LLP covers the full spectrum of advice on governance, regulatory compliance and risk management issues Legal 500 UK 2019 Corporate Governance © Allen & Overy LLP 2019
3 Why the shift? The main reason for greater activity in this market is the softening regulatory environment worldwide. Cannabis is now authorised for medicinal use in more than 25 countries, including Canada, Israel, Germany and the UK. Cannabis is proven to be effective in a number of areas of unmet clinical need including the treatment of chronic pain – a market currently experiencing significant challenges as governments, lawmakers and healthcare practitioners respond to the epidemic of abuse and addiction associated with opioids. Another significant treatment area is anxiety, depression and sleep disorders. Cannabis-based products have also been used to treat the nausea and vomiting associated with chemotherapy and a wide range of conditions associated with inflammation (eg eczema). One of the most high profile areas is the treatment of epilepsy (indeed in June 2018, the FDA approved GW Pharma’s Epidiolex – the first approved drug to contain CBD and one of a category of antiepileptic drugs targeting early onset of the condition). On 17 October 2018, Canada also became the first G7 country to legalise cannabis for recreational use. Interestingly, few traditional players seem interested in exploring commercial production of “joints” or cannabis cigarettes. The most active part of the market so far is for edibles such as ice-cream, sweets, and cookies. There is also growing interest in the potential for products which are infused with cannabis including beverages and beauty and skin-care. Vaporisers are another active segment of the market. Advises on many of the most significant transactions of the day. Draws on its international footprint to handle work in multiple jurisdictions including the emerging markets. Chambers UK Guide 2019: UK: Life Sciences Heavyweight corporate and M&A practice that boasts an exceptional coverage across Europe. Chambers Europe-Wide 2018 Corporate/ M&A Department allenovery.com
4 Cannabis practice | 2019 Why does this matter? As the cannabis market opens up, it signals both opportunity and disruption for our clients – for example, if the recreational marijuana market liberalises, will this impact the size of the alcoholic beverage market? However, one of the key risks for new market entrants is the changing regulatory landscape. Our regulatory team is developing particular expertise in understanding the nuances of regulation in different markets and helping our clients to assess how their products may be affected. Our team is actively monitoring the changing status of regulations of cannabinoid-containing products around the globe and thinking about the impacts this will have on our clients’ businesses. Our experience includes advising key industry players, on: – national regulations related to hemp-based ingredients (such as cannabidiol/CBD), when included in regulated products such as food supplements, cosmetics, vaping and medicinal products; – agreements for the supply and licencing of cannabis for medical use; – sale of cannabis-based products on e-commerce platforms; – legal opinions to support investment strategy; – working with industry bodies and liaising with regulators to shape the definition of the law; and – securities and reporting requirements for companies involves in the manufacture, distribution or sale of cannabis-based products. Alongside our regulatory and compliance lawyers, we have built a multidisciplinary group focused on the cannabis market and offering expertise in key areas including investment, M&A and commercial alliances; intellectual property (brands, patents and trade secrets); distribution and licencing; marketing and advertising; and employment, among other areas. We can offer strategic and practical legal advice from practitioners who understand the specific sector and the particular challenges it may bring (including reputational issues). Tier 1: Pharmaceuticals and biotechnolog y Tier 1: Commercial litigation Legal 500 UK 2019 Legal 500 UK 2019 Allen & Overy LLP is ‘top of the game’ Legal 500 EMEA Healthcare and Life Sciences They are excellent; it was a proper partnership. Chambers Global, Life Sciences 2017 Top multidisciplinary firm recognised for its expertise in life sciences. Chambers Europe, Life Sciences 2016 © Allen & Overy LLP 2019
5 Case study: Acquisition of HemPoland by The Green Organic Dutchman Allen & Overy advised Green Organic Dutchman Holdings Slovenia, Lithuania, and Estonia, and e-commerce Ltd., a Canadian cannabis research & development company, platform and product sales in over 700 locations. In 2017, (TGOD) on its USD 15.5 million acquisition of 100% of the company produced over 32,000 kgs of organic dried shares in HemPoland sp. z o.o., (HemPoland), a leading flower and 310 kgs of organic CBD oils. European manufacturer and marketer of premium organic Our involvement in the transaction included the due CBD oils. The acquisition provides access to HemPoland’s diligence of the target, negotiations of the transaction vast distribution network, premium Cannabigold brand, documentation and the assessment of the regulatory regime state-of-the-art hemp oil extraction technologies, and in the EU and more than 13 EU jurisdictions governing provides a strategic pathway into the European market the production and sale of HemPoland’s products for TGOD’s medical & recreational products and (ie CBD-derived products) in the EU. The transaction licensing deals. was required to be cleared before the Toronto Stock Founded in 2014, HemPoland was the first company in Exchange and the process included TGOD to Poland to obtain a state licence allowing the company providing: (i) an overview of the regulatory framework; to grow hemp and manufacture CBD oil products. and (ii) opinions confirming the legality of marketing and HemPoland’s management is comprised of experts in distributing HemPoland’s products for each jurisdiction to cultivation, oil extraction, and marketing of high-quality which HemPoland exports its products. We also advised organic CBD oil. The company is vertically integrated, TGOD on the EU regulatory framework relating to sales with over 1,250 acres of cultivation leveraging third parties, of CBD products across the EU, and our opinion was multiple commercial scale extraction units, local distributors instrumental in having the deal cleared. Projects of this in Poland, Austria, Netherlands, Germany, United Kingdom, nature demonstrate the unique strength and capabilities of Italy, Switzerland, Portugal, Ireland, Czech Republic, our network; and the depth of our knowledge of this area. Definitions – Cannabis: a broad term used to describe organic products (eg cannabinoids, marijuana, hemp) derived from the Cannabis genus of plants. – Cannabinoids: a class of diverse chemical compounds that act on cannabinoid receptors in cells that alter neurotransmitter release in the brain, spinal cord and peripheral nerves. Cannabinoids can be naturally derived from the cannabis plant, or manufactured. Non–psychoactive examples include cannabinol and cannabidiols. Source: Report reviewing the current evidence on of the medicinal benefits of cannabis–based products by the Chief Medical Advisor to the UK Government, June 2018 allenovery.com
6 Cannabis practice | 2019 Other Relevant Expertise Licensing of cannabis for Patient access to CBD Review of regulatory medical use based medicines status CBD in EU We have assisted several pharmaceutical We have provided general advice on issues We have reviewed the regulatory status of companies with the drafting and negotiating related to patient access to cannabis based CBD in food, cosmetics and medicinal of supply and licence agreements for the medicines, and the interpretation of ECHR products in the EU and several EU MS. supply and licencing of cannabis for case law in this respect. medical use. Seizure of hemp products Advertising related to cannabis Regulatory cannabis monitoring (> 0.2% THC) We have provided a legal risk assessment We have assisted a client with respect to the We perform a regulatory monitoring on cannabis related advertising and claims seizure of hemp tea (containing more than of evolutions with respect to the (eg use of the slogan “keep calm and” 0.2% THC) by the customs authorities, and regulations regarding cannabis based together with a cannabis leaf) as well as the related potential classification of hemp as products in Europe, the U.S., and Canada, sponsorship restrictions under EU member narcotic under EU and local legislation and for different clients. state law. case law Sale and cultivation of hemp seeds Legal highs monitoring We have advised on the legality of the sale We perform a regulatory monitoring of of cannabis/hemp seeds for (i) food/feed evolutions with respect to “legal highs” purposes and (ii) cultivation purposes; as well for some of our clients. as the actual cultivation of those seeds in several EU jurisdictions. Global reach and cross-border approach We are one of the few firms able to put at our clients disposal a truly global and “one firm” cohesive network now spanning 44 offices in 31 countries from Europe, Asia Pacific, the Middle East and Africa to the Americas, as well as selecting a network of leading regulatory specialists in places where we do not currently have a physical presence or the specific expertise which our clients require. This unified approach enables us to offer a “one-stop-shop” mechanism, where our clients have one main point of contact able to coordinate regulatory advice across multiple jurisdictions. Our firm is regularly acknowledged as market leader for life sciences (eg in Chambers & Partners and Legal 500). 550 2,800 5,500 44 31 Partners Lawyers People Offices Countries © Allen & Overy LLP 2019
7 A&O Life Sciences Hub A blog where experts from Allen & Overy analyse the latest EU and national legal and regulatory developments in the life sciences sector. For relevant news, visit us here. Cannabis Legal & Regulatory Update Our monthly selection of handpicked news and legal developments. For relevant news, visit us here. Subscribe here to our dedicated Cannabis newsletter. KEY CONTACTS Cannabis Sector Lead M&A & Investments IP (Patents) IP (Brands) Eveline Van Keymeulen Jeremy Parr Marc Doring David Stone Head of the Life Sciences Partner – Corporate Partner – IP Partner – Litigation/IP Regulatory Practice Tel +44 20 3088 3383 Tel +44 20 3088 4197 Tel +44 20 3088 2920 Tel +33 1 40 065 566 jeremy.parr@allenovery.com marc.doring@allenovery.com david.stone@allenovery.com eveline.vankeymeulen@allenovery.com Commercial Disputes & Investigations Trade & Regulatory Jim Ford Hippolyte Marquetty Matthew Townsend Isabella Kelly Partner – Corporate Partner – Litigation/Corporate Partner – Corporate Associate (adnitted in Victoria-Australia) Tel +44 20 3088 4797 Tel +33 1 40 06 53 98 Tel +44 20 3088 3174 – Corporate jim.ford@allenovery.com hippolyte.marquetty@allenovery.com matthew.townsend@allenovery.com Tel +44 20 3088 1717 isabella.kelly@allenovery.com allenovery.com
GLOBAL PRESENCE Allen & Overy is an international legal practice with approximately 5,500 people, including some 550 partners, working in 44 offices worldwide. Allen & Overy LLP or an affiliated undertaking has an office in each of: Abu Dhabi Bucharest (associated office) Ho Chi Minh City Moscow Seoul Amsterdam Budapest Hong Kong Munich Shanghai Antwerp Casablanca Istanbul New York Singapore Bangkok Doha Jakarta (associated office) Paris Sydney Barcelona Dubai Johannesburg Perth Tokyo Beijing Düsseldorf London Prague Warsaw Belfast Frankfurt Luxembourg Riyadh (cooperation office) Washington, D.C. Bratislava Hamburg Madrid Rome Yangon Brussels Hanoi Milan São Paulo Allen & Overy means Allen & Overy LLP and/or its affiliated undertakings. The term partner is used to refer to a member of Allen & Overy LLP or an employee or consultant with equivalent standing and qualifications or an individual with equivalent status in one of Allen & Overy LLP’s affiliated undertakings. © Allen & Overy LLP 2019 | CS1811_CDD-53099_ADD-80776 allenovery.com
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