Medical Cannabis & Cannabinoid Regulation 2021

The new Medical Cannabis & Cannabinoid Regulation 2021 guide provides the latest legal information on the industry's regulatory authorities, companies’ legal risks, cross-jurisdictional issues, legal elements affecting access to medical cannabis, the use of non-controlled cannabinoids in food, and decriminalisation or recreational regulation.

Last Updated: June 15, 2021

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Mackrell.Solicitors is an award-winning, full-service law firm, with a truly global reach. Headquartered in Central London, with offices in the heart of Birmingham, the firm has been providing high-quality legal advice and services since 1845. Mackrell.Solicitors was also one of the founders of Mackrell International, the 33-year-old global network made up of 104 firms across 60 countries, enabling it to offer the added value of immediate international legal advice and assistance in any jurisdiction worldwide. Mackrell.Solicitors set up the first designated cannabis legal team three years ago, so in terms of sector-specific knowledge it is at the cutting edge of the current regulatory regime in the UK and Europe. The firm provides regulatory advice and services for the medicinal cannabis and CBD industry, from cultivation licence applications, product and labelling reviews to advice on import/export best practice. In addition, via Mackrell International, it provides multi-jurisdictional advice for all EU countries and beyond.


The Growth of Cannabis Law

A practice area that initially attracted more flippant remarks than serious recognition now facilitates a multibillion dollar industry, providing for everything from textiles and biofuel to life-saving medicines.

Whereas certain jurisdictions always enjoyed a buoyant but limited cannabis sector – think Amsterdam’s historic recreational market, or China’s leading industrial hemp industry – it was the relaxation of medical cannabis rules across the USA and Canada that was probably to thank for the astonishing pace of legislative reform that has since swept the globe.

This, together with the helpful discovery that a little-known non-controlled cannabinoid (cannabidiol, or CBD) could be widely sold without medicines approval, allowed the plant to shake off its historic associations and be reintroduced to the public in the form of a versatile, innocuous and investable asset, albeit in an industry desperately in need of regulatory reform.

What is clear from many of our authors is that most jurisdictions’ legislative frameworks were not ready for the challenges and opportunities that the new global cannabis industry posed. Outdated conventions, uncertain and untested regulations, commercially restrictive policies, ill-informed domestic authorities and inconsistent enforcement are but a few of the barriers faced across the board.     

The Medical Cannabis & Cannabinoid Regulation 2021 guide summarises the key principles of cannabis law in six jurisdictions. In addition to several Trends and Developments articles, each jurisdiction is reviewed following the same 11-question format, allowing for easy comparisons on specific issues and concerns. It is designed to provide an easy-to-understand guide that is both specific to each jurisdiction whilst also demonstrating how certain areas of practice have reached a near-homogenous position internationally.

The Four Branches of the Industry

Another element that is clear from contributors to this guide is that the global industry is divided into four distinct sectors: medical, wellness, recreational and industrial hemp. As the industrial hemp industry has historically existed without any hindrance, owing to complicated and stringent legal rules, this guide focuses more on the medicinal framework and regulation pertaining to the legally controlled parts of the cannabis plant.

Recreational markets only currently exist in a handful of jurisdictions, including 17 US states and Canada, although it is an electoral topic for 2021 in a number of other jurisdictions, including Germany and Mexico.

Medical cannabis has been legalised much more widely (currently including most of North and South America, Canada, much of Europe, and Australia). What is clear from authors in the medical sphere is that legalisation and actual access to medical cannabis are two different things – and that cannabis education, for everyone from politicians through to doctors, is of paramount importance to achieving access for all.

On the wellness side, one theme that is evident across the jurisdictions is the inconsistency with regard to applicable THC thresholds. These inconsistencies are preventing the harmonisation and free movement of products. For instance, in the UK the level of THC permissible is 1 mg in the end product (regardless of the size of the product), in some European countries the accepted level is 0.2%, in Switzerland it is 1%, while in Germany and certain US states it is 3%. It is clear to see why producers of wellness products are wrong-footed when products are seized at customs.     

International Decisions

Developments on the international stage have meant a number of beneficial ramifications for the global industry, although these have not gone as far as hoped. In January 2019, the World Health Organization (WHO) made eight recommendations on cannabis and cannabis-related substances to the United Nations’ Commission on Narcotic Drugs (CND). These included recommendations for relaxing controls on THC, and extracts from the plant (including CBD).

On 2 December 2020, the CND held a vote that rejected most of the WHO’s recommendations, but resulted in the removal of “cannabis and cannabis resin” from Schedule IV (reserved for the most harmful narcotic substances) of the main international convention controlling the plant. This is expected to alleviate issues with access and availability of cannabis for medical and scientific purposes at national levels. However, this will not affect the CBD industry greatly, as “extracts […] of cannabis” were left in Schedule 1, allowing legal controversy around CBD extracts to continue.

Furthermore, the CND rejected a proposal on the clarification of CBD – which would have provided for an additional note to accompany the Schedules elucidating that preparations that contain predominantly CBD and less than 0.2% THC should not fall under international control. Summarily, these two decisions demonstrate that the CND recognises cannabis as having a beneficial medical application. However, as far as recreational and wellness use is concerned, there remains reluctance to relinquish full control.

At a continental level, the EU is progressing towards a more harmonised set of laws to establish consistency in the industry, and this was demonstrated in the recent Kanavape case (the Court of Justice of the European Union (CJEU) case number C-663/18), where the CJEU clarified that, subject to narrow exemptions, the principles of EU law supersede those at member state/national level, regardless of the product or interest in question.

The CJEU went one step further in its decision by announcing that, based on the available safety and scientific evidence, CBD cannot be classified as a narcotic, especially in light of the recent UN decision – in particular noting that controlling a substance with no apparent psychotropic effect, nor any harmful effect on human health, goes against the spirit of the Convention, which was drafted for protection against harmful and damaging drugs.

As a result, the European Commission has publicly announced that CBD should not be treated or regulated as a narcotic.

International Impacts

COVID-19

The COVID-19 pandemic has disrupted businesses in ways that were unthinkable at the beginning of 2020. Global lockdowns put the brakes on everyday business life, affecting even the most profitable sectors and plunging even the strongest economies around the world into deep debt and recession, the likes of which have not been seen since the last world war. 

However, there were many notable developments during the height of the pandemic which can only be seen as positives. As discussed in this guide, cannabis-based medicines (CBMs) are not always freely available as a prescribed medicine, yet CBMs are becoming an acceptable method of treatment. Plainly, a lot more can be done in this area – as demonstrated by initiatives such as Carly Barton’s Cancard, designed to protect medical cannabis users from prosecution (as described in more detail below). There is a subtle but discernible shift in attitudes – for instance, during the pandemic the UK government lifted strict import barriers, allowing UK companies which supply CBMs to hold more stock. 

In the CBD wellness sector, we saw established companies able to push on and continue productivity, and there was a considerable increase in online sales for products such as oils, tinctures and cosmetics. It appears that during the pandemic those businesses which marketed successfully online, or whose brands were sufficiently recognisable, flourished as these products become an essential item for those stockpiling for quarantine at home, some of these products being perceived to help alleviate anxiety and sleep disturbances caused by the intense lockdown periods that people have had to endure.

Brexit

Brexit disruption saw goods between the UK and EU plummet by 23% in the first quarter of 2021. This was effectively caused by the additional import/export checks and paperwork that was now required, when before there was free movement. For the medicinal cannabis sector, Brexit caused another dilemma: during the Christmas week of 2020, the UK Department of Health announced that medicinal cannabis prescriptions issued in the UK would no longer be lawfully dispensed in EU member states, due to the end of the Brexit transition period. Delivered to the prescribing doctors of over 40 medicinal cannabis patients, the news came as a bombshell to the families affected, who were effectively given just two weeks’ notice before losing access to the life-saving medicine, Bedrocan, from the Netherlands. As a consequence, the UK government agreed with the Dutch government to allow such prescriptions to take place for a further six months to 1 July 2021; it is understood that this has now been extended further until the end of the year. This issue has highlighted the need for greater regulation to allow for development of CBMs so that they are readily accessible to patients.

Licensing Systems

A number of jurisdictions note that problems lie with the national cannabis licensing systems, which are the frameworks in place to permit the cultivation or possession of plants for legitimate commercial or research purposes.

Across the globe, contributors report that licensing authorities are taking a conservative approach. Relatively few licences are granted and licensing requirements are notably high (sometimes prohibitively so). Licensing regimes are reportedly not transparent, with little guidance, and are particularly expensive, ultimately pushing product prices up and discouraging competition.

Lack of Legal Certainty

A lack of legal certainty tends to arise in two forms. Firstly, most of the laws and regulations that govern cannabis are unfit for the objectives of the modern cannabis industry. This is because the laws were originally put in place to control the criminal trade of the plant, and license hemp for agricultural use, rather than to regulate a sophisticated medical and wellness sector. What we see across the board is reliance on international law to some degree, law that dates back to the early 1960s and the 1970s.

For these reasons, many of the legal concepts are not only unclear given the modern context, but they are also untested in the courts.

This situation creates a second type of legal uncertainty, in that the rules are frequently changing. This is both because existing rules are in the process of being interpreted by various authorities, and because new rules are being put in place to govern the rapidly changing commercial landscape. Naturally, it is difficult to achieve legal certainty when rules and regulations may change over the life cycle of product development or business plans.

Industry Bodies

One common theme noted by contributors is the absence of a unified, authoritative body to orchestrate sensible regulation for the industry.

In a seminal discussion paper, the authors of the UK Law and Practice article recommended to the government that a UK Office for Medicinal Cannabis should be established to bring together the various regulatory responsibilities and oversee the implementation of policy recommendations.

Our Spanish authors note that the incorporation of an association or a similar body will be critical for pushing through a sensible regulatory framework; essentially this would open the local market and ensure patient access to cannabis-based products with high standards of quality, safety and consistency. Increasing awareness and education for politicians, legislators and clinicians is identified as key and needs to be effectively channelled.

Criminal Sanctions and Decriminalisation

There is still disparity around the world with regard to the criminal aspect of dealing with cannabis and its trade. Global in nature, owing to the initial harmonisation of its illegality (through the UN Single Convention on Narcotic Drugs 1961), in recent decades the divergent paths adopted by jurisdictions around the world have reflected the development of a greater understanding of the plant, and its potential medical benefits. As more information surfaces, and social and scientific studies grow more robust and frequent, the changing attitudes towards cannabis can be seen in the context of its treatment in criminal law.

The recurrent theme in those countries that are on the path to legalisation is a gradual relaxation towards the penalties or sanctions for those who are breaking the laws in their jurisdiction by carrying on activities with cannabis.  Mexico, a jurisdiction on the precipice of full legalisation of cannabis, has legislation that permits possession of up to 5 g of cannabis per person of legal age, as set out in the General Health Law, a piece of primary legislation. This “blind-eye” approach could be seen as a first step towards the recreational or commercial regulation of cannabis in a jurisdiction.

In England and Wales, the Cancard initiative is a programme where those who are eligible for a private medical cannabis prescription may pay an annual fee to the organisation and receive a holographic ID card. The initiative, supported by members of the UK Parliament and the police, provides a validated indication that the holder of the Cancard is consuming cannabis for medical reasons. This development in the UK, a country with historical social and political aversions to cannabis, is indicative of the global trend of decriminalisation and de-stigmatisation of the plant, providing for autonomous use by those who benefit the most from its properties.

It can be postulated that this is a stepping stone along the way to full legalisation, a trend that we have seen in those countries where recreational and medical cannabis regulations now sit side-by-side.

Authors



Mackrell.Solicitors is an award-winning, full-service law firm, with a truly global reach. Headquartered in Central London, with offices in the heart of Birmingham, the firm has been providing high-quality legal advice and services since 1845. Mackrell.Solicitors was also one of the founders of Mackrell International, the 33-year-old global network made up of 104 firms across 60 countries, enabling it to offer the added value of immediate international legal advice and assistance in any jurisdiction worldwide. Mackrell.Solicitors set up the first designated cannabis legal team three years ago, so in terms of sector-specific knowledge it is at the cutting edge of the current regulatory regime in the UK and Europe. The firm provides regulatory advice and services for the medicinal cannabis and CBD industry, from cultivation licence applications, product and labelling reviews to advice on import/export best practice. In addition, via Mackrell International, it provides multi-jurisdictional advice for all EU countries and beyond.