We are extremely pleased to announce the launch of our Global Medical Cannabis Dashboard, a new interactive tool covering cannabis regulatory regimes in 112 countries (and counting) across the world. We reached out to our global network of healthcare regulatory specialist lawyers across 39 Baker McKenzie offices and 70+ of our correspondent firms and asked them to share their knowledge on this subject. Our resulting dashboard is unique in its scope and stretch and we invite you to explore it yourself.
Our dashboard covers the overall feasibility of marketing medical cannabis, permissibility of medical cannabis in its raw form and in pharmaceuticals, clinical trials, export/import, recreational use, hemp definitions, and private sector involvement for each jurisdiction. This tool enables users to see overviews of cannabis regulations globally in the form of interactive heat and geographical maps, with the option to select specific regions, countries, or specific responses, to quickly and easily spot local and global trends.
For the purposes of our global survey, we used a broad definition of ‘cannabis’ and followed the approach taken by the FDA. The FDA defines cannabis as a plant of the Cannabaceae family containing more than 80 biologically active chemical compounds, most commonly known of these being delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).[1] When engaging in cannabis related transactions, it is extremely important to understand the specific cannabinoid involved as regulations may vary greatly depending on the chemical makeup of the substance.[2]
1. Feasibility of Marketing Medical Cannabis
The first question we asked our network of experts as on the overall feasibility of marketing medical cannabis in their jurisdiction. Their responses fall into one of these options:
- Feasible: this means that medical use of even the raw/unprocessed form of cannabis is permitted, for example this is the case in the UK, Canada and many other jurisdictions. From the data collected, we have found that marketing medical cannabis across the Americas is largely feasible and across Europe and Africa there is generally good feasibility, with some markets already well established, such as the Netherlands and South Africa. While the US has been marked as ‘feasible’, it should be noted that only 36 states have legalized marijuana for medical uses however it remains illegal at the federal level.
- Moderate: this most commonly means that only approved pharmaceutical products containing cannabis are permitted, for example in France and Brazil.
- Not feasible: this means that there is a general prohibition against all medical use of cannabis, including using cannabis as an ingredient in approved pharmaceutical products. There are also some instances where countries have been marked as not feasible where, despite the law seeming to permit medical use of cannabis, marketing medical cannabis, in practice, would not be possible due to harsh criminal sanctions. This was the case for a number of countries in the Middle East, such as Saudi Arabia.
2. Medical Use vs. Pharmaceutical Use
We asked whether a) medical use of cannabis is permitted (i.e. whether cannabis in its raw and minimally processed form can be used for medicinal purposes – see fig. 2 below); and b) whether pharmaceutical drugs containing cannabis (i.e. medical products with a marketing authorization, such as Sativex) are permitted.
Using our medical cannabis dashboard, we overlaid these two questions, as demonstrated below in Fig. 4. We found that where the medical use of raw cannabis is permitted, pharmaceutical drugs containing cannabis tend to also be permitted. However, there were a couple of interesting instances where this was not the case:
- In Morocco, the cannabis product itself can be used as a treatment for medical conditions and symptoms, but the current legislation prohibits cannabis from being used as an ingredient in pharmaceutical drug products.
- In The Philippines, cannabis is expressly prohibited as an ingredient in pharmaceutical products, however medical use of the raw cannabis product is permitted in certain specific circumstances. This involves obtaining special permits and licences which are only issued to patients for a very limited number of serious medical conditions.
3. Overall Feasibility vs. Hemp Definition
Using our cannabis dashboard, we overlaid the responses to ‘overall feasibility’ (see the top row in fig. 5 below) against responses to the question of whether local market has a legal definition of hemp (where the key shows red along the bottom question, this means that there is not a definition of hemp).
We found that the presence of a hemp definition can be used as an indicator that a local market is becoming more comfortable with the idea of regulating cannabis for medicinal use. Where there is feasibility but no hemp definition, this has tended to indicate that there is a less extensive legal regime or a less mature market in place. Good examples here are the Democratic Republic of Congo and Malawi. The exception to this is that jurisdictions that permit recreational use tend not to set out THC amounts in law e.g. South Africa, Chile, and the Netherlands (THC being the psychoactive element of cannabis, which elicits the “high” experienced by recreational users).
4. THC Limits
We asked our experts, where hemp is defined, what is the THC limit imposed by law. The modal value most common globally is that Hemp must not contain more than 0.2% THC. This is a very common standard across Europe, although there are plans to increase this to 0.3% across the EU. We have been able to draw the following conclusions from our research:
EMEA:
- In Africa, hemp was only defined twice among the countries surveyed (Malawi and Zimbabwe). In Europe, the most common percentage of THC included in Hemp definitions was 0.2%. There are some notable outliers, with a 0.001% THC cap for North Macedonia and Norway, effectively requiring hemp to be THC free. Where defined, there was a trend towards lower percentages in the CIS, e.g. in Russia and Ukraine the THC limit is set at 0.1%. We can see that in the Middle East, where hemp is not legally defined with a THC cap, that a high appetite for enforcement exists, even for products that are available to buy on the street in the UK.
Americas:
- Where hemp was defined, which was not common in Central/South America, there are trends towards permitting higher THC levels – with Uruguay and Ecuador setting a more generous 1% cap. By contrast, in North America, Canada and the US it’s 0.3%.
APAC:
- Hemp was not commonly defined in Asia Pacific. In Asia, only Thailand defines hemp, requiring THC levels to be less than 1% (which is higher than most other jurisdictions that include a THC definition). Thailand is the most developed market regionally in this regard. Australia and New Zealand both define hemp, but at varying levels. For example, in Australia, this will differ from state to state but in New South Wales it is 1%, whereas New Zealand requires hemp to contain less than 0.35% THC, which is still higher than the average across the countries surveyed.
5. Clinical Trials
Even in countries where a hard stance against medical cannabis is taken, we have largely seen that clinical trials are permitted to take place, often requiring an additional layer of regulatory licences. This could be a positive sign for change in some of these jurisdictions, as in many markets cannabis is not permitted for medical use on the basis of a lack of recognised medical use. It is likely that with more trial data, more reassurance can be demonstrated.
In China, clinical trials are permitted subject to special approvals, and interestingly, must not involve healthy trial subjects.
Where a ‘Yes/No’ answer was given to this question, this tended to mean that there would be governmental discretion involved around whether a clinical trial could be permitted in a jurisdiction with a hard line stance against cannabis, for example this is the case in Oman or where there was general legal ambiguity. This meant that even though it would technically be possible to make an application to run a clinical trial involving cannabis, it is unlikely that this would be accepted.
6. Import/Export
While international treaties prohibit import and export of cannabis globally, many countries permit the import and export of hemp based products in a limited number of circumstances with comprehensive regulatory hurdles. Interestingly, some countries that have a strong stance against medical cannabis nevertheless permit import and export, e.g. Russia.
An answer of Yes/No to this question meant that either just import or just export was permitted. In some of the Yes/No responses, there was an express prohibition on export / import, but there is the potential to import or export cannabis in a very limited number of circumstances. This answer was also given where import/export was technically permissible but due to either legal or other constraints this would be practically impossible. We have also received responses of Yes/No for countries where only CBD products, i.e. cannabis products containing below a prescribed amount of THC, are permitted to be imported or exported, as is the case in Hong Kong.
7. Recreational Use
Recreational use of cannabis is largely prohibited, however in some jurisdictions recreational use has been decriminalized. Interestingly, decriminalization does not always mean that the jurisdiction will permit medical use of cannabis or have an established medical cannabis market, for example in Spain and Austria, where only pharmaceutical products containing cannabis are permitted, and not cannabis in its raw form for medical purposes.
An answer of Yes / No here meant that recreational use of cannabis was either decriminalized or, despite a general criminal prohibition individuals are allowed to possess small quantities of cannabis for personal use.
There are a number of jurisdictions that have complex arrangements with respect to recreational use of cannabis. Spain has a singular situation, with a complex legal situation not legalizing but not strictly decriminalizing recreational use, and with an explicit decriminalized exception for habitual consumers gathering together to consume cannabis in private clubs, which are permitted providing they don’t grow too large. In Mexico the General Health Law still does not allow recreational use, but sets out a maximum amount for personal possession and consumption of 5 grams, exempted from the general prohibition and thereby essentially decriminalizing small amounts. Further reform is anticipated to open the market there but the legislation has been stalled for the last few years.
8. Private Sector Involvement:
Finally, we asked whether the local law allows cannabis business to be carried out by the private sector. There are two different reasons given where countries are marked as ‘No’:
- The private sector is not permitted to get involved in cannabis business due to a prohibition on cannabis under criminal law. For instance, in Ireland there is legislation that prevents the manufacturing and sale of cannabis products, and these activities can only be carried out on an exceptional basis by obtaining a license and having the business listed under regulations allowing it to be prescribed; we understand that no such licenses have been issued to date.
- Another reason for answering No to this question has been due to state involvement in the sector. For instance, in Thailand, private business must collaborate with government agencies in order to operate in this sector. In China there are significant barriers preventing private sector involvement. This is also common in South and Central America: for instance, in Argentina the main involvement is by the government. In some circumstances businesses must engage in a tendering process with the state, such as in the Czech Republic.
Note that the US is an outlier for this question, as there is a general federal prohibition on company involvement in cannabis business despite this being permitted by some states under state legislation.
9. Conclusion
The conclusions we have drawn above represent a small number of the fascinating insights to be drawn from our Global Cannabis Dashboard. Please be sure to request access to our tool by clicking here. If you would like to watch a recording of the first in our series of cannabis webinars, Cannabis, Hemp and Psychedelics: the regulatory landscape across 100 jurisdictions, which provides an overview of our Global Cannabis Dashboard as well as a panel discussion on the cannabis landscape across key jurisdictions, please click here.
On 20 January 2022 we will be hosting the second webinar in our series, focusing on import/export issues. To register or find out more, please click here.
Please reach out to a member of our cannabis team below for more information on this topic. For further information please contact Julia Gillert or Lilli Meldrum.
[1] FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) | FDA
[2] This global survey provides a general overview of cannabis regulation in various countries of the world and should not be relied on as confirmation of the legality of any specific activity in any particular country. Anyone considering engaging in any cannabis related activity should always first consult a qualified local legal counsel to obtain guidance related to the particular activity contemplated.
