The State of Regulatory for Cannabis and Cannabinoids
This is just an excerpt of our article. The full article with case study can be read on our website: https://regask.com/the-state-of-regulatory-for-cannabis-and-cannabinoids/
Article written in collaboration with Life Science Law – Legal experts in life science industry laws and regulations; providing practical solutions to business challenges and objectives. LS Law provides confidence to businesses that the legal landscape is known, risk has been identified and mitigated in proportionately in a manner which supports the attainment of its goals and priorities.
In 2013, Dr. Sanjay Gupta of CNN presented a program called ‘Weed’ (*1), in which he profiled a young girl with Dravet syndrome whose life was turned around and significantly improved after being given a CBD-rich hemp extract. This documentary catapulted a fringe product into the mainstream, and within 10 years, surveys suggest that 60% of US adults (*2) and 15% of consumers across Europe (*3) have tried CBD.
Meanwhile, the regulatory status of cannabidiol (CBD) and cannabis-containing products is playing catch up with consumer demand. Many regulatory agencies across the globe are looking into how to develop a legislative framework fit for purpose.? The current routes to market vary widely and are highly complex. Understanding the relevant national and regional status of cannabis products is critical for any company wishing to enter this sector, including manufacturers, distributors, and life sciences companies.
Regulatory Status of Medical Cannabis
It is impossible to summarize the regulatory status of medicinal cannabis in a simple way.? The reason being that each country translated the UNSC into their National Misuse of Drugs Act and Regulations with variations.? More pertinently, only a few Countries so far have developed a medicinal cannabis programme and the license requirements set out for all parties in the supply and distribution chain are unique in each jurisdiction.? There is also no harmonized approach in Europe nor in the US yet either. It is strongly recommended to seek regulatory advice for the type of product and jurisdiction a company wishes to enter.
How to bring a cannabis-based product to market
Whilst it is not permissible on all countries, as there isn’t a harmonized approach, where it is legal to place cannabis on the market, the options include:
Marketing Authorisation
Where a product is to be used for a medical purpose, the traditional route is to carry out clinical trials in order to confirm the safety and efficacy of a product for the treatment of a specific indication. In the event the primary end point of a phase III trial is successful, it is then permissible to the Regulatory Authorities for a marketing authorisation within the jurisdiction in which you wish to place the medicine on the market.? The Regulatory Authorities will assess the data, and if a marketing authorisation is granted, the product can then be placed on the market for use in relation to the specific indication for which the product has been assessed.
National Medical Cannabis Programmes
Almost 50 Countries have now legalized medical use of cannabis and every year additional Countries introduce access programmes. Navigating the Regulatory landscape is highly complex and can be challenging as each Country has a unique approach and different procedures in place both for how patients can access cannabis-based medicines and what stringent processes need to be followed to import, handle and distribute the products. There is no unified approach and country programmes can vary widely. In 2019, Europe commenced deliberations to create an EU-wide Regulation for medicinal cannabis.? Meanwhile several member states have their own, unique national programmes.
Most Countries select a pharmacy-only approach. Often a special license regime permits licensed compounding pharmacies to prepare the cannabis-based medicinal product in accordance with the doctor’s prescription for an individual patient. A doctor may prescribe flowers, capsules, resin, eye drops, suppositories, creams, transdermal gels, edibles and syrups and the pharmacist will prepare and dispense the prescribed cannabis-based medicine.
CBD as a Food Supplements
Some Countries permit or tolerate the sale of food supplements that contain primarily the non-psychoactive compound cannabidiol (CBD). It is important to note that a food supplement cannot be marketed or claim to treat a medical condition. If medical claims are made, it is likely to fall foul of the legislation and be deemed to be a medicinal product, for which a full marketing authorisation is required.
Nevertheless, CBD is a hugely popular food supplement and is sold widely, particularly in the US, Europe, the UK, South Africa and Japan. However, the sale of food supplements of CBD is more aptly described as tolerated, rather than meets a current regulatory framework. In Europe, there is a public register, called the Novel Food Catalog, which lists products of animal and plant origin and other substances subject to Novel Food Regulation.? A novel food is defined as a food that had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation on novel food came into force.
In January 2019 a new entry was added to the EU novel food catalog for ‘’cannabinoids’’.? It states that the Hemp plant (Cannabis sativa L.) contains a number of cannabinoids and the most common ones are as follows’’… it proceeds to list a number of individual cannabinoids such as ‘’THC, THCA, CBD, CBDA, CBG, CBN, CBC and THCV’’ and states that ‘’extracts of Cannabis sativa L and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated.? This applies to both the extracts themselves and any products to which they are added as ingredients.? Synthetically obtained cannabinoids are considered as novel.
In Europe, novel foods are subject to the novel foods directive, Regulation (EU) 2015/2283? (12*) which requires that a company submits a novel food application to the European Food Standards Agency (EFSA) which needs authorisation prior to placing the product on the market.? Several applications for CBD have been submitted but no authorisations have been granted yet. Under the Brexit Transition Agreement, the UK adopted the novel food catalog and its corresponding entries but companies had to submit a separate novel food application to the UK Food Standards Agency (FSA), in addition to their EFSA submission.? The UK has taken a more pragmatic approach and permits CBD products that were on the market prior to 13 February 2020, subject to having submitted a novel food application, pending the outcome of the assessment process.? (13*)? A public list of permitted for sale products has been published by the FSA.
However, there have been regulatory actions against the free access of citizens to purchase CBD products as a food. Hong Kong banned CBD as a dangerous drug in February 2023, following China’s lead having banned CBD in 2022. The US FDA also grapples with how to categorize CBD food products.? In January the FDA announced that it concluded that existing regulatory frameworks for foods and supplements are not appropriate for CBD and that they will work with Congress to find a new way forward. (14*) Japan permits only products that are made from the seed and stalk of the plant, and not the flower.? The list of countries permitting CBD products to be sold as a food is currently less than countries permitting it as part of a medicinal cannabis programme.
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5 Tips and Reminders for Market Entries
Understanding the relevant national and regional status of cannabis products is critical for any company wishing to enter this sector, including manufacturers, distributors and life sciences companies. The terminology is confusing, different regulators apply different parameters, and so there is no harmonized approach.??
In this Article, we have provided a snapshot into the main routes to market and some clarity into the terminology and some insights into the different approaches taken to cannabis products in various jurisdictions. What is clear, is that the regulatory and legal landscape is far from straightforward, and it is imperative that a detailed analysis is carried out in terms of the indication, which is proposed, and what are the options available in terms of placing it on the market before embarking on the journey.??
We have industry experts who can help you to navigate the landscape and to provide you with a clear path. For an initial consultation, please do contact us, and we will assign one of our cannabinoid regulatory experts to help you.??
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