Medical cannabis is gaining popularity around the world as a treatment for various illnesses and conditions. However, strict regulations in many countries make it difficult for patients to access it.
Studies have shown that medical cannabis can be beneficial for people with a variety of conditions, including Alzheimer’s disease, epilepsy, chronic pain, and mental health conditions.
Despite its potential, regulations around the globe often restrict patient access to these treatments. However, ongoing clinical trials are underway, and as our understanding of treatment capabilities grows, these regulations may change.
In this article we explore the medical potential, the stages of development for countries and regions, and the access solutions.
Medical Benefits of Cannabis
In January 2023, the UK’s NHS started prescribing cannabidiol (CBD) to patients with a rare, seizure-causing genetic disorder in England, after approval from the National Institute for Health and Care Excellence (NICE). Tuberous sclerosis complex (TSC) causes seizures, which severely affect the quality of life for patients from a young age.
Used alongside standard patient care – such as typical antiseizure medications – cannabidiol (Epidyolex®) has been found to reduce the frequency of seizures by almost a third and is expected to treat around 1,000 patients initially.
Medicinal cannabis has also been approved as a treatment for Dravet and Lennox-Gastaut Syndrome (LGS), helping to reduce the frequency of seizures in patients. In the US, the FDA has approved a CBD product to treat seizures associated with LGS.
Furthermore, medicinal cannabis has been found to be effective in managing chronic pain and providing relief for patients with conditions such as fibromyalgia and osteoarthritis.
In 2022, the largest study of its kind in Latin America published clinical evidence[i] on the safety and effectiveness of CBD oil-based cannabis formulations to treat chronic pain. Results contained promising data on the safety, efficacy, and cost-effectiveness of the products.
It has been suggested that using cannabis could potentially reduce the reliance on opioids for pain management, although further research has been called for.[ii]
Another promising development has been the reported benefits for treating types of mental health, notably with CBD oil. Studies have shown a reduction in symptoms of depression and anxiety in some patients.[iii]
Medicinal cannabis can also be used as an alternative treatment option for patients who have not responded well to conventional therapies. Studies have shown “very promising effects” for patients with autism[iv] and can be used as a therapeutic alternative to relieve anger, hyperactivity, sleep problems, anxiety, and psychomotor agitation, as well as improve sensory sensitivity, cognition, attention, and social interaction.
The biggest challenges for medical cannabis access
According to GlobalData, medical cannabis research is set to escalate. In 2020, pre-pandemic, there were already 60 ongoing clinical trials with cannabis-based products, the majority being tested for pain or psychosis. However, barriers remain for such products in clinical trials.
The regulatory landscape for medicinal cannabis is complex and varies across different countries and jurisdictions. While some health authorities have legalised medicinal cannabis, others have strict regulations or classify it as illegal. According to research by GlobalData, the medical use of cannabinoid drugs is banned in 137 countries[v], although the United Nations removed cannabis from Schedule IV of the 1961 Single Convention on Narcotic Drugs in 2020.[vi] Legalisation remains the greatest barrier to access and research.
Furthermore, there is limited scientific and medical data on the safety and efficacy of cannabis products for their intended use. The medical community is still studying the long-term health effects and potential benefits.
The use of cannabis, even for medical purposes, can still face a negative perception among healthcare professionals, patients, and the public.
Countries and regions exploring medicinal cannabis
Regulations for medicinal cannabis can vary greatly around the world. Germany is currently reviewing its laws around cannabis for medical purposes and could soon have the most lenient in the EU. However, legislation must still be approved by lawmakers. Medicinal cannabis can be prescribed by a doctor in the country, but supply is limited as only small amounts of available products are imported. In Germany, patients can also be reimbursed for medicinal cannabis.
According to GlobalData’s Clinical Trials database, as of December 2023, Germany is currently hosting 35 clinical trials for medicinal cannabis. These include treatments for chemotherapy-induced nausea and vomiting, psychosis, chronic pain, and schizophrenia.
In contrast, despite the UK being one of the world’s biggest producers and exporters of medicinal cannabis, uses for patients in the country remain limited. Medicinal cannabis was legalised in the UK in 2018. But five years later, there is a lack of availability on the NHS. The advisory body for England’s NHS, the National Institute for Health and Care Excellence (NICE), highlighted the lack of quality clinical trials. However, the National Institute for Health Research revealed it has not funded any studies for cannabis since the law was changed.[vii] The families of those suffering from chronic illnesses are now calling for more research funding and have set up support and lobbying groups.
There are currently 44 clinical trials into medicinal cannabis underway in the UK, according to GlobalData’s clinical trials database. Indications include multiple sclerosis, Alzheimer’s, obsessive-compulsive disorder, and epilepsy.
Meanwhile, in Australia, any medical doctor can prescribe medicinal cannabis with approval from the Therapeutic Goods Administration (TGA) and the relevant state or territory’s department of health.
Australia currently has 75 ongoing clinical trials, including using cannabis for stress, anorexia, and chronic neuropathic pain caused by spinal cord injury. Upcoming trials, currently recruiting, cover paediatric palliative care[viii].
Medicinal cannabis in the Middle East and Africa
The Middle East and Africa have a combined 41 clinical trials in progress for medicinal cannabis in treating chronic pain, Parkinson’s disease, Crohn’s, and schizophrenia.
In August 2023, Israel’s Health Ministry announced new reforms for medicinal cannabis[ix], reducing regulations in the sector, improving accessibility, and boosting research. At present, there are a reported 100,000 Israeli patients with licences to take medicinal cannabis for conditions that include cancer, Crohn’s, multiple sclerosis, and epilepsy.
Across the country, GlobalData has identified 30 clinical trials underway, including for Alzheimer’s, autism, and back pain.
In Africa, many Southern African countries possess an ideal climate for growing the cannabis plant. In 2017, the Kingdom of Lesotho became the first African nation to grant a licence to grow, manufacture, and export, medicinal cannabis and related products. Ghana followed with a similar set of approvals in 2023. As of 2022, African countries that have legalised cannabis for medicinal use are Ghana, Lesotho, Malawi, Morocco, Rwanda, South Africa, Zambia, and Zimbabwe. Whereas Uganda only allows the export of cannabis.
Treating PTSD with medicinal cannabis in Ukraine
June 2023, President Zelensky called for legalising cannabis-based medicine, scientific research and “controlled Ukrainian production”, partly to allow for it to treat injured soldiers and those suffering from post-traumatic stress disorder (PTSD) in the ongoing war with Russia[x]. Despite considerable resistance to changing the law within the government amid concerns that it may lead to more unregulated, illegal uses, the legalisation of medical cannabis was granted in December 2023. This new law will become effective 6 months after President Volodymyr Zelensky brings it into force in January 2024 with Ukrainian citizens being able to access medical cannabis in the latter half of the year.
There are currently just four trials ongoing in Ukraine for medicinal cannabis. Conditions being treated include depression – including bipolar disorder – and multiple sclerosis. As Clinical Trials Arena has been reporting, all foreign-sponsored trials with a site in Ukraine have been classified as disrupted by the war with Russia. The new legislation opens the door for more research.
Oximio – Overcoming access barriers to medicinal cannabis
Specialists in clinical trial services at Oximio are well-versed in overcoming barriers to medical treatments. The company supports clinical trials worldwide by facilities in Europe, Africa, and the Middle East, as well as trusted partners throughout North America and Asia.
Founded in 2004, Oximio offers support services for clinical trials with services such as project management, logistics, comparator sourcing, and medicine access solutions.
To assist in procuring medicinal cannabis, Oximio recently attained a special provision to its SAHPRA Licence, meaning that it has the capability to support licensed manufacturers and cultivating farms in exporting medicinal cannabis from South Africa on their behalf.
Oximio is now also able to accept medicinal cannabis for storage on behalf of local manufacturers and cultivators who are licensed. This bolsters the company’s position as a reliable distributor of medicinal cannabis products from Africa, supporting the international market offering a white glove service.
On the announcement, Mykola Nikolaiev, Oximio CEO, said: “This marks a significant turning point in our operations, exemplifying our commitment to supporting the use of medicinal cannabis in clinical trials.”
Further Reading:
Oximio, South Africa, attains an additional resolution to SAHPRA Licence, Paving the Way for Medical Cannabis Innovation
Ukraine Legalises Medical Cannabis in Life Changing Legislation
References:
[i] https://pharma1.globaldata.com/News/leading-global-medical-cannabis-company-khiron-publishes-clinical-study-on-the-effectiveness-of-its-products-at-controlling-chronic-pain
[ii] https://pharma1.globaldata.com/News/medical-cannabis-can-reduce-use-of-opioids-in-patients-with-chronic-back-pain-and-osteoarthritis-but-further-study-needed
[iii] https://pharma1.globaldata.com/News/MediPharm-Labs-Publishes-Study-Investigating-Medical-Cannabis-Impacts-on-Anxiety-and-Depression-Outcomes-in-Fibromyalgia-Patients
[iv] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9887656/#:~:text=Cannabis%20and%20cannabinoids%20have%20very,anxiety%2C%20restlessness%2C%20psychomotor%20agitation%2C
[v] https://pharma1.globaldata.com/News/cannabinoids-receptors-popular-preclinical-target-but-banned-in-137-countries_170545
[vi] https://news.un.org/en/story/2020/12/1079132
[vii] https://news.sky.com/story/still-no-medical-cannabis-trials-for-nhs-five-years-on-from-legalisation-13020499
[viii] https://www.sydney.edu.au/lambert/clinical-trials.html
[ix] https://www.jpost.com/health-and-wellness/article-754051