The author of this article is Michael Sassano, the CEO of the renowned European cannabis pharmaceutical company Somai Pharmaceuticals. Following is the details:
Recently, I have become more optimistic about the global landscape of medical cannabis and the direction of major regulatory agencies. The suffocating regulatory environment and political resistance that have hindered the development of the cannabis industry for years seem to be giving way to real progress.
Earlier this year, the US Department of Health and Human Services (HHS) released a 252-page report stating that cannabis is safe. The health agency further noted that cannabis as a medicine has genuine potential to help alleviate at least 15 medical conditions. However, for decades, people have claimed that there was not enough evidence to suggest that cannabis as a medicine is safe and valuable, but this event is indeed a significant turning point for the industry.
Most of those who have read the report understand this. In fact, many believe that these hostile, politically motivated, and biased authorities have been preventing hundreds of millions of people from accessing safer medicines, and the HHS report can and does portend a major shift in regulatory stance.
Cannabis Helpful For Symptomatic Neuropathic Pain: Moving Away from Opioids
Let’s take a simple example: recognizing that cannabis can help alleviate symptomatic neuropathic pain, a symptom typically treated with opioids. Can the epidemic of opioids, which has led to hundreds of thousands of deaths and millions of addictions, be mitigated by opening up medical cannabis?
The HHS report clearly indicates that cannabis is a safer alternative to opioids, as it is less addictive and has much lower likelihood of overdose and adverse reactions than any opioid.
Regardless of legislators’ personal biases or whatever societal or religious beliefs may hinder advocacy for cannabis, this report clearly demonstrates that cannabis is a safer alternative to dangerous opioids (such as hydrocodone).
The Next Steps for Medical Cannabis Development
Authorities must face this reality: both the HHS document and a plethora of anecdotal evidence suggest that cannabis is a safe and widely used therapeutic compound for a variety of medical conditions.
Current Cannabis Recommendations and Consumption
The HHS document states that there are 30,000 professional doctors recommending medical cannabis in the United States, with over 6,000,000 patients reporting positive treatment outcomes. These statistics do not include the millions of adult consumers in the US and countless unregulated market customers. These patients provide the most important evidence that cannabis can help individuals in various ways.
Reclassifying Cannabis
How should cannabis be classified – as a medicine, an herb, or a recreational product derived from novel foods?
The answer is all of the above.
Cannabis Medicine vs. Herbal Cannabis
It’s important to consider the market size of the relevant industries in the United States to understand the possible paths of cannabis regulation (Note: the global market size is estimated to be much higher; the following are U.S. data).
- Cannabis Pharmaceuticals: $500 billion
- Cannabis Herb: $201 billion
- Unregulated Cannabis Market: Estimated value exceeding $75 billionÂ
- Adult-Use and Medical Cannabis: Approximately $33 billion
- Medicinal Cannabis Formulations (such as Sativex, Epidiolex, etc.): $770 million
Regulated and Medicinal Cannabis
The difference in market size between regulated cannabis and medical cannabis primarily stems from the 5-10 year timeframe for drugs to enter the market and longer periods required for physician education. In addition, adult-use and medical cannabis are much more profitable than medical cannabis, to the extent that many investors are unwilling to spend hundreds of millions on clinical trials.
The regulated cannabis market is more promising and profitable than medical cannabis, as people want immediate access to drugs. Immediate access is crucial, as people now have a better understanding of the therapeutic potential of cannabis and do not want to wait for breakthroughs in cannabis drugs. Regulatory agencies must find a balance between immediate access and consumer safety.
Undoubtedly, there will be more cannabis drugs in the future. However, the herbal cannabis route will provide quicker access to cannabis drugs, as adult-use cannabis is still struggling to gain political, social, and regulatory acceptance.
Political Barriers to Medical Cannabis in the US and Elsewhere
The US is seeking to reclassify cannabis from Schedule I to Schedule III, considering the plant’s medical benefits. Additionally, Germany appears poised to remove the narcotic label from cannabis in the coming months. However, politics still hinder progress.
In fact, whether one or two countries succeed or not, the HHS report has now been made public, and other countries as well as the World Health Organization (WHO) must recognize that people are consuming cannabis.
Cannabis Medication
In countries worldwide, the most regulated and straightforward path for cannabis is through medical use. This approach is conducive to the medical supervision and distribution of cannabis medicines registered as herbal products under the European Union’s Good Manufacturing Practice (EU-GMP) standards.
Cannabis Herb
For cannabis herbal remedies, another potential avenue is adopting the novel food Good Manufacturing Practice (GMP) standards. This operational model closely resembles the current distribution and licensing frameworks for cannabis and CBD products, integrating medical supervision through pharmacy systems. However, this model may be applicable only to certain countries.
Adult-use Cannabis
As for adult use cannabis, true recreational or adult-use cannabis (such as in the United States and Canada) may not be feasible for many other countries at present. However, as understanding of broader issues surrounding legalization continues to progress globally, the future holds promise.
Obtaining herbal cannabis is the safest and most politically correct route. As the HHS report states, people should have access to cannabis, and if regulated medical cannabis cannot be obtained safely, people will enter the illegal market or opt for more harmful opioids.
In fact, we are witnessing the beginning of a global medical cannabis explosion. We already have over 30,000 international clinical reports, hundreds of pages of reports on Canadian medical cannabis patients, and countless observational data and reports from adult consumers and medical cannabis patients in the US.
Based on recent news, this powerful data will only continue to grow. Even important health organizations acknowledge the safety of cannabis and provide a wealth of reports on its medical benefits, which is an incredible development for the industry. We believe that positive changes and massive growth in the global medical cannabis industry are only a matter of time.
In other words, the floodgates have opened, and the deluge is about to hit.
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