Written by Michael Sassano, CEO, Somai Pharmaceuticals

On January 12, the United States Department of Health and Human Services (HHS) released a letter and supporting 252-page document that will make it extremely difficult for the Drug Enforcement Agency (DEA) to ignore its findings on the benefits of cannabis and all but ensuring that the U.S. will reschedule cannabis from current listing as a Schedule I to a Schedule III drug.

However, the biggest ramification for the global medicinal cannabis market is that every regulator in every country woke up to the most influential regulator on earth telling the world that cannabis is both safe and indeed is a medicine that treats at least 15 ailments, especially pain.

The International Cannabis Market is a Ready-to-Ignite Fuse

Looking back on this author’s 2024 predictions article, it is now more apparent that the U.S. will reschedule, and it is equally increasingly possible that Germany will remove its narcotics classification from cannabis. Although these two events are more common-sense symbolic changes than functional, since we all know cannabis is a medicine with benefits, the result will be countries reevaluating their out-of-date stance and bringing their rules up to global standards.

Reclassification in these significant markets will ignite the worldwide redesignation of cannabis and mark the beginning of the most transformational movement cannabis has seen since the U.S. started state-by-state legalization and Canada went federally legal. The result will be a global medicinal cannabis market that benefits patients and consumers by creating a robust international business framework.

Major Takeaways From the HHS Cannabis Rescheduling Letter

The HHS letter and enclosed document prepared by the FDA’s Controlled Substance Staff contained gems for health and regulatory health professionals worldwide. To oversimplify, the evidence within puts to rest the repeated mantra of professionals and politicians who do not wish to acknowledge that cannabis is indeed helpful for many indications and is safe to use. Below are the critical points from Marijuana Moment’s coverage of this momentous missive:

Cannabis’ “potential for abuse [is] less than the drugs or other substances in Schedule I and II.”
Thirty thousand healthcare professionals “across 43 U.S. jurisdictions are authorized to recommend the medical use of marijuana for more than six million registered patients for at least 15 medical conditions.”
“There exists widespread, current experience with medical use of the substance by [healthcare practitioners] operating per implemented jurisdiction-authorized programs, where medical use is recognized by entities that regulate the practice of medicine.”
“Marijuana meets the findings for control in Schedule III.”
“The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain).”
“[Cannabis has] some evidence of benefit in Crohn’s disease when treated with marijuana… mostly limited to subjective symptoms and not disease activity.”
“The available data indicate that there is some credible scientific support to substantiate the use of marijuana in the treatment of: pain; anorexia related to certain medical conditions; and nausea and vomiting (e.g., chemotherapy-induced), with varying degrees of support and consistency of findings.”
“The risks to the public health posed by marijuana are low compared to other drugs of abuse (e.g., heroin, cocaine, benzodiazepines), based on an evaluation of various epidemiological databases for [emergency department] visits, hospitalizations, unintentional exposures, and most importantly, for overdose deaths.”
“For overdose deaths, marijuana is always in the lowest ranking among comparator drugs.”

Are There New Findings in the HHS Cannabis Recommendation Letter?

Let’s face it: the above takeaways aren’t anything new to the tens of millions of people in the world who get relief from cannabis. Patients hardly require clinical trials to tell them cannabis helps solve the issues they are facing; patients and consumers around the world already know this. Additionally, there are over 30,000 published papers on cannabis’ primarily positive effects, so blindness regarding the plant’s benefits seems inherently political, not factual. And surly, the big pharma pain industry tried to keep this document out of view, since their $78 billion market has a new competitor verified by the United States Government.

What the HHS cannabis rescheduling recommendation letter does not just allow for much more research and development that, in turn, opening doors for new demographics who could benefit from cannabis but don’t know about it and cannot obtain it. But additionally, it’s a document that can be used by any regulator to justify medical cannabis to their local population as a safer alternative as well as medicine that can help their people safely. The global medicinal markets and new demographics worldwide will open faster than ever imagined. Many thanks must go to pioneers and advocacy groups internationally that have been tirelessly fighting for access. Their time has come to see the result of this hard work. And remember the fight isn’t over, this information was given due to a US Freedom to Information Act lawsuit and was hidden since August, so now that it is in the public, it can be used to fight globally for access as representations of medical benefits.

2024 International Cannabis Regulation Movements Are Firing Up

The year is beginning with new countries making announcements, and more will follow this report released by the HHS:

Spain just announced it would finally be delivering its long-awaited medical cannabis framework in two months to “bring in line with global standards.”
Czechia recently just presented a draft for new medical cannabis laws as well as social clubs that deeply resemble the German program.
Ukraine is now debating a medical cannabis bill in the government.
Greece is trying to open its doors to the global cannabis world.
Japan has modified its rules to clarify cannabis guidelines, signaling future changes.
Thailand is still bouncing back and forth, but recently, it seems more in line with medical cannabis than adult use.
Brazil has already started limited access to high CBD products with THC.
Even countries like Albania are moving forward with cannabis reform.

Global Medical Cannabis is On an Undeniable Upward Trajectory

Global cannabis regulations are going to spark in 2024 and set 2025 up to cause an enormous global explosion in medical cannabis. Some countries will follow stricter medical platforms like the United Kingdom, others will follow more social club expansions like Germany, and a few will follow adult-use style programs like Canada and the U.S.

Regardless of methodology, almost every country will be implementing a cannabis policy — even if it’s simply CBD regulation — as the globe realizes not only is cannabis safe, but it helps you in many ways. While rescheduling should have happened ages ago, let’s be thankful it’s happening now. Be ready to make some noise at the DEA, Germany and all the country regulators to show the globe how to move forward and desist from the false narrative that no medical cannabis benefits exist!

 On January 12, the United States Department of Health and Human Services (HHS) released a letter and supporting 252-page document that will make it extremely difficult for the Drug Enforcement Agency (DEA) to ignore its findings on the benefits of cannabis  Read More  

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