Skip to content
  • About
  • Contact
  • Contribute
  • Book
  • Careers
  • Podcast
  • Recommended
  • Speaking
  • All
  • Physician
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
  • Video
    • All
    • Physician
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • Video
    • About
    • Contact
    • Contribute
    • Book
    • Careers
    • Podcast
    • Recommended
    • Speaking

Why North American medical cannabis can’t compete globally

Michael Sassano
Meds
February 5, 2023
Share
Tweet
Share

The United States and Canada started a movement that began as medical cannabis and quickly exploded into adult-use cannabis markets. However, the North American operators failed to properly regulate the processes from growing to manufacturing to compete in a global pharmaceutical-level market. Europe has taken the lead as the heavy-weight producer of truly medical-grade pharmaceutical cannabis flowers and products. Notably, many operators in the U.S. and Canada claim to produce medical-grade products, but the structural reality is impossible.

API registration in North America vs. the EU

You must respect requirements when considering registering a medical-grade active pharmaceutical ingredient (API).

Consider cannabis flower cultivation: Although many states and Canada have regulations on how you can grow and what you can use to grow, the pharmaceutical API market is much stricter and requires certification of how you grow and dry. You must grow in line with strict good agricultural and collection processes (GACP) and dry conforming to pharmaceutical good manufacturing processes (GMP) requirements.

Companies that follow European Union-GMP pharmaceutical standards are the gold standard for global medicinal products. The process is regulated, and the reporting and conditions are essential. For example, each new cannabis flower genetic must undergo stability testing to register the API’s shelf life.

International GDP and GLP standards require careful, controlled protocols.

Once you have registered your flower API and the appropriate regulatory agency has accepted the dossier, distribution or further processing adheres to good distribution practices (GDP), and manufacturing follows pharmaceutical GMP. These guidelines and processes have specific requirements for what you are making. Cannabis is a controlled narcotic and requires additional security and properly registered transportation groups to handle and protect the distribution of a controlled substance. GDP and GMP also regulate the cleanliness and air temperatures in the products’ processing or storage rooms. GMP even regulates the airflow inside processing rooms, equipment specifications, cleaning protocols and a litany of requirements for creating products consistently by following protocols and addressing deviations in a controlled fashion.

Good laboratory practices (GLP) are also a large part of product and medicine registrations. Self-governing labs and reporting your lab results at various steps in your processes is crucial to making consistent medicinal products. From the flower to the extraction to distillation and through to formulation and primary packaging, the lab will collect samples to verify conformity. And above the lab is a quality assurance (QA) team monitoring the results, paperwork, and processes by the production team. In simplified flow, the production teams work to make products and send samples throughout the process to the lab for verification, and the QA team watches that procedures are adhered to, and results are in line. The QA team addresses deviations and regulators’ inquiries, all while working to produce consistent medical products registered with regulators.

The impossibility of pharmaceutical cannabis in North America

To a large extent, the adult-use markets of the U.S. are unregulated due to non-federal recognition; otherwise, their governing body would be the Food and Drug Administration (FDA). However, the general rules are not even novel foods GMP and resemble restaurant rules modified with semi-medical requirements like standard operating procedures (SOPs) and independent lab verifications because these are state-regulated entities.

These regulations differ significantly from the strict pharmaceutical GMP standards and the non-standardized global medicinal manufacturing level. Additionally, the buildings’ physical modifications, air handling units, and regulatory requirement updates would make it impossible for almost every facility in the U.S. or Canada to conform to international medicinal standards.

To clarify, it’s unlikely international markets will ever accept U.S. products due to the product manufacturing requirements Europe has adopted.

European operators are poised to lead the global pharmaceutical cannabis market.

ADVERTISEMENT

In comparison, Europe has strictly adopted the proper medical and pharmaceutical standards for cannabis product growing, drying, manufacturing and distribution. Furthermore, when Europe transforms to an over-the-counter (OTC) model that resembles the adult-use markets of North America, the standard of medical-grade products will enable mainstream distributors and sales outlets like pharmacies to accept the higher standards of products easily.

The global manufacturing and distribution of cannabis require standards to which only novel foods and pharmaceutical GMP products can conform. Additionally, due to cannabis’ scheduling as a psychotropic narcotic, the global rules governing bodies require the trade of pharmaceutical-grade GMP medicines.

These registered APIs and finished market-authorized drugs have the highest quality standards for consumer sale around the globe and can be sold as pharmaceuticals or OTC products that do not require a regular prescription as most drugs do.

As early markets like the U.S. fix cannabis’ federal legal status, they will have to grapple with regulations that could be minimal and follow novel foods GMP or possibly maximal, unachievable pharmaceutical GMP standards. Either way, producers must meet some criteria for consumers’ safety and the products’ uniformity.

Michael Sassano is a health care executive.

Prev

The dark side of medicine: How the profession can become an emotionally and psychologically manipulative relationship

February 5, 2023 Kevin 5
…
Next

Transcription troubles: the hilarious and alarming consequences of speech recognition in medicine

February 5, 2023 Kevin 1
…

Tagged as: Medications

Post navigation

< Previous Post
The dark side of medicine: How the profession can become an emotionally and psychologically manipulative relationship
Next Post >
Transcription troubles: the hilarious and alarming consequences of speech recognition in medicine

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

Related Posts

  • Digital advances in the medical aid in dying movement

    Jennifer Lynn
  • Clearing the misinformation surrounding medical cannabis

    Samoon Ahmad, MD and Kevin Hill, MD
  • How medical societies can save American medicine

    Steve Levine
  • Supporting anti-racist American medical students: What residency programs can do

    Daniel Skinner, PhD
  • How the COVID-19 pandemic highlights the need for social media training in medical education 

    Oscar Chen, Sera Choi, and Clara Seong
  • End medical school grades

    Adam Lieber

More in Meds

  • Why does rifaximin cost 95 percent more in the U.S. than in Asia?

    Jai Kumar, MD, Brian Nohomovich, DO, PhD and Leonid Shamban, DO
  • A world without antidepressants: What could possibly go wrong?

    Tomi Mitchell, MD
  • The truth about GLP-1 medications for weight loss: What every patient should know

    Nisha Kuruvadi, DO
  • The hidden bias in how we treat chronic pain

    Richard A. Lawhern, PhD
  • Biologics are not small molecules: the case for pre-allergy testing in an era of immune-based therapies

    Robert Trent
  • The anesthesia spectrum: Guiding patients through comfort options in oral surgery

    Dexter Mattox, MD, DMD
  • Most Popular

  • Past Week

    • The silent toll of ICE raids on U.S. patient care

      Carlin Lockwood | Policy
    • Why recovery after illness demands dignity, not suspicion

      Trisza Leann Ray, DO | Physician
    • Addressing the physician shortage: How AI can help, not replace

      Amelia Mercado | Tech
    • Why does rifaximin cost 95 percent more in the U.S. than in Asia?

      Jai Kumar, MD, Brian Nohomovich, DO, PhD and Leonid Shamban, DO | Meds
    • Bureaucracy over care: How the U.S. health care system lost its way

      Kayvan Haddadan, MD | Physician
    • From hospital bed to harsh truths: a writer’s unexpected journey

      Raymond Abbott | Conditions
  • Past 6 Months

    • What’s driving medical students away from primary care?

      ​​Vineeth Amba, MPH, Archita Goyal, and Wayne Altman, MD | Education
    • The hidden bias in how we treat chronic pain

      Richard A. Lawhern, PhD | Meds
    • Residency as rehearsal: the new pediatric hospitalist fellowship requirement scam

      Anonymous | Physician
    • A faster path to becoming a doctor is possible—here’s how

      Ankit Jain | Education
    • Make cognitive testing as routine as a blood pressure check

      Joshua Baker and James Jackson, PsyD | Conditions
    • The broken health care system doesn’t have to break you

      Jessie Mahoney, MD | Physician
  • Recent Posts

    • From hospital bed to harsh truths: a writer’s unexpected journey

      Raymond Abbott | Conditions
    • Reclaiming trust in online health advice [PODCAST]

      The Podcast by KevinMD | Podcast
    • The business lesson new doctors must unlearn

      Stanley Liu, MD | Finance
    • 9 proven ways to gain cooperation in health care without commanding

      Patrick Hudson, MD | Physician
    • Closing the gap in respiratory care: How robotics can expand access in underserved communities

      Evgeny Ignatov, MD, RRT | Tech
    • Model context protocol: the standard that brings AI into clinical workflow

      Harvey Castro, MD, MBA | Tech

Subscribe to KevinMD and never miss a story!

Get free updates delivered free to your inbox.


Find jobs at
Careers by KevinMD.com

Search thousands of physician, PA, NP, and CRNA jobs now.

Learn more

View 1 Comments >

Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories.

Social

  • Like on Facebook
  • Follow on Twitter
  • Connect on Linkedin
  • Subscribe on Youtube
  • Instagram

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

  • Most Popular

  • Past Week

    • The silent toll of ICE raids on U.S. patient care

      Carlin Lockwood | Policy
    • Why recovery after illness demands dignity, not suspicion

      Trisza Leann Ray, DO | Physician
    • Addressing the physician shortage: How AI can help, not replace

      Amelia Mercado | Tech
    • Why does rifaximin cost 95 percent more in the U.S. than in Asia?

      Jai Kumar, MD, Brian Nohomovich, DO, PhD and Leonid Shamban, DO | Meds
    • Bureaucracy over care: How the U.S. health care system lost its way

      Kayvan Haddadan, MD | Physician
    • From hospital bed to harsh truths: a writer’s unexpected journey

      Raymond Abbott | Conditions
  • Past 6 Months

    • What’s driving medical students away from primary care?

      ​​Vineeth Amba, MPH, Archita Goyal, and Wayne Altman, MD | Education
    • The hidden bias in how we treat chronic pain

      Richard A. Lawhern, PhD | Meds
    • Residency as rehearsal: the new pediatric hospitalist fellowship requirement scam

      Anonymous | Physician
    • A faster path to becoming a doctor is possible—here’s how

      Ankit Jain | Education
    • Make cognitive testing as routine as a blood pressure check

      Joshua Baker and James Jackson, PsyD | Conditions
    • The broken health care system doesn’t have to break you

      Jessie Mahoney, MD | Physician
  • Recent Posts

    • From hospital bed to harsh truths: a writer’s unexpected journey

      Raymond Abbott | Conditions
    • Reclaiming trust in online health advice [PODCAST]

      The Podcast by KevinMD | Podcast
    • The business lesson new doctors must unlearn

      Stanley Liu, MD | Finance
    • 9 proven ways to gain cooperation in health care without commanding

      Patrick Hudson, MD | Physician
    • Closing the gap in respiratory care: How robotics can expand access in underserved communities

      Evgeny Ignatov, MD, RRT | Tech
    • Model context protocol: the standard that brings AI into clinical workflow

      Harvey Castro, MD, MBA | Tech

MedPage Today Professional

An Everyday Health Property Medpage Today
  • Terms of Use | Disclaimer
  • Privacy Policy
  • DMCA Policy
All Content © KevinMD, LLC
Site by Outthink Group

Why North American medical cannabis can’t compete globally
1 comments

Comments are moderated before they are published. Please read the comment policy.

Loading Comments...