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January 22, 2019
MARIJUANA MYTHS AND FACTS: The Future of Cannabis in the Pharmaceutical Industry
Introduction of Keynote Speaker - John Oster
Ms. Karina Lahnakoski: Vice-President Quality and Regulatory at Cannabis Compliance Inc. She has expertise in International cannabis licensing, and 20 years experience in regulated industries (cannabis/bio/pharmaceutical/medical device).
Marijuana Plant Overview
- The female plant has centuries of experience in medical use and 95 years of prohibition.
- The plant contains two well-known molecules: THC and CBD.
- THC is psychoactive; CBD is not.
Key Milestones for Cannabis Legalization in Canada
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8000 B.C.
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The use of hemp is traced back as far as this time. Hemp is cannabis with a low level of THC (<0.3%) and is used for textiles and fibres.
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1923 A.D. (Canada)
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Narcotics Drug Act; cannabis is added as a scheduled drug without much deliberation justifying this action.
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1996
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The Terry Parker case paves the way to legalize medical marijuana. Terry Parker suffered seizures and could only find relief from marijuana. Access for other patients remains difficult at this time.
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2001
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Legal framework for medical marijuana is developed, called the Marihuana Medical Access Regulations (MMAR). All Patients needing medical marijuana can possess the dried flower and must have a government-issued license signed off by a doctor.
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2014
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The Marihuana for Medical Purposes Regulations (MMPR) replaces the MMAR and allows patients to access medical cannabis through a licensed producer (LP). There is an influx of LPs getting Health Canada approval.
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2016
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Access to Cannabis for Medical Purposes Regulations comes in effect.
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October 17, 2018
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Legalization of recreational cannabis through Bill C-45, the Cannabis Act.
The federal government provides licenses for LPs and the provincial governments decide how to distribute the products. There are different distribution models throughout Canada: public retailers, private retailers, online system.
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December 22, 2018
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New regulations approving edibles and extracts.
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Relevant Information for Product Development
- Schedule II of the Controlled Drugs and Substances Act specifically used to list cannabis, but that part of it has been repealed; cannabis is no longer controlled, but synthetic cannabinoid receptor agonists (e.g. Nabalone) are still on the list.
- The Cannabis Act allows for several different types of licenses:
- Cultivation License: to grow cannabis
- Processor License: to make cannabis products
- Medical Sales License: to sell for medicinal purposes (This is the license Pharmaprix uses.)
- Analytical Testing License
- Research License: for R&D — New
- Cannabis Drug License (CDL): to manufacture pharmaceutical products — New
- Product types:
- Dried cannabis: flower or pre-rolled joint
- Oils: in a bottle or capsule (will soon be reclassified as an extract)
- Extracts
- Edibles: solid or liquid form, but can’t be appealing to children
- Extracts for inhalation
- Topicals: creams, lotions, etc.
- There are restrictions on THC concentrations and packaging.
- Non-medical vs. medical cannabis:
- The regulations and the product types are the same, but the distribution differs.
- The quality and security review processes are the same.
- There is a pre-market review for medical cannabis to approve the health claims.
- The manufacturing requirements are the same, but consumer cannabis uses Good Production Practices (GPP) while medical cannabis uses Good Manufacturing Practices (GMP). Both GPP and GMP are quality management systems, but they differ slightly: one of the biggest examples is that if you are manufacturing a drug under GMP, you need to have an expiry date and a stability program to support that expiry date. That’s not required under GPP, in which all that is needed is the production date. This difference affects the movement of the product, as do the UN treaties we have — most other countries have not decriminalized or legalized marijuana yet, so we have a lot of restrictions on how we can move cannabis internationally. Canada does not import cannabis, but Canada is becoming a major exporter of medical cannabis, particularly as many EU countries are considering legalizing medical cannabis. Any company that wants to export to Europe needs to meet GMP requirements because that’s what is established over there, so there is a shift in the industry to do that.
- The global cannabis market was valued at 11.4 billion dollars and has a huge annual growth projection of 17.1%.
- The chronic pain segment alone is about 40% of global revenue.
- Cancer is the fastest growing segment in medical cannabis revenue.
- Medical cannabis is expected to outpace the recreational market by 2021 because of the EU countries opening up this market.
- Pharma is getting involved in the cannabis industry and there are already some approved drugs, such as Marinol and Epidiolex.
- Advantages for the Pharma industry:
- Product consistency and safety
- Approval can be obtained in markets where medical cannabis is not legal — not every market is going to open to medical cannabis, but Pharma can get drug approval in those markets and bring those medicines to people who might not otherwise have access.
- Capital and regulatory expertise to get these drugs to market
- Disadvantages for the Pharma industry:
- Cost – high price tag for drugs
- A lot of work and investment to get drugs to market
- Can’t promote drug before approval or for unapproved uses — so, while the cannabis industry is already out there talking about it, the pharma industry can’t do the same until the drug is approved.
- Other important considerations:
- Patients can always have access to the recreational drug.
- Drug-drug interactions will impact the design of clinical studies. THC and CBD are inhibitors of the cytochrome P450 pathway.
- There is a huge demand for medical education.
- The “entourage effect”: the cannabis plant has many molecules and there are many strains that are grown in different ways; thus, smoking the plant is not the same as consuming an extract.
Medical Uses of Cannabis
- Indications being studied:
- Epilepsy — see the story of Charlotte’s Web
- Pain
- Fibromyalgia
- Nausea, vomiting
- Anxiety
- ADHD
- Multiple sclerosis
- Opioid addiction — cannabis may be used as an alternative to opioids
- Impact on the pain space:
- A self-reporting survey of patients using medical marijuana and opioids simultaneously asked patients, “Are you able to decrease your opioid dose by taking medical cannabis?,” “Do you have side effects from the cannabis?” and “Would you use cannabis as a substitute for opioids?” There was overwhelming agreement from the patients that they preferred cannabis over opioids.
- An American study examined the longstanding assumption that there will be less use of drugs in the long-term with the availability of medical cannabis. The study looked at states with and without medical use laws and validated the findings that where medical cannabis is available legally, the number of drug prescriptions for certain indications dropped. In the pain segment, it dropped dramatically.
- Impact on the cancer space:
- Cannabis is the fastest growing segment at 18.2%.
- Most medications will be for the treatment of symptoms, but the challenge during clinical trials will be teasing apart the impact of cannabis with that of the cancer drugs.
Industry players and collaborations
Common Cannabis Myths
Myth #1: Cannabis cannot be covered by insurance like prescription drugs.
Not true. There are private insurers that will reimburse and a huge push in Canada with Veterans Affairs to cover cannabis. This is becoming increasingly common.
Myth #2: Cannabis has only two molecules worth studying.
Not true. There are at least 113 known cannabinoids and more research being done every day.
Myth #3: Cannabis has a foul odour because of the THC.
The smell components are actually associated with terpenes, which are organic hydrocarbons also found in wine. When crystallized, CBD and THC are odourless and tasteless.
Myth #4: Cannabis as a medicine will be limited to dry cannabis or oil-filled capsules.
Here is where Pharma has an advantage with dosage forms because Pharma has already done that in the past with spray technologies, transdermal patches, topicals, suppositories, eye drops, etc.
Justine Garner
Freelance Medical Writer
Cell: (514) 605-5109
Courriel: jgarnerwriting@gmail.com
www.jgarnerwriting.com
