Terri Thrower, Ph.D.

Personal history •  Juvenile Idiopathic Arthritis & chronic pain •  Prescription Opioid use for 9 years •  2016 urged to reduce opioids • Medical Cannabis allowed in IL •  Stopped opioids and switched to medical

cannabis in 2017

Medical Cannabis in Georgia

•  2015: GA Enacted “Low THC Oil” law

•  2017: added “peripheral neuropathy” 2017 Greg and I moved to GA

What is “Low THC Oil” in GA?

•  “Low THC oil,” is defined as an oil that contains “an amount of CBD and not more than 5 percent by weight of THC, THCA or a combination of both THC/THCA, and which does not contain plant material exhibiting the external morphological features of the plant of the genus Cannabis.”

•  http://www.namsdl.org

Overview: Low THC OIL Registry in Georgia

•  Oil only: tincture/oil, concentrated oil •  No flower, and no smoking •  5% THC (or less) •  Qualified and registered patients or

caregivers •  Allowed to possess 20 fluid ounces •  Program administered by GA Department of

Public Health

GA Low THC Oil

•  9,561 Georgians (current total)

•  16 Qualifying conditions •  Most specify “end stage or severe”:

– Cancer – Alzheimer's – Parkinson’s – AIDS – ALS (Amyotrophic Lateral Sclerosis) – Multiple Sclerosis (MS)

16 Qualifying Conditions, cont’d…

• Crohn’s Disease •  Sickle Cell disease •  Seizure disorder • Mitochondrial disease •  Tourette’s syndrome •  Autism •  Epidermolysis bullosa

And finally

•  Peripheral Neuropathy •  Intractable pain •  Post traumatic stress disorder (adults only)

How do you register? •  Consult with your physician

•  If approved, the patient or patient’s caregivers’ information will be entered into DPH’s secure “Low THC Oil Registry” and a card(s) will be issued. – Process takes 15 days

•  •  Pick up your card(s) from one of five DPH

locations – Card expires in 2 years

•  Costs $25

But, where do you obtain it?

•  You don’t

• Currently, GA provides no legal, in-state method to purchase Low THC Oil

NC H401 (2019)

Directs the Department of Agriculture and Consumer Services to establish a medical cannabis supply system to provide a safe, regulated supply of cannabis appropriate for medical use by qualified patients with a valid registry identification card and to generate revenue sufficient to maintain and operate the system. Prohibits use of appropriations from the General Fund to establish or operate the system, which must be funded by authorized fees. Establishes criteria for licensing of medical cannabis supply centers (for the sale of cannabis, cannabis-infused products, and related paraphernalia to qualified patients and caregivers holding a valid registry identification card), producers of medical cannabis, and producers of cannabis-infused products, as well as for suspending or revoking licenses. Requires the Department of Agriculture and Consumer Services to maintain a confidential list of licensees and specifies when it may release information to law enforcement.

NC H401 (2019)

Requires the Board of Agriculture, in consultation with the Medical Care Commission, to adopt rules to implement the supply system, and provides for temporary rules in the interim. Specifies when medical use of cannabis may be asserted by qualified patients and caregivers as an affirmative defense to a criminal charge. Expresses the General Assembly's intent that the University of North Carolina system undertake scientific research regarding the efficacy and safety of the medical use of cannabis and, subject to approval by the UNC Board of Governors, directs the university to create the North Carolina Cannabis Research Program. Provides a severability clause. Directs the Department of Health and Human Services to issue temporary certificates for participation in the regulation medical supply system, as established, in the manner specified, and maintain a list of all temporary certificates issued. Makes conforming changes to GS 106-121 (definitions under Food, Drugs, and Cosmetics Act). Amends GS 105-164.4(a) to impose a privilege tax of 5 percent on specified cannabis sales.

HB 324 – Georgia’s Hope Act 2019 – Summary • Establishes an in-state cultivation and distribution program to give registered Georgia patients access to safe, regulated medical cannabis products they are already allowed to legally possess with their Low THC Oil Registry card. • Creates a 12-member “Low THC Oil License Oversight Board” as a division of the Department of Public Health to review applications and select manufacturers and distributors. • Creates an “Office of Low THC Oil Control” as a division of the Department of Public Health to oversee, control, and supervise the entire program

Establishes 5 Class 1 licenses. Those licenses allow a large company to grow, process and manufacture medical cannabis oil in Georgia. o Applicants must have $10,000,000 in capital o Non-refundable $50k application fee. $100k initial license fee; $50k annual license renewal o Option for 5 Safe Access Retail locations • Establishes 5 Class 2 licenses. Those licenses allow a smaller company to grow, process and manufacture medical cannabis oil in Georgia, with a limit of 20,000 sq. ft. for cultivation. o Applicants must have $1,000,000 in capital o Non-refundable $12.5k application fee. $25k initial license fee; $12.5k annual license renewal o Option for 3 Safe Access Retail locations

Both Class 1 and Class 2 license holders would be allowed to deliver anywhere in state with own labeled vehicles

Establishes 10 Safe Access Retail licenses. Those licenses allow a company to distribute medical cannabis oil in Georgia to registered patients. o Applicants must have $250,000 in capital o Non-refundable $10k application fee. $20k initial license fee; $10k annual license renewal o Option for 2 Safe Access Retail locations • Requires all products to undergo third-party safety and efficacy testing.

Comments:

Former Rep. Allen Peake on non-profit

Sheriff Couch (Hall County) on capacity and importance of all in one facilities (growth/production/distribution

Pat Malone interview WJUL/WJRB – “Follow the Money”

Price Controls?

Parent’s perspective – “I don’t care who makes money as long as my child has the medication they need.”

Georgia’s Hope Commentary

HB 324 – Georgia’s Hope Act 2019 – Facts HB 324 is a MEDICAL/HEALTH bill and will NOT impact Georgia Sheriffs’ operations whatsoever. • Only <5% THC oil product will be legal, same as today. All other products are illegal, same as today. • Legal oil products will be easier to identify, with detailed labels & bar codes from local companies. • Terry Norris, Executive Director of the Georgia Sheriff’s Association has said, “The path Georgia is taking now is a very treacherous and dangerous path. The sheriffs are serious when they say that marijuana is a dangerous, addictive gateway drug. Even though we’re not talking about legalization for recreational purposes, we believe all the notoriety of this discussion will lead to increased marijuana use by children.”

We find three main issues with this statement: 1. Low-THC oil is NOT a dangerous, addictive gateway drug. Many studies refute this, and even the National Institute on Drug Abuse says that “the majority of people who use marijuana do not go on to use other, "harder" substances.” 2. Not only is cannabis not a gateway drug, it can help patients reduce their opioids. Dr. David Bradford at UGA has published a study mathematically proving that states with access to medical cannabis have seen a 25% reduction in opioid deaths. This bill will directly save lives and save money in decreased Medicare & Medicaid costs. 3. HB 324 will NOT lead to increased marijuana use by children. In fact, a recent study even shows that teen use of marijuana is actually LOWER in medical cannabis states. Journal of Drug and Alcohol Abuse - Rebekah Levine Coley, Ph.D., a professor of developmental and educational psychology at Boston College – “The findings suggest that concerns over increasing levels of adolescent use in response to passage of medical marijuana laws are misplaced, and that that concern should not serve as a barrier to passing such laws.”

HB 324 is NOT about recreational use and will NOT lead to increased recreational use in Georgia. ▪ Virginia Galloway, Regional Field Director of the Faith and Freedom Coalition has said, “There is no difference, really, in the marijuana that we call medical and the marijuana that is recreational.”

We find four main issues with this statement: 1. Our law, the US government, and thousands of studies define marijuana as medicine. 2. Our doctors know the difference, our children know the difference, and patients know the difference. Many GA patients who can procure low THC oil have seen tremendous success, including epilepsy patients with drastically reduced seizures, cancer patients with decrease in pain and nausea, Crohn’s patients with complete remission, MS and Parkinson’s patients with decreased spasms and tremors, Autism patients with increased cognition and behavior, and pain patients who have reduced opioids. 3. A bottle of low THC oil is expected to cost ~$100-$150 per 2-ounce bottle, which is expected to last 1-2 months. Recreational users don’t want this product nor this price. 4. THIS bill only provides access to medical cannabis patients working with their doctor. Please don’t incorporate separate issues that may or may not be in future legislation.

Senate 2019 HB 324 Substitution

Class 1

Class 2

provide for dispensing licenses by the State Board of Pharmacy provide for the dispensing of low THC oil by pharmacies

Dispensaries

Each licensee can have 2 retail facilities.

No home delivery.

to prohibit ingesting low THC oil through vaping

Georgia’s Hope Comments to Senate 2019 HB324 Substitution

1. Regarding the university approach, we need the “right of first refusal” language removed from the bill. We have been told by the Lieutenant Governor’s office that the two private licenses can proceed without universities’ right of first refusal, but their language in their substitute is confusing and appears to be added at the last minute. Only one state has attempted university growth and it has failed to provide any medicine to patients after four years, so we MUST allow experienced licensed companies to begin their operations quickly. 2. Licensed companies cannot be limited to only two licenses for ALL Georgia patients. This will not provide access to everyone. Available licenses must be allowed to grow with the demand of patients. We suggest adding one Class 1 license and one Class 2 license for every 10,000 patients added to the Low-THC oil registry.

3. Patients must have home delivery as originally included in HB 324. Many patients are bed-ridden and have no means of transportation to visit a safe-access retail location. Products will be tracked all the way to the patient, regardless of whether they’re able to visit a safe access location or not. 4. All experienced companies must be able to apply. The Senate Substitute contains language preventing companies who have made any campaign contribution within the last five years, as well as any company providing recreational products in legal recreational states. This language acts as a “poison-pill” as it restricts any Georgia company that has made any campaign contributions to anyone, as well as any company with expertise in making medical cannabis products simply because they are following laws in other states.

5. The Senate Substitute needs to include other extraction methods besides ethanol, such as CO2. The licensed companies need to determine the safest, most efficient extraction method. 6. The Senate Substitute states that licenses are only applicable for 5 years, but their bill is silent on what happens to licensees after 5 years.

We have many more concerns about the Senate Substitute to HB 324, including limits on advertising, removal of testing language, reduction of the oversight commission from 12 to 5 members, inclusion of a 7% tax, and the legality of pharmacy participation. We are unsure why the Lieutenant Governor and the Georgia Senate decided not to listen to what patients were telling them would work, and to make drastic changes at the last minute to a bill that had already been researched and had overwhelming support.

On-going federal issues with both THC and CBD

Controlled Substances Act of 1970 still places marijuana (THC and CBD) as Schedule I controlled substance

Branded Marinol (synthetic THC) is Schedule III

Branded Epidilolex (“pure” CBD) is Schedule V

FDA cannot sanction placing a DEA scheduled drug in food products

Strengthening the Tenth Amendment Through Entrusting States (STATES) Act -

The act would amend the Controlled Substances Act of 1970 to exempt from federal enforcement individuals or corporations in states who are in compliance with U.S. state, U.S. territory and the District of Columbia, or tribal law on cannabis, with certain additional provisions such as minimum ages.