The History of
The Florida Medical Cannabis (Marijuana) Program
The Florida Medical Cannabis Alternative Treatment (FMCAT) Program
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The Florida Compassionate Medical Cannabis Act of 2014
In 2014, Florida passed its first medical cannabis law entitled the Florida Compassionate Medical Cannabis Act of 2014(FCMCA 2014). The FCMCA and its supporting regulatory framework created a new alternative medical treatment program with a myriad of rules regarding benefit entitlements, rights, duties, obligations and standards of care affecting every program participant. The participants face many unique legal-medical issues and challenges as they attempt to navigate the unknown waters of the Florida medical cannabis alternative treatment (FMCAT) program. With medical cannabishitting Florida’s shores, a new demand for professional services was essentially created. Professional administrative and managerial service providers will be necessary to assist FMCAT program participants with meeting their legal obligations to keep them in strict regulatory compliance and out of legal trouble.
In 2014, mothers of children suffering from severe and life-threatening epileptic conditions lead the drive to allow patients with certain medical conditions to use a low-THC form of cannabis as an alternative medical treatment. The Florida Department of Health (FDOH) was charged with the duty of developing the administrative rules and they developed a very strict regulatory framework to implement the new law.
Florida is a very conservative southern state that demands full control of its budding medical cannabis industry. As a control mechanism, Florida has rolled out a ‘vertically-integrated’business model whereby only five (5) nursery-lead dispensary organizations were initially authorized to cultivate, process and dispense non-smoking forms of low-THC medical cannabis and derivative products for all of the state’s qualifying patients. Unlike many other states, Florida has made it illegal for patients and/or caregivers to cultivate their own cannabis supply at home.
Florida justified this strong regulatory approach in fear of opening up “Pandora’s Box” and allowing ‘pot shops’ or ‘pot doc shops’ to pop up on every city corner of the state. Florida is determined not to become another ‘wild-wild-west’ medical cannabis state like California or Colorado. It will not be easy to obtain medical cannabis in Florida. State regulators will maintain a strict chain of custody on all medical cannabis productsto prevent diversion and other illegal activities. Florida has allowed local governments and municipalities to make up some of their own rules and regulations on how to treat the new medical cannabis industry within their own jurisdictional borders, but the state has reserved the regulatory power over the cultivation and processing of medical cannabis products.
Under the 2014 law, doctors were supposed to have been able to start ordering non-euphoric marijuana in January 2015. But legal challenges to the rule-making process and the original selection of the nursery-run dispensary organizations delayed implementation of the program until the summer of 2016.
In the fall of 2015, health officials selected the first five (5) nursery groupsas "dispensing organizations" to cultivate, process and dispense the low-THC cannabis products. However, more than a dozen (13) challenges were filed with DOAH by some of the original twenty-eight (28) losing applicants.
The five (5) nurseries selected to be the first dispensing organization in the five (5) regions are as follows:
1Hackney Nursery Quincy Northwest NW
2Chestnut Hill Tree Farm Alachua CountyNortheastNE
3Costa Nursery FarmsMiami Southeast SE
4 Alpha FoliageHomestead Southwest SW
5Knox NurseryWinter GardenCentral C
In 2015, the Legislature adoptedthe Right to Try Act (RTTA). The RTTA authorizes an eligible patient with a “terminal condition” (meaning that the patient will die within one year if the condition runs its normal course) to receive an “investigational drug, biological product, or device” (meaning a drug, product, or device that has successfully completed phase 1 of a clinical trial but that has not been approved for general use by the United States Food and Drug Administration).
In the 2016 legislative session, a bill was introduced to amend the RTTA to allow for an expansion of the use of medical cannabis to treat the terminally ill. House bill HB 307 (and Senate mirror-bill SB 460) authorized dispensing organizations to cultivate medical cannabis, allowing for the use of the whole cannabis plant to make medicines, not just cannabis limited to certain cannabinoid compositions (ie, low-THC cannabis). The bill allowed physicians to order (high THC) medical cannabis only for qualified patients who have been diagnosed with a terminal condition under the RTTA.
The 2015 RTTA was an essential vehicle used to revise the new Florida MCAT program so as to allow for the cultivation and use of high-THC plants (in limited situations) and to make some finishing touches to the existing regulatory framework before the November 2017 vote on Amendment 2. Provisions were included to address certain concerns, loop holes and matters that were not addressed or overlooked when the first set of laws, rules and regulations were created by the legislature and the FDOH.
Many legislators tried to use these RTTA bills to try to expand and revamp the scope of the Florida MCAT program even more. HB 307 was eventually substituted for SB 460. HB 307 was introduced to the Senate floor, and on 02/25/16, more than thirty (30) amendments stacked up on the bill. In a rare legislative move, Senate President Andy Gardiner yanked the medical marijuana measure off the floor and sent it back to committee for another vetting.
The legislatorshad a very heated debate regarding the proposed bills and amendments. Some of the legislators were concerned that the current law restricts the cultivation, processing and dispensing to only five (5) lucky companies that would become very rich and the largest MC farms in the U.S.; that basically, the Legislature had set up five (5) state-sanctioned ‘drug cartels’; that the legislation failed to utilize a free-market approach and principles and deemed ‘un-American’; that future dispensing organizations (DOs) would be at a great competitive disadvantage to the initial five (5) selected entities; that these DOs would be able to control both the supply and the price of medical cannabis products; that other states allowed for patients to grow their own medicine which significantly increases the availability and lowers the cost of those medicines for which the patient bears the full burden of paying for (since Medicare and insurance health policies will not cover these expenses); that the bill was so restrictive and complex that the patients would find it difficult to even get MC medicines; that it was unreasonable to allow only five DOs with thirty (30) year old nursery partners to be eligible to apply for a DO license; that other agricultural and food source companies would be better choices than nurseries to be DOs; that other legal MC states allow for more qualifying medical conditions so that more needy patients can participate in the program; that despite the fact that these states have larger patient population bases, no legal MC state has yet to hit the 250,000 patient mark that would trigger and allow another three (3) DOs to be chosen under the proposed bill; that patients should not have to be on their ‘death beds’ just to qualify for high-THC MC medicines and that other patients’ lives could be extended and/or made better by expanding the list of qualifying medical conditions and uses; that only a few physicians have signed up due to lack of incentive to participate in the program; that the Legislature itself was to blame for the dozen legal challenges to the DO selection process since they insisted on implementing a vertically-integrated system in fear of losing full control of all of the FMCI players; that money and greed took hold of the process subsequent to the passage of FCMCA 2014; that the original legislation was about helping people and sick children, but that two (2) years later, these needy people still have not been able to get any MC medicine due to the system that the Legislature created; that this system was designed for profit and not about helping sick children and people; that the bills were written to politically benefit only a few well-connected folk; that the focus so far has been on who gets the golden tickets for DO licenses and the creation of the strict regulatory process and NOT on the needs of the patients who are still looking for their medicine to come to market; and that next year, the Legislature needs to put into place a better system, and done more like the rest of the legal MC states for the good of the patients.
On 03/03/16, HB 307 passed the House by a vote of 99-16. That same day, the Senate voted on all of the filed thirty-plus (30+) amendments. Despite all of the good things and merits that the amendments stood for, including an amendment to allow for the use of medical cannabis to treat U.S. Veterans for post traumatic stress disorder (PTSD) and traumatic brain injuries (TBIs), the Senate ended up voting against all but one to three (1-3) of the amendments. Fearing that the bill was in jeopardy of not passing before the close of the legislative session on 03/11/16, Senate members were asked to vote against all of these amendments so that the bill passed by the Senate would mirror the bill passed by the House. On 03/07/16, the bill finally passed the Senate by a vote of 28-11. The bill was presented to Governor Rick Scott, and on 03/25/16, he signed HB 307 into law, effective that same date.
In February 2016, an administrative law judge found that health officials had wrongly disqualified
San Felasco Nurseries, which received the highest score in the Northeast region. Thus, the Department of Health granted the Gainesville-based grower the sixth (6th) dispensing organization license on April 4, 2016.
Under the FDOH administrative rules created to establish the regulatory structure to support the FCMCA 2014 (Florida Administrative Code, F.A.C. 64-4), dispensing organizations (nurseries) were required to begin dispensing medical cannabis derivative products within 210 days of passing a DOH inspection of their growing and processing facilities and being granted cultivation authorization. As of early February 2016, all five (5) of the nurseries initially selected had requested cultivation authorization ahead of the deadline.
On 02/24/16, Alpha Foliage became the first licensed nursery (DO) to legally plantmarijuana for medical use in Florida.
On July 26, 2016, the FMCAT Program finally got under way when Trulieve opened their first retail outlet in Tallahassee, Florida, and made history. Trulieve reported that the company fielded 500-600 phone callswithin 24 hoursfrom patients, caregivers and physicians calling for information about medical cannabis and how to qualify and participate in the Florida MCAT program. Trulieve CEO Kim Rivers said that the biggest challenge facing the fledgling FMCAT program is educating the community,physiciansandpatients in terms of “the steps” required to obtain the legal medical marijuana in Florida. She believes that the industry is going to steadily ramp up with time, but only after much education is done upfront.
In July of 2016 when the program opened up, the FMCAT programbarely existed. It consisted of only one (1) opendispensary retail store (Trulieve), 96physicians and less than 100patients registered in the program.
At the beginning of year 2017, the dispensaries had only about six (6) retail stores open throughout the state. There were approximately 340physicians and 1500patients registered in the program. On July 3, 2017, the Florida medical cannabis (marijuana) laws implementing Amendment 2 went into effect. At that time, there were more than 900physicians and20,000patientsregistered in the program and seven (7) licensed dispensaries, now called Medical Marijuana Treatment Centers (MMTCs).
As of 08/15/17, there were over1002physicians and approximately 30,000patients registered the program, and twelve (12) licensed dispensaries now called Medical Marijuana Treatment Centers (MMTCs)
with sixteen (16) known retail outlets posted on the Office of Medical Marijuana Use (OMMU) website.
October 3, 2017 was the DEADLINE for the state of Florida to have the entire program up and running, including the licensing of a total of seventeen (17) MMTCs. Each of these MMTCs will be allowed to open twenty-five (25) retail outlets and to deliver cannabis-based medicines/delivery products throughout the state.
Thus, Florida could have 425 MMTC retail outlet stores open in no time at all.
There are now thirteen (13) licensed MMTCs as the result of two (2) successful administrative law challenges and the new SB 8-A law mandates. The Florida Department of Health failed to meet a October 3, 2017 deadline to license another five (5) dispensaries (now called Medical Marijuana Treatment Centers (MMTCs), but soon there will be seventeen (18) licensed dispensaries to operate in the state. As of 12/22/17, there were reportedly1293 (or 1331)physicians and approximately 63,054patients registered the program.
The Florida Medical Cannabis Industry (FMCI) is estimated to blow up into a $500 Million-$1.5 Billionindustry in the next 2-3 years. Many find this hard to believe by just looking around at the current Florida landscape. But nevertheless, those are the estimates ...
Floridais the nation’s third (3rd) most populated state with more than 20 million people. Florida’s potential medical cannabis market base is insurmountable, but estimated to reach anywhere between 400,000-500,000 patients. Per a 2015 study done by the Florida Legislature’s Office of Economic and Demographic Research (EDR), at least 250,351caregivers and 1,789 treatment centers and18,000physicians would be needed to service an estimated417,252patients. That study was conducted before a 2016 law (HB 307) expanded the program to include terminally ill patients; so most people believe that the actual potential medical cannabis market will be at least 450,000-500,000 eligible patients. As more and more patients and doctors sign up, more dispensary stores will open throughout the state and the MCAT program will begin to grow rapidly.
By comparison, Colorado has a total population of 5.5 million people and has only 106,000registered medical cannabis patients. Colorado cleared around $1 billion in combined sales by the end of year 2016 with medical marijuana sales accounting for 40% and adult recreational sales accounting for 60% of the total sales. To date, Colorado has raked into its coffers more than $500 million that has allowed the state to apply that money wisely to bolster many of their public service and education programs.
Conservatively, Florida expectsapproximately 500,000patients will sign up in the next 2-3 years; but many proponents believe that under Amendment 2, the patient population could swell to a figure realistically closer to 1 millionpatients. Regardless, the FMCAT program will soon become a huge economic force.
Until this year (2017), the breadth and scope of the FMCAT program has been quite limited.
Under the old law (as well as the current law), only allopathic (MD) or osteopathic (DO) physicians with active and unrestricted licenses in Florida could (and can) participate in the program.
Before 2017, a qualified physician could “order” medical cannabis derivative products for only
four (4) qualifying medical conditions (QMCs): cancer, seizures, muscle spasms and terminal illness.
The physician was allowed to order:
1Low-THCcannabis(non-euphoric)to treat qualified patients suffering fromcancer,or from a physical medical condition that chronically produce seizures or severe and persistent muscle spasms;
2Full-Plantmedical cannabis(psychoactive, high-THC) to treat eligible terminally ill patients diagnosed with less than (1) one year left to live; and
3The physician could also order cannabis delivery devicesfor the patients to use to administer low-THC cannabis or (full plant) medical cannabis.
Under the old FMCAT laws (2014-2016), the medical cannabis patient base was quite limited.
By most estimates, only around 100,000-150,000 patients would have potentially qualified for the program under the limited list of four (4) QMCs.
On November 5, 2014,Floridians went to the ballots to vote on a medical cannabis (marijuana) legalization constitutional initiative. Amendment 2 failed to reach the required super-majority vote (60%) at the ballot that year by a very slim margin (58.6%). On November 8, 2016, US General Election Day, a revised Amendment 2 passed at the ballots by a landslide (71.2%). In a special legislative session, Senate bill SB 8-A was passed and Governor Rick Scott signed it into law implementing Amendment 2effectiveJune 23, 2017.
Florida Constitutional Amendment 2 has significantly opened the Florida MCAT program up to a substantially larger marketing segment and pool of Florida patients. Patients cannow qualify touse full plant (including high-THC plant strain) medicines and treatments under a greatly expanded list ofqualifying medical conditions(QMCs). Now, there aretwelve (12) qualifying medical conditions(QMCs), plus a "catch-all" QMC provision for patients who can show that their medical condition(s) is/are "of the same kind or class as or comparable to those (12 QMCs) enumerated".
Although the FCMCA passed more than three (3) years ago, the actual Florida MCAT program just came online and opened in late July of 2016. Since then, state authorities have been preoccupied with promulgating the rules, setting up the basic regulatory framework, selecting the initial dispensary winners, addressing rule and dispensary legal challenges and getting the cultivation and processing of medical cannabis under way. In all of this chaos, Florida officials have regrettably failed to address the basic needs of the participants who will mean the very most to the system itself.
Patients, caregivers, physicians and the community at large havenot been afforded very much information about the program, nor have they been given much meaningful advise, education or instruction on how to participate in the program. Patients and caregivers do not know what to do and they do not know what medical information they need in order to prove that they qualify for the MCAT program. They do not know how to find a qualified doctor to treat them or their loved ones, nor do they know how to discuss the medical cannabis alternative treatment issue with their conventional treating physicians. Physicians do not know enough about medical cannabis properties or the legal risks of recommending medical cannabis to feel comfortableabout program participation. Although intrigued, doctors understandably remain skeptical and apprehensive about the merits of medical cannabis and the Florida MCAT program itself. Doctors wonder whether participation in the Florida MCAT program is really worth all of their time, effort and risk.