Tag Archives: department of health

Florida On Path to Implement Medical Cannabis Legalization

By Aaron G. Biros
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Voters in Florida passed Amendment 2 last year with an overwhelming majority of over 70%. The constitutional amendment went into effect on January 3rd this year and regulators have until July 3rd to promulgate the rules.

The Florida Department of Health set up the Office of Compassionate Use (OCU) in July of 2014 after the passing of the so-called Charlotte’s Web measure (HB 843). That bill allows use of low THC/high CBD cannabis for treating seizures. The OCU is charged with the task of writing and implementing medical cannabis rules. Ongoing public hearings and workshops at the Department of Health (DOH) are meant to give stakeholders the opportunity to chime in on the proposed rules.

Florida State Capitol, Talahasse Stuart Seeger, Flickr
Florida State Capitol, Talahasse
Stuart Seeger, Flickr

On January 17th, the DOH published proposed rules and announced public hearings, seeking input from the public on the matter. The OCU is required to implement rules consistent with Amendment 2, but they would defer to the legislature if a bill were passed, promulgating rules consistent with Amendment 2 and the bill.

After the passing of Amendment 2, Sen. Jeff Brandes (R-St. Petersburg) filed SB614, a bill that establishes four license categories instead of the currently required vertically integrated business model. Notably, Sen. Brandes’ bill requires laboratory batch testing, whereas other proposed rules do not include such a measure. Sen. Brandes sees the DOH’s proposed rules as more of the same from the current medical program, according to a quote from FloridaPolitics.com. “Any proposal which seeks to mold the spirit of Amendment 2 into the narrow and flawed law on the books today should be rejected, and a more comprehensive strategy must take priority,” says Sen. Brandes. “I will support no bill, nor any rule, that maintains the established state sanctioned cartel system we have today, and I urge my colleagues to join me in proposing a free market solution for Florida.” He is referring to the seven licensed nurseries from the low THC/high CBD medical program, all of which are vertically integrated.

Matthew Ginder, senior counsel of the cannabis practice at Greenspoon Marder
Matthew Ginder, senior counsel in the cannabis practice at Greenspoon Marder

According to Matthew Ginder, senior counsel in the cannabis law practice at Greenspoon Marder, the biggest question for the legislature is how many licenses will they issue and what kind of structures are required for the licensees. Another big issue is the process by which patients access medical cannabis through their physicians. “The current program requires physicians to register as the orderer of medical cannabis, specify dosing and order medical devices, which is highly uncommon in other state programs,” says Ginder. “Sen. Brandes’ bill removes these requirements and is more consistent with other states by requiring a physician’s recommendation.” He says that bill would create four licenses: cultivation, processing transportation and retail.

Sen. Robert Bradley (R-5th District) also filed legislation (SB 406) to implement Amendment 2, but this bill is very different from Sen. Brandes’ bill. “Bradley’s bill is built upon the statutory framework that is already in place,” says Ginder. “Bradley’s is keeping vertical integration intact, seeking to also limit the amount of vertically integrated license based on a patient ratio of about 20,000 registered patients per license issued.” Bradley’s bill does not provide for independent lab testing requirements. Some might characterize Bradley’s bill as more of the same, allowing for the consolidation of existing monopolies.

Ginder says these are just two bills from the Senate, the House still has not proposed any bills. “We will most likely see more bills,” says Ginder. “We still don’t know what iteration of the bill or what language might be adopted and you can expect them to change as it moves through the committees.” With the legislative session beginning on March 7th, we can expect to see these bills debated on the floor and likely the filing of other legislation.

gm-horizontal-bw_nolaw (4)On February 1st, Greenspoon Marder announced the launch of their Organization for Safe Cannabis Regulation (OSCR) in Florida. By hiring lobbyists and making contributions to certain political candidates, the OSCR aims to advocate for a broad and fair marketplace, specifically “advocating for laws that create independently “registered” entities that perform specific functions along the production and distribution chain.”

Pennsylvania Temporary Rules for Growers & Processors Released

By Aaron G. Biros
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Last week, Pennsylvania Department of Health Secretary Dr. Karen Murphy announced the formation of temporary regulations for cannabis growers and processors in the state, according to a press release. Those temporary rules were published on Saturday, October 29. Secretary Murphy asked for public comment on developing regulations for dispensaries as well.padeptofhealthlogo-768x186

The PA Department of Health published the new set of temporary regulations this past Saturday, outlining “the financial, legal and operational requirements needed by an individual to be considered for a grower/processor permit, as well as where the facilities can be located.” The regulations also discuss tracking systems, equipment maintenance, safety issues, disposal of cannabis, tax reporting, pesticides, recalls and insurance requirements. “One of our biggest accomplishments to date is the development of temporary regulations for marijuana growers and processors,” says Secretary Murphy. “We received nearly 1,000 comments from members of the community, the industry and our legislative partners.”

The general provisions published on Saturday outline the details of the application process, fees, inspections, reporting, advertising and issues surrounding locations and zoning. The temporary regulations for growers and processors delve into the minutia of regulatory compliance for a variety of issues: including security, storage, maintenance, transportation, tracking, disposal, recall, pesticides and packaging and safety requirements. A list of pesticides permitted for use can also be found at the bottom of the rules.

PA Department of Health Secretary Dr. Karen Murphy
PA Department of Health Secretary Dr. Karen Murphy

The document discusses the regulations for performing voluntary and mandatory recalls in great detail. It requires thorough documentation and standard operating procedures for the disposal of contaminated products, cooperation with the Department of Health and appropriate communications with those affected by the recall.

The department has yet to release temporary regulations for laboratories and dispensaries, but hopes to do so before the end of the year. “I am encouraging the public – and specifically the dispensary community – to review the temporary regulations and provide us with their feedback,” says Secretary Murphy. “The final temporary regulations for dispensaries will be published in the Pennsylvania Bulletin by the end of the year.”

Since Governor Tom Wolf signed the medical cannabis program bill into law in April 2016, the state has made considerable progress to develop the program, including setting up a physician workgroup, public surveys for developing temporary rules and a request for information for electronic tracking IT solutions. The PA Department of Health expects to implement the program fully in the next 18 to 24 months.

Marijuana Matters

The Legal State of Cannabis in Florida

By David C. Kotler, Esq.
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It is now December of 2015 and we are one year removed from the loss at the polls of an amendment that would allow for full spectrum medical cannabis in Florida. The defeat of Amendment 2 allowed for the implementation of the Compassionate Medical Cannabis Act of 2014, albeit a rather rocky implementation, thus legalizing low THC, high CBD cannabis strains. I participated in many of the public meetings which took place and watched the different draft regulations set forth by the Florida Department of Health be debated, commented on and ultimately revised. The process underwent legal challenges and as of the publication of this, applications for five license holders were awarded.

As many might be aware, the Compassionate Medical Cannabis Act applicants were required to be nurseries continuously operating for over 30 years with a plant registration of 400, 000 plants as of the time of application. There were other relevant requirements, but the two foregoing were the most restrictive and narrowed the market of potential applicants.

Following in line with legislative means to put cannabis in the hands of a few large, Florida-centric entities, a Bill recently passed the Senate in Florida allowing for the expansion of the use of cannabis with higher THC content for patients with debilitating diseases under Florida Statute 499.0295. Presumably, the five licensees would then be authorized to expand their crop to include THC based plants and provide those to qualifying patients.

My fear all along has been that Florida would abandon the possibility of having a robust economic, yet patient-centric model not dissimilar to Colorado, Washington or Oregon, but more akin to what one might see in New York or what was narrowly avoided in Ohio. In fact, I have considered the possibility that should the new Amendment supported by United for Care passed, since that Amendment allowed for the Department of Health to promulgate the rules and regulations, that the Department could, assuming the five licensees are operational, merely give responsibility to the five licensees, allowing them to expand.

Alas, I believe, and I am happy to admit it, I may be wrong. In Florida, constitutional amendments require a review by the Office of Economic and Demographic Research. It is the focus of this body to analyze and report the economic impact that a particular amendment might have upon passage and effectuation. Data from numerous sources are reviewed and integrated into the Committee’s opinion. Of note, during my review of the October Economic Estimating Conference Meeting and Reports was the position taken by the Department of Health. Specifically, the Department of Health did not indicate that it could implement a system by merely expanding or working off of the framework it has for the Compassionate Medical Cannabis Act. Instead, the Department took the approach that a new set of regulations and guidelines, as well as departmental operations, would need to be implemented. In fact, it would need to be implemented to comply with the MMTC system authorized by the amendment. Whether one believes in the vertical model or one which licenses similar to Maryland and a few other states, the important point is that the Department of Health seemingly recognizes that a more robust model will have to be implemented.

So what does all this mean for patients and potential businesses in Florida? In regard to patients, I wish I could say that the potential for treatment through cannabis is foreseeable in the short term. However, I am not convinced of this. I do believe that the selections and process for which applications were selected under the Compassionate Medical Cannabis Act will be challenged, thus resulting in more delays. With regard to the Amendment and implementation should it pass, it will not be until the middle of 2017, approximately one and one-half years away. Should businesses begin preparations in Florida currently? In my honest opinion I believe it is hard to say. In the summer of 2014, I spent a lot of time counseling individuals and businesses on planning for the legalization of medical cannabis in Florida. Some clients were more aggressive than others and ultimately spent time and money, perhaps unnecessarily. On the flip side, I participated in the application process in Maryland and am of the belief that individuals who made application for Maryland cultivation licenses benefitted from an early start and preliminary planning.

I know a number of successful cultivators in legal states who moved on Maryland as a last minute decision once recognizing that although scored as part of an application, residency or lack thereof was not a bar to licensure. I am therefore of the opinion that certain preparation in advance is advantageous and allows alteration of the plan and adaptation at a later stage without wasting resources to accomplish much of the work that is capable of being accomplished in advance. I do believe there are a good deal of uncertainties, depending on how things move forward, as to what our model will look like and if that model will get into place, depending on the rollout of the Compassionate Medical Cannabis licenses as well as the possibility of some of the legislative initiatives catching wildfire, much as the Compassionate Medical Cannabis Act of 2014 did at the very end.