Veronique Urban

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On January 15, 2019, Governor Andrew Cuomo delivered his 2019 State of the State Address. Part of his address centered on the legalization of recreational marijuana in New York State.

The Cannabis Regulation and Taxation Act was introduced as part of the Governor’s Executive Budget, which is expected to be acted upon by April 1st. If it is approved, New York will join ten other states – Alaska, California, Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont and Washington – and Washington D.C., in adopting laws legalizing marijuana for recreational use.

As you may recall from one of our previous posts, as part of his 2018 State of the State Address Governor Cuomo directed the Department of Health (“DOH”) to conduct a study to determine the potential impact of a recreational marijuana program in New York State.

The Report from the DOH, issued in July 2018, concluded that the positive impacts of a regulated marijuana program in New York State outweigh the potential negative aspects. The Report stated that the regulation of marijuana benefits public health by enabling government oversight of the production, testing, labeling, distribution, and sale of marijuana. The Report further found that the creation of a regulated marijuana program would enable New York State to control licensing, ensure quality control and consumer protection, and set age and quantity restrictions.

Details of the program are still being developed, but the Governor’s proposed bill would create a new Office of Cannabis Management (OCM) which would administer all licensing, production, and distribution of cannabis products in the adult-use, industrial and medical marijuana markets. Governor Cuomo predicts that a recreational marijuana program in New York State will generate approximately $300 million in tax revenue and create jobs. That number could vary slightly, however, as the program would allow counties, as well as cities with a population of more than 100,000, to affirmatively opt out of the program and pass laws blocking one or more types of allowed marijuana operations.

During his 2019 State of the State Address Governor Cuomo also emphasized that the any implementation of a regulated marijuana program will also provide for the implementation of quality control and consumer protections to safeguard public health. His proposal would also automatically seal criminal records for marijuana offenses that are no longer crimes.

As with the other states that have legalized recreational marijuana, recreational marijuana use in New York State will be restricted to adults over the age of 21.

While there is growing support for a recreational marijuana program in New York, not everyone is optimistic that the Legislature will vote to legalize recreational marijuana as part of the state budget, which is due on April 1. At an event on January 31, 2019, Assembly Speaker Carl Heastie indicated that six weeks may not provide enough time to parse out the terms of such a complicated issue. He later tweeted: “Being honest and saying six weeks may not be enough time to come up with regulations, deal with economic impact on communities and the criminal justice aspects, somehow gets reactions of outrage instead of understanding and acknowledgment of the commitment to get this done…And done right.”

In response, Governor Cuomo said on February 1st during an interview with WCNY radio that he remains confident the Legislature can vote to legalize recreational marijuana as part of the state budget. “We’ll work very hard to get it done,” Cuomo said on WCNY radio. “In this business, six weeks is a lot of time. If we can’t do it right, then we’ll do it later.”

The Compassionate Care Act has expanded and changed each year since Governor Andrew M. Cuomo signed it into law in 2014 and 2018 was no different.

Among others, one big change that was made to the Medical Marijuana Program was the addition of opioid replacement as a qualifying condition[1] for medical marijuana. As a result of this change, patients with severe pain that doesn’t meet the definition of chronic pain can use medical marijuana as a replacement for opioids. The regulation also added opioid use disorder as an associated condition, allowing patients with opioid use disorder who are enrolled in a certified treatment program to use medical marijuana as an opioid replacement.

In 2019, New Yorkers will continue to see changes and tweaks to the Medical Marijuana Program as the State aims to improve the program. Change may also be on the horizon with respect to recreational marijuana use in New York State.

Medical Marijuana Update

On November 14, 2018, the New York State Department of Health published its Medical Use of Marijuana Under the Compassionate Care Act Two-year Report – 2016-2018. The purpose of the report is to provide an overview of the program’s activities since the last two-year report was published in 2016. You can view the Report for the years 2014-2016 by clicking here.

In the 2018 Report the DOH recommends “expanding the medical marijuana program to reach patients who may be self- medicating with marijuana from sources that are not regulated or held to the same high-quality standards as the medical marijuana products manufactured by registered organizations in New York State.”

In order to expand the program the DOH lists nine steps it will endeavor to undertake, some of which New Yorkers will likely see in 2019.

One of the changes the DOH wishes to make in order to expand and improve the program is to afford practitioners more clinical discretion in determining whether or not to certify patients for medical marijuana, based on an evaluation of the patient’s condition, past treatment and the overall risks versus benefits for each patient.

In addition, the DOH wants to increase the number of practitioners available to certify patients, by permitting all prescribers of controlled substances to humans to participate in the program. This is a change from current regulations that only allow physicians, nurse practitioners and physician assistants to certify patients to use medical marijuana.

In the 2018 Report the DOH also recommends increasing the number of caregivers for each certified patient to five caregivers per patient in hopes that this will allow for increased flexibility for families in providing care to their loved ones. Currently the number of caregivers for each certified patient is capped at two.

Recreational Marijuana Update

Nine states, plus Washington D.C., have all fully legalized marijuana use. As we had noted in New York May Consider Recreational Marijuana Legalization, in his January 2018 budget address Governor Cuomo called for an assessment of the possible impact of regulating marijuana in New York State. The Governor directed certain New York State agencies to evaluate the health, public safety, and economic impact of legalizing marijuana.

In July 2018, the DOH published its findings in the “Assessment of the Potential Impact of Regulated Marijuana in New York State.” Overall, the DOH indicated that it would be in favor of the establishment of a regulated marijuana program.

The positive effects of a regulated marijuana market in NYS outweigh the potential negative impacts. Areas that may be a cause for concern can be mitigated with regulation and proper use of public education that is tailored to address key populations. Incorporating proper metrics and indicators will ensure rigorous and ongoing evaluation.

A full summary of the DOH’s findings can be found in our previous blog post, NYS Department of Health Report Green Lights Legalization of Marijuana.

Following the issuance of the Report Governor Cuomo held Regulated Marijuana Listening Sessions, the purpose of which was to gather input from community members on the possible enactment of a regulated marijuana program in New York State. The Listening Sessions were held across New York State during September and October.

On November 21, 2018, a spokesperson for Governor Cuomo confirmed that creating a framework for legalizing adult marijuana use is among the administration’s 2019 legislative priorities.

The goal of this administration is to create a model program for regulated adult-use marijuana – and we determined the best way to do that was to ensure our final proposal captures the views of everyday New Yorkers,” said Tyrone Stevens, a spokesperson for the Governor. “Now that the listening sessions have concluded, the working group has begun accessing and reviewing the feedback we received and we expect to introduce a formal comprehensive proposal during the 2019 legislative session.

 

[1] Opioid replacement joins the following 12 qualifying conditions under the state’s Medical Marijuana Program: cancer; HIV infection or AIDS; amyotrophic lateral sclerosis (ALS); Parkinson’s disease; multiple sclerosis; spinal cord injury with spasticity; epilepsy; inflammatory bowel disease; neuropathy; Huntington’s disease; post-traumatic stress disorder; and chronic pain.

With so much happening in the cannabis industry we thought we’d take this time to highlight some of the industry’s most recent happenings.

  • Increasing Support for Decriminalization of Marijuana (Federal): On April 20, 2018, Senate Minority Leader Chuck Schumer of New York said he’ll introduce a bill taking marijuana off the federal list of controlled substances — in effect decriminalizing its use at the federal level. The bill is expected to be similar to the one proposed by Senator Cory Booker (D-NJ) in 2017. In a tweet to his Twitter followers Chuck Schumer stated: “The time has come to decriminalize marijuana. My thinking – as well as the general population’s views – on the issue has evolved, and so I believe there’s no better time than the present to get this done.”

FDA Approves Marijuana-Derived Drug (Federal): On April 19, 2018, advisers for the Food and Drug Administration unanimously supported the first-ever government approval of a medication made from cannabis. The drug, Epidiolex, is made from a purified ingredient in cannabis called cannabidiol, or CBD. It is intended to treat severe seizures in children caused by rare forms of epilepsy called Lennox-Gastaut and Dravet syndromes.

Cole Memorandum Update (Federal): On January 5, 2018, we discussed the rescission of the Cole Memorandum by the federal government. The Cole Memorandum outlined the federal government’s general policy prohibiting federal prosecutors from pursuing cases against people following marijuana laws in states that have legalized the drug. The rescission of the Cole Memorandum created much concern and confusion at the state level. In a change of direction, President Donald Trump stated on April 13, 2018, that he will support legislation protecting the marijuana industry in states that have legalized the drug. Republican Sen. Cory Gardner (D-CO) said that President Trump made the assurance to him during a conversation. “President Trump assured me that he will support a federalism-based legislative solution to fix this states’ rights issue once and for all,” Gardener said in a statement.

Marijuana Key Issue in Governorship Race (New York): In February 2018, we discussed Governor Cuomo’s statement during his annual budget address that New York should undertake a study of the possible impacts of legalizing recreational marijuana. The issue of legalization recreational marijuana at a state level is becoming a key issue for his campaign, especially in light of Cynthia Nixon’s recent comments. Ms. Nixon, who is challenging Governor Cuomo in a Democratic primary for the governorship, supports the decriminalization of marijuana. “I believe it’s time for New York to follow the lead of eight other states and D.C. and legalize the recreational use of marijuana,” says Ms. Nixon in a video she posted to Twitter.

New Medical Marijuana Dispensaries Poised to Open (New York): In Medical Marijuana 102 we reviewed New York medical marijuana dispensaries and the issuance by the NYS Department of Health (“DOH”) of licenses to five new companies in addition to the original five companies chosen by the DOH to manufacture and sell medical cannabis. The five new companies will be opening up a total of six New York City dispensaries, one of which will be in Manhattan, bringing the total number of medical marijuana dispensaries to nine.

Number of Certified Patients and Practitioners Continues to Rise (New York): In Medical Marijuana 103, we noted that 1,184 practitioners had registered with the DOH for the purpose of certifying patients for medical marijuana use and that 28,077 patients had been certified for such use. That number has grown exponentially since then – the DOH reports that as of April 17, 2018, there are now over 1,500 registered practitioners and over 50,000 certified patients.

As we’ve discussed in previous blog posts, marijuana, whether used for medicinal or recreational purposes, is classified as a Schedule 1 drug under the Controlled Substances Act (CSA). The CSA prohibits the manufacturing, distributing, dispensing or possession of certain controlled substances, including marijuana and marijuana-based products and services. In addition, the CSA makes it unlawful to sell, offer for sale or use any facility of interstate commerce to transport illegal substances, including marijuana.

In August 2017, U.S. Senator Cory Booker (D-NJ) and Representative Barbara Lee (D-CA) introduced bills to both chambers of Congress – the Marijuana Justice Act of 2017 – that seek to remove marijuana completely from the list of controlled substances, making it legal at the federal level.

Last year U.S. Senator Ron Wyden (D-CA) was the first senator to co-sponsor the Marijuana Justice Act. On Wednesday, February 14, 2018, New York Senator Kirsten Gillibrand announced that she is also co-sponsoring the Marijuana Justice Act to end the federal prohibition on marijuana.

“Legalizing marijuana is a social justice issue and a moral issue that Congress needs to address, and I’m proud to work with Sen. Booker on this legislation to help fix decades of injustice caused by our nation’s failed drug policies,” Gillibrand said in a statement.

The Marijuana Justice Act aims to implement a number of reforms relating to marijuana. The most significant reform would be the removal of marijuana from the list of controlled substances in the CSA. Such a reform would effectively end the federal criminalization of marijuana.

Other reforms proposed by the Marijuana Justice Act include: (1) providing incentives to states to reduce racial disparities in connection with arrests made for marijuana; (2) expunging federal convictions relating to marijuana possession; (3) allowing individuals serving time in federal prison for marijuana-related offenses to petition the court for resentencing; and (4) developing a community reinvestment fund to invest in communities most impacted by the failed War on Drugs, such as by providing in-job training programs, educational opportunities, public libraries and community centers.

There is growing support for removal of marijuana as a Schedule I drug under the CSA, especially as courts have recently held that only the Drug Enforcement Agency (“DEA”) can make such a change.

Most recently, on February 26, 2018, U.S. District Judge Alvin Hellerstein in Manhattan ruled dismissed a lawsuit seeking to overturn the United States’ prohibition of marijuana on the grounds that the ban was unconstitutional. Judge Hellerstein ruled that the lawsuit must be dismissed because the plaintiffs had failed to use administrative procedures within the DEA to challenge the ban. Judge Hellerstein said his decision “should not be understood as a factual finding that marijuana lacks any medical use in the United States,” but, rather, that the authority to make that decision lies with the DEA, not with the court.

As of now the Marijuana Justice Act has not seen much movement in Congress. Since its introduction it has been read twice and then referred to the Committee on the Judiciary. It will be interesting to see if additional senators act to support the Marijuana Justice Act as the debate over the decriminalization of marijuana continues.

New York is currently taking steps to investigate the possible legalization of recreational marijuana in New York.

In July 2017 we talked about the Marijuana Regulation and Taxation Act (“MRTA”), S.3040B/A.3506B, in Medical Marijuana 101: The State of the Law in NY. At that time, the bill, which seeks to regulate the growth, taxation, and distribution of recreational marijuana in New York, was sitting idly in the Senate Finance Committee. On January 11, 2018, however, the New York State Assembly Standing Committees on Codes, Health, and Alcohol and Drug Abuse held a public hearing to discuss the MRTA. The hearing reviewed the potential for allowing the regulated sale and adult possession of marijuana in New York and how it would affect public health and the criminal justice systems. A transcript and video recording of the hearing can be found here.

The hearing was held just days before Governor Andrew Cuomo’ annual budget address on January 16, 2018. During his budget address Governor Cuomo stated that New York should undertake a study of the possible impacts of legalizing recreational marijuana. The study would be undertaken by the NYS Department of Health, with input from state police and other state agencies, to determine the health and economic impacts of legalizing the drug.

“New Jersey may legalize marijuana. Massachusetts already has. On the other hand, Attorney General Sessions says he’s going to end marijuana in every state. So you have the whole confluence of different information,” Cuomo said during his presentation to the Legislature.  “I think we should fund [the Department of Health] to do a study. Let them work with state police and other agencies. Look at the health impact and economic impact,” he said during his address.

This is a change from Governor Cuomo’s position from last February in which he told reporters that he remained “unconvinced on recreational marijuana.”

This change of heart, however, shouldn’t come as a surprise to most New Yorkers. Momentum for marijuana reform has been building steadily in New York since the passage of the Medical Marijuana Act in 2014. A poll of New York voters released in late 2017 showed that over 62% of New Yorkers support making marijuana use legal in New York for adults over the age of 21. In addition, more than 60% of those polled stated that they prefer using revenue from a legal marijuana market to address New York’s budget deficit over other options such as increasing sales taxes, increasing highway and bridge tolls and cutting public service funds.

The recreational use of marijuana is already legal in a growing number of states, including Washington, Oregon, Nevada, California, Alaska, Colorado, Maine, Massachusetts and the District of Columbia.

In New Jersey, newly elected Democratic governor Phil Murphy stated in his inauguration speech that his vision for a “stronger and fairer New Jersey … includes a process to legalize marijuana.” He aims to legalize marijuana within his first 100 days in office.

In Massachusetts, Gov. Charlie Baker signed a bill legalizing recreational marijuana on July 28, 2017. The law permits adults over the age of 21 and who are not participating in the state’s medical marijuana program to legally grow up to six plants and to possess personal use quantities of marijuana up to one ounce and/or up to 5 grams of concentrate. The regulations also allow for the licensing of commercial marijuana production and retail sales. Regulations with regard to the commercial marijuana market will go into effect on July 1, 2018.

In January 2018 Vermont became the first state in the country to legalize marijuana by legislation rather than through a citizen referendum. The new law, H. 511, takes effect on July 1, 2018. Similar to the regulations passed in Massachusetts, the Vermont law authorize adults over the age of 21 to legally possess up to one ounce of marijuana, and/or to privately cultivate up to six marijuana plants. The regulations also impose new civil penalties for consuming marijuana while driving, and imposes additional penalties for those who operate a motor vehicle impaired with a minor in the vehicle.

What happens in New York remains to be seen, but it is clear that the debate over whether to legalize the recreational use of marijuana is just getting started.

Despite numerous states having legalized medical marijuana, and a handful of others having legalized marijuana for recreational use, it still remains impossible to obtain a U.S. federal trademark registration for marijuana products or related goods or services.

The U.S. Patent and Trademark Office (USPTO) is the federal agency charged with granting U.S. patents and registering trademarks. The USPTO registers trademarks based on the commerce clause of the Constitution (Article I, Section 8, Clause 3) and registration is governed under various rules of practice and federal statutes.

The USPTO Trademark Manual of Examining Procedure (TMEP) Section 907 explains that under Trademark Rule of Practice 2.69, “[u]se of a mark in commerce must be lawful use to be the basis for federal registration of the mark. . . . Generally, the USPTO presumes that an applicant’s use of the mark in commerce is lawful and does not inquire whether such use is lawful unless the record or other evidence shows a clear violation of law, such as the sale or transportation of a controlled substance.”

As we’ve discussed in previous blog posts, marijuana, whether used for medicinal or recreational purposes, is classified as a Schedule 1 drug under the Controlled Substances Act (CSA). The CSA prohibits the manufacturing, distributing, dispensing or possession of certain controlled substances, including marijuana and marijuana-based products and services. In addition, the CSA makes it unlawful to sell, offer for sale or use any facility of interstate commerce to transport illegal substances, including marijuana.

As a result of the CSA, U.S. trademark applications related to marijuana or marijuana related goods and services will be refused registration under TMEP Section 907. TMEP Section 907 further provides that “[r]egardless of state law, the federal law provides no exception to the above-referenced provisions for marijuana for ‘medical use.’” Recent decisions issued by the USPTO continue to deny the federal registration of trademarks relating to marijuana and related goods and services despite the legality of such products and services under state law.

Trademarks that reference marijuana but that are used in commerce on lawful products, such as clothing, may be registered with the USPTO. For example, the trademark “MARIJUANAMAN” was registered by the USPTO as the mark will be used in connection with books about cannabis. Similarly, the trademark THE MARIJUANA COMPANY was approved in connection with the mark’s use on clothing.

Since federal registration is not permitted for trademarks that cover the sale or transportation of marijuana, such trademark applicants must rely on state trademark filings for the registration of their trademarks. This has become an important issue since so many states have now enacted legislation legalizing the medical – and in some cases, recreational – use of marijuana.

State trademark registrations are more limited in scope than federal trademark registrations as they don’t offer national protection or afford a registrant a presumption of ownership and validity of the underlying trademark on a national level. They are relatively inexpensive to obtain, however, and can afford the registrant at least certain benefits under state law. States like Washington, Oregon, Nevada and Colorado already allow for the registration of cannabis-related marks.

Nevada, for example, enacted legislation governing the use of names, logos, signs and advertisements by medical marijuana establishments. Pursuant to NAC 453A.402, any such names, logos, signs and advertisements must be approved by the Administrator of the Division of Public and Behavioral Health. In addition, Nevada has established guidelines which provide design guidelines for medical marijuana establishments. The guidelines specify, among other things, that the overall appearance of the mark or advertisement must not be appealing to minors; not contain cartoon-like figures or illustrations; not contain humor and must avoid script, decorative or gimmicky fonts. The use of of marijuana slang in the mark or advertisement, such as pot or weed, is also strictly prohibited.

Most recently, as of January 1st, 2018, customers may also register cannabis-related marks with the California Secretary of State. In order to register the mark California requires that (1) the mark be lawfully in use in commerce within California; and (2) the mark match the classification of goods and services adopted by the USPTO. To be lawfully using the mark in commerce within California requires that the registrant be licensed by California to provide the goods and services for which he or she is seeking protection and that such goods and services have already been sold to the public. Unlike registration of a trademark at a federal level, California does not have an intent-to-use trademark application. As such, the mark must be in use prior to registering the mark with the Secretary of State.

New York has not yet enacted any special legislation or guidelines relating to the registration of marijuana-related trademarks with the New York Secretary of State. That may soon change, however, as more and more states start to allow state registration of marks relating to marijuana and marijuana-related goods and services.

As we previously discussed in Medical Marijuana 103: Patient and Practitioner Regulations in New York State, practitioners in New York must be registered with the New York State Department of Health (“DOH”) in order to certify patients for medical marijuana use. The DOH maintains a list of registered practitioners on its website, however such list is woefully incomplete. As of the date of this writing there are over 1,360 providers statewide that are registered to certify patients for medical marijuana, but only 32 percent are included on the public list maintained by the DOH.

On Wednesday, November 28, 2017, Governor Andrew Cuomo signed a bill which requires the the DOH to list on its website all practitioners who are certified to recommend medical marijuana to patients.

Sen. Diane Savino (D-Staten Island), the primary sponsor of the bill, stated that one of the biggest complaints from patients in the medical marijuana program was finding a registered doctor.

“People complained that it was difficult to find a doctor near them so they could  be certified as a patient. Because the Department of Health kept the list proprietary, it made it that much harder for patients,” said Senator Savino.

A vote on the bill was held in June 2017, with 62 senators voting in favor of the bill and only 1 senator opposing it. The bill requires that the name, contact information, and other information relating to practitioners registered with the DOH to certify patients for medical marijuana be public information and that the information be maintained on the DOH’s website in searchable form. There is an exception, however – practitioners may still opt-out if they do not wish for their information to be public by informing the DOH in writing. The new requirements will be implemented sixty (60) days after the bill was signed into law by Governor Cuomo.

Sen. Savino was also the main proponent of the bill signed on November 11, 2017 by the Governor which adds post traumatic stress disorder to the list of qualifying conditions treatable with medical marijuana in New York State. The date on which the bill was signed into law is no coincidence, as veterans groups in particular had urged Governor Cuomo to allow those with PTSD to use medical marijuana. According to the Department of Veterans Affairs, about eight million adults suffer from PTSD in any given year, including tens of thousands of Afghanistan and Iraq veterans. Somewhere between 11% and 20% of those vets will suffer from it each year.

On November 1, 2017, the Food and Drug Administration (FDA) published a release concerning its issuance of warning letters to four companies concerning the marketing of products containing cannabidiol (CBD).

CBD is a cannabinoid found in hemp which lacks the psychoactive ingredient THC. Hemp and its derivatives are legal to import to the US and ship from state to state. According to a 2013 review published in the British Journal of Clinical Pharmacology, CBD may help in reducing nausea and vomiting; seizures; psychosis disorders; inflammatory disorders; tumor and cancer cells; and anxiety and depression disorders. CBD can be marketed in a variety of product types, such as oil drops, capsules, and topical lotions. CBD oil is legal in New York State.

The four companies that received warning letters from the FDA — Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC — are accused of illegally selling CBD products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. The FDA’s warning letters further provide that the four companies distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer’s and other serious diseases.

Examples of claims made by these companies include:

  • “CBD makes cancer cells commit ‘suicide’ without killing other cells”
  • “…considering the lack of risks associated with CBD it is an attractive alternative or addition to anyone’s treatment for Alzheimer’s disease.”
  • “Adding CBD oil as part of your daily Alzheimer’s medicine routine has a good chance at delaying the progression of the disease…”

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” said FDA Commissioner Scott Gottlieb, M.D. “There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

Each company is being offered fifteen (15) working days after receipt of the warning letter to notify the FDA in writing of the specific steps that it has taken to correct the violations. The FDA letters warn that the company’s failure to correct the violations promptly may result in legal action, including product seizure and injunction.

In our previous post, Medical Marijuana 103: Patient and Practitioner Regulations in New York State, we discussed that patients certified for medical marijuana use can designate up to two caregivers. Caregivers can assist patients who are unable to pick up medical marijuana at a dispensing facility or are unable to administer medical marijuana to themselves properly.

Previously the Medical Marijuana Program only allowed for designated caregivers to be natural persons. On October 5, 2017, however, the New York State Department of Health (“DOH”) issued emergency regulations that expand the definition of caregiver to allow certain facilities to be designated caregivers. By expanding the definition in this way, patients who are located in or reside at certain facilities can designate their facility as their caregiver, thus making it easier for such patients to obtain medical marijuana.

The new regulations define a designated caregiver as either a natural person or a facility. The term “facility” is further defined as, among others, hospitals, adult day care facilities, community mental health residences, and private and public schools. In addition, each division, department, component, floor or other unit of a parent facility may be designated as a “facility” for purposes of being designated a caregiver.

Just like natural persons, facilities will need to register with the DOH in order to be designated a caregiver for purposes of the Medical Marijuana Program. Once registered with the DOH facilities will be authorized to lawfully possess, acquire, deliver, transfer, transport and/or administer medical marijuana to certified patients residing in, or attending, that facility.

The DOH considered alternatives prior to issuing the emergency regulations, stating:

The Department could have chosen to keep the status quo and not allow patients to designate facilities as designated caregivers. The Department could have also allowed certified patients to designate an individual within the facility to be a caregiver. However, these options are not viable since patients in facilities may be cared for by multiple staff members in the course of a day. Certified patients have severe debilitating or life-threatening conditions and the regulatory amendments would help to prevent adverse events associated with abrupt discontinuation of a treatment alternative that may be providing relief for certified patients in these facilities.”

The regulations were published in the New York State Register on October 25, 2017. The DOH will accept comments from the public for a minimum of 45 days following the date of publication. After publication in the Register and receipt of public comment, the agency may either adopt, revise or withdraw the proposal. This change is just one of the latest revisions implemented by the DOH in an attempt to strengthen and expand New York’s struggling Medical Marijuana Program.

This blog post is the last in a series of articles discussing the current state of the law in New York regarding medical marijuana. To read the previous post in the series, Medical Marijuana 105: Marijuana in the Workplace, click here.

Despite its potential, New York’s Medical Marijuana Program is off to a slow start. The Program’s struggle is mostly due to the fact that it is one of the most restrictive medical marijuana programs in the country. For example, medical marijuana offerings are limited to mostly liquids, oils and capsules and only state-certified marijuana patients are allowed to enter the limited number of dispensaries. In September 2017, the NYS Department of Health (“DOH”) announced that it would be issuing new regulations in an effort to bolster the Program. Under the new regulations, patients certified for medical marijuana use will have access to more types of products including lotions, tablets, lozenges, patches and more. In addition, prospective patients and practitioners interested in the medical marijuana program will be able to enter a dispensing facility to speak directly with representatives of registered organizations, learn about products, and get information about the medical marijuana program. The regulations will also allow doctors to take a shorter, two-hour program to become eligible to certify patients for medical marijuana use as opposed to the four-hour program that was originally required.

Since the Program’s inception the DOH has also attempted to expand the reach of the Program by adding new qualifying conditions for medical marijuana use. The addition of chronic pain as a qualifying condition, for example, led to a surge of patients seeking to become certified for medical marijuana use. The DOH announced in August 2017 that the number of certified patients increased by 10,744 (72%) since the addition of chronic pain in late March of this year.

Most recently efforts have been made to allow medical marijuana to be used to treat post-traumatic stress disorder (“PTSD”). Veterans groups in particular have urged Governor Cuomo to allow those with PTSD to use medical marijuana. According to the Department of Veterans Affairs, about eight million adults suffer from PTSD in any given year, including tens of thousands of Afghanistan and Iraq veterans. Somewhere between 11% and 20% of those vets will suffer from it each year. Over 23 states allow medical marijuana use to treat PTSD, including Connecticut, New Jersey and Pennsylvania. It seems likely, especially given New York’s penchant for growing the Program, that Governor Cuomo will pass the bill adding PTSD as a qualifying condition for medical marijuana use.

The DOH is hoping that all of these changes will bolster the Program. That would be welcome news to New York’s registered organizations which are authorized to manufacture and dispense of medical marijuana in New York State. You may recall from our previous article in this series that on August 1, 2017, the DOH announced the licensure of five new companies to act as registered organizations. In April 2017, however, knowing that the DOH was planning to take such action, the New York Medical Cannabis Industry Association sued New York State on behalf of New York’s original registered organizations. The lawsuit aims to stop the DOH from issuing the new licenses and alleges that increasing the number of registered organizations from five to ten will harm the industry because there is not enough demand to meet supply. “The program is still in its infancy, and patient demand is currently too low to support an expansion of the supply market for medical marijuana,” the lawsuit states. “As it is, all five of [the original registered organizations] are sustaining tremendous operating losses, after having made millions of dollars in initial investments.” The five newly-awarded registered organizations filed a motion to dismiss the lawsuit but the Court denied the motion last week. We will continue to monitor the litigation and post updates to the New York Health Law Blog as developments occur.

Thank you for being a part of this series discussing the current state of the law in New York regarding medical marijuana. The medical marijuana field is constantly changing as the program in New York grows and evolves. To stay up to date on all of the developments we invite you to subscribe to the Farrell Fritz New York Health Law Blog.