Harris Sliwoski LLP 的作者 Simon Malinowski 艰难的市场,大胆的律师 Tue, 26 Dec 2023 19:58:30 +0000 en-US 每小时 1 https://wordpress.org/?v=6.4.3 https://harris-sliwoski.com/wp-content/uploads/cropped-Harris-Sliwoski-Logo-FinalIcon-White-1-32x32.png Harris Sliwoski LLP 的作者 Simon Malinowski 32 32 纽约推出医用迷幻药立法 https://harris-sliwoski.com/psychlawblog/new-york-introduces-medical-psilocybin-legislation/ Thu, 16 Dec 2021 21:57:02 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=100338 On Monday, November 13, 2021, New York Assemblyman Pat Burke introduced medical psilocybin legislation. The “purpose or general idea of bill” provides a good summary: this legislation would “create psilocybin service centers to provide innovative treatment options for ailments such as PTSD, depression, alcohol dependency, anxiety, among others.” The bill echoes two separate pieces of

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On Monday, November 13, 2021, New York Assemblyman Pat Burke introduced medical psilocybin legislation. The “purpose or general idea of bill” provides a good summary: this legislation would “create psilocybin service centers to provide innovative treatment options for ailments such as PTSD, depression, alcohol dependency, anxiety, among others.”

The bill echoes two separate pieces of controlled substance legislation: (1) Oregon’s legalization of psilocybin (a topic we have written about extensively (here, here and here, to list a few); and (2) New York’s Marijuana Regulation and Taxation Act (MRTA), which is another topic we have written about extensively (see here, here and here, to start).

A few key points from the bill:

Several License Types

Like the MRTA, this medical psilocybin legislation includes several license types with a similar path for licensure:

  • Registration as a psilocybin service center, which will include preparation, administration, and integration sessions, all of which are guided and monitored by a psilocybin service facilitator.
  • Registered organizations, which will be allowed to acquire, possess, manufacture, sell, deliver, transport, distribute or dispense psilocybin.
  • Psilocybin research license, which will allow testing potency, conducting clinical investigations, researching efficacy and safety, and agricultural research.
  • Psilocybin service facilitator license, which will allow individuals to facilitate psilocybin administration sessions. As noted in the bill, “to receive a license, that person must have a high school diploma or equivalent, complete training requirements as determined by the department, meet examination requirements, and demonstrate facilitation and support skills.”

Expansive List of Qualifying Medical Conditions

The bill includes this definition of qualifying medical conditions:

“Condition” means having one of the following conditions: cancer, positive status for human immunodeficiency virus or acquired immune deficiency syndrome, amyotrophic lateral sclerosis, Parkinson’s disease, multiple sclerosis, damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity, epilepsy, inflammatory bowel disease, neuropathies, Huntington’s disease, post-traumatic stress disorder, pain that degrades health and functional capability where the use of medical cannabis is an alternative to opioid use, substance use disorder, Alzheimer’s, muscular dystrophy, dystonia, rheumatoid arthritis, autism or any other condition certified by the practitioner.

Qualifying medical practitioners would need to take a two-hour training course provided by the Department of Health in order to certify patients for psilocybin treatment.

Rules and Restrictions

There are numerous rules and restrictions for licensees and practitioners, including a ban on having a psilocybin manufacturing facility being owned, or having employees, with certain felony convictions in the past three years. Like the MRTA, there is an exception for felony convictions for selling or possessing controlled substances, however, unless those operations involved minors.

Social Equity

Similar to the MRTA, licensing factors will include whether applicants are a “minority- and/or women-owned business enterprise, a service-disabled veteran-owned business, or from communities disproportionally impacted by the enforcement of psilocybin prohibition.”

The bill also provides for the creation of a psilocybin services grant program fund for veterans and first responders, to be jointly managed by the Commissioner of Health and the state comptroller. The bill allocates $2 million for the grant program.

Broad Justification

We cannot put it better than this medical psilocybin legislation does:

“Struggles with diseases like PTSD, depression, anxiety, and alcoholism can be major disruptors to a person’s livelihood as well as their family’s. These mental health detriments can deteriorate physical health, result in performance deficits on tasks, and increase rates of suicide. Psilocybin therapy is a breakthrough avenue for providing people with treatment for these ailments.

Certain occupations, particularly those that serve society by running into danger, have increased prevalence of these health disruptors. Data from the RAND Corporation show that 8,000 New York veterans from the wars in Iraq and Afghanistan suffer from PTSD. Firefighters, police officers, and EMS workers have a higher prevalence of depression, PTSD, and substance abuse than the general population.

The FDA recognizes psilocybin therapy as substantially better than present treatment options. Establishing a widespread route to provide New Yorkers with this medical treatment would be a monumental step in providing mental health care to improve lives. Oregon, Texas, and several cities have taken similar steps to increase access to psilocybin treatment.

These therapy centers would offer a safe physical environment supervised by trained monitors to negate the minimal risk involved with psilocybin. Researchers at Johns Hopkins Medicine report that psilocybin shows low potential for abuse and can be classified as ‘least harm to users and society.’

Beyond enabling the creation of treatment centers, this legislation would also create a $2 million fund for veterans, firefighters, police officers, and EMS workers, who can apply for financial support towards treatment. Our first responders expose themselves to potential trauma on a daily basis to keep us safe and well. Ensuring their access to this treatment demonstrates our reciprocity to keep them safe and well.

As exciting as this is, it is important to remember that this is proposed legislation. Various versions of the MRTA were filed in the years leading to its passage earlier this year. We are now waiting to see how the legislation is received and whether it progresses towards actual medical psilocybin legalization. Stay tuned!

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迷幻疗养院:组织者的法律问题 https://harris-sliwoski.com/psychlawblog/psychedelic-retreats-organizer-legal-issues/ Sun, 12 Dec 2021 22:27:22 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=100341 Psychedelic retreats are all the rage (and that’s not a new thing), which causes a variety of organizer legal issues and a corresponding spectrum of liabilities. At Wonderland Miami, Horizons NYC, and on a regular basis outside of conferences, we are asked about legal advice for the organizers of psychedelic retreats. Both recreational and therapeutic

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Psychedelic retreats are all the rage (and that’s not a new thing), which causes a variety of organizer legal issues and a corresponding spectrum of liabilities. At Wonderland Miami, Horizons NYC, and on a regular basis outside of conferences, we are asked about legal advice for the organizers of psychedelic retreats. Both recreational and therapeutic psychedelic consumption are often consumed/administered in group settings, lending themselves to psychedelic retreats, usually in rural settings.

Horizons founder and director Kevin Balktick said it best during his speech at Horizons NYC (and I’m very loosely paraphrasing here): using psychedelics is a risk, and a risk that needs to be measured carefully. That sage advice applies in any circumstance and immeasurably so if you are planning on organizing a psychedelic retreat, soliciting participants, or accepting compensation as the organizer.

To that end, there are a few main points to hammer home. The risk associated with psychedelic retreats fall into two main categories: (i) the fact that psychedelics are illegal (but there are paths to federal legalization and change is already afoot on the state level (hi Oregon!)); and (ii) the use of psychedelics, particularly by individuals already suffering from treatment resistant depression, anxiety disorders, and PTSD (among a number of other disorders), can have severe adverse outcomes.

From a practical perspective, the risks based on the illegality of psychedelics are twofold. The first is pretty obvious: hosting and possibly providing psychedelics to retreat attendees subjects the organizers to potential criminal liability, ranging from distribution of a controlled substance to aiding and abetting the use psychedelics. Even if the retreat is placed in a jurisdiction that has decriminalized psychedelic drugs to some extent, significant penalties often remain in place for distribution, and federal law remains supreme.

The second is that, based on federal illegality of psychedelics, obtaining event insurance is impossible. Without insurance, the retreat organizer is exposed to significant risks associated not only with psychedelic-related adverse events, but also the sort of things that can happen any time groups of people get together. Slip and fall claims, bad weather events, and even employment issues, are often covered by an event-specific insurance policy.

Without insurance in place, the retreat organizer (and any individuals behind the “organizer,” if the organizer is a company) could be forced to defend against claims without indemnity or support. If that doesn’t sound so scary, I should mention that our law firm represents well-run events which have been subject to claims on everything from slip-and-fall to wrongful death. The absence of insurance in these situations is a huge risk.

With that said, as attorneys, it is not our job to eliminate all risk for our clients (an impossible task in any event). It is our job to help our clients mitigate risk as best possible. So what do we generally advise clients planning on hosting a psychedelic retreat? Here is the shortlist:

Have A Really Good Waiver/Release

A well crafted waiver/release agreement should address all of the risks associated with the event, however remote or attenuated. For psychedelic retreats, a detailed acknowledgement of the risks associated with consuming psychedelics and an assumption of all associated risks is necessary. We also include an acknowledgement and assumption of the risk of personal injury before, during, and after the retreat.

Waiver/release agreements are by no means foolproof and do not prevent retreat organizers from getting sued, but having an express acknowledgement and assumption of specifically enumerated risks (particularly risks specifically associated with consuming psychedelics) works in the organizer’s favor should a claim arise.

Make Sure Event Vendors Have Insurance and That They Indemnify You (If Possible)

For larger events, organizers will typically bring in third-party vendors for help, i.e. security, medical professionals, moving and installing equipment, etc. While the retreat itself may not be insured, third-party vendors may be able to obtain insurance. All contracts with third-party vendors should have an insurance and indemnification provision that requires the vendor to: (i) carry insurance; (ii) list the retreat organizer as an additional insured (if possible); (iii) provide proof of that insurance well in advance of the event and (iv) indemnify and hold harmless the retreat organizer, its directors, officers, members, managers, etc., for any and all claims not arising out of the retreat organizer’s negligence.

Recon Medical Assistance

We cannot overstate it: no matter how much control you have over the retreat, psychedelic retreats carry the risk of serious adverse medical events. These adverse events occur even in controlled drug study environments. If you are not going to have on-site medical professionals (which you should), it is important to be familiar and establish contact with local medical services. If something happens, scrambling to figure out where you can get medical assistance (including calling 911) is a recipe for disaster.

Organize Through An Entity

Standard legal advice for any business is to operate the business through a legal entity (i.e. a corporation or LLC) to shield principals from personal liability. This is by no means fool-proof: corporate veil piercing is always a risk. But organizing a psychedelic retreat as an individual, without any liability shielding, is a needless risk to take.

The plain reality is that organizing a psychedelic retreat is inherently risky. The steps we provide in this post are only a starting point and, as in all things legal, the devil is in the details. But at a minimum, these are issues to be aware of if you are planning on organizing a psychedelic retreat.

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爆炸性新闻:德国将使成人使用的大麻合法化 https://harris-sliwoski.com/cannalawblog/breaking-germany-to-legalize-adult-use-cannabis/ Fri, 19 Nov 2021 22:13:10 +0000 https://harris-sliwoski.com/?post_type=cannalawblog&p=97679 Germany stands to become the next of shockingly few countries that have approved full legalization of adult-use cannabis, joining Canada and Uruguay (and a number of US states. The societal benefits of adult-use legalization in Germany are obvious (and similar to those in the US): an estimated €4.7 billion benefit to the German economy, which includes the cost savings of cannabis-related criminal enforcement and incarceration as well as generated taxes.

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On November 18, 2021, local media sources confirmed that members of Germany’s incoming governing coalition (comprised of the Social Democratic Party of Germany (SPD), the Free Democratic Party (FDP), and the Greens) intend to introduce legislation to legalize adult-use cannabis in Germany.

Germany stands to become the next of shockingly few countries that have approved full legalization of adult-use cannabis, joining Canada and Uruguay (and a number of US states. Germany would become only the second G-7 nation to legalize adult-use cannabis and the first on the European continent to do so. As noted in this Prohibition Partners article, the Netherlands and Switzerland are also set to introduce adult-use cannabis legislation on a trial basis in 2022.

What will the adult-use cannabis industry look like in Germany? From a coalition spokesperson:

We’re introducing the controlled distribution of cannabis to adults for consumption in licensed stores. This will control the quality, prevent the transfer of contaminated substances and guarantee the protection of minors. We will evaluate the law after four years for social impact.

The societal benefits of adult-use legalization in Germany are obvious (and similar to those in the US): an estimated €4.7 billion benefit to the German economy, which includes the cost savings of cannabis-related criminal enforcement and incarceration as well as generated taxes.

As is the case every time broad adult-use cannabis legalization is announced, the devil is in the details. We will need to see the actual text of the legalization, any rules and regulations that will govern licensure and operation, and timeframes for implementing said rules and regulations, before really being able to evaluate the potential business opportunities for entrants into Germany’s prospective adult-use cannabis industry.

Still, any time national adult-use cannabis legalization is announced, let alone in a country as significant as Germany, it’s a big deal. We will provide a summary of the proposed legislation and keep you apprised of any developments as Germany moves towards legalized adult-use cannabis. Stay tuned!

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来自迈阿密仙境的消息 https://harris-sliwoski.com/psychlawblog/dispatches-from-wonderland-miami/ Mon, 15 Nov 2021 23:04:58 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=100356 Microdose hosted its annual psychedelics conference in Miami last week (appropriately titled “Wonderland”). We were there, meeting industry insiders and clients, and keeping on the cutting edge of the psychedelics space. For our readers who weren’t able to make it, here are some of our key takeaways from two days of all things psychedelics: Everyone

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Microdose hosted its annual psychedelics conference in Miami last week (appropriately titled “Wonderland”). We were there, meeting industry insiders and clients, and keeping on the cutting edge of the psychedelics space. For our readers who weren’t able to make it, here are some of our key takeaways from two days of all things psychedelics:

Everyone is interested in figuring out how to legalize federally

The conference’s opening panel was on pathways to federal legalization. This is a topic we have covered regularly on the Canna Law Blog, most recently by Mason Marks, here. Rescheduling psychedelics (most notably, psilocybin and MDMA) will be critical to bringing their full scope of medical applications into the mainstream.

Ketamine clinics are flourishing

There was a fascinating panel on the use of ketamine treatments for, among other things, depression and anxiety disorders. We continue to see an uptick in ketamine clinic transactions (the complexities of which we have written about extensively). Our observation was supported by the attendees of Wonderland. With ketamine as the only psychedelic treatment that can (currently) be legally prescribed and administered “off label” by licensed physicians, many entrants into the psychedelic space have started with operating ketamine clinics, with the goal of expanding to other psychedelic treatments when legally permissible.

Pharmaceutical start-ups are betting on the treatment potential of psychedelics

One thing we immediately noticed about Wonderland’s numerous panels was the prevalence of MDs in leadership positions at pharmaceutical start-ups already in or planning on entering the psychedelic space. Companies are all-in on researching potential applications for treatment resistant depression, anxiety disorders, PTSD, pain treatment, and a number of other disorders. Some of these companies are already engaged in clinical trials, a key indicator that significant capital and resources are behind entrants into the market. Coupled with the fact that, as of October 2021, 50 psychedelics companies are now publicly listed on U.S. exchanges, it is clear that the industry has real potential from both medical treatment and business perspectives.

Psychedelics are not cannabis

A recurring theme during Wonderland was comparisons to the cannabis industry. We have written about the differences in the industries (see here and here), which was reinforced during the conference’s panels. In large part, cannabis legalization efforts have focused on ending and reversing incarceration for cannabis-related crimes and capitalizing on the business opportunities created by a legal and regulated adult-use cannabis industry. Medical cannabis legalization was the pre-cursor to adult-use cannabis legalization, but on the whole, the industry has focused on adult-use (i.e. recreational) business opportunities.

Most of what we heard during Wonderland focused on the medical applications of psychedelics, and with good reason: psychedelics offer a safe alternative to many traditional medical treatments that can be ineffective or harmful (both in terms of side effects and potential addiction) to many people.

To that end, our biggest takeaway from Wonderland is the real pharmacological potential of psychedelics. For many Americans suffering from depression, anxiety, PTSD, and any number of other debilitating disorders, psychedelics offer a non-opioid option that has clinical evidence of both effectiveness and safety. The more safe and effective alternatives we, as a society, can offer people who are suffering, the better.https://harris-sliwoski.com/wp-admin/post-new.php?post_type=psychlawblog#psychlawcategory-add

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美国,我们在做什么? https://harris-sliwoski.com/cannalawblog/america-what-are-we-doing/ Mon,05 Jul2021 14 :00 :20 +0000 https://harris-sliwoski.com/?post_type=cannalawblog&p=85346 Like many Americans, one of the first things I do every morning is check the overnight headlines, including anything that happened in the sports world. Recently, I woke up to an article about Los Angeles Lakers guard Alex Caruso being arrested at Easterwood Airport in College Station, Texas for “possession of marijuana and drug paraphernalia.”

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Like many Americans, one of the first things I do every morning is check the overnight headlines, including anything that happened in the sports world. Recently, I woke up to an article about Los Angeles Lakers guard Alex Caruso being arrested at Easterwood Airport in College Station, Texas for “possession of marijuana and drug paraphernalia.”

Given that Mr. Caruso is a guard on the reigning NBA championship team and an alumnus of Texas A&M, I assumed that his arrest, which would obviously make national headlines, was for some absurd amount of marijuana. I was wrong.

Mr. Caruso was arrested after the TSA searched his bags and found an “herb grinder that contained marijuana.” The arrest was for possession of “less than two ounces of marijuana.” It was likely significantly less than two ounces of marijuana considering the fact that it was in an herb grinder.

I get it, a professional basketball player getting arrested for trying to board a flight with a federally illegal substance is not a national tragedy. But you know what is? The fact that 545,602 Americans were arrested for marijuana-related offenses in 2019. And that 40,000 Americans were incarcerated for marijuana-related offenses in 2020. And that, in extreme cases, people are still being locked up for life for possessing a similar amount of marijuana to Mr. Caruso.

In all, that is 545,602 Americans who will have a much harder time finding a job because we, as a country, seem determined to keep marijuana federally classified as an illegal drug for reasons that are either based on a false premise or inherently racist. As for the politicians who push against the national trend towards legalization because of social or “public safety” reasons, well, those politicians are either stupid or lying.

Here in Harris Sliwoski’s New York office, we have been giving a lot of thought to “why” recreational marijuana should be legal. We have clients who are interested in getting licensed in New York. Regardless of whether they plan to obtain a cultivation license or a retail license, engendering the support of the local government is important for long-term success. Which means that we, as our clients’ advocates, sometimes need to explain to local government officials why: 1) embracing legal recreational marijuana is beneficial for their community; and 2) embracing legal recreational marijuana will not destroy the fabric of their community (dramatic, I know).

Our arguments in favor of embracing legalization apply on a federal level, and quite frankly, it doesn’t take a rocket scientist to get to the inescapable conclusion that there is no justifiable reason for marijuana to remain an illegal drug.

From a financial perspective, the benefits are obvious. The estimated value of America’s illegal marijuana market is $100 billion. Billion with a “B.” That is $100 billion that is currently unregulated and largely untaxed, to the benefit of no one. Conversely, with just 15 states having legalized recreational marijuana in some form (now 16, hello Connecticut!), the estimated value of the legal marijuana market in 2021 is $16.1 billion. That is projected to increase to $24 billion by 2022. Here in New York alone, the legal marijuana market is expected to reach $3.7 billion in value by 2025.

The tax revenue from legal sales is already a boon for many states. Let’s assume that federal legalization, when it finally happens, comes with a tax structure sufficient to offset the overnight IRC § 280E drain. Why on earth wouldn’t we, as a country with a healthy budget deficit, also want to capture some tax revenue from the other $100 billion of sales floating around the country?

Tax revenue aside, the ancillary revenue from national marijuana legalization would bolster our economy. Banking services, transportation and logistics, software, security, real estate, and on and on, are all industries that would gain revenue and, in turn, offer additional employment opportunities. Maintaining the status quo keeps all of those economic benefits in the black market.

And it’s not just making more money from a legal industry. The average annual cost of incarcerating a single American is $33,274. That is $1,330,960,000 a year spent on incarcerating Americans for marijuana-related offenses. Which does not even include the exponentially greater resources expended by law enforcement in investigating and prosecuting these “crimes” or the human cost of the lives ruined by such arrests.

But those are all easy statistical arguments that are hard to contradict with data. The social “harm” of marijuana is what politicians tend to rely on when claiming that legalizing marijuana would be a catastrophe of epic proportions. We are all familiar with the social arguments against legal marijuana: marijuana needs to be kept out of the hands of children; marijuana is a dangerous gateway drug; and marijuana somehow breeds criminal activity.

Let’s start with the ease of access argument. The reality is that marijuana will be harder for minors to purchase after it is legalized. I think I speak for many people when I say that in high school it is probably easier to buy marijuana than alcohol. Why? Because you can only buy alcohol from a licensed establishment that risks its license when it sells alcohol to minors. As far as I know, there aren’t any drug dealers that are concerned about “licensure” when selling marijuana to a high school senior.

That changes immediately when marijuana is legalized. A retail dispensary will not only have to prove that it can prevent sales to minors, but risk losing its license if it fails to implement systems for preventing underage sales. Those arguments against arresting and prosecuting marijuana sales become a lot different (i.e. justifiable) when tweaked to prosecuting illegal marijuana sales.

Of course the other reality is the fact that marijuana is really easy to buy now, even as an illegal substance. I am relatively certain that almost every American could buy marijuana right now within one phone call. I am 100% sure that every single American is no more than two phone calls away from buying marijuana. Ease of access can only get harder after legalization.

Is marijuana dangerous? Potentially. Anyone who argues that marijuana is harmless is doing a disservice to the industry. Just like any other substance, dependence on marijuana can have serious negative effects. I know people who failed to reach their potential because of marijuana usage. But I also know people who are dependent on alcohol with equally negative consequences, and the prohibition movement has been really quiet for the last hundred years.

In terms of marijuana being a gateway drug, I have yet to see an honest study that shows that marijuana use leads directly to narcotics use. I would argue that we all have seen many more people make bad life decisions under the influence of alcohol than after consuming marijuana.

But I won’t belabor the point. The alcohol vs. marijuana argument is well-tread and, quite frankly, irrelevant. Both should be legal. Both should be regulated. And both need systems in place to avoid consumption by minors.

In terms of marijuana breeding criminal activity, it sure does when it is federally illegal. Setting aside the obvious definitional argument (it’s criminal activity because we choose to define it as a criminal activity), it is hard to argue that America’s well-developed black market is better than a well-regulated legal market. And organized crime activities within the marijuana black market have been well-publicized.

You might again be asking: “what does this have to do with Alex Caruso?” Nothing and everything. A single professional athlete getting arrested for marijuana possession doesn’t actually move the needle, but it is a public reminder of where we are. With all of the excitement in New York legalizing recreational marijuana, it is easy to ignore that federal law still considers marijuana an illegal drug. Which means we, as a country, will continue to waste lives, time, and money fighting a “battle” against ourselves where everyone loses for no good reason. We at the Canna Law Blog hope the tide is turning and maybe, just maybe, putting a few more rational arguments into the ether will nudge us over the finish line.

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