Psilocybin Therapy for Patients with Advanced Illness in Oregon

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One of the known beneficial uses of psilocybin is as a palliative care tool for patients with advanced illness who suffer from anxiety and/or depression. A multitude of recent clinical trials shows the clear promise of psilocybin for this population suffering from these debilitating conditions. However, this drug is not presently legally available, as it is classified as a Schedule I drug, severely restricted and regulated by the federal Controlled Substances Act. Accordingly, it cannot be prescribed by a physician and it is not legally accessible to those who might benefit from it as a therapeutic treatment.

Access Pursuant to the Oregon Psilocybin Services Act

Oregon’s Psilocybin Services Act(“PSA”), adopted via initiative in November 2020, makes therapeutic use of psilocybin legal under Oregon state law. Adult Oregonians will be able to access psilocybin therapy under the PSA beginning in January 2023; patients with advanced illness are among those who may benefit from this therapy.

The PSA sets out detailed requirements specifying who will be permitted to provide psilocybin therapy and where such therapy can take place. The provider of the therapy must be a licensed “facilitator” pursuant to the statute. Recommendations for the training required of such facilitators are being developed now by a Psilocybin Advisory Board established by the PSA. The Oregon Health Authority will receive these recommendations and adopt rules regarding requisite training, examination, and licensing of facilitators.  Other than taking the training the OHA determines necessary and passing the required exam, facilitators need not have any other education or credential beyond a high school diploma to be certified as a facilitator.

Certainly, it is likely that some who pursue a facilitator license will have advanced education and/or credentials in a health care specialty. It is likely that some who are palliative care nurses, end-of-life care doulas, social workers, mental health counselors, and/or physicians will become licensed facilitators pursuant to the PSA.

Administration of the psilocybin and the experiencing of its effects must occur in a licensed “facilitation center”. A subsequent “integration session” must be offered to the client; however, participation in the integration session is not mandatory and this session need not be held at a facilitation center.

Patients with advanced illness who could benefit from psilocybin therapy, and who are able to visit a facilitation center, will be able to receive such therapy at a licensed center. As noted, the integration session could be conducted elsewhere, possibly at the patient’s home or at a clinician’s office. For patients with advanced illness, it would likely be desirable to seek psilocybin therapy from a facilitator knowledgeable in providing care to medically fragile patients with advanced illness. Such providers must of course be aware that while psilocybin therapy under Oregon’s new PSA law will be legal for state law purposes, psilocybin remains illegal under federal law.  It is possible that a form of “cooperative federalism” will arise with regard to psilocybin therapy in Oregon. This is a policy where the federal government, the DEA, will refrain from taking prosecutorial action if state law permits, regulates, and carefully controls the use of a drug. The shelter provided by this approach depends on the policy of the U.S. Department of Justice, which can change as the political winds or officeholder changes—as occurred in the case of cannabis.

Access to Psilocybin Therapy Pursuant to Right to Try Laws

In recent years “Right to Try” laws have been adopted by a supermajority of states, including Oregon, and the Federal Congress. These laws recognize that patients with advanced illness ought to be able to access certain investigational drugs for therapeutic use before completion of later-stage clinical trials and the potentially long process of rescheduling. Psilocybin meets the requisites of RTT laws to be deemed an ‘eligible investigational drug’.  Under the letter and spirit of these laws, it is intended to be available for this population of patients while still under investigation. Litigation to compel DEA to respect RTT laws and allow access to psilocybin for therapeutic use is pending before the Ninth Circuit Court of Appeals. If Petitioners prevail in this landmark case, access to psilocybin for patients with advanced illness will become available, protected by both state and federal law. Under this scenario, none of the requirements of the PSA would be applicable. Psilocybin therapy would likely be accessed through the patient’s palliative care physician who would obtain a form of permission from the DEA to obtain this investigational drug from a manufacturer. The therapy could take place wherever most convenient to the patient in light of their advanced illness, for example, if the patient were receiving hospice services at home, the therapy could be provided in the patient’s home, or at the office of the palliative care provider.

Conclusion

There is tremendous interest in the benefits of psilocybin for the relief of a variety of distressing mental health conditions, including anxiety and depression in patients with advanced illness. Oregon has stepped forward in enacting the nation’s first psilocybin therapy law, which will make such therapy legal under a heavily regulatory state law regime beginning in 2023; federal exposure will remain unless a policy of nonenforcement is adopted by the US DOJ. Right to Try laws may compel DEA to allow access sooner and more widely across the nation.

 

 

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We also help potential franchisees interested in buying a franchise. We are able to assist with evaluation of franchise opportunities with respect to:

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However, not all businesses are suited to franchise. We are also experienced with helping clients structure alternative distribution methods to prevent classification as a franchise.

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Our M&A attorneys are highly experienced in counseling clients who are considering acquisitions or exit strategies.  We have many years of experience handling deals of various types and sizes, ranging from sales of small closely-held business, private companies, and publicly-traded corporations.  We have represented business owners, private equity firms and investment banks in a wide range of industries. 

We have a deep business bench, and Emerge attorneys have handled transactions of all shapes and sizes.  Whether your deal is valued at $100,000 or $100,000,000, our experienced attorneys will guide you through the deal process.

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Emerge Law Group is highly experienced in the cannabis industry.  We have helped many clients obtain state licenses and local permits to operate cannabis businesses throughout California, Oregon, and Washington.

Emerge attorneys were instrumental in the drafting and passage of Oregon Measure 91, legalizing marijuana in the State of Oregon, and have represented cannabis businesses well before many law firms were willing to enter the cannabis industry. As a firm that has provided legal services in the cannabis space for many years, we are familiar with the unique and complex issues businesses and individuals face in an emerging and highly regulated industry.

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See our Cannabis Industry page for more information.

PSYCHEDELICS

There is tremendous excitement about the potential for psychedelic drugs to benefit a wide variety of populations, including terminally ill patients suffering with anxiety and depression. Until recently, psychedelic substances have been accessible only in the illicit market and are illegal under federal and state to manufacture, distribute, or possess. These substances have, since 1970, been treated as having no legitimate medical use, and no commercial application. As such, no one invested in this area or required legal services, outside of the criminal context.

Today, researchers in a multitude of clinical studies are proving the medical safety and efficacy of these medicines, with the objective of changing the treatment of these substances under the Controlled Substances Act. Companies are now actively raising money to develop intellectual property and seize market opportunities associated with psychedelic drugs.

In addition, advocates at the state and local levels are not waiting for the rescheduling of these substances and are active in undertaking efforts to decriminalize these substances and/or make them affirmatively legal under state and/or municipal law. Decriminalization already has occurred in cities including Denver, Oakland, Santa Cruz, and Ann Arbor. Oregon is poised to be the first state to make psilocybin therapy affirmatively legal. Emerge Law Group is working with a wide array of clients pushing forward in this emerging area.

See our Psychedelics Practice Group page for more information.

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In states where new cannabis banking opportunities exist, Emerge Law Group has the proven expertise in creating canna-banking programs to efficiently capitalize on those opportunities. Our Banking Practice Group specializes in working with banks and credit unions to develop regulatory compliant programs and operational best practices. We also train banking staff to become experts in canna-banking so they can effective understand and manage the risk affiliated with canna-banking.

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ALCOHOL AND BEVERAGE INDUSTRY

Emerge attorneys have represented businesses in the alcohol and beverage industry, including wineries, breweries, distilleries, restaurants, bars, movie theaters, golf courses, and gas stations.  We can help you vet new locations, acquire existing locations, and apply for the appropriate liquor license.  We also provide training to comply with applicable rules and regulations, prepare operating procedures, submit renewals, and keep clients protected in the event of any potential violations or administrative hearings.

CANNABIS INDUSTRY

Emerge Law Group is highly experienced in the cannabis industry.  We have helped many clients obtain state licenses and local permits to operate cannabis businesses throughout California, Oregon, and Washington.  We regularly help clients with:

Cannabis laws and rules are also regularly changing.  Members of our team are dedicated to attending legislative hearings, state agency and local city and county meetings to stay up-to-date on any new changes and how to adjust to any new changes.

See our Cannabis Industry page for more information.

PSYCHEDELICS INDUSTRY

Emerge Law Group is a leader in the psychedelics industry.  There is tremendous excitement about the potential for psychedelic drugs to benefit a wide variety of populations, including veterans struggling with PTSD and terminally ill patients suffering with anxiety and depression.  Until recently, psychedelic substances have been accessible only in the underground; they are illegal under state and federal law to manufacture, distribute, or possess.  These substances have, since 1970, been treated as having no legitimate medical use, and no commercial application.  As such, businesses have not invested in this area or required legal services, outside of the criminal context.

Today, psychedelics are proceeding toward legalization on multiple paths.  Researchers in a multitude of clinical studies are proving the medical safety and efficacy of these medicines, with the objective of changing the treatment of these substances under the federal Controlled Substances Act, opening legal access to them.  Private and public companies are now actively raising money to develop intellectual property and capitalize on the market opportunities associated with psychedelic drugs.  Opportunities to be early actors in this new arena are tremendous.

See our Psychedelics Practice Group page for more information.

BUSINESS AND CORPORATE

Our business transactions team is made up of highly experienced transactional attorneys who have practiced at large law and accounting firms, worked as in-house counsel for public companies and investment banks, and owned and operated start-up companies. We understand complex legal matters and provide high quality legal services in a cost-effective manner.  Our clients value our experience, knowledge and judgment.

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