Emerge Law Group

10/11/2024

Join us for a community discussion about the Oregon Health Authority’s proposed Oregon Psilocybin Services rule amendments
 
Wednesday, October 16, 2024
12pm to 1pm Pacific Time
Via Zoom (registration required)

Register through link in photo or DM us for registration link!

The Oregon Health Authority issued proposed amendments to the rules governing the Oregon Psilocybin Services program.  If adopted, the amendments would have major impacts on the psilocybin industry. The public comment period to provide feedback on the proposed rules ends at 5pm PT on Monday, October 21, 2024.  This is the only chance to request changes to the rule amendments before they become final.
 
From Emerge’s perspective, many of the proposed amendments could negatively affect licensees’ ability to do business and significantly increase costs for psilocybin clients.  Prior to the webinar, Emerge will circulate to attendees our draft public comments to the proposed rules. At the webinar, we will briefly provide our thoughts on how these rule changes may impact licensees and summarize our draft public comments. We want to hear from attendees about how these proposed rules will affect their businesses and hope for a robust conversation about how we can collaborate to push back against some of the most worrisome proposed amendments.
 
Hope to see you there!

10/02/2024

Emerge attorneys Kaci Hohmann and Alex J Berger attended the Oregon State Bar Cannabis & Psychedelics Law Section’s Sixth Annual Conference last weekend.

Alex and Kaci participated in a presentation with attorney Jon Dennis broadly covering the U.S. psychedelics landscape and practical issues for Oregon psilocybin facilitators.

The conference is an intimate group of the lead attorneys serving Oregon cannabis and psychedelic clients and Emerge looks forward to seeing everyone again next year!

09/26/2024

After four rewarding years of dedicated service to its clients, Plant Medicine Law Group, a New York-based psychedelics law firm, is winding down and transitioning relationships and certain clients to Emerge Law Group, a leading Portland-based law firm with extensive expertise in cannabis and psychedelics.

Both law firms specialize in advising psychedelic companies domestically and internationally. The transition builds upon the collaborative co-counsel arrangement that formed between Emerge and PMLG earlier this year and is a significant step forward for the emerging psychedelics industry.

Founded in 2014, Emerge Law Group has established itself as a pioneer in the cannabis and psychedelics legal sectors. The firm’s attorneys played pivotal roles in drafting Oregon Ballot Measure 109, which legalized psilocybin services in Oregon, and Oregon Ballot Measure 91, which legalized recreational adult-use cannabis in the state.

The transition of PMLG’s extensive network of relationships across the psychedelic industry and successful representation of some of the most innovative companies operating at the intersection of healthcare and psychedelics further enhances Emerge’s industry knowledge and provides clients access to additional top-tier attorneys.

08/23/2024

On Friday, 8/9, the FDA released its decision to not approve M**A-assisted therapy for PTSD, stirring ongoing debate in the psychedelic research community. Many in the field were optimistic when Lykos Therapeutics initially submitted their New Drug Application in Dec. 2023, pointing to promising Phase 3 trials showing that over 70% of participants no longer met PTSD criteria after M**A treatment. Anticipation of approval lessened significantly in June, however, when the FDA’s advisory committee recommended against approval of M**A-assisted therapy. Despite support from veterans, mental health professionals, and politicians, the FDA cited concerns about the quality of the research and overall safety and efficacy of the drug. Lykos says it plans to seek reconsideration of the decision. But this process will delay the therapy's availability for years, at least.

While some experts view the FDA’s decision as overly cautious, fearing it could stifle innovation in psychedelic therapies, others believe that the rejection might prompt stronger competition and better research quality in the future. The ruling also highlights the broader policy and regulatory challenges facing the psychedelic industry, bringing to light concerns about data quality, clinical trial designs, and the influence of public pressure on regulatory decisions. Despite this setback, Lykos says it remains committed to pushing forward with further research and regulatory efforts. Meanwhile others have been suggesting that psilocybin may now be on track to gain approval ahead of M**A.

Emerge Law Group shareholder Sean Clancy had this to say: “FDA’s decision is not a surprise, given the advisory committee’s prior recommendation against approval. But it certainly is a disappointment for Lykos and others wishing for M**A to be legalized as mental health medicine. Many are speculating about FDA’s exact rationale. And although Lykos will ask FDA to reconsider, it’s safe to assume that Lykos probably needs to revisit its methods and protocols to craft a better case for M**A’s approval as a medicine. That will be expensive and time consuming. As FDA’s conclusion reverberates around the world of psychedelics, I will be interested to see how this affects psychedelic operators outside of pathology-focused medical frameworks.”

The much-anticipated decision has rattled supporters of psychedelic therapies. The drugmaker says it will ask the agency to reconsider.

08/23/2024

In this edition of PsychedeLinks:

✨Get Emerge's Hot Take on the FDA's decision to not approve M**A-assisted therapy for PTSD - with attorney Sean Clancy.

🍄Gov. Healy Signs HERO Act, Establishing Psychedelics Working Group for Massachusetts Veterans

🍄New Psychedelics Medical Research Center Opening in Kingston, Ontario

🍄Psychedelic Mushroom Edibles Could Soon be Legally Available in Oregon for the First Time

🎧LISTEN: UNM Researchers Are Studying Psychedelics to Treat Depression and M**h Addiction

https://emergelawgroup.com/blog/psychedelinks-august-23-2024

07/31/2024

We are pleased to announce that three attorneys at Emerge Law Group have once again been recognized as Oregon Super Lawyers and Rising Stars!

Marco Materazzi – Super Lawyer - Securities & Corporate Finance
Alex J Berger - Rising Star - Cannabis Law, Land Use & Zoning
Sean Clancy - Rising Star - Intellectual Property, Business & Corporate

Super Lawyers is an impartial rating service created by Thompson Reuters, a legal products company known for platforms like FindLaw. Super Lawyers rates attorneys by evaluating professional achievement across various practice areas. The merit-based rating service employs a patented annual selection process that incorporates independent research, peer nominations, and peer evaluations to honor attorneys who have achieved exceptional recognition within the legal community.

07/31/2024

We’re here to set your business up for success, whether you are a publicly-traded company, closely-held business, or start-up. Our business transactions team is made up of highly experienced transactional attorneys who have worked at AmLaw 100 law firms, big accounting firms, and in-house for public companies and investment banks. Our lawyers have also personally owned and operated start-up companies, so we understand complex legal matters and aim to provide high quality legal services in a cost-effective manner.

Call or message us at one of our office locations. Emerge Law Group is conveniently situated to serve your legal needs.

07/26/2024

Intellectual property (“IP”) license agreements come in many shapes and flavors. But all IP licenses boil down to one party giving another party permission to use some IP.

IP may include patents, trademarks, copyrights, trade secrets, and rights of publicity. Some license agreements cover one type of IP like a single trademark, or copyrights for a single song, or maybe a single valuable data set. But often a single license agreement covers multiple types of IP.

Check out this two part blog from the Emerge archives, written by shareholder Sean Clancy.

https://emergelawgroup.com/blog/critical-terms-for-intellectual-property-license-agreements-part-1/

https://emergelawgroup.com/blog/critical-terms-for-intellectual-property-license-agreements-part-2/

07/15/2024

In this edition of PsychedeLinks:

✨Get Emerge's Hot Take on how Oregon is teaching states how to tax psychedelic mushrooms - with attorney Dave Kopilak.

🍄In-Home Psilocybin Use Should Be Allowed in Oregon for Disabled and Terminally Ill People, Lawsuit Says

🍄New Washington Ballot Measure Would Legalize Psychedelic Plants and Fungi

🍄Health Officials say Mushroom Candies Sold in Oregon Stores Were Poisonous

🍄New Jersey Lawmakers Amend Psilocybin Bill to Focus Only on Therapeutic Use, Removing Broader Legalization Provisions

🍄Psilocybin Therapy, One Year In: Data from One Year of Legal Psilocybin Offers Insights

📺WATCH: Psychedelics Are Now Legal in Australia – With a Catch

07/15/2024

In 2023, Oregon became the first in the nation to establish a comprehensive framework for a legal psilocybin-assisted therapy program, implementing strict protocols for licensing manufacturers, service centers, facilitators, and testing laboratories. This regulatory system, which includes a 15% tax on psilocybin products, has been navigated by hundreds of facilitators and centers, and is the chief model for approximately a dozen other states drafting their own proposed psychedelic legislation.

While it is tempting to draw comparisons to Oregon’s established cannabis industry, the regulatory mechanisms in play are quite different. For example, accessing psilocybin requires clients to engage with licensed service centers, undergo preparatory consultations, and participate in supervised sessions. This rigorous process aims to ensure safety and efficacy but admittedly comes with heightened costs, ranging from $1,500 to $3,000 per experience. While the current financial barriers limit widespread access, Oregon’s program and psilocybin market has significant potential to expand over the next decade if policy makers take steps to reduce operational risks, says business attorney Dave Kopilak.

“While the facilitation model certainly has its benefits when it comes to supervision, guidance, safety, and in many cases a client’s entire psilocybin experience, it also has its challenges, because it makes access to psilocybin products substantially more expensive, thereby reducing overall access,” says Kopilak, a shareholder with Emerge Law Group in Portland who served on Oregon’s Psilocybin Advisory Board and drafted Measure 109. “But things will evolve, and I suspect at some point in the future the facilitation process will be optional and folks will be able to buy at least some psilocybin products from retail stores.”

Ram Dass, the spiritual teacher and Harvard researcher on the therapeutic effects of psychedelic drugs, once observed that spiritual journeys are highly personal and “can’t be organized or regulated.”

07/08/2024

The Oregon Consumer Privacy Act (“OCPA”) is a recent state-level privacy law designed to give Oregon consumers greater control over their personal information. The OCPA became legally effective July 1, 2024, except that 501(c)(3) nonprofits have until July 1, 2025 to comply. The OCPA requires certain businesses and individuals to implement measures to ensure compliance, which include updating privacy notices, establishing processes for handling consumer data requests, and enhancing data security practices.

Emerge's Sean Clancy and Leticia Maskell break it down in our latest blog:
https://emergelawgroup.com/blog/understanding-the-oregon-consumer-privacy-act-what-you-need-to-know/

07/02/2024

ICYMI: Still have questions about the OLCC CAMP updates and batch tagging? Check out a recent webinar we co-hosted with Kevin Jacoby from Jacoby Law!

Oregon's cannabis industry has already encountered significant regulatory changes in 2024: batch tagging delays and OLCC's new CAMP licensing system. This we...