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Psychedelics Law
Preparing for Legalization
Psychedelic lawyers providing industry-expert legal planning, regulatory support, corporate guidance, compliance strategies, and litigation.
Contact UsPsychedelics’ Changing Legal Status: A New Frontier for Business and Law
Once relegated to the fringes of society, psychedelics are undergoing a remarkable transformation, with significant legal and commercial implications. This change is driven by two key trends:
Pharmaceutical Drug Development
The U.S. Food and Drug Administration (FDA) has taken significant steps in recent years. In 2019, the FDA approved Spravato, a ketamine-based nasal spray for treatment-resistant depression, and granted “breakthrough status” to psilocybin therapies for depression. This has spurred private and public companies to invest in psychedelic drug development, creating a new market with immense potential.
Psychedelics Legalization Efforts
The legal landscape is shifting beyond the FDA’s actions. In 2020, Oregon became the first state to legalize psilocybin therapy for adults with mental health conditions, while Denver decriminalized psilocybin use and possession in 2019. These represent significant steps towards broader legalization, opening doors for potential recreational use and various therapeutic applications.
Navigating the Complexities of Psychedelics
These rapid developments create a complex legal environment for businesses venturing into this new frontier. Expertise in areas like drug development regulations, intellectual property law, and compliance with emerging state and local regulations is crucial to navigate the legalities of this evolving marketplace.
Psychedelics’ Opportunities and Challenges
Private and public companies are now racing to raise money, develop intellectual property, and capitalize on the market opportunities associated with government-approved psychedelic drugs. These opportunities are tremendous but legally arduous. Challenges include navigating regulatory frameworks, securing intellectual property, and managing public perception and societal acceptance.
Psychedelics Global Trends
The movement towards psychedelics legalization and research is not limited to the United States. Countries like Canada and the Netherlands are also exploring the therapeutic potential of psychedelics, creating a global shift that further underscores the need for informed legal guidance.
Our Expertise
Harris Sliwoski’s team of legal experts, located in Arizona, California, Oregon, and Washington, as well as in Australia, China, Mexico, and Spain, offers comprehensive legal services to help you navigate the complexities of the psychedelics industry. From regulatory compliance and intellectual property protection to corporate governance and strategic planning, we provide the expertise you need to succeed in this evolving market.
Stay Informed: Harris Sliwoski Psychedelics Law Blog
For in-depth analysis and up-to-date information on the evolving legal landscape surrounding psychedelics, be sure to visit our Psychedelics Law Blog, a leading source of insights since 2018. Our blog explores a wide range of topics relevant to businesses and individuals, including recent legal developments, regulatory updates, and industry trends.
If you ready to unlock the potential of psychedelics, contact us today and let our experienced legal team guide you through this exciting new frontier.
State Decriminalization and Legalization
The path toward psychedelic legalization is unfolding on two fronts: federal and state/local. While federal scheduling remains a hurdle, progress is being made at the state and local levels through decriminalization and legalization efforts. Cities like Santa Cruz, Denver, Seattle, and Oakland have already decriminalized psychedelics, and states may soon follow. The commercial opportunities associated with decriminalization are less clear-cut, but the potential is undeniable.
Oregon stands as a prime example of the possibilities. In 2020, Oregon legalized psilocybin therapy with the passage of Measure 109. This groundbreaking legislation paved the way for a variety of commercial licenses in Oregon, allowing businesses to manufacture psilocybin and operate facilities for administering and facilitating psilocybin-assisted therapy sessions.
Our firm has extensive experience providing business and legal services in the cannabis space since 2010. This experience positions us well to understand the unique challenges and opportunities presented by the emerging psychedelic market. We stay at the forefront of psychedelic policy and legal developments with our Pyschedelics Law Blog which regularly covers these topics. We’ve also compiled a comprehensive and ever-evolving Psychedelics Glossary to help navigate the industry’s specific terminology.
Expanding Commercial Opportunities
Decriminalization and legalization at scale could open doors for a wide range of commercial endeavors, including the following:
- Psilocybin Production Facilities: Similar to Oregon’s model, licensed businesses could cultivate, process, and manufacture psilocybin for therapeutic use.
- Therapy Centers: Clinics specializing in psychedelic-assisted therapy could emerge, staffed by trained therapists and facilitators to guide patients through psychedelic experiences in a safe and controlled environment.
- Psychedelic Retreats: Depending on future regulations, destination retreats could offer immersive psychedelic experiences under professional supervision, potentially combining therapy with elements of nature and self-discovery.
- Research and Development: Legalization will unlock a new wave of research into the therapeutic potential of various psychedelics, creating opportunities for companies developing and testing new psychedelic medicines.
- Supporting Products and Services: A supportive ecosystem of businesses could develop, offering products and services such as integration coaching, pre- and post-treatment support, and supplies for safe psychedelic use.
It’s important to note that regulations on psychedelics are still evolving, and the specific commercial opportunities will depend on the legal framework established in each jurisdiction. However, the potential for growth in the psychedelic sector is undeniable.
Our Psychedelics Legal Services
Building a successful psychedelic business requires a strong legal foundation. Our firm provides a full spectrum of legal services to guide you through every stage of your journey, ensuring compliance, protecting your assets, and fostering growth. Here’s how we can help:
Business Formation and Operations:
- Entity Formation, Administration, and Governance: We help establish your psychedelic business entity, set up proper governance structures, and ensure ongoing compliance with relevant regulations.
- Licensing and Permits: Secure the licenses and permits required to operate in the ever-evolving psychedelics industry.
- Employment Law: Comply with labor laws and address employment-related issues specific to the psychedelics industry.
- Contracts: Craft, review, and negotiate contracts essential for your psychedelic business operations.
Financial and Strategic Growth:
- Finance and Investment: Navigate financial regulations and develop strategies to attract investment for your psychedelic venture.
- Mergers and Acquisitions: Guide you through legal aspects of mergers, acquisitions, or other business combinations within the psychedelic sector.
Intellectual Property and Technology:
- Intellectual Property Protection and Registration: Protect your inventions, trademarks, or copyrights related to psychedelics.
- Technology-Related Agreements: Draft and review agreements for technology used in your psychedelic business.
Regulatory Compliance and Risk Management:
- Regulatory Compliance Advice and Counsel: Stay ahead of the curve and ensure your psychedelic business operates compliantly with evolving regulations.
- Clinical Trials and Research Compliance: Navigate the legal complexities of conducting psychedelic clinical trials and research.
- Health and Safety Compliance: Ensure your psychedelic facilities meet all relevant health and safety regulations.
- Risk Management: Develop strategies to mitigate legal and operational risks associated with your psychedelic business.
Data Privacy and Legal Representation:
- Patient Privacy and Data Protection: Maintain compliance with privacy laws and regulations regarding patient data in clinical settings.
- Litigation: We represent you in court or arbitration proceedings related to your psychedelic business.
- Legal Opinion Work: Get expert legal insights on specific psychedelic law issues to make informed decisions.
- Advertising and Marketing Compliance: Navigate legal restrictions around advertising and marketing psychedelic products.
By leveraging our comprehensive legal services, you can focus on innovation and growth, leaving the legalities to us.
THOUGHT LEADERS IN
PSYCHEDELIC LAW
The Psychedelics Law Blog is a forum for discussing the impact of psychedelics laws on industry stakeholders. We provide insight for readers to use this dynamic body of law and policy to their advantage. In plain language, our blog posts analyze what works, what doesn’t, and why. Our aim is to further the development of this exciting field in a collaborative environment with our readers.
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Our Clients' Successes
“Harris Sliwoski expertly guided us through the formation of our company. They continue to assist with necessary registrations and compliance with numerous regulations. They were able to promptly answer all our many questions and provide understandable options, explanations and practical advice. We expect to continue to use Harris Sliwoski on a regular basis as our company expands. They were also able to introduce us other professional experts. We would not hesitate to recommend Harris Sliwoski to any companies in need of legal advice.”
Three Continents Foods LLC
This law firm was a huge help as our company went through the process of commercial licensing in the California cannabis industry. They have helped us with a variety of legal issues in a timely fashion, while clearly communicating with us throughout the process. Everyone we’ve worked with at Harris Sliwoski is an expert in their field and we have always felt that we were in good hands through our legal representation.
Wil Crummer, CEO PRO Farms
Legal stuff is always scary. And I’ve had to play offense a couple times, begrudgingly. To have Harris Sliwoski have my back? It made things a lot less prickly. They quickly walked me through my options, and were refreshingly consistent in their communications, timing and billing. I’ve been lucky to stay out of the legal side of things my whole career, thankfully. When things went a little wrong, Harris Sliwoski quickly made things right.
Aaron Draplin, Founder Draplin Design Co.
I am impressed with this law firm. They answered all my questions regarding cannabis businesses and the California cannabis framework, and they have helped me with a variety of legal issues in a timely fashion, while always clearly communicating with us throughout the process. They also redirected me to other quality people for my business needs. Everyone I worked with at Harris Sliwoski is an expert in their field, and I was in good hands throughout my legal representation.
Corey T., CEO Thinc Cubed, LLC
I have been working with the lawyers at Harris Sliwoski for more than 20 years both as a business owner and as an executive at a large east-coast health system and that is because they have always efficiently provided high level and clear international law advice. Most recently, Harris Sliwoski provided legal support on many matters related to procuring medical products worldwide. Their support was particularly helpful to during the onset of COVID, when there was a big need for securing PPE quickly, all while navigating complicated international and domestic legal requirements. Harris Sliwoski’s team of international lawyers helped by conducting rapid-fire due diligence on potential suppliers, navigating the legal logistics for getting product from overseas and through U.S. customs, and drafting contracts to protect against various sorts of horribles. They did this by essentially providing what amounted to 24/7 service. I cannot recommend them highly enough.
Dan Pak Hospital Supply Chain Executive
Harris Sliwoski has represented our company in the legal cannabis industry for years. Harris Sliwoski has advised us in a wide variety of legal matters, and they are truly experts in their field. I would highly recommend Harris Sliwoski to anyone with questions about cannabis law, or any legal matters. They have been great for our Company, and will continue to guide us as our industry evolves
Matt Hurt, COO Cannabis Nation
You won’t find a better partner than Harris Sliwoski when trying to navigate the complex world of healthcare regulations. They not only give sound and reliable legal advice, but they are also very responsive and are able to guide you in a way that helps you reach your business objectives as well.
Joseph Axelrod, General Counsel Irwin Naturals
When we started the process of building a ‘seed to sale’ cannabis company in Oregon, we saw the need for expert legal counsel. The cannabis sector is fraught with potential peril at every turn, and we wanted the best legal advice we could find. After talking to several firms and individuals, we feel extremely fortunate to have chosen Harris Sliwoski as our legal counsel.
Tony Theiss, CEO and Co-Founder Redbarn Cannabis
We use Harris Sliwoski on all our international legal matters, including on our international litigation matters. We have over the last few years been involved in a couple big international legal disputes and Harris Sliwoski’s international dispute resolution team provided us with expert legal assistance on both matters. They were always very careful to explain to us what they were doing and why and what their actions would likely cost us in legal fees. Most importantly, we did extremely well on both cases and I have no doubt Harris Sliwoski was a big factor in that.
Kevin English, CEO We Are Camp
We have used Harris Sliwoski for legal help related to our international manufacturing. The lawyers with whom I worked had extensive familiarity with the international legal issues involved in our various projects and offered us key insights. I particularly appreciated how they always quickly and efficiently do what they say they will do and always within their cost estimates.
Andrea Barona Valladolid, Senior Legal Counsel Fairphone