Psychedelic Decriminalization, Data Privacy, Patents, and Colorado's Natural Medicine Advisory Board
Psychedelic Decriminalization, Data Privacy, Patents, and Colorado's Natural Medicine Advisory Board
Drug decriminalization expands & draws new criticisms, journalists respond to Oregon psychedelic surveillance plan, chemists opine on secondary patents, and Colorado appoints an advisory board
Decriminalization Disputes
On January 31, possessing small amounts of certain controlled substances will no longer be a criminal offense in British Columbia (B.C.), Canada. Health Canada, the agency responsible for national health policy, has granted B.C. an exemption to Canada’s Controlled Drugs and Substances Act.
According to the B.C. government, “we’re decriminalizing personal possession of some drugs” as “a critical step in B.C.’s fight against the toxic drug crisis.” Thanks to Leonard Pickard for bringing this to my attention.
B.C.’s plan is part of a trend to reduce criminal penalties associated with possessing controlled substances like psychedelics. Portugal was the first country to systematically reduce criminal penalties in 2001 while simultaneously investing in harm reduction and substance use treatment services.
Inspired by Portugal’s success, Oregon voters approved Measure 110 in 2020, eliminating criminal penalties for possessing small amounts of psychedelics and other controlled substances. Since then, over a dozen U.S. cities have deprioritized the enforcement of penalties associated with psychedelics.
Last year, Colorado voters approved Proposition 122, the Natural Medicine Health Act, a hybrid law that blends elements of decriminalization with regulated sales and supervised administration. More recently, California, Illinois, Massachusetts, and New Hampshire unveiled decriminalization proposals of their own.
Despite these developments, whether to regulate psychedelics or decriminalize them remains one of the most contentious issues in the psychedelic policy space. While these two approaches are not incompatible, stakeholders often gravitate toward one extreme or the other.
Supporters of decriminalization view it as an ethical, public health-oriented approach to drug policy. Advocacy groups like Decriminalize Nature and Decrim First have coalesced around this issue. Civil rights organizations like the ACLU and the Drug Policy Alliance also support decriminalization.
Meanwhile, critics believe decriminalization promotes drug use and threatens public health and safety. These opposing sides have butted heads in Oregon and Colorado. They will soon face off again.
Last week, I discussed a new proposal to repeal Oregon’s Measure 110. Since voters approved the measure, people in possession of small amounts of drugs pay a $100 fine instead of facing misdemeanor or felony charges. They can avoid the fine by undergoing a substance use evaluation paid for by the state.
In addition to eliminating criminal penalties, Measure 110 siphons tax revenue from Oregon’s cannabis industry to fund services that support people with substance use conditions. So far, over $300 million has been funneled to these services, which include peer support, housing assistance, and harm reduction services.
However, four Oregon lawmakers are sponsoring HB 2831, which would repeal Measure 110 and reinstitute criminal penalties for personal possession, including prison time and large fines. They say Measure 110 is a failure because it doesn’t pressure people into treatment and substance use rates have not decreased following its adoption.
Last May, Representative Lily Morgan, who filed HB 2831, conveyed her frustrations to Steve Allen, Director of Behavioral Health at the Oregon Health Authority (OHA), the agency that dispenses funds allocated by Measure 110. “People are dying while the state waits for Measure 110 to have a positive effect,” said Morgan before asking, “how long do we wait before we have an impact that we’re saving lives?”
Though he did not advocate for Measure 110’s repeal, addiction medicine physician Todd Korthuis told an Oregon Senate committee that few people cited for possession choose to undergo the optional substance use evaluation.
“Only 1% of those issued a ticket for drug possession requested information about treatment resources,” said Korthuis. Specifically, of the 3,169 individuals cited by August 2022, 137 called the state hotline to receive an evaluation. 36 callers requested information about enrolling in treatment. Korthuis speculated that most people called the hotline to avoid paying the $100 fine.
These statistics are useful. But despite what critics say, Measure 110 is a success, and repealing it would be a huge mistake.
Measure 110 routed over $300 million in tax revenue to services that provide housing and peer support. It’s unrealistic to expect a sudden reduction in substance use and overdose deaths. The funds unlocked by Measure 110 were significantly delayed in reaching support programs (by over a year), prompting intense criticism. According to the OHA’s Allen, “we understand the frustration this caused in our communities . . . When you do something for the first time you’re going to make mistakes.”
The OHA’s fumbling of Measure 110’s implementation was a contentious issue during Oregon’s gubernatorial race, and recently elected Governor Tina Kotek has vowed to hold the OHA accountable.
Rates of enrollment in treatment services are important statistics. But they’re not a proper yardstick for gauging Measure 110’s success. The measure never intended to force people into treatment. Its first paragraph states, “[d]rug treatment and recovery ought to be available to any Oregon resident who requests it [emphasis added].”
Measure 110 successfully funds valuable support services. So, instead of asking only how many people sought treatment, it makes sense to ask how many have been provided housing, peer support, and other services? But critics seem to ignore these benefits.
Importantly, eliminating criminal penalties for personal possession is an end in itself. Measure 110 has inspired cities and states across the country to implement decriminalization, and that may be its greatest success.
Journalists Respond to Steiner’s Psychedelic Surveillance Bill
I recently wrote about Elizabeth Steiner’s Oregon’s SB 303, a bill that would subject clients in Oregon’s regulated psilocybin program to mandatory government surveillance.
Filed by Senator Elizabeth Steiner, SB 303 would force Oregon psilocybin facilitators and service centers to share large amounts of client data with the Oregon Health Authority (OHA) and Oregon Health Science University (OHSU). Last week, several journalists picked up the story.
In an article for Lucid News, Ken Jordan interviewed SB 303 supporters, which include lobbyist Sam Chapman who directs the Healing Advocacy Fund. Chapman told Jordan forced data collection is the only way to know whether Oregon’s psilocybin program is successful.
In his newsletter On Drugs, attorney Matt Zorn poked holes in Chapman’s claim. Zorn correctly points out that statisticians and epidemiologists have long used data drawn from segments of a population to draw inferences about the entire group. This is the statistical practice of sampling, and it’s ubiquitous.
Clinical trials in medicine rely on sampling. The human subjects in a trial are only a small fraction of the individuals with a specific medical condition. However, by using statistics, researchers analyze the sample to draw valid conclusions about the entire groups.
Chapman frequently relies on sampling when the Healing Advocacy Fund informs its political strategies by polling samples of Oregon voters to draw inferences about all voters. During the Measure 109 campaign, Chapman would readily spend tens of thousands of dollars on a poll. But you won’t hear him claim that unless he surveys every Oregon voter, he can’t draw meaningful conclusions about the entire group. That’s because it’s unnecessary to collect data on every voter. It would also be cost prohibitive and overly invasive.
The same is true of forcing data collection from all psilocybin clients. In addition to being unnecessary, it would be expensive and raise the costs of administering the psilocybin program (the system has already run out of money, and the OHA has asked voters for an additional $6.6 million to fund it). Mandating data collection also violates the privacy and autonomy of Oregon clients and disregards the will of voters who approved Measure 109 with robust privacy protections for clients.
As Zorn puts it, “I’m sure that’s not what the Oregon people thought they were voting for, and the level of contempt for individuals baked into this new legislation, and the justification offered for it by the individuals who directed the ballot measure [Measure 109] is astounding.” Senator Steiner introduced SB 303 less than two weeks after the OHA published rules that gave clients control over their data and how it’s used. Those rules were the product of two years of government deliberation with public input, which Steiner and Chapman seek to overturn.
In the latest podcast episode from Psychedelics Today, hosts Joe Moore and Kyle Buller express concerns regarding “substantial risks” of Chapman and Steiner’s proposal. They worried mandatory data collection could expose clients’ identities, potentially having legal and financial consequences.
Moore notes that psilocybin remains illegal under federal law, and consequently, the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule does not apply. He suggests legislators wait a few years, to get a sense of the federal government’s reaction to Oregon’s program, before attempting to collect data from clients.
Moore is right that HIPAA does not apply to psilocybin service centers, facilitators, or client information. These centers and professionals fall outside the healthcare system and their actions are illegal under the federal Controlled Substances Act. Notably, if that wasn’t the case, and HIPAA did apply, then collecting the kind of data that Steiner and Chapman propose would likely constitute a HIPAA violation.
A public health agency like the OHA can collect limited information from medical patients, but HIPAA restricts that data to the “minimum amount necessary” to achieve a specific public health purpose. The seemingly boundless surveillance program proposed by SB 303 is the antithesis of that requirement. If HIPAA applied (and again, it does not), it would be impermissible to do what Chapman and Steiner suggest, which is a shotgun approach to data collection, seeking everything they can get their hands on.
In last week’s edition of The Trip Report by Beckley Waves, Zach Haigney encouraged readers to follow SB 303 closely. According to Haigney, “Measure 109 was crafted so as not to require personal data collection—but SB 303 would reverse that and create an arduous process for service centers to adhere to and require clients to disclose specific personal information.”
Haigney worries Steiner’s data collection mandate might drive clients away from Oregon’s regulated psilocybin program and make it harder for psilocybin service centers to stay in business.
In recent weeks, I’ve heard from people around the country expressing concern regarding SB 303. The bill has been assigned to Oregon’s Senate Committee on Health Care, where its future is uncertain. If there are any further developments, I’ll be sure to cover them at Psychedelic Week.
Chemist Opine on Secondary Psychedelic Patents
In 2022, co-author Glenn Cohen and I published an article on psychedelic patents in the Harvard Law Review Forum. We describe how companies have capitalized on the increasing popularity of psychedelics to patent inventions for which patent protection may be unwarranted. These inventions are often subtle variations of existing technologies, and in the case of psychedelics, they may have been copied from the practices of Indigenous communities.
Last week, a pair of chemists published a response critiquing our claims in ACS Pharmacology & Translational Science. Thanks to attorney Graham Pechenik of Calyx Law for bringing it to my attention.
The authors address our conclusions regarding secondary patents, which claim modified versions of existing substances. For example, a secondary patent might claim the left- or right-handed version of an existing psychedelic compound (an enantiomer), a different crystalline structure (a polymorph), a different pharmaceutical formulation, or a version where an element such as hydrogen is replaced with another element such as deuterium (a process called deuteration).
All these approaches have been exploited in the psychedelic space. For instance, Janssen Pharmaceuticals patented the use of the left-handed enantiomer of ketamine (called esketamine), which Janssen markets as Spravato. Similarly, Compass Pathways Limited patented certain polymorphs of psilocybin, and the drug company Cybin patented deuterated versions of psilocybin and dimethyltryptamine (DMT).
These tactics have become common in the pharmaceutical industry. Accordingly, one might question whether the compounds they produce are novel or inventive enough to deserve patent protection. One requirement for receiving a patent is that an invention would not have been obvious to someone having skill in the relevant field. If everyone in the pharmaceutical field knows that commercializing an enantiomer, polymorph, or deuterated version of a substance is not only possible but commonplace, then these subtle variations on existing compounds arguably become obvious, rendering those variations non-patentable.
Some governments believe the drugs claimed by secondary patents lack novelty. The Federal Court of Appeals in Canada held that Janssen’s Spravato is not an innovative drug. That case involved data protection rights rather than patent rights, but the same reasoning can be applied to patents.
The Indian Patent Act of 1970 distinguishes polymorph patents that represent true technological innovation from those that are not new and merely bolster a company’s intellectual property portfolio. In 2015, the United Nations encouraged government officials who evaluate patents to presume that enantiomers and polymorphs of existing inventions are unpatentable.
In their response article, authors Ilaria D’Acquarica and Israel Agranat defend secondary patents while critiquing our claims. I’ll let the authors speak for themselves. Though I appreciate their analysis, I’m not persuaded they’ve addressed our core claim that secondary patents are not novel or non-obvious.
Colorado Governor Interviews Candidates for Natural Medicine Advisory Board
This month, the office of Colorado Governor Jared has been interviewing candidates for Colorado’s Natural Medicine Advisory Board. His appointments will be finalized by January 31st.
This fifteen-member board will sit within Colorado’s Department of Regulated Agencies (DORA), the department responsible for implementing the Natural Medicine Health Act (Proposition 122). Voters approved this ballot initiative in November, triggering an eighteen-month rulemaking period in which the board will make recommendations to DORA.
Several parties have been lobbying the Governor’s office to appoint specific members. Natural Medicine Colorado, the political campaign that lobbied to pass Proposition 122, and the Nowak Society, a psychedelic advocacy group, submitted slates of preferred candidates.
In Oregon, lobbyists at the Healing Advocacy Fund played a large role in shaping the composition of the state’s psilocybin advisory board. The Fund now works in Colorado to influence implementation of the Natural Medicine Health Act, and its lobbyists have likely urged Polis to appoint specific members to Colorado’s board.
The Natural Medicine Health Act provides some guidelines regarding the board’s composition. For instance, at least one member must have expertise or experience in traditional, Indigenous use of natural medicines. However, the Act gives Governor Polis significant discretion over the remaining board members. Depending on his choices, some communities could be overlooked or overrepresented.
In Oregon, the state’s psilocybin advisory board was comprised largely of healthcare professionals. Few members appeared to have expertise regarding psychedelics. For over a year, the Oregon Health Authority failed to fill the seat reserved for a member of a federally recognized Indian tribe. The spot saved for a naturopathic physician was vacant for months.
I would not be surprised if Colorado’s board contains an abundance of people close to the Natural Medicine Colorado campaign, its funder the New Approach PAC, and the Healing Advocacy Fund. These organizations have the funding and connections to influence political processes behind the scenes.
One week from today, the board’s composition will be set. We’ll soon know whether the voices of Indigenous communities, people of color, underground “legacy” practitioners, religious organizations that utilize psychedelics, people with disabilities, and other marginalized groups are represented.
Stay tuned to Psychedelic Week for further news and analysis.
*The views expressed on Psychedelic Week do not represent the views of POPLAR at the Petrie-Flom Center at Harvard Law School or the Florida State University College of Law. Psychedelic Week is an independent project unaffiliated with these programs and institutions.
Mason Marks, MD, JD is the Florida Bar Health Law Section Professor at the Florida State University College of Law. He is the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.