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Could Italy decriminalise psychotropic substance cultivation? 

Psychedelic Health speaks with co-founder and international co-ordinator at Associazione Luca Coscioni, Marco Perduca, to find out more about what Italy’s campaign to decriminalise the cultivation of psychotropic substances means for the Right to Science.

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Study to evaluate psilocybin for cannabis use disorder

An Italian cannabis referendum could potentially lead to the decriminalisation of psychotropic substance cultivation, such as cannabis and mushrooms, for personal use if successful. 

The campaign has gained more than half a million signatures supporting the decriminlisation of psychotropic substance cultivation in less than a week, the amount needed to see a potential vote on the referendum. 

Focusing on the decriminalisation of cannabis cultivation and removal of sanctions for conduct related to cannabis, the campaign aims to modify the wording of “cultivation” in the Consolidated Law on the Discipline of Narcotic Drugs and Psychotropic Substances in the Presidential Decree 309/1990.

This would not lead to the legalisation of all substances, however, the campaigners say

“…eliminating the word “cultivate” decriminalizes the cultivation of all narcotic substances. However, this does not mean legalizing all drugs. In fact, the cases of illicit production, manufacture and possession remain and can also be applied to the farmer who produces for the purpose of selling.” 

They go on to say: “It is also worth remembering that with the exception of cannabis inflorescences (and mushrooms), all other narcotic substances necessarily require subsequent steps for the substance to be consumed, activities which continue to be punished in Article 73.” 

The right to cultivation

The campaign is spearheaded by Forum Droghe, Meglio Legale, Antigone, Luca Coscioni Associations, Società della Reagione, and supported by parties including Volt Italia, Possible, Italian + Europa, and the Communist Refoundation. Its launch follows a proposed referendum launched by Riccardo Magi to decriminalise cannabis cultivation.

Commenting on the campaign, president of the Organising Committee for the Cannabis Referendum, and co-founder and international co-ordinator at Associazione Luca Coscioni (Science for Democracy), Marco Perduca, said: “Associazione Luca Coscioni has been following all drugs-related issues since inception some 20 years ago. It is a splinter group of the only seriously anti-prohibition political party in Italy called Radical Party that, since the mid-60s, has been advocating the decriminalisation or legalisation of all substances. So it came naturally. 

“The moment we understood that signatures for a national referendum could be collected online, we put our conviction to the test, and because over the last five, six years, the debate on cannabis in particular, has grown exponentially, especially on social media and among the youngsters, and also in some cultural and musical quarters.

“I think our assumption was correct, because in five days we collected over 500,000 signatures, and, in order to qualify for a ballot next year, we needed the 500,000.”

Perduca, who was a senator in Italy from 2008 to 2013 and expert on UN mechanisms with an emphasis on drug policy reform, continued: “Now the process hasn’t stopped yet, but we are confident, and if the bureaucracy doesn’t slow down, and it doesn’t create obstacles, we’re good to go out on the 30 September to the Cassation Court to submit everything, then the Constitutional Court will have to take a decision in January. 

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“Our Constitution allows national referenda, provided they don’t touch the Constitution, they don’t touch the fiscal system and they don’t infringe with the ratification of international documents. Because cannabis, like all the other narcotics, is at the centre of an international drug control system, we decided to eliminate sanctions and criminal and administrative sanctions that did not have anything to do with the three UN conventions, so, we are confident that at least on that, there are no problems. 

“We know that the jurisprudence of the court in the past has been critical of the so-called manipulation of texts, so that sometimes you take away one word, and the entire architecture of the law crumbles down. We discussed this with jurists and experts in constitutional law, and we believe that this is the minimum that we could prepare, but the maximum in terms of the facts.

“We are, so to speak, liberating any kind of cultivation, but we are not deleting the verbs that are “produce” and “fabricate” which in Italian could mean “manufacturer”, so it would be okay to grow, but the moment in which you transform what you’re growing into something else it will be penalised.

“Now of course, this includes mushrooms and peyote – certainly for personal use, if that is not taken somewhere else and does not become something else – we are creating a new framework. Many of the substances that are in the same scheduling as cannabis have – and we know because of scientific literature that is being developed these days – very efficient and effective therapeutic implications. So, we hope that, by taking away the penalties, we take away the stigma. We have already started several campaigns.”

The Right to Science

Perduca emphasises that the issue spans further than an individuals’ right to cultivate and consume psychotropic substances for personal use, but that these restrictions interfere with the Right to Science. 

“We are also now pushing not only to allow people to grow, but also to use, what can be grown without problems for specific scientific research that is targeting specific physical conditions or pathologies because Italy is behind a lot of other countries in this kind of research. We only have one centre at the University of Rome that is starting to study psilocybin for therapeutic purposes. We also grow cannabis for medical reasons, but nobody’s studying it,” says Perduca. 

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“We hope that after next spring, if all goes well, there is going to be a new scenario, culturally, but also scientifically and then we can keep on insisting on this. So, we are taking away penalties for growing, but it depends on what you grow and how you use them.

“We are now working on something that is called the “Right to Science”, which is a not too well-known right enshrined in the International Covenant on Economic, Social and Cultural Rights, which entered into force in 1976, so it is not a new thing.

“What is new is that the UN at the Committee on Economic, Social and Cultural Rights in April 2020 adopted the general comment on Article 15 of the covenant, which is called General Comment 25 on Science

“There are three elements of the Right to Science including freedom of research, regardless of the topic research, the sharing of knowledge which is open access, free science, and free and open data are part and parcel of this right, and the last element of the Right to Science is the right to benefit scientific progress and its application. 

“The General Comment speaks clearly, it has one paragraph dedicated to cannabis as the example where prohibitionist laws have impeded research on the plant. It says that if you keep on insisting on limiting or prohibiting certain kinds of presences in the scientific sphere, you’re violating the right to science.

“There is another paragraph about the precautionary principle that says that if you have imposed restrictions for a limited amount of time because you fear that a new thing should be regulated in a way in which shouldn’t create harm to humans, animals or the environment, and after five, 10, 20, or in this case we are talking about 60, years – if you have seen that no such harm has been produced, then you have to upgrade or update those laws. In economic circles it’s called the Innovation Principle, here, it is an adjustment to the precautionary principle to the new general situation substantiated by scientific evidences.

“We have a lot of evidence that has been produced by groups like MAPS that has been produced over the last few years on MDMA and also cannabis. You have also other studies that say these substances regulated under the three UN conventions have become a threat because they are prohibited, not because they are dangerous in themselves.

“And so, scientific research for therapeutic uses should be taken into consideration but also statistics and criminology that will tell you that perhaps regulating the presence of these plants in our life in a different way could trigger different scenarios, and if we were to judge from the evidence that is coming from the US states or Canada or Uruguay, where you have contained the phenomenon, you will have to say that this type of evidences will need to be taken into consideration, certainly at the national level but one day possibly also at the international level.”

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Associazione Luca Coscioni has a publication coming out next week – The Dose Makes the Poison – which is a collection of presentations and international symposia it has conveyed over the last four years with psychedelic pioneers such as Amanda Feilding, Rick Doblin, Ben Sessa and Carl Hart. 

“In order to assist each other, together with the researchers, we are planning on launching a World Coalition for the Right to Science, to frame this according to existing international law, in order to go to the United Nations and show there is a contradiction between what the UN Convention on Drugs says, and the new clarification of the elements of the Right to Science.

“The three UN conventions were adopted to allow access to these plants and to the medicines that can be derived from them. At the same time, a punitive system was created if those plants and substances are not used for medical purposes. Now, the non-medical purposes have taken over in terms of our culture. While there is no problem, at least in my view, to do whatever you want to do, as long as you know what you’re doing and what you’re getting and so, it is a matter of personal responsibility, but it has to be informed decision, of course. But this stigma has percolated into the other domains which are science and medicine. We have to not only separate the two, but possibly make dialogue for the betterment of welfare and wellbeing at the global level.”

Perduca says the coalition should be ready to launch in November, and will be working at a global level not only on drugs but also on other issues such as genome editing, global warming and women’s rights.

ReferendumCannabis thinks the campaign to legalise the cultivation of psychotropic substances in Italy will gain the extra signatures needed to secure reviewal by the house. 

Società della Ragione, which attributes the success of the campaign so far to the ability to use digital signatures, describing their use as “a possibility unique for the practice of direct democracy by telematic means”, says that cannabis cultivation is a theme that “crosses justice, public health, safety, business opportunities, scientific research, individual freedoms and, above all, the fight against the mafia.”

Markets & Industry

Compass, Transcend, and Usona Identified as Receivers of Priority Vouchers Following Psychedelics Executive Order

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Compass Pathways, Transcend Therapeutics, and the Usona Institute have been named the first recipients of FDA National Priority Vouchers following last week’s landmark executive order, for programs developing psilocybin and methylone, an MDMA analog.

“These medications have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions,” said FDA Commissioner Marty Makary, M.D., M.P.H.

Issued by President Trump on April 18, the “Accelerating Medical Treatments for Serious Mental Illness” order directed the FDA to provide these high-value regulatory tools to designated breakthrough therapies. By securing these vouchers, the three organizations are now positioned to shave months off the typical regulatory review timeline, significantly shortening the path to commercialization for their lead candidates.

The vouchers, known as Priority Review Vouchers (PRVs), are powerful regulatory assets that grant the holder a fast-track review from the FDA by reducing the target review time from ten months to six. Originally designed to incentivize development in rare pediatric or tropical diseases, their application to psychedelics marks a strategic shift in federal policy. 

Compass Pathways appears to be the closest to utilizing this advantage. Recent Phase 3 data for its lead compound, COMP360 (synthetic psilocybin), demonstrated a “highly statistically significant” antidepressant effect in patients with treatment-resistant depression (TRD). 

The company was the first to confirm being a recipient of one of the three vouchers, via a press release published Friday.  

According to CEO Kabir Nath, the company is potentially the first to bring a classic psychedelic to market, with a rolling NDA submission already underway. Compass expects to complete its filing by the second half of 2026.

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The remaining two organisations to receive the vouchers were not identified by the FDA on its release, but can be deducted from the information provided by the agency, as the only two working in late stage trials with the compounds targeted by the measure.

Transcend Therapeutics’ voucher comes at a pivotal moment in its corporate evolution. The New York-based firm was recently acquired by Japanese pharmaceutical giant Otsuka in a deal worth up to $1.2 billion, and is developing a pipeline for methylone, a non-hallucinogenic analog of MDMA. By focusing on neuroplasticity without the intense cognitive alterations associated with classic MDMA, Transcend is targeting a unique regulatory niche for PTSD. 

Finally, the Usona Institute—a non-profit medical research organization—continues its push for psilocybin as a treatment for Major Depressive Disorder (MDD). Unlike its commercial counterparts, Usona’s receipt of the voucher underscores the administration’s intent to support diverse research models, including non-profit institutes. Usona is currently conducting its “uAspire” Phase 3 trial, which evaluates a single 25mg dose of psilocybin. The voucher ensures that once Usona completes its trial work, the resulting data will receive the highest level of federal priority, ensuring that patient access is not delayed by administrative bottlenecks.

Interestingly, ibogaine was not targeted for the fast-track measure in spite of being a central protagonist of the executive order’s announcement last week by the White House.

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Trump Issues Executive Order to Accelerate Psychedelics for Mental Health 

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President Donald J. Trump signed an executive order on Saturday aimed at speeding up the development and approval of psychedelic-based treatments for serious mental illness in the United States.

The directive targets a range of conditions, including major depressive disorder and substance use disorders, specifically for patients who have not responded to traditional therapies.

The order signals a significant shift in federal drug policy by prioritizing the evaluation of substances like psilocybin and ibogaine, which are currently classified as Schedule I controlled substances. While advocates have hailed the move as a breakthrough for mental health innovation, medical experts have raised questions regarding the safety profile of some compounds and the practicalities of their implementation.

“Today’s Executive Order reflects growing recognition that modern mental health challenges demand new approaches,” said Betty Aldworth, Co-Executive Director of the Multidisciplinary Association for Psychedelic Studies (MAPS).

Key Provisions

The primary objective of the order is to streamline the regulatory pathway for “Breakthrough Therapy” drugs. Specifically, the directive instructs the Food and Drug Administration (FDA) to issue Commissioner’s National Priority Vouchers for psychedelic drugs that have already received breakthrough designations. These vouchers are designed to accelerate the review process, potentially reducing wait times for federal approval from months to weeks.

Furthermore, the order expands the “Right to Try” framework to include investigational psychedelic compounds. This provision is intended to allow patients with life-threatening or severely debilitating conditions to access experimental treatments—including ibogaine—provided they have met basic safety requirements and are currently under FDA review.

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To bolster research at the local level, the Secretary of Health and Human Services (HHS) has been directed to allocate $50 million through the Advanced Research Projects Agency for Health (ARPA-H). This funding is earmarked to match state-level investments in psychedelic research programs. The move appears to follow the lead of states like Texas, which recently authorized state-funded research into ibogaine for veterans.

Federal Coordination and Scheduling

The executive order also mandates increased inter-agency cooperation. The HHS, FDA, and Department of Veterans Affairs (VA) are required to sign data-sharing agreements to pool clinical trial results. The goal is to provide the FDA with a more robust evidence base to facilitate timely evaluations.

Addressing the legal status of these substances, the order directs the Attorney General to initiate a review of relevant products immediately following the successful completion of Phase 3 clinical trials. This is intended to ensure that if a drug is approved by the FDA, the process of rescheduling it under the Controlled Substances Act can occur as quickly as possible.

What the Order Doesn’t Do

Despite the sweeping language of the directive, several legal and medical hurdles remain. The order does not immediately legalize or “deschedule” psychedelics. Substances such as MDMA, LSD, and psilocybin remain in the most restrictive federal category for illegal drugs. Any rescheduling remains contingent on the completion of rigorous Phase 3 clinical trials and subsequent FDA approval.

Importantly, the order does not mandate insurance coverage for these experimental therapies. Industry analysts noted that because these treatments remain largely unapproved, they are unlikely to be covered by private or public insurance in the near term, potentially limiting access to those who can afford out-of-pocket costs at private clinics.

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“Today, people desperate for healing are traveling abroad or self-medicating with impure substances and little support. Efforts like today’s Executive Order must be paired with regulated psychedelics, provider training, and robust insurance coverage,” said Aldworth.

Finally, the order does not bypass existing safety protocols. While it seeks to “accelerate” the process, drugs must still demonstrate safety and efficacy through the standard clinical trial pipeline.

Medical and Scientific Context

The administration’s focus on ibogaine has drawn particular attention. Derived from a West African shrub, ibogaine has been studied for its potential to interrupt opioid addiction and treat post-traumatic stress disorder (PTSD). However, it is also known for potential cardiac toxicity. Some researchers expressed concern that emphasizing ibogaine over other psychedelics with more established safety profiles could be premature.

“As federal agencies move to reduce longstanding barriers to research, it is essential that progress across this broader class of compounds remains grounded in rigorous science, careful evaluation, and a commitment to patient safety,” said Ismail L. Ali, J.D., Co-Executive Director of MAPS. 

The advocate has called for “alignment with global public health principles” when working with ibogaine and the Iboga plant from which it’s extracted.

“Ibogaine has the potential to address the devastating crisis of opioid use disorder. However, because iboga is a limited resource, mass production of ibogaine can harm the people, traditions, and land where iboga is grow,” he said.

The order represents a rare area of emerging bipartisan interest, as lawmakers from both parties have expressed support for expanding research into how psychedelics might assist veterans and those struggling with treatment-resistant depression. However, the success of the initiative will ultimately depend on the results of ongoing clinical trials and the ability of federal agencies to navigate the complex safety and regulatory requirements involved in bringing Schedule I substances to the medical market.

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Market Impact

The news provided a boost for companies in the psychedelics sector that are publicly traded, reflecting growing investor confidence in the field. Shares from Compass Pathways, a company with a Phase 3 program in psilocybin, were up 43% on Monday. AtaiBeckley was up 24% and GH Research 16%.

Picture: courtesy of the White House.

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Pink Elephant Launches Seed Investment Program For Startups in the Psychedelics Space

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Elephant Gate, a new accelerator launched by Pink Elephant, has opened applications for its inaugural cohort, aiming to support early-stage companies building foundational infrastructure for the growing psychedelics sector. The program will deploy $150,000 into up to ten pre-seed and seed-stage startups annually, with submissions open through May 15, 2026.

The new accelerator initiative fits into a growing trend of interest from investors and funds, following a long capital drought that affected the space from 2022 to 2024. While investment and consolidation picked up during 2025, it was mainly focused on drug discovery and development, leaving small startups and companies focused on developing the infrastructure for the implementation of psychedelic therapies out of the radar and fighting to survive.

Elephant Gate describes the psychedelics infrastructure subsector as “a critical gap in the ecosystem.”

As clinical trials expand, regulatory pathways evolve, and new compounds move closer to approval, the need for scalable systems supporting delivery, training, and patient access has become increasingly apparent, they have said in a press release.

The accelerator will run from 2026 through 2028, backing a total of 30 companies across three cohorts. While headquartered in San Francisco, Elephant Gate operates as a fully remote program with a global scope, explicitly inviting founders from Europe, Asia, and beyond to apply.

The initiative has secured partnerships with Psychedelics Today and JLS Fund, reflecting a blend of media reach, education, and venture capital expertise. Psychedelics Today reports an annual audience of over 2.2 million learners, while JLS Fund focuses on investments across neuroscience, mental health, and enabling technologies within psychedelic medicine.

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Elephant Gate’s investment thesis centers on infrastructure layers rather than drug development itself. Areas of focus include education and training platforms, clinical support software, AI-assisted integration therapy, clinical delivery systems, and patient acquisition tools. However, the program maintains flexibility, encouraging applications from founders working outside these categories if they align with the broader ecosystem vision.

In addition to capital, selected companies will receive access to a network of practitioners and operators, along with go-to-market support and introductions to institutional co-investors. The program also emphasizes community building among founders navigating similar regulatory and operational challenges.

“The psychedelic ecosystem is emerging from the ground up,” said Natalia Fedulova, Partner at Elephant Gate. “We are here to back the entrepreneurs who are building the infrastructure that will define how millions of people access these therapeutic modalities over the next decades.”

Applications for the first cohort close on May 15, 2026, with the program open globally to pre-seed and seed-stage companies. Interested founders can apply directly or contact the team via email at hello@elephantgate.co

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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