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.
“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.
“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.”
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.”
Top UK and European academics join Clerkenwell Health advisory board
Renowned academics in the field of psychedelics from leading European universities will be joining clinical research organisation Clerkenwell Health.
Clerkenwell Health is expanding its pan-European advisory board with the addition of Dr David Erritzoe, Dr Dea Siggaard Stenbæk, Dr Kim Kuypers and Dr James Stone from Danish, Dutch and British universities.
With psychedelic research flourishing in Europe, Clerkenwell Health says it is building connections between commercial research organisations and academic institutions.
The expansion of its advisory board will give the company access to knowledge and networks from some of the most prestigious European universities – working to fulfil the company’s mission to create a more vibrant psychedelic clinical trial ecosystem and foster wider sharing of best practices across Europe.
Chaired by Dr Henry Fisher, the Clerkenwell Health CSO, the board will focus on clinical research and therapy, with its new members bringing expertise in areas of psychotherapy, psychopharmacology, mental health, experimental medicine and psychedelics.
Speaking to Psychedelic Health, CEO of Clerkenwell Health, Tom McDonald, said: “The UK is an attractive location to undertake psychedelic drug development as the government are opening up innovation pathways and championing clinical research.
“We are excited to be joined in our work exploring psychedelics-assisted therapy here in the UK with leading experts from prestigious European universities. Their involvement ensures we have a variety of expert opinions to shape innovative trial designs whilst preparing a platform for European expansion in the coming years.”
With an aim to support the commercial research ecosystem in the UK and Europe, the new board additions place Clerkenwell Health as an ideal partner to support drug developers wishing to conduct trials in European countries.
CSO of Clerkenwell Health, Dr Henry Fisher, stated: “I am delighted to be able to bring together such high calibre advisors into the Clerkenwell Health scientific advisory board. These researchers are leaders in their respective fields in Europe and are shaping the direction of clinical and fundamental research with psychedelics.
“This gives us access to the knowledge and network built in some of the most prestigious universities from Copenhagen to Maastricht and London, and it is a privilege to be able to consult with these figures on our own research.”
Meet the advisory board
Dr David Erritzoe is clinical director and deputy head of the Centre for Psychedelic Research at Imperial College London.
Erritzoe is currently investigating brain mechanisms and therapeutic potential of MDMA, ketamine and classic psychedelics, and is clinical senior lecturer in general psychiatry in Centres for Neuropsychopharmacology and Psychedelic Research at Imperial, as well as consultant psychiatrist at St Charles Hospital, CNWL Mental Health NHS Foundation Trust. Erritzoe also heads a NHS-based research clinic at St Charles Hospital, the CIPPRes Clinic.
Dr Dea Siggaard Stenbæk is an associate professor at University of Copenhagen and Copenhagen University Hospital.
Stenbæk’s research mainly focuses on neuropsychopharmacological effects of the 5-HT2A receptor agonist psilocybin. She collaborates with the Centre for Psychedelic Research at Imperial College London and is currently an honorary clinical research fellow in this group. As the clinical lead, she works on a study of psilocybin as a treatment for obsessive compulsive disorder.
Dr Kim Kuypers is an associate professor at Maastricht University. Her PhD focused on memory and risk-taking during MDMA intoxication.
Kuypers’ main goal is to understand the neurobiology underlying flexible cognition, empathy and wellbeing. To accomplish this she uses a psychopharmacological model, studying the (sub)acute and longer-lasting effects of psychedelics on these behaviours and their underlying biology.
Dr James Stone worked as a clinical senior lecturer at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London, with a focus on experimental medicine and clinical trials.
During his time there, Stone set up the ketamine clinic at the Maudsley Hospital for patients with treatment-resistant depression. He also worked at Imperial College London as a senior lecturer, working as co-director of the intercalated BSc in neuroscience as well as continuing research into the role of glutamatergic abnormalities in psychosis.
Psychedelics for addiction research gets $2.7m grant
The grant will fund research to investigate the efficacy of psychedelics for treating a variety of addiction disorders.
The University of California, Davis (UC Davis) and the University of Colorado Anschutz Medical Campus have received a $2.7m (~£2.15m) grant from the National Institute on Drug Abuse, part of the National Institutes of Health, to research psychedelics.
The researchers will use the funding to screen hundreds of compounds to discover new, non-hallucinogenic treatments for substance use disorders.
With previous research having shown that psychedelic drugs can rewire parts of the brain involved in depression, substance abuse and post-traumatic stress disorder, David Olson, associate professor in the departments of Chemistry, and Biochemistry and Molecular Medicine at UC Davis, is searching for similar effects among compounds without the hallucinogenic effects of drugs like LSD.
He calls these compounds psychoplastogens, for their ability to modify the brain.
Olson commented: “I’m very excited that NIDA is recognising the potential that psychoplastogens might have for patients with substance use disorders.
“This grant will help us to understand the basic mechanisms by which these compounds impact addiction, and hopefully develop more effective and better-tolerated treatments.”
Olson’s work is part of a growing focus on psychedelics research at UC Davis and UC Davis Health. His lab has synthesised hundreds of molecules related to psychedelics in the search for new drug therapies.
One such molecule, tabernanthalog, or TBG, produces both rapid and sustained anti-addictive effects in rodent models of heroin and alcohol self-administration.
The research will include mechanistic studies to understand how TBG impacts addiction and the development of new compounds with psychoplastogenic effects, he said. The team will use high-throughput screening to test for efficacy, safety and treatment potential. Promising compounds will undergo additional animal testing at CU Anschutz.
Delix Therapeutics, a startup founded by Olson, is also investigating non-hallucinogenic psychoplastogens for treating depression, anxiety and related disorders but is not involved in the project.
Beckley Psytech strengthens leadership team as it progresses clinical pipeline
Dr Laura Trespidi has been appointed as chief development officer (CDO).
Dr Laura Trespidi is joining the Beckley Psytech leadership team as CDO, bringing more than 30 years’ experience in global pharmaceutical and biotechnology companies.
Trespidi will bring world-class leadership and technical expertise to the Beckley Psytech team, having worked across clinical product development and manufacturing, from pre-clinical research through to market approvals and global product launches.
Trespidi will support the progression and development of Beckley Psytech’s investigational assets, including the proprietary formulations of intranasal 5-MeO-DMT, currently in Phase 1 studies.
CEO of Beckley Psytech, Cosmo Feilding Mellen, said: “Dr Trespidi joins us as our chief development officer at an exciting time, with our lead drug candidates in Phase 1 clinical studies. Laura’s impressive track record and expertise across clinical development and manufacturing will be invaluable, as Beckley Psytech continues to grow and progress its clinical pipeline in this groundbreaking area of medicine.”
Trespidi’s former roles were placed at Summit Therapeutics and other leading companies such as Mundipharma, Shire Pharmaceuticals and GlaxoSmithKline. Most recently Trespidi worked as senior vice president of chemistry, manufacturing and controls (CMC), supply chain and technical operations at Summit Therapeutics, successfully leading global CMC and external manufacturing teams through the development and market preparedness of investigational medicines, including end-to-end supply chain and manufacturing readiness and expansion.
Trespidi’s expertise extends further to formulation development, technology transfers, outsourcing and offshoring, with additional experience developing and executing change management strategies.
Throughout her career, Dr Trespidi has played a pivotal role in over 40 first-in-human clinical trials and pre-clinical trials, as well as contributing to four New Drug Applications (NDA) and market approvals, and over 40 Investigational New Drug (IND) applications.
Trespidi said: “I am thrilled to be joining Beckley Psytech at such a transformative time for the Company and for psychedelic medicines.
“Beckley Psytech’s innovative pipeline has real potential to offer meaningful improvement to patients’ lives, and I am looking forward to working alongside a world-class team to turn this vision into a reality.”
Trespidi received her PhD in Pharmaceutical Science from the University of Milan, Italy; an MSc in Medicinal Chemistry and Biochemistry from the University of North Carolina, US; and in 2008 she received an M.B.A from the Open University Business School, UK. She has also authored a number of papers published in peer-reviewed journals and is a member of several scientific societies and associations.
- Top UK and European academics join Clerkenwell Health advisory board
- Psychedelics for addiction research gets $2.7m grant
- Beckley Psytech strengthens leadership team as it progresses clinical pipeline
- Patient approved to receive psilocybin therapy for MDD
- World’s first study on ketamine for behavioural addiction now complete
- New partnership to harness digital tools to enhance psychedelic care
- World’s first study on ketamine for behavioural addiction now complete
- New partnership to harness digital tools to enhance psychedelic care
- DEA grants approval for the manufacture of psychedelic compounds
- Numinus receives Health Canada SAP approval for psilocybin therapy
- Clerkenwell Health is launching a free UK psychedelic therapist training programme
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