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Why Italy blocked the campaign on psychotropic substance cultivation

Legalizziamo! campaign coordinator Marco Perduca shares his thoughts on why Italy’s court has blocked the referendum.

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University of Guelph researchers to study psychedelic mushrooms

Last week Italy’s Constitutional Court blocked the country’s campaign calling for the decriminalisation of psychotropic substance cultivation.

The motivation for not allowing the referendum to proceed is not yet clear and the campaign has been accused of being misleading, says campaign coordinator Marco Perduca. 

Despite handing in 630,000 verified signatures calling for a referendum, Italy’s Constitutional Court stated that the campaign will not trigger a referendum. The Legalizziamo! campaign group has said the decision is a win for the mafia and “the failure of a court that cannot guarantee Italians a constitutional right”.

The campaign aimed to modify the wording of “cultivation” in the Consolidated Law on the Discipline of Narcotic Drugs and Psychotropic Substances in Presidential Decree 309/1990. The court, however, stated that the campaign would force the country to violate its obligations to the UN regarding the prevention of drug trafficking.

Find out about the global coalition pushing for psilocybin rescheduling

Marco Perduca is co-founder and international co-ordinator Associazione Luca Coscioni and founder of Science for Democracy, the international platform promoted by the Luca Coscioni Association. He has been the coordinator for the Legalizziamo! campaign since 2015.

In a comment to Psychedelic Health, Marco Perduca, said: “The motivation of the decision of the Constitutional Court against the admissibility of our referendum has not been published yet so we can only respond to the words of Giuliano Amato the President of the Court uttered in his press conference on 16 February.

“We were accused of having submitted a referendum that was poorly drafted, with a misleading title and that the whole proposal was not in line with Italy’s obligation stemming from the ratification of the three UN Conventions.

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“Mr Amato made reference to the website address on which we collected the signatures knowing quite well that that was the name of the political campaign to collect signatures but not the actual title of the question, which was decided in conjunction with the Cassation Court.

“Italy’s drugs law is very complicated to interpret but once you know your way through that legislative maze you know where it is heading: to punish conducts from cultivation to production, from transportation to export and import of illicit plants and substances. 

“Our referendum was deleting penalties only for one of those actions, cultivation, keeping all the other conducts in place – hence only growing for personal use would have been decriminalised, as massive cultivation would have remained illicit. Furthermore, one doesn’t need to be a botanist to know that one grows plants and not substance, one thing is cultivating coca bush, another producing cocaine, one thing is growing poppy seeds, another refining heroin. We do not cultivate wine but grapes.

“Mr Amato made that confusion and “forgot” to mention that prohibition to grow cannabis indeed appears in a paragraph of one of the articles we deleted as well as in the previous one – the 1990 law was toughened in 2006 but changed again in 2014 and sometimes it is difficult to keep track of all the changes, also for jurists – so, the accusation of having poorly drafted the referendum is a judgement that is up in the air as the law says otherwise. 

“Until we won’t have the motivations of the decision we can only speculate on the rationale behind it and respond to a brief, if not superficial, summary of the President of the Constitutional Court shared in a very unconventional manner on behalf of the 15 judges that took that decision.”

See also  Landmark psilocybin trial begins with dosing of patients

Speaking to Psychedelic Health, Perduca previously highlighted that the campaign also aimed to allow people to use cultivation for scientific research targeting specific physical conditions or pathologies. Perduca said that Italy is lagging behind other countries in psychotropic substance 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,” said Perduca.

Find out more on what the campaign means for the Right to Science

Perduca is also now involved in a campaign for the Right to Science – an enshrined right in the International Covenant on Economic, Social and Cultural Rights. This entered into force in 1976 and covers freedom of research, freedom of knowledge, including open access, as well as free and open data.

Whilst more studies are demonstrating the efficacy of psychotropic substances, such as psilocybin, for treating mental health conditions, prohibition of cultivating such substances hinders scientific research in Italy that could contribute to this new fountain of knowledge. 

To address what the country lacks in the field of psychedelic research, Associazione Luca Coscioni recently published a collection of presentations and international symposia – The Dose Makes the Poison. The collection features psychedelic pioneers such as Amanda Feilding, Rick Doblin, Ben Sessa, Carl Hart and Raphael Mechoulam.

The campaigners have stated they will not stop the fight to push through the referendum.

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Policy

UK advisory body issues rapid response on psychedelics for PTSD

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UK Government issues rapid response on psychedelic research

The UK’s independent Parliamentary Office of Science and Technology (POST) has issued a rapid response on psychedelic-assisted therapy for post traumatic stress disorder (PTSD).

The response is intended to inform policymakers on the topic as increasing research around psychedelics shows the compounds may hold promise as innovative treatments in the area of mental health.

The rapid response is the third response on psychedelics to come from POST – one of the first independent bodies of its kind in the world that sources independent analysis of public policy issues relating to science and tech for government.

Previous responses have covered depressive disorders, anxiety disorders and eating disorders.

See also  UK MPs demand answers as Drugs Minister dodges psilocybin debate

The response reads: “Research into the use of psychedelic-assisted psychotherapy for PTSD has been conducted using MDMA, ketamine, and the four ‘classical psychedelics’ (psilocybin, LSD, mescaline and DMT). These are described in POST’s rapid response article on depression.

“Generally, this approach involves ‘non-trip’ sessions with a medical professional to ensure safety, prepare the patient and build a relationship, and a minimum of one ‘trip’ session where the patient undergoes a form of talking therapy after administration of a psychedelic compound.

“Evidence from studies conducted in hundreds of participants suggests that psychedelic-assisted psychotherapy may be an effective treatment for PTSD. However, to date, there is not enough information from large clinical trials with sufficient participants comparing psychedelic-assisted psychotherapy directly to existing treatments.”

Responding to research and policy developments

POST’s responses on psychedelics have been issued following a parliamentary debate discussing psilocybin access in May 2023.

The debate saw a group of crossparty MPs call for the rescheduling of psilocybin to remove barriers to research and demand an urgent review of the evidence for psilocybin’s current status as a Schedule 1 drug under the Misuse of Drugs Regulations 2001, “with a view to rescheduling”.

The Royal College of Psychiatrists, psychedelic access non-profit Heroic Hearts UK, and other leading mental health charities, also wrote letters to the Veterans Minister and the Minister of State for Crime, Policing and Fire, urging them to champion access for patients in the UK.

The latest rapid response covers psychedelics for PTSD including Psychedelic-assisted psychotherapy for treating PTSD, MDMA, Ketamine, Classical Psychedelics and the Regulation of psychedelic drugs used in medicine.

Earlier this year, POST confirmed it intends to publish a major briefing on psychedelic drugs to treat mental health conditions in 2024.

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EMA workshop: One small step for Europe, one giant leap for psychedelics

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EMA workshop: One small step for Europe, one giant leap for psychedelics

In a watershed moment for psychedelics in Europe, the European Medicines Agency (EMA) held a workshop from 16 to 17 April to discuss regulatory guidelines for the development and therapeutic use of psychedelic medicines.

2024 is set to be an important year for psychedelics and the EMA multi-stakeholder workshop is just one of the key events kicking it into action.

The two-day workshop – Towards an EU Regulatory Framework – brought together patients, healthcare professionals, academia, regulators and industry.

As Europe risks lagging behind countries such as Australia and America in seizing the potential of psychedelics for mental health innovation, the meeting was held in response to a letter from a group of cross-party MEPs calling for the EU to act fast on these therapies.

See also  EMA adds psychedelics to major depression guidelines

The MEPs wrote to the EMA and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) to say the organizations need to play a more active role in the advancement of psychedelic medicines in Europe.

Highlighting that the recent shift in perspective towards psychedelics has garnered interest in Europe, the EMA has stated that concerns remain over challenges developers may face in meeting the scientific and regulatory expectations for receiving marketing authorisation for the medicines – holding the workshop as a starting point in working through these issues.

While the meeting marks one small, initial step for the EMA, the organisation’s interest in this developing field of research marks a giant leap for the advancement of the therapies in Europe.

Towards an EU regulatory framework for psychedelics

The meeting heard regulatory perspectives on psychedelic drugs in psychiatry from across Europe, Australia and America, as well as insights on the legal status of psychedelics and their impact on research.

Non-profit organisation PAREA highlighted how Europe is currently facing a mental health crisis with a desperate need for innovation in care, with not a single new medicine out of the 89 approved in 2022 targeting mental health.

The organisation emphasised the obstacles posed by regulation for scientific research and proposed a number of recommendations for a more supportive regulatory framework to help move psychedelic therapies forward, including:

  • Incentives such as regulatory protection: rescheduling psychedelic drugs to enable scientific research.
  • Enhanced EMA support: Utilising Europe’s PRIME scheme which focuses on medicines under development that are not yet authorised in the EU.
  • The establishment of an EU Commission on Novel Mental Health Therapies.
  • Accelerated assessments: Utilising Conditional Marketing Authorisation (CMA) and the EMA’s Adaptive Pathways programme for early patient access.
  • A more predictable reimbursement environment.

Speaking to Psychedelic Health, Tadeusz Hawrot, Founder and Director of PAREA, stated: “An importance of collaboration among different stakeholders felt central to the discussions, highlighting a need for joint effort to address the intricate issues surrounding psychedelic therapies.”

Building on the momentum created at the workshop, Hawrot said that PAREA will be exploring opportunities for a multistakeholder collaborative project as part of the Horizon Europe funding.

“The project would involve professional societies, patient groups, EMA and national competent authorities, addressing a number of most pressing topics related to psychedelic therapies at an intersection of regulation, science, and areas needed for implementing these therapies such as standards of care,” Hawrot explained.

“An upcoming EU Partnership on Brain Health will be an important opportunity to explore in this regard.”

Research and clinical trials

Further discussions focussed on methodological issues related to research and trials.

These surrounded issues with blinding and expectations, the importance of proper dosage justification and documenting dose-response relationships, as well as the need to investigate sub-psychedelic doses and their associations with psychoactive effects and neuroplasticity.

Hawrot commented: “In terms of some key areas addressed yesterday and today, discussion revolved around designing effective trials, the importance and type of therapeutic support, difficulties with using placebos, managing expectations, and how strict drug control policies are slowing down research.

“Exploring what can be standardised in trials, the crucial role of patient input and preferences, and the need for thorough aftercare provisions were further key points.”

The importance of Real World Evidence was also highlighted as a key path for advancing psychedelic therapies in Europe

Some implied next steps discussed were continuing dialogue between developers and regulators, seeking early feedback, and collaborating to address challenges in psychedelic drug development.

Patient representation and care

Ensuring the safe and effective use of psychedelic substances in clinical trials and real-world settings was also a main point of discussion, with patient representatives providing insight on their experience, as well as suggestions for patient care.

In particular, stakeholders including representatives of the Psychedelic Participant Advocacy Network (PsyPAN) highlighted the need for aftercare such as post-integrative therapy and peer support or professional guidance, however, it was also emphasised that these types of support are difficult to regulate.

The importance of patient involvement in research was also discussed, highlighting that patient involvement goes beyond study participation and includes a more active role in research design and decision-making.

Advancing innovation

Providing an environment where innovation can flourish will be vital for advancing psychedelics, and with companies already carrying out trails but hindered by strict regulations and expensive costs changes are needed sooner rather than later.

George McBride, Co-Founder of UK CMO Clerkenwell Health explained that the company is considering a significant investment into the EU to build out centres for the conduct of psychedelic research, querying the competitiveness of the EMA versus other jurisdictions such as the U.S FDA, Australia’s TGA, Health Canada and the UK’s MHRA.

EMA representatives provided assurance that the organisation is ready to be part of a collaborative and supportive effort to establish standards of care and standards for data gathering.

Speaking to Psychedelic Health, Stephen Murphy, CEO of PSYCH, commented: “This workshop is a key moment for the advancement of psychedelic medicines in Europe.

“The interest of the European Medicines Agency and the discussions in this week’s meeting highlights the organisation’s desire for innovation in mental healthcare and willingness to support psychedelic medicines through collaborative efforts.

“Taking action on psychedelic therapies now is a positive move towards preventative care in the area of mental health.

“We are pleased to see these developments at the start of 2024, which is set to be an important year for psychedelics across the globe.”

Harwot concluded: “The workshop made it clear that continuing conversations with regulators and developers and taking a measured approach to regulations are vital.

“It is very encouraging to see the degree of interest from EMA to explore the therapeutic potential of psychedelics and support developers in this field.”

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UK advisory body issues rapid response on psychedelics for anxiety

POST has confirmed it intends to publish a major briefing on psychedelic drugs to treat mental health conditions in 2024.

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Photo by Shreyas Sane on Unsplash

The UK’s independent Parliamentary Office of Science and Technology (POST) has issued a rapid response on psychedelic-assisted therapy for anxiety disorders.

The response is intended to inform policymakers on the topic as increasing research around psychedelics shows the compounds may hold promise as innovative treatments in the area of mental health.

The rapid response is the second response on psychedelics to come from POST – one of the first independent bodies of its kind in the world that sources independent analysis of public policy issues relating to science and tech for government.

See also  UK advisory body issues rapid response on psychedelic research

The response reads: “The social and economic costs of anxiety disorders in the UK are substantial, both for individuals and society. The Office for National Statistics reported that between 2019 and 2023, ‘depression, bad nerves and anxiety’ was the most prevalent health condition amongst those economically inactive because of long-term sickness.

“Beyond personal impacts, people with anxiety disorders account for a large amount of demand on healthcare. Consultations for GAD increased significantly between 1998 to 2018, and levels of anxiety were reported to increase during the COVID-19 pandemic.”

Responding to research and policy developments

Both rapid responses have been issued following a parliamentary debate discussing psilocybin access in May 2023.

The debate saw a group of crossparty MPs call for the rescheduling of psilocybin to remove barriers to research and demand an urgent review of the evidence for psilocybin’s current status as a Schedule 1 drug under the Misuse of Drugs Regulations 2001, “with a view to rescheduling”.

The Royal College of Psychiatrists, psychedelic access non-profit Heroic Hearts UK, and other leading mental health charities, also wrote letters to the Veterans Minister and the Minister of State for Crime, Policing and Fire, urging them to champion access for patients in the UK.

See also  UK MPs welcome psychedelic research, call for scheduling review

The rapid response covers psychedelics for anxiety including Treatment options for anxiety disorders, Lifestyle factors, Psychological treatments (psychotherapy), Pharmacological treatments, Psychedelic drugs for anxiety, Challenges in undertaking research involving psychedelics, Research examples and Ongoing research.

Joanna Neill, Professor of Psychopharmacology at the University of Manchester, acted as an external peer reviewer.

At the time of the first rapid response publication, speaking to Psychedelic Health, Neill commented: “It is very encouraging that Parliament is starting to engage with the enormous clinical potential of psychedelic medicine, particularly at a time when mental health disorders are at an all-time high.

“New therapies are urgently needed and psychedelics could provide just that. Given the weight of evidence presented in this new POST note, enabling safe patient access on the NHS must be a key priority for Parliament.”

POST has confirmed it intends to publish a major briefing on psychedelic drugs to treat mental health conditions in 2024.

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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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