Frequently Asked Questions

There are many different plants and medicines that currently exist around the world that are increasingly seen as safe and effective medicines that when used in controlled environments and administered by trained professionals, can assist in improving mental health conditions for those suffering various forms of mental illness. Other than psilocybin, drugs such as LSD, ketamine, MDMA, ayahuasca and others show similar promise when used in therapeutic settings.(4) The currently illegal status of these and other potentially useful substances used as medicine has prevented large-scale professional studies taking place for decades, though ever more studies have been undertaken in recent years with remarkable results. Nevertheless, due to their highly controlled and restricted status legally, it is difficult for researchers to carry through and prove the reliability of what are on a small scale, valid results. The Declaration specifically does not mention psilocybin or other currently illegal drugs since it is open to all research, on all substances, providing that there are genuine results validating medicinal uses for the substances.

The Declaration on Universal Access to All Forms of Safe and Effective Medicine (‘The Declaration’) is a globally relevant assertion that the right to universal access to all forms of safe and effective medicine forms a core element of the internationally recognised right to the highest attainable standard of physical and mental health.

In a therapeutic setting, psilocybin has both biological and psychological effects. Psilocybin is broken down in the liver into its active form psilocin, which then binds 5HT2A receptors throughout the body. Physiologically, psilocybin works by increasing the interconnectivity within the brain, supporting neurogenesis (creation of new brain cells), and serves as a potent anti-inflammatory agent. Psychologically, psilocybin allows people to see their realities with a new perspective, which can help process deep traumas or shift perceptions of one's existing struggles. Combined, these effects can catalyze a person out of their depression or addiction by providing a new perspective and the activation energy needed to make changes in their life.

Psilocybin’s molecular structure is almost identical to the structure of serotonin, a naturally occurring neurotransmitter in our brains. This means that the body is able to manage psilocybin without any toxic effects.

Yes! In addition to the decades of research conducted prior to the 1971 UN Convention on Psychotropic Substances which reclassified psilocybin and essentially halted research, there are currently dozens of studies underway across hundreds of sites throughout the world. Studies include the use of synthesized forms of psilocybin for devastating conditions such as Major Depression (USA, London), treatment resistant depression (USA, Zurich), eating disorders, alcoholism, smoking cessation, and post traumatic stress disorder (USA). Most recently a study was published comparing a classic antidepressant to psilocybin at Imperial College in London.

​Psilocybin in various forms is legal in Brazil, the British Virgin Islands, and Jamaica. In Portugal, psilocybin is decriminalised which means it is still illegal to possess, consume or cultivate psilocybin, but those doing so will not face criminal charges for doing so. In Mexico, psilocybin is illegal unless it is being used in First Nations communities, although LSD is decriminalised in this country, and legal in Ecuador.. Psilocybin remains illegal in most states in America with the exception of several states and cities such as the state of Oregon and city of Denver and several others. In the Netherlands, whilst psilocybin per se remains illegal, the root of the mushroom, which does not grow above ground, is legal and commonly known as ‘truffles’.

Psilocybin has not been shown to be addictive in animal models, and instead continues to show promise for the treatment of addiction. In 2016, NYU conducted a trial using psilocybin for alcoholism. Most recently, the National Institute of Health in the US provided its first grant for psilocybin research in 50 years to Johns Hopkins for a study using psilocybin for smoking cessation. Monash University in Melbourne, Australia is currently implementing a AUD 15 million grant, which has been describing in the following manner: Researchers at Monash University in Melbourne have achieved ethics approval for their research trial proposal seeking to study the effects of psilocybin (the active compound in “magic mushrooms”) as an adjunct to therapy in the treatment of Generalised Anxiety Disorder (GAD). Until now, worldwide research into psilocybin’s effects on anxiety has been focused on existential anxiety, such as that which can accompany a terminal diagnosis. Head of Clinical Psychedelic Research at Monash University Dr Paul Liknaitzky will lead the team who will assess the safety and efficacy of psilocybin-assisted psychotherapy alongside exploring how the treatment works. Whilst anxiety disorders are among the most common mental health diagnoses, GAD has been identified as the most prolific with around 6% of Australians suffering with a GAD diagnosis at some point in their life. Sufferers of GAD experience intense anxiety and worry most of the time which can be so excessive that everyday life becomes difficult, whilst current treatments can provide inadequate outcomes, problematic side-effects, and high relapse rates. ​ Evidence is accumulating that psychotherapy assisted by psilocybin can provide significant and lasting benefits across a range of mental health disorders. Psychedelic drugs can induce states of consciousness that are often reported to be remarkable, moving, beneficial, and difficult to describe. Clinical participants also report challenging experiences that, when well supported, are often felt to be highly valuable by the participant. Lead psychedelic trainer and therapist at Monash, Sean O’Carroll, says: “As psychotherapists, we regularly witness the psychological pain and suffering inflicted by severe GAD, a condition which is notoriously difficult to treat. It is increasingly clear that psychedelics – when used in conjunction with intensive and novel psychotherapeutic interventions – have great healing potential. This trial will provide us with an opportunity to make a real contribution to the field, by deepening our understanding of how to best work with these powerful substances. It’s very exciting.” Head of Psychiatry at Monash, investigator, and medical lead on this trial, Prof Suresh Sundram, says: “This is a critical hurdle to pass in our efforts to test a novel potentially game-changing treatment for people suffering an illness which is often under-recognised, poorly treated and disabling.” This trial, led by the Clinical Psychedelic Research Lab within the Department of Psychiatry and the Turner Institute for Brain and Mental Health, will be conducted at BrainPark, a state-of-the-art research facility at Monash University. “Given the early yet highly promising results from other psilocybin trials for different conditions,” says Dr Liknaitzky, “this treatment – alongside innovations we’ve developed – may deliver a substantial step forward in the treatment of anxiety disorders.” Looking to recruit 72 participants, it is set to be the largest psychedelic research and development project in Australia to date and will include psilocybin sessions alongside a program of specialised psychotherapy.(3)

Effectiveness is defined as being successful in producing a desired or intended result. In terms of effective medicine, this means that the intervention in question has been successful in producing a desired or intended result for the condition being treated. Evidence based medicine focuses on using data gathered from medical interventions and standardizing treatments based on what is the most effective intervention. Psilocybin is increasingly seen, based on a series of high-level and professional studies by leading universities and research institutes, as a safe and effective medicine. The High-level Meeting on Universal Health Coverage in Sec 49 of its decision affirmed that ‘safe, effective and essential medicines’ should be ‘equitably distributed… to ensure affordable health services and their timely delivery’.(2) Assertions such as this indicate that international law can provide a basis for new, ground-breaking ideas for determining what safe and effective medicines are, and in so doing they “reaffirm the right of every human being…to the enjoyment of the highest attainable standard of physical and mental health”.

Medicine, by definition, means a compound or preparation used for the treatment or prevention of disease, especially a drug or drugs taken by mouth. However, medicine can come in many forms. This includes synthesized compounds you get from your doctor, but it can also include the food you eat, as even Hippocrates once said “let food be thy medicine.” Medicine can also refer to the science or practice of the diagnosis, treatment, and prevention of disease.

Mushroom imagery has been prevalent throughout ancient civilizations, dating as far back as 10,000 BCE in Northern Australia. Images of mushrooms can be seen in archeological sites, religious texts, and everything in between. The use of these medicines dates back over 6000 years. It is believed that they were used by and influenced the philosophers in Greece, the Shamans in Russia, and the medicine women of Central America and countless others.

Although a resurgence of interest in this research is currently underway, clinical trials with psilocybin began in the 1960’s and therefore evidence of its safety and efficacy dates back decades. However, research such as the 2016 Johns Hopkins study using psilocybin for patients with terminal cancer diagnoses catapulted this renaissance when it revealed unprecedented effectiveness for treating end of life anxiety and depression, with about 80% of participants continuing to show clinically significant decreases in depressed mood and anxiety at a six-month follow up.

Yes. Rescheduling certain substances will positively affect the ability of professional technicians to conduct larger scale research studies on the typically banned or restricted. Rescheduling will not allow the full legalisation of psilocybin or protect a citizen’s unfettered access to the drug for recreational purposes. In Australia, the Therapeutic Goods Authority (TGA) which is responsible for drug scheduling is currently officially exploring whether or not to reschedule psilocybin to allow it to be used in clinical trials and assisted therapies in controlled settings under the control of trained and accredited professionals. In the United Kingdom the country would have to reschedule the status of psilocybin under the Misuse of Drugs Regulations 2002 which deals with the ability to research psilocybin, but not the Misuse of Drugs Act 1971 which confers criminal penalties on acts such as purchasing, supplying or possessing the psilocybin. A new international coalition, which we strongly support, the International Psilocybin Therapeutic Rescheduling Initiative (IPTRI) is seeking to have this substance rescheduled under the 1971 International Convention on Psychotropic Substances. We are unequivocal in our approach of focussing on prioritising those who have been struggling in their battle with mental health for years with access to psilocybin as a new medicine for them to try and help alleviate their suffering.

The Declaration is a re-assertion of pre-existing internationally recognised human rights. It does not assert a new right. Rather, it strongly reaffirms an existing right, and seeks a more expansive interpretation of what this right means in law, thus ensuring that the rights of everyone, everywhere to all forms of safe and effective medicine to treat all forms of physical and mental illness can become a reality. In simple terms this means that if there are medicines in existence that can be used to effectively treat certain illnesses and are now not officially or legally recognised as performing this function, and are scheduled accordingly under both international and national laws, this needs to change in order for the right to the highest attainable level of health to be complied with in full. We believe that combining the Hippocratic Oath taken by all doctors and the internationally recognised right to the highest attainable level of health amounts to a right to safe and effective medicine for everyone, everywhere. Para 1 Preamble WHEREAS Article 25 of the Universal Declaration of Human Rights asserts that every person has the right “to a standard of living adequate for the health and well-being of himself and of his family”; Preambular paragraph 1 of the Declaration reaffirms the first international mention of the right to health within a human rights standard, in this case the important Universal Declaration on Human Rights which was proclaimed on 10 December 1948, and which remains the founding cornerstone of the international human rights law regime to this day. This is a right of everyone, without exception. Para 2 Preamble WHEREAS, Article 12 of the International Covenant on Economic, Social and Cultural Rights, a binding treaty ratified by 171 States, recognizes the right of everyone to "the enjoyment of the highest attainable standard of physical and mental health"; The second preambular paragraph reaffirms the centrality of the right to health within the most important international treaty on economic, social and cultural rights. It reaffirms that the right to health is not merely a reductionist right to be free from disease, but rather a much broader right to the highest attainable standard of both physical and mental health, which simply cannot be achieved if existing forms of safe and effective medicine are not readily available to everyone who can benefit from it. This applies to both physical and mental health, but in particular the latter where access to safe and effective psychedelic medicines remain unavailable to the vast majority of those who could benefit from them including those with severe depression, anxiety, PTSD, end of life trauma, addictions and a range of other widespread mental and other health challenges. As of December 2021 the following countries have voluntarily ratified the International Covenant on Economic, Social and Cultural Rights(1): Afghanistan, Albania, Algeria, Angola, Antigua and Barbuda, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Cape Verde, Central African Republic, Chad, Chile, China, Colombia, Congo, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic People's Republic of Korea, Democratic Republic of the Congo, Denmark, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Estonia, Ethiopia, Finland, Fiji, France, Gabon, Gambia, Georgia, Germany, Ghana, Greece, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Madagascar, Malawi, Maldives, Mali, Malta, Marshall Islands, Mauritania, Mauritius, Mexico, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, North Macedonia, Norway, Pakistan, State of Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Republic of Moldova, Romania, Russian Federation, Rwanda, San Marino, Sao Tome and Principe, Senegal, Serbia, Seychelles, Sierra Leone, Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, Spain, Sri Lanka, St. Vincent and the Grenadines, Sudan, Suriname, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Tajikistan, Thailand, Timor-Leste, Togo, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Kingdom of Great Britain and Northern Ireland, United Republic of Tanzania, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia and Zimbabwe. ​ ​ The following countries have signed but not ratified and are thus not legally bound to comply with the terms of the Covenant but have indicated their intention to do so once ratification occurs: ​ Comoros, Cuba, Palau and the United States of America. ​ The following countries have neither signed nor ratified the Covenant and should be encouraged to do so! ​ Andorra, Botswana, Bhutan, Brunei, Kiribati, Malaysia, Federated States of Micronesia, Mozambique, Nauru, Oman, Saint Kitts and Nevis, Samoa, Saudi Arabia, Singapore, St. Lucia, South Sudan, Tonga, Tuvalu, United Arab Emirates and Vanuatu. ​ If you would like to learn more about the ICESCR you can look here: https://www.ohchr.org/en/professionalinterest/pages/cescr.aspx Para 3 Preamble WHEREAS both the Universal Declaration of Human Rights and the International Covenant on Economic, Social and Cultural Rights specify a number of means necessary to realise these rights, including medical care; Preambular paragraph 3 reiterates that a number of means are available to ensure the enjoyment of the right to the highest attainable level of health. This can and should include access to all forms of safe and effective medicine. General Comment No. 14 on the Right to the Highest Attainable Standard of Health (Art. 12) adopted on 11 August 2000 by the UN Committee on Economic, Social and Cultural Rights is the most important international legal interpretation of the meaning and contents of this right. General Comment No. can be accessed here: https://www.refworld.org/docid/4538838d0.html. Para 4 Preamble WHEREAS medical care includes access to those medicines necessary to preserve health and well-being; Preambular paragraph 4 reaffirms that if safe and effective medicine exists and is necessary to keep health conditions intact, including mental health, that these should be made available to everyone who can benefit from them. Para 5 Preamble NOTING that many medicines grow without human intervention in nature and therefore form part of the commons owned and shared by the human family; Preambular paragraph 5 notes that some medicines, such as psilocybin mushrooms grow naturally in nature without human intervention and that these form part of the global commons and are not subject to private ownership or patent, and thus should be shared with all of humanity. At the same time it is important to note that laboratory created substances with the virtually same chemical composition as psilocybin and with the same curative effects, also exist and should be subject to the same scheduling changes as those occurring in nature. Supportively, a recent statement by the European Union usefully notes that: “From a medical care perspective, it is particularly difficult to accept that people continue to suffer because of no or inadequate availability, or the lack of affordability of internationally controlled substances for medical purposes in reliable pharmaceutical quality” (EU Statement on the occasion of the 3rd Intersessional Meeting of the 63rd Session of the CND, Vienna, 19-21 October 2020). ​ Para 6 Preamble RECOGNISING the primary role of the medical and allied professions in preserving and enhancing the health and well-being of the individuals and communities they serve – and that in the pursuit of those noble ends they should have access to the full suite of remedies and tools that nature and human ingenuity have produced: Preambular paragraph 6 is extremely important in reaffirming the vital role of doctors and others to both preserve and enhance health and that in doing so they must have access to all forms of safe and effective medicines that exist, both those that grow naturally and those produced in laboratories. Those seeking to heal the physically and mentally ill must have access to every form of safe and effective medicine in order to do the jobs in which society vest such trust. ​ Para 1 Operative Paragraph 1. WE CALL UPON ALL GOVERNMENTS to make available, to all persons, every reasonably accessible form of safe and effective medicine – regulated only for reasons of safety and efficacy and then only to the extent strictly necessary. This single operative paragraph is the cornerstone of the Declaration and makes the simple but profound statement that all of us, everyone, must have access to every safe and effective medicine as a core component of our right to the highest attainable level of health. The Declaration will assist States to implement their obligations under the International Covenant on Economic, Social and Cultural rights (ICESCR) which legally recognises that everyone has the right to “the enjoyment of the highest attainable standard of physical and mental health”. We believe that international human rights law asserts that it is a basic human right to have access to medicines and practices that ensure a person’s wellbeing, and that these must match whatever needs are present at any given time. For instance, at present there is a well documented global mental health crisis affecting mostly younger generations that will require new safe and effective medicines be made accessible to both patients and doctors in order to successfully address such health challenges, in particular when new forms of medicines may prove more likely to ameliorate certain conditions that do not respond adequately to more commonly used medicines, in particular antidepressants.

Psilocybin is naturally produced by certain species of mushrooms called psilocybe mushrooms. These species have been found growing in nature throughout all of the habitable world but are believed to have originated from the Southern Hemisphere. Different species are found in different proportions throughout the world. Today, the country with the highest number of neurotropic species and varieties of Psilocybe is Mexico, with the US and Canada in second place followed by Europe, Asia, Oceania and indeed, the rest of the world. Psilocybe mushrooms can even be found growing in urban areas through concrete in cities across the world.

We are not advocating for the recreational usage of illegal drugs, although we do fully acknowledge and understand that a wide array of illegal drugs are routinely used recreationally on a very large scale across the world, and that some of these may have therapeutic purposes which, if properly regulated, could act as safe and effective medicine. We are simply advocating for the overwhelmingly strong contention that everyone, everywhere should have access to all form of safe and effective medicine as a core component of their right to the highest attainable level of health. We are advocating for a large-scale changing of minds and mindsets leading to rescheduling of substances that have been consumed safely by humanity for thousands of years but which are now legally out of reach for very ill people who can benefit remarkably from these forms of safe and effective medicine. To continue to deny people - former soldiers, mothers, uncles, crime victims, sexual abuse survivors and so many others suffering from anxiesty and other mental disorders is cruel and we believe this cruelty must end, and that international human rights law supports this contention. The unregulated nature of the black market means that there is no means of knowing how much psilocybin the population is consuming, thus the potential for misuse, addiction, or harm to welfare, is more apparent. In the research studies, ethical guidelines require the substance to be weighed precisely so that the effect is manageable. However, we realise the fact that psilocybin grows naturally in many countries around the world and that it has proven medicinal uses when used sensibly in a therapeutic setting. (5) We are advocating for a destigmatization of psilocybin so that it can be used to benefit sick individuals and help them to get better.

A wide range of existing international human rights can be subject to non-enjoyment or incomplete enjoyment when people are denied access to all forms of safe and effective medicine. These include but are not limited to the following rights: The Right to the Highest Attainable Level of Health, The Right to Freedom of Religion and Thought, The Right to Privacy and Respect for the Home, The Right to Cognitive Liberty, The Right to Equality of Treatment, The Right to Non-Discrimination, The Right to Culture, The Right to Physical Integrity and Dignity, The Right to Education, The Right to Property and Peaceful Enjoyment of Possessions and many others. By denying or not enabling universal access to all forms of safe and effective medicine it is possible that one or more of these rights will not be capable of full enjoyment as they are meant to be under international human rights law, thus eroding basic human rights protections and the overall enjoyment of human rights which are so fundamental to the strength of democratic systems of governance.

​No. The aim of the Campaign and the Declaration is to reduce the legislative and social barriers to exploring the potential therapeutic effects of psilocybin, and to promote rescheduling of these substances so that people from mental health challenges can access these forms of safe and effective medicine which can assist them and which are now out of reach. We are advocating for psilocybin to be rescheduled so that access to it for medical trials and investigation is easier, less bureaucratic and thus a faster process. Less hoops to jump through means more trials and studies, at greater speed than before, and thus getting the right medicine to the right people as soon as possible.

Psilocybin is a naturally occurring psychotropic tryptamine that is found in over 200 mushroom species in the genus Psilocybe. It is a “prodrug” meaning that it has to be broken down into its active form psilocin in order to elicit its medicinal effects. Gordon Wasson was the first Westerner to experience a traditional psilocybe mushroom ceremony in Mexico with Maria Sabina in 1955 and brought back samples, and which he described in his famous article in Life magazine. These samples were subsequently used by Albert Hofmann in Switzerland to synthesize psilocybin in the lab for the first time in 1958. Hofmann, of course, discovered LSD-25 in Basel in 1938, and became the first human to ingest it in April 1943.

7.1 Send a series of formal memoranda with the full text of the Declaration and links to the website to all relevant businesses, companies, clubs, associations, hospitals, doctors, medical associations and others seeking formal endorsement of the Declaration.

4.1 Promote the Declaration and seek endorsements with creative and well-produced social media postings on all major social media platforms.

8.1 Send a series of formal memoranda with the full text of the Declaration and links to the website to celebrities, athletes, public figures and others seeking formal endorsement of the Declaration.

Keep us update with your work.

6.1 Send a series of formal memoranda with the full text of the Declaration and links to the website to all national government bodies seeking official endorsement from as many such bodies as possible, including by individual members of parliament/government, political parties, relevant government ministers including the Minister of Health and Minister of Justice, among others. 6.2 Prepare a detailed list of all relevant jurisdictions and contact points and contact each one after the other. 6.3 Meet with and request to do presentations on the Declaration to all relevant contacts at the national level of government. Scott and Timmy are available to provide inputs, presentation, expert witness testimony, etc.

9.1 Send a series of formal memoranda with the full text of the Declaration and links to the website to lawyers, law firms, judges, human rights organisations and others seeking formal endorsement of the Declaration.

3.1 Offer to do interviews with local, regional and national media in support of the Declaration. Scott and Timmy are available for interviews, as well.

2.1 Create a portal/section of your website dedicated to the Declaration and the Campaign, including easy links to the Campaign website https://www.safe-and-effective-medicine.org. 2.2 Please include the full text of the Declaration in as visible a format as possible on your website. 2.3 Specifically ask people and supporters to formally endorse the Declaration by filling out the endorsement form on the Campaign website.

5.1 Send a series of formal memoranda with the full text of the Declaration and links to the website to all local government bodies seeking official endorsement from as many such bodies as possible at all levels - village/local, district, county, region, province, state, etc. 5.2 Prepare a detailed list of all relevant jurisdictions and contact points and contact each one after the other. 5.3 Meet with and request to do presentations on the Declaration to all of these levels of government. Scott and Timmy are available to provide inputs, presentation, expert witness testimony, etc.

1.1 Please formally endorse the Declaration by filling in the form at the bottom of this page.