The Anouncement of Ayahuasca “Pill” by a Canadian Pharmaceutical Company Brings Much Controversy

    Indigenous communities denounce violation of the “Nagoya” Protocol

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    A Canadian company announced the development of a pill made from an extract of two plants used to brew Ayahuasca. But supposingly this goes against the “Nagoya Protocol”, an international treaty to protect biodiversity, since they had to previously obtain an informed consent and share its benefits with Indigenous peoples.

    Ayahuasca is a psychedelic sacred preparation used by many Indigenous populations of the Amazonian basin. The infusion is made with the plant chacruna (Psychotria viridis) and the vine known as cipó-mariri (Banisteriopsis caapi).

    Chacruna provides dimethyltryptamine (DMT), a psychoactive component that is the source of the characteristic “trips” and altered conscience induced by Ayahuasca. And cipo-mariri gives it the enzyme inhibitors with which DMT reaches the brain. The beverage also produces vomiting and diarrhea, considered in the rituals as a means of physical and spiritual cleansing.

    The Canadian company bets on a natural products Brand for future “psychedelic” therapies, assuming that customers would choose to use plant-based rather than pharmacological preparations to get the desired effects of Ayahuasca that preliminary clinical investigations prove effective against conditions such as depression and post-traumatic stress disorders, among others.

    The company´s extract contains not only DMT from chacruna and ß-carbolines (MAO inhibitors) from the vine, but other alkaloids and compounds in both plants. These can also be produced in stable and verifiable doses, unlike traditional tea, whose concentrations vary quite considerably depending on local recipes.

    Other companies have already manufactured “pharmahuasca,” capsules containing a synthetic combination of DMT and ß-carbolines such as harmine, but the Canadian´s proposal is different: to take advantage of an “entourage effect,” based on the notion that the preparation’s chemical complexity with its myriad of active substances has already proven to be safe and beneficial in ceremonial uses for centuries. An initial clinical trial with 30 volunteers has indicated that Ayahuasca gives immediate, sustainable, beneficial effects for people with treatment-resistant depression.

    Safety and Standardization

    Standardization brings more safety to clinical tests and therapies, if it is approved by the regulatory agencies. The Canadian company has also announced stable extracts of Psilocybe mushrooms containing the psychedelic compound psilocybin that has been approved for legal use in some US states.

    In order to get approval from the FDA, the company has stablished a cooperation for clinical testing with UCSF Translational Psychedelic Research (TrPR). Plans for clinical tests with mushrooms extracts are more advanced than with Ayahuasca extracts.

    Ethical concerns are raised

    Brazilian anthropologist Beatriz Labate, executive director of Chacruna Institute, raises many ethical questions around the project. “Has there been any previous and informed consent from Indigenous organizations? Is there a baseline for reciprocity and benefit sharing?” She points out that the recent 4th Indigenous Ayahuasca Conference has brought together 35 traditional groups and explicitly denounced Ayahuasca patenting and associated commercial uses.

    Many questions remain unanswered

    “How much money has been set aside for sensitive and pressing issues, such as natural species conservation, cultural appropriation, justice, equity, extractivism, biopiracy? Where do the plants used in research come from? How to reconcile commercialization and medicalization with the plants’ sacred status?”

    A spokeperson for the company maintains that it has consulted with several local communities in South America, but would not disclose further details. “Our research needs to progress before these relationships can be formalized and made public. We recognize that there are many perspectives on the study of ayahuasca. The groups that we’ve communicated with believe in the healing power of the plants and that humanity stands to benefit from it,” the statement reads.

    The company claims that it is working with groups in Brazil and Peru who are guiding the process of importing raw materials under the Nagoya Protocol. Given the early stage of the research, they says, the necessary consent and documentation from appropriate groups is already at hand.

    Not patentable

    Ayahuasca itself is not patentable, because there is no innovation worthy of intellectual property protection in an invention whose roots are buried in time. Interested parties could, in any event, seek protection for its methods of plant alkaloids extraction and stabilization, ones that Amazon Indigenous peoples were the first in combining for spiritual and healing purposes.

    Other companies, respectful of traditional knowledge and also anticipating ethical and legal challenges, try to prevent the clash of ancestral wisdom with intellectual property by establishing a “Reciprocity Trust” that holds part of the founding equities designated to Indigenous community stakeholders, as to increase equitable access.

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