In Colombia, regulations regarding psychedelic substances, including those for medicinal use, are influenced by national drug laws and the policy on the control of psychoactive substances. According to Law 30 of 1986, which regulates the use of psychoactive substances in the country, most psychedelic drugs are classified as prohibited for recreational use. This includes substances such as LSD, psilocybin, DMT (dimethyltryptamine) and mescaline. The law establishes that their possession, production, and commercialisation are illegal.

In Colombia, psychedelic medicines are primarily supervised by several health and regulatory authorities.

The primary institutions involved in the regulation and oversight of these substances include the following.

• The Ministry of Health and Social Protectionis responsible for public health policy, including the regulation and control of medicines and controlled substances. Although psychedelic medicines are not generally legalised at present, the Ministry may intervene in discussions about their future regulation or in scientific research on their therapeutic use.
• The National Institute for Food and Drug Surveillance (INVIMA)is responsible for ensuring the safety and efficacy of medicines. While psychedelic substances are not approved as medical treatments, INVIMA could be involved in approving clinical studies or regulating pharmaceutical products containing psychedelic compounds.
• The National Administrative Department of Narcotics (DNE)is responsible for policy and control over psychoactive substances. Its role is to ensure the correct application of regulations on substances classified as narcotics, many of which include psychedelics such as psilocybin (the psychedelic compound in mushrooms). Although the DNE currently focuses more on controlling illegal drugs, it also plays a part in the regulation of experimental medical uses.

• The Attorney General’s Officemay become involved in monitoring and prosecuting illegal activities related to the trafficking of unauthorised psychedelic substances, although its primary role is crime prosecution.

• The National Narcotics Councilcoordinates policies related to drugs and psychoactive substances in Colombia. If, at any point, the regulation of certain psychedelic substances for therapeutic purposes is proposed, the council could be involved in discussions about their classification and control.

In Colombia, the regulation and oversight of psychedelic medicine, including clinical trials involving psychedelics, is subject to the broader framework of the country’s health and pharmaceutical regulations. While there are no specific self-regulatory bodies dedicated solely to the psychedelic medicine industry, several authorities oversee aspects of the industry through their regulation of pharmaceuticals, clinical trials, and controlled substances. The authorities and their scope of authority are presented below.

• National Food and Drug Monitoring Institute (INVIMA)
• Scope of authority – INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is the regulatory authority responsible for monitoring and controlling food, drugs, medical devices and other health-related products.
• Psychedelic medicine – INVIMA has the authority to regulate the registration, clinical trials and marketing of drugs, including psychedelic substances, once they are legally approved for medical use. For psychedelic medicine to be used in Colombia, pharmaceutical companies must submit their drugs for evaluation and approval.
• Clinical trials – INVIMA oversees the authorisation and monitoring of clinical trials, including those involving psychedelics. These trials must be conducted in compliance with Good Clinical Practice (GCP) standards, and INVIMA must approve the protocols before any clinical trials are initiated.
• National Narcotics Directorate (Dirección Nacional de Estupefacientes, DNE)
• Scope of authority – the National Narcotics Directorate is the government body in charge of enforcing Colombia’s drug control laws, which includes regulating the production, trafficking, and consumption of controlled substances.
• Controlled substances – psychedelic substances such as psilocybin, MDMA, and LSD are typically considered controlled substances under Colombian law, although exceptions may be made for medical or scientific use. The DNE oversees the regulation of such substances in the context of medicinal or research applications.
• Psychedelic trials – while the DNE itself may not directly govern psychedelic trials, any legal use of psychedelic substances for clinical or therapeutic purposes would need to be approved by this body in relation to its regulatory framework on controlled substances.
• Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social)
• Scope of authority – the Ministry of Health is responsible for setting health policy in Colombia and overseeing healthcare systems. It is involved in the regulation of medicinal products, including novel or experimental treatments like psychedelic-assisted therapy.
• Psychedelic research and trials – the Ministry may play a role in the approval of specific medical treatments and therapy programs that involve psychedelics, especially if these treatments are not yet approved for widespread medical use but are in clinical trials.
• Regulatory oversight – it may also collaborate with INVIMA to ensure that any psychedelic treatments comply with health standards, including safety, efficacy, and ethical standards.
• Ethics Committees and Institutional Review Boards (IRBs)
• Scope of authority – while these bodies are not self-regulatory authorities per se, ethics committees and institutional review boards are essential in overseeing clinical trials in Colombia. They ensure that studies involving psychedelic substances meet ethical standards and protect the welfare of participants.
• Role in psychedelic trials – any clinical trials involving psychedelics would require approval from an IRB before being conducted, ensuring that the trials adhere to ethical guidelines, informed consent processes, and safety standards.
• Colombian Congress (Legislative Oversight)
• Scope of authority – the Colombian Congress has the power to pass laws related to public health and drug policy, including the regulation of controlled substances and medical treatments.
• Influence on psychedelics – while it does not self-regulate, the Colombian Congress could pass laws that affect the legal status of psychedelics in Colombia, including the potential for decriminalisation, medical use, or legalisation for therapeutic trials.
• Colombian Pharmaceutical Industry (Autoregulation)
• Scope of authority – while Colombia does not have a specific self-regulatory body focused exclusively on psychedelic medicines, there is a general culture of self-regulation within the pharmaceutical and biotech industries in Colombia. Associations such as the Colombian Pharmaceutical Industry Association (AFIDRO) work to set industry standards and ethical guidelines for the development, approval, and marketing of pharmaceuticals, including experimental and controlled substances.
• Relevance to psychedelic medicine – these organisations play an important role in creating industry standards, ensuring that pharmaceutical companies involved in psychedelic medicine adhere to ethical practices in research, development, and commercialisation. They may also help shape public policy discussions and raise awareness about the benefits and risks of psychedelic treatments, although they do not have formal regulatory powers over psychedelic drugs.
• Colombian Society of Neuroscience (Sociedad Colombiana de Neurología) and Medical Associations
• Scope of authority – while not regulatory bodies, medical and scientific associations, such as the Colombian Society of Neuroscience, may contribute to the discourse on psychedelic medicine by setting clinical guidelines and promoting ethical research practices. These associations also work to ensure that physicians and researchers adhere to the highest medical and ethical standards when participating in psychedelic drug trials or prescribing such treatments.

• Relevance to psychedelic medicine – as interest in psychedelic medicine grows, these associations may create frameworks or best practices for the clinical use of psychedelic substances, influencing the broader regulatory landscape in Colombia.

Although the psychedelic medicine market is emerging globally, in Colombia, the use of substances such as psilocybin, MDMA, and ayahuasca has been a subject of debate and experimentation in very specific contexts, such as scientific research, spiritual retreats, and some therapeutic treatments.

Colombia is one of the countries in Latin America with a relatively flexible regulatory context regarding the experimentation with controlled substances for therapeutic purposes. In recent years, legislation on the use of psychedelics has been evolving, driven by the growing evidence of the potential benefits of these substances in treating disorders such as depression, anxiety, and post-traumatic stress disorder.

Although there is not yet a formalised or legalised “market” for the commercialisation of psychedelic medicines in Colombia, there are ongoing initiatives aimed at creating legal frameworks for the medicinal use of these substances. The focus of these initiatives is more on clinical research and patient treatment than on the open sale of psychedelics to the general public.

In summary, the psychedelic medicine market in Colombia is in its early stages, primarily centred on scientific and therapeutic research, with growth prospects as legislation and studies on their effectiveness progress.

The psychedelic medicine market in Colombia, like in many other countries, presents both exciting opportunities and significant challenges. These challenges primarily stem from legal, regulatory, and social complexities associated with the use, production, and commercialisation of psychedelic substances.

The most notable challenges faced by market participants in Colombia are outlined below, with a particular focus on legal risks.

• Legal uncertainty and ambiguity
• Limited legal framework – while Colombia has made progress in certain areas (such as decriminalising the possession of small amounts of some drugs for personal use), the legal status of psychedelic substances, especially in the context of medicine and therapy, remains ambiguous. As of now, substances such as psilocybin and MDMA (which are central to many psychedelic therapies) are not explicitly legalised for therapeutic or medical use.
• Regulatory gaps – there is no comprehensive national regulatory framework that clearly addresses the legal use of psychedelic substances for medicinal purposes. Market participants could face significant legal uncertainty as they navigate this evolving landscape.
• Potential conflict with international drug control obligations

• International treaties – Colombia is a signatory of various international drug control agreements, such as the 1961 Single Convention on Narcotic Drugs, which classifies many psychedelic substances as controlled drugs. Any moves to commercialise psychedelics for medical purposes may come into conflict with international commitments, leading to legal complexities and possible international pressure.
• Diplomatic and trade relations – diverging from international drug policy norms could strain relations with countries that are strict in their drug control policies, such as the United States. This could affect trade relations, diplomatic ties, and even access to international markets for Colombian companies.
• Licensing and regulatory hurdles

• Regulatory approval for medical use – companies wishing to produce or distribute psychedelic medicines in Colombia would likely need to navigate a complex approval process with the National Food and Drug Surveillance Institute (INVIMA), the agency responsible for regulating drugs and medical products. The approval process for new therapeutic substances can be lengthy and costly, and the lack of established pathways for psychedelics could create additional challenges.
• Manufacturing regulations – the production of psychedelic substances for medicinal purposes is highly regulated. Companies will need to adhere to strict guidelines regarding the cultivation, extraction, formulation, and distribution of psychedelics. This involves ensuring compliance with regulations on controlled substances and meeting the good manufacturing practices (GMP) required for pharmaceuticals.
• Public health and safety concerns

• Psychiatric use and clinical trials – the use of psychedelics in mental health treatments (such as for depression, PTSD, and addiction) is still under scientific investigation. While there is a growing body of evidence supporting their efficacy, the legal and regulatory frameworks for conducting clinical trials on psychedelics in Colombia are not fully developed. Companies will need to ensure that their clinical research complies with both local regulations and international ethical standards.
• Safety and side effects – there may be concerns about the safety of psychedelic medicines, especially in light of their potentially potent effects. Companies could face legal risks associated with adverse reactions or misuse, as well as potential litigation from patients or clients if things go wrong.
• Cultural and social barriers
• Public perception and stigma – psychedelic substances, particularly those with a recreational use history, are often stigmatised in many cultures, including Colombia. Despite growing interest in their potential medicinal value, there may be resistance from local communities, government officials, or religious groups. Companies entering the market must consider how to address this stigma and build public trust.

• Resistance to decriminalisation – while Colombia has taken steps toward decriminalising certain substances, there may still be resistance to the broader medical use of psychedelics. Public debates over the potential risks and benefits could slow down legislative progress or lead to public backlash.
• Intellectual property (IP) risks

• Patentability – in the rapidly evolving psychedelic medicine space, intellectual property issues can be a significant challenge. While companies may seek patents for specific formulations or delivery methods, the patenting of substances derived from plants (such as psilocybin from mushrooms) could face legal challenges, as these substances have long been in the public domain.
• Protection of trade secrets – companies involved in the development of psychedelic medicines will need to ensure the protection of proprietary information, including production processes and formulas, from competitors or from being appropriated by illegal market actors.
• Complexities in marketing and distribution
• Advertising restrictions – psychedelic substances remain highly regulated, and any marketing efforts to promote them for medical purposes must comply with strict advertising laws. There may be limitations on how companies can advertise or promote their products, especially in relation to medical claims.
• Cross-border trade and export challenges – while Colombia has made strides in legalising cannabis for medical use, the export of psychedelic substances (such as psilocybin) to international markets is likely to face significant hurdles, both from local and foreign regulatory agencies. Companies must ensure compliance with both Colombian laws and the regulations of countries they seek to export to.

In Colombia, as in many other countries, the regulation and use of psychedelic medicines raise several cross-jurisdictional issues, primarily due to the complex intersection of national laws, international treaties, and emerging scientific research.

The following are some of the most significant cross-jurisdictional issues concerning psychedelic medicines in Colombia.

• International drug control frameworks
• United Nations drug conventions – Colombia is a signatory to the 1961 Single Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances. These international treaties require member countries to control substances that are considered narcotics or psychotropic drugs. Many psychedelics, such as psilocybin and MDMA, are classified under these conventions, posing a challenge to any movement toward legalising or decriminalising these substances in Colombia.
• Challenges to reform – advocates for the medicinal use of psychedelics in Colombia may face opposition from international bodies and legal challenges related to Colombia’s international obligations. Navigating these treaties while advocating for the medicinal use of psychedelics requires careful consideration of both national sovereignty and international law.
• Legal status of psychedelic substances

• National drug laws – in Colombia, psychedelic substances such as psilocybin, LSD, and DMT are classified as illegal under national drug laws, which largely follow the UN conventions. However, Colombia has made significant strides in regulating other controlled substances, such as medical cannabis, which creates a complex legal landscape for psychedelic drugs.
• Policy shifts and public opinion – there is increasing public interest and political support for reevaluating the legal status of psychedelics in Colombia, especially for therapeutic purposes. The movement towards legalising medical cannabis is a precedent for the potential future legal status of psychedelics. However, shifts in policy can be slow and face resistance from traditional political and legal institutions.
• Indigenous use and traditional practices

• Ayahuasca and indigenous practices – psychedelics like ayahuasca (a brew containing DMT) are used by indigenous groups in Colombia, particularly for spiritual and healing purposes. These traditional practices often face legal scrutiny due to the status of DMT as a controlled substance.
• Cultural recognition versus legalisation – there is tension between the legal framework and the traditional use of psychedelics. Some legal exceptions or protections for indigenous practices may be needed, but reconciling indigenous rights with national drug policies remains a challenge, especially if there is a move toward broader legalisation for medical or recreational use.
• Clinical trials and scientific research

• Regulatory approvals – the approval and regulation of clinical trials involving psychedelic substances in Colombia is a significant issue, especially when considering the growing body of international research on the therapeutic potential of psychedelics for conditions like depression, PTSD, and addiction.
• Cross-border collaboration – Colombia has the potential to become a hub for psychedelic research due to its relatively lower cost of conducting clinical trials and a growing interest in alternative medicine. However, navigating cross-jurisdictional issues related to international research standards and regulatory approval processes can complicate collaborations, particularly if researchers seek to work across multiple countries with varying legal frameworks.
• Tourism and cross-border drug use

• Ayahuasca tourism – Colombia, like some other South American countries, is a destination for “ayahuasca tourism”, where individuals from abroad come to participate in traditional ceremonies. These activities can raise legal issues, particularly for foreigners who consume psychedelic substances legally in their home countries but face legal repercussions when they return home.
• International legal risk – travellers engaging in activities involving psychedelics may unknowingly violate Colombian law, and the international nature of such activities may lead to legal conflicts when crossing borders. This can involve complex legal processes regarding extradition, drug trafficking, and the movement of substances across jurisdictions.
• Ethical and regulatory concerns

• Standardisation and safety – as Colombia explores the potential for psychedelic medicines in clinical settings, ethical and regulatory challenges arise concerning the safe production, distribution, and administration of these substances. Ensuring that psychedelic medicines meet both international and national safety standards is crucial, and cross-jurisdictional collaboration will be necessary to create a uniform regulatory framework.
• Impact on vulnerable populations – ensuring that the potential benefits of psychedelics are equitably distributed and that vulnerable populations (eg, people with mental health issues or indigenous communities) are protected from exploitation is a key concern. This requires careful regulation and oversight, potentially involving both local and international bodies.
• Economic and trade considerations

• Cross-border trade of psychedelic substances – while Colombia is exploring the medicinal potential of psychedelics, the exportation or importation of these substances remains a grey area under current laws. As global markets for psychedelic medicines evolve, there may be opportunities for Colombia to engage in the trade of these substances, but the legal and economic implications would need careful consideration under both Colombian and international law.
• Export of expertise – Colombia could also play a significant role in training professionals or conducting international research on psychedelics, which could lead to cross-border collaborations but would require navigating international legal issues regarding the use and dissemination of psychedelic substances.

Access to psychedelic medicines in Colombia can be influenced by developments in other jurisdictions, but the situation is nuanced. While Colombia has its own legal framework and cultural context, global trends in the research, regulation, and decriminalisation of psychedelic substances can affect local perspectives, policies, and the potential for access. Here are a few ways this interaction may happen:

Global Research and Policy Shifts

Countries such as the US, Canada, the Netherlands and Brazil have seen significant developments regarding psychedelic medicine, particularly around psilocybin, MDMA, and other substances. These shifts can have a ripple effect on Colombia. Research findings, particularly those showing the medical benefits of psychedelics in treating mental health issues such as depression, PTSD and addiction, can inspire a broader conversation in Colombia about the potential benefits.

• Research influence – Colombia may be influenced by international clinical trials and research that show promising results with psychedelics, which could eventually lead to discussions about regulating these substances for medical use.
• International advocacy – organisations and activists advocating for the therapeutic use of psychedelics can also apply pressure on Colombian lawmakers, urging them to reconsider existing laws or initiate studies into the medical use of psychedelics.

Cultural Exchange and Public Opinion

Colombia’s public opinion may be influenced by global shifts in the understanding of psychedelics, as these substances are increasingly viewed as therapeutic rather than recreational drugs in many parts of the world. As awareness about the mental health crises (such as depression, PTSD, and addiction) grows globally, Colombians may be more receptive to these ideas.

• Media and social movements – international movements, documentaries, and media campaigns focused on the healing properties of psychedelics, particularly for mental health, might affect public attitudes in Colombia. This can create a more favourable environment for legalisation or decriminalisation debates.

Regional Cooperation and Influence

Given Colombia’s position in Latin America, where there are already a few countries exploring or advancing psychedelic research (eg, Brazil and Mexico), there may be regional influences at play. Brazil, for example, has allowed the medical use of psilocybin for certain conditions, and has hosted clinical trials on psychedelic therapy. If other Latin American countries move forward with psychedelic medicines, it may prompt Colombia to follow suit.

Colombia is also part of international networks where medical and policy trends regarding psychedelics in other Latin American countries may influence local lawmakers and regulators. For instance, discussions on drug decriminalisation or medical use in neighbouring countries could push Colombia to align its policies.

Legal and Regulatory Developments

Despite the global momentum towards psychedelic decriminalisation and medical legalisation, Colombia currently has strict regulations around illegal drugs, including those considered psychedelics (eg, psilocybin mushrooms). However, it has also been a part of international conversations about drug policy reform, so developments in places such as Canada or the US, where medical or regulated use of psychedelics has been legalised, might eventually push Colombia to adopt similar policies. These changes could take the form of:

• medical regulation – if international studies and regulatory bodies in countries such as the US or Europe recommend the medical use of psychedelics for specific conditions, Colombia might follow the global trend and legalise them for therapeutic use; and
• reform movements – advocacy and lobbying from international organisations, as well as local activists, could encourage legal reform in Colombia that aligns with broader global trends.

Tourism and Indigenous Practices

In Colombia, like in other parts of Latin America, indigenous practices using psychedelics such as ayahuasca (a powerful psychoactive brew) have been legal for traditional and religious use. There has been growing interest in psychedelic tourism, and as other countries develop frameworks for psychedelic-assisted therapy or tourism, Colombia might be influenced to regulate and capitalise on this industry more formally, much like Brazil has done with ayahuasca tourism.

While the current legal framework in Colombia restricts access to most medical psychedelics, there is a discernible shift towards re-evaluating these policies. Discussions at both national and international levels suggest a growing openness to considering the medical benefits of psychedelics, which could lead to regulatory changes in the future. However, as of now, significant legal and regulatory hurdles remain.

Colombia has been actively engaging in discussions about drug policy reform, including the regulation of certain substances for medical use. The government’s stance has evolved over time, reflecting a growing recognition of the potential therapeutic benefits of substances like psychedelics.

• Policy discussions – there have been talks about decriminalising the use of certain entheogenic plants and fungi and introducing a legal framework for substances that provide medicinal value, such as MDMA or ketamine.
• International influence – Colombia has participated in international discussions advocating for a shift in global drug policy. In 2016, during a UN General Assembly special session, Colombia, along with other countries, supported regulating the medical uses of previously illegal drugs, including cannabis.
• Regulatory agenda – the topic of medical psychedelics is gaining attention within Colombia’s regulatory and policy-making circles. The government’s approach to drug policy is becoming more progressive, focusing on public health perspectives and the potential benefits of regulated medical use.
• Truth Commission recommendations – Colombia’s Truth Commission has recommended the legal regulation of drugs as a means to achieve peace and reduce violence associated with illegal drug markets. This includes considering the regulation of substances like psychedelics.
• Public and political discourse – the conversation around drug policy reform, including the potential medical use of psychedelics, is becoming more prominent in public and political discourse, indicating a shift towards considering alternative approaches to traditional prohibitionist policies.

In Colombia, the initial legislative route for regulating psychedelic medicines would follow the standard legislative process but involve additional considerations due to this particular segment’s sensitivity and overlap with existing drug laws, health regulations, and international treaties. The following is a snapshot of how the process might look.

Proposal Stage

Key Stakeholders for initiating the Bill:

• Members of Congress: Legislators interested in public health, innovation, or drug policy reform.
• Ministry of Health and Social Protection: Could propose legislation based on evidence of medical benefits and public health needs.
• Academics and experts: Universities or researchers may advocate for regulation based on scientific studies.
• Civil Society Organisations: Groups focused on drug policy reform, mental health, or indigenous rights may push for the initiative.
• Citizen Initiative: Advocates could draft a proposal supported by sufficient signatures (popular legislative initiative).

Considerations for justification:

• Scientific evidence supporting therapeutic uses of psychedelics (eg, for PTSD, depression, or addiction treatment).
• Alignment with Colombia’s mental health policy.
• Economic benefits, including research, development, and export opportunities.
• Indigenous traditions, as certain psychedelics like ayahuasca have cultural and spiritual roots.

Drafting the Bill

Content of the Bill:

• Clear definitions of psychedelic medicaments.
• Conditions for medical use (eg, prescriptions, administration by licensed professionals).
• Oversight and regulatory frameworks (eg, INVIMA, the Ministry of Health, or specialised agencies).
• Research provisions to support scientific validation and innovation.
• Safeguards against misuse or diversion into recreational use.

Responsibility for submission to Congress:

• The Senate or House of Representatives, depending on the originator.
• Relevant committees, such as the Committee for Health and Social Protection (primary oversight for medical-related legislation) and the Committee for Legal Affairs (if legal frameworks for controlled substances are addressed).

The likelihood of an “adult-use market” for psychedelic medicines in Colombia depends on several intersecting factors, including cultural, legal, political, and economic conditions.

An analysis of the current landscape and what a regulated recreational market might look like is presented below.

Factors Influencing Likelihood

Legal framework

Colombia has a long history with drug policy reform. While psychedelic substances like psilocybin remain controlled, Colombia has shown openness to progressive drug policies, such as its leadership in decriminalising personal possession of small amounts of certain drugs. Additionally, Colombia has already developed a regulated medical cannabis industry, which could serve as a template for psychedelic regulation. The country may also look to countries like Jamaica, the Netherlands, or Oregon in the US that have moved toward decriminalisation or regulation of psychedelics.

Political willpower

The political climate in Colombia is crucial. The current left-leaning government under President Gustavo Petro has emphasised harm reduction and public health approaches to drug use. Petro’s administration has also advocated for moving away from punitive drug policies toward regulation. This could create a pathway for conversations about regulated psychedelic use.

Indigenous and cultural backdrop

Colombia is home to indigenous communities that have used psychedelics, such as ayahuasca and yagé, for centuries in spiritual and therapeutic practices. Recognition of these traditions may make the introduction of a regulated market more culturally acceptable, provided it respects indigenous rights and knowledge systems.

Public health and safety concerns

Colombian authorities would likely prioritise ensuring that an adult-use psychedelic market is regulated to prevent misuse, ensure product safety, and educate users. Harm-reduction policies, training for facilitators, and safe consumption environments would be essential.

Economic and tourism opportunities

A regulated market could be economically beneficial, especially for psychedelic tourism. Colombia’s biodiverse environment is conducive to producing natural psychedelics like psilocybin mushrooms, and its reputation as an emerging wellness destination could attract international visitors.

The emergence of an adult-use market for psychedelics in Colombia is plausible but not imminent. It would likely begin with decriminalisation and limited medical or therapeutic use, gradually expanding into recreational markets under stringent regulation. The success of such a market would depend on political will, cultural sensitivity, and public health considerations. If implemented thoughtfully, Colombia could become a global leader in the regulated use of natural psychedelics.