Medical cannabis in Paraguay: regulatory framework and development opportunities

Viviana Cervieri
Cervieri Monsuárez, Montevideo
vivianacervieri@cmlawyers.com.uy 

Romina González
Cervieri Monsuárez, Asunción
rgonzalez@cmlawyers.com.py

Lucía Arimón
Cervieri Monsuárez, Asunción
larimon@cmlawyers.com.py 

Introduction

In Paraguay, Law No. 6007/2017 creates a national programme for medical and scientific study and research on the medicinal, therapeutic, and/or palliative use of the cannabis plant and its derivatives in humans (Que crea El Programa Nacional para el Estudio y la Investigación Médica y Científica del uso Medicinal de la Planta de CANNABIS y sus Derivados or PROINCUMEC), which paves the way for the promotion of research on the plant for medicinal purposes, in addition to setting the stage for the development of a regulatory framework.

In recent years, Paraguay has implemented significant changes in regard to the licensing of medical cannabis production. From initially only issuing five such licences to allow a company to produce medical cannabis, the number rose to 12, and currently the market offers significant opportunities for companies wanting to become involved in medical cannabis research and production, as there is no established limit on the issuance of licences.

A notable aspect of Paraguayan legislation is the guarantee of access to cannabis-derived medicines, which is backed by the Ministry of Health. These medicines are intended for patients who have made the necessary corresponding request and are registered on the National Registry of Users of Cannabis-Derived Products, which is an essential requirement for the use of cannabis-derived products in the medical field.

However, it is crucial that the country carries out further work to structure more accessible mechanisms that allow for greater access to these products and to explore the various opportunities that could arise in both domestic and international markets.

The regulatory framework for medical cannabis

The regulatory framework for medical cannabis in Paraguay is based on Law No. 6007 of 2017, which provides the legal basis for the development of this sector and marks a turning point in the approach to the use of the cannabis plant for therapeutic purposes. This law expressly recognises the medical and scientific value of cannabis and its derivatives, establishing as its central objectives the promotion of research, the encouragement of clinical studies and the provision of controlled access to palliative treatments for patients with pathologies that require new therapeutic alternatives. The National Health Surveillance Directorate (Dirección Nacional de Vigilancia Sanitaria or DINAVISA) is the relevant enforcement authority, with the power to grant production and industrialisation licences and authorise research, in addition to administering the National Registry of Users of Cannabis-Derived Products, which is an instrument that ensures that access to such products by patients is supervised and controlled by the state.

One of the most innovative aspects of the Paraguayan law is the incorporation of a system of public production and mandatory donations by private laboratories, which must allocate at least two per cent of their production to the state in order to guarantee free treatment for registered patients. This hybrid model of state intervention and corporate responsibility seeks to balance the right to health with the development of a nascent industry.

Following the enactment of the law, Decree No. 9303 of 2018 and its subsequent amendments, through Decree No. 6519 of 2021 and Decree No. 7761 of 2022, specified the conditions for the production, import, export and dispensing of medical cannabis. The licensing regime was designed to be strict: licences are specific, non-transferable and renewable every five years, ensuring ongoing control by the health authority. A significant change, introduced in 2022, was the elimination of geographical restrictions and limitations on the number of licences that could be granted, representing a shift towards opening up the market and a greater commitment to research and domestic production.

Paraguayan regulations make a clear distinction between psychoactive and non-psychoactive cannabis, requiring that medical cannabis does not have a tetrahydrocannabinol (THC) content of higher than 0.5 per cent. These regulations are not just intent on setting out the technical details, but they are a reflection of how the law must adapt to scientific evidence in order to design regulatory frameworks that are consistent with medical practice.

The complementary resolutions issued by the DINAVISA, the National Anti-Drug Secretariat (Secretaría Nacional Antidrogas or SENAVE) and the Ministry of Public Health and Social Welfare strengthen this regulatory framework by establishing detailed requirements for the issuance of licences, patient and physician registries, seed imports and product health controls. Although these instruments may be perceived as overly bureaucratic, they respond to the need to ensure traceability, safety and legitimacy in a field that still generates social and political resistance. The mandatory nature of the safety protocols that are required in this field at all stages of the process, from cultivation to final waste disposal, confirms the intention by lawmakers to build a model based on maximum precautions, geared more towards control than flexibility.

An assessment of the regulatory framework reveals an ambitious regulatory design that attempts to articulate three fundamental axes: guaranteeing patients’ right to access innovative treatments, stimulating research and productive development and maintaining strict state control over a historically stigmatised substance. However, experience shows that regulations alone do not guarantee results. Paraguay faces the challenge of moving from a legal framework to an effective public policy that ensures that the benefits of the law translate into real improvements for patients.

It is important to note that the removal of certain restrictions and the increase in the number of licences issued represent progress in this direction, but there is still a need to strengthen the institutional control capacity, generate incentives for national research and overcome prejudices that still surround cannabis, even in regard to the production of such products for export purposes.

In short, Paraguay’s legal framework on medical cannabis illustrates the country’s progressive but cautious approach to such products. The challenge lies in balancing the letter of the law with the reality of its implementation, ensuring that the spirit of the law, focused on the health and wellbeing of patients, is not diluted by the labyrinths of bureaucracy or due to the slowness of the state apparatus.

Access to cannabis-derived medicines

To date, a total of 107 patients and ten medical professionals are registered on the National Registry of Users of Cannabis-Derived Products. Of the total number of registered patients, 103 suffer from refractory epilepsy and four from multiple sclerosis. The regulations establish that people diagnosed with these conditions and duly registered in order to benefit from the programme can access free medicinal cannabis oil.

The prescription regime distinguishes between different concentrations of cannabinoid. For cannabidiol (CBD)-based medicines, a simple prescription is required; for those that combine CBD with THC at levels up to 0.5 per cent, the regulations require a simple prescription on file; and for products with a THC content of more than 0.5 per cent, a quadruplicate prescription is required, issued exclusively by treating physicians registered with the programme. This scheme seeks to balance access to such products with strict health controls, considering the psychoactive properties of THC and its therapeutic implications.

Although Paraguay’s regulatory framework provides for controlled access to cannabis-derived medicines, in practice such access remains in its infancy. The National Registry of Users of Cannabis-Derived Products, designed as a tool to ensure that such use is supervised, has made slow progress in terms of both its coverage and the availability of information. Furthermore, there is no clear and accessible data on the quantities of products actually delivered to patients or the number of registrants, which can only be obtained through specific inquiries to the relevant health authority, rather than this information being published in a visible and transparent manner.

At this point, there is a clear challenge in regard to aligning the legislative intent with the relevant operational implementation. Although the regulations recognise and guarantee this right, its full effectiveness requires the strengthening of administrative processes, active cooperation by the private sector and the development of public mechanisms to ensure equitable distribution. The reality is that many families continue to depend on imported products that are purchased at high prices, which has an impact on equity of access and limits the scope of the social impact envisaged by the regulations.

It is therefore advisable to explore policies that strengthen domestic production, optimise health registration processes and facilitate more agile access mechanisms for patients, so that the regulations in this field can effectively contribute to improving the quality of life of those patients who need these products the most.

Product liability

The expansion of the medical cannabis market in Paraguay also raises questions about who bears the legal responsibility for such products. The current regulatory regime establishes strict requirements for licensing, traceability and safety protocols, creating a framework in which laboratories are responsible for the quality, efficacy and safety of the products that they place on the market.

In this regard, pharmacovigilance is an essential component of drug management, ensuring the detection and monitoring of adverse events and promoting transparency in regard to the information provided to healthcare professionals and patients who have been granted access to these types of drugs. This approach is particularly relevant for cannabis derivatives, given the need to ensure the safe and effective use of such products within the remit of the regulatory framework.

The challenge lies in building a culture of shared responsibility between the government, industry and healthcare professionals. The government has a duty to monitor and penalise non-compliance, but companies must also take a proactive role in ensuring that ethical and quality standards are adopted that go beyond what is legally required. Only then will a medical cannabis market that is perceived as safe, legitimate and reliable be created.

Final thoughts

The regulation of medical cannabis in Paraguay is fertile ground for those looking to benefit from such opportunities, but many challenges remain. Law No. 6007/2017 and the relevant implementing decrees have set a progressive course for the development of the market, placing the country at the forefront of the region in terms of regulatory design. However, the gap between the regulatory intent and the reality is evident: access to medicines remains limited, domestic production has not yet reached significant levels, due to low output and a lack of licensees to meet the demand, and persistent cultural and bureaucratic resistance is slowing progress.

The key will be to transform the regulatory framework into genuine public policy that combines strict control measures with effective access mechanisms, encourages local research and allows Paraguay to effectively enter the international medical cannabis market. In this scenario, coordination between the public and private sectors is essential to overcome prejudices and ensure that the social, health and economic benefits of this emerging industry are realised. Complementarily, healthcare professionals and patients should receive clear and concise information on the medicinal consumption of such products through interviews, training and workshops that provide practical tools on the possible uses and the correct application of cannabis derivatives.

In short, medical cannabis represents not only an innovative therapeutic product for patients, but also an opportunity for Paraguay to strengthen its healthcare system, diversify its economy, advance scientific research and position itself in a growing global sector. The challenge is clear: to move from theory to practice, from the legal framework to effective implementation, from the promises made to tangible results for patients and society as a whole.