Medical cannabis: regulatory divergence and product liability

Fernando Martinez Zuviria
Allende & Brea, Buenos Aires
fmartinez@allende.com

Lucrecia Re
Allende & Brea, Buenos Aires
lre@allende.com

Delfina Buffetti
Allende & Brea, Buenos Aires
dbuffetti@allende.com

Introduction

The regulatory framework for medicinal cannabis in Argentina has advanced significantly over the past eight years, with developments primarily centred on two key areas.

Advancing research into the medicinal and scientific applications of cannabis and its derivatives, with the aim of supporting and enhancing comprehensive healthcare

Based on the Medicinal Cannabis Act No 27,350 and its regulatory decree, the Ministry of Health created both the National Programme for the Research of the Medicinal Use of the Cannabis Plant and the REPROCANN^[1] (Cannabis Program Registry). This is the regulatory foundation for the medicinal and scientific research and use of the cannabis plant for medicinal, therapeutic and palliative purposes in Argentina.

REPROCANN registers patients with the required medical prescription and grants the corresponding access authorisations. The programme ensures timely, safe and inclusive access for non-commercial purposes, strictly intended for medical use, while maintaining rigorous oversight of the authorisation, access and utilisation processes.

Patients may register to obtain cultivation authorisation for themselves, through a family member, third party cultivators or legal entities for research purposes.

Development of the national production and commercialisation chain of the cannabis plant, its seeds and its medicinal derivative products

In 2022, Law No 27,669 created the Regulatory Agency of the Hemp and Medicinal Cannabis Industry (ARICCAME), which is responsible for the regulation and oversight of the productive activities of the cannabis industry, as well as its commercialisation and distribution for medicinal and industrial use within Argentina.

Furthermore, the scope of ARRICAME covers all matters related to the acquisition, cultivation, production, commercialisation, manufacture, importation and exportation of cannabis seeds, the cannabis plant, and their medicinal or industrial derivatives.

These laws, along with the provisions and resolutions that complement them, constitute the basis of the national regulatory framework on medicinal cannabis.

Regulatory divergence

Argentina is a federal country: the current cannabis legal framework is applicable almost nationwide, since the majority of the provinces adhere to the Medicinal Cannabis Act No 27,350. The provinces have also enacted their own regulations that complement and add to the existing national legal framework.

Upon analysis of each province’s regulatory framework, the following trends can be outlined.

Some provinces (such as Tierra del Fuego, Salta, Neuquen, Rio Negro and Santa Fe) have focused their efforts on implementing the necessary measures to facilitate access of medicinal cannabis for patients with a duly issued prescription, in order to safeguard public health as established under Law No. 27,350.

Certain jurisdictions (such as Salta and Santiago del Estero) have enacted specific regulations establishing programmes that provide access to medicinal cannabis or its derivatives for patients suffering from drug-resistant epilepsy.

Other jurisdictions (such as Chubut, Jujuy, Mendoza and San Juan) have prioritised the commercial development of the medicinal cannabis industry.

For instance, the Province of Mendoza established the Provincial Registry of Cannabis and Industrial Hemp under Law No 9,617. The scope of this registry includes the authorisation, supervision and control of the production, distribution and commercialisation of cannabis for medicinal, therapeutic, palliative and/or industrial purposes within the province. These provisions complement the national legal framework and further expand the range of authorisations that may be issued for conducting activities involving medicinal cannabis within the jurisdiction.

Product liability

Under Argentine law, cannabis-based products for medicinal use are deemed consumable goods subject to state regulations insofar as they involve public health. Patients prescribed with cannabis for medicinal purposes can be reasonably qualified as consumers, which is necessary insofar as product liability under Argentine law is reserved for consumers or persons equated to consumers, though the general tenets of liability for defective things could be extended to a manufacturer under the theory of structural guardianship.

National health regulations assign responsibility for ensuring product safety to public or private laboratories (whether domestic or foreign) that maintain a registered office within Argentina and possess the appropriate marketing authorisation to manufacture, import, export or commercialise cannabis-based plant products and their derivatives intended for medical use. Holders of marketing authorisations bear primary responsibility for ensuring the quality and safety of cannabis-based plant products and their derivatives.

However, liability is also assessed in light of consumer rights and the entire chain of relationships involved in the manufacture and distribution of medicinal cannabis. In this context, it is important to note that a broad spectrum of public policy laws, along with general and sector-specific product liability regulations, may apply.

For example, the Consumer Protection Act establishes that liability is strict and objective. Any harm caused by risky or defective goods acquired by consumers (or by individuals legally deemed equivalent to consumers, such as patients in Argentina) must be jointly and severally borne by the manufacturer, importer, distributor, provider, seller or trademark holder. This obligation applies regardless of any internal claims for reimbursement or compensation that may exist.

Concerning liability, the following should be borne in mind as far as Argentine law is concerned:

• Joint and several liability for all providers in favour of the consumer, as stated above.
• Liability is strict and objective: insofar as damages are caused by the good’s inherent risk or defect, any of those indicated as liable by the law must answer. The same rule applies in general to any damage caused by the inherent risk or defect of a product.
• Exemptions are limited and strictly interpreted: to be exempt from liability the given party must prove an extraneous factor leading to the damage: either the victim’s or a third party’s fault, or a force majeure case.
• Pro-consumer and pro homine slant: there is a marked slant in favour of any person insofar as their personal rights (especially to health) are involved, as well as in favour of the consumer for affectations derived from products, and, as a principle of law, any damage is illicit and must be fully repaired unless justified. All this contributes to extending liability and implying legal procedures are adjusted in favour of the damaged person.
• Three-year statute of limitations since the damage and its cause are effectively known or could have been known.

It is important to note that the risk of development or state-of-the-art defence is not contemplated in law, and has been either strictly pondered or held inadmissible by case law. State authorisation provides no exemption either.

Conclusion

Argentina’s regulatory framework for medicinal cannabis has undergone substantial transformation over the past eight years, laying a robust foundation for both scientific research and the development of a national production and commercialisation chain.

While the federal structure has led to some regulatory divergence across provinces, this has also fostered innovation and tailored approaches to patient access and industry growth at the local levels. However, despite these advancements, the market remains in its early stages, and further alignment of regulations across jurisdictions is essential to unlock its full potential. At the same time, the legal landscape surrounding product liability underscores the importance of rigorous safety standards and consumer protection.

As the sector continues to evolve, harmonising regulatory efforts and strengthening liability safeguards will be key to ensuring the responsible and sustainable advancement of medicinal cannabis in Argentina.