Peru: New Medical Cannabis Regs

06 Mar Peru: New Medical Cannabis Regs

Peru has new regulations for the use of medical cannabis, following the issuance of Supreme Decree (Decreto Supremo) No. 004-2023-SA on February 28 of this year. The decree approves the Regulation that Regulates the Medicinal and Therapeutic Use of Cannabis and Its Derivatives (Reglamento que regula el uso medicinal y terapéutico del cannabis y sus derivados). The Regulation implements the provisions of Law No. 30681 and Law No. 31312.

The Regulation details the requirements to obtain the different types of cannabis licenses available. Licenses to import cannabis and/or market cannabis derivatives may be granted to pharmaceutical laboratories and droguerías, duly authorized to operate by the Peruvian government. While in some Spanish-speaking countries the term droguería could mean a drugstore, in Peru it is legally defined as a “pharmaceutical establishment, which is dedicated to the import, export, marketing, quality control, storage and/or distribution of pharmaceutical products, medical devices and medical devices.”

As part of the application process, applicants must certify that they will only sell cannabis or its derivates to other licensed entities, such as pharmacies and similar businesses, again duly authorized to operate by the Peruvian government. These businesses are not able to legally import cannabis into Peruvian businesses, but they may apply for a license to market cannabis derivatives.

In line with the framework in some other Latin American countries, such as Colombia and Ecuador, cannabis is classified as “psychoactive” (Cannabis psicoactivo) or “non-psychoactive” (Cannabis no psicoactivo), depending on the THC content. Psychoactive cannabis is that whose THC content is equal to or exceeds 1%. The Regulation contemplates the use of both psychoactive and non-psychoactive cannabis for medical and therapeutic purposes. As such, both types of cannabis may be imported into Peru under the Regulation. Importers of psychoactive cannabis, however, must obtain an import certificate from the General Directorate of Drugs, Supplies and Drugs (DIGEMID).

The Regulation also provides for other types of licenses that, while perhaps of limited interest to foreign cannabis businesses, are significant to stakeholders in Peru. These include licenses for the production of cannabis derivatives, which may include authorization to grow cannabis. In addition, licenses are available for accredited patient associations. The Regulation also establishes requirements for cannabis prescriptions for patients.

Considering the fraught political environment in Peru, that there was bandwidth in the Palacio de Gobierno to tend to the Regulation is by itself remarkable. Is embattled President Dina Boluarte seeking to shore up support for her government, by appealing to medical cannabis patients? We see no indication of such a ploy, which is just as well, since at least some patients are unhappy with the new rules. Perhaps, though, the businesses set to take advantage of the opportunities presented by the medical cannabis market will be more pleased.