Bill 348.

Summary.

The bill amends the licensing framework for manufacturing medical cannabis derivatives under Law 242 of October 13, 2021. It proposes that the Ministry of Health may determine the number of licenses that can be authorized. Five years after the first license is issued, it would allow up to seven manufacturing licenses to be authorized as a measure to supervise and monitor the domestic market. Once that period has elapsed, the Ministry of Health could not reduce the number of previously approved licenses.

To meet patients’ needs and establish the National Medical Cannabis Use Program (Programa Nacional de Uso del Cannabis Medicina) and the domestic market, the bill provides temporary authorization to import derivatives for holders of a Medical Cannabis Derivatives Manufacturing License (Licencia de Fabricación de Derivados de Cannabis Medicinal). The authorization would last five years from the issuance of each license and would serve to supply the program’s patients and the domestic market during that period.

License holders authorized by the Ministry of Health could obtain supplies only from companies permitted to manufacture and export medical cannabis derivatives in the country of origin, provided those products may be exported to the Republic of Panama. For the health registration of derivatives intended for therapeutic and scientific purposes, as well as medicines needed in the local market, the Ministry of Health could recognize high-standard jurisdictions accredited by an international body.

The bill retains the setting of annual fees by the oversight authorities for evaluating and monitoring license holders, in accordance with the law’s regulations. It also requires each license holder to establish a social responsibility program offering medicines free of charge or at reduced prices to low-income patients. The program would allow medical cannabis to be donated to institutions, hospitals, and patient associations that need it. In each calendar year, each license holder would have to make in-kind donations of at least 50,000 balboas and no more than 100,000 balboas. The full amount of those donations could be treated as a deductible expense or expenditure under Article 697 of the Tax Code.

Each license holder would also have to obtain the insurance required by the relevant oversight authority, in accordance with the requirements of the Superintendency of Insurance and Reinsurance (Superintendencia de Seguros y Reaseguros). Patients registered in the Registry of Patients Using Cannabis and Its Derivatives for Medicinal and Therapeutic Use (Registro de Pacientes de Usuarios de Cannabis y sus Derivados para uso Medicinal y Terapéuticos) who have private insurance would be treated in private hospitals, which would accept prescriptions issued by authorized physicians for their treatment. The bill expressly identifies Articles 21, 24, 26, 63, and 76 as the provisions amended and provides that the proposed law would take effect upon promulgation.

Given its content, the bill relates to the Ministry of Health, the oversight authorities, and the Superintendency of Insurance and Reinsurance. It could be of interest to or affect manufacturers and importers of medical cannabis derivatives, insurers, private hospitals, authorized physicians, institutions and patient associations, and people listed in the patient registry.