Draft bill 13.

Summary.

The draft bill establishes a legal framework for pharmaceutical care as a component of the right to health. Its purpose is to ensure the rational, safe, effective, and timely provision of medicines and the active participation of pharmacists in comprehensive patient care. The proposed framework covers the public, private, and mixed national health system. It defines pharmaceutical care as services aimed at improving pharmacotherapy, preventing medication errors, optimizing medicine use, and supporting adherence to treatment. It also defines a pharmacist by reference to a university degree in Pharmacy and professional authorization under Panamanian law, and describes pharmacotherapeutic monitoring and pharmaceutical consultation as activities involving ongoing assessment and direct patient guidance.

Pharmaceutical care would be governed by the principles of accessibility without discrimination or geographic, economic, or administrative barriers; rational treatment; patient safety; pharmacist participation; interdisciplinary work; and respect for patient autonomy. These principles encompass the appropriate use of medicines, the prevention of associated risks, and the patient's right to receive information and make decisions about pharmaceutical treatment. The State would ensure that this care is included at every level of the national health system, including public and private clinics, polyclinics, and hospitals.

Health facilities would be required to include pharmacists on medical care teams to provide individualized pharmacotherapeutic monitoring. The Ministry of Health would establish, through regulations, criteria for gradually implementing that requirement according to each facility's level of complexity and existing capacity. In coordination with academic institutions, it would also promote pharmacists' continuing education and training in pharmaceutical care. The draft bill assigns these professionals responsibility for providing information about treatments and monitoring them, helping oversee individualized medicine use, detecting adverse reactions, and reporting them to the bodies responsible for pharmacovigilance. They would also participate in programs to improve the quality of pharmaceutical care and prevent disease.

The Executive Branch (Órgano Ejecutivo) would issue implementing regulations within 180 calendar days after the law's promulgation. Noncompliance with its obligations by public or private health institutions would be penalized under the Health Code (Código Sanitario) and other health regulations in force, without prejudice to the powers of the relevant oversight bodies. The proposed law would take effect on the day after its promulgation.

Given its subject matter, the draft bill relates to the Ministry of Health, the Executive Branch, academic institutions, and the bodies responsible for pharmacovigilance and health oversight. Its provisions would apply to public and private health facilities, pharmacists, medical care teams, and patients, and could be of interest to the health services, pharmacy, and academic training sectors.