In an effort to ensure access to essential medicines at more affordable prices, the Government of Panama, through Law 462 of March 18, 2025, adds new articles to Law 419 of 2024, which regulates medicines, other products for human health, and the public procurement of medicines, to incorporate the procedure for the parallel importation of medicines. This measure aims to expand the availability of pharmaceuticals within Panama's public health system. Ley 462 del 18 de marzo de 2025, adiciona nuevos artículos a la Ley 419 de 2024, que regula los medicamentos, otros productos para la salud humana y, la adquisición pública medicamentos, para incorporar el procedimiento de importación paralela de medicamentos. Esta medida busca ampliar la disponibilidad de fármacos en el sistema de salud pública en Panamá.
¿What is the Parallel Importation of Medicines??
It is a mechanism that allows public health institutions to acquire/import patented essential medicines in Panama directly from other countries where the medicine is available at a more accessible price, without the intermediation of exclusive distributors. The importation will be carried out for the purpose of distribution and supply within Panama’s health systems, provided the requirements established by law are met and without contravening the provisions of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and other binding international regulations. Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual Relacionados con el Comercio (ADPIC) de la OMC, así como otras normativas internacionales vinculantes.
¿What medicines can be imported under this mechanism??
According to the new legislation, parallel importation applies exclusively to:
- Medicamentos incluidos en la lista de medicamentos básicos y esenciales determinada por la • Medicines included in the list of essential medicines determined by the World Health Organization (WHO)..
- Productos innovadores con patente reciente que hayan demostrado costo efectividad, que sean de Recently patented innovative products that have proven to be cost-effective, are in high demand, and are necessary to treat highly prevalent diseases in the Panamanian population, especially those that affect public health. y necesarios para tratar enfermedades de alta prevalencia en la población panameña, especialmente aquellas que afectan a la salud pública.
¿Who can import and under what conditions??
Importation is only authorized for the Ministry of Health and the Social Security Fund (CSS), without the involvement of exclusive distributors. The National Directorate of Pharmacies and Drugs will issue a Parallel Import Permit for Essential Medicines (PIPME) to authorize the importation, which will be subject to the following conditions: el Ministerio de Salud y la Caja de Seguro Social (CSS), sin intervención de distribuidores exclusivos. La Dirección Nacional de Farmacias y Drogas expedirá un Permiso de Importación Paralela de Medicamentos Esenciales (PIPME) para autorizar la importación, el cual estará sujeto a las siguientes condiciones:
- The medicine must be essential and listed by the WHO.
- It must be guaranteed that the imported medicines are of the same quality and effectiveness as the patented and marketed medicines in Panama.
- The price must be significantly lower than that available in the Panamanian market.
- The importer must be exclusively a public health institution.
- Permit validity: 2 years, extendable for one additional year.
Impact and benefits of this regulation
The implementation of parallel importation in Panama seeks to generate a positive impact on access to essential medicines, allowing for:
- Cost reductions for the public healthcare system. para el sistema de salud pública.
- Greater availability of essential medicines for the population. de medicamentos esenciales para la población.
- Guaranteed quality and effectiveness, ensuring that imported products comply with required health standards., asegurando que los productos importados cumplan con los estándares sanitarios exigidos.
Conclusion
The parallel importation of medicines represents progress in Panama’s public health policy, aligning with international models that have proven effective in reducing costs and improving access to essential treatments. With this measure, the country strengthens its capacity to guarantee the right to health for its population without violating international intellectual property commitments. In this context, the government, through its public policy initiatives, opens the door to the participation of pharmaceutical laboratories committed to public health. Parallel importation not only promotes competition and cost reduction but also represents a strategic opportunity for pharmaceutical sector stakeholders interested in expanding their presence in the market. laboratorios farmacéuticos comprometidos con la salud pública. La importación paralela no solo promueve la competencia y reducción de costos, sino que también representa una oportunidad estratégica para aquellos actores del sector farmacéuticos interesados en ampliar su presencia en el mercado. If you are interested in exploring this opportunity or would like more details on how to participate in the parallel importation process with the government, feel free to contact us. We are ready to assist you with any inquiries!
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