Around the Globe: Latin America

Advancing Biopharmaceutical Innovation and Patient Access: Call to Action for Latin American Regulators
Silvia B. Bendiner
WESSX Inc.
Belkis Romeu
T

he need for further regulatory convergence and collaboration among regulators in Latin America remains an urgent topic. This article advances this discussion by expressing the strategic vision and professional legacy of Dr. Rafael Pérez Cristiá, a leading advocate for strengthening the region’s medicines regulatory systems. It also proposes how regulators in Latin America can leverage an initiative envisioned during his three-decade tenure as head and director of the Cuban Regulatory Authority (CECMED) and support advancing healthcare innovation in the region through knowledge sharing and training in regulatory sciences.

CECMED’s Office of Innovation

The Cuban Regulatory Authority is one of the regulatory bodies recognized by the Pan American Health Organization (PAHO) as a National Regulatory Authority of Regional Reference (NRAr). In addition to Cuba, this NRAr Group consists of the National Administration of Drugs, Food and Medical Devices (ANMAT) of Argentina, the National Health Regulatory Agency (ANVISA) of Brazil, the National Institute of Drug and Food Surveillance (INVIMA) of Colombia, the Public Health Institute (ISP) of Chile, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) of Mexico, Health Canada, and the US Food and Drug Administration (FDA). This designation of these authorities, based on a Resolution of PAHO’s Directing Council, is a recognition of their leadership in regulatory capacity in the region.

This designation is also linked to the NRAr’s commitment to actively promoting the exchange of information on the regulation of medicines and other health technologies, thus strengthening other national regulatory partners. Aware of its role as a regional reference, CECMED has historically worked with regulators throughout the Caribbean, Latin America, and the rest of the world to build processes and systems that contribute to transforming the effectiveness and efficiency of regulatory agencies and facilitating their ability to ensure timely access to quality, safe, and effective therapies, including innovative medicines.

Under Dr. Pérez Cristiá’s leadership, CECMED established an Office of Innovation in 2019. The goal of this flagship initiative, the first of its type in Latin America and the Caribbean, is to serve as a driving force for national and regional biopharmaceutical innovation. This office was created with the goal of building regulatory capacity and implementing regulatory science tools as well as good regulatory practices, while considering the budgetary constraints and resource limitations of Cuba’s economy. In its strategic framework, scientific innovation is assessed by dedicated teams of researchers, clinicians, and (both national and global) regulatory assessors in tandem with the Cuban industry association BioCubaFarma, supported by the advice of local and global experts. These parties collaborate with this Office of Innovation to consolidate shared risks and strategies during development of innovative products, guaranteeing safe and efficacious alternatives to counteract life-threatening diseases and public health emergencies, and conveying a positive and direct impact on the Cuban population.

Call for Action to Regulators in Latin America

This example from Cuba can be of great use to other Latin American NRAr, fostering innovation and regional access to novel effective therapies, based on lessons learned during and after the COVID-19 pandemic. Within the framework of a globalized approach to regulatory alignment, and on the basis of the above initiative in Cuba, the authors wish to bring the new pilot project described herein to the attention of, and for consideration by, the NRAr and other regional health stakeholders,.

The pilot project would include establishing a Regional Innovation Task Force (a/k/a Regional Working Group of Regulatory Assessors), with the core function of jointly assessing the development of and early access to regional biopharmaceutical innovation. This initiative is in line with ongoing regional regulatory cooperation mechanisms, especially the collaboration among NRAr, designed to strengthen a more sustainable Latin American regulatory innovation ecosystem. This Regional Innovation Task Force (RITF) would function as a coordination platform with adaptive capacity-building capabilities able to support public health emergencies and ensure not only the availability but early access to high-quality innovative or essential therapeutic products.

When extrapolating CECMED’s experience to an RITF, this RITF would proactively support regional alignment initiatives primarily by focusing on joint technical and clinical assessments of novel product candidates and rolling reviews in collaboration with global regulators such as the EU Innovation Offices Network or the Competent Authorities of Medicines in the Iberoamerican Countries (EAMI Network). In the context of alignment with existing international regulatory standards and best practices, this support would also result in more efficient and faster access to innovative medicines for patients throughout Latin America.

When further considering the regional and global relationships among NRAr, the RITF could function (depending on the specific need and/or requirements) as the Regional Working Group authorized to execute activities documented in Cooperation Agreements, Memorandums of Understanding, Letters of Intent, or other agreements between NRAr of the region, to support access to therapeutic innovation, information exchange and data sharing, as well as use of other reliance mechanisms.

An RITF can greatly facilitate the flow of regulatory knowledge across regulatory agencies and regulatory scientific committees, as well as facilitate the review and assessment of innovative medicines. This dialogue must be transparent and inclusive, and incorporate all stakeholders who can support and will benefit from the initiative—especially industry and patients.

An RITF is more a paradigm than an initiative for the Latin American region, and the NRAr of Latin America—ANMAT, ANVISA, CECMED, COFEPRIS, INVIMA, and ISP—should discuss this model and proposed pilot in consultation with national and regional stakeholders. It could potentially provide a mechanism to build solid and robust medical, scientific, and technical competencies within the region’s diverse legal frameworks, while providing a practical tool for regional regulatory coordination and collaboration which facilitates general regulatory harmonization across Latin America.

Global Forum will continue to provide updates on and insights from these and related regulatory activities in Latin America regional reports.

This article was written to honor the memory of Dr. Rafael Pérez Cristiá, who passed away in June 2020.

Belkis Romeu is presently working at the Permanent Mission of Cuba to the International Organizations in Vienna.

Disclaimer: The opinions expressed in this paper are solely the authors’ and do not represent the views of their organizations. The authors are grateful to Lawrence Liberti and Cammilla Horta Gomes for their assistance with this article.
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