Conversations with the Academy series webinar, June 24, 2021

How Regulatory Sciences and Stakeholder Collaboration Could Improve Access to Medical Innovation and Public Health ~ Perspectives for Latin America

Over the years, the ethos that we live in an interdependent world is ingrained in scientists, philosophers, and politicians. But recent times have accentuated the increasingly syncretic dynamics needed for the optimization of healthcare systems and the global economy. The realization from ongoing experiences underscores the demand for dispensing with traditional mindsets, policies, and practices – and, more critically, breaking down the barriers between stakeholders if we are to achieve our aspiration of improving patient community outcomes.

We have witnessed that it is feasible for traditional industry rivals to collaborate to deliver, it is possible for global data sharing, with greater transparency, without impeding intellectual property, it is doable for regulators and the industry to engage in early dialogue and rolling reviews, and it is foreseeable that this innovation could be extended to future access of novel drugs for very sick patients.

In this challenging scenario, regulatory sciences and regulators have emerged as facilitators of innovation, driving the expeditious availability of safe and effective medicines for patients. In Latin America, regulators are undertaking state-of-the-art initiatives, applying inventive concepts of regulatory sciences to promote collaboration and innovation. And, while the spotlight is on Latin America, being an integral part of the global regulatory sciences and medicines development ecosystem, universal, worldwide influences also need to be accounted for in the region.

Elaborating on the evolving dynamics and synergies in the region, Silvia Bendiner Executive Partner, Wessx, Lawrence Liberti, Adjunct Assistant Professor, Temple University School of Pharmacy, Miriam Loera, Director of International Affairs, COFEPRIS, Mexico, and Cammilla Gomes, LATAM Regulatory Policy Lead, Roche, representing FIFARMA, highlighted diverse perspectives across academia, research, regulatory authority, and industry lenses.

The Conversation explored recent developments and initiatives in Latin America, forging stakeholder partnerships and alignment, which have facilitated creative opportunities to optimize the regulatory landscape, promising improved patents’ access to next-generation biopharmaceutical products.

The robust discussions shared keen insights on the impact of global advancements in medicines development and regulatory oversight on the emergent health regulations and policies in the Latin American region, offering an environment of enhanced cross-functional and trans-national stakeholder partnerships, thereby promoting access within underserved patient communities. What are the gaps and challenges with implementing sustainable solutions, and the considerations with overcoming these?

Regulatory authorities could advance innovation by implementing Regulatory Sciences best practices, aligning with recognized international standards, and establishing an Innovation Office – as exemplified by COFEPRIS in Mexico, and CECMED, in Cuba.

Reliance on regulatory process simplification, efficient resource allocation in more strategic arenas, reducing shortages, eliminating redundancies and regulatory duplication, encouraging continuous improvement, strengthening and consolidating supply chains, even as aligning with international regulators and partners is critical for ensuring safety, efficacy, quality, and timeliness of innovative therapeutic modalities.

The universal message was the imperative of driving dialogue and fostering collaboration, both within industry players and with critical stakeholders – public-private, inter-governmental and non-governmental organizations — not only for a more cohesive and concerted COVID-19 pandemic management but also bringing value to society by advocating for sustainable health systems.

Building trust and promoting transparency is fundamental to enabling international cooperation and disrupting fragmentation, duplication, and inefficiency in regulatory systems.

This sets the stage for initiating the vital dialogue around potentially breaking down the barriers that could impede progress with medicines development and patient access to innovation, with the promise of better health outcomes.

We express our sincere appreciation for the contributions of our expert faculty. And, we are motivated by your continued engagement at these events.