Writing in the November issue of DIA Global Forum, Lawrence Liberti, Mario Alanis, Pravin Chopra, and Silvia Bendiner examine how the COVID-19 pandemic facilitated greater inter-stakeholder collaboration across the healthcare ecosystems in Cuba and Mexico, and how the learnings from this period can be leveraged for better patient outcomes moving forward.
The COVID pandemic precipitated sweeping changes in established policies and practices and emphasized the confluent dynamics of disease burdens, optimized healthcare systems, and the socio-economic influences of globalization. We now stand at the crossroads of an unprecedented global challenge which demands that researchers, regulators, policy makers, and governments address multiple dimensions that go far beyond the implications of any one healthcare scenario.
The favorable outcome of accelerated vaccine development triggered an increasingly empowered patient voice advocating for access to investigational treatments and biopharmaceutical innovation. It has also drawn attention to revisiting traditional tenets for future approvals of new drugs, and the likely longer-term considerations for medicine development paradigms.
As the healthcare and regulatory landscape evolves in Latin America, early dialogue and enhanced partnerships between biopharmaceutical industry stakeholders, and streamlined coordination among healthcare and regulatory agencies, are critical to expedite decision-making, promote increasingly sophisticated systems and data-sharing, and leverage global ecosystems and synergies in response to emerging regional challenges.
Fostering innovation, translating learnings into competency-based training and education, prioritizing resources, and optimizing clinical development and regulatory models will not only deliver better medicines to the region (and better value to its patients) but also help Latin America reimagine sustainable solutions for unmet medical and social needs, and remain relevant on the global stage.
In parallel, it is paramount to continue to cultivate trust and transparency.
Regulatory Modernization: Best Practices from Cuba and Mexico
Development of innovative medicines is essential to maintaining progress in disease prevention and treatment. Innovating through regulatory modernization is a key goal promulgated by ICMRA (the International Coalition of Medicines Regulatory Authorities) through its Statement on Innovation. Medicines regulators can help to characterize or define future innovations and identify scientific uncertainties and address regulatory barriers they face. However, this will require a global approach and highlight the role of dialogue between regulators, legislators, and policy makers on strategies to innovation and regulation.
Enabling a regulatory system that looks forward and continually evolves to support innovative product research and regulation is critical. Three ways that an agency can work toward these goals are by implementing regulatory science best practices; following international standards; and establishing an Innovation Office to coordinate these activities.
The Cuban regulatory agency (CECMED) has recently addressed this need through developing its Office of Innovation with the aim of building a comprehensive regulatory framework to accelerate innovation and enable the transition of innovative products from clinical research to clinical practice—the first formal initiative of this type in Latin America and the Caribbean. Its goal is to serve a leading role in national and regional biopharmaceutical innovation by adopting science-based approaches and regulatory strategies for product development by improving the flow of knowledge across drug innovators, regulatory agencies, and regulatory scientific committees. While the establishment of this office in CECMED contributes to the efficiency and productivity of the national Cuban biotechnology industry, the office will also play an international role as CECMED seeks to align its harmonization initiatives with the European innovation networks and regulations to ensure better alignment for new market access opportunities for Cuban biotechnology products.
