Special Section: Latin America
Commentary: Closing the Gap in Latin America – Patient Access to Innovative Products Requires Innovative Action
Yaneth Giha
Latin American Federation of the Pharmaceutical Industry (FIFARMA)

iscussions about health regulations usually focus on creating laws, regulations, and regulatory processes that, in many cases, address the science of medical products. However, this very technical approach (which is imperative) can lead us to overlook the essentials: the quality of life of patients and their families.

The people of Latin America deserve a good quality of life and rapid and efficient access to safe and efficacious new healthcare technologies. It is crucial to understand the fundamental role that state-of-the-art regulations and mechanisms play in the region’s health systems to support this humane approach. Collaboration among all actors, from favorable regulations to a mindset open to innovation, is key to driving technological progress and improving the health and well-being of people in Latin America.

However, Latin America sometimes seems to lag behind other regions of the world with regard to health regulation. For example, reliance has not been implemented efficiently in some countries in the region even though this regulatory mechanism is widely used elsewhere. What is the reason?

Closing the Gaps

The complete answer is complex, but one reason is undoubtedly how different actors relate to each other. We have cultural barriers that hinder collaborative work and reduce trust among actors in health systems. However, if we can put these barriers aside, we will surely provide obvious benefits to patients. Moving forward on applying regulatory reliance would be a huge step towards timely patient access to innovative medicines and better quality of life for patients. For that, appropriately adopting the recommendations of WHO established in Annex 10: Good reliance practices in the regulation of medical products and frequently reviewing the regulatory impact of these actions are highly recommended to move forward on applying regulatory reliance.

When we look at new ways to generate scientific evidence in the pharmaceutical industry in various regions, the gap between Latin America and the rest of the world seems to widen. The use of innovative and complex clinical trial designs, of Real-World Data (RWD)/Real-World Evidence (RWE), or of clinical trials that use surrogate endpoints for Regulatory Decision-Making are innovative tools that facilitate patients’ access to new treatments but are not yet widely used in our region.

These state-of-the-art tools aim to bring innovative high-quality medicines to patients but are unfortunately not addressed in the health regulations of many Latin American countries. Updates to these regulations are too slow to match the high-speed progress of innovation in science and research. Jurisdictions like the United States of America or Europe with regulations that favor the generation of new scientific evidence in their health systems provide enormous advantages for their patients and caregivers.

The Challenge of Financial Sustainability

Innovation in pharmaceutical research and development in Latin America provides the region with broader socioeconomic benefits. However, as an emerging region, Latin America labors under a different socioeconomic situation compared to more developed countries; this influences the circumstances and conditions (and associated regulations) that enable and encourage scientific progress.

It is difficult to talk about “modernizing” or “developing state-of-the-art” health regulations in Latin America without mentioning the financial sustainability of the region’s national health systems. Efficient management of available resources and increased health spending are critical to ensuring timely access to growing medical and pharmaceutical innovation. This is where “innovating to innovate” becomes important: For scientific innovation to reach patients effectively, we must focus on an innovative transformation of health regulation and on creating models that can sustain the incorporation of innovative technologies into these healthcare systems.

Managed access agreements (MAA) or risk-sharing agreements, a type of Managed Entry Agreement (MEA) or Patient Access Scheme, provide a good example. These agreements between a manufacturer and a payer/supplier allow access to healthcare technology, subject to specific conditions. Despite wide variability in terminology and classification, these schemes share a common goal: to reduce financial uncertainty when incorporating a new product into a healthcare system. MAAs create a formal business space where financial risk is shared between buyers and payers when introducing new technologies guided by pre-defined goals.

The development of these models arose from the combined need to integrate technological evolution and incorporate innovative products in healthcare systems. This requires improving regulations, in response to population and epidemiological changes, advances in technology, and efficient use of available resources—elements that impose challenges on nearly every country in the world and particularly in Latin America. In this region, Uruguay is a good example of the implementation of this kind of agreement where the patients can benefit from innovation.

Looking Ahead

The need is clear: To close the gap in access to innovation, Latin America needs the collaboration and commitment of all stakeholders, who must contribute their experience and will.

The challenges are enormous. The first is strengthening trust among all parties to co-create roadmaps to develop healthcare systems that truly focus on patient benefit. The second is being open to exploring new ways of doing things. We already have several tools on the table; for example, adopting MEAs, efficiently implementing regulatory reliance and similar mechanisms, and accepting new ways and means of generating scientific evidence. Thus, it is essential for all actors in the healthcare ecosystem to maintain the spirit of innovation and cooperation.

Latin America is a vibrant, creative, and hard-working region. Now is the time to unite around patients. This is more than a financial issue. It is more than a health regulation issue. It is a matter of coming together to create more opportunity, and a better life, for our loved ones. Is this not enough motivation to work together?

Read Part 1 of Global Forum‘s Special Section on Research and Regulation in Latin America in our previous issue.