While regulatory agencies in several Latin American countries have made significant efforts to improve processes and accelerate approval times, a number of access hurdles still remain across the region. Here, the representatives of some of pharma’s most important companies in LatAm share their experiences of the evolution of market access on the continent and the road still to travel.
Progress on the regulatory front
Regulatory agencies in several Latin American countries have made considerable progress in improving their efficiency and speeding up drug approval processes. Several of these agencies have achieved the World Health Organization (WHO) / Pan American Health Organization (PAHO) Level 4 certification, ensuring international standards of efficacy, safety, and quality of drugs, including Argentina’s ANMAT, Brazil’s ANVISA, Chile’s ANAMED, and Mexico’s COFEPRIS.
The stereotype that LatAm takes a longer time than other regions to incorporate new products is no longer true, and there is real stakeholder willingness to bring innovation to market as soon as possible
Local pharma bosses are already seeing the results of this progress. “We are quite happy with the speed at which products are approved here,” says Allan Finkel, SVP LatAm for Danish diabetes and obesity specialist Novo Nordisk. “Regulatory agencies across LatAm are improving a lot and in Brazil, for example, we are now able to launch products almost simultaneously with Europe and the US. Similar timeframes are emerging in countries like Argentina, Colombia, and Mexico. The stereotype that LatAm takes a longer time than other regions to incorporate new products is no longer true, and there is real stakeholder willingness to bring innovation to market as soon as possible.”
Regulatory alignment across the region is another hot topic regional leaders feel optimistic about. As Rolf Hoenger, Roche’s LatAm area head explains, “We have had some spectacular success around regulatory alignment, especially in Mexico and some of the Central American countries. Despite these successes, we would like to see a faster rate of change in this priority area.”
“I believe that the much-discussed topic of regulatory alignment between countries in LatAm will soon become a reality, further bolstering approval speeds,” Finkel agrees.
Underfunding still an axe to grind
According to the United Nations Economic Commission for Latin America and the Caribbean (Spanish), health systems in the region are drastically underfunded with a third of the countries in Latin America and the Caribbean managing a share of out-of-pocket spending greater than 40 percent of total healthcare spending.
“The Pan American Health Organization (PAHO) recommends that each country invests around six percent of their GDP on public health, but the regional average is still well under this benchmark. This level of underfunding creates issues not only around access to innovation, but also the provision of basic care,” says Hoenger.
“We are starting to see signs of change, with greater dialogue between society and governments on healthcare, but we need to see more action, including Ministries of Finance dedicating a greater amount of resources to health,” he continues.
Essential partnerships
Regional pharma leaders highlighted the importance of partnerships in the access equation, many of which go well beyond alliances with local authorities. “As a leader in LatAm, we need to continue working independently from the position that we have in the healthcare system to identify alternatives and to be proactive in providing opportunities so that more patients can receive the right treatment at the right moment. To do this we need to understand how we can work with different stakeholders in the region and how we can partner with institutions to ensure that patients can access care,” says Sandra Ramirez, Latin America Area Lead at Astellas Pharma.
We need to continue working independently from the position that we have in the healthcare system to identify alternatives and to be proactive in providing opportunities so that more patients can receive the right treatment at the right moment.
“In Mexico, we are collaborating with the government and different institutions. Also, we are building important partnerships to support healthcare providers. In Colombia, we are working with health maintenance organizations (HMOs), with logistics operators, and with medical societies. As a part of this process, it is also a priority for us to work with distributors, and with civil societies and the community,” she continues.
“As we are one of the companies that will have a strong portfolio in specialty care (rare/orphan diseases), we recognize the importance of the public/government sector as a key stakeholder who we want to pro-actively engage on ways and means to ensure we are able to identify best possible paths to creating access to these innovations for patients,” says Dirk Van Niekerk, managing director for South America at Boehringer Ingelheim.
Companies are dedicating significant resources to building these alliances. “We have just established a comprehensive Corporate Affairs team to work hand in hand with our dedicated market access teams communally working with public stakeholders in this regard,” Van Niekerk says.
Public vs Private
The varying degrees of private sector participation in healthcare across the LatAm region is another factor the industry must take into account and adapt to. “Considering the fact that we have very specialized products, we offer them in both private and public markets, and we work to ensure patients get access regardless of the channel,” says Ramirez.
“We should remember that there are still significant differences between countries in the region, with each having its own dynamic. The beauty of our job is being able to understand those systems and how we can best facilitate patient access to our medicines. Argentina, for example, is much more reimbursement-driven than Brazil, at least for diabetes and obesity treatments. We need to adapt to that and foster a full understanding of the journey taken by doctors and patients,” adds Finkel.
