OBJECTIVES: To identify and analyze the regulatory framework and practice of access policies for ATPM in four Latin America countries to identify regulatory gaps.

METHODS: The countries selected are Argentina, Brazil, Colombia and Mexico. Access policies to be identified in each country are registry, provisions and diagnostic and treatment channels.

RESULTS: Argentina and Brazil have specific under construction regulations for ATMPs registration, but with few precedent cases and regulatory agencies with lack of experience which makes the level of legal uncertainty high. However, regulatory uncertainty is still higher in Colombia and Mexico, where the is absence of registry provisions, so advanced therapies are registered trough a general drug registration process.

Access to diagnostic testing is pulverized between the public and private healthcare systems and geographically spread with concentration of few health centers in in main cities and regions.

These countries face cost containment contexts without clear financing arrangements for high-cost treatments. In this sense, juridical pathways are often used since all countries have a legal framework that obliges them to provide health care, especially for rare disease patients.

There’re still incipient discussions to move forward with arrangements to mitigate uncertainties and contain costs, such as risk sharing agreements and other innovative models and there are efforts to update the pricing rules.

CONCLUSIONS: ATMPs registration is very incipient in Colombia and underdeveloped in Mexico. Futhermore, the four countries’ diagnostic centers are concentrated in main regions and patients may resort to private health. Lastly, the selected countries lack specific financing channels for ATMPs so patients tends to use legal measures. However, governmental actors are interested in regulating high-cost medicines pricing.