According to the announcement, the study will assess the conditions of competition across the entire pharmaceutical value chain, including all channels of commercialization, while also considering the regulatory and institutional framework governing the sector.

This initiative represents the second comprehensive review of Chile’s pharmaceutical market by the FNE, following its landmark 2020 study, which identified significant competitive distortions and issued a series of structural policy recommendations aimed at improving market functioning.

The new analysis is driven by evidence suggesting that competition challenges persist. In particular, the FNE has highlighted ongoing concerns regarding the limited penetration of bioequivalent medicines and the slow pace at which these alternatives enter the market, despite regulatory progress over recent years.

The study will focus on three key dimensions:

• Evaluating the implementation and impact of the recommendations issued in 2020;
• Reassessing the validity of the original diagnostic and policy proposals in light of market evolution;
• Expanding the analysis to segments not previously addressed in depth, including patented medicines and biosimilars.

With pharmaceutical expenditure in Chile continuing to grow—exceeding USD 4.4 billion and representing over 1% of GDP—this renewed scrutiny underscores both the economic relevance of the sector and the importance of ensuring well-functioning competitive dynamics for patients and public systems alike.

The FNE is widely regarded as one of the leading competition authorities in Latin America, with a strong technical track record and increasing specialization in complex sectors such as healthcare and pharmaceuticals. Its market studies have historically played a critical role in shaping policy debates and informing regulatory reforms.

At Thera Health Policy & Access, we will closely monitor the development of this study given its significance not only for Chile, but also for other markets facing similar structural challenges in pharmaceutical access, competition, and regulation.