By Anna Petherick

Chile’s growing trade with the US, Europe and China in recent years has made the Andean nation one of the most economically stable and prosperous countries in South America. Yet, despite Chile’s economic success, the country has continued to fall short on intellectual property laws. This lax enforcement of patent rights, experts say, has dissuaded many international companies, including the pharmaceutical sector, from investing in the country.

To bolster Chile’s patent protections and create a friendlier business environment for pharma, the country’s ministry of health last month announced plans to introduce legislation that would establish a new national medicines agency, called the Agencia Nacional de Medicamentos. The regulatory body, to be modeled after the US Food and Drug Administration, would replace the existing agency, the Instituto de Salud Pública de Chile, which has been criticized for showing favoritism to local firms and for turning a blind eye to sloppy manufacturing standards. In 2009, for example, just nine out of 34 drugmakers in Chile were certified as having good manufacturing practices.

The new agency, known as ANAMED, is intended to sort this out. First among its tasks will be to ensure that generic drugs meet bioequivalency standards—that is, that their rates and extents of action are statistically similar to the medicines that they imitate. At present, Chile enforces such requirements for only a small number of drugs, such as antibiotics, leaving the bulk of the industry to demonstrate bioequivalency on a voluntary basis. According to Ruben Gennero, a Latin American healthcare and pharmaceutical analyst with IHS Global Insight, only eight medicines currently comply with bioequivalency standards; by the end of January 2012, however, ANAMED intends to enforce these requirements for more than 300 medicines.

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