Argentine Prescription System Remains Controversial

Although Argentina's drug regulator ANMAT generally provides automatic marketing approval for all products cleared by the US FDA, the standard of regulation remains the cause of severe tension between the country's government and the research-based industry.

A particular cause for concern is Argentina's unique prescription system, which was substantially altered in 2002, during the country's most recent period of economic crisis. Under Law 25.649, doctors are required to prescribe medicines using the product's chemical name, apparently as a means to familiarise both medical professionals and the public with such terms as a precursor to the introduction of generic legislation. However, as yet no specific generic legislation has been implemented in Argentina.

Further, the law removes the entitlement of prescriptions which do not carry a generic name to reimbursement, and also encourages pharmacists to substitute a generic product for a branded one. Doctors are also obliged to give reasons for a stated preference on prescription forms for many multinational products. As Argentina already has a sizeable generics-based manufacturing industry, there remain suspicions that the law is intended to stimulate the locally-based sector and cut government drug spending, a view reinforced by an apparent deadlock on patent approvals in the country.