El Salvador's drug industry association Inquifar has protested alleged government discrimination against home-grown firms. The complaints centre on a series of "technical" market access barriers, which mainly involve requirements for GMP compliance, patenting and bioequivalence that local producers are largely unable to meet.
Following the approval of CAFTA, El Salvador's government has published clearer rules for government drug tenders, which account for much of the local market. Under the new criteria, drug products for acquisition by the government are subjected to tough new rules. The most challenging is the obligation for registration in no fewer than two major developed markets -- a difficult proposition for the country's copy-based, regional-scale producers.
US trade association PhRMA has lobbied for continued monitoring of El Salvador's intellectual property regime, as the country reportedly fails to offer data exclusivity safeguards or adequate controls on the use of compulsory licensing and second-use patents.
Nevertheless -- despite attempts by local companies to have the tender rules declared illegal -- the new procurement rules are expected to drive up demand for genuine, bioequivalent generics. It is hoped that recently reported drug supply shortages can be alleviated by the entry of new market players.