A provision in Cambodia’s World Trade Organization accession agreement could severely restrict the country’s ability to provide low-cost generic drugs to its citizens, despite a recent international accord designed to improve access to drugs in poor countries, a report from the NGO Oxfam International states.
As a least developed country joining the WTO, Cambodia does not have to fulfill international patent requirements on pharmaceuticals until 2016. However, a stipulation called “data protection” essentially eliminates the need for patent protection. The report claims that as soon as Cambodia joins the WTO, probably in early 2004, the Ministry of Health must implement the provision, which the report claims was included due to pressure from the US trade representative.
Currently, any drug company that wants to sell a drug in Cambodia must register the drug’s chemical composition and other data with the Ministry of Health. Under data protection, for five years after the drug is registered, the ministry must keep the registration information secret—meaning generic-drug importers and manufacturers can’t access it, according to the Oxfam report.
Generic drugs could previously win approval by demonstrating that their chemical composition was identical to that of approved drugs. But the new rule would mean that drug producers and importers “would have to repeat all the trials—expensive and slow—or wait the five years,” the report states.
A US Embassy official said protection of intellectual property was fundamental to trade. Data protection would improve the drug market by making more companies feel secure about introducing their products to Cambodia, the official said.
Dr Chroeng Sokham, head of the Ministry of Health’s pharmacy division, said whether the provision would hurt generic drug makers “depends on their ability” to find the information elsewhere.