- The Colombian Health Ministry intends to override Novartis’ patent on its blockbuster cancer treatment Gleevec, potentially laying the foundation for the government to issue a compulsory license for the drug, Stat reports.
- Gleevec is listed as an essential medicine by the World Health Organization, but commands a high annual list price. In March, the Colombian Health Ministry recommended a license be issued, which would allow a generic drugmaker to manufacture Gleevec.
- Although countries have the right to issue compulsory licenses under an international agreement through the World Trade Organization, the pharma industry has argued such measures should be reserved only for use in public health emergencies.
Compulsory licenses have become a point of contention between the pharma industry and developing country governments. India has received most of the attention recently, particularly because of its large generics industry.
Amid lobbying from the industry, the U.S. Trade Representative again included India on an annual watchlist highlighting intellectual property concerns in countries around the world. Humanitarian and patient groups had hoped India would be left off as they view the government’s stance as protective of access to affordable generic drugs.
In the case of Colombia, Novartis is adamantly opposed to the issuance of a compulsory license for Gleevec.
“There is no shortage of Gleevec or evidence of other access issues, the price is already subject to government controls, and there is no monopoly with multiple generics already on the market,” a company spokesperson told Stat.
Like other pharma companies, Novartis sees pricing as insufficient grounds to override its intellectual property rights.
When Gleevec was approved in 2001 for the treatment of chronic myeloid leukemia, it substantially improved life expectancy and was later approved to treat gastrointestinal stromal tumors. Last year, Gleevec generated roughly $4.66 billion in revenues, making it Novartis's top-earning drug.
The Colombian government would reportedly save $12 million in healthcare costs per year if a compulsory license was invoked.