By Nicole Gray,BioPharma DIVE |
- A committee of the Colombia Ministry of Health and Social Protection has recommended a compulsory license be issued for Novartis’ Gleevec (imatinib), a widely used cancer drug, Stat reports. The Ministry has to approve such a license before it would take effect.
- Often a point of contention between pharmaceutical companies and developing economy governments, a compulsory license allows a local company to make a patent-protected drug without the consent of the patent holder.
- Gleevec lists for an annual price of about $15,000, nearly twice Colombia’s per capita gross national income. As in other countries, however, price regulations can help Colombians obtain the drug.
Colombia is not the first country to attempt to use compulsory licensing to allow generic companies to produce cheaper versions of patent-protected drugs. India issued a compulsory license in 2012 for the production of a cancer drug patented by Bayer.
However, a recent document submitted to the US Trade Representative by the U.S.-India Business Council indicatesthe Indian government has made private promises not to use this authority for commercial purposes.
The World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement grants the authority for governments to override a patent, but typically in case of a public health emergency.
In the case of India, pharma companies have accused the country’s interpretation of compulsory licensing as favoring domestic firms. But India makes a large portion of the world’s generic drugs, making this threat hold more weight. Colombia is not known for its pharmaceutical manufacturing base, diluting some of the rhetoric Novartis could bring to bear on any eventual licensing decision.