The Colombian health ministry plans to override a patent that Novartis holds on its widely used Gleevec cancer treatment, the latest clash between the pharmaceutical industry and some governments over intellectual property and access to medicines.
The move, which the health ministry announced last week, could prompt the government patent office to grant a so-called compulsory license to allow a generic company to make a lower-cost version of the drug. A generic version of Gleevec would reportedly save Colombia about $12 million a year.
Compulsory licenses allow generic drug makers to make low-cost versions of brand-name medicines without the consent of the company holding a patent. This right was memorialized in a World Trade Organization agreement known as Trade-Related Aspects of Intellectual Property Rights, or TRIPS.
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In March, a Colombian government committee explained that issuing licenses to other companies would be in the public interest by widening access and saving health care dollars. Issuing a license would “restore competition for this product in the Colombian market,” the committee determined. Consumer groups have noted that Gleevec is on the World Health Organization list of essential medicines.
The pharmaceutical industry, however, has argued that compulsory licenses should be reserved for public health emergencies and as a measure of last resort. But consumer advocates say a WTO primer on the topic notes that a health emergency is “not necessarily” required for a license to be issued.
“This is a common misunderstanding,” the WTO wrote. “The TRIPS agreement does not specifically list the reasons that might be used to justify compulsory licensing. However, [a 2001 declaration] confirms that countries are free to determine the grounds for granting” licenses.
Nonetheless, Novartis is livid.
“A Declaration of Public Interest leading to a compulsory license should never be used as a mechanism to force price negotiations,” a company spokesman wrote us. “This runs counter to the spirit and intent of a compulsory license and its legal framework, and would create a damaging precedent that could apply to all patent-covered innovations — pharmaceutical or otherwise.”
A declaration is “inappropriate as 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,” he added. A compulsory license “is not a solution to the financial challenge faced by Colombia´s health care sector. The arbitrary disregard of patent rights damages industries, which make huge investments in revolutionary medicines.”
The issue began four years ago when Colombia’s patent office denied Novartis a patent for Gleevec. The drug maker responded by successfully going to court to win a patent, which prevented generic versions of the medicine from being produced.
The government then attempted to negotiate a lower price. When that failed, a group of consumer advocacy groups in 2014 asked the health ministry to override the patent by arguing such a move would be in the public interest. The Swiss government lobbied against the move. Novartis is headquartered in Switzerland.
“It is a very courageous decision by the minister given the pressure from his own commerce ministry, Novartis, the US, Switzerland, and the pharma industry as a whole,” Patrick Durisch of Berne Declaration, nongovernmental group, told the website swissinfo.ch.