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Colombia fighting to break Glivec monopoly Posted 03/06/2016

Colombia has appealed to the World Health Organization (WHO) in an attempt to break the monopoly Swiss pharma giant Novartis has for its blockbuster cancer drug Glivec (imatinib) in the country.

Imatinib mesylate is a kinase inhibitor that is indicated for the treatment of adults with chronic myeloid leukaemia with Philadelphia chromosomes, as well as several other cancers.

At the WHO Assembly in Geneva on 23 May 2016, Colombia’s Minister of Health Alejandro Gaviria said that the sustainable development of countries like Colombia was being threatened by the high prices of [essential] drugs.

The statement follows the decision by the country’s Ministry of Health Technical Committee to declare imatinib (Glivec) to be of public interest, thus paving the way for Colombia to issue a compulsory license. A compulsory license allows governments to grant a non-patent holder permission to make a drug on condition that the originator has not been able to make it accessible to those who need it at an affordable price. Novartis has had a monopoly on imatinib in Colombia since 2012 when generics were banned in the country after a decade of litigation. Novartis charges more than double the nation’s per-capita income to treat a patient with Glivec, or Gleevec, for one year, which has spurred the decision to issue a compulsory license.

However, Colombia has been coming under intense lobbying pressure. Colombian diplomat Andrés Flórez, after meetings with the Office of the US Trade Representative and a Republican staffer on the Senate Finance Committee, is convinced that the US Government vehemently opposes Colombia’s plan to allow a generic version of Glivec. He has also warned, in memos, that if his government proceeds with plans to lower the price of Glivec it risks losing US support for a major peace initiative intended to resolve decades of violent conflict in the South American nation and even US support for Colombia’s bid to join the proposed Trans-Pacific Partnership trade zone.

Colombia’s healthcare system guarantees patients’ access to all approved drugs and the budget is straining after years of price rises. In 2009, the government declared a public health emergency after spending on sophisticated drugs had risen tenfold in just a few years. Novartis has already rejected Gaviria’s proposal to reduce the price for Glivec to 140 pesos (US$0.05) per milligram, which is less than half the current regulated price, but still well above the price for generics prior to the 2012 ban.

More than 120 lawyers and health experts across the world recently signed a letter to the Colombian Government endorsing their right to issue a compulsory licence for imatinib. It remains to be seen whether the WHO will also take this stance. Imatinib is on the WHO’s List of Essential Medicines, i.e. on the list of the medications needed to cover the majority of healthcare needs in a health system.

Gaviria is reportedly giving Novartis some time to reconsider its decision over the price of imatinib. But otherwise the health minister says that the country will open competition to generic rivals. If it goes ahead this will be Colombia’s first compulsory licence.

Novartis already lost its monopoly in the US in February 2016 when Sun Pharmaceutical Industries launched its generic version of imatinib following the settlement of patent litigation with Novartis back in May 2014 [1]. In Colombia, the patent is due to expire in July 2018.

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1. GaBI Online - Generics and Biosimilars Initiative. Sun Pharma launches imatinib mesylate in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 3]. Available from: www.gabionline.net/Generics/News/Sun-Pharma-launches-imatinib-mesylate-in-the-US

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Source: Colombian MoH, Colombia Reports, Daily Mail

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