Formal price offer for compulsory license
On April 11, 2016, the Colombian Health and Social Protection office approached Novartis AG regarding a formal price offer as part of the Administrative Process for the Declaration of Public Interest.
This request is regarding a compulsory license for a patent directed to a polymorph of the anti-cancer drug imatinib (marketed by Novartis as Gleevec/Glivec). The request for the Declaration of Public Interest, which is the first step towards a compulsory license in Colombia, was filed by iFarma (representative in Colombia of Health Action International, HAI), Misión Salud (Mission Health) and the Universidad Nacional de Colombia (CIMUN) in November 2014.
The Minister´s communication was made under the recommendation of the Technical Committee for Declaration of Public Interest of the Ministry of Health and Social Protection, and a price of COL$ 140 per milligram of imatinib as the maximum selling price to the public was bid, which involves a 60 percent discount over the marketed drug Glivec.
A compulsory license is a legal mechanism by means of which a government allows for the generic production of a drug without permission of the patent holder. It is one of the flexibilities on patent protection included in the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement.
In Colombia, compulsory licenses are established in Chapter VII of Decision 486 of the Andean Community Commission. When a request for a compulsory license is based on a declaration of public interest, the procedure is governed by Decree 4302 of 2008.