Health Minister Alejandro Gaviria issued a declaration that it would be in the public interest for the government to lower the price of Novartis’ expensive leukemia drug, Gleevec (imatinib).
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Washington, DC, June 17, 2016 — Colombian Minister of Health Alejandro Gaviria today issued Resolution 2475 of 2016, declaring that it would be in the public interest for the government of Colombia to lower the price of an expensive leukemia drug. The Ministry of Health describes this resolution as unprecedented in Colombia.
The drug, imatinib, is marketed as Glivec in Colombia by the Swiss pharmaceutical company Novartis at a price of approximately $15,000 per patient per year, nearly twice the average income of a Colombian resident. Glivec has generated over $47 billion in global revenue for Novartis.
The Minister’s actions come after months of government deliberations and negotiations with Novartis in regard to imatinib, along with pressure from the United States Trade Representative and the Senate Finance Committee, and over a year and a half from the date that a petition to issue a compulsory license was submitted by the Colombian non-governmental organizations CIMUN, IFARMA, and Misión Salud.
Colombian Minister of Health Alejandro Gaviria signed a declaration that it would be in the public interest for the Colombian government to lower the price of imatinib. | El Espectador
The Declaration cites Chapter 24 of Decree 1074 of 2015 (which incorporates in full Decree 4302 of 2008), the law governing the procedure for compulsory licenses, and requests that the National Commission for Medications and Medical Devices control the price of imatinib by setting a price limit on the drug according to a methodology that would address the reasons for the public interest declaration. The Minister has publicly stated that he believes that the price reduction could be 40-50%.
Under Article 7 of Decree 4302 of 2008 (Article 188.8.131.52.7 of Decree 1074), the Superintendencia de Industria y Comercio is legally obligated to process the compulsory license.
The articles of the resolution are as follows:
Artículo 1. Declarar la existencia de razones de interés público frente al medicamento imatinib, conforme al Capítulo 24 del Decreto 1074 de 2015, Único Reglamentario del Sector Comercio Industria y Turismo.
Artículo 2. Solicitar a la Comisión Nacional de Precios de Medicamentos y Dispositivos Médicos que considere someter al medicamento Glivec® al régimen de control directo de precios usando una metodología general que regule las situaciones de interés público tal como se menciona en la parte motiva de la presente Resolución.
Artículo 3. Notificar a los solicitantes Fundación Ifarma, Acción Internacional por la Salud, Misión Salud Veeduría Ciudadana –coordinadora de la Alianza LAC Global por el Acceso a Medicamentos- y Centro de Información de Medicamentos de la Universidad Nacional –CIMUN, el contenido del presente acto administrativo.
Artículo 4. Notificar el presente acto administrativo al Representante Legal de Novartis A.G. en su condición de titular de la patente y a los titulares de registro sanitario para el principio activo imatinib, de acuerdo con la información reportada por el Instituto Nacional de Vigilancia de Medicamentos y Alimentos –INVIMA.
Parágrafo. Contra el presente acto administrativo procede el recurso de reposición, el cual podrá ser interpuesto dentro de los diez (10) días siguientes a su notificación, de conformidad con lo establecido en el artículo 74 del Código de Procedimiento Administrativo y de lo Contencioso Administrativo (Ley 1437 de 2011).
Artículo 5. Ordenar la publicación del presente acto administrativo en el Diario Oficial, así como en la página web del Ministerio del Ministerio de Salud y Protección Social.
Artículo 6. La presente resolución rige a partir de su ejecutoria.
A translation of the articles of the resolution is below.
Andrew Goldman, Counsel for Policy and Legal Affairs, described the Resolution as a significant precedent for governments to curb high drug prices in the face of budget constraints:
“The public interest declaration establishes a tremendous precedent in the fight against high drug prices. This case has demonstrated for the world that budget constraints and the problems caused by high prices are a legitimate reason for a government to issue a compulsory license. Under Chapter 24 of Decree 1074 of 2015, the Superintendencia de Industria y Comercio is required to now process the compulsory license and should do so immediately. The Colombian people have waited long enough.”
KEI Director James Love pointed out that further delays would only empower Novartis and its Obama Administration allies:
“It is in Colombia’s interest to resolve this sooner rather than later. Delays are both costly, because they extend the period of the monopoly, and give Novartis and other drug companies, and their allies in the Obama Administration, more time to mount opposition to the compulsory license. The Colombian government should basically ignore the Obama Administration at this point, because they will be out of power in November. Hillary Clinton is less inclined to side with the drug companies, and no one knows what Trump’s views will be.”
The World Health Organization, Senators Sherrod Brown, D-Ohio, and Bernie Sanders, D-Vt., and 15 members of the House of Representatives led by Representative Sandy Levin, D-Mich., as well as dozens of civil society organizations and over 100 international trade and health experts, have all supported Colombia’s rights to grant a compulsory license under international trade law including the U.S.-Colombia Free Trade Agreement.
English translation of the Articles of the Resolution:
Article 1. To declare the existence of the public interest to the drug imatinib, under Chapter 24 of Decree 1074 of 2015, Unique Regulatory Sector Commerce Industry and Tourism.
Article 2. To request that the National Commission for Prices for Drugs and Medical Devices drug consider submitting Glivec to the regime of direct price control using a general methodology governing situations of public interest as mentioned in the relevant part of the this resolution.
Article 3. To notify applicants Fundación Ifarma, Acción Internacional por la Salud, Misión Salud Veeduría Ciudadana – Coordinator of the LAC Global Alliance for Access to Medications- and Drug Information Center of the National University -CIMUN, the content of this administrative act.
Article 4. To report this administrative act to the legal representative of Novartis A.G. in his capacity as holder of the patent and sanitary registration for the imatinib active ingredient, according to information reported by the National Institute of Food and Drug Monitoring -INVIMA.
Paragraph. Against this administrative act an appeal for reconsideration may be brought within ten (10) days following notification days in accordance with the provisions of Article 74 of the Code of Administrative Procedure and Administrative (Law 1437 of 2011).
Article 5. To order the publication of this administrative act in the Official Journal and on the website of the Ministry of Health and Ministry of Social Protection.
Article 6. This resolution is effective as of its execution.