Timeline of Colombia CL Campaign
1992- Article 4 of Decree 2153 of 1992, provides the Superintendent of Industry and Commerce with the authority to issue compulsory licenses.
· 1995- Decree 677 of 1995 states that in order to get market approval for an imported drug, the importer must obtain authorization from the manufacturer. This decree all but hindered parallel importation despite the fact that this mechanism is a public health safeguard in the TRIPS Agreement.
- 2000- Decision 486 is adopted by the Andean Community. The legal document regulates intellectual property and patents in the Community. Chapter VII provides a framework for compulsory licensing.
- 2001- Resolution 17585 of May 25, 2001 establishes procedures for compulsory licensing based on Article 65 of Decision 486.
· 2002-Decree 2085 of 2002 provides data exclusivity for undisclosed information. Exceptions can include public health, among others.
2005-Law 972 of 2005 defines HIV/AIDS to be an interest and national priority for the Colombian government. According to the law, the Social Security and Health System commit to ensuring supply of medicines and medical devices necessary for treating catastrophic illnesses. The law provides the Colombian government with the authority to use regulatory mechanisms to guarantee access to medicines for people in need.
· February –April 2008-Colombian organizations hold preliminary meetings to develop a national action plan followed by trainings and workshops to mobilize society. They invite Peter Maybarduk from Essential Action to lead local and regional training workshops on compulsory licensing.
· April 7, 2008- Health groups send Abbott Laboratories a request for a license from Abbott Laboratories for lopinavir+ritonavir.
· July 15, 2008- Health groups send request letters for an open compulsory license on lopinavir+ritonavir to the Superintendent of Industry and Commerce, home of the patent office, and the office of the President of the Republic. They also send a letter to the Ministry of Health (MoH) requesting that lopinavir+ritonavir be declared in the public interest.
· July 25, 2008-The Superintendent of the Industry and Commerce responds to the compulsory license request. The letter lays out a procedure for initiating a compulsory license request highlighting the need for petitioners to obtain a declaration of public interest, emergency, or national security, that would justify a license to be issued on the grounds of public interest.
· August 12, 2008-The MoH replies to the compulsory license request claiming that they do not have the authority to issue a compulsory license. The Ministry defers responsibility to the Superintendent of Industry and Commerce. The Ministry also replies to the request for a declaration of public interest and claims that the request cannot be resolved with the timeframe established under the law. The letter commits to providing a request within 2 months.
· August, 2008-INVIMA, Colombia’s drug regulatory body, suspends the registration process for Ranbaxy Laboratories’ lopinavir+ritonavir application citing a judicial order issued as part of the legal action initiated by Abbott Laboratories against the generics manufacturer.
September 2, 2008-Abbott files a request to be included in the administrative process as an interested third party.
· October 14, 2008-In a response to the general petition for a declaration of public interest, the MoH defers authority for issuing a declaration to the Superintendency of Industry and Commerce.
- November 13, 2008-The Superintendent of Industry and Commerce issues Decree 4302 which confirms MoH’s authority to make a declaration of public interest.
· December 1, 2008- The National Commission on Medicine Prices issues Circular 002 de 2008 which places lopinavir+ritonavir on the “régimen de libertad regulada”, a list of drugs that have special implications for public health, whose price is regulated by the government.
· December 22, 2008-Resolution 05283 establishes the “Comité Técnico para la declaracion de razones de interés público”, a technical committee in charge of evaluating the evidence for a declaration of public interest. The committee will ultimately recommend that the MoH not declare Kaletra to be in the public interest.
· January 24, 2009- Activists in Colombia, Mexico, and the United States demonstrate in front of Abbott offices in protest against the prices being charged for Kaletra.
· January 28, 2009-Abbott files a petition In limine requesting the rejection of the declaration of public interest request.
· April 28, 2009- The National Commission on Medicine Prices issues Circular 002 de 2009 which pegs Kaletra’s price at $1,067 for the public sector and $1,591 for the private sector, representing average price reductions of 54% - 68%.
- May 8, 2009-The MoH issues Resolution No. 001444 which supports the findings of the technical committee not to issue a declare a public interest.
- June 1, 2009-Civil society groups send a letter to the MoH expressing strong criticisms of the ministry’s decision. The letter demands a second analysis.
- September 28, 2009-RECOLVIH with the support of other civil society groups files a groundbreaking “Acción Popular” against the MoH, the Superintendency of Industry and Commerce, INVIMA, and Abbott Laboratories.
· October 15, 2009-The judge accepts to hear the “Acción Popular”.
· January 21, 2010-The MoH issues Decree 126 de 2010 declaring a “Social Emergency” in order to avert the crisis affecting the viability of the Social Security and Health System and the system’s ability to provided continued access to public services essential for health and for guaranteeing the fundamental right to health.
February 8, 2010-Civil society groups send a letter to MoH reiterating the need for a compulsory license on Kaletra and other medicines on the grounds of the social emergency. The petition highlights three concerns: the high cost of the drug, increased use, and the transfer of non-financial cost burdens of the system on to patients.
· February 11, 2010-In a letter to the Comisión Nacional de Precios de Medicamentos (CNMP), Abbott finally agrees to comply with the pricing regulation established by the CNMP citing the obligations in Decree 126. The letter also complains about not being able to participate in the decision-making process of CNPM’s circular or being provided with the opportunity to intervene.
· February 16, 2010-The Archbishop of Bogotá, Cardinal Pedro Rubiano Saenz, writes to the Colombian President Alvaro Uribe in a letter joined by Colombian NGOs and the President of the Colombian Medical Federation, disagreeing with the government’s assertions that the health system crisis was unforeseeable. The letter highlights the role that high cost patented drugs played in contributing to the financial collapse of the health system, notably that only 5% of drugs, all of which are patented, constituted 85% of government’s expenditures on the promotion of health. The letter urges the government to use three policy tools “inexplicably” left out of the government’s recent legislative decrees including registering generic medicines, compulsory licensing and parallel importation.
· February 23, 2010-Civil society groups send a petition to the Superintendent of Industry and Commerce requesting a compulsory license on lopinavir+ritonavir and other medicines in light of the social emergency.
· March 1, 2010-Civil society groups send a petition to the Superintendent of Industry and Commerce reiterating their request for an open compulsory license on lopinavir+ritonavir.
· April 21, 2010-The Ministry of Social Protection issues Decree 1313 of 2010 which establishes requirements and procedures for facilitating parallel importations of medicines.
· February 29, 2012-Colombian administrative judge agrees with civil society’s complaint and declares that Abbott Laboratories and the MoH have threatened and violated the collective rights to public health by maintaining the price of Kaletra above the international reference price.
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