Colombia's CL Campaign Story
Timeline of Colombia compulsory licensing campaign
In Colombia, Latin America’s third most populous country, Abbott Laboratories long charged several thousand dollars per person per year for its patented Kaletra (lopinavir+ritonavir). In 2005, about 1,257 People Living with HIV/AIDS (PLWHA) were taking the anti-retroviral (ARV) as part of their treatment regimen. Between 2004 and 2006, the unit consumption of the drug doubled from 3 million to 6 million. In these two years, Kaletra constituted about 25% of total expenditures on ARVs. It was one of the most expensive medicines on the national market.
Exceedingly high prices, irregularities in drug delivery, and a growing number of patients with limited access led several civil society groups to launch a national compulsory license campaign to promote generic competition and price reductions. Beginning in February 2008, they engaged in extensive advocacy and education work and mobilized individuals, networks, experts, and decision makers throughout Colombia. The group developed training materials on intellectual property and patents, brand-name drugs and generics, anti-retroviral treatments (ARVs) for HIV/AIDS patients, human rights, national drug policies, and best practices for compulsory licensing. They held workshops for leaders from various regions who then disseminated the information to their communities.
Activists worked with Fundación Comunicación Positiva to develop communication strategies and launch a national education campaign. The NGO produced a series of documentary audio programs and a short video covering the evolution of the HIV/AIDS compulsory license & access to medicines campaign in Colombia, 2008-2009.
In April 2008, the health groups sent an open license request to Abbott Laboratories to facilitate generic competition. When Abbott did not respond, in July, they delivered compulsory license request letters to the Superintendency of Industry and Commerce, which houses the patent office, and the Office of the President of the Republic. In addition, they delivered a letter to the Ministry of Health (MoH), requesting a declaration of public interest in access to lopinavir+ritonavir.
The activists faced an uphill battle, since President Uribe’s government favored big business and maintained close ties with Washington. Nevertheless, civil society pressure, in the form of general petitions, meetings with government officials, demonstrations and press led to important changes including major price reductions. The Superintendent for Industry and Commerce issued a decree that clarified the process for a declaration of public interest and confirmed the MoH’s authority to issue a declaration.
While the Ministry did not declare access to Kaletra to be in the public interest at the time, Colombia’s National Medicines Pricing Commission (CNPM) issued Circular 002 in April 2009 to regulate Kaletra’s price. CNPM fixed maximum prices of $1,067 for the public sector and $1,591 for the private sector, representing average price reductions of 54% - 68%. This change was projected to save Colombia’s HIV programs about US$12 million in the first year alone. Abbott flouted the order and kept its prices high.
Additionally, in 2008, INVIMA, Colombia’s drug regulatory authority, suspended applications for generic versions of lopinavir + ritonavir. But Colombia’s laws do not provide for linking drug registration to patent status. Abbott’s influence became clear when, for one of the applications, the drug regulatory body cited a judicial order arising from a legal challenge initiated by Abbott requiring the suspension of the application process.
According to Dr. Rossi, Abbott exerted subtle pressure on the civil society groups’ actions as well. The company reached out to regional organizations, primarily those offering Kaletra, and invited them to join a program that provided discounts and other benefits. As a result, two organizations removed themselves from the compulsory licensing requests and one organization resigned from the working group altogether. Interestingly, Abbott presented this split to the MoH in an effort to undermine the petition for the declaration of public interest. In addition, Abbott organized a national meeting of HIV/AIDS activists in order to establish a rival network to the existing network of HIV/AIDS activists, RECOLVIH. Abbott provided substantial financial aid for related activities and promised to support the development of the network.
On September 16, 2009, Colombian civil society filed a groundbreaking “Acción Popular,” a mechanism under Article 88 of the Colombian Political Constitution to protect collective rights to public health and administrative morality. The lawsuit sought requests that the Superintendent of Commerce and Industry issue an open compulsory license on LPV/r, that Abbott suspend any actions intended to impede health registration, and that INVIMA permit the registration of generic LPV/r, provided applicants satisfy the requirements of quality, bioequivalence and good manufacturing practices.
Meanwhile, the Colombian healthcare system was experiencing grave financial difficulties which led the government to declare a state of Social Emergency. On January 21, 2010, the government assigned new broader price-regulating powers to the national medicines pricing commission through President Uribe’s Decreto 126. The crisis underscored the need for competition and savings on medicines including lopinavir+ritonavir. The decree stated that sanctions could be levied on health services providers if they did not respect pricing regulations. On February 11, Abbott finally agreed to comply with the national pricing regulations.
Following the decree, health groups resubmitted a petition for a declaration of public interest and renewed their petition to the Superintendency of Industry and Commerce for an open compulsory license on lopinavir+ritonavir and other medicines. The letters highlighted three concerns: price, increased use, and system disorder. Even under the government price order, Kaletra’s Colombia price was several times greater than the price for generic lopinavir+ritonavir. Peru, for example, paid just $396 for the generic version of the drug. Meanwhile, the number of people taking Kaletra in Colombia had quadrupled over the past five years. A growing number of patients took Kaletra as a first-line treatment, even though the country’s treatment guidelines listed Kaletra as a second-line drug—raising costs and questions about Abbott’s aggressive marketing practices. High drug costs also contributed to treatment exclusion and stock-outs, exacerbating failures in Colombia’s complex and imperfect health system.
On February 23, 2010, the Archbishop of Bogotá, Cardinal Pedro Rubiano Saenz, wrote to President Uribe in a letter joined by Colombian NGOs and the President of the Colombian Medical Federation, disagreeing with the government’s assertions in Decree 126 that the health system crisis was unforeseeable. The letter asserted that cost burdens had grown consistently since at least 2003, a year after Colombia expanded protection for patent holders (Decree 2085 of 2002). The Archbishop emphasized the role that high cost, patent-monopolized drugs played in contributing to the financial collapse of the healthcare system and urged the government to use three policy tools “inexplicably” left out of the government’s decree: registering generic medicines, compulsory licensing of patents, and parallel importation (shopping on the world market for the best price).
The civil society campaign facilitated a new regulation, Decree 1313 of 2010, which implemented procedures for parallel importation of medicines when the price in Colombia is greater than in other countries. For years, Colombia had all but barred parallel importation through a rule that required would-be importers to obtain the authorization of the manufacturers, against its profit interest (Decreto 677 of 1995). The new rule reinstating parallel importation can help Colombia save costs, defeat pricing abuses and stabilize health system finances.
In February 2012, two and a half years after the start of the “Acción Popular”, the 37th Circuit Court issued a decision agreeing with the health groups’ complaint and declaring that Abbott Laboratories and the MoH threatened and violated collective rights to public health by maintaining the price of Kaletra above the international reference price. This order is a groundbreaking condemnation of pharmaceutical pricing abuses and a precedent for health rights in Colombia.
Nevertheless, the court failed to order remedies that would break Abbott’s monopoly. Parties on both sides—the health groups and Abbott—are appealing this decision to the Supreme Administrative Court. Plaintiffs seek to obtain the global low price of $400 through a compulsory license and subsequent generic competition which could reduce prices further still.
Since 2008, civil society action in Colombia successfully mobilized a pro-competition campaign that has won major cost reductions and new regulations in favor of access to medicines. By exposing industry abuse and highlighting pro-health alternatives, the access movement persuaded even the pro-big business Uribe administration to begin asserting a modest independence from the pharmaceutical industry and tend to society’s healthcare needs.
 Including the Group of NGOs working on HIV-AIDS (Mesa de Organizaciones con Trabajo en VIH SIDA), the Colombian People Living with HIV-AIDS Network (RECOLVIH: Red Colombiana de Personas con VIH), Fundación IFARMA, Misión Salud and Essential Action, the precursor to Public Citizen’s Global Access to Medicines Program.
 The letters were accompanied by appendices and a technical document, approximately twenty pages in length, analyzing potential cost savings, legislation, drug quality, license procedures, human rights and AIDS treatment accords, lopinavir+ritonavir indications, and the medicine's importance to national programs. (see Technical Documents)
 Instituto Nacional de Vigilancia de Medicamentos y Alimentos