Colombia says no to Kaletra compulsory licence

Scrip News
By Francesca Bruce

The Colombian government will not be declaring Abbott’s antiretroviral Kaletra (lopinavir plus ritonavir) to be of public interest, leaving the patent on the product intact until 2016. Civil society has accused the government of putting politics first.

The decision comes soon after the government set a price ceiling for Kaletra (scripnews.com, May 13th, 2009). NGOs had been pushing for the government to declare the drug to be of public interest and to issue a compulsory licence, claiming that Kaletra’s high price barred access to the drug (scripnews.com, July 29th, 2009). However, the government rejected this, largely on the grounds that all patients who required Kaletra were covered by some sort of health insurance and did not have to pay for the medicine. This was also one of the main arguments put forward by Abbott, according to the government in its justification for the decision.
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Antiretrovirals (ARVs) are included on Colombia’s essential medicines list, and all health insurers – public and private – must offer these drugs. However, in Colombia there is no single ARV purchaser and different public and private institutions compete within the national health system. This leads to wide price discrepancies throughout the country, say civil society organisations.

The cost of the drug creates barriers to access, while having health insurance does not automatically give access to the ARV, maintains RECOLVIH, which represents the organisations petitioning for a compulsory licence. For example, problems arise when HIV/AIDS patients lose their jobs and also when there are delays in provision. The high level of stigma and bureaucracy involved in accessing ARVs can also deter patients from following their regime.
The government also went on to say that the main problems hindering access were to do with failures within the health system, including reaching vulnerable populations or providing adequate diagnosis. Such issues did not merit declaring the drug to be of public interest, it said.

Added to this, the financial impact of declaring the drug to be of public interest was unclear and difficult to calculate, the government said. However, this was poor reasoning, Peter Maybadurk, a spokesperson for the NGO Essential Action, told Scrip. “The government has decided not to save more money, but to protect Abbott’s monopoly,” he said. Although RECOLVIH estimates that the price ceiling will save the government around $10 million each year, greater savings could have been made through introducing competition, he said. “Competition could lead to even lower prices, which could free up more resources to eliminate other barriers,” he added. RECOLVIH accuses the government of ignoring societal needs and basing its decision on politics. Colombia is in the middle of negotiating a free trade agreement with the EU, alongside Peru and Ecuador. It is also waiting for the US to ratify a bilateral FTA.

Moreover, the civil society groups behind the move were not given the chance to participate in the process, said Mr Maybadurk. “During the whole process, which began a year ago, the government never allowed HIV/AIDS patients to participate in the negotiation process to arrive at the price recently negotiated,” says RECOLVIH. Abbott’s involvement in the process is unclear.

Abbott declined to comment. Kaletra is patented in Colombia until December 2016. INVIMA, the medicines regulator, rejected applications from Ranbaxy and Focus Pharmaceuticals to register generic versions of the combination product.