Imatinib, a drug used to battle some forms of cancer such as leukemia was recently declared of public interest, after the Colombian Ministry of Health and Social Protection signed the corresponding bill.

This decision is a response to a request submitted in 2014 by the Universidad Nacional de Colombia (UNal) Drug Information Center (CIMUN, for its Spanish acronym), the Ifarma Foundation and Misión Salud, who on behalf of civil society requested that the drug be labeled as such due to its high cost for the health system.

According to Department of Pharmacy Professor and CIMUN Director Julián López, the petition alerted that the drug had entered the Colombian market in a free-competition context. This due that in 2003 the Colombian Superintendence of Industry and Commerce denied the patent for Imatinib to Novartis, because it considered it with low inventive level and reduced contribution to therapeutics and technology, as it simply had a different crystallization form.

However Novartis sued and the case reached the Council of State and compelled the Superintendence to grant the patent, making treatment with Imatinib for patients to be in the order to COL $47.540.160 (US $15.966)

“This was slowing the competition in the market and wearing down our health system, which is already void of resources, with mechanisms that are not the most appropriate,” said López.

Therefore Alejandro Gaviria, the Colombian Minister of Health announced that after a couple of years of assessments, the drug complied with all the requirements for being pronounced as of public interest.

The bill authorizes manufacturing a generic drug, enabling free competence. Later the Colombian Commission on Drug Prices will be in charge of placing a price which could diminish the current price between 40 and 50%.

This means other pharmaceuticals, besides Novartis could market the drug, and which according to figures of the Medical Federation’s Drug Observatory, the system could save COL $31.000 million (US $10.41 million) a year.

“This is a historic measure, as this is the first time that due to a civil society request, the government establishes a public interest declaration. Although the government took the decision it was made possible thanks to the request of several industry organizations,” said López.

Lopez also congratulated the Ministry for its commitment with the health of the Colombian population, as this decision will undoubtedly improve the quality of life of many people. However, he did alert of the situation of other drugs which up to now have been subjected to commercial treaties and interests of huge multinational companies.

Imatinib is the first drug of a series of drugs specifically engineered to treat chronic myeloid leukemia, a form of cancer which comes from blood forming cells in the bone marrow. Compared to other cancer drugs, patients often have a better response.

The concerns

However former UNal Professor Saúl Franco, who currently supports the UNal doctorate Inter-Faculties Public Health program, has some objections to the official announcement.

One of these objections is that the battle was centered on declaring the drug of public interest with the purpose of a compulsory license, not a price control battle. He also said declaring an obligatory license falls under the realm of the Superintendence of Industry and Commerce, an agency which has expressed its reluctance on the subject. He also questioned if Novartis had already denied the agreement to reduce prices, who will warrant they will submit to the prices assigned by the Ministry of Health?

If Novartis persists on not accepting price regulations, the mortal victims of the lack of supply will be the patients,” said Franco.

Breaking the monopoly with quality generic drug competition should not be a heroic decision of a solitary minister is state, but a public health policy and national dignity of the whole government, including the Superintendence,” said López.

Agencia de Noticias UNAL |