Guest Post: Nine Mandatory Licences Allow Greater Access To Medicines In Ecuador

By Maria Augusta Alvarez Moreno

What is a mandatory licence? Mandatory (compulsory) licences are a legal remedy within the intellectual property flexibilities provided by the World Trade Organization allowing a government to grant permission to third parties to produce a patented product or use a patented process without the consent of the patentee, in order to address a priority status for the country.

Ketty Véliz, patent coordinator of the Ecuadorian Institute of Intellectual Property (IEPI), said that “with the patent we give a monopoly for 20 years and when an invention has a patent, prices are high. Pharmaceutical patents are a very sensitive area because they limit access to medicines.”

In 2009, in order to achieve greater public access to medicines, the Government of Ecuador, by Executive Decree Number 118, declared of public interest the access to medicines, a declaration that allows domestic and foreign laboratories based in the country to solicit mandatory licensing of patented drugs to produce and market them nationally.

Mandatory Licences in Ecuador

At present, IEPI has 32 applications for mandatory licences pending, some of which have been denied, others have abandoned and nine have been issued for the production of drugs in widespread use. The first three licences were issued for antiretrovirals: Ritonavir, Lamivudine and Abacavir, which are drugs that the Ministry of Public Health provides as free treatment to patients suffering from HIV / AIDS.

According to the data handled by IEPI, these licences are issued on the basis that in Ecuador there are about 37,000 infected patients with the virus and approximately 700 recorded annual deaths from this disease. According to this information, as a result of the application of mandatory licences, savings of between 30 and 70 percent have been achieved for the Ministry of Public Health in buying these medicines, which must be provided by the state.

According to Ketty Véliz, “The idea is, as an example, that if previously five million dollars were used so that a hundred thousand people could have access to medicines, now with the same investment of five million, two hundred thousand people could be serviced, in other words, granting a higher percentage of the population access to medicines.”

In addition to the licences issued for antiretroviral drugs, subsequently licences were issued for: Etoricoxib (Arcoxia), a drug proven effective for the treatment of diseases with severe pain; Mycophenolate Sodium (Myfortic), a drug used in the treatment of kidney transplant recipients; Etoricoxib, the only commercial licence granted in Ecuador, meaning that its production may be acquired directly by the people; Sunitinib, an anti-cancer drug used for the treatment of renal cell carcinoma (RCC) and gastrointestinal stromal tumors (GIST); and finally, Certolizumab, used to counter rheumatoid arthritis.

With regard to the last licence, Véliz said it is the first licence issued in biotechnology as well as being the first to treat rheumatoid arthritis. “To issue this licence is to break barriers,” she said.

Mandatory Licensing of Domestic Production

In 2009, with the aim of carrying out scientific research and development of active ingredients for creating generic drugs at lower cost, the public pharmaceutical company ENFARMA was created. Its mission is to contribute to an increased percentage of the population so that they may have access to drugs that serve in the treatment and cure of their diseases.

Of the 32 applications for mandatory licences that are pending in the IEPI, nine have been submitted by the public company ENFARMA. Of the nine licences granted, two were issued to this lab: Sunitinib and most recently, Certolizumab.

Thus, with the issuance of mandatory licences, the National Government aims to ensure that in addition to a significant reduction in drug prices, the domestic pharmaceutical industry is strengthened and allowed in the future to replace the largest possible amount of medicines that are imported.

Maria Augusta Alvarez Moreno is a journalist with ANEPI, Agencia de Noticias Especializada en Propiedad Intelectual. This article was translated from the original in Spanish.

Image Credits: Photo courtesy of Erich Ferdinand Flickr Creative Commons License 2.0