Compulsory license for the treatment of cystic fibrosis: an urgent step towards universal access

On September 2, various civil society organizations and patient groups submitted a request to the Executive Branch to declare the triple immunomodulatory therapy composed of elexacaftor, ivacaftor, and tezacaftor—marketed under the name Trikafta® and with a patent in force in Peru until 2039—as being in the public interest.

This drug combination has proven to improve significantly the quality of life and survival of up to 90% of patients with cystic fibrosis. However, its high cost constitutes a critical barrier: the Peruvian State has acquired this treatment at a price of S/ 823,032 per patient/year, which has only allowed 12 people to be treated, while more than a hundred remain on the waiting list.

Declaring this treatment of public interest would pave the way to activate the compulsory license mechanism under the modality of government use. This mechanism, provided for in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), would allow the importation of generic versions available from countries such as Argentina at an approximate cost of S/ 162,000 per patient/year. This would represent savings of more than 80% and guarantee the sustainability of treatment for all those who need it.

International experiences reinforce the urgency of this measure. Brazil, Ecuador, and, more recently, Colombia have used compulsory licenses to improve access to medicines. In the case of Colombia, in 2024 a compulsory license was granted for the antiretroviral dolutegravir, achieving a 96% reduction in price and ensuring a sustainable supply of the drug.

The organizations’ request is based on the Political Constitution of Peru, the General Health Law, the Law on Rare and Orphan Diseases, as well as international agreements such as TRIPS, the Doha Declaration (WTO), and Decision 486 of the Andean Community, among others. This legal framework empowers the peruvian government to prioritize the right to health and adopt legitimate measures to protect the life and health of citizens.

The signatory organizations — Los Pacientes Importan, Acción Internacional para la Salud (AIS-Peru), GIVAR with the support of Public Citizen and Innovarte NGO — stress that the Peruvian government has the obligation to guarantee the continuity and sustainability of treatment for people with cystic fibrosis. With this measure, Peru would join the list of countries that have already applied compulsory licenses to ensure access to high-cost medicines, reaffirming the principle that health and life take precedence over commercial interests.