September, 16

The Government of Uruguay has issued a public call for individuals interested in obtaining a license that allows for the importation, sale, and commercialization of a high-cost medication used in patients with cystic fibrosis.

The drug is a combination of three modulators (tezacaftor/ivacaftor in combination with elexacaftor) that has proven effective in treating this condition, as it improves the quality of life for patients. So far, the only supplier of the drug in Uruguay is Laboratorio Scienza, which represents the patent holder, Vertex Pharmaceuticals Incorporated, in the country.

Cystic fibrosis is a rare, complex, multisystem genetic disease that primarily affects the respiratory tract and the pancreas. Morbidities include progressive obstructive lung disease with bronchiectasis, frequent hospitalizations due to lung disease, recurrent bronchitis, sinusitis, pancreatic insufficiency, malnutrition, and male infertility.

Currently, this medication is not included among the benefits of Uruguay’s National Fund for Resources (FNR), and patients access it through court rulings via protective actions, similar to what happens in Chile.

The Uruguayan state, in compliance with court rulings, provides care for about 80 patients with cystic fibrosis. Since 2023, $22 million has been allocated to comply with judicial rulings resulting from various protective actions for cystic fibrosis treatments. Meanwhile, in Chile, only in the first quarter of 2024—according to reports sent to the National Congress—Fonasa has allocated $22,448,783 million from its budget to cover the purchase and administration of high-cost drugs obtained through judicial means across the country. This is a significant amount, considering that throughout 2023, $32,679,215,779 was executed for this same item.

In this regard, the Government of Uruguay considers it a “highly sensitive treatment for the population it targets, which must be provided throughout the patients’ lives, in order to safeguard the right to health.” The potential inclusion of the drug in the National Fund for Resources (FNR) could only occur with a significant reduction in its price, something that has not been achieved so far in negotiations with the supplier. Therefore, “due to the public interest at stake,” the government has made an open call for interested parties to obtain a license for the importation, sale, and commercialization of the triple combination therapy consisting of the three modulators.

To adopt this measure, the government of Uruguay relied on Article 55 of Law No. 17,164, which empowers the Executive Branch to grant compulsory licenses or other uses without the patent holder’s authorization in special situations that may affect the general interest, national defense or security, economic, social, and technological development of certain strategic sectors for the country, as well as in cases of health emergencies or other circumstances of public interest. Furthermore, the World Trade Organization (WTO) recognizes each state’s right to take measures to protect, among other aspects, public health, the economy, defense, or national security.

The granting of compulsory licenses is foreseen and regulated in international intellectual property agreements through the Paris Convention for the Protection of Industrial Property, Law Decree No. 14,910 of 1979, and in the Agreement on Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization (WTO), according to Law No. 16,671 of 1994.

Based on these legal provisions, the government has announced a call for interested parties to obtain the license for 20 business days, while also creating an Interministerial Commission to advise the Executive Branch on the matter, consisting of representatives from the FNR and the ministries of Economy and Finance, Public Health, and Industry, Energy, and Mining.

These measures reflect good public health management that could also be replicated in Chile for the Trikafta therapy.