Peru Approves Measures to Facilitate Access to Generic Medicines

By Espinosa Bellido Abogados

In recent years, the limited availability and high cost of certain medicines in Peru have raised concerns regarding equitable access to healthcare. In response, the Peruvian Congress approved Law 4995/2022-CR, which establishes a streamlined approval process for generic medicines originating from countries with recognized high regulatory standards, such as the United States and European Union members. The new framework sets a maximum review period of 45 days by the Dirección General de Medicamentos, Insumos y Drogas (Digemid), significantly shortening the authorization process that previously could extend over several years.

In addition to simplifying regulatory procedures, the government introduced a requirement for private pharmacies to maintain a minimum stock of generic medicines, representing at least 30% of their inventory. This obligation covers a list of over 400 essential medicines and is intended to ensure broader availability for the population, particularly for vulnerable groups.

Generic medicines are pharmaceutical products that contain the same active ingredients, dosage forms, and strengths as brand-name drugs but are typically offered at lower prices. They are introduced to the market once patent protections and other exclusivities on the original products have expired. Generics play an important role in improving access to treatment and managing healthcare costs, while also operating within frameworks designed to protect innovation through intellectual property rights.