The National Directorate of Medicines (DNM) in El Salvador will have a new Special Law on Service Prices that will have a significant impact on the pharmaceutical industry and related sectors.

This regulation will be effective from January 1, 2024, and aims to strengthen the regulation and control of products such as medicines, cosmetics, hygiene products, chemicals, nutritional supplements, medical devices, and clinical trials, among others.

We spoke with our lawyer and head of the Intellectual Property Department, Fátima Espinal, to get her opinion on this matter.

Increase in Fees and New Charges

One of the characteristics of the law is the increases in fees that the DNM charges to companies related to the mentioned products. The “Annual maintenance fee for market surveillance” is one of the most notable examples, with specific rates for different product categories. Fátima Espinal explains that “they will charge $100 for pharmaceutical products, $35 for cosmetic and hygiene products; $85 for medical devices and other healthcare technologies.”

Gradual Implementation of Fees

To mitigate the immediate financial impact of these changes, the new law establishes a period of gradual transition. This means that companies will have time to adapt to the new fees before they are fully applied. Espinal shares that the fees “will be applied and increased gradually by 50% starting from January 1, 2024, 75% from January 1, 2025, and 100% from January 1, 2026.”

Exemptions and Maintenance Fee

The new law also includes exemptions for certain free health services, as well as procedures related to orphan drugs that are not available in the local market. Additionally, a “maintenance fee” has been introduced, which will be applied to different pharmaceutical products and others. Espinal believes these exemptions are important to ensure that essential services remain accessible.

Impact on the Pharmaceutical Industry

Our expert assures that this new law can have a significant impact on the pharmaceutical industry and its stakeholders, including manufacturers, importers, and distributors. Adapting to the new fees and proper financial planning will be essential for long-term success in this sector.