This is the question that should guide the analysis.

Ordinance No. 12,011/2026 does not limit negotiation to high-cost medicines. Its scope encompasses various health technologies undergoing incorporation or involved in procurement processes carried out by the Ministry of Health.

The Committee’s role will be particularly significant in cases involving sole suppliers, concentrated markets, or high budgetary impact. While the term “high-cost technology” appears in specific scenarios, it is not a general prerequisite for negotiation.

In practice, the company must examine the situation of each product, rather than merely its regulatory or commercial category.