Clinical Research Law: regulation boosts pharmaceutical sector in Brazil

The overturning of the vetoes Clinical Research Law (Law No. 14.874/2024) marks a new moment for science and the health industry in Brazil. The new legislation, sanctioned in 2024, guarantees clear rules, legal certainty and encourages investment in clinical trials with human beings.

This change strengthens the role of the Anvisa as a regulator and creates a more competitive and attractive environment for companies operating in the sector. supply and logistics of medicines for clinical research.

What is the Clinical Research Act?

A Clinical Research Law establishes a legal framework that defines how clinical studies on human beings should take place. Before its creation, Brazil based these activities solely on resolutions from the Anvisa and the National Health Council. As a result, there was legal uncertainty and delays in approving new studies.

With the new law, researchers, sponsors and volunteers gain more clarity about rights, duties and responsibilities. In this way, the country is aligned with international standards and is attracting more multicenter studies and foreign investment.

Which vetoes were overturned?

During the presidential sanction, two vetoes removed points considered essential by the scientific community. However National Congress overturned both, restoring the legal text to its original and balanced form:

1. Article 24, §3 - It required research with indigenous people to be reported to the Public Prosecutor's Office. Congress considered the measure excessively bureaucratic and unnecessary in already regulated ethical contexts.
2. Article 33, VI - It limited the free supply of post-study drugs to just five years. With the overturn, patients will continue to receive treatment for as long as there is a proven benefit.

These changes therefore promote both protection of study participants regarding the continuity of care after the end of the research.

How does the Clinical Research Act impact the pharmaceutical sector?

The new regulation creates favorable conditions for the growth of companies in the pharmaceutical sector, especially those involved in clinical research. Among the most relevant impacts are:

• Increase in the number of clinical trials approved by Anvisa;
• Growth in demand for suppliers of medicines for research;
• Expansion of specialized pharmaceutical logistics, with traceability and temperature control;
• Need for companies with the structure to carry out imports under special arrangements and safe, technical deliveries.

As a result, companies like FIC Company, which already operate with excellence in this segment, are gaining prominence and increasing their relevance on the national and international stage.

More competitiveness for Brazil in the health sector

By guaranteeing Modern Clinical Research Law, Brazil is taking an important step towards strengthening its position in the global market. Countries wishing to attract investment in health and innovation need to demonstrate legal certainty, ethics and regulatory efficiency - and that's exactly what the new law delivers.

In addition, the Anvisa becomes more efficient, with defined deadlines and transparent criteria for analyzing and approving clinical studies. This directly benefits patients, researchers and society in general.

Access the full Clinical Research Law

A Law 14.874/2024 is available to read on the Planalto website.
👉 Click here to access the official text of the law

Real impacts and next steps for the sector

The final approval of the Clinical Research Law represents a regulatory milestone for Brazil. The legislation makes the country more competitive, attracts investment in health and innovation and strengthens the role of companies specializing in the supply of medicines for clinical studies.

In addition, overturning the vetoes reinforces the commitment to ethics, continuous patient care and the trust of international sponsors. So now is the ideal time for the pharmaceutical sector to adapt, invest and grow.