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Biologics Compliance Guide for Brazil

This is a compliance guide for clinics that want to operate in Brazil

Key Pieces of Legislation:

1. ANVISA Regulations and RDC 214/2018

This regulation defines the rules for "advanced therapies," including stem cell treatments. Stem cells are categorized into:

Class I: Minimally manipulated products (e.g., autologous cells used for the same purpose within the body).

Class II: Substantially manipulated products, including tissue engineering and gene therapies. These require more stringent clinical trial approval before use in patients.


2. Clinical Trials and Authorization

Treatments involving substantially manipulated or non-homologous use of stem cells must undergo clinical trials approved by ANVISA. Some products can receive conditional marketing authorization based on safety and efficacy data collected during these trials.


3. Ethical Considerations

Brazilian law mandates that all biological materials, including cells used in therapies, must be donated voluntarily and cannot be commercialized. The use of stem cells follows strict bioethical principles, focusing on preventing unregulated treatments.


4. Compliance with Local and International Standards

ANVISA's framework aligns with the regulatory models of the European Union, Japan, and the U.S., though adapted to the Brazilian research and healthcare environment. The focus includes lifecycle monitoring, ensuring the quality, safety, and efficacy of treatments from development through patient use.


5. Compliance Checklist
  • Confirm compliance with the Brazilian National Health Surveillance Agency (ANVISA) regulations regarding stem cell therapies.
  • Ensure adherence to Law No. 11.105/2005, which regulates biosecurity and the use of biological materials in Brazil.

Patient Informed Consent:

  • Obtain informed consent from the patient, detailing the nature of the treatment, potential risks, and benefits.
  • Confirm that consent forms meet legal standards and are written in clear language understandable to the patient.

Source of Stem Cells:

  • Ensure that stem cells are obtained from legally approved sources, such as:
  • Umbilical cord blood banks authorized by ANVISA.
  • Autologous sources where patients use their own cells.
  • Verify that any donor consent complies with Brazilian laws regarding organ and tissue donation.

Ethical Oversight:

  • Submit treatment protocols for approval to an Institutional Review Board (IRB) or Ethics Committee recognized in Brazil.
  • Ensure compliance with ethical standards outlined by the National Health Council (CNS) and Brazilian Federal Medical Council (CFM).

Clinical Protocols:

  • Follow established clinical protocols that are evidence-based and recognized in the medical community.
  • Ensure that the treatment does not exceed the scope of what is legally permitted by Brazilian law.

Record Keeping:

  • Maintain comprehensive medical records that document:
  • Patient assessments and eligibility.
  • Informed consent processes.
  • Sourcing and administration of stem cells.
  • Ensure records are kept confidential and secure as per the General Data Protection Law (LGPD).

Safety Monitoring:

  • Implement monitoring protocols to observe and report any adverse effects following treatment.
  • Establish follow-up care procedures to ensure patient safety and address any complications.

Advertising Compliance:

  • Ensure any advertising for stem cell therapies complies with CFM regulations, avoiding misleading claims.
  • Clearly communicate the experimental nature of treatments if applicable.

Collaboration and Reporting:

  • Collaborate with other healthcare professionals and institutions as necessary to provide comprehensive care.
  • Report any serious adverse events to ANVISA and other relevant authorities per Brazilian regulations.

Continuous Education and Legal Consultation:

  • Stay informed about updates in Brazilian laws, regulations, and ethical guidelines related to stem cell therapy.
  • Consult with a legal expert specializing in healthcare law in Brazil to ensure ongoing compliance.


6. Who can administer

Only qualified medical professionals authorized by ANVISA and affiliated with professional medical councils can administer these treatments. The therapies fall into two categories: conventional (e.g., bone marrow transplants) and advanced therapies (e.g., gene therapy, manipulated stem cells). Clinics must meet ANVISA’s quality, safety, and efficacy requirements, and therapies must align with Good Cell Practices and relevant medical ethics guidelines​


6. Litigation Trends

Lawsuits against clinics have typically focused on false advertising, harm from unapproved treatments, or lack of proper medical oversight. While specific cases involving stem cells have been mentioned in news sources, these disputes are often centered around whether the clinics followed the stringent guidelines laid out by ANVISA and CONEP. In cases where clinics advertised experimental therapies as fully approved treatments, patients have initiated legal actions, with courts scrutinizing the clinics’ compliance with regulatory frameworks.

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