🇧🇷Brazil

Multa por Violação de Competência Profissional e Risco de Revogação de Alvarás

3 verified sources

Definition

Federal Court in Brasília (TRF-1) suspended CFF Resolution 5/2025 on March 31, 2025, ruling that pharmacists lack legal competency and technical preparation for diagnosis and prescription. The CFM successfully argued that Law 12.842/2013 reserves diagnostic and prescription acts as exclusive medical functions. Pharmacies operating under the suspended resolution face legal challenge and potential license revocation.

Key Findings

  • Financial Impact: Estimated R$ 50,000-200,000 per pharmacy location in compliance remediation, system reversion, and staff retraining. Plus exposure to administrative fines (Lei 6.437/77) for operating without proper competency authorization.
  • Frequency: One-time capital loss from system/process reversion; ongoing legal defense costs if CFM challenges continue.
  • Root Cause: Pharmacies implemented prescription services based on CFF Resolution 5/2025 without anticipating judicial suspension. Federal Court determined Resolution 5/2025 violates Law 12.842/2013 exclusivity clause for medical diagnosis.

Why This Matters

The Pitch: Brazilian retail pharmacies waste operational capital and face regulatory fines by continuing or having implemented pharmaceutical prescription services now invalidated by federal court ruling. Audit and reversion of non-compliant prescription workflows eliminates legal exposure.

Affected Stakeholders

Pharmacy managers, Prescription verification staff, Compliance officers, Finance/IT (system reversion)

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Financial Impact

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Current Workarounds

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

Perda de Capacidade Operacional e Desperdício de Investimento em Sistemas de Prescrição

Estimated R$ 100,000-500,000 per pharmacy network in sunk IT/software costs. Plus 40-80 hours/month of staff capacity previously allocated to prescription verification now unproductive.

Perda de Receita por Serviços de Prescrição Farmacêutica Agora Proibidos

Estimated R$ 5,000-25,000/month per pharmacy location in lost prescription consultation revenue. Annual impact: R$ 60,000-300,000 per location for pharmacy networks.

Erros de Decisão Estratégica Baseados em Regulação Revogada

Estimated R$ 200,000-1,000,000 per pharmacy network in erroneous hiring, system contracts, and service buildout tied to prescription authorization now suspended.

Multa por Violação de LGPD e Privacidade do Consumidor

R$ 8,497,500.00 (confirmed fine); potential industry exposure: R$ 50,000–R$ 3,000,000 per administrative proceeding depending on scale and intent.

Risco de Recusa de Cobertura de Plano de Saúde por Violação de Dados Sensíveis

Per-customer litigation cost: R$ 10,000–R$ 50,000; churn impact: 2–5% customer base loss annually; class action risk: R$ 5,000,000+.

Penalidades por Não-Conformidade ao SNGPC (Portaria 344/1998)

LOGIC-based estimate: Typical ANVISA administrative fines for non-compliance range R$ 5,000–R$ 50,000 per violation; larger networks face R$ 100,000+ for systemic SNGPC failures. Operational costs from license suspensions or revocation: loss of controlled-substance revenue (15–30% of pharmacy revenue), estimated R$ 50,000–R$ 500,000+ per pharmacy per month during suspension.

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