COPLAC – Estatuto dos Direitos do Paciente no Brasil: perspectivas de aplicação nos serviços de saúde

O webinar focou no Estatuto dos Direitos do Paciente no Brasil e sua conexão com uma “revolução do paciente” mais ampla, descrita como uma mudança global rumo ao cuidado focado no paciente, empatia clínica, segurança, tomada de decisão compartilhada, direitos dos pacientes, alfabetização em saúde e participação do paciente e família. Os palestrantes enfatizaram que os direitos dos pacientes têm origem nos direitos humanos e devem ser traduzidos em leis concretas, políticas públicas, protocolos e práticas institucionais para que tenham efeito real no cuidado diário.

Aline Albuquerque explicou que o estatuto brasileiro surgiu de um processo de dez anos envolvendo acadêmicos, sociedade civil, organizações de pacientes e associações profissionais, e que reflete uma mudança de paradigma do cuidado centrado na doença ou profissionais para o cuidado centrado no paciente. Ela destacou a vulnerabilidade do paciente, a importância da autonomia relacional e a necessidade de colaboração ética entre profissionais, pacientes e famílias. Ela também listou os direitos abrangidos pelo estatuto, incluindo representação, companhia, cuidados seguros e de qualidade, não discriminação, participação em decisões, informações, consentimento informado, recusa, prontuários médicos, confidencialidade, segunda opinião, diretivas antecipadas, cuidados paliativos e direitos em pesquisa clínica.

Cláudia Matias focou na implementação nos serviços de saúde, ressaltando que o estatuto sozinho não é suficiente sem mudança cultural, compromisso de liderança, treinamento e estruturas organizacionais que apoiem os direitos dos pacientes. Ela descreveu ferramentas práticas como gestão documental, autoavaliação, reuniões de segurança, rodadas de liderança, educação de pacientes e famílias e serviços de ouvidor, com uma abordagem restaurativa e de resolução de problemas. Ela também enfatizou que pacientes e famílias devem ser tratados como parceiros, que as reclamações devem ser bem-vindas e resolvidas, e que o estatuto deve ser integrado à governança e às rotinas diárias, em vez de ser tratado apenas como um documento formal.

Na discussão, os palestrantes abordaram questões sobre outras experiências latino-americanas, a judicialização e como envolver pacientes e famílias de forma mais eficaz. Eles argumentaram que as leis de direitos dos pacientes podem reduzir litígios quando acompanhadas por mecanismos de resolução de conflitos, sistemas abertos de reclamações e participação genuína no cuidado. O webinar foi encerrado reforçando que implementar os direitos dos pacientes é um processo cultural contínuo voltado para melhorar a qualidade, a segurança e o respeito na saúde.

Se você perdeu a sessão ao vivo, uma gravação está disponível na biblioteca de recursos da ISQua – https://login.isqua.org/resources/coplac-estatuto-dos-direitos-do-paciente-no-brasil-perspectivas-de-aplicacao-nos-servicos-de-saude. Observe que você deve fazer login como convidado ou membro da ISQua para acessar este conteúdo.

El seminario web se centró en el Estatuto de Derechos del Paciente en Brasil y su conexión con una “revolución del paciente” más amplia, descrita como un cambio global hacia una atención centrada en el paciente, la empatía clínica, la seguridad, la toma de decisiones compartida, los derechos del paciente, la alfabetización en salud y la participación de pacientes y familias. Los ponentes enfatizaron que los derechos del paciente se originan en los derechos humanos y deben traducirse en leyes concretas, políticas públicas, protocolos y prácticas institucionales para tener un efecto real en la atención diaria.

Aline Albuquerque explicó que el estatuto brasileño surgió de un proceso de diez años que involucró a académicos, sociedad civil, organizaciones de pacientes y asociaciones profesionales, y que refleja un cambio de paradigma que se aleja de la atención centrada en la enfermedad o en los profesionales hacia una atención centrada en el paciente. Destacó la vulnerabilidad del paciente, la importancia de la autonomía relacional y la necesidad de una colaboración ética entre profesionales, pacientes y familias. También enumeró los derechos cubiertos por la ley, incluyendo representación, compañía, atención segura y de calidad, no discriminación, participación en decisiones, información, consentimiento informado, negativa, historiales médicos, confidencialidad, segunda opinión, directivas anticipadas, cuidados paliativos y derechos en la investigación clínica.

Cláudia Matias se centró en la implementación de los servicios de salud, subrayando que el estatuto por sí solo no es suficiente sin un cambio cultural, compromiso con el liderazgo, formación y estructuras organizativas que respalden los derechos de los pacientes. Describió herramientas prácticas como la gestión documental, la autoevaluación, reuniones de seguridad, rondas de liderazgo, educación para pacientes y familias, y servicios de defensores del pueblo con un enfoque restaurativo y de resolución de problemas. También subrayó que los pacientes y las familias deben ser tratados como socios, que las quejas deben ser bienvenidas y resueltas, y que el estatuto debe integrarse en la gobernanza y las rutinas diarias en lugar de tratarse solo como un documento formal.

En la discusión, los ponentes abordaron preguntas sobre otras experiencias latinoamericanas, la judicialización y cómo involucrar a pacientes y familias de forma más eficaz. Argumentaron que las leyes de derechos del paciente pueden reducir los litigios cuando van acompañadas de mecanismos de resolución de conflictos, sistemas abiertos de quejas y una participación genuina en la atención. El seminario web concluyó reforzando que la implementación de los derechos de los pacientes es un proceso cultural continuo orientado a mejorar la calidad, la seguridad y el respeto en la atención sanitaria.

Si se perdió la sesión en vivo, hay una grabación disponible en la biblioteca de recursos de ISQua - https://login.isqua.org/resources/coplac-estatuto-dos-direitos-do-paciente-no-brasil-perspectivas-de-aplicacao-nos-servicos-de-saude. Tenga en cuenta que debe iniciar sesión como invitado o miembro de ISQua para acceder.

The webinar focused on the Patient Rights Statute in Brazil and its connection to a broader “patient revolution,” described as a global shift toward patient-centred care, clinical empathy, safety, shared decision-making, patient rights, health literacy, and patient and family participation. The speakers emphasised that patient rights originate in human rights and must be translated into concrete laws, public policies, protocols, and institutional practices to have a real effect in daily care.

Aline Albuquerque explained that the Brazilian statute emerged from a ten-year process involving academics, civil society, patient organisations, and professional associations, and that it reflects a paradigm shift away from care centred on disease or professionals toward care centred on the patient. She highlighted the patient’s vulnerability, the importance of relational autonomy, and the need for ethical collaboration between professionals, patients, and families. She also listed the rights covered by the statute, including representation, companionship, safe and quality care, non-discrimination, participation in decisions, information, informed consent, refusal, medical records, confidentiality, second opinion, advance directives, palliative care, and rights in clinical research.

Cláudia Matias focused on implementation in health services, stressing that the statute alone is not enough without cultural change, leadership commitment, training, and organisational structures that support patient rights. She described practical tools such as document management, self-assessment, safety huddles, leadership rounds, patient and family education, and ombudsman services with a restorative, problem-solving approach. She also emphasised that patients and families should be treated as partners, that complaints should be welcomed and resolved, and that the statute should be integrated into governance and daily routines rather than treated solely as a formal document.

In the discussion, the speakers addressed questions about other Latin American experiences, judicialization, and how to more effectively involve patients and families. They argued that patient rights laws can reduce litigation when they are accompanied by conflict-resolution mechanisms, open complaint systems, and genuine participation in care. The webinar closed by reinforcing that implementing patient rights is an ongoing cultural process aimed at improving quality, safety, and respect in health care.

If you missed the live session, a recording is available through ISQua’s resource library – https://login.isqua.org/resources/coplac-estatuto-dos-direitos-do-paciente-no-brasil-perspectivas-de-aplicacao-nos-servicos-de-saude. Please note that you must log in as an ISQua Guest or ISQua member to access this.


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Nourhan Kawtharani


Nourhan, a quality and safety coordinator with eight years of experience in ambulatory healthcare in Lebanon, aims to deepen her understanding of the systemic and holistic approach to healthcare through this fellowship.

She aims to identify gaps and develop tailored interventions that address specific contexts rather than applying general solutions. Engaging with diverse professionals and perspectives during this educational journey will expand the application of these concepts across different cultural settings.

Nourhan emphasizes the importance of promoting a culture of continuous learning and improvement within healthcare institutions, considering it a vital leadership responsibility to integrate quality and safety initiatives into the organizational culture.

Nourhan's commitment to patient safety and quality management includes sourcing practical resources and transforming insights into actionable knowledge to drive continued progress in healthcare practices and outcomes.

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Elom Otchi


Elom is passionate about improving quality of care and patient safety outcomes.

In view of this, he has had the opportunity to work in various capacities with various organisations including AfIHQSA, WHO, UNICEF and others undertaking research, supporting the development of national quality policies and strategies, facilitating the establishment of quality governance systems across all the levels of the health sector and building capacity of national and sub-national quality leads/teams to institutionalize the practice of quality and patient safety across the continent.

He has also worked extensively across all levels of care in the health sector of Ghana, including leading the Quality & Patient Safety program in its largest teaching hospital.

I would like to use this Fellowship as a learning platform and an opportunity to acquire the requisite knowledge, skills and competencies to complement ongoing efforts by like-minded individuals and organizations to continuously advance improve the quality and patient safety in Ghana and the continent.

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Stephen Taiye Balogun


Stephen is a Senior Programme Officer at the Institute of Human Virology in Nigeria as well as Country Representative for Health Information for All (HIFA).

Stephen plans to use this opportunity to maximise his impact by championing the cause of patient safety and quality in Nigeria and across Africa.

Stephen says "Quality and safety is a major wheel through which universal healthcare coverage can be achieved. The goal is to be a bridge in the gap between the International Quality Improvement and Patient Safety community and my country to ensure rapid spread, adoption, implementation and practice."

We are looking forward to working with both Stephen and our 2020 winner Rhoda Kalondu over the next year.

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Dr Rhoda Kalondu


Rhoda is the Head of the Patient Safety Unit at Kenyatta Hospital in Nairobi and wants to use this Fellowship to learn how to establish a culture of safety and develop systems for assessment and analysis at her institution, and more widely. As well as this, Rhoda intends to develop and execute an intervention to improve patient safety in Kenyatta National Hospital.

It is one thing to institute measures and processes for improvement, but quite another to change the culture of an environment. Rhoda's ambition to lead others in this change inspired the panel.

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Dr Subhrojyoti Bhowmick


I am an MBBS graduate from Calcutta University with a Gold Medal in Gynecology & Obstetrics.

I have completed M.D in Pharmacology from IPGME& R, Kolkata and have over 12 years of experience in the field of Clinical Research, Pharmacovigilance and Medication management in Hospitals.

I have completed certification in Clinical Research Administration & Project Management from Stanford University, USA and in Patient Safety from Johns Hopkins University, USA.

I am an Assessor for National Accreditation Board for Hospitals & Health care providers (NABH), India assessing hospitals for medication safety and clinical quality standards and NABH Assessor for Ethics Committee Accreditation program in India as well.

I serve as the Chairperson, Institutional Ethics Committee of Health Point Hospital, Kolkata and am associated with 2 other Hospital ethics committees as a member.

I finished my Fellowship in Healthcare Quality from the International Society of Quality in Healthcare (ISQua) from Ireland in 2017.

I have published several research articles and have also authored a chapter on “Regulations governing Clinical Trial” in the book “Fundamentals of Clinical Trial & Research”.

I am a peer reviewer for prestigious international journals like the British Journal of Clinical Pharmacology, CNS Drugs and Drug Safety case reports.

I am the recipient of the UK Seth Oration Award for Best Clinical Pharmacology paper by the Indian Pharmacological Society in 2009 and the “Most promising Healthcare professional in Patient Safety in India” award by the Asian African Chamber of Commerce and Industry in October 2018.

Recently in April 2019, I received the Young Quality Achiever award by Consortium of Accredited Healthcare Organizations (CAHO), India for 2019 for my work in the field of medication safety and clinical research.

I have a keen interest in teaching and am visiting adjunct faculty of Pharmacology at KMC, Mangalore, India and for Healthcare technology at MAKAUT, Kolkata, India.

I was associated with Stanford University School of Medicine, in the USA as a Senior Clinical Research Associate from 2015 to 2017 and have certification in Biostatistics, Evidence-based Medicine and Medical Writing from Stanford University.

Currently, I am working as the Clinical Director of Academics, Medical Quality and Clinical Research at Peerless Hospital and B K Roy Research Centre, Kolkata.

I am very happy and thrilled to receive the prestigious ISQua Lucian Leape Patient safety Fellowship Award for 2019 and I look forward to honing my skills further in the field of healthcare quality and patient safety through my experiences during this fellowship.

I sincerely believe that successful completion of this fellowship will help me evolve as a more confident Patient safety leader in India who in turn can provide significant inputs on policy changes through NABH for the Indian healthcare system.

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