Exploring patient participation in reducing health-care-related safety risks

CoE
Recommendation 2006/7 of the CoE outlines a comprehensive policy to improve
patient safety (11) starting from the viewpoint that access to safe health care is the basic
right of every citizen in all Member States. The recommendation states that patients
should participate in decisions about their health care and recognizes that they should
receive adequate and clear information about potential risks and their consequences to
ensure informed consent to treatment. It is accompanied by an extensive appendix that
provides a full technical and scientific background and rationale. The main legal features
in the field of patient safety and patients’ rights are set out in Annex 1 of this report.
The recommendation emphasizes the importance of protecting patients’ rights. It
promotes a comprehensive approach, including not only an adverse event reporting
system, but also a fair and open complaints system, a just and adequate compensation
system and an efficient and reliable supervisory system.
EU
The EU is engaging with a range of areas to facilitate improvement of patient safety
(12). It has been regulating health care aspects of the safety of blood, tissues and
cells over many years. More recently, patients’ and health professionals’ right to free
movement has generated patient safety concerns at EU level.
The Council of the EU expresses a general view on patient safety in the EU context in
its 2009 recommendation on patient safety and prevention and control of HAIs (7). The
recommendation focuses on empowering and informing citizens and patients by:
» involving patient organizations and representatives in developing policies and
programmes on patient safety at all appropriate levels;
» disseminating information to patients on patient safety standards and measures in
place to reduce or prevent errors and harm (including best practice and the right to
informed consent to treatment) to facilitate patient choice and decision-making;
» outlining complaints procedures and available remedies and redress and the terms
and conditions applicable; and
» developing core competences in patient safety describing the knowledge, attitudes
and skills required to achieve safer care for patients.
Annex 1 sets out some specific features of the EU recommendation.
WHO
The draft guidelines for adverse event reporting and learning systems (10) is the
WHO document most relevant to legal aspects of patient safety and participation. This
document, produced in 2005 by the World Alliance for Patient Safety, can be seen as a
means to implement World Health Assembly resolution WHA55.18 on quality of care
and patient safety (9). It focuses specifically on the role of reporting adverse events in
enhancing patient safety (10):
In seeking to improve safety, one of the most frustrating aspects for patients and professionals
alike is the apparent failure of health care systems to learn from their mistakes. Too often
Patients’ rights and patient safety
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