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Appendix G. Patients’ empowerment and citizens’ participation

The Committee of Ministers, under the terms of Article 15.b of the Statute of the Council of Europe,

  • Considering that the aim of the Council of Europe is to achieve a greater unity between its members and that this aim may be pursued in particular by the adoption of common rules in the health field;

  • Considering that access to safe health care is the basic right of every citizen in all member states;

  • Recognising that although error is inherent in all fields of human activity, it is however possible to learn from mistakes and to prevent their reoccurrence and that health-care providers and organisations that have achieved a high level of safety have the capacity to acknowledge errors and learn from them;

  • Considering that patients should participate in decisions about their health care, and recognising that those working in health-care systems should provide them with adequate and clear information about potential risks and their consequences, in order to obtain their informed consent to treatment;

  • Recalling that Article 2 of the Council of Europe’s Convention on Human Rights and Biomedicine (ETS No. 164) establishes the primacy of the human being over the sole interest of society or science, and recalling its Article 3 on the equitable access to health care of appropriate quality;

  • Considering that the methodology for the development and implementation of patient-safety policies crosses national boundaries and that their evaluation requires substantial resources and expertise and should be shared;

  • Recalling its Recommendations Nos. R (97) 5 on the protection of medical data, R (97) 17 on the development and implementation of quality improvement systems (QIS) in health care, and R (2000) 5 on the development of structures for citizen and patient participation in the decision-making process affecting health care, and its Resolution ResAP(2001)2 concerning the pharmacist’s role in the framework of health security, which explicitly suggests working in partnership with other health professionals;

  • Noting the relevance of the World Health Organisation (WHO) “Health for All” targets for the European Region (target 2) and of its policy documents on improving health and quality of life and having regard to its Health Assembly Resolution 55.18 (2002) on “Quality of care: patient safety”, which recognises the need to promote patient safety as a fundamental principle of all health systems;

  • Considering that patient safety is the underpinning philosophy of quality improvement and that all possible measures should therefore be taken to organise and promote patient-safety education and quality of health-care education;

  • Considering that the same principles of patient safety apply equally to primary, secondary and tertiary care and to all health professions as well as to health promotion, prevention, diagnosis, treatment, rehabilitation, and other aspects of health care;

  • Recognising the need to promote open co-ordination of national and international regulations concerning research on patient safety,
  • Patients’ empowerment and citizens’ participation


  • See Appendix G (pdf-file) of Recommendation Rec(2006)7 of the Council of Europe


  • NOTE: text markers added to increase readability (not applied in the original).


    1. Policy makers, planners and organisations delivering health care place patients and the public at the centre of delivering safe health care:

    2. Citizens should be able to rely on the safety of their health services. Information should be available to the public about the safety of their health services, together with safety improvement measures.

    3. Patients using health services must have adequate information available, allowing them to include safety considerations when making decisions:

      a. this information should allow patients to balance the risks and benefits of different treatment options;

      b. when asking for the patient’s informed consent, a clinician must explain the risks and benefits of the treatment in terms that the patient can understand;

      c. patients, along with health-care staff, should be involved at an early stage in the design and testing of medical procedures, devices and equipment;

      d. patients should receive information about who is responsible for their treatment, especially when this involves interdisciplinary co-operation, and learn how to establish a positive relationship with health professionals;

      e. patients and relatives should be made aware of their own “risky” behaviour and encouraged to adopted more appropriate habits.

    4. People who have been harmed because of their treatment must be taken care of openly, honestly and with compassion – a transparent communication policy should be followed:

      a. patients must feel able to speak up when they feel that something could go, or has gone, wrong during the course of their treatment;

      b. organisations should have mechanisms to allow patients to report safety incidents to health-care organisations, so that these organisations can learn from what has gone wrong;

      c. these reporting systems should be in addition to the organisations’ complaints procedures;

      d. patients who have been harmed because of their treatment should have the possibility of receiving financial compensation without lengthy legal action.



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