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Appendix J. Legal framework
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,
Legal framework
See Appendix J (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. Legislation constitutes one of the most important regulatory mechanisms in health care, but the diversity of existing legal traditions and practices in Europe calls for a country-specific approach.
2. Member states shall consider the following elements:
a. Legal approaches regarding a patient safety reporting system should:
i put in place national and local policies and mechanisms enabling a timely and explicit assessment of the nature of the incident:
- what must be reported and to whom;
- what can be reported;
- what kind of incidents should be reported in the context of the reporting system;
ii. oblige all providers of health-care services – both public and private – to receive, record and analyse reports on patient-safety incidents for use in the improvement of patient safety and treatment;
iii. ensure that reports on patient-safety incidents, which may be attributed to specific individuals, can be exchanged within the group of people who locally handle tasks pursuant to paragraph ii. above;
iv. ensure that reports on patient-safety incidents can be passed on to clinical databases and other registers where health information is recorded with a view to increasing documentation and improving quality in the area of patient safety;
v. comply, as regards approaches under paragraphs iii. and iv., with professional-secrecy and data-protection rules, for example by providing the information in a register in an anonymous form;
vi. ensure the confidentiality of the reporting procedure, that is, ensure the identity of the reporting health-care professional or patient shall not be disclosed to patients or to the public; if the event is to be analysed and learned from, the names of the personnel involved may need to be known locally (that is, inside the actual institution);
vii. ensure the legal protection of the reporting health-care professional, that is, ensure that a health-care professional reporting to the system shall not, as a sole result of such reporting, be subjected to disciplinary investigation or measures by the employing authority, or reprisals such as supervision or criminal sanctions by the courts;
viii. not, as regards the questions of when, by whom and how the reporting is to be done, be a matter of free choice or open to random decision making but must follow an established, well justified policy.
3. Legal approaches regarding patients’ rights should:
a. ensure that complaints, criticism or suggestions made by patients or their representatives are taken seriously and handled appropriately;
b. ensure that patients are immediately informed of an adverse event and of any events entered into the patient’s medical file;
c. ensure that patients who have been harmed by a patient-safety incident are entitled to receive financial compensation;
d. ensure the presence of an efficient and sufficient supervisory system to identify and manage cases of malpractice;
e. take into consideration the fact that any incident can have multiple legal consequences, depending on the nature and severity of the incident and on the causal relationship between the process of care and an adverse event.
4. It may appear difficult to establish a patient-safety reporting system without compromising patients’ rights. However, if the public is ready to accept the presence of a confidential, anonymous, non-punitive reporting system the public must be assured that its legal and financial rights will be protected. The existence of a fair and open complaints system, a just and adequate compensation system and an efficient and reliable supervisory system will certainly make the process easier and politically more acceptable. Promoting a “no blame” culture is not intended to diminish the effective legal protection of patients.
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