The legal framework for patient safety in Switzerland

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1 The legal framework for patient safety in Switzerland Prof. Olivier Guillod Institut de droit de la santé Université de Neuchâtel

2 Ascona /

3 What are the relevant facts? Hospitals save lives but are complex organizations Adverse events frequenty occur in hospitals, a proportion of which are preventable Preventable adverse events may harm patients (bodily injury, death; between 750 and 1500 a year) Preventable adverse events have become a public health issue Injured patients often seek an explanation and an apology as much as a financial compensation Most litigation is due to breakdowns in physician-patient communication Society at large should seek to lower this toll 3

4 What are the central issues? Two separate (but interrelated) main issues 1. How can we reduce the number of preventable adverse events? 1. Medical education? 2. Medical and institutional culture : from denial to learning from errors? 3. Transparency : CIRS, disclosing preventable adverse events to patients? 2. When a preventable adverse event occurs, how can we treat fairly the injured patient? 1. Duty to disclose the adverse event to the patient? 2. Proposal of some sort of compensation? 3. System of no-fault compensation? 4

5 A European-wide concern Member States of the Council of Europe (47!) should «ensure that patient safety is the cornerstone of all relevant health policies, in particular policies to improve quality» «patient safety is the underpinning philosophy of quality improvements» Recommendation (2006)7 of the Committee of Ministers to member States on management of patient safety and prevention of adverse events in health care 5

6 A European-wide concern Member States should «promote the development of a reporting system for patient-safety incidents in order to enhance patient safety by learning from such incidents; this system should: a. be non-punitive and fair in purpose; b. be independent of other regulatory processes; c. be designed in such a way as to encourage health-care providers and health-care personnel to report safety incidents (for instance, wherever possible, reporting should be voluntary, anonymous and confidential); ( ) Recommendation (2006)7 of the Committee of Ministers to member States on management of patient safety and prevention of adverse events in health care 6

7 A European-wide concern ( ) d. set out a system for collecting and analysing reports of adverse events locally and, when the need arises, aggregated at a regional or national level, with the aim of improving patient safety; for this purpose, resources must be specifically allocated; e. involve both private and public sectors; f. facilitate the involvement of patients, their relatives and all other informal caregivers in all aspects of activities relating to patient safety, including reporting of patient-safety incidents.» Recommendation (2006)7 of the Committee of Ministers to member States on management of patient safety and prevention of adverse events in health care 7

8 Law as a social and political tool Law is the primary tool a society can use to pursue its goals Switzerland is a federal State with a complex division of legislative powers between the Swiss Confederation and the cantons Law can require, promote, ignore, deter or prohibit specific human / professional behaviors; it can, therefore, influence professional and institutional cultures (takes time!) BUT : we need to gather empirical evidence on the global efficiency of CIRS in improving patient safety and on the most appropriate features of such systems Law may contribute to patient safety 8

9 Some features of present Swiss law 1. Legal status of CIRS Federal law does not make running a CIRS a legal obligation Federal law has no specific provisions on CIRS Cantonal laws could regulate CIRS ; see VS, NE 2. Confidentiality of data collected through a CIRS Legal basis needed for health professionals to report a critical incident (when patient is identified or identifiable) CIRS data are protected by the laws on data protection as well as on professional and official secrecy ( CP) but there is a (limited) obligation to testify in civil and criminal proceedings; a court has the power to force someone to give relevant documents in a pending case 9

10 Some features of present Swiss law 3. Legal protection of reporters and other professionals involved Federal law does not grant any legal immunity against disciplinary proceedings Cantonal laws could grant such immunity (e.g. in VS) No protection against a lawsuit for medical malpractice (in private hospitals; in public hospitals, professionals can t be sued by patients) No protection against criminal proceedings 4. Legal regime of professional liability Professional liability is based on proof of individual negligence Hospitals may also be held liable (e.g. Organisationshaftung) Professionals also incur criminal liability (often ex officio) Professionals further incur disciplinary liability 10

11 Some features of present Swiss law «Another proposed reform, no-fault compensation for medical injuries, might promote reporting by eliminating the adversarial inquiry into fault and blame that characterizes the current liability system» Recommendation (2006)7 of the Committee of Ministers to member States on management of patient safety and prevention of adverse events in health care 11

12 Does the present Swiss legal framework enhance patient safety? NO! It reinforces rather than helps changing the traditional medical culture of secrecy A good physician doesn t make any mistake! The only concern of the law (and of most lawyers) has been to provide for financial compensation when a health professional was found to be negligent 12

13 Does the present Swiss legal framework enhance patient safety? Legal solutions, though not easy, do exist but the political will is still lacking 13

14 Issues that the law could help solving Should the law require hospitals to run a CIRS? Should the law make it a legal obligation for health professionals to report any critical incident? Should the law ensure that CIRS data can never be used in court? Should the law protect health professionals reporting a critical incident from legal proceedings (disciplinary / civil / criminal)? Should the law impose a duty or set incentives for physicians to disclose one s errors to the patient? Should the law encourage hospitals to offer compensation? Should the law prevent an apology from being held as an admission of liability / guilt? Should the law provide for a system of no-fault compensation? Should the law require communicative skills from licensed physicians and other health professionals? 14

15 Does the present Swiss legal framework enhance patient safety? Legal solutions, though not easy, do exist but the political will is still lacking We launched a study precisely on that topic within the Institute of Health Law at the University of Neuchâtel But legal solutions are not enough : changes in professional and institutional cultures are needed 15

16 THANK YOU FOR YOUR ATTENTION! Institut de droit de la santé Faculté de droit Université de Neuchâtel Av. du 1er Mars 26 CH-2000 Neuchâtel 16

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