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Origin and Development of a ‘Just Culture’

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The Just Culture Principles in Aviation Law

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Abstract

According to an ancient, well-known Latin phrase, errare humanum est, i.e. to err is human. In fact, people make errors, whatever their level of skill, experience or training.

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Notes

  1. 1.

    Kohn et al. (2000), p. 1 ff., asserts that the problem is not bad people in health care, but it is that good people are working in bad systems that need to be made safer.

  2. 2.

    Kim (1989), p. 301 ff.

  3. 3.

    Marti et al. (2011), p. 2 f; Contissa et al. (2012), and Contissa et al. (2013), p. 79 ff.

  4. 4.

    Pidgeon and O’Leary (2000), p. 15 ff., Reuter (2013), p. 49 ff.

  5. 5.

    For this concept, see Rasmussen et al. (1987); Shappell and Wiegmann (1997), p. 269 ff.

  6. 6.

    Anderson (2015).

  7. 7.

    Johnson (1995), p. 121 ff.

  8. 8.

    See Hollnagel (2009). The ETTO principle refers to the fact that people and organisations, as part of their activities, frequently have to make a trade-off between the resources they spend on preparing to do something and the resources they spend on doing it. The trade-off may favour thoroughness over efficiency if safety and quality are the dominant concerns. It follows from the ETTO principle that it is never possible to maximise efficiency and thoroughness at the same time. At this purpose, efficiency means that the level of investment or amount of resources used or needed to achieve a stated goal or objective are kept a slow as possible. Thoroughness means that an activity is carried out only if the individual or organisation is confident that the necessary and sufficient conditions for it exist so that the activity will achieve its objective and not create any unwanted side-effects. See website erikhollnagel.com’.

  9. 9.

    So Johnson (2005).

  10. 10.

    Reason (1990b), p. 475 ff.

  11. 11.

    Hale et al. (1997); Arnesen (1995).

  12. 12.

    For example, in the USAir Flight 427 disaster, the NTSB concluded that the accident was due to mechanical failure: it determined that the probable cause was a loss of control of the airplane resulting from the movement of the rudder surface to its blowdown limit. USAir Flight 427 was a scheduled flight from Chicago’s O’Hare International Airport to Pittsburgh International Airport, with a final destination of West Palm Beach, Florida. On Thursday, September 8, 1994, the Boeing 737 flying this route crashed while approaching runway 28R of Pittsburgh International Airport, located in Pennsylvania. All 132 people on board the aircraft were killed. See Byrne (2002).

  13. 13.

    For the design of man-machine interface Reason mainly refers to improper allocation of man-machine functions and unreasonable engineering design that can induce man to error easily. See Suchman (1987); Summerton and Benner (2003).

  14. 14.

    Man-machine-environment system engineering is a new developing synthesis frontier science. It analyses three factors for man, machine and environment of system and the relationship among them to make the system become “safety, cost-effective and highly efficient”. So Song and Xie (2014), p. 87 ff. See Yang et al. (2005), pp. 50 ff.; Liu and Zhang (2007), pp. 107 ff.; Piao et al. (2009), p. 44 ff.; Long and Dhillon (2016).

  15. 15.

    Hollnagel (2004).

  16. 16.

    See Reason (1990b), p. 475 ff. See McGrath (2015), model 67, p. 184 f.; Manners-Bell (2014), p. 14 f.; Davina et al. (2016), p. 31.

  17. 17.

    This model, that has been called ‘cumulative act effect’ and is considered to be a useful method to understand accident causation, has been subject to criticism.

  18. 18.

    Reason (1990a), p. 173 f., p. 188 and p. 208 ff.

  19. 19.

    Human Factors Analysis and Classification System (HFACS), in https://www.skybrary.aero/index.php/Human_Factors_Analysis_and_Classification_System_(HFACS) one can find these clear definitions: “Skill-Based Errors: Errors which occur in the operator’s execution of a routine, highly practiced task relating to procedure, training or proficiency and result in an unsafe situation (e.g., fail to prioritise attention, checklist error, negative habit). Decision Errors: Errors which occur when the behaviors or actions of the operators proceed as intended yet the chosen plan proves inadequate to achieve the desired end-state and results in an unsafe situation (e.g, exceeded ability, rule based error, inappropriate procedure). Perceptual Errors: Errors which occur when an operator’s sensory input is degraded and a decision is made based upon faulty information”.

  20. 20.

    For more on this topic, see Nordby et al. (1995), p. 33 ff.; Glendon et al. (2006).

  21. 21.

    See Caldwell (2018), Chapter 2, in particular para. 2.3.2.

  22. 22.

    Cromie et al. (2013).

  23. 23.

    “The Human Factors Analysis and Classification System (HFACS)” Approach, July-August 2004, developed by Scott Shappell and Doug Wiegmann. See Shappell (2000), Wiegmann and Shappell (2003), Shappell and Wiegmann (2001), p. 59 ff. See also Leplat (1982) and Ford et al. (1999), p. 343.

  24. 24.

    HFACS Analysis of Military and Civilian Aviation Accidents: A North American Comparison, ISASI, 2004. See also Li and Harris (2005), p. 67 ff.

  25. 25.

    In contrast, the United States does not criminalize operators involved in controversial circumstances after aviation accident, but the penalties are primarily financial. See Lintner and Dunlap (2013), p. 52 ff.

  26. 26.

    Scholtze (2014), para. 1.

  27. 27.

    Festinger (1957); Johnston et al. (1994).

  28. 28.

    Norman (1988, 2013).

  29. 29.

    So Strauch (2017), p. 19.

  30. 30.

    Sternberg (1996). Robert Sternberg is an American psychologist and psychometrician. He is Professor of Human Development at Cornell University.

  31. 31.

    Jen Rasmussen was senior member of IEEE, institute of Electrical and Electronic Engineers, New York. See Rasmussen (1982, 1983), p. 257 ff.

  32. 32.

    McDonald et al. (2002), p. 205 ff.; Catino (2013).

  33. 33.

    Rasmussen (1983), p. 258.

  34. 34.

    Ibid., p. 259.

  35. 35.

    See also Wickens et al. (1998).

  36. 36.

    Senders and Moray (1991), p. 25, defined error as “something that has been done which was not intended by the actor, not desired by a set of rules or an external observer, or that led the task or system outside its acceptable limits”. See also Woods et al. (1994), p. 2, defined error as “a specific variety of human performance that is so clearly and significantly substandard and flawed when viewed in retrospect that there is no doubt that should have been viewed by the practitioner as substandard at the time the act was committed or omitted”. More recently, Strauch (2004), p. 21 defined error as “an action or decision that results in one or more unintended negative outcomes”.

  37. 37.

    Reason (1990a), p. 5.

  38. 38.

    Reason (1997). See also Reason (2000a), p. 768 ff.

  39. 39.

    See Pepe and Cataldo (2011), p. 56 f.

  40. 40.

    Otherwise, Wickens et al. (2016) say that “whereas slips represent the commission of an incorrect action, different from the intended one, lapses represent the failure to carry out an action at all” (see chapter 7, par. 5.1).

  41. 41.

    Woods (2017).

  42. 42.

    See Dismukes et al. (2017), and Flin et al. (2008).

  43. 43.

    GAIN (Working Group E. Flight Ops/ATC Ops Safety Information Sharing) (2004), A Roadmap to a Just Culture: Enhancing the Safety Environment, 1st edition, vi.

  44. 44.

    The term was first applied in 1986, with respect to the Chernobyl disaster. See Carnino and Weimann (1995); Wiegmann et al. (2002).

  45. 45.

    See Johnson (1995), p. 15, p. 33 ff., Pellegrino (2004), p. 83 ff.

  46. 46.

    Cromie and Bott (2016), p. 258 ff.

  47. 47.

    Reason (1998), p. 293 ff. See also Hudson (2003a), p. 7 ff. and Hudson (2003b), p. 27 ff.

  48. 48.

    See also Reason (2000b), p. 3 ff. See also Pidgeon and O’Leary (1994), p. 21 ff., where they suggested that a good safety culture’s concern for safety is distributed and endorsed throughout the organisation; Pidgeon (1998), vol. 12, issue 3, p. 202 ff.; Guldenmund (2000), p. 216 ff.; Cooper (2000), pp. 111 ff.; Wiegmann et al. (2002); Harris and Li (2006), p. 345 ff.; Morley and Harris (2006), p. 3 ff.; Cooper and Findley (2013).

  49. 49.

    Ferguson and Fakelmann (2005), p. 33 ff.

  50. 50.

    Rasmussen (1983). See also Catino and Patriotta (2013), p. 437 ff.

  51. 51.

    Pidgeon and O’Leary (1994), p. 21 ff.; Daniels (2017).

  52. 52.

    For a commentary of the Reason model, see Hudson (2001), p. 8 and Hudson (2003b), p. 27 ff.; Sumwalt (2007), p. 38.

  53. 53.

    Jeffries (2011), p. 202 f.; Pellegrino (2014, 2015).

  54. 54.

    Reason (1995), p. 1708 ff. See also Harris (2011), p. 292.

  55. 55.

    See Annex 13, Aircraft Accident and Incident Investigation, eleventh edition, July 2016, chapter 1. For a commentary, see Pellegrino (2003), p. 805 ff. and Pellegrino (2007), p. 107 ff.; Beveridge (2009), p. 151 ff.; Challinor (2016).

  56. 56.

    Convention on International Civil Aviation, done at Chicago on the 7th of December 1944. For a commentary, see Giannini (1944), p. 101 ff.; Giannini (1953a), p. 11 ff., Giannini (1946), p. 83 ff., Giannini (1949), p. 41 ff., Giannini (1952), p. 729 ff., Giannini (1953b), p. 269 ff., Giannini (1953c), p. 130 ff.; Giannini (1953c), p. 101 ff.; Quercietto (1954), p. 1225 ff.; Fragali (1967), p. 159 ff.; Mateesco Matte (1995), p. 641 ff.; Lu (2013), p. 13 ff.; Haanappel (2003), p. 43 ff.; Milde (2008), p. 17 ff. and 63 ff.; Benkö (2012); Havel and Sanchez (2014), p. 28 ff.; Weber (2017), chapter 2.

  57. 57.

    For a commentary of these definitions, see Pellegrino (2007), p. 27 ff.

  58. 58.

    Annex 13, chapter 1.

  59. 59.

    Examples of serious incidents can be found in Attachment C of Annex 13 and in the Accident/Incident Reporting Manual (Doc 9156).

  60. 60.

    These considerations are drawn from Perez Gonzales (2012), p. 13 ff. See also Khatib (1996), p. 8 ff., p. 19; Patankar et al. (2012), p. 179 ff.

  61. 61.

    See Perez Gonzales (2012), 13 ff., chapters 2 and 3, where the following is stated: “Active failures are typically carried out by operational personnel, whereas latent failures are due to decisions or actions typically performed by decision-makers such as managers and system designers” […] “Safety feedback systems are also required for reporting active risks and hazards, auditing the organization to uncover latent failures and dissemination of information throughout the industry”. See Douglas (1992).

  62. 62.

    International organization established by Convention relating to Co-operation for the Safety of Air Navigation of 13 December 1960, as amended by the amending Protocol of 12 February 1981 (amended Convention) and by the Brussels Protocol of 27 June 1997 (revised Convention), consolidating the Eurocontrol International Convention relating to Co-operation for the Safety of Air Navigation of 13 December 1960; Sardella (1995), p. 12 ff.; Schwenk and Schwenk (1998), p. 129; Spadoni (2001), p. 259 ff.; Trovò (2008), p. 163 ff.

  63. 63.

    The Task Force is composed of representatives of the European Commission, the European Aviation Safety Agency (EASA), the International Federation of Air Traffic Controllers’ Associations (IFATCA), the European Regional Airlines Organisation (ERA), the European Cockpit Association (ECA), accident investigation boards, national prosecutors, Civil Aviation Authorities (CAAs), Air Navigation Service Providers (ANSPs), the National Transportation Safety Board (US NTSB) and ICAO.

  64. 64.

    So https://www.eurocontrol.int/articles/just-culture.

  65. 65.

    Eurocontrol (2008), Just Culture Guidance Material for Interfacing with the Judicial System, Edition 1, EATM (European Air Traffic Management) Infocentre, Bruxelles, 11 February 2008 (Reference: 08/02/06-07). See North (2000), p. 66.

  66. 66.

    Dekker (2008).

  67. 67.

    The Provisional Council of the Eurocontrol Organisation has unanimously endorsed this Policy at its session of 10th May 2012. See Eurocontrol (ed), Just Culture Policy, Bruxelles, September 2012, which presents the said Model Policy.

  68. 68.

    Eurocontrol is an intergovernmental organisation with 41 Members: Albania, Armenia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Cyprus, Croatia, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Moldova, Monaco, Montenegro, Norway, Benelux countries, Poland, Portugal, United Kingdom, Czech Republic, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, Hungary.

  69. 69.

    On this subject see ICAO Annex 19 (Safety Management. The first edition of Annex 19 was February 2013 and becomes applicable on 14 November 2013. The Safety Management Annex 19, representing the first new ICAO Annex to be adopted in over 30 years, became applicable on 14 November 2013. For a commentary see Rallo (2014), p. 101 ff.

  70. 70.

    Annex 19 (Safety Management), Second Edition, was adopted by the Council on 2 March 2016, became effective on 11 July 2016 and will be applicable on 7 November 2019. This edition supersedes the previous edition 2013.

  71. 71.

    For a summary of the new provisions contained in Annex 119, Second Edition 2016 see COSCAP (Cooperation Development of Operational Safety and Continuing Airworthiness Programme), 16th Steering Committee Meeting, Update on ICAO State Safety Programme and Safety Management System Implementation, Discussion Paper 6 (presented by the ICAO Montrea), Summary, para. 2.2.

  72. 72.

    Assembly Resolution A36-13, Appendix A. ICAO Doc 9902, Assembly Resolution in force as of 28 September 2007.

  73. 73.

    Ibid.

  74. 74.

    See Czech et al. (2014).

  75. 75.

    According to Article 5 of Regulation (EU) No. 996/2010 on the investigation and prevention of accidents and incidents in civil aviation, examined in the following. Article 5(1) of ICAO Annex 13, mentioned above, imposes to carry out an investigation only of accidents, while recommends to carry out an investigation of serious incidents.

  76. 76.

    Dusi (2017), p. 35 ff.

  77. 77.

    Reason (1997), chapter 9.

  78. 78.

    Hobbs and Robertson (1995), p. 468 ff.

  79. 79.

    Council Directive 94/56/EC of 21 November 1994 establishing the fundamental principles governing the investigation of civil aviation accidents and incidents (O.J. L 319 of 12 December 1994, p. 14).

  80. 80.

    Comenale Pinto (2015), p. 91 ff.

  81. 81.

    Haslam et al. (2004), p. 401 ff.

  82. 82.

    IATA, Safety: The Blame Game, Airlines, 1 June 2012. See also IATA, Operational Safety Audit (IOSA), Montreal (Canada), 2011.

  83. 83.

    So Lawrenson and Braithwaite (2018), p. 251 ff. and, in particular, para. 3.

  84. 84.

    EC, Parliament and Council Directive 2003/42/EC of 13 June 2003 on occurrence reporting in civil aviation (O.J. L 167 04/07/2003, p. 23). For a commentary, see Pellegrino (2007), p. 273 ff.; Ingratoci and Michaelides-Mateou and Mateou (2014), p. 265 ff.

  85. 85.

    See Balcerzak (2017), p. 5 ff.

  86. 86.

    Hollnagel (2013), p. 10 f.

  87. 87.

    See Working Paper of ICAO Assembly, 36th Session, Technical Commission, A36-WP/232, TE/76, 18 September 2007, p. 2 “Protection of certain accident and incident records and of safety data collection and processing systems in order to improve aviation safety”, in Organization ICAO, Montréal. See Milde (2012), p. 159.

  88. 88.

    So Bijlsma (2013), p. 64 ff.

  89. 89.

    So Information Paper of Safety Information Protection Task Force (SIPTF), fourth Meeting, Montréal, 21–25 January 2013, “Just Culture”, SIPTF/4-IP/2 of 17 January 2013, presented by Professor Roderick van Dam, 1.6.

  90. 90.

    Weston (2014), p. 69 ff.

  91. 91.

    So Pellegrino (2013), p. 472; Hollnagel (2013), p. 81 ff.

  92. 92.

    See Panelli (2015), p. 231 ff.

  93. 93.

    Regulation (EU) No. 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No. 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No. 1321/2007 and (EC) No. 1330/2007 (O.J. L 122 of 24 April 2014, 18).

  94. 94.

    Commission Implementing Regulation (EU) 2015/1018 of 29 June 2015 laying down a list classifying occurrences in civil aviation to be mandatorily reported according to Regulation (EU) No. 376/2014 of the European Parliament and of the Council (O.J. L 163 of 30 June 2015).

  95. 95.

    Amalberti (2001), p. 110 ff.

  96. 96.

    Pellegrino (2004), p. 83 ff.; Berlinger (2005), Merry (2009), p. 265 ff.

  97. 97.

    Kennedy and Kirwan (1995), p. 282 ff; Westrum (1996).

  98. 98.

    Heinrich et al. (1980), and Perrow (1984).

  99. 99.

    David Marx, President of Outcome Engineering, a risk management company located in Dallas, USA. See Marx (1997), pp. 1 ff. and Marx (2009), in which he explores the role of human error in society from aviation and health care and speaks about culpability, accountability, behavioural choices, system design and the ‘benefits’ of a ‘just culture’. He says: “The challenge lies in distinguishing between a system that might create risks, human error which may result in a bad outcome, and reckless behavior that intentionally puts lives or organizations at risk”. See Outcome Engineering LLC. (2008) Just Culture Training for Healthcare Managers. See also Weston (2014), p. 69 ff.

  100. 100.

    Hudson (2003a), p. 7 ff. See also Perrow (1984), and Green (2003).

  101. 101.

    Westrum (1993).

  102. 102.

    Merry and McCall Smith (2001), and Morreim (2004), p. 213. See also Leape (1994), p. 1851 ff. He says that in a punitive stem, no one learns from their mistakes. More recently, see Dekker (2007), chapter 5.

  103. 103.

    So Marx (2001), p. 25. See also Whitehead et al. (2017), p. 126; Barnsteiner and Disch (2012a), p. 407 ff.

  104. 104.

    Carrol (2010), p. 101 ff.; van Asselt and Renn (2011), p. 431 ff.; Ingratoci (2014), p. 293 ff.

  105. 105.

    Arghami et al. (2014), p. 143 ff.

  106. 106.

    Dekker (2003a), 233 ff.; Dusi (2017), p. 81.

  107. 107.

    Gulseth (2007), p. 17; Van Beuzekom et al. (2010), p. 52 ff.; Van Beuzekom (2012), 12:10.

  108. 108.

    See Page (2007), and Thew (2013).

  109. 109.

    Dekker (2003b), p. 83 ff. and Dekker (2005).

  110. 110.

    Sidney Dekker is a Professor at Griffith University in Brisbane, Australia, where he founded the Safety Science Innovation Lab and at Lund University School of Aviation (Ljungbyhed, Sweden).

  111. 111.

    Dekker (2016a), chapter 5 and Dekker (2007). See also Boysen (2013), p. 402 ff. and Boysen (2014–2015), issue 7.

  112. 112.

    See Almond and Colover (2010), p. 323 ff.

  113. 113.

    Flin et al. (2000), p. 77 ff., Yule (2003), p. 1 ff., Mearns et al. (2003), p. 641 ff.

  114. 114.

    Van het Kaar (2010), p. 64 ff.

  115. 115.

    LeSage et al. (2011), p. 8 ff.

  116. 116.

    Wise et al. (1993); Cook and Render (2000), p. 791 ff., Sharpe (2003), S1 ff., Youngberg (2010), p. 267 and Youngberg (2012), p. 171; Barnsteiner and Disch (2012b), p. 407 ff.; Dekker (2016b); Woodward (2017).

  117. 117.

    Sharpe (2004); Katri et al. (2009), p. 313 ff.

  118. 118.

    Dekker (2008).

  119. 119.

    See Reinhart (1996), Hudson (1996), Cox and Flin (1998), p. 189 ff.; Wiegmann et al. (2004), p. 117 ff.

  120. 120.

    Uttal (1983).

  121. 121.

    Advisory Committee on the Safety of Nuclear Installations (ACSNI), Human Factors Study Group: Third report - Organising for safety, HSE Books, 1993.

  122. 122.

    See Court of Cassation, section IV, criminal division, 6 March 1967 and 21 October 1970, Rivista italiana diritto e procedura penale, 1973, p. 255; 4 February 1972; 17 February 1981; 2 June 1987; No. 10289 of 23 July 1990. They considered Article 2236 and the degrees of fault applicable to the criminal system.

  123. 123.

    See Nuvolone (1969b); Sharpe (1999), p. 5; Miller and Jones (2011); Amato (2018a), p. 28 ff.

  124. 124.

    In fact, Article 43 (Mental element of the offense) of the Italian Penal Code says that a crime is negligent when the event, even though foreseen, is not desired by the actor and occurs because of carelessness, imprudence or lack of skill or failure to observe laws, regulations, orders or instructions. See Palombi (2018a), p. 352 ff.

  125. 125.

    Thomas (2007), p. 57 ff.

  126. 126.

    In addition, according to Italian doctrine and jurisprudence, there is another type of willful misconduct, called dolus eventualis (wilful and wanton conduct or oblique/indirect intent) that is when the wrongdoer foresees the risk and despite this, he acts, accepting the risk of it occurring (see Supreme Court of Cassation, section I, No. 18220 of 11 March 2015 and Section IV, No. 14663 of 30 March 2018). It is called “quasi intent”. See Delitala (1932), Ballinari (1992), Prosdocimi (1993), Brunelli (2014), Carboni (2015), chapter 1, para. 1.4; Piqué (2017), p. 1083 ff. See also Oberdiek (1972), p. 389 ff.; Damar (2011), p. 272; Badar (2013), p. 933 ff.; Baker (2016), 121 ff.; Guilfoyle (2016), p. 189.

  127. 127.

    See Spitzmiller (2011), p. 11.

  128. 128.

    See Ziccardi (2011), p. 110.

  129. 129.

    Italian Constitutional Court No.166 of 28 November 1973.

  130. 130.

    Koch (2011), p. 305; Agich (2012), p. 262; Ferrara et al. (2013), p. 355; Hondus (2014), p. 55.

  131. 131.

    Crespi (1960), p. 484 ff., Crespi (1973), I, p. 255 ss.; Cattaneo (1958), p. 73; De Simone (1972), p. 825 ff.

  132. 132.

    Court of Cassation, criminal division, section IV, No. 4028 of 12 April 1991 and 22 February 1991.

  133. 133.

    Pontonio and Pontonio (2006), p. 31 ff.

  134. 134.

    Court of Cassation, section IV, criminal division, No. 5278 of 10 May 1995, Responsabilità civile e previdenza, 1995, p. 903 ff.

  135. 135.

    Grasso (1979), p. 80, Muscolo (1970), p. 457 ff.

  136. 136.

    More recently, the Italian Court of Cassation reiterated the general principle that the application of Article 2236 of the Italian Civil Code is limited to compensation for damages in civil proceedings (Court of Cassation, section IV, criminal division, 17 December 2008, No. 46412) and it is not directly applicable in criminal proceedings. In this respect, see also Court of Cassation, section IV, criminal division, No. 11733 of 2 June 1987.

  137. 137.

    Cattaneo (1982), p. 9; Cian and Trabucchi (1981).

  138. 138.

    Article 14 of the Italian Civil Code (so-called ‘preleggi’) does not allow the use of analogy mechanism to fill the regulatory gaps as regards criminal law or in case of exceptional rules. See Morselli (1990), p. 505 ff.; Gallo (2001), p. 1 ff.; Falcinelli (2004), p. 147 ff.

  139. 139.

    At this end, the ‘degree of fault’ must be interpreted with reference to the degree of predictability of the damaging event (conscious or unconscious fault) and to the expected behaviour.

  140. 140.

    Judgement of the United Sections of the Court of Cassation, No. 30328 of 11 July 2002, concerning a case of omissive medical responsibility. For a commentary, see Angioni (2006), p. 1282 ff.; Masera (2007), p. 166; Viganò (2006), p. 962, Viganò (2009), p. 1679 ff. and Viganò (2013); Moccheggiani (2017), p. 571 ff.; Mura (2017), p. 3396 ff.; Venturato (2017), p. 1596 ff.; Palombi (2018b), p. 32 ff.

  141. 141.

    For this concept, see Nocco (2006), p. 1239 ff.; Grassi (2007), p. 404 ff.; Di Landro (2008), p. 181 ff.; Brusco (2008), p. 1875 ff.; Iacoviello (2014), p. 241 ff.

  142. 142.

    Mandel (2003), p. 245 ff.

  143. 143.

    Pizzi (2015), p. 1.

  144. 144.

    Firstly elaborated by Maximilian Von Buri, a German jurist. See Von Buri (1873), and Infantino and Zervogianni (2017), p. 393.

  145. 145.

    Strachan (1970), p. 386 ff.

  146. 146.

    Mason (2017), p. 147 ff.; Frecklelton and Mendelson (2017).

  147. 147.

    Marandola (2012), p. 367 ff.; Polidori (2014), p. 574 ff.; Somma (2014), p. 366 ff., Canzio (2015), p. 193 ff.; Mauceri (2015), p. 114; Paliero (2015), p. 1507 ff.; Saponaro (2018), p. 469 ff.

  148. 148.

    Laying down urgent provisions to promote the development in Italy of an higher level of health protection”, published in G.U. No. 214 of 13 September 2012, converted in the Law No. 189 of 8 November 2012. For a commentary, see Iadecola (2013), p. 549 ff.; Cupelli (2017b), p. 196 ff.; Alagna (2017), p. 1466 ff.; Di Bitonto (2017), p. 3799 ff.

  149. 149.

    For an overview of the previous legal system, see Zana (1987), p. 420; Ferrari (2004), p. 1492; Marseglia and Viola (2007).

  150. 150.

    Franzoni (2016), p. 801 ff.; Hall and Roussel (2017), p. 178 ff.

  151. 151.

    Cupelli (2017c), p. 135.

  152. 152.

    See Skegg (1998), p. 220 ff.; Pandit (2009), p. 379 ff.

  153. 153.

    Hudson et al. (2002), p. 1 ff.

  154. 154.

    Problems were raised in applying this Decree, due to the fact that, in relation to the guidelines, the text referred to a Scientific and Technical Committee for the Guidelines National System (SNLG), established by the so-called ‘Sirchia Decree’ (Ministerial Decree, Ministry of Health, 30 June 2004), that had never been established. Then the reference to this Committee has been eliminated by the ‘Lorenzini draft law’ of 2017 on reorganizing the professional associations, which became Law No. 3 of 11 January 2018.

  155. 155.

    Helreich and Foushee (1993), p. 3 ff.; LeSage et al. (2011), p. 8 ff.

  156. 156.

    Italian Court of Cassation, section IV, criminal division, No. 46753 of 22 November 2013.

  157. 157.

    Dauer (2004), p. 185 ff.

  158. 158.

    Italian Court of Cassation, section IV, criminal division, No. 4468 of 29 October 2015.

  159. 159.

    For the difference between penal and civil fault, in the Italian legal system, see Gallo (1960), p. 624 ff.; Nuvolone (1969a), p. 696; Castronuovo (2009).

  160. 160.

    Zana (2016), p. 19 ff.; Barbarisi (2017), p. 217 ff. See also Gallone (2017), p. 380 ff.

  161. 161.

    Masieri (2016), p. 1440 ff.

  162. 162.

    Italian Court of Cassation, section IV, No. 50078 of 19 October 2017 (deposited on 31 ottobre 2017). For a commentary see Cupelli (2017e), p. 250 ff. and Amato (2018c), p. 75 ff. See also Court of Cassation, section IV, criminal division, No. 28187 of 7 June 2017. For a commentary see Palombi (2018b), p. 32 ff. See Court of Cassation, United Criminal Sections, 21 December 2017, Diritto penale contemporaneo, 11/2017, https://www.penalecontemporaneo.it/upload/9488-su-aiello.pdf.

  163. 163.

    So Free Legal Dictionary, (2016), Legal Information Institute (LII), Cornell University Law School, Farlex Inc. See Scarabello (2017), p. 40 f.

  164. 164.

    Comenale Pinto (2009), p. 373 ff.; Rizzo (2009).

  165. 165.

    Weiner et al. (1993); Catalisano (2015), p. 27 ff.

  166. 166.

    Schubert (2013), p. 46 ff.

  167. 167.

    In Merriam-Webster’s (Dictionary of Law, Springfield, Massachusetts, 1996) gross negligence’ is described as “failure to exercise the degree of care expected of a person of ordinary prudence in like circumstances in protecting others from a foreseeable and unreasonable risk of harm in a particular situation”.

  168. 168.

    See the Free Legal Dictionary (2005), Legal Information Institute (LII), Cornell University Law School, Farlex Inc.

  169. 169.

    Italian Court of Cassation, section IV, criminal division, No. 22405 of 8 May 2015, in CED Cassazione penale, 2015, 263736. See also Court of Cassation, criminal division, criminal division, section III, No. 5460 of 4 December 2013, section IV, No. 18430 of 5 November 2013, and No. 47289 of 9 October 2014.

  170. 170.

    Crespi (1955); Cattaneo (1977); Finucci (1992), p. 420 ff.; Castelletta (2004).

  171. 171.

    Law No. 24/2017, laying down provisions on safety of care and assisted persons, as well as on the professional responsibility of healthcare professionals (G.U. No. 64 of 17 March 2017). For a commentary, see Sicurezza delle cure e responsabilità sanitaria. Commentario alla legge 8 marzo 2017, n. 24, Quotidiano sanità edizioni, Roma, 2017, passim; Hazanlso (2017), p. 75 ff.; Ponzanelli (2017), p. 356 ff.; Caputo (2017b), p. 724 ff. Caputo (2017a), p. 293 ff.; Pardolesi and Simone (2017), p. 161 ff.; Scognamiglio (2017), p. 740 ff.; Caletti and Mattheudakis (2017), p. 85 ff.; Iadecola (2017), p. 53 ff.; Di Giovine (2017), p. 386 ff.; Palma (2017), p. 523 ff.; Velliscig (2018), p. 267 ff.

  172. 172.

    Regarding relations between the old and the new law under examination, attention has to be drawn to the ruling No. 3/2017 of the Italian Court of Cassation, that clarifies that the ‘Gelli’ Law “because of its novelty, shall apply only to the events occurred after the entry into force of the new law. To the events which took place before that date, shall continue to apply the repealed Article 3(1), of the Law No. 189 of 2012, pursuant to Article 2 of the Criminal Code, which excluded criminal law liability of harmful conduct characterized by simple negligence, in a framework regulated by guidelines and best practices recognized by the scientific community”. In another judgment (No. 50078 of 21 October 2017, subject to commentary by Palombi (2018b), p. 32 ff., the same Court, with reference to the new Law, pointed out that “the eventual impunity, because of its substantial nature, is also applicable, for acts committed before the entry into force of the Law 24/2017, to cases pending before the Court of Cassation and the relevant issues, under Articles 2(4), of the Criminal Code and 129 of the Code of Criminal Procedure, are lodged ‘ex oficio’ ex Article 609(2), of the Code of Criminal Procedure, even in the case of appeal considered inadmissible. […] Doubts of interpretation of the new provision are well-known. What is clear, as expressly provided by Article 590 sexies (2), is that has been repealed the criminal regime on the decriminalization of simple negligence provided for by the Balduzzi Law, having been repealed the whole Article 3(1). Therefore, there is no longer a question of the degree of fault, except in specific cases, in which the Balduzzi Law constitutes provision more favourable for crimes committed when it was in force, involving aspects of negligence and imprudence qualified as simple fault (extended enforcement of the more favourable regime). It is also clear that the legislator has aimed to limit innovation only to situation of malpractice, i.e. to the fault that is based on the leges artis, considered as not punishable also in case of gross negligence”. See Massaro (2017), p. 1 ff.; Carbone (2017), p. 737 ff.

  173. 173.

    The innovation brought about by the ‘Gelli’ Law, compared to the ‘Balduzzi’ Decree, is that the task and the power of producing clinical guidelines and recommendations have been extended to private and public bodies/institutions/associations and no longer reserved for the scientific societies of healthcare, as we have seen. Cf. Cupelli (2017d), p. 1765 ff.; Cembrani (2017), p. 873 ff.; Di Giovine (2017), p. 386 ff.

  174. 174.

    This provision is governed by the key principles of transparency.

  175. 175.

    See Bettiol (2017), p. 237 ff.

  176. 176.

    Roncali (2017), p. 280 ff.

  177. 177.

    Definition elaborated by the IOM Institute of Medicine (ed), Clinical practice guidelines we can trust, The National Academies Press, Washington, DC, 2011. See also Hudson and Stephens (2000), 1 ff.; Steel et al. (2014), p. 1251 ff.

  178. 178.

    So Perleth et al. (2001), p. 237 f.

  179. 179.

    Driever (2002), p. 591 ff. say that “best practice is not a specific practice per se but rather a level of agreement about research-based knowledge and an integrative process of embedding this knowledge into the organization and delivery of health care”.

  180. 180.

    Best practice require specific indicators to be continuously monitored and may vary depending on the sector to which it refers, as well as on the basis of individual areas. So Perleth et al. (2001), p. 237 f.

  181. 181.

    Cupelli (2017d), p. 1765 ff.; Garzone and Nocco (2017), p. 885 ff.; Hazan (2017), p. 523 ff.; Pavich (2017), p. 2961 ff.

  182. 182.

    See Article 6 of the ‘Gelli’ Law. See Caletti and Mattheudakis (2018), p. 25 ff.

  183. 183.

    D’Alessandro (2017), p. 573 ff.

  184. 184.

    See Article 590-sexies of the Italian Criminal Code, added by Article 6 of the ‘Gelli Law’.

  185. 185.

    Miglio (2016), p. 1250 ff., Dell’Osso (2016), p. 364 ff.

  186. 186.

    Almond (2012), in particular, chapter 3.

  187. 187.

    The punishment for (involuntary/culpable) manslaughter is 6 months-5 years’ imprisonment, increased up to three time in the case of death of several people (Article 589 of the Criminal Code). The punishment for culpable injuries is a maximum of 3 months’ imprisonment (Article 590 of the Criminal Code). In case of serious injury, the penalty is 1–3 months’ imprisonment or, alternatively, a fine, excluding the case of serious injuries punishable more severely. In the latter case, the punishment is 3 months-2 years’ imprisonment (Article 590(2), of the Criminal Code). See D’Alessandro (2017), p. 573 ff.

  188. 188.

    On the issue of the prosecutor’s discretion, see Cordero (1957), p. 158 ff.; Luparia (2002), p. 1751 ff.; Vicoli (2003), p. 251.

  189. 189.

    Panelli and Scarabello (2013), p. 18, 59 f.

  190. 190.

    Brüggen (2013), p. 44 f.

  191. 191.

    Cupelli (2018), p. 246 ff.

  192. 192.

    In fact, Article 43 of the Italian Penal Code says that a crime is negligent when the event, even though foreseen, is not desired by the actor and occurs because of carelessness, imprudence or lack of skill (or failure to observe laws, regulations, orders or instructions).

  193. 193.

    Diehl (1989).

  194. 194.

    Drobnig et al. (2017), p. 103; Buzzoni (2007), p. 60; Lobato de Faria (2010), p. 99; Nefeli Gribaudi (2012), p. 55; Risicato (2013), p. 15 f., Winger et al. (2018), p. 784; Terrizzi (2018), p. 93 ff.

  195. 195.

    Caletti and Mattheudakis (2017), p. 101 ff.

  196. 196.

    Italian Court of Cassation, section IV, criminal division, No. 3 of 20 April 2017.

  197. 197.

    Bartoli (2018), p. 233 ff.

  198. 198.

    Piras (2018), p. 4 ff.

  199. 199.

    See Todeschini (2017).

  200. 200.

    Italian Court of Cassation, section IV, criminal division, 19 September 2012.

  201. 201.

    See Cavaliere (2017).

  202. 202.

    Italian Court of Cassation, Joint Sections, No. 8770 of 21 December 2017, Guida al diritto, 2018, 12, p. 40. For a commentary, see Brusco (2007), p. 205 ff. and Brusco (2018), p. 646 ff.; Amato (2018b), p. 299; Palombi (2018b), p. 32 ff.; Risicato (2018), p. 948 ff.; Palmieri (2018), p. 235 ff.

  203. 203.

    See para. 9.1 of the Court of Cassation judgement No. 8770 of 21 December 2017, cited above.

  204. 204.

    See also Massaro (2017), p. 12; Cupelli (2017c), p. 135 ff., Cupelli (2017a), p. 244 ff. and Cupelli (2017e), p. 250.

  205. 205.

    So Tirella (2017).

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    Francesca Pellegrino

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Pellegrino, F. (2019). Origin and Development of a ‘Just Culture’. In: The Just Culture Principles in Aviation Law. Legal Studies in International, European and Comparative Criminal Law, vol 3. Springer, Cham. https://doi.org/10.1007/978-3-030-23178-1_1

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