Civil Aviation Act 1988

Civil Aviation Regulations 1988

Civil Aviation Safety Regulations 1998

Re Window and Civil Aviation Safety Authority [1999] AATA 525

1. Mr Rohan Hall, who is aged 56, applied for the issue of a medical certificate under Regulation 6.06 of the Civil Aviation Regulations 1988 to enable him to obtain a private pilot's licence.

2. A delegate of the Civil Aviation Safety Authority ("CASA") refused Mr Hall's application on the basis that he suffers from impaired circulation to his heart muscles and that in the interests of air safety, a multi-crew condition should attach to Mr Hall's medical certificate. The delegate therefore granted Mr Hall a conditional special Class 2 Medical Certificate necessitating that Mr Hall flies as or with a co-pilot and only in an aircraft configured with side by side seating in the cockpit and dual flying controls.

3. The Applicant, Rohan Hall, was born on 14 January 1947 and is aged 56. On 14 June 1990, Mr Hall suffered a heart attack and subsequently underwent a triple coronary bypass at the Royal North Shore Hospital on 13 September 1990 (T3 p10).

4. On 27 December 1990, Mr Hall was notified by CASA of the suspension of his medical certificate for its remaining period and that revalidation would require a satisfactory cardiovascular assessment 12 months from the date of his bypass surgery (T2 p6).

5. From September 1991 until September 2001, Mr Hall received satisfactory medical reports in respect to his heart condition. During this period, he was issued with a regular Class 2 Medical Certificate by the Respondent (T2 p6).

6. In late 2002, Mr Hall suffered typical ischaemic chest pains (T p21). Medical tests revealed a complete occlusion of the graft to the right coronary artery that he had undergone in 1990. As a result, Rapamycin-coated stents were inserted in his native right coronary artery and distal left main and proximal part of the native circumflex (T p21).

7. On 23 May 2003, Mr Hall submitted to CASA for the issue of a Class 2 Medical Certificate for the year 2003, a Medical Questionnaire and Examination Form completed by Dr John Evans, a designated aviation medical examiner for CASA, and attaching a medical report from Dr John Woods, Mr Hall's treating Cardiologist dated 19 May 2003 (T6 p19).

8. On 28 May 2003, CASA requested further medical evidence from Mr Hall's treating Cardiologist (T7). On 11 June 2003, CASA received a medical certificate from Dr Woods dated 6 June 2003 (T8) setting out the history of Mr Hall's heart condition and concluding that Mr Hall has "a mildly impaired left ventricular ejection fraction at 41%" and "slight peri-infarctional ischaemia" (T8 p21).

9. On 17 June 2003, the Director of Aviation Medicine for CASA notified Mr Hall that after consideration of his medical evidence, his Medical Certificate would be endorsed "Class 2 `As or With Co-pilot' valid for 12 months" (T9 p22).

10. On 7 July 2003, Mr Hall lodged an application for a review of this decision by the Tribunal (T1).

11. At the hearing, Mr Hall was self-represented and the Respondent was represented by Greg Parkin, Legal Counsel, of CASA. The evidence before the Tribunal comprised the documents produced pursuant to s 37 of the Administrative Appeals Tribunal Act 1975 ("the T Documents") together with evidence presented by the parties at the hearing. At the hearing, Mr Hall gave oral evidence, as did Dr Howard Peak and Dr Peter Wilkins for the Respondent.

12. Section 20AB of the Civil Aviation Act 1988 ("the Act") prescribes that a person must not perform any duties essential to the operation of an Australian aircraft unless that person is authorised to do so, which includes the holding of a licence. At the date of the decision, the authorisation procedure was set out in the Civil Aviation Regulations 1988 ("the old regulations"), which includes Part 6 dealing with the issue of medical certificates.

13. Regulation 6.06(1) states that CASA must issue a medical certificate to a person who complies with certain requirements including, in paragraph (e), meeting "the relevant medical standard". Medical standards are set out in Schedule 1, Part 1 of the Regulations. Those relevant to the cardiovascular system are contained in paragraphs 5 to 7:

Cardiovascular system

5. A person must not possess any congenital or acquired abnormality of the heart that is likely to interfere with the safe exercise of privileges, or performances of duties, under the license that the person holds or has applied for, as the case may be.

6. The systolic and diastolic blood pressures of a person must be within normal limits but drugs approved by the Director of Aviation Medicine may be used to maintain the blood pressure within normal limits.

7. A person must have no significant functional or structural abnormality of the circulatory tree.

The standard at issue in this matter is that in paragraph 5.

14. Regulation 6.10 permits CASA to issue a special medical certificate to a person who does not meet the relevant medical standard if CASA "is satisfied that issuing a medical certificate to the person will not adversely affect the safety of air navigation". Regulation 6.12 empowers CASA to make the issue of such a certificate "subject to any condition that is necessary in the interests of the safety of air navigation, having regard to the medical condition of the person".

15. The Tribunal notes that the Civil Aviation Amendment Regulations 2003 (No 6), which took effect on the date of their gazettal on 3 September 2003, amended the Civil Aviation Regulations 1988 by deleting Part 6 and substituting equivalent new provisions in the Civil Aviation Safety Regulations 1998 ("the new regulations"). These 1998 Regulations were previously cited as the Civil Aviation Regulations 1998. The change of citation to Civil Aviation Safety Regulations 1998 was effected by the Civil Aviation Amendment Regulations 2002 (No 11) on 20 December 2002, the date of gazettal of those Amendment Regulations. The provisions relevant in this matter are those in Part 67 of the new regulations.

16. Regulation 67.180 states that CASA must issue a medical certificate to an applicant provided the applicant satisfies certain requirements including, pursuant to paragraph (2)(c), meeting "the relevant medical standard", or if the applicant does not meet the relevant medical standard, "the extent to which he or she does not meet the standard is not likely to endanger the safety of air navigation" (paragraph (2)(e)). Regulation 67.195 empowers the Authority to issue a medical certificate "subject to any condition that is necessary in the interests of the safety of air navigation, having regard to the medical condition of the person".

17. The relevant medical standard in the case of private pilot licenses is medical standard 2. The criteria for medical standard 2 are set out in Table 67.155. In respect of the cardiovascular system, the following criteria are stated:

Cardiovascular system

2.9 Has no safety-relevant heart abnormality

2.10 Systolic and diastolic blood pressures are within limits specified by CASA from time to time in the Designated Aviation Medical Examiner's Handbook (even if approved drugs are used to maintain the blood pressure within those limits)

2.11 Has no significant functional or structural abnormality of the circulatory tree

a medically significant condition is safety-relevant if it reduces, or is likely to reduce, the ability of someone who has it to exercise a privilege conferred or to be conferred, or perform a duty imposed or to be imposed, by a licence that he or she holds or has applied for.

19. The Tribunal notes that the new standard is similar to the old. However, the reference to the safety of air navigation in regulation 67.180(2)(e) also introduces a second "likely" test, not formerly present in regulation 6.10 of the old regulations.

20. In its Statement of Facts and Contentions, the Authority states "it would appear" that the new provisions apply to Mr Hall's application. The Tribunal takes a different view. The transitional provisions in the Civil Aviation Amendment Regulations 2003 (No 6) state, at regulation 202.363, that the new provisions apply if "an application under Part 6 of the old regulations for the issue of a medical certificate was pending immediately before the commencement of this regulation".. As stated above, those provisions took effect on 3 September 2003. At that time, Mr Hall's application had already been determined and so the transitional provisions do not apply. The Tribunal must, therefore, apply the old regulations.

21. Mr Hall said the heart attack he suffered in September 1990 occurred in hospital, was controlled by drugs and did not damage his heart. Following this, he underwent surgery including a coronary artery graft. He was advised at the time that the shunt that had been inserted would require attention in 10 to 15 years time. Following the surgery, Mr Hall made a complete recovery and, after a 12 month suspension, he was issued with a medical certificate for his pilot's licence in late 1991. Thereafter, this was renewed annually, although he was required to have a nuclear scan of his heart every five years (performed in 1995 and 2000).

22. Towards the end of 2002, Mr Hall was in the process of preparing his annual application for medical re-certification, when he had to go overseas. In late October 2002, while in the United Kingdom, he experienced shoulder and back pain. He described it as uncomfortable but not debilitating and he did not immediately seek medical treatment. However, three or four days later, in the United States, he sought medical advice and was told that the incident was cardiac-related. Nevertheless, he was advised that it was safe to return to Australia.

23. On arriving home, in November 2002, Mr Hall had an angiogram that showed he had a "complete occlusion of the saphenous vein graft to the right coronary artery" (T8 p21). The surgeon, the same person who had operated on him in 1990,

inserted a Rapamycin-coated stent to the most focal lesion in the native right coronary artery, and a second stent to the distal left main and proximal part of the native circumflex (T p21_)._

Mr Hall said he has been healthy and asymptomatic since the surgery.

24. As a result of these events, Mr Hall's pilot's licence was suspended and, six months later, he had medical examinations with a view to reports being produced for CASA. In June 2003, Mr Hall spoke with a CASA medical officer, Dr T Sham. Dr Sham suggested that it was unusual for a person with a second bout of heart trouble to keep on flying. Mr Hall got the impression that CASA was very conservative in its approach and had overlooked the fact the problems he had in October 2002 were a follow on from the surgery in September 1990. As noted, in September 1990, Mr Hall was advised that the shunt inserted would require attention in 10 to 15 years time.

25. Mr Hall said he was unaware, until being informed of this at the hearing, that he could reapply for a medical certificate at any time without having to await the expiry of his current licence.

26. CASA produced a specialist report from Dr Howard Peak, a recently retired distinguished cardiologist, dated 13 November 2003 (R2). Dr Peak has been a consultant on aviation medicine in cardiological matters for some years. He said the Gated Cardiac Blood Pool Study for Mr Hall dated 5 December 2003 (A1) shows an improved Right Ventricular Ejection Fraction ("LVEF") of 48% which is an acceptable reading. An LVEF of about 50 is normal. The LVEF measures the volume of blood ejected from the left ventricle and is an indication of how efficiently the ventricle is pumping. Dr Peak acknowledged that the December 2003 edition of the Designated Aviation Medical Examiner's Handbook ("the DAME Handbook") states that the Gated Blood Pool Scan for applicants "should show an ejection fraction greater than 45%" (R1).

27. However, Dr Peak said the recent Gated Cardiac Blood Pool Study does not deal with other relevant issues. Because of Mr Hall's cardiac history, he has an increased risk of arrythmia or heart failure, for example, as a result of a surge of adrenalin because of fright in a mid air incident. What is required is a Stress Myocardial Perfusion study to show whether Mr Hall has an impaired blood flow to the heart muscle (cardiac ischaemia). A person is not always aware of "silent ischaemia" which may, however, be picked up on an echocardiogram.

28. Dr Peak acknowledged that Mr Hall "looked healthy" and that most of the complications of stent implantation have usually sorted themselves out after six months. He estimated that Mr Hall now has a 3% risk of having a rhythm disturbance or some other cardiac problem. This can be compared with a 1% risk with the population as a whole.

29. CASA also called its Director of Aviation Medicine, Dr Peter Wilkins, to give evidence. Dr Wilkins provided a statement dated 17 November 2003 (R3). He has been involved in the assessment of aviation medical standards applied to aircrew since 1974 and has held his current position since August 1998. Dr Wilkins said that having seen Mr Hall's Gated Blood Pool Study dated 5 December 2003, he still believes the decision dated 17 June 2003 was appropriate, although he acknowledged that he now holds his view less strongly than he did on 17 November 2003. The Study shows that Mr Hall's LVEF has improved although it is still not normal. The other concern is whether Mr Hall has damage to his heart muscle.

myocardial dysfunction carries with it a real risk, whilst he is flying an aircraft, that he would experience cardiac arrythmia, and that the ability of his heart to pump blood to various parts of his body would be impaired. Furthermore, the likelihood of these events may be increased by the relative hypoxia experienced at altitude and by the adrenergic effects of any acutely stressful episode experienced during flight (R3 p10).

He accepted Dr Peak's estimate of Mr Hall's experiencing arrythmia or some other cardiac problem as being three per cent.

31. Dr Wilkins acknowledged that the December 2003 edition of the DAME Handbook provides for a LVEF of at least 45%. He emphasised that the Handbook is not intended to be completely prescriptive or authoritative but is intended as a guide to current clinical practice. He noted that the equivalent International Civil Aviation Organisation (ICAO) standard LVEF for "normal or near normal" is more than 50%. However, the ICAO tends to be conservative in their approach while Australia tends to take a more liberal approach.

32. Dr Wilkins said test results to determine whether Mr Hall's heart muscles are functioning properly is what is needed currently and, if those results are favourable, then this should impact favourably on any future decision concerning Mr Hall. Mr Hall can reapply for a medical certificate at any time. He does not need to wait for the 12 months of his current certificate to expire before reapplying.

33. Dr Wilkins said that as Director of Aviation Medicine, he has regular case meetings with the two medically qualified CASA case officers to discuss applications for medical certificates. In the case of applications involving heart conditions, a cardiologist will also attend such meetings. Before he retired in May 2003, this would often have been Dr Peak. Dr Wilkins said the "likelihood" of a person's condition interfering with the safe exercise of privileges or performance of duties is considered in individual cases. He acknowledged that CASA did not consider alternative conditions to that of the dual pilot requirement imposed on Mr Hall.

34. Under the applicable, old regulations referred to above, the issue for the Tribunal to determine is whether Mr Hall's heart condition "is likely to interfere with the safe exercise of privileges, or performance of duties" under the private pilot's licence that he applied for. If the new regulations were to apply, there are two relevant issues: first, whether pursuant to the medical standard (regulation 67.180(2)(c)) set out in Table 67.155, paragraph 2.9, Mr Hall has a "safety-relevant heart abnormality"; and, second, if he does, the extent to which he does not meet the medical standard "is not likely to endanger the safety of air navigation" (regulation 67.180(2)(e)).

35. In their submissions, both parties referred to the discussion of the meaning of the word "likely" in the Tribunal decision in Re Window and Civil Aviation Safety Authority [1999] AATA 525, and sought to rely on the Tribunal's exposition at paragraph 60:

Having regard to the need to protect public safety while having regard to a person's entitlement to pursue his or her ambitions, we consider that the word "likely" means "a substantial or real and not a remote chance". That is not a matter which can be assessed on statistical likelihood and certainly does not mean "more likely than not", "odds on" or "a more than 50% chance of a thing happening". To adopt those latter three meanings would, in our view, be to place too little weight on the protection of public safety and too much on an individual's entitlements.

36. The Tribunal notes that the meaning of words should be considered in the context in which they appear. The discussion in Re Window (supra) was in the same context as in this matter - that is the Act, the old regulations and medical standards. The Tribunal endorses that discussion and the meaning accorded to "likely" which it adopts for the purpose of its decision.

37. Mr Parkin, for the Respondent, also referred the Tribunal to s 9A(1) of the Act. This states:

in exercising its powers and performing its functions, CASA must regard the safety of air navigation as the most important consideration.

The Tribunal considers that air safety was given appropriate weight in Re Windows (supra).

38. There is no dispute that Mr Hall suffers from a heart abnormality. Following a myocardial infarction (heart attack) in September 1990, he underwent a three vessel coronary bypass procedure at Royal North Shore Hospital. He was advised at the time that the vein graft to the right coronary artery would require attention in 10 to 15 years time. In October 2002, Mr Hall experienced "typically ischaemic chest pain" (Dr John Woods' report of 6 June 2003 - T8 p21) while he was overseas. On his return to Australia, he had an angiogram which indicated that the vein graft was blocked. He then underwent a procedure to insert:

A Rapamycin-coated stent to the most focal lesion in the native right coronary artery, and a second stent to the distal left main and proximal part of the native circumflex (T8 p21).

39. At the time Mr Hall went overseas in 2002, he was in the process of completing the necessary documentation to apply for the annual renewal of his Class 2 Medical Certificate with a view to the renewal of his private pilot's licence. As a result of the events of October 2002, described above, he did submit the necessary Medical Questionnaire and accompanying medical reports for the renewal of his Class 2 Medical Certificate until late May 2003. A later report from Mr Hall's treating cardiologist, Dr John Woods, dated 6 June 2003 (T8 p21) reported a "mildly impaired LVEF at 41%". Dr Woods concluded:

Mr Hall is stable from a cardiac view point without clinical symptoms to suggest ongoing ischaemia. There is minimal reversible ischaemia on his perfusion scanning. His LVEF is normal or, at most mildly impaired. Risk factors are gradually coming under control, although he does need to lose weight.

40. On 17 June 2003, CASA issued a medical certificate for Mr Hall with the following endorsement (T9 p22):

Class 2 `As or With Co-pilot' valid for 12 months.

This is the decision under review, the issue being whether Mr Hall's heart condition was likely to interfere with the safe exercise of his private pilot's licence. Dr Wilkins' evidence is that Mr Hall's:

Myocardial dysfunction carries with it a real risk, whilst he is flying an aircraft, that he would experience cardiac arrythmia, and that the ability of his heart to pump blood to various parts of his body would be impaired. Furthermore, the likelihood of these events may be increased by the relative hypoxia experienced at altitude and by the adrenergic effects of any acutely stressful episode experienced during flight (R3 p10).

41. Dr Wilkins and Dr Peak gave evidence of there being two principal concerns: first, Mr Hall's lower than usual LVEF; second, whether Mr Hall has reversible cardiac ischaemia (impaired blood flow to the heart muscle). Although Mr Hall subsequently provided a Gated Cardiac Blood Pool Study dated 5 December 2003 (A1) recording an improved LVEF of 48%, a Stress Myo-cardial Perfusion study is required to show the blood flow to Mr Hall's heart muscle.

42. Was Mr Hall's heart condition likely to interfere with the safe exercise of his private pilot's licence in the sense of "a substantial or real and not a remote chance" (Re Windows (supra) para 60)? Dr Peak gave evidence that on the basis of what he now knows of Mr Hall's condition - in particular, his improved LVEF of 48%, he assessed the risk of Mr Hall having a rhythm disturbance or some other cardiac problem at 3%. The equivalent risk for the population as a whole is 1%. Dr Wilkins accepted Dr Peak's estimates.

43. Mr Hall, while accepting the meaning of "likely" set out in Re Windows (supra), submitted, nevertheless, that the risk in his case is so small that it could not reasonably be considered "likely".. He said aviation has for him been a lifetime passion. With the current endorsement on his Class 2 Medical Certificate requiring that he only fly with a co-pilot in a dual control aircraft with adjacent seating, he is unable to fly the aircraft that he co-owns which has tandem seating, and he cannot operate in the gliding club to which he belongs. Mr Hall is a recreational flier who in any year would not fly more than 50 hours. He suggested that CASA had not given proper consideration to his circumstances in assessing what was "likely" and had not considered, as Dr Wilkins acknowledged, imposing alternative conditions on his medical certificate, such as an altitude limitation to address the risk of hypoxia.

44. Mr Parkin emphasised that the safety of air navigation is the most important consideration. He submitted that the risk in Mr Hall's case was more than remote and was appropriately addressed in his current licence by the requirement that he only fly with a co-pilot.

45. As the Tribunal stated in Re Windows (supra), the assessment of what is "likely" cannot be based on statistical likelihood. In this context, it is a matter of weighing up the requirements of air safety with the applicant's interest in the safe exercise of the privileges and performance of the duties associated with holding a private pilot's licence. The Tribunal's view is that in June 2003, given the medical information available to CASA, a decision to impose a condition on Mr Hall's Class 2 Medical Certificate was reasonable given the risks associated with his heart condition when considered in the context of air safety. In terms of the medical standard in Schedule 1, Part 1 of the old regulations, and whether his heart condition was likely to interfere with the safe exercise of his privileges or performance of his duties associated with his holding a private pilot's licence, there was a real risk, albeit a small one. When issues of air safety are under consideration, a small risk may be sufficient to trigger the need to take appropriate action to address the risk. This was the case here.

46. Having determined that Mr Hall did not meet the medical standard in Schedule 1 of the old regulations, regulation 6.10 then permits CASA to issue a special medical certificate which, pursuant to regulation 6.12, CASA may issue "subject to any condition that is necessary in the interests of the safety of air navigation, having regard to the medical condition of the person".

47. Although Mr Hall expressed scepticism about CASA's decision-making process and the failure to consider alternative conditions to that imposed, the Tribunal considers that it was not unreasonable, having regard to Mr Hall's medical condition at that time, to impose a condition limiting Mr Hall to fly with a co-pilot for the 12 month duration of the certificate. The Tribunal therefore affirms the decision under review.

48. The Tribunal notes that even if the new regulations had applied, it would have made the same decision. In the Tribunal's view, Mr Hall has a "safety-relevant, heart abnormality" (Table 67.155, paragraph 2.9) in so far as it "is likely to reduce" (regulation 67.015) the ability to exercise the privileges or to perform the duties associated with holding a private pilot's licence: there is a real risk of this, albeit a small one. Mr Hall does not therefore, meet the medical standard. Regulation 67.180 permits the issue of a medical certificate in these circumstances provided it "is not likely to endanger the safety of air navigation". Regulation 67.195 permits CASA to impose a condition on the medical certificate for this purpose. In the Tribunal's view, the condition imposed by CASA in June 2003 was appropriate to ensure that the issue of the medical certificate was not likely to endanger the safety of air navigation. The Tribunal would, therefore, have affirmed the decision under review had the new regulations applied.

49. In giving evidence, Dr Wilkins stated that Mr Hall is not limited to waiting for the expiry of his current 12 month medical certificate before reapplying: he can apply for a new certificate at any time. Mr Hall said he was unaware of this and, had he known, he might have reapplied and these proceedings might have been avoided. It is obviously unfortunate that he was not aware of this previously.

I certify that the 49 preceding paragraphs are a true copy of the reasons for the decision herein of Mr RP Handley, Deputy President

Signed: .......................................................................................

Representative for the Respondent Mr G Parkin, Legal Counsel