OVENS and CIVIL AVIATION SAFETY AUTHORITY
[2010] AATA 481
•29 June 2010
Administrative Appeals Tribunal
DECISION AND REASONS FOR DECISION [2010] AATA 481
ADMINISTRATIVE APPEALS TRIBUNAL )
) No 2009/3959
GENERAL ADMINISTRATIVE DIVISION ) Re RODERICK OVENS Applicant
And
CIVIL AVIATION SAFETY AUTHORITY
Respondent
DECISION
Tribunal Professor RM Creyke, Senior Member Date29 June 2010
PlaceCanberra
Decision The decision under review, to issue Mr Ovens a Class 2 medical certificate with a condition that he flies with a safety pilot, is affirmed.
.......................[sgd]................
Professor RM Creyke, Senior Member
CATCHWORDS
CIVIL AVIATION – Conditions for private pilot licence – Class 2 medical certificate under Regulation 67.155 of the Civil Aviation Safety Regulations 1998 (Cth) – Type 1 diabetic to fly with safety pilot – safety requirements under the Civil Aviation Act 1988 (Cth) and associated regulations – Applicant diabetic over 50 years with progressive and irreversible symptoms – Civil Aviation Safety Authority ‘Protocol for Type 1 Diabetic Pilot Applicants’ preferred over US Federal Aviation Authority Protocol – decision under review affirmed.
Civil Aviation Act 1988 (Cth) ss 3, 9A, 20AB
Civil Aviation Regulations 1988 (Cth) reg 5.04
Civil Aviation Safety Regulations 1998 (Cth) regs 67.015, 67.155, 67.175, 67.180, 67.195
Convention on International Civil Aviation 1947
Re Serong and Civil Aviation Safety Authority (2006) 93 ALD 673
29 June 2010 REASONS FOR DECISION
Professor RM Creyke, Senior Member 1. Mr Ovens is 62 years old and has held a private pilot’s licence since 1981. He has more than 425 flying hours of experience flying single and twin engine aircraft.
2. Mr Ovens was diagnosed with Type 1 diabetes in 1960 when he was 12 years old. He is insulin dependent and since 12 December 2008 has used an insulin pump which better enables him to monitor his blood sugar levels.
3. Mr Ovens has a Class 2 medical certificate enabling him to fly with a safety pilot. He has sought a Class 2 medical certificate without the requirement for a safety pilot. He said he wished to fly up to 300 hours a year for social and recreational purposes.
4. On 22 July 2009, the Civil Aviation Safety Authority (Authority) refused his request on the grounds that he does not meet the safety requirements under the Civil Aviation Act 1988 (Cth) (Act) and its associated regulations.
5. Instead, the Authority issued Mr Ovens with a class 2 medical certificate with a condition permitting him to fly an aircraft as an insulin dependent pilot, but only when accompanied by a safety pilot. On 7 August 2009, the Authority affirmed that decision. On 19 August 2009, Mr Ovens applied to the Tribunal for review of the decision.
6. Since then the Authority has issued the Protocol for Type 1 Diabetic Pilot Applicants (Authority’s Protocol), which contains specific requirements for the issue of a Class 2 medical certificate. The Protocol is based on an equivalent protocol issued by the US Federal Aviation Authority (FAA Protocol). A final version of the Authority's Protocol was issued on 22 April 2010 during the course of the Tribunal proceedings. The Authority is seeking a cohort of pilots with diabetes to test the Protocol.
Legislation
7. The relevant legislation is contained in a combination of the Civil Aviation Act 1988 (Cth) (Act), the Civil Aviation Regulations 1988 (Cth) (1988 Regulation), and the Civil Aviation Safety Regulations 1998 (Cth) (1998 Regulations). The relevant provisions are:
Civil Aviation Act 1988 (Cth)
3Interpretation
civil aviation authorisation means an authorisation under this Act or the regulations to undertake a particular activity (whether the authorisation is called an AOC, permission, authority, licence, certificate, rating or endorsement or is known by some other name).
9A Performance of functions
(1) In exercising its powers and performing its functions, CASA must regard the safety of air navigation as the most important consideration. …
20AB Flying aircraft without licence etc.
(1) A person must not perform any duty that is essential to the operation of an Australian aircraft during flight time unless:
(a) the person holds a civil aviation authorisation that is in force and authorises the person to perform that duty; or
(b) the person is authorised by or under the regulations to perform that duty without the civil aviation authorisation concerned.
Penalty: Imprisonment for 2 years. …
Civil Aviation Regulations 1988 (Cth)
5.04Medical certificate: flight crew licence
(1)Without the permission of CASA, the holder of a flight crew licence must not perform a duty authorised by the licence if the person does not hold a current medical certificate that is appropriate to the licence.
Penalty: 50 penalty units.
(1A)An offence against subregulation (1) is an offence of strict liability. …
(3)For the purposes of this regulation, a medical certificate is appropriate to a flight crew licence if:…
(b) in the case of …a private pilot licence … the medical certificate is a class 1 or class 2 medical certificate.
Note 1 Class 1 and class 2 medical certificates are issued under Part 67 of CASR.
Note 2 The medical standards for obtaining each class of medical certificate are set out in Part 67 of CASR.
Civil Aviation Safety Regulations 1998 (Cth)
67.015Meaning of safety‑relevant
For the purposes of this Part, 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.
67.155 Who meets medical standard 2
(1)Subject to subregulations (2) to (7) a person who satisfies the criteria in table 67.155 meets medical standard 2. …
Table 67.155 Criteria for medical standard 2
Item
Criterion
Abnormalities, disabilities and functional capacity
2.1 Has no safety‑relevant condition of any of the following kinds that produces any degree of functional incapacity or a risk of incapacitation:
(a) an abnormality;
(b) a disability or disease (active or latent);
(c) an injury;
(d) a sequela of an accident or a surgical operation
2.2 Has no physical conditions or limitations that are safety‑relevant 2.3 Is not using any over‑the‑counter or prescribed medication or drug (including medication or a drug used to treat a disease or medical disorder) that causes the person to experience any side effects likely to affect the person to an extent that is safety‑relevant … Nervous system
2.7 Has no established medical history or clinical diagnosis of:
(a) a safety‑relevant disease of the nervous system; or
(b) epilepsy; or
(c) a disturbance of consciousness for which there is no satisfactory medical explanation and which may recur
[Cardiovascular system] …
Alimentary system and metabolic disorders
… 2.14 Is not suffering from safety‑relevant metabolic, nutritional or endocrine disorders 2.15 If suffering from diabetes mellitus:
(a) the condition is satisfactorily controlled without the use of any anti‑diabetic drug; or
(b) if an oral anti‑diabetic drug is used to control the condition:
(i) the condition is under on‑going medical supervision and control; and
(ii) the oral drug is approved by CASA …
[Visual requirements] …
67.175Medical certificates — application
A person may apply to CASA for the issue of a medical certificate.
67.180Medical certificates — issue and refusal
(1)Subject to this regulation, on receiving an application under regulation 67.175, CASA must issue a medical certificate to the applicant only if:
(a)the applicant meets the requirements of subregulation (2); …
(2)For paragraph (1) (a), the requirements are:
(a)the applicant has undergone any relevant examinations that, in the opinion of CASA, are necessary in the particular case; and
(b)each relevant examination has been carried out by an examiner to whom subregulation (4) applies; and
(c)for each relevant examination, the applicant answers every question asked by the examiner that the examiner considers necessary to help CASA to decide whether the applicant meets the relevant medical standard; and
(d)subject to subregulation (5), the applicant authorises the disclosure to CASA and the examiner of any information about the applicant that may help CASA to decide whether the applicant meets the relevant medical standard, being information that is held by a person, organisation, body or authority referred to in subregulation (6); and
(e)either:
(i)the applicant meets the relevant medical standard; or
(ii)if the applicant does not meet that medical standard — the extent to which he or she does not meet the standard is not likely to endanger the safety of air navigation; and
(f)if, in addition to any relevant examinations that the applicant has undergone under paragraph (a), CASA has directed the applicant to undergo an examination under subregulation 67.165 (1):
(i)the applicant has undergone that examination; and
(ii)having taken into account the result of the examination, CASA is satisfied that issuing a medical certificate to the applicant would not endanger the safety of air navigation.
Note 1 The routine examinations that an applicant for the issue of a medical certificate must undergo to establish whether he or she meets the relevant medical standard for the certificate are those set out in the Designated Aviation Medical Examiner’s Handbook. …
(7)CASA must not issue a medical certificate to an applicant if it is satisfied that the applicant:
(a)has knowingly or recklessly made a false or misleading statement in relation to the application for the medical certificate; or
(b)does not satisfy the requirements of this regulation; or
(c)has not, in the course of undergoing a relevant examination for the medical certificate, complied with a request made under subregulation 67.170 (1).
(8)A medical certificate issued to an applicant who does not meet the relevant medical standard for the issue of the certificate, or to whom subparagraph (2) (f) (ii) applies, must bear a note of that fact.
(9)The fact that an applicant who does not meet the relevant medical standard in all respects has previously been issued with a medical certificate under subparagraph (2) (e) (ii) or (f) (ii), or a special medical certificate (within the meaning of Part 6 of CAR), does not automatically entitle him or her to the issue of a further such medical certificate.
67.195Medical certificate — conditions
(1)CASA may issue a medical certificate to a person 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.
(2)In particular, CASA may issue a medical certificate subject to a condition that the period during which the certificate remains in force may be extended only by CASA.
(3)A person must not contravene a condition subject to which his or her medical certificate is issued.
Penalty: 50 penalty units.
(4)An offence against subregulation (3) is an offence of strict liability.
(5)A condition to which a medical certificate is subject must be set out in the certificate.
Issues
8. The following issues were identified:
·Whether Mr Ovens satisfies the criteria in regulation 67.180 of the 1998 Regulations?
·If so, whether the medical certificate should be subject to any condition(s), and if so, what condition(s)?
·Whether any condition(s) should be imposed in accordance with the Authority's Protocol issued on 22 April 2010, or the US FAA Protocol, or a like protocol devised by the Tribunal?
Background
9. Mr Ovens was born on 19 April 1948. He is a long time diabetic, having been diagnosed with diabetes in 1960 at age 12 on the first day of high school. He is insulin dependent, which brings him within the Type 1 category.
10. Mr Ovens said the diagnosis meant he was unable to do sports or to go away for school excursions in high school, as he had to inject himself with insulin and have regular urine tests to check his blood sugar levels. At that time, there were few specialists in diabetes and there was considerable stigma attached to the condition. Mr Ovens said at the hearing that at various times this prejudice has prevented him joining the public service and the armed services (he had wanted to go to Vietnam). As he said, the condition has meant he has not 'been able to do a darned thing for my country.’
11. Subsequently, knowledge of diabetes has improved and medical expertise has increased. In particular, since Mr Ovens has been on an insulin pump, the operation of which he demonstrated to the Tribunal, monitoring blood sugar levels is much easier and less accident-prone. He said the practicalities of testing his blood sugar levels with a pump only requires him to prick a finger and squeeze out some blood, which is read by a glucometer. The process, which he demonstrated, takes only about five seconds.
12. Being a diabetic means he is reliant upon receiving insulin. The insulin pump that Mr Ovens uses is strapped to his body and delivers a small amount of fast-acting insulin on a regular basis every three minutes. This is known as the ‘basal’ amount. Prior to a meal, Mr Ovens calculates the carbohydrate content of the meal and programs the pump to provide extra – or bolus – insulin to counteract the effect of the increased carbohydrate or sugar. The pump has an alarm and vibrates as a safety mechanisms if it fails for any reason.
13. The purpose of a level of tight control of blood sugar levels is to avoid the long-term damaging effect of excess sugar on the body's systems. At the same time, keeping sugar levels low means the person is also at risk of having a hypoglycaemic episode, which may affect cognitive functioning. The Authority's Protocol provides that in order to fly, the person must keep their sugar at a slightly elevated level, that is, between 5 and 15,[1] in order to avoid hypoglycaemia. If a person's blood sugar level falls below a safe level, they take carbohydrates to elevate the blood’s sugar level. If a person's blood sugar gets too high, this can produce hyperglycaemia, a condition which also can affect cognitive ability.
[1] The world unit of measurement of blood sugar is mmol/L = millimoles/litre of glucose in the blood. For ease, only the raw numbers will be given in these reasons.
14. Other conditions for diabetics which cause concern are autonomic neuropathy, peripheral neuropathy, heart conditions, renal conditions, and damage to the eyes.[2] Autonomic neuropathy is damage to the non-voluntary, non-sensory nervous symptom which affects internal organs such as the bladder, the cardiovascular system, the digestive tract, and the genital system. Having autonomic neuropathy reduces the body's ability to produce signs which a diabetic can recognise, for example, of an impending hypoglycaemic event, and can lead to hypoglycaemic unawareness. Peripheral neuropathy leads to loss of nerve functions which can affect coordination and sensation. Damage to the eye can take the form of maculopathy, that is, damage to the macula, an area at the centre of the retina that is associated with highly sensitive, accurate vision. An issue was whether Mr Ovens had any of these conditions. He is generally a fit person.
[2] As listed in Civil Aviation Safety Regulations 1998 (Cth) reg 67.155 – Table 67.155 criteria for medical standard 2.
15. Mr Ovens said he had had a variety of occupations, and most recently, from 1996 he spent nine years driving buses for the New South Wales State Transit Authority, both articulated buses and rigid vehicles. Initially, he said he found the shift work involved in bus driving interrupted his administration of his insulin schedule. At that time, his control was not as good as at present and he was relying on self-injection of slow-acting insulin. However, he said he managed by taking a blood sugar test at the end of a bus run and if his level dropped he generally took some carbohydrates.
16. In 2005, he had an incident while driving a bus. He became unconscious for a short while – in his words, he had a vasovagal faint – that is, a ‘temporary loss of consciousness caused by an abrupt slowing of the heartbeat’[3]. Despite his short lack of consciousness, he managed to park the bus and check on his passengers and then he reported the incident. The bus came to a halt before he regained consciousness because his arm came forward when he hit the curb and automatically threw on the brakes.
[3] G Macpherson (ed), Black’s Medical Dictionary (40th ed, 2002), 659.
17. .Mr Ovens was stood down from duty and returned to Gosford, New South Wales, on the central coast where he lives. He then admitted himself to his local hospital for checking. While there, he had a second episode. A neurologist, Dr Jonathon Sturm, found no neurologic abnormality and said he thought Mr Ovens had appendicitis Mr Ovens said sugar samples were taken at the hospital, where he stayed for five days, and he was not found to be hypoglycaemic. However, it was unclear what caused the incidents. Mr Ovens said that he had a gastric condition that day and had been feeling unwell. [Trans 71]
18. Dr John Woods, cardiologist, in a report of 10 April 2008, noted that he and Dr Sturm, consultant neurologist, had agreed that the conditions that day were probably due to ‘vasovagal syncope’ or fainting. They noted that Mr Ovens had no similar incident in the subsequent three years. Mr Ovens was promoted to be an accident prevention officer for the State Transit Authority some time after the bus accident, but has since retired.
19. Mr Ovens said he has had only two hypoglycaemic events since he began using his insulin pump in December 2008 and they were in the early months when he was becoming accustomed to the device. On the first of these occasions, Mr Ovens said he had taken the day off work to attend an appointment with Dr Sulway, his treating endocrinologist. The train trip from the central coast to Sydney takes about an hour and a half and Mr Ovens intended to have something to eat at a cafe on arrival but it was closed and he had not taken his bag which contained his carbohydrates and sugars. When he arrived at the surgery, he told Dr Sulway his blood sugar was low and Dr Sulway’s receptionist provided him with a fruit juice and he recovered. His blood sugar level on that occasion was 2.2, which is categorised as a grade 2 or 3 diabetic incident.[4]
[4] There are a variety of descriptions of levels of hypoglycaemic episodes. A medically accepted description is that Grade 1: can be detected biochemically but it does not produce symptoms; Grade 2: produces only mild symptoms and can be easily treated by the affected person; Grade 3: produces more severe symptoms and requires the assistance of another person; and Grade 4: is very severe, producing unconsciousness, coma and/or convulsions and requiring emergency treatment in hospital.
20. On the occasion of his second hypoglycaemic incident he was at work at the Waverley Bus Depot, which was not his usual base. Because he was behind schedule he had rushed to get to the Waverley Depot and had left his briefcase at his usual workplace. As a consequence, he missed lunch. On visiting Dr Sulway, his blood sugar was again low (3.2) and Dr Sulway gave him fruit juice and his blood sugar level recovered. On neither occasion did Mr Ovens lose consciousness. He explained that prior to a hypoglycaemic episode he gets a tingling in his toes and becomes ‘a bit sweaty and headachy’. He said at the hearing that he was confident that he could 'identify any symptoms of a hypoglycaemic episode'.
21. Mr Ovens said there was also an occasion in 2007 when he had what was described by Dr Sulway in his report of 30 June 2008 as another ‘grade 2 hypoglycaemic episode’. He was at home, preparing a meal and his blood sugar levels became low. A guest, who was unfamiliar with the symptoms, became anxious and called an ambulance. However, Mr Ovens took sugar in the meantime, and when the paramedics arrived he was tested and his blood sugar levels were at an acceptable level, so the paramedics left. Mr Ovens’s evidence is that he has had no serious hypoglycaemic episode so as to need external intervention in the last ten years. He did concede in cross-examination, however, that while he was working for the State Transit Authority in the late 1990s, doing shift work, his overall glycaemic control was poor.
22. Mr Ovens said he started flying in 1981 and obtained his unrestricted private pilot’s licence in September 1982. He flies for social and recreational purposes only. He has never wanted a commercial licence. He has done over 430 hours of flying and has conversions for certain single and twin engine planes and has obtained his night visual rating.
23. In May 1994, Mr Ovens received a letter from the Authority saying he did not meet the criteria for a Class 1 or Class 2 medical certificate. Partly as a result, he did not fly again between 23 January 1994 and 7 September 2008. In late 2007 he renewed his application for a medical certificate. As he said, at this point he was no longer doing shift work so it was possible to find time to fly. Initially, the request was refused on the basis that Mr Ovens had a blood sugar reading of 7.9, higher than the preferred maximum level of 7.5 in the Designated Aviation Medical Examiners Handbook at 2.4 Endocrinology, p 2.4-7. The permission was eventually granted, but the certificate was issued with the condition that he must only fly with a safety pilot. In order to maintain the currency of his medical certificate, Mr Ovens is required annually to submit a report by an endocrinologist, a cardiologist, and an ophthalmologist.
24. Mr Ovens last flew in February 2009. The longest leg of a flight he managed since resuming flying in 2007 was in 2008 when he flew non-stop from Gladstone to Burketown, which took over five hours. On that trip, according to his fellow pilot on that occasion, Mr Hugh Bridge, Mr Ovens efficiently managed his blood sugar level. In total on that trip, he flew for 13.3 hours over four days.
25. Mr Ovens retired in 2009 and is anxious to do more flying, preferably without a safety pilot, since that will markedly reduce the cost. In 2008 and 2009, Mr Ovens has been bringing his flying skills up-to-date and in the period October 2008 to April 2010 he has undertaken some 27 hours flying. When asked how he would manage his blood sugar monitoring in difficult flying conditions, Mr Ovens said that he had faced at least three occasions when flying conditions were adverse and he managed all of them without incident, including one which involved activating the emergency services at Bankstown airport prior to landing.
26. Mr Ovens conceded that he had some maculopathy. However, he said the condition was stable and did not affect his ability to fly. He also has symptoms of autonomic neuropathy and some level of peripheral neuropathy. Mr Ovens said that in practice the peripheral neuropathy, although affecting his feet, is irrelevant to his flying, provided he complies with his insulin protocol. He also has some wasting of his thumbs.
27. Mr Ovens explained to the Tribunal how he had no difficulty taking blood samples when he flies. He said if it was time to take his blood sugar levels and the weather was rough, he could manage by putting one arm around the gear-stick of the aircraft and would take his blood sugar levels with one hand in that position. Mr Ovens said when he flies he reduces his basal rate by 70 per cent and that works admirably to maintain his blood sugar at an acceptable level.
28. He acknowledged that if his glucometer failed it could lead to problems and he said he would be prepared to get a second device as a back-up while flying if he were permitted to fly solo. If the insulin pump did fail he said that he would either land the plane if there was a nearby airport or continue to his destination, depending on his sugar levels, which he would continue to monitor. As he said, it takes some time for the impact of insulin deficiency adversely to affect someone and since his plans were not to go on long trips he would never be too far away from an airport base.
29. For adult diabetics the blood sugar level for everyday activities should be between 6.5 and 7.0. In a report on Mr Ovens’s insulin levels dated 2 February 2009, it was noted that as at 7 May 2008 Mr Ovens’s blood sugar (HbA1c[5]) level was 7.6, on 28 November 2008 7.8, on 30 January 2009 7.5, and on 16 April 2009 it was 7.3. Mr Ovens tendered his diabetes control logbook for 2 March 2010 to 8 April 2010 which showed the number of readings per day averaged 4.3. He also noted that his pump is called an Animas and it is manufactured by a company called Johnson & Johnson. However, he did not provide evidence about its performance at altitude.[6]
[5] HbA1c is a test that measures the amount of glycosylated haemoglobin in the blood.
[6] The Tribunal was provided with references to the Animas 2020 User Guide, the full version of which was accessible online. The User Guide advised (at p 13) that the device should be disconnected, but not suspended, in aircraft without cabin pressurisation. The Tribunal did not receive evidence as to whether the single and twin aircraft flown by Mr Ovens are pressurised. However, it notes that he has flown previously with an experienced pilot using his glucometer. Page 109 of the User Guide also recommends disconnecting the device at 106kPA ambient pressure, or 10,000 feet: evidence
30. Concurrent evidence was given by three endocrinologists; Professor Creswell Eastman, Dr Martyn Sulway and Professor Geoff Nicholson.
31. Dr Martyn Sulway is currently the staff specialist in endocrinology at North Shore Hospital, Sydney. In addition to his oral evidence, Dr Sulway provided a number of written reports: one dated 30 June 2008; a second on 18 June 2009; a third, dated 21 July 2009; and a fourth dated 26 March 2010.
32. In his 30 June 2008 report, Dr Sulway noted Mr Ovens’s general good health, but also referred to him having ‘some diabetic retinopathy’; ‘gross peripheral neuropathy with very elevated vibration sense thresholds … absence of tendon reflexes at the ankle, and loss of his 10 gm monofilament sensitivity’ and ‘diminished light touch over the lower third of his tibias bilaterally’. In his 21 July 2009 report, he said: ‘This peripheral neuropathy is in line [with] the degree of autonomic neuropathy that has been demonstrated in the past year on objective testing’.
33. Dr Sulway reported two incidents in which he categorised Mr Ovens as hypoglycaemic. At the hearing, he noted that the first was on 6 June 2008, Mr Ovens announced on arrival that his blood sugar levels were low and when Dr Sulway took a reading they were 2.2. Dr Sulway said Mr Ovens ‘stated that he was unaware … he was hypoglycaemic, behaving slightly erratically and feeling quite well as far as he was concerned’. He also commented that ‘parallel with his objective evidence of peripheral neuropathy, [there is] some degree of autonomic neuropathy which is irreversible’. At a second visit 30 January 2009, when Mr Ovens had arrived in Sydney by train and had not had lunch. His blood sugar level was 3.2. Dr Sulway noted Mr Ovens’s low blood sugar levels were 'Not detected by him'. However, he acknowledged that Mr Oven's cognitive level did not seem to be impaired.
34. At the hearing, Dr Sulway agreed that on both occasions Mr Ovens's behaviour could not be recognised as cognitively deficient. At the same time, he noted that Mr Ovens had been a diabetic for over 50 years and studies indicate that progressively, 10 years after having diabetes, there is a decrease in the hormones that enables a person to be aware that they are becoming hypoglycaemic. In these circumstances, his view was that Mr Ovens’s diabetic awareness levels must be suspect. Even though he conceded that Mr Ovens's diabetic control was good, and that under the Authority's Protocol he would be required to test his blood sugar levels a half hour prior to flight and while in flight to measure his blood hourly, or if he could not take a reading, to ingest carbohydrate, Dr Sulway’s opinion was that there remained a risk if Mr Ovens flew without a safety pilot.
35. In his 18 June 2009 report, Dr Sulway commented on Mr Ovens’s printout of his glucose levels for a three month period between 22 January 2009 and 15 April 2009. He explained that readings by a glucometer of the kind used by Mr Ovens could involve an error rate of plus or minus up to 0.9 of the unit of measurement at the lower end of the range. Values between 3 and 4 could he said to ‘represent incipient hypoglycaemia’ and he said that ‘values before 3 are very likely to be hypoglycaemic values’.
36. Dr Sulway examined Mr Ovens’s glucometer readings between the period 22 and 27 January 2009. They showed that 12.2 percent of the readings were values of 3 and 4 and 9.8 per cent had values below 3. In the period 3 to 7 February 2009, 14.6 per cent of values lay between 3 and 4, and 14.6 per cent were below 3. For the period 28 February to 15 April 2009, on average, 4.3 per cent of readings lay between values of 3 and 4, while 1.8 per cent of readings lay below 3.
37. In relation to autonomic neuropathy, Dr Sulway conceded that Mr Ovens's tests were normal in one case but a second tilt-table test indicated he had a mildly abnormal condition. However, because of the strong association of unawareness in diabetics and autonomic neuropathy, his peripheral neuropathy, his length of time as a diabetic and the reduction in endocrine safety factors, Mr Ovens was at a greater risk than others. That meant Mr Ovens had an ‘enhanced risk of suffering hypoglycaemia, which would impair consciousness, reaction times, and alertness which would be potentially disastrous in flying conditions’.
38. In his report of 21 July 2009, Dr Sulway noted that Mr Ovens had reported no grade 2 or grade 3 hypoglycaemic episodes. For the period 12 May to 10 July 2009, 11.8 per cent of Mr Ovens’s readings were between the values of 3 and 4, and 3.4 per cent were below 3. He also said Mr Ovens has –
…marked peripheral neuropathy as indicated by elevated vibration sense thresholds as measured by biothesiometer and loss of his … sensitivity. This peripheral neuropathy is in line [with] the degree of autonomic neuropathy that has been demonstrated in the past year on objective testing.
39. At the hearing, Dr Sulway said in his view Mr Ovens had 'gross peripheral neuropathy'. The biothesiometer test, which measures sensation, indicated that Mr Ovens had a 25 per cent increase risk as compared with a normal person. At the same time, Dr Sulway acknowledged that Mr Ovens’s peripheral neuropathy was not affecting him at that stage. It was only the association with autonomic neuropathy which heightened his concern. Dr Nicholson strongly disagreed with Dr Sulway's conclusion based on sensation testing that Mr Ovens had gross peripheral neuropathy. Professor Eastman said the disagreement could only be solved by taking nerve conduction studies which had not yet been done, a suggestion disagreed with by Dr Sulway.
40. Dr Sulway acknowledged at the Tribunal that he is not a pilot, nor is he a Designated Aviation Medical Examiner (DAME). He could only comment on the influence of hypoglycaemia on mental performance and judgment and reflexes, but not in the context of flying conditions. He noted that he would have no hesitation about certifying Mr Ovens for the purpose of a driving licence, but in his view, the risk of an air accident to the public was greater,than for a car accident. Dr Sulway also pointed out that diabetic incidents can be unpredictable and even his patients using insulin pumps can have an 'unpredictably bad hypoglycaemic reaction'.
41. He also suggested that before the safety pilot was dispensed with, any person with diabetes should be subject to a period of observation to check whether the person was becoming unaware of being hypoglycaemic during flying, and also to ensure the person could comply with the conditions in the Authority's Protocol.
42. Dr Sulway noted that the company which manufactured the glucometer used by Mr Ovens could not establish the meter’s reliability between 3000 and 10,000 feet. Testing had only been done in unpressurised cabins up to 3,000 feet. Mr Ovens gave evidence that his pump model had been tested up to 10,000 feet. The issue is that the higher the altitude, the less the external pressure, and this could mean increased pressure in the syringe which would expel excess insulin.
43. The other experts also expressed views on this issue. Professor Eastman suggested that both the insulin pump and the glucometer should be tested at high altitude. Dr Nicholson's view was that the equipment should be assessed at the Aviation Medicine Institute at Edinburgh, South Australia. The medical experts were unaware whether the US Federal Aviation Authority had included a height restriction in relation to insulin pumps.
44. In addition, the experts noted the related issue of lack of records by the US Federal Aviations Authority on the level and type of incidents from the pilots with diabetes in the US who are authorised under the FAA Protocol to fly. Dr Fitzgerald, a medical expert employed by the Authority, noted that since the FAA’s Protocol had been in force, there was no data on the level of incidents, although the FAA did record accidents. There was evidence from Dr Silberman, a representative of the US Federal Aviation Authority, that over 500 pilots have been given medical certificates to fly under the US Protocol. In an email on 30 October 2009, he said that, to that date, only five accidents had been reported in 660,529 flying hours.
45. Professor Eastman expressed considerable concern about the failure of the FAA to test whether pilots flying under the protocol have been tested for compliance. There is only a self-reporting requirement. In other words, there was no statistical evidence of incidents such as whether a pilot had to divert to another airport, whether there were violations of controlled airspace, how often blood sugar levels dropped, and how often the pilot had to take action to increase blood sugar levels in flight. Professor Eastman also suggested that Mr Ovens should be tested to demonstrate his ability to fly in different conditions and to follow the Protocol. The experts suggested that two to three hours of testing along these lines would be sufficient.
46. Professor Creswell John Eastman is a consultant physician and endocrinologist, formerly head of the Diabetes Centre, at Woden Valley Hospital, subsequently Director of the Institute of Clinical Pathology and Medical Research at Westmead Hospital, now in private practice but also Clinical Professor of Medicine at the University of Sydney. He is also a Designated Aviation Medical Examiner (DAME) for the Authority. Professor Eastman provided an opinion for the purpose of the hearing, dated 10 November 2009. He had not conducted a medical examination of Mr Ovens.
47. In his report, Professor Eastman noted that Mr Ovens had had Type 1 diabetes mellitus for almost 50 years, seemed to be in good health and his diabetes appeared to be well-controlled. Mr Ovens was also free of coronary heart disease, peripheral vascular disease and diabetic nephropathy. However, he did note some deterioration of the joints in Mr Ovens’s hands and wrists, some eye complications of diabetic retinopathy and maculopathy (although these conditions did not cause any impairment of vision), peripheral neuropathy, and autonomic neuropathy. He commented that Mr Ovens’s peripheral neuropathy was unlikely to have any effect on his hypoglycaemia. He concluded that the risk for flying in Mr Ovens’s case was increased by his autonomic neuropathy and his joint conditions, conditions which were irreversible and usually progressive with age. In his view the disease of his joints -
will cause stiffness, pain, and impaired function in his hands, wrists and other joints; the peripheral neuropathy will cause decreased sensation power and coordination in the feet and legs; the autonomic neuropathy will cause gastric, bowel and bladder problems… and the diabetic retinopathy may cause impaired vision.
48. He added that autonomic neuropathy ‘is the most important cause of “hypoglycaemic unawareness”’. A normally functioning autonomic nervous system mediates against a rapid fall in blood glucose. However, if a person is suffering from autonomic neuropathy, the response to hypoglycaemia is impaired leading to possible ‘cognitive impairment, confusion, impaired consciousness and ultimately coma if the hypoglycaemia is severe and persistent’. In summary, it was Professor Eastman’s opinion that Mr Ovens ‘most likely suffers from hypoglycaemia unawareness and is at increased risk of being incapacitated by hypoglycaemia’.
49. At the same time, he also noted that Mr Ovens’s metabolic control ‘is very good’ and had improved since early 2008, probably due to his use of the insulin pump. He noted that the printout of Mr Ovens’s blood sugar readings indicated that between 21 February and 21 May 2009, he had readings below 2.8 on 13 separate days. He noted, however, that most of his low blood sugar readings indicated only minor hypoglycaemic episodes that did not require outside intervention.
50. It was Professor Eastman’s view that ‘any episode of hypoglycaemic occurring while piloting an aircraft poses a risk to flight safety’. So if measures can be taken early to detect and treat lowered blood sugar levels with taking glucose, this would mitigate the risk. However, Mr Ovens's risk level was higher because of his autonomic neuropathy. In his view, the occasion referred to by Dr Sulway, when Mr Ovens was consulting him and had a blood sugar level at 2.2, leading him to behave erratically but claiming to be well, was a good example of the impact of autonomic neuropathy on levels of awareness. At the hearing, Professor Eastman also pointed out that it was not uncommon for someone with a blood sugar level of 2.2 to behave normally from a cognitive perspective when visiting their endocrinologist. At the same time, he said if you know the patient well you can detect subtle signs. He was also concerned about the unpredictability of diabetes, so that on occasion even the most controlled patient may have a hypoglycaemic incident. [Trans 60] That concern would be heightened should Mr Ovens be faced with dangerous flying conditions, such as a thunderstorm. Professor Eastman said he had no experience of pilots using insulin pumps in flight.
51. Professor Eastman pointed out that the Authority’s medical officers formed the view that:
Mr Ovens’ medical condition poses a real and not a remote risk of in-flight incapacitation due to hypoglycaemia – that the applicant has marked peripheral and autonomic neuropathy and that he has frequent biochemical hypoglycaemic episodes.
52. Professor Eastman noted that the conditions imposed on a Type 1 diabetic by the decision of the Tribunal in Re Serong and Civil Aviation Safety Authority[7] would not be appropriate for Mr Ovens. In that case, Mr Serong did not suffer from autonomic neuropathy and hypoglycaemia unawareness, nor had he been observed to suffer from hypoglycaemia, to act erratically, or to be unaware of his abnormal behaviour. In addition, Professor Eastman said during the hearing that it was his understanding that Mr Serong was an experienced pilot, had an obsessive personality and was meticulous in everything he did. In addition, he had only had diabetes for 10 years, so his diabetes had not impacted on other organs. Nor did he have peripheral neuropathy or autonomic neuropathy. Professor Eastman said that Mr Serong had demonstrated on numerous occasions to an observer that he could fly and maintain control over his blood sugar levels and comply with the conditions in his medical certificate, which were a modified version of those in the FAA Protocol.
[7] Re Serong and Civil Aviation Safety Authority (2006) 93 ALD 673.
53. Professor Eastman also pointed out that Mr Ovens, unlike Mr Serong, had not demonstrated under flight conditions an ability to comply with conditions like those imposed on Mr Serong. Finally, Professor Eastman expressed his concern that any protocol permitting Type 1 diabetic pilots to fly without a safety pilot would need to be subjected to a ‘rigorous monitoring and assessment process.’
54. Professor Geoff Nicholson, consultant endocrinologist, Director of endocrinology and diabetes for Barwon Health, Victoria, and head of the Department of clinical and biomedical sciences, University of Melbourne, provided three reports: one dated 12 August 2008, another dated 2 October 2009 and a final report dated 24 November 2009. He also provided oral evidence. Professor Nicholson is also a Designated Aviation Medical Examiner (DAME). The report dated 2 October 2009 referred specifically to the conditions in the FAA Protocol. In the second report dated 2 October 2009 Professor Nicholson noted that he had examined Mr Ovens on 12 August 2009.
55. In particular he noted that Mr Ovens:
... has no history of hypoglycaemia resulting in loss of consciousness, seizure, impaired cognitive function or requiring intervention by a party, or occurring with warning (hypoglycaemic unawareness). ... Mr Ovens does not have cerebrovascular disease or peripheral vascular disease, but does have mild peripheral neuropathy that is not clinically significant.
56. Professor Nicholson’s view was that Mr Ovens was proficient in monitoring his blood sugar level and managing his insulin pump. In his 12 August 2009 report he noted that Mr Ovens’s improvement in hypoglycaemic control was evident in his blood sugar results, which had reduced from 7.6 per cent in May 2008 to 6.6 per cent in August 2009. In his view, ‘clinically significant hypoglycaemia unawareness is unlikely to be present’. He also found Mr Ovens well educated in diabetes management, and that he ‘monitors regularly with a memory-chip glucometer (ACCU-Chek)’. He expressed his confidence in Mr Ovens's ability to manage the conditions in the FAA Protocol and said his ‘overall risk of significant hypoglycaemia is low’.
57. In his second report, having read the reports of the other specialists, Professor Nicholson affirmed that Mr Ovens’s peripheral neuropathy was moderate. He conceded, based on clinical history, clinical examination, the gastric emptying study, and the clinical neurophysiology studies that Mr Ovens’s autonomic neuropathy was ‘mild’ or, at worst, mild-to-moderate and certainly not ‘marked’, as suggested by Dr Fitzgerald. In this context he noted that, according to Professor Eastman’s table ‘Clinical manifestations of diabetic autonomic neuropathy’, the only clinical feature in the table present in Mr Ovens’s case was erectile dysfunction, a condition which according to studies is present in at least 50 per cent of men over the age of 60.
58. Professor Nicholson’s views on the relationship between HbA1c and severe hypoglycaemia were that Mr Ovens’s risk, given his average HbA1c measurement of 7.1 per cent since he started using the insulin pump, would mean that he had a 65 per cent chance of an episode each year. That calculation was an inaccurate predictor of severe hypoglycaemic episodes for two reasons: ‘the number of prior episodes of severe hypoglycaemic was the strongest predictor of the risk of further episodes’; and the fact that severe hypoglycaemia occurred most frequently – in 55 per cent of cases – during sleep, 43 per cent between midnight and 8:00am.
59. He also noted that the new analogue insulin pumps for many of those with Type 1 diabetes mellitus led to good glycaemic control without increased hypoglycaemia, some studies reporting up to 50 per cent reduction in severe hypoglycaemia. Professor Nicholson calculated the absolute risk of a severe episode for Mr Ovens while flying solo, for up to 100 hours a year, during waking hours, would be 0.334 per cent. That is below the internationally accepted risk of 1 per cent. In addition, since Mr Ovens had not had a severe event over a number of years, and his controls were good, the risk for him was lower still, particularly if he adhered to the Authority’s Protocol, since it was specifically designed to reduce the risk of hypoglycaemia.
60. Professor Nicholson referred to the occasion in 2008 when Mr Ovens’s guest had called an ambulance, and stated that it was not by definition a severe hypoglycaemic episode, since Mr Ovens ingested sugar so there was no need for the ambulance officers to administer treatment. In view of his assessment of Mr Ovens as having only mild autonomic neuropathy, he said this did not substantially increase Mr Ovens’s overall risk of impairment and hence he discounted Dr Fitzgerald’s and Dr Sulway’s concerns on that account.
61. At the hearing, Professor Nicholson conceded that almost everybody with diabetes will have hypoglycaemia occasionally. He also noted that it commonly occurred in endocrinologist's offices since patients reduced their sugar levels prior to a visit to impress their specialists. At the same time, he noted that pilots follow rules strictly while flying and this meant a pilot would monitor their blood sugar levels as directed. In that event, and given the relatively small number of hours a year that a private pilot would be flying, in his view, the risk of hypoglycaemia was 'infinitely small'. He also said that the incidence of hypoglycaemia is reducing and even one severe episode per patient a year these days is unusual. In comparing the situation of Mr Ovens with Mr Serong, Professor Nicholson agreed that Mr Ovens should be tested under the Authority's Protocol for a period and should travel with a safety pilot before the requirement to have a safety pilot was withdrawn.
62. Dr Pooshan Navathe, the Principal Medical Officer with the Authority, provided a report dated 4 November 2009. The report noted that when making a medical certification decision, the Medical Officers consider ‘the overall risk that the applicant’s medical condition presents to aviation safety and the utility and reliability of risk mitigation efforts’. As he said this includes ‘a consideration of the individual’s age, experience, type of flying, currency, extent of flying, the medical condition, the treatment, possible side effects of treatment and a range of other similar and interrelated issues’. Opinions by specialists take into account ‘the specialist’s experience and expertise in relation to aviation medicine and aviation medical certification decision-making’. He noted that:
By and large, unless the diabetes mellitus is severely uncontrolled, the risks arising out of DM [diabetes mellitus] are primarily as a result of the secondary effect on the organ system. However, treatment of the DM places the individual at risk of hypoglycaemia.
63. Dr David Fitzgerald, senior medical officer at the Authority, provided a report dated 10 November 2009 and an affidavit dated 20 April 2010. In Dr Fitzgerald’s opinion, expressed in his 10 November 2009 report, insulin-treated diabetics, particularly Type 1 diabetics, are at greater risk than others of having hypoglycaemic episodes. In his view, despite ‘new advances in diabetes such as insulin pump therapy, these modalities have not been associated with the expected reduction in hypoglycaemic episodes, as current technology … does not mimic natural, biologic controlled insulin secretion’.
64. In Dr Fitzgerald’s opinion, in-flight hypoglycaemia is a significant risk to aircraft safety, and he cited studies showing that ‘even mild degrees of hypoglycaemia are associated with subtle and unrecognised cognitive-motor slowing and poor driving performance, even long before frank unconsciousness occurs’. He conceded, however, that ‘a definitive link between type 1 diabetic drivers and accident risk is more difficult to prove’. In part, he said this is because ‘driving legislation effectively selects out those at high risk’ (a view with which Professor Nicholson disagrees). Counsel for Mr Ovens also objected to this analogy on the ground that there was no reference to sugar levels, time frames or the degrees of cognitive loss involved.
65. In Dr Fitzgerald’s view, ‘hypoglycaemic unawareness puts the diabetic at an up to eight-fold increased risk of severe hypoglycaemia’ Also of concern for Dr Fitzgerald, based on Dr Sulway’s report on Mr Ovens, was the presence of other complications such as ‘gross peripheral neuropathy’, erectile dysfunction, retinopathy in the right eye, and the two vasovagal syncope incidents in 2008. In his view, ‘in the absence of other evidence, a hypoglycaemic episode could not be ruled out’ as the cause. Dr Fitzgerald pointed out that:
CASA will normally not issue a medical certificate to an Applicant who suffers from diabetes of any type if the applicant's level of risk of experiencing hypoglycaemic events is unacceptable.
CASA will normally consider issuing an Applicant with a medical certificate with relevant conditions (in accordance with regulation 67.195), for example, that the Applicant flies only with a qualified safety pilot, as a means of risk mitigation, in cases where:
(a) despite there being a risk of in-flight incapacitation, the nature of the incapacitation is such that, in the event of an incapacitation, the safety pilot will most likely be able to take over control of the aircraft; and
(b) the estimated risk of such events occurring would be very low.
66. Dr Fitzgerald said in terms of any other conditions that may mitigate the risks 'CASA's view [is] that there has at this time been no clinically or statistically proven mechanism or protocol to prevent in-flight hypoglycaemia'. He noted that the Authority intended to trial the Protocol using a group of pilots who would be closely monitored, initially with a safety pilot. As he said 'ongoing solo privileges will be dependent on ongoing clinical review and review of in-flight monitoring', the critical element missing from the FAA approach to date. In his view, Mr Ovens would not be a suitable candidate to participate 'primarily due to his more advanced diabetes, already present complications, relatively increased risk of hypoglycaemia and impaired autonomic and symptomatic response to hypoglycaemia should it occur'.
67. In his affidavit, Dr Fitzgerald said he had consulted Dr Silberman, FAA, who advised that the FAA accepts blood sugar levels in private pilots between the equivalent of levels 6.4 and 8.9. Dr Silberman said the FAA had not accepted a blood sugar level below 6.4 since 'it would put a pilot at an unacceptable risk of hypoglycaemia'. He also said that the FAA would not accept under its Diabetes Protocol a pilot with diabetes who had documented autonomic neuropathy or hypoglycaemic unawareness. He confirmed that there were 516 pilots with diabetes flying in the US cohort, and there had been five accidents involving these pilots. The accidents were considered to be airmanship, not diabetes, related. One pilot had an accident related to insulin and hypoglycaemia, but he was not in the protocol group and had failed to disclose his condition. He confirmed that the FAA in practice does not review the in-flight blood sugar readings of the certified pilots. However, if a pilot had an in-flight hypoglycaemic episode, the FAA practice would be to refer the person to the Federal Air Surgeon and it was likely that permission to fly would be withdrawn.
68. In the course of his evidence to the Tribunal, Dr Fitzgerald noted that it was relevant to Mr Ovens's application that although none of the conditions today would prevent him flying, they were relevant because they were an indicator of the severity and length of his diabetes and the amount of damage it had done. However, he agreed that none of the conditions would 'ground [Mr Ovens] now'. In response to a question about the comment in his report that 'CASA will normally not issue a medical certificate to an applicant who suffers from diabetes of any type if the applicant's level of risk of experiencing hypoglycaemic events is unacceptable', Dr Fitzgerald said what was 'acceptable' led to the 'one per cent rule’'[8] and the criteria are set out in the new Protocol. However, he acknowledged that each case must be considered on its merits since as he put it 'every diabetic is so different'. One of the criteria was to measure blood sugar levels pre-flight and in-flight so as to be able to show they had not dropped below 5 or gone above 15. The Protocol requires up to 15 flights which meet the criteria if the person is to be accepted as suitable for a Class 2 medical certificate without a safety pilot. Dr Fitzgerald also confirmed that the Protocol did not take into account the accuracy of meters at altitude. He conceded this was a step which was needed and he would contemplate asking pilots to obtain that information from the manufacturers of the various devices on the market.
[8] The one per cent rule is the internationally accepted risk level according to the International Civil Aviation Organisation (ICAO) convention, Chapter 6 of Annexe 1. [check]
69. Dr Joanne Hayes, Mr Ovens’s general practitioner, provided a report dated 29 October 2009, and also gave oral evidence. She noted her belief that, prior to his adoption of an insulin pump, Mr Ovens's 'diabetic control was poor' but it had since 'tightened considerably'. At the same time, she said 'I have no concerns for his safety or the safety of others with Mr Ovens flying solo, as long as he adheres to the FAA protocol'. In cross-examination, she said she gave that assurance by analogy with the comparable challenges for diabetics of driving motor vehicles.
70. In oral evidence at the hearing, Dr Hayes said she had only been treating Mr Ovens since February 2008. However, in more recent times she had become involved in his diabetes management and in her view Mr Ovens is aware of when he is becoming hypoglycaemic because, as he had told her, he gets tingling in his feet and becomes a bit sweaty. She also noted some wasting in his thumbs, a symptom of carpal tunnel syndrome, and another symptom of being a long-term diabetic.
71. A report from Dr Stephanie Young, retinal specialist, dated 16 Jun 2008, noted that Mr Ovens had ‘maculopathy in the right eye’ and ‘mild diabetic retinopathy in the left also’ but that neither eye ‘needs treatment at the moment’.
72. An Authority’s Eye Examination Report of 28 November 1997 recorded Mr Ovens as having 'a few macular region aneurysms. Never needed laser therapy. Requires annual review' and 'Excellent vision when astigmatism is corrected'. A further Eye Examination Report by the Authority dated 24 November 1998 found 'No diabetic retinopathy ie No ocular pathology'. Another report dated 7 May 2009 noted: 'Modest right maculopathy with excellent vision. Review 12 months'. A Medical Examination Report of 22 May 2009 for the Authority noted only that Mr Ovens must have ‘distance vision correction’ when flying. Mr Ovens said he wears glasses but his prescription changes only 'modestly'.
73. Dr John Woods, cardiologist, provided several similar reports including one on 25 March 2008 in which he found ‘no symptoms to suggest coronary disease’ and noted that Mr Ovens’s diabetes ‘has been well controlled, as has his blood pressure’ and that his general health was good. Dr Jonathan Sturm, neurologist, provided a report to Dr Woods dated 10 April 2008 in which he affirmed ‘there are no neurological issues that would stop [Mr Ovens] from resuming flying’, a view he affirmed on 25 May 2009.
Other evidence
74. Evidence was provided by Mr Roger Serong, a Type 1 diabetes sufferer with a Class 2 medical certificate. Mr Serong noted that at the time he was granted the certificate, he had a total of 550 hours flying since being diagnosed with diabetes, of which 220 hours were flying solo. In addition, the records of his in-flight blood glucose level tests showed that he performed a further 80 in-flight blood glucose level tests on 92 flights, of which only one (4.9) was marginally below the lower limit of 5. On one earlier occasion, his blood sugar levels had fallen to 3.3 and he took glucose and retested until a satisfactory level was obtained while flying and then safely landed the aircraft. However, in his view:
...the intense scrutiny which the pre- and in-flight testing regimen imposes, together with the requirement to always carry readily accessible supplies of glucose and carbohydrate sufficient for the flight duration, eliminates the likelihood of the occurrence of in-flight episodes of hypoglycaemia of such severity as to cause incapacitation... [T]he risk of in-flight incapacitation due to hypoglycaemia [is] negligible while adhering to the conditions specified.
Consideration
75. The power to issue medical certificates that enable people to fly is governed by Part 67 of the 1998 Regulations. Regulation 67.180 provides for the issuing of medical certificates; regulation 67.195 allows the Authority to issue a medical certificate to a person who has applied under regulation 67.175 ‘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’. Regulation 67.180 prevents the Authority issuing a medical certificate unless the person meets the ‘relevant medical standard’ or, to the extent the person does not meet that standard, that the person is not likely to endanger the safety of air navigation. The criteria for medical standard 2 are set out in regulation 67.155.
76. Mr Ovens does not meet criteria 2.1(b) and 2.3 of the medical standard 2 in regulation 67.155. That is, he has a ‘safety-relevant’ disease that ‘produces any degree of functional incapacity or a risk of incapacitation’ (67.155 clause 2.1(b)). A ‘safety-relevant condition’ is one which ‘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’ (regulation 67.015). Mr Ovens has a safety-relevant condition of insulin dependent Type 1 diabetes mellitus. His insulin therapy produces a risk of incapacitation due to hypoglycaemia. In other words Mr Ovens does not meet the 'relevant medical standard'.
77. Despite not meeting the standard, the Authority can issue a special certificate to exercise the privileges of a person's licence subject to any condition considered necessary by the Authority (regulation 67.195). In exercising that discretion the Authority must be satisfied either that the person’s medical condition is not ‘likely to reduce’ the person’s ability to pilot an aircraft or that allowing him to fly is not ‘likely to endanger the safety of air navigation’.
78. Use of ‘likely’ requires an exercise of judgment, but that judgment must be made against the overriding consideration in the Act that any grant of a medical certificate must ensure the decision is not likely to endanger the safety of air navigation.[9] Dr Navathe expressed the test in these terms: ‘ultimately [the decision] must be made on the basis of a judgment as to whether there is a real and substantial (and not trivial) risk to the safety of air navigation’. According to Dr Navathe this is a judgment based on the individual’s ‘personal, aviation and aeromedical circumstances’.
[9] Civil Aviation Act 1988 (Cth) s 9A.
79. For a person with diabetes this means the person must not suffer from significant diabetic complications and can provide evidence of an acceptable level of blood glucose control and freedom from hyperglycaemia requiring intervention. In deciding what is acceptable, regulation 67.180(2) requires an examination of the extent to which the person does not meet the standard. The principal consideration will be the extent to which the person is likely to endanger the safety of air navigation, taking into account the personal, aviation and aeromedical circumstances of the individual.
80. The issue is whether the Tribunal can be satisfied that the extent to which Mr Ovens does not meet the relevant criteria of medical standard 2 would not endanger the safety of air navigation due to his peripheral and autonomic neuropathy, any resultant hypoglycaemic unawareness and biochemical hypoglycaemic episodes.
81. If the discretion is exercised favourably, regulation 67.195 provides for the issue of a medical certificate subject to a particular condition that is necessary in the interests of the safety of air navigation, having regard to the medical condition of the person. At present, Mr Ovens's condition is that he can only fly with a safety pilot. He is seeking an alternative condition, namely, that he be permitted to fly without a safety pilot but in compliance with the safety conditions in either the FAA Protocol or the Authority's Protocol or a protocol as modified by the Tribunal.
Extent to which the person does not meet medical standard
82. General health and visual acuity. The medical evidence, which the Tribunal accepts, is that Mr Ovens is generally a fit person. He does not have a heart condition, and although he wears glasses to correct astigmatism, any age-related deterioration of his eyes is only modest, and his general vision is excellent. He has mild diabetic retinopathy in the left eye, and mild maculopathy in the right eye, but neither eye needs treatment and check ups are to occur only on an annual basis. In relation to these conditions, the Tribunal finds that Mr Ovens's health and visual ability provides no 'real and substantial (and not trivial) risk to the safety of air navigation’.
83. Peripheral neuropathy. Mr Ovens has symptoms of peripheral neuropathy affecting his feet to a minor degree. Dr Sulway described the symptoms as ‘marked’ or ‘gross’ but acknowledged that they were not affecting Mr Ovens at present. The Authority’s medical officers, including Dr Fitzgerald, and Professor Eastman, simply accepted the assessment of ‘marked’ or ‘gross’ symptoms of peripheral neuropathy since they did not examine Mr Ovens. Professor Nicholson, who had examined Mr Ovens, preferred to describe his peripheral neuropathy initially as ‘mild’ and as, at most, ‘moderate’ and said the condition was ‘not clinically significant’. Dr Fitzgerald, in cross-examination, said none of his conditions would prevent Mr Ovens flying but they were an indication of the severity and length of this diabetes. Dr Hayes, Mr Ovens's general practitioner, said she had no concerns about Mr Ovens flying solo provided he adhered to the FAA protocol. Mr Ovens said his peripheral neuropathy, although affecting his feet, is irrelevant to his flying, provided he is complying with his insulin protocol.
84. The Tribunal considers that Mr Ovens's peripheral neuropathy is at most moderate. That is the view of Professor Nicholson, one of the two endocrinologists who examined Mr Ovens. The Tribunal accepts that view, taking into account his personal experience of Mr Ovens, his expertise and the fact that he did not resile from this view despite questioning at the hearing by the other two expert witnesses as well as the Tribunal. In particular, the Tribunal accepts the good sense, in Dr Navathe's words, of assessing the evidence of specialists by taking into account 'the specialist's experience and expertise in relation to aviation medicine and aviation medical certification decision-making'. In that context the Tribunal notes that Professor Nicholson is a Designated Aviation Medical Examiner, whereas Dr Sulway is not. The Tribunal also accepts that the condition does not at present affect Mr Ovens's ability to fly, an opinion held also by Dr Sulway, Dr Fitzgerald, Dr Hayes and Professor Nicholson. On that basis Mr Ovens's peripheral neuropathy by itself, at present, provides no 'real and substantial (and not trivial) risk to the safety of air navigation’.
85. Autonomic neuropathy and hypoglycaemic unawareness. The greater concern is with Mr Ovens's autonomic neuropathy since it is the most important cause of hypoglycaemic episodes and hypoglycaemic unawareness. The degree to which Mr Ovens suffers from the condition is an issue. Dr Sulway in his 21 July 2009 report said that Mr Ovens's 'autonomic neuropathy' had been 'demonstrated in the past year on objective testing'. It transpired at the hearing that the 'objective testing' referred to a tilt-table test which showed normal in one test and mildly abnormal in a second test. To that evidence Dr Sulway added his knowledge of the two occasions on which Mr Ovens had presented at his surgery with low blood sugar levels, on one occasion of which Dr Sulway said he detected a subtle level of cognitive unawareness.
86. Professor Nicholson did not test specifically for autonomic neuropathy. However, based on Mr Ovens's clinical history, his clinical examination, the gastric emptying study and the clinical neurophysiology studies his opinion was that Mr Ovens's autonomic neuropathy was 'mild' or at worst, 'mild-to-moderate'. He disagreed with Dr Fitzgerald's description, based on Dr Sulway's report, that Mr Ovens's condition was 'marked'. On a third occasion in 2007, not observed by Dr Sulway, Mr Ovens had a hypoglycaemic episode at home and a concerned visitor called an ambulance.
87. On each of these occasions, the Tribunal finds, based on the evidence, that Mr Ovens was aware that the episode was occurring, took measures to boost his sugar levels and recovered quickly. The Tribunal also notes that in 2007 Mr Ovens's hypoglycaemic control was not as good as it is since he started using an insulin pump in December 2008 and that his blood sugar levels have consistently improved over the months since he did so.
88. Professor Nicholson's evidence, in his written report, was that Mr Ovens had no history of hypoglycaemia of the kind which endangers flying, namely, loss of consciousness, seizure, impaired cognitive function, or requiring intervention by a third party. Professor Nicholson did not comment on Dr Sulway's perception that on the occasion in 2009 when Mr Ovens presented to Dr Sulway with a blood sugar level of 2.2, Dr Sulway had also detected some level of cognitive unawareness. The Tribunal notes that at the hearing, Dr Sulway agreed that on both occasions Mr Ovens's behaviour could not be recognised as cognitively deficient.
89. Professor Nicholson also noted that the only clinical feature Mr Ovens exhibited was erectile dysfunction which he discounted since the incidence of this condition in the general male population over 60 is 50 per cent. Professor Nicholson's view, based on Mr Ovens's blood sugar readings since he started using the insulin pump, was that he had a 65 per cent chance of an episode each year, but the absolute risk of a severe episode for Mr Ovens, if he was flying only 100 hours a year, would be 0.334 per cent which is below the internationally accepted risk level of one per cent. Mr Ovens has indicated his interest in flying up to 300 hours a year, in which event, the percentage would only just exceed the one per cent level (1.002 per cent). Mr Ovens's evidence was that he has had no serious hypoglycaemic episode so as to need external intervention in the last ten years.
90. The Tribunal notes that Mr Ovens's control of his condition has improved since he began using an insulin pump, and that even Dr Sulway and Dr Fitzgerald conceded that at present Mr Ovens's autonomic condition was not of sufficient concern as to prevent him flying.
91. Mr Ovens's also meets the criteria in the Designated Aviation Medical Examiners Handbook under the Authority's Protocol in that he has had no 'recurrent (two or more) episodes of hypoglycaemia (resulting in intervention by another party) in the past 5 years and none in the preceding 1 year'.[10] On its own, based on the evidence, the Tribunal does not consider that Mr Ovens's autonomic neuropathy is likely to provide a 'real and substantial (and not trivial) risk to the safety of air navigation’.
[10] Civil Aviation Safety Authority (2010) Designated Aviation Medical Examiner’s Handbook (DAME Handbook), p 2.4-8.
92. At the same time, the Tribunal takes account of the accepted evidence that the risk of hypoglycaemia leading to cognitive unawareness is the most serious for a pilot with diabetes mellitus, that hypoglycaemic episodes can be unpredictable, and that each diabetic is different. In addition, the Tribunal notes that Mr Ovens's level of autonomic neuropathy can not be looked at on its own. The conjunction of Mr Ovens's advancing age (he is 62), the fact that he has now had diabetes mellitus for over 50 years, that he is evidencing – admittedly mild or at most moderate – symptoms (retinopathy, maculopathy, peripheral neuropathy and autonomic neuropathy) which are associated with diabetes and are progressive and irreversible, is indicative of the development of the disease, even though at this stage they would not affect his ability to fly.
93. The Tribunal also notes that the Authority's Protocol cites as an exclusionary criteria autonomic neuropathy and retinopathy, without specifying any extent or level of either condition. If Dr Navathe's principle was applied, however, these conditions would only be exclusionary to the extent that they created a 'real and substantial (and not trivial) risk to the safety of air navigation’. In that context the Tribunal notes that in the Information to be Provided part of the Protocol[11] the reference to 'diabetic eye disease' requires that it be 'significant' which is consistent with Dr Navathe's principle.
[11] Id, p 2.4-9.
94. The Tribunal had no evidence to assist in resolving this issue since the Tribunal was only made aware that the Authority had issued its Protocol during the last day of hearing and it did not have the opportunity to see the Protocol before the end of the hearing. However, it recommends that the Authority clarify whether simply having any of these condition is exclusionary or whether it is only if the condition poses a 'real and substantial (and not trivial) risk to the safety of air navigation’ that someone would not be able to fly.
Which Protocol?
95. The Tribunal notes that counsel for Mr Ovens argued strongly at the hearing that the Tribunal should apply the FAA Protocol, rather than the Authority's Protocol to Mr Ovens's application. This was in part because counsel, like the Tribunal, was unaware that the Authority's Protocol was about to be published. However, it also reflects the fact that on its face, the FAA Protocol does not include autonomic neuropathy as an absolute bar to solo flying of a pilot with diabetes mellitus. During the hearing, however, the Authority produced evidence from Dr Silberman, a representative of the FAA, that in practice in the United States the discretion to allow a person to fly solo would not be exercised in relation to a person with autonomic neuropathy.
96. Accepting that this evidence is correct, and again, without any information as to what level of the condition would be exclusionary, this negates the principal benefit which adoption of the FAA Protocol would provide for someone like Mr Ovens. In any event, since the Authority, with the benefit of the FAA Protocol as a guide, and following consultation with medical experts on the issue in late 2009, has promulgated its own Protocol, the Tribunal accepts that the Authority's Protocol should be accepted as applying in Australia and, therefore, to Mr Ovens's application. The Tribunal also finds that since the Authority has issued its Protocol, it would be inappropriate for the Tribunal, as happened in Re Serong, to devise a specific protocol for Mr Ovens, given that the Authority’s Protocol has been published followed extensive consultation with experts, an advantage not available to the Tribunal.
97. The Tribunal notes that in relation to the Information to be Provided in the Protocol, Mr Ovens would also need to establish to the satisfaction of the Authority that he complies with a number of other criteria. These include that he 'has been educated in diabetes and its control and understands the actions that should be taken if complications, especially hypoglycaemia, should arise',[12] a criterion which he clearly meets.
[12] Ibid.
98. The Tribunal is not in a position to assess whether Mr Ovens would meet other requirements in the Protocol. These include, for example, having acceptable blood sugar readings within the 90 days prior to the application, having reasonable scores in a report of the results of a 'maximal graded exercise stress test'[13], and that he has an acceptable level of blood sugar control as demonstrated by the results of the blood sugar analysis over a three month period immediately prior to the application referred to in the Medical factors considered in CASA's decision making.[14] The Tribunal notes that it appears from the way the Protocol is written that any 'documented hypoglycaemic unawareness' need only be revealed if the unawareness occurred in the three months prior to the application.[15] This too may need clarification. However, if that reading is correct, Mr Ovens would meet that factor.
[13] Ibid.
[14] Ibid.
[15] Ibid.
Conclusion
99. The Tribunal is aware that the conjunction of the issue of the Authority's Protocol with the Tribunal proceedings meant the hearing, in many respects, was premature. That is because the Tribunal did not have the benefit of evidence in Mr Ovens's case in relation to all the criteria in the Protocol. The Tribunal's findings on some, but not all, of the matters covered in the Protocol indicate its findings that, in Mr Ovens's case, the extent of some of the medical conditions relevant to whether he could fly without a safety pilot were not of such a real and significant nature as to be disqualifying.
100. The Tribunal notes that Professor Eastman suggested that Mr Ovens’s level of autonomic neuropathy should be tested with a nerve conduction study, a view with which it agrees. The Tribunal also notes the suggestion by Professor Eastman and Dr Sulway that for Mr Ovens, before the safety pilot can be dispensed with, he should be subjected to a period of observation, according to the medical experts for two to three hours, to ensure he could maintain control over his blood sugar levels while flying in a variety of conditions, and be tested to demonstrate his ability to comply with the Authority’s Protocol.
101. However, if any degree of autonomic neuropathy or retinopathy is sufficient to disqualify a pilot from flying in accordance with the Protocol, Mr Ovens would automatically not be eligible.
102. If that is not the case, and it is only a real and significant level of diabetes-related conditions that create a real and substantial risk to the safety of air navigation which is exclusionary, then the Tribunal recommends that Mr Ovens be considered favourably for inclusion in the cohort of those who should trial the Protocol.
103. He is generally fit, is now experienced in managing his insulin pump, has good awareness of any impending hypoglycaemic episode, has demonstrated his ability to manage his condition under both a lengthy flight (the Gladstone to Burketown trip) and difficult flying conditions, and is proficient in use of his blood sugar recording device. Both Dr Fitzgerald and Dr Sulway conceded that Mr Ovens's conditions were not currently disabling, and Professor Nicholson reported his risk of having a hypoglycaemic episode as within the internationally tolerated one per cent level. In addition, the Tribunal notes that in order to fly, pilots are required to exercise a level of hyper-vigilance which further mitigates the risk of a hypoglycaemic episode. Permission to participate in the cohort and to trial the criteria in the Authority's Protocol, including with a safety pilot for the requisite number and length of flights, would provide the objective evidence of Mr Ovens's capacity which is currently not available.
104. The Tribunal, however, given the state of the evidence, has no option but to affirm the decision under review, namely, to deny Mr Ovens request for a Class 2 medical certificate without the condition that he fly with a safety pilot.
105. The usual order as to costs applies.
I certify that the 105 preceding paragraphs are a true copy of the reasons for the decision herein of Professor RM Creyke, Senior Member.
Signed: ....................[sgd]...............................
C. Kocak, AssociateDate/s of Hearing 9 April 2010
Date of Decision 29 June 2010
Counsel for the Applicant Christopher McKeown
Counsel for the Respondent Ian Harvey
Solicitor for the Respondent Civil Aviation Safety Authority
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