Serong and Civil Aviation Safety Authority
[2006] AATA 1123
•22 December 2006
DECISION AND REASONS FOR DECISION [2006] AATA 1123
ADMINISTRATIVE APPEALS TRIBUNAL № V2005/398
№ V2006/444GENERAL ADMINISTRATIVE DIVISION
Re: ROGER ADRIAN SERONG
Applicant
And:CIVIL AVIATION SAFETY AUTHORITY
Respondent
DECISION
Tribunal: Mr Egon Fice, Member
Dr Kerry Breen, Member
Date:22 December 2006
Place:Melbourne
Decision:The Tribunal affirms the reviewable decision dated 5 May 2006 not to issue a class one medical certificate to the applicant. .
The Tribunal varies the reviewable decision dated 5 May 2006 to issue Mr Serong a class two medical certificate with the condition that he only exercises the privileges of a private pilots’ licence as or with a co-pilot to include the conditions set out in paragraph 65 of these reasons for decision.
(sgd) Egon Fice
Member
CIVIL AVIATION – type one diabetes – hyperglycaemia – hypoglycaemia – hypophysitis – medical certificate – Chicago Convention – Civil Aviation Safety Authority policy – United States Federal Aviation Administration protocol regarding type one diabetes – conditions attached to medical certificate – fetter on the exercise of discretion – risk to safety of air navigation – blood glucose control – hypoglycaemic awareness
Civil Aviation Act 1988 s 9A, s 11
Civil Aviation Safety Regulations 1998 reg 67.150, 67.155, 67.175, 67.180, 67.195
United States of America Federal Aviation Administration Policy
Re Drake and Minister for Immigration and Ethnic Affairs (1979) 2 ALD 634
Re William Wai Ming Lee and Department of Immigration and Ethnic Affairs (1988) 10 AAR 270
REASONS FOR DECISION
22 December 2006 Mr Egon Fice, Member
Dr Kerry Breen, Member
1. In 1996 Mr Roger Adrian Serong developed type one (insulin dependent) diabetes mellitus which caused him to cease flying for one year. He resumed flying in June 1997 when his class two medical certificate was renewed on the condition that when flying, he only did so as or with a safety pilot endorsed on the aircraft that was being flown. His class one medical certificate was not renewed.
2. Mr Serong accepted the restrictions placed on his licence to fly aeroplanes as a result of his diabetes until 2005, when he applied to the Civil Aviation Safety Authority (CASA) for a renewal of his class two medical certificate and the issue of a class one certificate. CASA refused to issue Mr Serong with a class one medical certificate and it issued a class two medical certificate on the condition that he only exercise the rights conferred by that certificate when flying as or with a qualified co‑pilot. His class two medical certificate was valid for 12 months from the date of issue.
3. Although Mr Serong applied to this Tribunal for a review of the decision made by CASA on 19 April 2005, his class two medical certificate expired on 18 April 2006 before his application could be heard. At that time Mr Serong sought renewal of his class two medical certificate and again applied for the issue of a class one medical certificate. On 5 May 2006 CASA granted Mr Serong a class two medical certificate under the same conditions which applied to his expired class two medical certificate but refused to issue a class one medical certificate. Mr Serong made a further application to the Tribunal seeking a review of CASA’s decision of 5 May 2006. The parties have agreed that this review should only be concerned with the decision of 5 May 2006 which is the subject of application N°V2006/444.
4.The issues before the Tribunal in this matter are:
(a)whether the decision to refuse Mr Serong a class one medical certificate was correct; and
(b)whether the conditions imposed on Mr Serong’s class two medical certificate are necessary in the interests of the safety of air navigation.
Relevant Facts
5. Mr Serong commenced flying in 1968, having joined the Royal Australian Air Force (RAAF). He learnt to fly on the Winjeel, the RAAF basic trainer at that time, although he did not complete the pilots’ course.
6. After practising for some 25 years as an architect, Mr Serong decided to return to aviation in 1995. He qualified for a commercial pilot licence and an instructor rating by 1996.
7. Mr Serong developed type one diabetes mellitus in April 1996. In October 1996 he also developed the rare condition of hypophysitis, which is an inflammation of the pituitary gland.
8. In June 1997 Mr Serong resumed flying after having his class two medical certificate renewed on the condition that he flew as or with a qualified co‑pilot. CASA refused to issue Mr Serong with a class one medical certificate, which would have enabled him to fly commercially.
9. The United States Federal Aviation Administration (FAA) introduced a protocol in 1996 under which selected applicants, assessed on an individual basis, were permitted to fly solo privately, despite having type one diabetes. The United Kingdom and Canada have adopted similar certifications to the FAA in respect of pilots diagnosed with type one diabetes. The FAA protocol requires type one diabetes pilots to maintain blood glucose levels of between 5.5 mmol/L and 16.7 mmol/L. Canada and the United Kingdom have adopted a range of between 6 mmol/L and 15 mmol/L.
10. Mr Serong’s hypophysitis was treated in 1997 and has remained stable for the past 10 years. His pituitary gland has returned to normal size although he is required to take medication for that condition.
THE LEGISLATIVE REGIME
11. The Civil Aviation Safety Regulations 1998 (the Regulations) set out the medical requirements which must be met for the issue of pilot licences. They establish three classes of medical certificates. Pilots who hold a commercial pilot licence or an air transport pilot licence are required to have a class one medical certificate. Pilots holding a private pilot licence, glider pilot licence or free balloon pilot licence are required to have a class two medical certificate. Air traffic controllers are required to have a class three medical certificate.
12. Regulation 67.150 of the Regulations, in so far as it is relevant, provides that a person who satisfies the criteria in table 67.150 meets medical standard one. Table 67.150, provides, at 1.1:
Abnormalities, disabilities and functional capacity
1.1 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.
13.The expression safety-relevant is defined in reg 67.015 as follows:
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.
14.Table 67.150 also refers to the following disorders:
1.15Is not suffering from any safety-relevant metabolic, nutritional or endocrine disorders.
1.16If suffering from diabetes mellitus – the diabetes is satisfactorily controlled without the use of any anti-diabetic drug.
15. The standard for the issue of a class two medical certificate is set out in reg 67.155. Clause 2.1 is identical to cl 1.1 for a class one medical standard. Clause 2.15 addresses diabetes as follows:
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.
16. The issue and refusal of medical certificates is dealt with under reg 67.180 which, insofar as it is relevant, provides:
(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); or
…
(2)For paragraph (1)(a), the requirements are:
…
(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 or air navigation; and …
17. Where an applicant does not meet the standard required by the medical certificate for which he or she has applied, CASA may issue the relevant medical certificate subject to certain conditions. Regulation 67.195 specifically permits CASA to do this, as it provides:
(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.
CASA POLICY REGARDING TYPE ONE DIABETES
18. Section 9A of the Civil aviation Act 1988 (the Act) provides that CASA must regard the safety of air navigation as the most important consideration.
19. Mr I. Harvey of counsel, representing CASA, directed the Tribunal to s 11 of the Act which requires CASA to perform its functions in a manner consistent with Australia’s obligations under the Convention on International Civil Aviation (the Chicago Convention) and any other agreement between Australia and any other country or countries relating to the safety of air navigation. The Chicago Convention is defined in the Act as a convention on international civil aviation entered into at Chicago on 7 December 1944. The convention establishes rules of airspace, airplane registration and safety, and details the rights of the signatories in relation to air travel. It received the requisite 26th ratification on 5 March 1947 and went into effect on 4 April 1947. It also established the International Civil Aviation Organization (ICAO), a specialized agency of the United Nations charged with co‑ordinating and regulating international air travel. It includes annexes to that convention relating to international standards and recommended practices being annexes adopted in accordance with Article 37 of the Chicago Convention.
20. Chapter 6 of Annex 1 to the Chicago Convention provides that Applicants with insulin treated diabetes mellitus shall be assessed as unfit.
21. In its written submissions, CASA referred to an aviation research investigation report prepared by Dr David G. Newman for the Australian Transport Safety Bureau (ATSB) in June 2005. In that report Dr Newman stated that CASA policy regarding the granting of medical certificates to diabetic pilots was subject to evidence of good blood glucose control, no evidence of diabetic complications and satisfactory specialist medical reports. Diabetics who achieve control by diet and an oral hypoglycaemic drug may be certified to class two or class three standard only if they have evidence of good blood glucose control; no side effects from the drug; no episodes of symptomatic hypoglycaemia in the preceding twelve months; no evidence of complications; and satisfactory specialist medical reports. Dr Newman then pointed out that diabetics controlled with insulin do not satisfy the certification criteria but, nevertheless, CASA policy gives CASA aviation medicine staff the discretion to grant certification at class two level so as to permit flights to be undertaken as or with a co-pilot and only for operations in Australian airspace, provided of course that the applicant satisfies the conditions which apply to type two diabetics. After setting out the policy, Dr Newman stated:
This policy gives sufficient flexibility to the issue of diabetic pilot certification, which is consistent with the ICAO flexibility standard.
22. In its written submissions, CASA contended that the imposition of the co-pilot requirement for type one diabetics, together with the requirements for the grant of a licence for type two diabetics, is consistent with the prevailing approaches of regulatory bodies internationally and with the aviation legislation. What Dr Newman said in the ATSB report is that CASA policy fits within the ICAO flexibility standard which is standard 1.2.4.8 published in Annex 1. Under this standard, according to Dr Newman, ICAO signatories such as Australia may take into account accredited medical conclusions, operational limitations, and experience and qualifications of the pilot in order to reach a decision regarding aeromedical certification. Annex 1 to the Chicago Convention deals with Personnel Licensing. Standard 1.2.4.8 provides:
1.2.4.8 If the medical Standards prescribed in Chapter 6 for a particular licence are not met, the appropriate Medical Assessment shall not be issued or renewed unless the following conditions are fulfilled:
(a)accredited medical conclusion indicates that in special circumstances the applicant’s failure to meet any requirement, whether numerical or otherwise, is such that exercise of the privileges of the licence applied for is not likely to jeopardize flight safety;
(b)relevant ability, skill and experience of the applicant and operational conditions have been given due consideration; and
(c)the licence is endorsed with any special limitation or limitations when the safe performance of the licence holder’s duties is dependent on compliance with such limitation or limitations.
In other words, a policy permitting insulin dependent pilots to operate in Australian airspace, while not fitting within the ICAO Chapter 6 requirements, is nevertheless permissible under the so called flexibility standard.
23. The flexibility standard is given effect under reg 67.195 of the Regulations, which provides that CASA may issue medical certificates subject to any condition that is necessary in the interests of the safety of air navigation. According to Dr Newman, class two medical certificates may be issued to insulin dependent diabetics whose diabetes is well controlled on the condition that:
(a)they only fly as or with a co-pilot;
(b)the aircraft has side by side seating with full dual controls; and
(c)a shoulder harness is worn by the diabetic pilot.
24. According to Dr Newman’s report, it must be recognised that aero-medical standards need to be continually re-appraised in the light of the results of ongoing medical research and improving treatment outcomes. Aero-medical policies need to be sufficiently flexible in order to take these developments into account and thereby remain evidence based, justifiable and legally defensible.
25. It is clear to us that CASA’s policy regarding the issue of medical certificates to insulin dependent pilots may, strictly speaking, not be in accordance with ICAO standards. However, by relying on the ICAO flexibility standard, CASA has permitted such pilots, on an individually assessed basis, to be granted a class two medical certificate under conditions which CASA has determined are necessary to ensure the safety of air navigation.
26. Mr Harvey submitted that not only is CASA’s policy regarding the grant of medical certificates to insulin dependent diabetic pilots consistent with the prevailing approaches of the regulatory bodies internationally, CASA’s policy regarding the issue of such medical certificates should be adopted by the Tribunal. Mr Harvey contended that CASA’s policy extended to the conditions it imposed on insulin‑dependent diabetics who had been issued a class two medical certificate. However, it appears to us that the conditions which may be imposed by CASA on insulin dependent medical certificate holders are flexible. For example, in Mr Serong’s case, CASA agreed to lift the restriction on side by side seating at Mr Serong’s request following his purchase of a Sky Arrow tandem seated aircraft. We have no doubt that this change of conditions applied to Mr Serong was not in fact a change of policy, but rather a review of the conditions necessary to ensure the safety of air navigation in his case. In other words, CASA’s policy regarding insulin‑dependent diabetics is that certain individuals, who can provide evidence of good blood glucose control and no evidence of diabetic complications, including no episodes of hypoglycaemia requiring intervention from others, may be issued a class two medical certificate for flying operations within Australian territory subject to those conditions CASA considers necessary for the safety of air navigation. The policy reflects the standard set out in 1.2.4.8 of Annex 1 of the Chicago Convention.
27. The conditions which may be imposed on individual applicants will depend on their circumstances. To limit the conditions imposed by CASA under reg 67.195, or to treat the conditions as if they were mandatory in every case is, in our view, an impermissible fetter on the discretion granted by reg 67.195, which expressly permits any condition necessary in the interests of air navigation to be applied to a medical certificate issued by CASA. As Brennan J said, when dealing with Ministerial policy, in ReDrake and Minister for Immigration and Ethnic Affairs (No 2) (1979) 2 ALD 634 at 640-641:
… policy must be consistent with the statute. It must allow the Minister to take into account the relevant circumstances, it must not require him to take into account irrelevant circumstances, and it must not serve a purpose foreign to the purpose for which the discretionary power was created. A policy which contravenes these criteria would be inconsistent with the statute … Also, it would be inconsistent with ss 12 and 13 of the Migration Act if the Minister's policy sought to preclude consideration of relevant arguments running counter to an adopted policy which might be reasonably advanced in particular case… His discretion cannot be so truncated by a policy as to preclude consideration of the merits of specified classes of cases. A fetter of that kind would be objectionable, even though it were adopted by the Minister on his own initiative…
That is not to deny the lawfulness of adopting an appropriate policy which guides but does not control the making of decisions, a policy which is informative of the standards and values which the Minister usually applies. There is a distinction between an unlawful policy which creates a fetter purporting to limit the range of discretion conferred by a statute, and a lawful policy which leaves the range of discretion intact while guiding the exercise of the power.
28. In Re William Wai Ming Lee and Department of Immigration and Ethnic Affairs (1988) 10 AAR 270, when dealing with the exercise of discretion under s 13(9) of the Migration Act 1958, Gray J said that there can be no sound objection taken to a policy requiring certain matters to be taken into account. However, he then said:
A policy which sets inflexible criteria, however, would constitute a fetter upon the discretion under s 13(9), if the Minister or his delegate took the view that he or she was bound by the policy. The circumstances of each case must be taken into account, and a decision-maker must always be ready to accept the proposition that the circumstances of a particular case may render it inappropriate to apply a policy which may be applied without difficulty in the majority of cases.
Therefore, in our view, CASA’s policy regarding the issue of medical certificates to insulin dependent applicants may be subject to any condition that is necessary, in the individual applicant’s case, to ensure the safety of air navigation. This may or may not require operations with a co-pilot. It applies to class one and class two medical certificates.
TYPE ONE DIABETES MELLITUS
29. As stated by Dr Newman in his Aviation Research Investigation Report, diabetes can be defined simply as an excess of sugar in the blood. It reflects an underlying problem with carbohydrate metabolism. In a normal person, the body maintains a relatively tight control of blood sugar level in order to prevent the adverse consequences of either too little or too much blood sugar. One of the key regulating hormones for the control of blood glucose is insulin. This is secreted by the β-cells of the pancreas. After eating, blood glucose levels rise and this triggers the release of insulin from the pancreatic β-cells. The liver plays an important role as it acts as a storage depot and a producer of glucose. It takes up glucose when there is an abundant supply in the blood, storing it in the form of glycogen, and reducing its own production of glucose. When the blood glucose level is low, as in the fasting state, it releases glucose into the circulation.
30. The role of insulin in the metabolic control of glucose is to reduce an excess level of glucose in the blood to the normal range. Hyperglycaemia, in extreme cases, may lead to diabetic ketoacidosis which causes nausea, vomiting, and abdominal pain and can progress to cerebral oedema, coma and death. Years of poorly controlled hyperglycaemia leads to multiple primarily vascular complications that affect small and large vessels. Micro-vascular disease underlies the three most common and devastating manifestations of diabetes mellitus: retinopathy, nephropathy and neuropathy.
31. Hypoglycaemia is caused by an excess of exogenous insulin either due to excessive dose or inadequate oral intake of glucose. As J. Larna in Goodman and Gilman’s the Pharmacological Bases of Therapeutics, 7th Edition, states:
The pattern and temporal sequence of signs and symptoms [of hypoglycaemia] are fairly… constant. When the rate of fall in blood glucose is rapid, the early symptoms… include sweating, weakness, hunger, tachycardia and “inner trembling”. When the concentration of glucose falls slowly, the symptoms… include headache, blurred vision, diplopia, mental confusion, incoherent speech, coma and convulsions…
A prolonged period of hypoglycaemia causes irreversible damage to the brain...
Hypoglycaemia is treated by an oral intake of glucose or intramuscular injections of glucagon.
32. For aviators, hypoglycaemia is the more significant problem. The onset of hypoglycaemia can be subtle and difficult for the diabetic to detect. It can lead to impaired decision making, disorientation, poor performance and incognisance of skills, confusion and unconsciousness.
33. The major concern of CASA is the fact that persons with type one diabetes mellitus have a blunted or diminished adrenalin response to hypoglycaemia which, in a normal person, causes subjective symptoms such as hunger, tachycardia, sweating and feeling of apprehension (report by Dr Westerman dated 19 February 2006). According to Dr Westerman, this occurs in type one diabetics because the blood glucose level at which the adrenalin response triggers is reset to a lower glucose level. For that reason, the blood glucose level must fall to a much lower level before a diabetic person is aware of any subjective symptoms of hypoglycaemia. By this time, the diabetic may show subtle incapacitation and be unaware of any functional impairment. S.R. Heller and A.N. Nicholson, in an article dealing with aircrew and type one diabetes mellitus in the Journal of Aviation, Space and Environmental Medicine, Volume 77, N° 4, April 2006, state that diminished awareness of hypoglycaemia is surprisingly common; some surveys indicating that over 20 per cent of individuals with type one diabetes mellitus may report difficulty in recognising hypoglycaemia from time to time. Heller and Nicholson state that some individuals develop profound unawareness and are then at serious risk of severe cognitive dysfunction without warning. Patients with these problems have to monitor their blood glucose regularly, but despite these precautions they remain susceptible to occasional periods of sudden disabling hypoglycaemia. Heller and Nicolson also point out that an individual’s symptoms may vary from time to time. Also, many persons who claim to recognise the onset of hypoglycaemia failed to do so when tested in a laboratory situation.
34. According to a report prepared by Professor G.C. Nicholson on 10 May 2006, 25 per cent of patients with type one diabetes mellitus are affected by hypoglycaemia unawareness. However, Professor Nicholson also said that the 25 per cent of the patients who are affected by hypoglycaemia unawareness includes those experiencing frequent or severe hypoglycaemia and those with autonomic neuropathy. Therefore, according to Professor Nicolson, the prevalence amongst those who are well-controlled and do not have autonomic neuropathy would be much lower.
35. In a research study conducted by the Diabetes Control And Complications Trial Research Group at Bethesda, Maryland, in the United States and published in Diabetes, Volume 46, February 1997, the researchers found that patients who experienced severe hypoglycaemia were at increased risk of subsequent episodes. Approximately 30 per cent of patients experienced a second episode within the four months following the first episode of severe hypoglycaemia. It found that the number of prior episodes of hypoglycaemia was the strongest predictor of the risk of future episodes, followed closely by the current HbA1c value (glycosylated haemoglobin level).
RISK TO THE SAFETY OF AIR NAVIGATION
36. According to CASA, there is insufficient evidence to enable the Tribunal to be satisfied that the extent to which Mr Serong does not meet the medical standard is not likely to endanger the safety of air navigation, because, even accepting the vast bulk of Mr Serong’s evidence, it cannot be said with confidence that he will not under any circumstances fail to recognise the symptoms of the onset of hypoglycaemia or fail to be in a position to respond to any perceived symptoms appropriately. It seems that CASA will only be satisfied if there is a zero risk of Mr Serong suffering a hypoglycaemic event which is likely to endanger the safety of air navigation. In our opinion, that sets the standard at too high a level. As Dr R. Liddell pointed out in his report of 11 January 2006, in aircraft engineering design, the risk of failure of a critical component is not to be more probable than one event in 10 million flying hours, and major structures are designed so as to be failsafe. According to Dr Liddell, there is no logic in having a pilot certified to a level of risk of failure in excess of the certification requirements for risk of failure of the aircraft being operated. Since about 1991, an attempt has been made to relate the risk in medical certification to the risk level practised in the remainder of the aviation industry for failure in aircraft system and structures. By utilising a process of average flight times for commercial aircrew per year and the percentage of flight time that is considered critical in an air transport situation, it is possible to match the structural failure risk target to the crew failure risk target. According to Dr Liddell, this was found to be a risk of 0.1 per cent per year for single pilot operations and 1 per cent per year for multi-crew operations.
37. As for private aviation, it operates at a different level of risk because private aircraft are not designed to the same levels of risk of component failure, and there is no general failsafe design requirement. The level of risk of incapacity for the private pilot need not be at the same level as for a pilot involved in commercial operations. For that reason, the level of risk for private pilot operations was relaxed by a factor of ten and was not to exceed one per cent per year for single pilot operations or ten per cent per year for two pilot operations. According to Dr Liddell, since the early 1990’s, these general principles in aircrew medical certification have been largely accepted by the aviation medicine community and are generally used to assess an individual’s ability to meet the medical standard for a particular class of licence. While Dr Liddell, conceded that humans are not components that can be tested to destruction to establish time to failure, he was of the view that there was generally sufficient experience with disease in the medical community to be able to put a reasonable risk on the probability of failure for individual diseases and that this was as close as the industry could get to a scientific way of approaching medical certification.
38. Dr Liddell also made the point that the only real risk of sudden incapacitation by an insulin dependent pilot results from low blood sugar caused by too much insulin injected. The chance of hyperglycaemia causing problems for a pilot who is well at the outset of a flight is virtually non-existent.
39. Professor C.J. Eastman, a Consultant Physician and Endocrinologist and the current Clinical Professor of Medicine/Pathology at the University of Sydney, gave evidence on behalf of CASA. In an expert report which was, in effect, a response to questions asked by CASA, he noted that episodes of hyperglycaemia were far more common than hypoglycaemia in insulin-dependent patients. However, he noted that patients readily tolerate milder to moderate hyperglycaemia but do not tolerate symptomatic hypoglycaemia. This is despite the fact that in his oral evidence Professor Eastman said a patient may be at risk of impairment if blood glucose levels rise above 15 mmol/L.
40. Professor Eastman said that there was a considerable variation in hypoglycaemic awareness in any individual patient injecting insulin on a daily basis. He then referred to a number of articles which describe the percentage of well controlled, insulin diabetics, not suffering from autonomic neuropathy, who suffered hyperglycaemic events without awareness. It seems that those figures range between 9 per cent and 30 per cent of patients tested.
41. The FAA has conducted a review of its policy dealing with insulin dependent diabetics applying for airman medical certification. Prior to conducting a re‑evaluation of its policy, the FAA noted that its concern about granting licences to insulin‑dependent diabetics was based on the long term medical risks associated with diabetes and, particularly in the aviation environment, the immediate risk posed by hypoglycaemia. The FAA noted that every diabetic is at some risk for hypoglycaemia which can produce impaired cognitive function, seizures, unconsciousness and death. It also noted that functional incapacitation associated with hypoglycaemia may occur insidiously and may not be recognised by the diabetic or by other observers. It acknowledged that diabetics using insulin are at greater risk for hypoglycaemia than those treated by diet or oral hypoglycaemic agents.
42. Following a successful program under a special medical protocol instituted in 1992 to permit type one diabetic air traffic control specialists to continue with their duties, the FAA decided to extend that protocol to selected type one diabetes affected individuals who applied for the issue of an airman medical certificate. These were third class medical certificates under which the holders could only exercise its privileges in respect of student, recreational or private pilot licences. In addition to strict criteria for the selection of persons who may be eligible for a third class medical certificate under the protocol, the FAA also required those granted a special medical certificate to only operate an aircraft under very strict conditions. These conditions included testing of blood glucose levels before and during flight and carrying amounts of rapidly absorbable glucose. In formulating its new policy, the FAA noted that the Federal Air Surgeon had reviewed the success of the FAA’s program for air traffic control specialists suffering from type one diabetes and also considered the medical and technological advances in the treatment of diabetes. The FAA noted that application of the protocol, and in particular preliminary screening, would effectively exclude those persons at significant risk for incapacitation caused by hypoglycaemia. The Federal Air Surgeon found that advancements in the knowledge, treatment and self-management of diabetes have made certification of type one diabetes individuals possible under certain circumstances.
43. By 19 October 2005 there were 448 type one diabetic aviators in the United States who had been granted a medical certificate permitting them to obtain a third class licence. Since the protocol was established in 1996, according to Mr W.S. Silverman, Manager of Aerospace Medical Certification at the FAA, there have been five accidents/incidents involving persons who were issued medical certificates with this condition. However, none of those accidents/incidents were attributed to their diabetes.
44. Mr D. Cairns, a former Royal Air Force pilot who developed type one diabetes in 1989, was granted FAA approval for a third class medical certificate in 2000. He provided a statement to the Tribunal and gave oral evidence. Since obtaining a private pilot’s certificate under the FAA protocol, Mr Cairns has flown some 1,500 hours, with 1,400 hours as pilot in command, either solo or accompanied by passengers without flying experience. In 2002, Mr Cairns conducted a round the world flight in a Beech Baron aircraft. The journey took some five months and Mr Cairns logged 187 hours in the course of the flight. He flew solo while in United States territory but had a safety pilot with him for the remainder of the journey. The safety pilot was not required at any stage of the flight and the longest leg time was 11 hours between Hawaii and California, which he flew solo. Mr Cairns’ experience is published in a book, Dare to Dream, Flying Solo with Diabetes, Albyne Press, 2005. It is clear that he experienced challenging flying conditions at times, including severe unexpected icing. Nevertheless, according to Mr Cairns, he was able to meet blood sugar testing protocols at all times and although he measured his glucose levels at below 5.5 mmol/L, which is the lowest acceptable reading for the purposes of the protocol, on some 16 occasions, he ingested 20 grams of readily absorbable carbohydrate and did not suffer any hypoglycaemic effects. According to Mr Cairns, the FAA protocol system is safe and effective.
45. It seems to us that the only reliable long term study of the risk of a type one diabetic pilot becoming incapacitated due to hypoglycaemia is the one that has been conducted in the United States by the FAA over the past 10 years. Despite concerns expressed in various studies about hypoglycaemic unawareness and the risk of a type one diabetic being incapacitated as a consequence of a hypoglycaemic event, the FAA experience clearly establishes that such risks can be reduced to an acceptable level by implementing the FAA protocol.
46. CASA drew our attention to Re Badaoui and Civil Aviation Safety Authority [2003] AATA 1059, a decision of Senior Member G. Ettinger. Dr Badaoui suffered from type one diabetes and he applied to have the restrictions regarding flying with a qualified co-pilot lifted from his class two medical certificate. Dr Badaoui relied heavily on the FAA protocol and its operation in the United States over a period of some six to seven years, as evidence of a safe system for solo operation by insulin‑dependent diabetics. In the course of that hearing, a Dr Johnston gave evidence regarding the effectiveness of the FAA protocol and he said that there was no evaluative material available to assess whether it was successful. He also noted that some 190 countries who are members of ICAO have not adopted the protocol. Dr Johnston also gave evidence that there were some 325 pilots licensed under the protocol and that 5 events had been recorded, although he did not know whether the events were accidents.
47. However, according to Mr Serong, Dr Wilkins who was then the CASA Director of Aviation Medicine, and who gave evidence in the Badaoui hearing, knew the answer to that question but failed to inform the Tribunal that he was aware that there were approximately 364 airmen who had been granted certificates under the FAA protocol and that the four or five incidents referred to by Dr Johnston had nothing whatsoever to do with the diabetes suffered by those pilots. In other words, there had been no incidents or accidents attributable to type one diabetes over the six or seven year period that the FAA protocol had been operating. In his evidence at the Badaoui hearing, when Dr Wilkins was asked why the FAA protocol had not been adopted in Australia, he said that it was experimental, and had not yet been demonstrated to be safe (para 82 of the Tribunal’s reasons for decision). At para 160, the Tribunal, when referring to Dr Wilkins’ opinion regarding the FAA protocol, said:
I accepted his explanation that the FAA Protocol had not been adopted in Australia because it was experimental and had not yet been demonstrated to be safe.
48. In our opinion, had the Tribunal in Dr Badaoui’s case been made aware of the true position regarding pilots who had operated under the FAA protocol, it is quite possible that it would have come to a different view. Having now been in operation for some 10 years, without a single incident attributable to diabetes, the FAA protocol is most certainly no longer experimental and its safety has been adequately demonstrated.
MR SERONG’S BLOOD GLUCOSE CONTROL
49. Since being diagnosed with type one diabetes, Mr Serong has not experienced an episode of hypoglycaemia requiring intervention by another person and he has never lost consciousness. It is clear from the numerous records provided by Mr Serong of his blood glucose levels since 1999 that he has conscientiously undertaken a rigorous program of blood glucose level testing to control his diabetes. CASA acknowledges this. While his testing discloses readings above and below optimum levels, according to Associate Professor P. Colman, an endocrinologist, who has assisted Mr Serong with his diabetes management since 1997, Mr Serong’s diabetes is extremely well controlled with blood sugar levels between 6‑8mmol/L for much of the time. In February 1997 his HbA1c level was 8.8 per cent, indicating his diabetes control was extremely satisfactory. Associate Professor Colman was of the view that his HbA1c level would be even lower at the next test. In a report dated 10 February 2000 Associate Professor Colman noted that Mr Serong’s most recent HbA1c level was at 7.3 per cent. He noted that Mr Serong had not had any episodes of hypoglycaemia. In a report dated 4 April 2005 Associate Professor Colman wrote that he had continued to see Mr Serong at regular intervals and that his diabetes control remained excellent as was confirmed by his HbA1c results. There were no other complications from his diabetes.
50. In a report dated 11 May 2005 Associate Professor Colman noted that Mr Serong’s diabetes is controlled expertly with four times a day insulin injections combining Actrapid and Humalog before meals and Protaphane before bed. He again commented that Mr Serong’s glycaemic control was excellent, as evidenced by his HbA1c level which was 6.6 per cent on 4 April 2005. He also noted that, over the past several years, Mr Serong’s HbA1c levels have been consistently around the target level of 6 to 7%. He had suffered from …no complications of diabetes affecting the eyes, kidneys, peripheral nerves or vascular system or the heart. He also noted that Mr Serong was not subject to sudden unexpected hypoglycaemia and has an excellent understanding of the steps required to avoid hypoglycaemia. According to Associate Professor Colman, Mr Serong …has evolved an excellent approach to checking his blood sugar before and during flights… and he was of the view that Mr Serong was …at no risk whatsoever of hypoglycaemia on this basis. Associate Professor Colman provided a document recording all of Mr Serong’s HbA1c results between 21 June 2004 and 28 November 2005. The results all fall between 7.1 per cent and 6.6 per cent.
51. Mr Serong also provided to the Tribunal pre and in-flight blood glucose test results taken between 15 March 2006 and 30 July 2006 while flying his Sky Arrow tandem seat aircraft. The total flying time recorded was 60.3 hours. The blood glucose levels ranged between 4.2 and 15.9 mmol/L. There are no readings below 3.5mmol/L which would indicate a risk of hypoglycaemia.
52. A brief report was also provided by Dr D. Birch, a general medical practitioner who has been treating Mr Serong for some 16 years. According to Dr Birch, Mr Serong’s type one diabetes has been very well controlled and stable. He has never shown any symptoms or signs that were referrable to unstable diabetes. Dr Birch also commented that Mr Serong’s overall health, physically and mentally, was excellent and that he had never demonstrated any episodes of cognitive impairment.
53. Mr Serong also put into evidence blood glucose level testing conducted prior to and during flight between 6 May 2006 and 14 June 2006 when he flew a total 41.3 hours. The results of those tests disclosed blood glucose levels between 3.7 and 14.7 mmol/L. The 3.7mmol/L reading was taken prior to take-off, which was delayed, and a reading taken 6 minutes after take-off indicated a level of 6.4 mmol/L.
54. Dr R.A. Westerman, a consultant neurophysiologist, provided a report dated 10 November 2005, after reviewing some 90 pages of evidence produced to the Tribunal including a large number of blood glucose readings between 1997 to the end of 2000. In that report Dr Westerman referred to the FAA protocol and noted that the scheme was also operating in the United Kingdom and Canada. He said:
… I consider that this FAA Protocol provides a management strategy for the risk of hypoglycaemia to be minimised to the point that safe flying operations may be guaranteed for selected individuals. I therefore recommend that CASA adopt the FAA Protocol for the certification of private pilots on an individual assessment basis.
Dr Westerman also said that if Mr Serong met all of the requirements in the FAA protocol, he should be granted a class two medical certificate without the condition requiring him to fly with a qualified co-pilot.
55. It appears Dr Westerman was asked for a further report, which he provided on 5 December 2005, after being provided with further blood glucose readings in order to confirm Associate Professor Colman’s opinion that Mr Serong’s diabetes control remained excellent. Dr Westerman noted that there were some 20 instances where Mr Serong’s blood glucose fell to 3 mmol/L or below. Although Dr Westerman accepted that some of Mr Serong’s low readings were at night, he noted that others in daytime might well have occurred in flight and would certainly have been risky if Mr Serong were flying solo. However, Dr Westerman failed to state that if a pilot were flying in accordance with the FAA protocol, he most certainly wouldn’t be taking off on a solo flight with blood glucose levels below 3 mmol/L. Nevertheless, Dr Westerman again indicated that relative to many other insulin treated diabetic persons he has seen, Mr Serong’s overall control on average was good. Dr Westerman then proceeded to update what he described as interim comments made previously, regarding the FAA protocol. Dr Westerman stated that given some of the low readings in Mr Serong’s blood glucose recordings between 2000 and 2002, he considered it would be difficult for Mr Serong to meet all the requirements of the FAA protocol, and that Mr Serong should not be granted a class two medical certificate without the condition that he must fly with a co-pilot. Dr Westerman did not explain why Mr Serong’s low blood glucose recordings would not meet the requirements of the FAA protocol. He made no reference at all to Mr Serong’s HbA1c readings during this period. We were troubled by Dr Westerman’s retreat from the position he adopted in his first report and also by the fact that he was not called at the hearing to give evidence despite the fact that he appears to reside in Melbourne.
56. Dr Westerman provided a final report dated 19 February 2006. After again noting the number of low blood glucose readings (below 3 mmol/L), he nevertheless conceded that Mr Serong’s glycaemic control improved after 2002. But he then claimed that it deteriorated in the last quarter of 2003 and in the first quarter of 2004. He said Mr Serong’s control was more stable between 15 March 2004 and 13 April 2005. He also accepted that between 25 July 2005 and 22 January 2006 Mr Serong’s control had improved. He noted that relative to many other insulin treated diabetic persons he had seen, Mr Serong’s overall control on average was good and appears stable.
57. Dr Westerman opined that a diabetic patient is well controlled if the HbA1c readings are less than 6.5 per cent. This, according to Dr Westerman, indicates excellent control of blood glucose on average. Levels between 6.5 and 7 per cent are considered good controls. Dr Westerman nevertheless agreed that Mr Serong’s diabetes was well controlled. However, Dr Westerman said that while there were some low glucose records between 2002 and 2006, he considered it would be difficult to meet all the requirements in the FAA protocol. He did not venture to say how this could be. We reviewed the FAA protocol and could find nothing in the eligible criteria on initial evaluation which would support Dr Westerman’s statement.
58. Professor G.C. Nicholson, an endocrinologist, also provided an expert report on behalf of CASA. According to Professor Nicholson, the criteria used to describe a diabetic as being well controlled are:
(a)HbA1c levels less than 7 to 7.5 %;
(b)no frequent mild clinical or bio-chemical hypoglycaemia;
(c)no (or very rare) severe hypoglycaemia (ie hypoglycaemia requiring the assistance of another person).
Quite clearly, Mr Serong falls within the well controlled description. Professor Nicholson confirmed that to be the case and went further to state that compared with most persons with type one diabetes, Mr Serong would be regarded as exceptional.
59. Professor Nicholson was also asked how often he would expect a typical patient, in the course of a year, to be outside the normal blood glucose range. He said it was highly variable between individuals; although in a patient measuring glucose levels four times a day (before meals and before bed), it would not be unusual for 25-50 per cent of readings to be outside the normal range.
60. Professor Nicholson was asked, referring to Mr Serong’s glucometer data, how confident CASA could be that Mr Serong would be able to maintain his blood sugar levels within the accepted levels during flight when operating solo. He replied that it was extremely unlikely that Mr Serong would experience hyperglycaemia sufficient to affect flight operation and that issue need not be considered further. Upon examining Mr Serong’s blood glucose levels between August 2005 and January 2006 he noted that 38 events of blood glucose levels below 3.5 mmol/L were recorded. He said it would be reasonable to assume about an equal number of unrecorded events occurred during this time. However, Professor Nicholson, correctly in our opinion, noted that those results were based on everyday life. He then said that during solo flight the probability of hypoglycaemia would be markedly reduced by the intensified blood glucose monitoring and carbohydrate ingestion regimen imposed and heightened awareness and motivation of the pilot to avoid hypoglycaemia. In those circumstances, Professor Nicholson was of the view the probability of an episode of blood glucose below 3.5 mmol/L during 100 hours of flight would be less than 1 per cent. He agreed that Mr Serong would be certified by the FAA according to its protocol.
61. There is one further complication: that is Mr Serong’s condition of hypophysotsitis, which has resulted in his pituitary gland’s function being reduced. Associate Professor Colman said in evidence that his condition had settled and was considered very stable at this time. Associate Professor Colman was of the opinion that his condition would not mask the symptoms of hypoglycaemia. In his report dated 11 May 2005 Associate Professor Colman said that Mr Serong’s pituitary gland problem was extremely stable and that there were no concerning features. He had not had to increase his Prednisilone unexpectedly at any stage and his monitoring tests for thyroid function remained excellent.
62. Professor Eastman also provided an opinion on the effect of Mr Serong’s hypopituitarism on his diabetes. According to Professor Eastman, Mr Serong is theoretically at increased risk of developing and having an impaired counter‑regulatory response to hypoglycaemia because he lacks the counter‑regulatory hormones secreted by the pituitary gland and the adrenal glands. Although Associate Professor Colman concurred with Professor Eastman’s opinion regarding a theoretically increased risk of having an impaired counter‑regulatory response to hypoglycaemia, he did not consider it relevant in Mr Serong’s case. The medication used to treat Mr Serong’s pituitary gland problem would not mask hypoglycaemia. Professor Eastman conceded that it was a rare combination of problems, probably occurring in less than 1 per cent of patients suffering from diabetes. He was not able to say if it produced a higher risk of hypoglycaemia.
63. In our view, the weight of evidence supports Mr Serong’s claims that his diabetes is well controlled and that he does meet the initial requirements for certification under the FAA protocol. We are also of the view that Mr Serong meets the guidelines set out in the designated Aviation Medical Examiners Handbook for the issue of a class two medical certificate.
Necessary Conditions in the Interests of the Safety of Air Navigation
64. As we have set out above, CASA may issue a medical certificate to a person who does not meet the medical standard for a particular class of certificate, subject to any conditions that are necessary to ensure safe air navigation. Although Mr Serong seeks a review of the decision made not to issue a class one medical certificate as well as the decision to issue a class two medical certificate subject to conditions, because of a lack of evidence available regarding air operations by an insulin dependent diabetic in commercial operations, we have confined our examination of the necessary conditions to a class two medical certificate.
65. In our opinion, the condition imposed on Mr Serong’s class two medical certificate that he only exercise the privileges of his private pilot licence as or with a co‑pilot is unnecessary when Mr Serong engages in day flying under the visual flight rules (VFR), on flights not exceeding three hours duration. Instead, the following conditions should apply to Mr Serong when conducting day VFR solo flights not exceeding three hours duration:
1.Mr Serong must carry two functioning glucometers on each flight, together with an amount of readily absorbable glucose, in 10 gram portions, appropriate for the planned duration of the flight.
2.One half hour prior to the commencement of the flight, Mr Serong must measure his blood glucose level. If the reading obtained is less than 5 mmol/L he must ingest not less than 10 grams of a glucose snack and wait for a further one half hour before taking another blood glucose measurement. If that measurement is between 5 and 15 mmol/L, Mr Serong may commence his flight. If his blood glucose level remains below 5 mmol/L a further glucose snack must be ingested and a further measurement taken one half hour later. Should his blood glucose level exceed 15 mmol/L after ingesting the absorbable glucose snack, Mr Serong must cancel the flight.
3.Mr Serong must test his blood glucose level within one hour of becoming airborne and every hour thereafter for the duration of the flight. If his blood glucose level falls below 5 mmol/L, he must ingest a 20 gram snack of absorbable glucose. He must maintain a blood glucose reading of between 5 and 15 mmol/L throughout the duration the flight. If his blood glucose level exceeds 15 mmol/L, he must land at the nearest suitable airfield and not resume flight until his blood glucose level falls back within the range of 5-15mmol/L.
4.Thirty (30) minutes prior to his estimated time of arrival on any flight, Mr Serong must measure his blood glucose level to ensure that it is not less than 5 mmol/L prior to making an approach and landing.
5.On application for renewal of the class two medical certificate, Mr Serong must provide the following:
(a)a clinical report from his endocrinologist with particular reference to the presence or absence of any end organ changes;
(b)daily blood glucose estimations for the preceding 12 months performed on a memory glucometer with the hard copy printouts endorsed by his doctor;
(c)a collated report of glycosylated haemoglobin (HbA1c) estimations performed every three months ie tests must be done every three months and the reports provided to CASA at the end of the year;
(d)a report from an ophthalmologist with regard to any diabetic retinopathy; and
(e)a report from a cardiologist who has conducted a coronary risk assessment including a Stress ECG (Bruce Protocol) while not taking any Betablockers.
CONCLUSION
66. Although Mr Serong has also asked the Tribunal to review CASA’s refusal to issue a class one medical certificate, we are not in a position to properly evaluate that request. Although there is some evidence of type one diabetic pilots conducting commercial operations in Canada, there is insufficient evidence and material before us to make a proper assessment of conditions which must attach to such a licence to ensure the safety of air navigation. The nature of commercial air operations varies widely and most are likely to have additional complicating factors. That is not to say that Mr Serong should never be granted a class one medical certificate with conditions, but rather that the precise nature of those intended commercial operations needs to be identified along with any additional risks. Therefore, CASA’s decision to refuse to issue a class one medical certificate to Mr Serong on 5 May 2006 must be affirmed.
67. However, CASA’s decision to issue Mr Serong a class two medical certificate with the condition that he only exercises the privileges of a private pilots’ licence as or with a co-pilot should be varied to include the conditions set out in paragraph 65 of this decision.
I certify that the sixty‑seven [67] preceding paragraphs are a true copy of the reasons for the decision herein of
Mr Egon Fice, Member
(sgd) Olympia Sarrinikolaou
Clerk
Dates of Hearing: 30‑31 October2006
Date of Decision: 22 December 2006
Advocate for the applicant: Self‑represented
Counsel for the respondent: Mr I. HarveySolicitor for respondent: Mr A. Anastasi, Office of Legal Counsel
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