20 February, 2001 Media Statement

Aviation medical system to be rebuilt

Transport Minister Mark Gosche today introduced legislation to Parliament to begin rebuilding the aviation medical certification system.

Mr Gosche said decisive action was needed after an independent study found serious flaws in the current system.

The report by Professor Gorman and Professor Sir John Scott concludes that the current system is ¡§defective¡¨:

¡§Our overall conclusion is that public safety demands urgent changes to the process of determining medical fitness to fly aeroplanes in New Zealand.¡¨

Professor Gorman is head of occupational medicine at Auckland University and the leading New Zealand academic on occupational medicine. Professor Sir John Scott is one of this country¡¦s most eminent doctors and a renowned expert on medical processes and ethics. Both professors are experts in health surveillance systems.

¡§They have revealed a serious public safety issue,¡¨ Mr Gosche said. ¡§Passengers should be able to have confidence in their pilot¡¦s fitness. Unless we take rapid action they will be not be able to do so.¡¨

¡§The Government has to address the fact that independent experts have found serious faults with the present system and that the New Zealand system is not up to international best practice.¡¨

At present, private sector practitioners known as Aviation Medical Assessors (AMAs) assess pilot medical records compiled by Designated Medical Examiners (DMEs) who conduct the physical examination of pilots.

In future, the report recommends the DMEs¡¦ reports should be assessed by a team of specialists employed by the CAA in a model similar to those of Canada and Australia. The Director must be given the legal power over the medical assessment process that he needs to protect public safety.

Mr Gosche said the legislation would give the Director of Civil Aviation clear statutory responsibility for aviation medical certification. This included the power to appoint and remove medical examiners, to issue directions to medical examiners, to conduct medical assessments and to issue and withdraw medical certificates.

The Bill would also ensure validation of all existing medical certificates, he said.

¡§These changes effectively recentralise a medical system that was decentralised in 1992. That was done with the best of intentions, but the experiment has not worked.¡¨

¡§I could not allow a system with such inherent flaws to continue.¡¨
Mr Gosche said overseas experience suggested more centralised systems permitted a collegial approach that helped doctors make complex assessment decisions, and also helped develop a depth of experience and precedent.
Independent Examination of Medical Standards

Mr Gosche also announced that, separately from the Bill, he was establishing an independent examination of the medical standards contained in the Civil Aviation Rules, and that examination would include looking at the contentious ¡§one percent rule¡¨.

The one percent rule relates to cardiovascular risk and provides a threshold beyond which further checks or health intervention may be necessary. Strong aviation industry opposition to the one percent rule has recently led to legal action.
Mr Gosche said he recognised the strong concerns of the aviation industry on this issue. This was, however, separate from the medical process.

The examination panel would consist of an eminent lawyer and an overseas aviation medical expert to consider international best practice in regard to medical risk standards. The panel would hear the views of all parties and make recommendations directly to him.

¡§The panel¡¦s report, and that of the professors, will form the backbone of a complete rewrite of the medical rules and the medical manual.¡¨

¡§I am hopeful that that rewrite will go some way to mending relationships between the CAA and the aviation industry. These have been badly strained in recent times and I want to do all I can to fix that.¡¨

¡§I am aware, also, of the public¡¦s interest in this. Whatever the outcome, public safety has to be paramount,¡¨ Mr Gosche said.

Mr Gosche said he was hopeful that the new rule could be in place by Christmas.

ENDS

For more information:

20 February 2001
STRICTLY EMBARGOED UNTIL 4.30PM THIS AFTERNOON
Background Information

New Zealand¡¦s 13,000 pilots hold a licence issued under the Civil Aviation Act 1990. The validity of the licence depends on the pilot holding a current medical certificate. This means they must pass regular medical checks. So must air traffic controllers.
Under the current system, as established under Civil Aviation Rule Part 67, medical examinations are conducted by Designated Medical Examiners (DMEs) who are private doctors. Aviation Medical Assessors (AMAs) then review their reports.
AMAs are also private doctors but are appointed by the Director of Civil Aviation to review the DME reports and issue (or decline to issue) the medical certificate. Sometimes an AMA carries out both roles so there is no overview.
The de-centralised system is based on the assumption that the AMAs can and will provide, without compromise, medical assessments to promote public safety even though they may have a doctor¡Vpatient relationship with the pilots.
The instigation of audits of doctors was signalled by the CAA at the Aviation Medical Society 1998 conference. In 1999 the CAA began auditing the AMAs. The audits showed an unacceptably wide variance of standards and an unacceptably high clinical error rate. In one case an AMA who undertook 30 per cent of the 8000 pilot assessments conducted each year was suspended just before Easter last year.
Presland Case
Around the same time the Director¡¦s powers, and the use the CAA has made of the medical manual, have come under challenge. This includes a District Court judgement in April 2000 in the case CAA v Presland where a pilot was found to have flown without a valid medical but not convicted due to the assessment procedures used. The CAA had been relying on its medical manual and its procedures to maintain a measure of control over the assessment system.
There has also been concern from pilots about the ¡§one percent rule¡¨ for cardiovascular and other medical risk, and the use of the ¡§Flight Fit¡¨ programme - a computer programme for determining when one percent is exceeded.

What is the One Percent Rule?
While the report doesn¡¦t specifically look at the one percent rule, this issue is a contentious one for many pilots.
The one percent ¡§rule¡¨ is not a rule and it¡¦s not law. It is an internationally accepted boundary between an acceptable and unacceptable level of risk in a pilot or air traffic controller for any sudden incapacitating event (such as heart attack, stroke or epileptic fit).
The rule has been around almost 30 years ago. At that time it was felt that the risk of pilot ¡¥failure¡¦ through medical incapacitation should be treated in a similar way to the requirements for mechanical reliability of an aircraft, where the acceptable level of risk was defined as no greater than one as an event involving the loss of an aircraft and/or fatalities in every ten million flying hours.
The idea was taken up by the UKCAA, which in 1982 convened the first of a series of workshops on the assessment of risk to pilots from cardiovascular disease. From there the concept was refined, and a number of tools were developed to help aviation doctors assess risk. The ¡¥1% rule¡¦ is now widely used internationally as an acceptable level of pilot risk.

Although the one percent rule has been in use in New Zealand since the mid 1990s, and overseas far earlier, in the past year the way it was being applied has become particularly controversial and has encountered strong opposition from pilots and a number of medical practitioners. Discussions with industry on these issues ended in impasse when a consultative review was stalled by legal action.
The Minister is announcing that, separate from the new legislation, he is establishing an independent examination of the medical standards contained in the Civil Aviation Rules. That examination will include looking at the one percent rule.

Independent Review

The Director of Civil Aviation, Kevin Ward, commissioned in May 2000 a totally independent review of the aviation medical certification system from eminent medical experts Professor Sir John Scott and Professor Des Gorman.
Their report, released today, says that the medical assessment system is fundamentally flawed and needs urgent legislative action to restore integrity and protect public safety.
They found the medical system has become too decentralised, lacks adequate controls, and has inappropriate incentives.
In particular they found:
„h the commercial relationship between the pilots and the private medical practitioners, who effectively administer the system, creates incentives that are potentially inconsistent with the public interest in aviation safety;
„h the decentralised process is at variance with international best practice. (New Zealand practice was compared with that in Australia, Canada, the USA and the UK. New Zealand is the only one of the major aviation countries to have devolved and decentralised its aviation medical system, and in the USA 99 percent of all assessments are conducted by a panel of doctors within the Federal Aviation Administration.);
„h some AMAs are not qualified to undertake the assessments, and in some cases test results to establish knowledge of CAA requirements had been changed before a pass mark was achieved. Some often exceeded their authority delegated by the CAA;
„h the standard of medical assessments is variable and has an unacceptably high error rate. (Those AMAs, which were audited, had a mean error rate of 55% with the highest being 81%. Some of these errors were minor but some were serious clinical errors.).
The clinical errors included:
„h Un-corrected visual acuity not recorded
„h Visual acuities recorded at a higher level than actual
„h ECGs cleared as normal when they were not
„h One AMA saying he could not read ECGs yet these are critical to the examination
„h A series of pilots seen by one doctor having identical ECGs.
„h Many pilots indicating health problems which were not followed up. These included renal colic, depression, malignancy, significant hearing impairment, heart problems, blood problems, kidney problems.

The Professors said this list was meant to be illustrative and not exhaustive.
To remedy the position, the Professors recommended a revised system adopting best international practice and as similar as feasible with Australia¡¦s. Their recommended system also incorporates the Transport Canada Aviation Medical Review Board process.
They said urgent legislation is needed to rectify flaws in the regulatory framework and provide the Director clear statutory responsibility for aviation medical certification matters, coupled with the necessary powers to discharge this responsibility effectively and be in line with overseas practice, particularly Australia.

Professor Scott and Professor Gorman Biographical Details

Professor Sir John Scott is an eminent clinician and medical ethicist. Professor Scott was awarded the KBE in 1987 and is a fellow of the Royal Australasian College of Physicians, the Royal College of Physicians, London, and the Royal Society of New Zealand. He has worked as an academic physician at hospitals in New Zealand, the United Kingdom and the United States, and has held research and teaching roles in Universities in Australia and the United Kingdom. His primary areas of research are arterial wall disease, lipoprotein physiology and patho-physiology, and human nutrition. He has published over 200 papers, and has been a member of a large number of high-level government committees and inquiry teams. Professor Sir John¡¦s other interests include medico-legal matters, health service development, and he has served on the editorial boards of several professional and scientific journals.

Professor Des Gorman is a leading expert in occupational health issues. Professor Gorman has specialised in occupational medicine and public health and is a fellow of the Australasian College of Occupational Medicine, and the Royal Australasian College of Physicians. He is the Professor of Medicine and Head, Occupational Medicine, at Auckland University. His extensive experience includes service in both the Australian and New Zealand Navies. Professor Gorman has published six textbooks and has contributed to many others. He has also published hundreds of papers, reports, reviews, abstract and letters. His ongoing research record includes work on critical decision-making in aviators, decompression illness, workplace intervention, diving and submarine escape accidents, and hypoxia.

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