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Richard Ottaway : Just a second ago the right hon. Gentleman said that in the September dossier the

4 Feb 2004 : Column 871

delivery systems were not under review. Can he explain the page in the dossier that has concentric rings showing the range of missiles from Iraq? How could he possibly say that that is not a delivery system?

Mr. Hoon: The key issue that was considered by United Nations inspectors and subject to a UN resolution was the distance capable of being covered by the missiles being developed by Iraq. If we really want to have a proper inquiry into this matter, the hon. Gentleman will reflect on what Dr. Kay recently discussed. The fact is that Iraq was in clear breach of its obligations as regards the development of missiles with a longer range than it was entitled to, and that map is a perfectly proper explanation.

Mr. Sayeed: Will the right hon. Gentleman give way?

Mr. Hoon: No, I am sorry, but I have given way a number of times.

For some, the inquiry became all the more uncomfortable because of the way in which its proceedings were reported. Some parts of the media were so determined to attack the Government, whatever the evidence, that it was sometimes difficult to reconcile what had taken place inside the inquiry with the following day's reports. There were even stories that were no more than fabrication, apparently printed solely to discredit officials who appeared as witnesses.

No one can object to fair and balanced criticism, but people—and particularly civil servants who are not allowed to answer back—should not have to suffer deliberate denigration of that sort. Civil servants in this country are hard-working, dedicated public servants; they are not party political and they serve Governments of all parties. I am sure that all parties in the House would want to see their professional independence maintained and safeguarded. [Interruption.] I hear the comments from the right hon. Member for Bracknell (Mr. Mackay), who I thought made a disgraceful attack on a serving civil servant—a civil servant who had apologised and who had made a mistake which he accepted. I doubt whether when the right hon. Gentleman served as a Minister he would have tolerated that kind of public attack on a civil servant trying conscientiously to do his job.

I believe that the House should again consider in particular Lord Hutton's observations in paragraph 280 of his report. This is an important restatement of the basic principles governing the relationship between the media and individuals working in government. A number of Members dealt with those issues, including

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my right hon. Friend the Member for Gateshead, East and Washington, West (Joyce Quin), my hon. Friend the Member for Thurrock (Andrew Mackinlay), and my right hon. Friends the Members for Swansea, East (Donald Anderson), for Manchester, Gorton (Mr. Kaufman) and for Hartlepool (Mr. Mandelson), who all made revealing and important comments on that relationship.

Lord Hutton's report has itself been the subject of some strong criticism, as has the learned and noble Lord. The report has been described as "a curiously unbalanced document". It has been said that


and that he


That criticism has related both to the specific findings on the facts and, in more general terms, to the fact that Lord Hutton's conclusions could in some way limit the freedom of expression. There has been wide reporting of Greg Dyke's view that the implications for journalism are grave and that there will be a legal sea change that silences whistleblowers.

Given the gravity of such criticism, it is worth examining what Lord Hutton set out. I apologise for quoting him in full. He states in paragraph 280:


This reflects precisely the Press Complaints Commission's code of practice, which all our national newspapers are supposed to uphold. On accuracy, it states:


I emphasise the phrase:


In concluding this debate, let me repeat that the Government accept the report—

It being Seven o'clock, the motion for the Adjournment of the House lapsed, without Question put.

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4 Feb 2004 : Column 873

Laser Eye Surgery

Motion made, and Question proposed, That this House do now adjourn.—[Margaret Moran.]

7 pm

Dr. Ashok Kumar (Middlesbrough, South and Cleveland, East): I thank you, Mr. Speaker, for granting me this debate. My own interest in the safety of laser eye surgery began about a year ago, when I read some reports in national newspapers on the matter. Since then, I have followed the subject with great interest; in fact, I even tabled some questions in the House on it. Recent advances in laser technology mean that both long-sightedness and short-sightedness can be treated, and in many cases corrected, through laser eye surgery. Seventy-seven corrective laser eye surgery establishments are currently registered with the National Care Standards Commission. According to a Health Which? report of February last year, some 100,000 people a year in the UK undergo laser eye surgery.

I want to comment on the history and popularity of laser eye surgery, and then to highlight my three main concerns about the safety and reliability of this service. First, on customer care, there is a need for development and extension of the consumer protection regime, and for the provision of detailed information about the potential risks and complications of surgery. Secondly, in terms of the qualifications of practitioners, there is a need for standardised training requirements for surgeons performing laser eye surgery procedures. My third concern relates to clinical audit and best practice, and the need for regulatory bodies to identify best practice, and to create standard regulations for the entire industry, including minimum standards of pre-care and post-care.

Laser eye surgery was developed by the ophthalmologist Dr. Steven Trokel in 1987, and first used on a patient in Germany in 1988. The first laser eye treatment clinic using Dr. Trokel's laser was founded by US-based investors in Toronto in 1989. Following the success of the US operation, the first UK clinic was opened at Clatterbridge hospital, in Wirral, in January 1991. It grew into a string of clinics now known as Ultralase, one of Britain's foremost laser eye treatment providers. Ultralase and other, smaller companies—along with Boots, Optimax and Maxivision—are believed to perform some 100,000 treatments a year in the UK.

The declining cost of laser eye surgery reflects increased demand and competition within the sector, and demonstrates its popularity. But that is matched by increasing concern among patients and clinicians alike about the resulting side effects and vision damage. Laser eye surgery, a relatively new form of elective surgery, is seen by many as a cosmetic procedure, but the changes made during it are irreversible and can lead to side effects ranging from dry eyes to worsened vision. Nevertheless, an increasing number of people, rather than wear glasses or contact lenses for the rest of their lives, are opting to spend money on a one-off surgical procedure that, in the majority of cases, eliminates the need for glasses or lenses.

There are those for whom refractive surgery is a godsend, freeing them from a lifetime's myopia with one quick, fairly pain-free and relatively cheap procedure,

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but my concern is that there is currently no adequate means of assessing the quality of the treatment available. If it is true that you get what you pay for, we may note that the range of fees payable for the surgery varies from £495 per eye for Lasek treatment at Optimax, through to £1,650 per eye for Wavefront LASIK at Laservision. In fact, the cost can be as much as £2,000 per eye, as reported by the Discovery Health channel last year when it investigated this topic. That is quite a range.

What exactly is it that people are paying for? What are the basic requirements, and what are the added extras? It is worth mentioning that there are vast differences in the regulations for cosmetic surgery and for laser eye surgery. Since April 2002, minimum standards for cosmetic surgery have been applied by the NCSC, which also vets cosmetic surgeons who generate regular complaints. In May 2002, the Department of Health provided additional reassurance by announcing proposals to require cosmetic surgeons to be medically qualified and to have attended a postgraduate course before being allowed to operate.

Where does that leave laser eye surgery? Surprisingly, the regulations covering the sector do not appear to be as stringent as those covering more traditional cosmetic procedures. I would be interested to hear the Minister's comments on why that is.

Negligence claims involving laser eye surgery against doctors belonging to the Medical Defence Union have more than doubled in the past six years. The Medical Defence Union is the largest insurer for UK doctors. It believes that, while some of the claims were for faulty surgery, many more centred on patients' unrealistic expectations about what could be achieved. Recent figures released by the union show that claims over laser eye surgery have increased by 166 per cent. in six years and now account for a third of all ophthalmology claims. The MDU has increased its subscription rates for laser eye surgeons and advised them on how to minimise the risk of a claim.

Dr. Christine Tompkins of the MDU is on the record as saying:


In very rare cases, complications can lead to corneal ectasia, where fluid pressure builds up on the eye, and patients can need a corneal transplant to correct the condition. Other complications, although deemed "minor" by clinics, occur "relatively frequently", according to a recent review by the American Academy of Ophthalmology. Patients can experience dry eyes or night vision problems that can affect the ability to drive or work in the evening or in dim light.

My first concern is about customer care and access to information. The guidelines make it clear that there should be information available about the possible negative effects of laser eye surgery, but it is for the clinic to determine whether this means blinding the patient with science through a list of technical outcomes or, alternatively, reassuring them that mishaps are so rare that they do not need to worry.

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The Health Which? Report last February catalogued a range of complaints from those who have experienced negative effects following laser eye surgery. Some were temporary, but in other cases long-term effects were cited. The report said:


He continued:


He concluded:


My second concern is the qualification of practitioners. Early last year, I tabled a written question about the qualifications required for laser eye surgery practitioners and the clinical assessment and audit of such procedures, and I received an answer on 28 April 2003. The then Minister, my hon. Friend the Member for Tottenham (Mr. Lammy), informed me that such establishments must register with the National Care Standards Commission and are required to comply with the private and voluntary health care regulations. He stated:


That answer is worrying on two counts. First, as the regulations stand at the moment, they require not the person conducting the procedure but the clinical director for the registered clinic to be qualified in, in this case, refractive eye surgery, which means that in practice the patient, who might naturally assume that the person responsible for changing the shape and size of their cornea using pulses of high-frequency light is qualified, may be operated on by a general practitioner or similar. Indeed, after speaking to the Royal College of Ophthalmology and the NCSC, it is unclear what standards of qualification exist for laser eye surgeons and what constitutes a competent and experienced surgeon.

Dr. Sherry Williams of the Medical Protection Society told me that because refractive surgery is not conducted in the NHS, no training is available through the NHS. It is therefore left to the industry to determine that each individual clinic sets its own standards, and that is not immediately apparent to patients seeking service in the industry.

There are no specific regulations in refractive surgery, and the only legal requirement for doctors performing laser surgery is that they are registered with the General Medical Council. Any doctor currently employed by a refractive surgery chain can operate after a laser surgery course of just a few days. I find the suggestion that surgeons operating in the private sector should not be

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bound by the same degree of clinical assessment and audit as those within the NHS worrying, and in that I am not alone.

The public minutes of the NCSC board meeting last June state:


I know that CHAI will become responsible for the sector in April this year, but I am still unaware of any efforts to address my specific concerns. Having researched the issue, there is general agreement among interested parties, which include NCSC inspectors, the RCO and the laser eye industry, that more detailed basic regulation would be welcome, as long as it is not too prohibitive or prescriptive. This agreement is particularly true in the light of the decreasing cost and increasing popularity of refractive eye surgery procedures.

One inspector told me that in the inspectors' opinion the regulations and guidelines that they were required to use during their inspection of laser eye surgery clinics were


Given that all inspectors for the NCSC are clinicians of one sort or another, to my mind that is not a statement to be ignored.

I come to best practice. I do not want to be seen as too critical of a new and innovative area of medical practice that is a great credit to those who developed it. I admire the spirit of innovation in laser eye surgery.

While researching the subject, I have become aware that there are those who exemplify the best practice, which I feel needs to be rolled out across the sector. Ultralase—whose chairman, Christopher Neave, is also chief executive of the relatively new industry body, the Eye Laser Association—is one of the larger independent health care providers in the laser eye surgery sector. It does not simply operate within company standards, which appear to be more severe than those required at the statutory level at present. Indeed, during a recent meeting I was most impressed to note that certain changes that I recommended are to be added to its guidance as a direct result of our meeting.

The NCSC, the RCO and the laser eye surgery industry have all expressed, to differing degrees, interest in creating a set of standards for the benefit of patient safety.

In conclusion, I should like to say that as patients' knowledge of their rights grows, so do their expectations and demands. After recent high-profile debates about the competence and clinical auditing of surgeons and other health care professionals in the public sector, I believe that it is important that we extend our gaze to the private sector as well.

I do not want to unduly criticise private health practitioners. In fact, the Eye Laser Association agrees with me that there are distinct benefits in recognising the best practice of some practitioners and requiring others to bring themselves up to scratch. Just one example is that of pre-care assessment. Ultralase reports that about 25 per cent. of people are ineligible for laser eye surgery due to certain medical conditions, and recommends that

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any clinic operating should not have a turn away rate significantly lower than 25 per cent. It also refuses to conduct surgery on the same day as a patient is assessed. I am led to believe that the RCO is drafting guidelines requiring a cooling-off period between assessment and treatment of patients, but this is not currently mandatory.

Similarly, different clinics offer different after-care advice and treatment. As long as the consumer has no indication what the recommended minimum information and treatment are, and as long as the industry has no requirement to provide that minimum, but simply to provide some, it will continue to be the consumer, if anyone, who suffers.

I look forward to hearing from my hon. Friend what steps are being taken to address my three concerns. I ask her to use the powers available to her under section 130(1) of the Health and Social Care (Community Health and Standards) Act 2003 to direct the Commission for Healthcare Audit and Inspection to investigate the need for closer scrutiny of the laser eye sector.


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