The IEU-Alliance arranged to meet in Strasbourg and held its Sunday  Convention to discuss strategy and the meetings that had been arranged for the following Monday. See photos below
 

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March 13th 2006

The Council of Europe is the continent's oldest political organisation, founded in 1949. It groups together 46 countries, including 21 countries from Central and Eastern Europe. It is distinct from the 25 nation European Parliament. Its headquarters is in Strasbourg, NE France.

The Aims of the Council are to:

• defend human rights, parliamentary democracy and the rule of law
• develop continent-wide agreements to standardise member countries' social and legal practices
• promote awareness of the European identity based on shared values
• cutting across different cultures. 

The Council of Europe has produced a an excellent document entitled "The Development of Structures for the Citizen; Patient Participation in the Decision-Making Process affecting Health Care". This emphasised the need that citizens and patients should be an integral part of health care. A more recent report ,Strasbourg April 2005 has been produced which was investigating " Prevention of Adverse Events in Health Care, a system approach". Here there is an acknowledgment that 'patient safety' is a European Challenge. It was disappointing that the IEU-Alliance  was unknown at the Council of Europe when this document was being produced,otherwise it might have been possible to have had an input.

The IEU-Alliance was able to discuss the problems of the iatrogenic patient and stressed the fact that remedial medical care was often denied because of legal liability. The EU-Alliance Declaration 2005 July was presented to Mr. Vladychenko and Mr. Mierzewski. See photo below.
 

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22nd May 2006
March 13th 2006 Afternoon IEU-Alliance meet with  Mr. John Bowis OBE MEP for London  UK Conservative party. He is the Conservative spokesman on Health & Consumer Affairs in the European Parliament and was former Minister of Healthcare UK. 

Mr. Bowis serves on the European Parliament's Environment, Public Health & Food Safety Committee and  it was in  this capacity that an appointment had been arranged. The IEU-Alliance was delighted to meet with Mr. John Bowis who listened  most  attentively as we discussed our concerns for the iatrogenic patient and the urgent need for remedial medical care irrespective of legal liability. 

Mr. Bowis lost no time in bringing to the European Council's notice at the following  Plenary Session just a few hours later that he had had a meeting that afternoon with a delegation of iatrogenic patient representatives.........

See photo below.
 

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22nd May 2006
March 22nd. 2006 IEU-Alliance meet with Mr. Karl-Heinz Florenz at the European Parliament Brussels. Mr. Florenz is German and joined the European Parliament in 1989 and is a member of the European People's Party (Christian Democrats) (EPP) and European Democrats (ED)

Karl-Heinz Florenz is Chairman on the prestigious  Environment, Public Health & Food  Safety Committee.  It was in his capacity of Chair that the IEU-Alliance had sought a meeting with him. 

Members of the Alliance  were very well received and  he listened sympathetically as we
discussed the position of iatrogenic patients: the necessity to establish statutory obligations to
register  medical errors, give full disclosure and to provide genuine follow-up diagnostics and
remedial medical care.  - the latter being the  most serious  and caused by  the problem of
potential litigation. 

The IEU-Alliance was delighted to be able to present him with the IEU-Alliance Declaration July 2005.  Mr. Florenz clearly stated his support to the delegation of the  IEU-Alliance. See photo below 
 

It is most gratifying that European politicians are taking the problem of medical errors so seriously. Recording medical errors is now a priority but the issue of providing genuine humane remedial care for seriously damaged patients and their families is a very urgent matter. If we get full open disclosure, which is surely,the only ethical and moral option, then medical-litigation will become, for the vast majority of cases, unnecessary.
 

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22nd May 2006

The Chief Medical Officer ( UK) Prof. Sir Liam Donaldson stated in his Paper: ‘Organisation with a Memory’ that it was estimated that 10% of patient hospital admissions in the UK would suffer a medical error ( 850,000 per year). This means that there were approximately 8 mill admissions to hospital in one year (representing 13% of population). Of these errors 1%  would be very serious causing death or permanent injury ( 80,000).( Estimated deaths in UK 34,000 per year and 40,000 seriously injured). It was decided to lower the expected number of hospital admissions to 10% of the population from 13% as in the UK, so that the data would not be overestimated. Using these percentage figures as a base the following can be extrapolated for Europe. We emphasise that the data has been extrapolated because there are no official data available.
*NPSA  report: Building a memory: preventing harm, reducing risks & improving patient safety, London July 2005 p53
 

Country/ Region	Population	Hospital Admissions 10% of popultaion per year	Medical Error Rate 10% of Hospital Admissions	Medical Errors 1% deaths & ser. injuries Victims	Approx 0.5% deaths Victims	Approx 0.5% ser. injuries Victims
Ireland	3,500,000	355,000	35,500	3,550	1,775	1,775
Denmark	5,300,000	530,000	53,000	5,300	2,650	2,6500
Austria	8,200,000	820,000	82,000	8,200	4,100	4,100
Belgium	10,000,000	1,000,000	100,000	10,000	5,000	5,000
Netherlands	16,000,000	1,600,000	160,000	16,000	8,000	8,000
Australia ***	20,000,000	---------	---------	---------	18,000	50,000
Italy	57,000,000	5,700,000	570,000	57,000	28,500	28,500
France	58,000,000	5,800,000	580,000	58,000	29,000	29,000
UK	60,000,000	6,000,000	600,000	60,000	30,000	30,000
Germany	83,000,000	8,300,000	830,000	83,000	41,500	41,500
USA **	300,000,000	30,000,000	3,000,000	300,000	150,000	150,000
EU 25 states	450,000,000	45,000,000	4,500,000	450,000	225,000	225,000
Council of Europe ****	800,000,000	80,000,000	8,000,000	800,000	400,000	400,000

**Journal of the American Medical Association (JAMA) in an article ( vol.284 nr42000) paper by Dr. Starfield estimated that deaths in the USA due to medical errors could be as high as 250,000 per year.  Other sources (‘ To Err is Human’) puts deaths at 100,000 per annum)

*** ‘Quality Health Care Study’:  Med. Journal of Australia (vol 163,1995) by Wilson, Runciman & Gibberd
**** 45 states Council of Europe

In 2006 within Europe there is still no mandatory, official system of registration of medical errors. Nor is there mandatory root cause analysis; nor are there systems established to prevent the occurrence of medical errors. In comparison, motor vehicle accidents have been for decades routinely and systematically registered with the recording of deaths and injuries. For fear of litigation victims of medical errors usually do not receive follow-up genuine diagnostic tests or genuine remedial medical***** care.This is unethical and inhuman.

We are aware that various necessary initiatives in the area of Patient Safety and research into the occurrence of medical errors are being implemented in many countries throughout Europe. This is indeed a very positive development. However, top priority should be given to the organisation of remedial medical care for the innocent and suffering iatrogenic patient regardless of legal liability of the respective Health Institution.

*****Bismark, M. PatersonR.‘No Fault Compensation in New Zealand: Harmonizing Injury Compensation, Provider Accountability & Patient Safety. Health Aff( Milwood) 200; 25:278-83
Bismark M. Paterson R. ““ Doing the Right Thing” after an adverse event”  NZ Med.J 2005 July 29th. 118 ( 1219(:U1592

 Copyright:  IEU-Alliance March 2006     www.ieu-alliance.org
 

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Mrs. Jane Kennedy was appointed Minister for Patient Safety 9th May 2005   and resigned on 8th May 2006.

SIN thought that by  creating a  Minister for Quality & Patient Safety  was a great step forward. Jane Kennedy spoke well  at the prestigious November London Patient Safety Conference and actually  stated that "litigation should not be a barrier to health care". This supported SIN's view and experience that litigation is the most serious barrier to Patient Safety & Justice - once a patient becomes a victim of a serious medical error he/she is perceived as a potential litigant and therefore an adversary and can no longer access genuine specialist medical care.. SIN had the pleasure of meeting Mrs. Kennedy briefly at the Summit and it was suggested that SIN made an appointment to see her in the Spring. She also spoke at the NPSA Patient Safety Conference 2006. We were, therefore, very disappointed to hear that she had resigned from her Ministerial position.

Andy Burnham has now replaced Jane Kennedy, but not only do we have a new Minister but the name of the Office  has been changed.  Minister for Quality & Patient Safety has now become: Minster for Delivery & Quality  - the words 'Patient Safety have been dropped .WHY? SIN believes that the words ' Patient Safety' were  very important.  It looked as though the UK was taking a global lead in providing patients with their very own  Minister for Patient Safety. A cynic suggested that Jane Kennedy's title, which included 'Patient Safety', was created for the Prestigious Patient Safety Conference only. SIN wishes to see the words 'Patient Safety'  returned to Andy Burnham's Ministeral 
title.
 

SIN has been campaigning for a Victim's Compensation Fund  since July 1999 and was delighted when this Labour government backed by the Chief Medical Officer decided to introduce such a Bill. SIN submitted comments to the CMO see Papers " "Balancing the Scales"  February 2002 &  " SIN's Response to the CMO's 'Making Amends'  consultative document" October 2003

It is important to remember that medical errors = £MONEY .  Medico-litigation is a very lucrative £multi million ( billion?) annual industry  with only 10% of this money going to the damaged patient /bereaved families. The medico-litigation route is a very flawed system.  Lord Woolf, former Lord Chief Justice of England & Wales , stated in his Inaugural Lecture 17th January 2001 that only 17% of cases in England pursued through the courts were successful.  Recent figures are that 5,609 legal claims were made in the year 2004 -5. This is a very small number considering the tens of thousands who are seriously medically  damaged ( 40,000) or killed ( 30,000) in one year   - all presumably entitled to take their case to court and win compensation. Therefore,  5609 is a very small number. Assuming that all the  5.609 did get to the courts then only 17% would be successful: 952.  Lord Woolf said that "The courts became increasingly conscious of the difficulties which bona fide claimants had in establishing their claims." A change was long over due.We find reference to a 'Compensation Culture' rather offensive when one considers the trauma and suffering of the innocent victims of serious medical errors.

SIN advocates a down-grading of the medico litigation route , the jettisoning of the nonsensical Bolam and other Torts which have governed the English law courts for five decades and the introduction of an open & honest disclosure of serious damage regardless of legal liability  and a Victim's compensation fund /Redress Bill with Mediation  assured remedial care and a thorough causal analysis into the error including the patient's perspective.

What SIN likes about the NHS Redress Bill:
The Scheme is Proactive - the Trust  idenitifes cases:
The original Bill  provided for a single scheme allowing a hospital trust to identify untoward incidents that might well involve clinical negligence, as well as dealing with complaints made to it directly by patients or their families. The trust would investigate and ascertain the facts and, with the patient’s consent, would refer the case to the scheme and to  the NHS Litigation Authority, to establish liability and an appropriate level of compensation. The patient would, however, have access to independent legal advice and, in some cases, to independent medical advice as well, because independent medical advice might well be needed to establish the full facts.

The Scheme also reacts to complaints made by patients/families.

This is exactly what SIN was looking for
Question?
What will happen when the  Trust discovers that the case is serious and worth a great deal more than £20,000- would this mean the patient /family could not be informed? This is hardly fair or sensible in fact it is unethical to withhold information of damage.
SIN has been calling for 'open & honest' discosure regardless of  legal libility . Damaged patients have a right to the truth. . This Redress Bill deals with the   low level cases  - now we want the Redress Scheme to consider the Higher value  cases of serious damages. Why should seriously ill patients and bereaved relatives  be forced to fight in the courts when the Trusts have  identified what went wrong? What waste of money!!

What SIN does not like:
1   That the 'Torts & the courts' are to be retained.
Who  wishes  the 'courts and the torts' to prevail?- the MDU, MPS & Medico-litigation lobby
In spite of the policy statement made by the Depart. of Health on the Redress Bill: "It would not be appropriate for the Bill to set out that the 'Bolam' and 'Bolitho' tests ( torts) will be applied to cases under the Redress bill." both the  The Medical Protection Society & the Medical Defense Union have both made public statements  that the torts should remain.. In the House Magazine issue  1054 the MPS stated that the it was necessary to keep  all the torts. 

To quote from the MPS website: "The current legal test, known as 'Bolam' is a tried, tested and respected ( ?) mechanism for assessing whether treatment fell below the accepted standards and must be  integral to the new Scheme." Which planet is the MPS inhabiting?

 There has been widespread criticism of the Torts  particularly Bolam. This states that if a 'body of medical opinion' says something - then  it is OK. The Judge is not expected to choose between two conflicting ' bodies of medical opinion'.  Just two doctors can constitute a 'body of medical opinion'. With the strong professional allegiance that exists amongst doctors it is not difficult for a doctor to find a colleague who will support him.

Australia has been very critical of Bolam : "The New South Wales Court has held that the Bolam test is not only the wrong  test where disclosure of risk is concerned, but it is also the wrong test  in relation to decisions concerning treatment and diagnosis." ( Lord Woolf's Inaugural lecture).  Lord Woolf initmated that it was time for Bolam to go in this Lecture Jan.17th 2001. He considered that  with improved procedures it would:"increase the ability of the courts to resolve medical issues justly and reduce the need for the courts to rely on the intrusive BOLAM.Another Law Lord said that the 'body of medical opinion' must withstand 'logical ' analysis' ( not always apparent with 'Bolam'). Canada has rejected Bolam and New Zealand in its wisdom  jettisoned Bolam 30 years ago!! Why does the UK remain in the Dark Ages?

2. The Low  Level of capping - reduced  to £20,000

 Who wants a Low Level of Capping for the Redress Bill?
The original consultative document ' Making Amends ' suggested £30,000. SIN argued this was much too low  Because such a capping would simply keep the status quo and really serious cases would still be forced  to go to Law. Apparently all the medico litigation stake holders  including AvMA argued for a LOWER  capping of £20,000. They  obviously wish to retain control of all the more serious and expensive cases.

Why will such a low capping change very little?
Because Chief Executives have told us that they  already have discretionary   powers  to make out compensation payments for low level of damage up to £20,000 - £40,000 with permission from the NHS Litigation Authority with out the recourse to Law. The Sec. State for Health, Mrs Patricia Hewitt , described a case in the House of Commons of a Trust being able to offer a damaged patient £12,000  compensation.Proving that low grade settlements are already being settled by the Trusts.Therefore the Redress Bill will change nothing .

Reasons given for the necessity of low capping:
  1. That high compensation cases are 'complex' and therefore  need to go to Law. This we refute - serious damage and death can have very obvious and simple causes.
  2   Everyone has a right to go to Law. In theory this is correct, but  in practice only the rich or the very poor have easy access to Justice. Many are denied this route to resolution - and it is the only route. No one is suggesting that this route is barred - only that there are alternatives.
  3. That every injured patient must be supported and  protected by legal representation. However, it is pointed out that this 'protection' & 'support' has achieved very little for the vast majority of bereaved families and seriously damaged patients over the last 50 years. SIN has suggested that where the compensation offer is disputed - Mediation would be available. NB Some of the court settlements have been derisory 

3 Proposed Amendment : Another level of Investigation in the Redress Bill ?( LibDems  & Cons)
It seems that there is an Amendment suggested  to the Redress Bill that argues ( even for these Low  capped NHS claims) that another 'investigative ' layer is added - containing lawyers and 'expert witnesses'.   With the  torts  being retained  then  it will be another unnecessary delay and expense!!   Surely this  is a retrograde step because low level injury compensation is already being given at the discretion of the Chief Executives without  recourse to  lawyers or expert witnesses? Such a new layer would just complicate matters. Estimated costs will be an additional £40mill.
NB Risk Managers of Trusts  already grade  serious incidents according to severity of damage sustained but these are kept as internal documents and not released to the patients/families.

SIN has asked that it will be a statutory obligation to record errors that harm patients and a statutory obligation to inform the patient of damages. All that is then left, is to decide on damages. The whole system hinges on the willingness to be honest when damage occurs. ( Damage does not have to be caused by negligence). We believe that most doctors would like to be honest and open with patients. SIN envisaged that the Trust would write out the report of the extent of the injury. -  send it to the NHS Compensation Assessment Unit - set against a National Tariff  and an award would be made, Mediation  if necessary. 

SIN is in agreement with Dr Graham Neale Clinical Safety Research Unit St. Mary's Hospital London when he states that the proposed amendment :"....may nullify the aim of the Bill which is to provide patients with open, transparent ,non adversarial proceedings and prompt redress. It will be difficult to satisfy these requirement by adding a layer of independent investigation that, in most cases, will slow resolution and reduce true understanding".

Lord Woolf ( Lecture Jan. 17th. 2001) also referred to this situation: "They needed to recognise that because patients felt they had been a victim of medical malpractice this did not justify withdrawing treatment. II meant that those who had responsibility for treating the patient had a particular duty to achieve the best results possible for the patient." 

Quote from the Harvard Medical Schools March 2006 Paper: "When Things Go Wrong":

14th November 2006

March 22nd. 2006 IEU-Alliance met with Mr. Karl-Heinz Florenz at the European Parliament Brussels. Karl-Heinz Florenz is Chairman on the prestigious  Environment, Public Health & Food  Safety Committee.  It was in his capacity of Chair that the IEU-Alliance sought
a meeting

 In July the IEU-Alliance received written confirmation of Herrr Florenz's support . The issues raised by the IEU-Alliance  and the 'professionalism' of the organisation impressed Herr Florenz.He appreciates that more attention must be given to the registration of medical errors and  that injured patients should be informed of damage sustained. He also recognised that  injured patients had difficulty in obtaining genuine diagnostic tests and treatment because of legal liability. He showed great compassion and understanding for the problem.

Herr Florenz believes that more improvement is needed in Europe in this area of Patient Safety. He has assured us that he will do his best to  represent our interests. To this effect he has requested a meeting for the IEU Alliance with officials  from the Commission's High Level Group dealing with 'Patient Safety'

On 12th September  a Teleconference took place between members of the IEU-Alliance and representatives of the PFPS Alliance. We were delighted to have this opportunity to hear at first hand about the great progress that had been made since the PFPS Alliance came into being in October 2004.

The PFPS Alliance has been very busy developing workshops  in various parts of the world and it tries to link them with important national events e.g.. The Prestigious Patient Safety Conference in London in Nov. 2005. More recent Workshops have been held in San Francisco for North America and also in South America ( Argentina) . The WHO 's remit is to improve Patient Safety throughout  the world - an enormous undertaking -  because there are such great variations in standards of medical care and expectations from Europe / North America to Africa. Patient Safety and Open Disclosure was always high on the patients' agenda.

IEU Alliance raised the problem of receiving  genuine remedial medical care because of the difficulty of obtaining open and honest disclosure after a serious  a medical accident. The IEU emphasises the need for DIALOGUE between patients and health professionals.  The progress that had been made in the USA was outlined: special courts to hear exclusively medical litigation cases were being set up with the Judges to appoint the expert witnesses.

It was explained that the WHO PFPS Alliance was planning to hold a large  Workshop in Europe in 2007.

It was concluded that that we have the same ultimate goals; that the Patients' Voice must be paramount and that we are all going in the same direction. In the words of Susan Sheridan:

10th June 2007

SIN Writes in WHO Patient For Patient Safety Newsletter Nov. 2006

SIN was delighted to be invited to write a short article in the November 2006 WHO PFPS Newsletter that is distributed globally. This Newsletter gives publicity to the work and activities of 'Patient Champions' and 'Patient Groups' who are trying to improve Patient Safety within their own country.This is what was written:

"Sufferers of Iatrogenic Neglect started in November 1998 to protect and promote the interests of patients who are the victims of serious medical errors. The UK has a very high standard of care, but medical errors are inevitable. Thankfully, medical mistakes are no longer a taboo subject. A most welcome development is that the 'Voice of the Patient' is being heard.

An exciting venture has been the 'European Initiative' when SIN was invited to join several like-minded European Patient Support groups, for the problems faced by damaged patients are similar throughout Europe. The iatrogenic Europe Unite ( IEU) Alliance was formed and the July Declaration was produced, incorporating the 'Aims & Objectives' of SIN-UK . This was presented to the members of the Council and Parliament of Europe in March 2006. The IEU-Alliance was well received and seen as a further step towards a patient friendly Europe. A Teleconference with PFPS in September was a welcome and productive experience.

The UK government id discussing a Redress Bill that offers the opportunity for compensation to be paid without recourse to the adversarial legal process. SIN is delighted with this development because it reflects what we have advocated wince our inception because patients are entitled to the truth.

We perceive there is a growing recognition of the need to register medical errors, to give open and honest disclosure, and to establish sensible compensation funds with genuine remedial care assured.

Thanks to the WHO World Alliance for Patient Safety, Patient Safety is now a global issue. Change is gathering pace".