Memorandum submitted by the Medical Defence Union (H&SC 10)



1. The MDU is a mutual, non-profit making, organisation providing a wide range of medico-legal services to its members who include over 50% of the UK's doctors in hospital and primary care, and 30 % of dentists. In exchange for payment of an annual subscription, members receive medico-legal benefits that include an insurance policy providing indemnity for clinical negligence claims, and access to advice and assistance with matters such as GMC and employers' disciplinary investigations into matters arising out of their provision of care to patients.


2. The MDU has taken part, on behalf of its members, in the consultation exercises that preceded the publication of the Health and Social Care Bill and expressed concern about a number of proposals that now feature in the legislation. They are:


Change to the civil standard of proof

Clause 104


3. While the GMC should, of course, take action to protect the public if a doctor represents a danger to patients, it is important to remember that the doctor whose fitness to practise is under consideration has a right to a fair hearing. There must be safeguards in place to protect this right, especially when there is the potential for the doctor to lose his livelihood.


4. The MDU believes that the criminal standard of proof should remain for Fitness to Practise (FTP) panels because a doctor's registration is at risk. We agree that there is a need to protect patients, but this must be balanced against the right of the doctor to have appropriate safeguards when his or her career is at stake. For cases that do not currently amount to impaired fitness to practise, the GMC already has the power to administer warnings where it considers it appropriate to register concerns about a doctor's behaviour or performance that indicate a significant departure from the standards set out in Good Medical Practice. This is a matter that will remain on the register for five years and, during that time, will be disclosed to the doctor's employer, and any prospective employer and to any other enquirer.


5. We have seen the GMC's proposals for the introduction of a civil standard to its FTP panel determinations and have no confidence in the proposed procedure which we believe is likely to lead to unfair and inconsistent decisions which will not inspire confidence in the procedure.


6. A civil standard of proof is likely to result in considerable additional delay and expense in cases and may well lead to legal challenges in order to protect doctors' interests. This would not be in the public interest


(please see pages 7-11 for further information)


Requirement to share 'soft intelligence' or soft information

Clause 112


7. Clause 112 provides for regulations to be made to require NHS trusts and other bodies to provide and share information about health care workers in circumstances where that person is likely to constitute a threat to the health and safety of patients. However the words used in (1) (a): 'which may show that the worker is likely to constitute a threat to the health and safety of patients,' make it clear that the threshold for sharing such information is very low. The use of the word 'may' would require such bodies to keep and pass on information in circumstances where it has not been shown to any recognised standard that the healthcare worker is a threat to health and safety of patients or, indeed, it would not require the person keeping the information on file, or passing it on, to even try to determine if the information is correct.


8. Contrast this with the guidance that the GMC gives to doctors in Good Medical Practice in the interests of protecting patient safety:


'The safety of patients must come first at all times. If you have concerns that a colleague may not be fit to practise, you must take appropriate steps without delay, so that concerns are investigated and patients protected where necessary.'


9. It is a serious failing that clause 112 makes no requirement for investigation of information before it is collected and shared, as this could allow dissemination of material that is inaccurate, damaging to and even defamatory of the individual concerned, without that person even knowing it is being passed on.


10. It is inappropriate to suggest that any information suggesting potential risk to patient safety should be passed on to other bodies by an employer/contracting body, unchallenged and uninvestigated. Employers/contracting bodies who become aware of 'soft information' that gives grounds for concern about issues of patient safety must investigate it to determine if the allegations are groundless, for example just gossip or arising from intra and inter-professional rivalry; or if there are serious concerns which should be acted upon. If there is 'soft intelligence' about a doctor, ie rumblings and vague concerns about potential risk to patient safety, that come to the attention of his or her employer, that 'intelligence' should be investigated locally and the doctor should be informed of its existence and allowed the opportunity to comment on it. It is in the doctor's interests and that of his patients that any concerns are properly investigated and addressed as appropriate.


11. In the interests of patient safety we do not support the concept of employers/contracting bodies keeping 'soft intelligence' on a file if it is unsubstantiated and does not amount to grounds for serious concern. If employers/contracting bodies merely keep 'soft intelligence' on file because it does not look serious, and the employer waits until further 'soft intelligence' arises, or there are more serious grounds for concern, opportunities may have been missed to prevent problems arising. We do not believe this approach would be in the interests of patient safety. If the employer/contracting body has any grounds for concern about potential risk to patient safety, even in the form of 'soft intelligence,' they should be properly investigated through appropriate channels at the time they are raised, to determine whether there is any substance to them, and if they need to be acted upon.


12. We understand this change is being proposed because in the past there have been concerns about a very few doctors that were 'below the surface' in cases where that doctor was later convicted of a serious crime. It is suggested that this change would prevent this happening in future and, if the same events happened today, any concerns would surface. We agree entirely that if there are any concerns about patient safety, they must be raised, but they must all be brought to the attention of the doctor in question and investigated. If concerns are substantiated, appropriate action will need to be taken, and if they are unfounded, they should not lie on a doctor's file and nor should they be shared without that doctor's knowledge.


13. It would be unfair and unlikely to comply with the provisions of the Data Protection Act 1998 (DPA), and potentially defamatory, to pass on to a prospective employer/contracting body 'soft information' suggesting concerns about a doctor's practice and patient safety. We believe such a practice would not comply with the data protection principles contained in the DPA. There are exemptions, but we do not believe they would apply in the case of 'soft intelligence' about patient safety held by the employer/contracting body which is passed on to a prospective employer/contracting body without investigation or verification, and when the subject is not aware that the data exists and is being processed in such a way.


14. A doctor has the right on request to be informed about data that is held. S31 of the DPA contains exemption from these subject information provisions for regulatory activity, but that only applies to the extent that providing information to the data subject would be likely to prejudice the proper discharge of the regulatory function. We do not believe that is the case here, indeed it is quite the opposite, as it can only benefit the regulatory function if the doctor can be given an opportunity to see and comment on data concerning issues of patient safety held by his employer/contracting body.


15. The fourth statutory data protection principle is that the data should be accurate and, where necessary, kept up to date. Schedule 1 pt II paragraph 7 provides that the fourth principle is not contravened if: a data controller accurately records information obtained by a third party, but only so long as, taking into account the purpose for which the data was obtained and further processed, (a) the data controller has taken reasonable steps to ensure accuracy of the data and (b), if the data subject has notified the data controller that in his or her view the data is accurate, the data indicates that fact. It will be inappropriate that information concerning potential risks to patient safety sits on a doctor's file with his employer/contracting body, accompanied by a note that the doctor regards it as inaccurate, without a proper investigation into the matter at the time.


16. To consider the potential practical effect if regulations were made as indicated in clause 112 (1) (a), it is conceivable that those advising doctors and other healthcare workers would advise them to ensure they are routinely aware of information about them that their employers and contracting bodies have on file and, if necessary to seek access to such information through the Data Protection Act, so that they are aware what is being said about them and that they are in a position to challenge the accuracy of such information if necessary. This would no doubt result in a deluge of requests by subjects for access to information about them and, if access were refused, appeals to the Information Commissioner. There is also the potential for libel actions if information that is passed on is defamatory and damaging to the healthcare worker, in circumstances where an employing body would not be able to rely on a defence of qualified privilege.


17. Further, to pass on information about an employee that was damaging and that had not been proven and without the knowledge of that employee, would contravene employment law. The requirement proposed in clause 112 in respect of sharing information about healthcare workers is contrary to the rights in employment law that are available to all citizens and healthcare workers cannot be deprived of such rights.


Introduction of responsible officers

Clauses 110 & 111


18. We do not support the introduction of responsible officers. We do not believe it has been adequately demonstrated that it is necessary or in the public interest to subject doctors to any new burden of regulation. Doctors are already held accountable in far more ways than any other UK profession, with the possible exception of other healthcare professionals such as dentists. In particular, we do not support the proposals for responsible officers with the powers to put 'recorded concerns' on a doctor's record.


19. It is our view that, in the interests of patient safety, better and more constructive use should be made of existing procedures and of other mechanisms that exist for measuring and assessing doctors' performance and conduct, with the aim of taking remedial action before serious concerns arise. We suggest it is possible to create 'a fairer, more reliable and better co-ordinated system for recognising and dealing effectively with concerns about a doctor's practice', principally by using or adapting existing procedures, structures and organisations. We believe that such a system would be more cost-effective than adding new and different regulatory layers, and have suggested to the Department of Health that comparative costings are prepared - though we have not seen such costings. Given that employers could, and arguably should, undertake functions proposed for responsible officers, with the assistance of the National Clinical Assessment Service, it may be better and more cost-effective to ensure there are adequate numbers of staff to perform this function, rather than to set up a whole new structure which will require substantial additional finance to administer, staff and ensure training and other needs are met.


20. As the responsible officer will investigate cases and apply 'sanctions' that are likely to have an effect on a doctor's current and future employment prospects, a statutory framework will be necessary. There will also need to be guarantees of the independence and objectivity of the affiliates and a robust means of ensuring consistency in their performance and decision-making nationally.


Criminal rather than civil standard of proof

21. The argument that the public interest justifies a switch to a lower standard of proof because public safety would be better safeguarded is flawed. It is an argument that would apply to criminal cases too. There is an overwhelming public interest in law and order, and the protection of the public from crime, yet the criminal standard of proof is applied across the range of offences, from minor misdemeanours to the most serious, such as child abuse, rape and murder, where the allegations (if true) may mean the defendant poses a serious threat to public safety. Nevertheless, it is widely accepted that the public interest is served by the application of the criminal standard. It cannot be in the public's, patients' or profession's interests for good doctors to be found impaired when they are not. A lowering of the threshold of proof risks such unfairness and will undermine confidence in the regulatory process.


22. What would a change to the civil standard achieve? If the purpose is to lower the threshold for findings of impairment of fitness to practise, thereby bringing more doctors under the FTP Panels, then the GMC itself does not believe the change would achieve this result. We note that in the GMC's consultation document it is stated the GMC has been advised by leading counsel that application of a flexible civil standard appropriate to the seriousness of the allegation and the consequences for the doctor should lead to the same or similar results as would application of the criminal standard. A change to the civil standard would import disadvantages associated with it, without meaningful benefit.


23. Important considerations in choosing the standard of proof are: the simplicity of legal concepts, consistency of result between FTP panels, transparency of decision-making and fairness.


24. A key virtue of the criminal standard is its simplicity. It is a legal concept embedded in the criminal justice system that is applied day in day out by members of the public. It has withstood the test of time.


25. It should be noted that the criminal standard of proof of 'beyond reasonable doubt' or of 'being sure' does not create an artificially high standard of proof: it does not equate with certainty. A reasonable doubt is the sort of doubt that might affect the mind of the person dealing with matters of importance in his own affairs. We contend it is this level of importance that in fairness to the doctor should determine the standard of proof of FTP hearings. This is especially so when decisions are being taken about a doctor's professional reputation and livelihood.


26. The criminal standard of proof can properly be regarded as a 'user-friendly' concept. By reason of its simplicity and familiarity it can be applied consistently by differently constituted FTP panels comprising non-specialists and non-lawyers. When findings of fact are made using this concept, all concerned know and understand the standard that has been applied. The fact-finding process is underpinned by transparency.


27. For there to be a fair hearing there needs to be a common, easily understood threshold for proof. In contrast a 'flexible' or 'sliding scale' civil standard is not a readily understood concept nor is it easy to apply. Essentially the sliding civil standard requires that more cogent evidence is needed to prove the allegation that has serious consequences. In practice, the more serious the allegation, and the more serious the consequence, the higher the degree of probability required.


28. The standard to be applied needs to be clear at the outset of the case. The prosecution, defence and the FTP panel need to know the standard to be applied at the start of the case. It is against this standard that the evidence to be called will be assessed. However, in FTP hearings the fact-finding stage precedes the sanction stage. In many cases the FTP panels will not know at the outset whether the allegations, if proven, are likely to result in suspension or erasure. How then will they know whether they should be applying the highest civil standard?


29. Furthermore, Notices of Inquiry often comprise a series of factual allegations that together are said to comprise impairment of fitness to practise. Some factual allegations are less serious than others. If a sliding scale or flexible civil standard were used, it would be necessary to apply different tests to the evidence in support of the less and more serious factual allegations. We set out below a factual scenario that illustrates the problems the civil standard may give rise to.


30. In response to a request for a home visit, a GP visited the patient at his home, in the presence of the patient's wife. There was a dispute about the symptoms complained of, the adequacy of the history taking and the extent of the examination. It was alleged the patient had complained of fever, abdominal pain and diarrhoea. It was alleged the GP was abrupt and dismissive of the patient's symptoms, had failed to check his temperature or examine the abdomen. The GP advised the patient had a viral illness that should begin to resolve within 48 hours.

31. The next day the patient's condition worsened. His wife summoned an ambulance. He was taken to hospital. A perforated appendix was diagnosed. The patient underwent emergency surgery. Widespread intra-abdominal infection was found. Despite intensive care the patient duly succumbed to sepsis.


32. An inquest was held at which the GP gave evidence on oath. He denied his history taking and examination had been inadequate. He said the patient had complained of diarrhoea and vomiting only, and he had carried out a careful examination that had included palpation of the abdomen but no abnormality had been detected. He produced a handwritten note to this effect that he said he had written in his car immediately after the visit. The patient's widow denied the doctor's account was true and she alleged the handwritten note was false because it did not record the main complaint of abdominal pain and the GP had not examined her husband's abdomen.


The widow complained to the GMC. In due course the case was referred to an FTP panel with allegations that:

At the home visit the GP had failed to obtain an adequate history of the illness and failed to carry out an adequate examination.

The GP had failed to make an adequate note of the home visit.

The GP had given an untruthful account at the Inquest in that he had falsely stated there had been no complaint of abdominal pain and that he had palpated the abdomen.


33. Each allegation of fact might be considered to raise a different degree of seriousness, raising issues both of performance and misconduct. The adequacy of the history taking and examination might be considered to be relatively straightforward matters importing no more than a simple balance of probability in deciding whether or not the widow's account was to be preferred over the GP's account. On this decision would turn the further allegation of the adequacy of the GP's note. However, resolution of these simple factual issues would also determine whether the GP had given an untruthful account at the inquest, and thus committed perjury. The highest civil standard should apply to such a serious allegation of a crime.


34. An FTP panel determining these allegations might be able to resolve the facts on a simple balance of probability, finding the allegation of a complaint of abdominal pain and a failure to examine the abdomen proved. The logical consequence of such a finding would be that the GP had also committed perjury at the inquest. Yet if a high civil standard equating to a criminal standard had been applied, in a situation where it was the complainant widow's word against the GP's word, an FTP panel might think there was sufficient doubt so that they could not be sure.


35. If, because of the perjury allegation, the FTP panel applied the highest civil standard equivalent to the criminal standard, it might then acquit the GP of all allegations. However, if the facts were changed, so that there had been no allegation of perjury at the inquest, the GP might have been found guilty on the simple application of a preponderance of probability.


36. Such a result would lead to inconsistencies of approach between cases, with some doctors whose facts give rise to more serious allegations of misconduct having the protection of a civil standard equivalent to the criminal standard, whereas doctors without an allegation equivalent to a crime being in jeopardy of an adverse finding based on a lower standard.


Additional Briefing


The Office of the Health Professions Adjudicator - clauses 91-102 and Schedule 7 - adjudication functions under the Medical Act 1983



1. In the interests of fairness and justice when a doctor's livelihood is at stake there is a good argument for suggesting that if the GMC is to be the 'prosecutor' in the context of complaints, it should not also be the judge and dispenser of sanctions. It is reasonable for the GMC to set standards of conduct, policy and procedural rules and to investigate complaints and to present them; but the adjudication function should be wholly independent of the GMC, since as setter of standards and prosecutor, it cannot be independent as an adjudicator. Thus we agree with the principle that formal adjudication should be undertaken by a separate and independent tribunal with legal, medical and lay representation and support the principles behind clauses 91-102 which allow for a new Office of the Health Professions Adjudicator.


We have, however, some concerns:


Clause 101

2. This clause relates to the duty upon the OHPA from time to time to seek the views of certain bodies including, at (d): 'any other bodies which appear to the OHPA to represent the professions regulated by the Medical Act 1983 ...'. We would expect that this clause should include bodies such as ourselves and other the medical defence organisations (MDOs) as that is what is already set out in legislation relating to the General Medical Council.


3. The relevant Schedule in the Medical Act [Sched 4 (1) (6)] refers to 'such bodies of persons representing medical practitioners, or medical practitioners of any description'. However, MDOs are mutual bodies representing individual doctors, rather than the medical profession as a whole and it could be arguable that this clause did not include such bodies. Given that the MDOs are the principal organisations providing doctors with advice and assistance with regulatory proceedings, it would be clearer if there was a specific requirement to consult such bodies. This could be achieved by refrence to bodies which appear to the OHPA to represent medical practitioners regulated by the Medical Act 1983.


OHPA not wholly independent of GMC - Schedule 7 Part 1 - 4

4. This clause inserts a new section into the Medical Act 1983 which provides for the General Medical Council to publish guidance on what are currently known as 'indicative sanctions', that is what type of sanctions should apply to the doctor, depending on the facts that are found by the adjudication panel. Further, the OHPA 'must take account' of this guidance and, a new S40A of the Medical Act, set out at clause 11, provides the GMC with powers to refer decisions to the relevant court on certain grounds, for example, leniency.


5. Although it is the intention that the OHPA is a separate and independent adjudicatory body, the clauses above will have the effect of allowing the GMC to continue to determine the sanctions that should apply in fitness to practise decisions, and the OHPA must take account of such guidance in making its determinations. Further, the GMC will be able to challenge decisions of OHPA panels on a number of grounds.


6. It is our view that for the GMC to retain the power to provide guidance, of which the OHPA is required to take account cannot make the OHPA properly independent and contravenes the right under Article 6 of the European Convention on Human Rights, to a fair hearing. We note that the explanatory note to the Bill has partially addressed this at paragraph 576 but it is our view that this is incorrect. The explanatory note suggests that the provision for the GMC to continue to set indicative sanctions does not compromise a doctor's rights under Article 6 because the OHPA will already have decided on the facts of the case before it applies any sanction. However, the decision on sanctions is as much a part of the panel's hearing as the finding on facts and the two cannot be separated. For the procedure to be compliant with Article 6, finding of facts and determination of the sanction would both need to be independent of the GMC.


7. No one would suggest that it would be appropriate for a judge in criminal proceedings to be required to impose a sentence on the basis of guidelines produced only by the Crown Prosecution Service. Rather, judges take account of guidance produced by the independent Sentencing Guidelines Council


8. The MDU believes that it is entirely appropriate for the GMC to set standards for the medical profession and that such standards will need to play a part in any decisions on sanction made by the OHPA. It is our view, however, that the OHPA should be able to decide upon sanctions that it considers appropriate and that, while it may seek advice from other bodies and consult on such sanctions in draft, it should not be required to take account of guidance provided by the GMC only. To protect the public, the Bill provides the GMC with powers to appeal decisions by the OHPA that it considers inappropriate for specified reasons and that should be an adequate check that the OHPA is applying the standards set out in Good Medical Practice appropriately.

January 2008