Public and Regulatory Law Group Alerter March 2013
Welcome to Fieldfisher's Public and Regulatory Group Alerter, highlighting the key cases and events taking place in February 2013.
This month saw the publication of the Francis report highlighting the findings of the Mid Staffordshire NHS Foundation Trust Public Inquiry into failures in care at the Trust between 2005 and 2009. See below for more on the report itself, and issues it raises regarding whistleblowing.
This month, in cases of note, the courts have held that a regulator was not obliged to give a respondent notice of proceedings by email as well as via registered post, have given a view on what amounts to practising as a doctor (in the context of of a practitioner who had been suspended from the medical register), and have also explored the availability of race and religious discrimination claims as a method of challenge to a regulator's decisions.
Health and social care
Mid-Staffordshire NHS Foundation Trust Public Inquiry publishes final report
Robert Francis QC's report was published on 6 February 2013. This built on his earlier report, of February 2010, which highlighted failures of care causing suffering to thousands of patients at the Mid Staffordshire NHS Foundation Trust between 2005 and 2008. The report identifies serious systemic failings amongst the Trust and other bodies responsible for oversight of patient care, including tolerance of poor standards and a disengagement of management from patient care and leadership responsibilities. A focus on targets was at the cost of delivering acceptable standards of care.
The report makes 290 recommendations. These include the fostering of a common culture of putting the patient first, the development of fundamental standards, ensuring openness, transparency and candour and increased accountability. The first recommendation is that all commissioning, service provision regulatory and ancillary organisations in healthcare should consider the findings and recommendations of this report and decide how to apply them to their own work. All such organisations must publish a report within a year detailing progress in relation to its plans. To read the report in full please click here
Following the publication of the report, there has been a renewed focus on whistle-blowing within the NHS. This issue is examined in more detail in our feature, below.
General Medical Council issues new guidance
The GMC has issued new guidance for doctors on prescribing medicines and guidance for its Investigation Committee and Case Examiners on dealing with allegations a doctor assisted in a patient's suicide. The prescribing guidance indicates that doctors should avoid prescribing for themselves or their families unless in an emergency where lives or health are at serious risk. They must also not prescribe performance-enhancing drugs or treatments to athletes. The guidance also reminds doctors of the adverse incidents which they must report. The guidance for the Investigation Committee and Case Examiners includes a re-statement of the relevant principles where a patient raises the issue of ending their life.
Professional Standards Authority report supports General Dental Council governance arrangements
A PSA report has concluded that the GDC's governance arrangements are reasonable and that the GDC has not failed and is not failing to carry out its statutory functions. In 2011 the Department of Health asked the CHRE (now PSA) to advise on concerns raised by the former Chair of the GDC about the organisation’s governance. The report examines the difficulties the GDC encountered in 2009 to 2010. It acknowledges that the new leadership is working effectively and recognises that it will take time for wide-reaching and significant changes to become evident within an organisation’s day-to-day activities.
To read the report in full please click here
Nursing and Midwifery Council to review overseas registration policy
The NMC has announced that it is reviewing its overseas registration policy and procedures. This is aimed at achieving a clearer registration process for overseas applicants. The NMC has a continuing commitment to review all of its practices and procedures following last year’s strategic review by the PSA.
For more information please click here
General Osteopathic Council publishes vision for future
The GOsC and other stakeholders have published a joint statement: 'A development agenda for UK osteopathy'. The statement includes aims and objectives, principles, and development projects. The stakeholders continue to work on the agenda and welcome feedback on the statement. For more information or to provide feedback on the statement, please click here
Care Quality Commission publishes Mental Health Act Annual Report
The CQC's Mental Health Act Annual Report concluded that mental health services must do more to ensure that the care they provide to patients in hospital is based on individual needs. The report reveals that 15% of people receiving care under the Mental Health Act are not involved in the decisions made about their care. The CQC also expressed concern that some hospitals have allowed cultures to develop where control and containment of detained patients are prioritised over treatment and care.
For more information click here
Care Quality Commission publishes Equality Matters report
The CQC's Equality Matters report demonstrates how the CQC regulates services and equality in its workforce. The CQC's Equality report from 2012 was used by the Equality and Human Rights Commission as an example of an organisation displaying good practice in fulfilling the duty to publish information about equality.
For more information click here
Human Fertilisation and Embryology Authority
A High Court Judge has ruled that two sperm donors can apply for contact with the children born from their donation. In this particular case, the sperm donation was to two same sex couples in a civil partnership but contact has not yet been granted. The ruling raises the question of whether, following donor conception treatment, a known donor can seek access to a child that he is biologically related to, even if he is not the legal father. For further information please click here
Scottish Government confirmed it will accept Electoral Commission recommendations
Following the Electoral Commission's recommendations on the referendum question, the Scottish Government has confirmed the question to be put before the Scottish Parliament. The question will be: ’Should Scotland be an independent country? Yes/No’.
The Deputy First Minister Nicola Sturgeon called on the UK government to accept the Commission's recommendations.
For more information click here
Financial Reporting Council launches consultation on improving auditors' reports
The FRC has launched a consultation aimed at improving auditors' reports to better meet the needs of investors and enhance the value of audit. It is proposed that auditors' reports should describe the risks of material misstatement identified and assessed by the auditor; explain how the auditor applied the concept of materiality and summarise the audit scope. The proposed changes build on changes made by the FRC to board and auditor reporting last autumn.
The Consultation period ends on 30 April 2013. For more information please click here
New measures to raise standards of integrity in the police
The Government has announced measures to improve integrity in policing. The measures include the expansion of the IPCC to deal with all serious complaints against the police. In addition, the College of Policing is to publish national registers of chief officers' pay and hospitality as well as a new code of ethics for officers of all ranks and a single set of professional standards which officers are to be tested on throughout their careers. Other proposals include a policy of continuing disciplinary hearings against officers even when they resign or retire and a stronger system of vetting for police officers. For more information please click here
Bar Council welcomes BSB proposed changes to public access
The Bar Council has welcomed the Bar Standards Board's (BSB) proposed changes to Public Access training. The changes are aimed at enhancing the course content and introducing an element of formal assessment to ensure barristers have the requisite knowledge and skills to carry out public access work.
For more information click here
Law Society responds to Ministry of Justice consultation on the proposals for the reform of judicial review
The Society has responded to the MoJ consultation by stating that it would not be appropriate to shorten the time limit for procurement and planning cases to 30 days and 6 weeks respectively because parties would have insufficient time to comply with pre-action procedures. The proposed time limits would cause claims to be brought earlier and be poorly drafted, causing delays and additional costs. The Society indicated however that it is not opposed to improving the efficiency of the judicial review process. To read the response in full please click here
Law Commission publishes its analysis of responses to its consultation on regulation of health and social care professionals
The Law Commission has published its analysis of responses to its 2012 consultation into proposals seeking simplify and modernise the law and establish a more streamlined, transparent and responsive system of regulation of healthcare professionals (and in England only, the regulation of social workers).
For further information, please click here
Legal Services Board
The Legal Services Board has recommended that will-writing activities become subject to regulation. Following a two year investigation, the LSB has proposed that the list of reserved legal activities be amended to include will-writing activities but not to include estate administration and probate activities. The proposals are aimed at giving customers better protection by allowing access to the Legal Ombudsman for consumers of will-writing providers as well as increasing competition in the market and encouraging regulators to adopt a more targeted approach. To read the recommendations please click here
Kumar v General Medical Council Queen's Bench Division (Administrative Court) 06 February 2013
K, a locum doctor, applied for an order revoking conditions imposed on him by an Interim Orders Panel of the GMC.
Following complaints submitted by a Consultant colleague of K to the GMC, with concerns over his attitude and clinical management of patients, K was invited to attend an interim orders hearing. The letter sent by registered post was not received by K and K consequently did not attend the hearing. In K's absence the panel imposed conditions of practice. K protested that he had not been given notice and a review hearing was arranged. The panel decided to maintain the supervision requirements imposed at the original hearing.
K submitted that the panel had erred in proceeding in his absence and in following advice from the legal assessor that it only had to be satisfied that the GMC had taken 'reasonable steps' to give K notice. He also contended that the panel had erred in failing to allow him to give oral evidence at the review hearing, imposing conditions on the basis of allegations which had not come to their attention in a 'fair way' and imposing conditions where it was disproportionate to do so.
In dismissing K's application, it was held by Underhill J that sending a letter by registered post did constitute all reasonable efforts (and that the GMC was not obliged to email notice to K) but it made no difference because the panel had in any event considered the matter of conditions afresh at the review hearing. There was no basis upon which an irregularity at the first hearing could vitiate the fairness of a subsequent hearing when K had been given the chance to state his case. There was held to be no substantial unfairness in the panel's approach at the review hearing.
Once it had been established that there was a real risk that K's clinical competence had been compromised, it was impossible to argue that the imposition of conditions was disproportionate.
Dutta v General Medical Council EWHC 132 (Admin)
D appealed a decision of the Defendant's Fitness to Practise Panel ordering his immediate suspension from the medical register for 12 months following findings of misconduct and impairment of his fitness to practise
D's registration had been suspended for 18 months by the Interim Orders Panel in September 2009. In May 2012 D was charged by the GMC with contravening this suspension and providing clinical care and treatment to a patient. Further allegations were made about the standard of the care provided to that patient. D submitted that he had merely looked at the patient's post-operative wounds and passed information to another doctor, making his involvement with the patient minimal. Following a hearing between June and September 2012, the Fitness to Practise Panel found D's fitness to practise to be impaired and suspended his registration for a further 12 months
D appealed only the finding that he had contravened his suspension in providing clinical care, contending that his involvement with the patient did not involve any activities for which as a matter of law medical registration was required and therefore there was no breach of a suspension order. He also contended that, in making a finding that he had not acted in the patient's best interests, the Fitness to Practise Panel had taken too narrow a view of the patient's “best interests” and that they should have taken account of the patient's medical interests rather than focusing on the fact that D had not told the patient of his suspension.
D's appeal was dismissed. On the issue of whether D's treatment of the patient was contrary to her "best interests" it was held that the Panel had approached the question of "best interests" sufficiently broadly as including both her medical and general welfare. The patient was distressed to have been treated by a doctor whom she was unaware was suspended.
In relation to the patient concerned, Mr Justice Haddon-Cave found that D was plainly doing what he was not supposed to be doing: continuing to practise whilst suspended. The judge found there to be no unfairness to Dr Dutta as he had previously admitted under cross examination that he understood his suspension to mean that he, "...could not have any patient contact as a doctor to a patient."
R (on the application of Erik Scholten) v General Medical Council (2013)
S was a private consultant plastic and cosmetic surgeon specialising in procedures involving female genitalia, breasts and the abdomen. His suspension arose out of his conduct towards an anaesthetised female patient (A). Whilst performing a breast augmentation on A, he noted that she had a 'very well-developed clitoral hood'. It was alleged that without A's consent, and whilst she was anaesthetised, he pulled aside A's surgical underpants and took a photograph on his iphone. This was observed by surgical staff who reported the incident to management and to A.
S offered his apologies to A, explaining that he had intended to use the photograph as the basis for discussing the possibility of cosmetic work with her, and that he wanted to add the photograph to his portfolio of images to show to other patients. He explained that he had intended to ask A's permission to retain the photograph.
Following referral to the GMC, the Interim Orders Panel ("IOP") made an interim order for 18 months suspension. Six months later, the IOP reviewed the order and decided that it should be maintained. On an application to terminate the suspension order (under s41A(10) of the Medical Act 1983), S submitted that the IOP had failed to deal with his submission that the incident was an isolated one and insufficient to meet the statutory test for possible impairment; that there was no evidence of any risk to patients or to public confidence such as to justify his suspension; that suspension was a disproportionate sanction; that the period of suspension was disproportionate and the IOP had given the appearance of having pre-judged the matter, inviting his representative to be brief and interrupting her submissions.
It was held that, whilst acknowledging that S accepted a serious error of judgement and that he would change his practices, his conduct amounted to a serious breach of the trust that was fundamental to the doctor-patient relationship and the IOP's conclusion that his fitness to practise might be impaired could not be said to be wrong. In addition, the transcript of the panel hearing revealed no basis for S's contention that the IOP had pre-judged the issues.
However, the reasons given by the IOP for its decision to maintain the order were inadequate. It had not sufficiently balanced the protection of patients and the public interest against the impact of a suspension order on S (who had lost his income, his home and his partner and was on the verge of bankruptcy). In terms of the length of the order, this was said to be a factor to be taken into account when considering whether the order of suspension was a proportionate response.
Finally, it was noted that the IOP determination did not set out what, if any, consideration it had given to those matters or addressed the level of risk posed by S's remaining in practice pending the resolution of the allegations. Critically, it had not explained why no workable conditions could be formulated or adequately taken into account the fact that the incident was a one-off (on which the IOP had received testimonial evidence).
In giving judgment, Supperstone J stated that had he had jurisdiction to do so, having regard to all the circumstances, he may well have substituted a conditional registration order for the suspension. However, in the event, he made no order, as the next IOP review was due to have taken place two days after the court hearing. At that review hearing of 6 February 2012, we note that conditions were imposed.
Luthra v General Medical Council EWHC 240 (Admin)
This was an appeal against the sanction of erasure made by the GMC's Fitness to Practise Panel ("FTPP") on the 28 August 2010.
In 2007, L underwent a GMC assessment of the standard of his professional performance which consisted of a peer review and test of competence. The assessments concluded that L's performance was unacceptable and a cause for concern and as such recommended that L undergo a period of supervised practice with training and assessment. However, L failed, on three attempts, the entrance examination to the London Deanery's induction and refresher scheme on which he was required to enrol in order to work as a supervised doctor. Both the London and Wessex Deaneries advised the GMC they were no longer able to assist L. The GMC case examiners requested a further assessment of L's performance in which he produced "disastrous" scores in some of his assessments. In the subsequent FTP proceedings the Panel considered erasure was the only appropriate sanction.
Counsel for L submitted that L was a victim of a "Catch 22" as he had been unable to undertake the recommended re-training because of the Deanery's refusal to accept him on the scheme. The Court disagreed and considered it was L's own failings that hindered him from taking up the training which the 2007 assessments had recommended. The Court also noted that L had been offered manifold opportunities for remediation and insight and that the GMC had "bent over backwards" to afford him these opportunities.
Although the Court acknowledged that L's performance was not a "universal picture of failure" it found that the Assessors and Panel had correctly decided that no amount of further opportunity for retraining would cure his core deficiencies in knowledge and defects in competence so as to eliminate risk to patients and the public. As a result, the Court considered the Panel's decision on sanction to have been correctly made.
The Court recognised that the FTP process must be thorough and scrupulously fair but also noted that an "inquiry with this degree of elaboration, and at inevitable expense to the profession, is perhaps a counsel of perfection particularly in this age of austerity in which we live".
The Queen (on the application of) London Borough of Lewisham and others v Assessment and Qualifications Alliance and others EWHC 211 (Admin)
This case concerned two claims for judicial review brought in relation to the award of GCSE English qualifications in August 2012. The claimants were comprised of over 150 local authorities, schools, teachers and pupils who shared a grievance about the way in which the boundary between the 'C' and 'D' grade was fixed in English GCSE examinations sat by pupils in June 2012. One judicial review was brought against the awarding organisation Assessments and Qualifications Alliance (AQA) and another was brought against the awarding organisation Edexcel. The statutory regulator, the Office of Qualifications and Examinations Regulation (Ofqual) was the second defendant to each claim.
The Claimants contended that students had been treated unfairly and the actual performance of students had not been fairly reflected in their grade because the results had been unjustly moulded to reflect predicted performance. The Claimants alleged that the conduct of the Defendants was conspicuously unfair in their inconsistent treatment so as to amount to an abuse of power. They also alleged that the Defendants failed to give effect to a legitimate expectation that grade boundaries would not change from one assessment point to the next; acted irrationally in failing to treat all candidates alike and subjecting them to different assessment standards and acted unlawfully in reliance on certain guidance. The remedy sought by the Claimants was that the June exam papers be assessed in accordance with the January boundaries.
In this rolled up hearing, the applications were dismissed (albeit Elias LJ and Sharp J acknowledged that they would have granted permission). The awarding organisations had not erred in law. It was held that Ofqual's decision to protect the comparable outcomes objective, although it meant that January candidates were treated more generously, was plainly open to them. The adverse consequences were relatively contained by acting at that point since far fewer students took the relevant units in January than in June.
Dr Uddin v General Medical Council and Ors 20 June 2012 (judgment handed down 14 February 2013) – heard together with Dr Depner v General Medical Council and Ors
In October 2010, U's name was erased from the Medical Register and an order for his immediate suspension was imposed. He appealed to the High Court, and also lodged proceedings with the Employment Tribunal ("ET") in which he complained of direct and indirect race discrimination and harassment related to race, as well as direct religious discrimination.
Following a Pre-Hearing Review, U was informed by the ET that it had no jurisdiction to hear his complaints. U appealed this finding, and it was argued on his behalf that his complaint was not against the Fitness to Practise Panel's ("FtPP") decisions of erasure and suspension (which, in the meantime, he had unsuccessfully challenged under the appeal provisions of sections 40 and 38 of the Medical Act) but of the administration and procedural actions by the GMC staff that predated those final sanction decisions. These acts were described as being "upstream" of the FtPP's decisions.
The Employment Appeal Tribunal ("EAT") held that the ET had erred in relying on there being a right of appeal under the Medical Act, when there was none in respect of acts by the GMC which predated the FtPP's decisions. Furthermore, the EAT noted that the acts relied upon as constituting harassment or discrimination (which predated the FtPP's decisions) had not been particularised and as such it was not possible to determine whether they would have been susceptible to challenge by judicial review. Therefore, the EAT held that the ET had erred in deciding that the judicial review proceedings were available without identifying the acts complained of and considering whether judicial review would have been available to challenge them.
The EAT also considered that the ET should not have relied upon the obiter dictum of another EAT decision in holding that judicial review proceedings were "proceedings in the nature of an appeal" within the meaning of s120(7) and thereby excluding ET's jurisdiction. It therefore allowed the appeal, determining that the case should be remitted to a different ET to consider whether the Tribunal had jurisdiction to hear U's claims.
Dr Depner v General Medical Council and Ors 22 June 2012 (judgment handed down 14 February 2013) – heard together with Dr Uddin v General Medical Council and Ors
In August 2010 a GMC Fitness to Practise Panel ("FtPP") suspended D's registration for 9 months and imposed an order for immediate suspension. The Appellant unsuccessfully appealed the FtPP's decisions under s40(7) and s38(8) of the Medical Act 1983.
D brought an appeal against an Employment Tribunal ("ET") decision that it had no jurisdiction to consider her claims of discrimination and victimisation against the GMC, which she had made under the Race Relations Act 1976 ("RRA").
The EAT held that the ET had correctly considered that D's complaints of direct discrimination, discrimination by way of victimisation and harassment all fell within s12(1) & (1A) of the RRA. The EAT also held that the ET had not erred in its ruling that s54(2) of the RRA excluded the right to bring a claim of discrimination and victimisation, as the Medical Act gave an alternative route of appeal under sections 38 and 40. As such, D's appeal was dismissed.
R (on the application of Daniel Roque Hall) v (1) University College London Hospitals NHS Foundation Trust (2) Secretary of State for Justice (2013)
The Claimant applied for permission to proceed with an application for judicial review of a decision by the first defendant ("the Trust") to discharge him from hospital and back to the prison being run by the second defendant.
The Claimant was severely disabled as a result of a brain disease, meaning that he required 24 hour care and was confined to a wheelchair. He had been convicted of importing class A drugs in July 2012, following the consideration of reports which confirmed that he could be provided with proper care in prison, he was sentenced to three years imprisonment.
On 22 August 2012, the Claimant was admitted to a Trust hospital. At around the same time, he issued a claim that the prison regime to which he was subject amounted to inhuman and degrading treatment, contrary to Article 3 (prohibition of torture and degrading treatment) and Article 8 (right to a private life) of the European Convention of Human Rights. He relied upon his hospitalisation and his failing health immediately before his admission to hospital. Permission to proceed with the claim was refused by the Administrative Court.
Whilst an application for an oral hearing to renew the application was outstanding, the Claimant was judged fit to be discharged from hospital. He then brought an additional claim that his previous time in prison had put his life at risk and reduced his life expectancy and that to return him to prison would put his life at risk and reduce his life expectancy in breach of Article 2 (right to life) of the Convention.
In considering the amended claim, the Court held that for individuals detained by the state, the Article 2 duty extended to an obligation to preserve life and provide necessary care to preserve life. However this Article was only engaged where there was a real and immediate risk of death to the individual. The Claimant's condition on admission to hospital was explained by his longstanding use of medication and not his treatment in prison. There was no evidential basis upon which to assert that the Claimant's life was in danger or his life expectancy reduced because of his time and treatment in prison. Therefore his Article 2 claim was without foundation.
The Court then applied previous case law which stated that the invocation of Article 3 required a high threshold of severity to be met, previously described as serious or intense physical or mental suffering. The Court held that the Claimant's treatment, even considered in aggregate, did not even arguably engage, let alone breach, his human rights.
In respect of the Article 8 claim, no discrete submissions on this point were made by the Claimant. The Court held that it was difficult to see the relevance of Article 8 and that there was no engagement or breach of Article 8. It noted that it was not the Court's role to assess whether the conditions of detention were optimal, or even of a reasonable standard, but simply whether they amounted to a breach of the Claimant's human rights.
Permission to proceed on any grounds was therefore refused. However, a separate appeal against the Claimant's sentence resulted in his sentence being quashed, meaning that upon discharge from hospital the Claimant was not discharged to the prison in any event.
Whistleblowers, gagging clauses and the Mid-Staffordshire NHS Foundation Trust Public Inquiry
'Whistleblowing is only necessary because of the absence of systems and a culture accepted by all staff which positively welcomes internal reporting concerns.' [Mid-Staffs final report para 2.400]
'Whistleblowers are of course no panacea to solve the failure of healthcare regulation, but they are one of the best tools available'. [Stephen Barclay MP, writing in the Daily Telegraph, 12 February 2013]
The raising of concerns by whistleblowers, and their inability to get their voices heard, were key features of the Mid-Staffordshire Inquiry. While the Inquiry rightly notes that the solution to the Mid-Staffordshire problem lies in creating an open and transparent culture, not in focusing on improvements to whistleblowing legislation, evidence of poor treatment of whistleblowers does not appear to be limited to Mid-Staffordshire, and there is a challenge for the NHS and for regulators to ensure that adequate support and protection is available for whistleblowers in order to protect patient safety.
The Inquiry heard that Nurse Helene Donnelly reported poor and dishonest practice in the Accident and Emergency Department at Stafford Hospital, including the "massaging" of waiting time, short-staffing, and a lack of care for patients. The Inquiry found that the Trust did not take her complaint seriously, that she was offered no adequate support and that she had to endure harassment from other colleagues which led to her eventually leaving the Trust for other employment. The Inquiry concluded that 'her evidence exposed the hollowness of the promises in the Whistleblowing policy'.
The Inquiry also heard evidence that when Dr Pradip Singh complained to nursing staff about not being accompanied on a ward round, he was suspended for 'abusive language' and 'inappropriate behaviour'. The Inquiry concluded that 'a greater priority is instinctively given by managers to issues surrounding the behaviour of the complainant, rather than the implications for patient safety raised by his complaint.'
Anecdotal evidence from elsewhere in the NHS suggests that such incidents as those detailed above are not isolated and that it is not uncommon for individuals who raise concerns to be suspended, subjected to internal disciplinary action and referred to their regulatory body. This is clearly a matter of grave concern which requires action.
Moreover, the Inquiry heard evidence of the use of contractual terms to prevent or inhibit employees or ex-employees from acting as whistleblowers by disclosing information critical of the employing organisation. These 'gagging clauses' have long been controversial. In 1997 the Public Interest Disclosure Act was introduced, amending the Employment Rights Act 1996 to render such clauses supposedly void, to the extent that they purport to prevent whistleblowers from making a disclosure in the public interest.
Notwithstanding this, gagging clauses appear to have been widely used by a variety of NHS Trusts, as well as by the CQC. As the Inquiry report makes clear, while the CQC accepted that, by virtue of the Employment Rights Act 1996, such gagging clauses may not prevent disclosures being made in the public interest, employees cannot be expected to understand this unless explicitly informed of the exception. In practice, the effect of such clauses may require legal advice to decipher. Facing the risk of breach, it is not surprising if those subject to gagging clauses err on the side of silence.
In addition, regardless of their legality (in relation to which Robert Francis QC refused to express any conclusive opinion), such clauses can have a potential 'chilling effect' whereby individuals are discouraged from making disclosures in the public interest through fear that they may be in breach of either a contract of employment or a severance agreement. One of the report's conclusions is that gagging clauses which might prevent a concerned employee or ex-employee from raising concerns about patient safety must be banned. This recommendation has been widely welcomed.
As the report implicitly acknowledges, outlawing gagging clauses is relatively straightforward. What is less easily achieved is a change of culture whereby 'a system which ignored the warning signs and put corporate self-interest and cost control ahead of patients and their safety' is replaced by one which welcomes individuals raising concerns and reporting failures which put patient safety at risk.
It is telling that one of the recommendations of the Bristol Royal Infirmary Inquiry report (published in July 2001) was the creation of an open and non-punitive environment in the NHS in which it is safe to report and admit to 'near-misses' and occasions of patient harm. The fact that the Mid-Staffordshire Inquiry was required at all suggests that the lessons of BRI were not learned. It is to be hoped that steps will be taken to ensure practical support is in place for those who seek to raise concerns, and that their messages will be welcomed in an environment of openness and accountability. The NHS and regulatory bodies will be able to ensure that concerns can be raised and dealt with so that similar examples of widespread failure can be avoided in the future.