Sir Liam's damning verdict heralds new dawn of regulation

The chief medical officer has proposed a total overhaul of the way doctors are scrutinised and rogue medics struck off. But relationships between regulators and the regulated will have to be carefully managed to avoid confrontation. Kaye McIntosh reports

'Few chief executive officers of health organisations match the depth of their fear of missing budgetary and productivity targets with the strength of their passion to improve quality and safety of services for their consumers.'

This is the damning verdict from chief medical officer Sir Liam Donaldson in the long-awaited government response to the Shipman Inquiry into the murder of an estimated 250 patients by their GP.

His report, Good Doctors, Safer Patients, published last month, proposes the most radical reforms to medical regulation across the UK for 150 years. The General Medical Council would be stripped of its role in deciding whether doctors should be struck off the medical register - this would be handed to an independent tribunal, with the GMC acting as investigator. The burden of proof would change from the criminal standard of 'beyond reasonable doubt' to the civil standard of 'the balance of probabilities', making it easier to remove bad doctors.

But the two proposals with perhaps the biggest impact for NHS managers will be plans to devolve some GMC powers to local level, and the creation of a twin-track system of regular checks on doctors' competence, for both the general and the specialist/GP registers.

Every healthcare provider, NHS or private, will have a GMC affiliate - a senior doctor, employed by the trust or organisation and licensed by the GMC to operate fitness-to-practise procedures locally. Every working doctor will have to be registered with an organisation that has an affiliate. A Department of Health spokesperson told HSJthis devolution 'will mean that the wider quality assurance framework [including the Healthcare Commission, internal clinical governance and professional regulation] will work together and regulatory gaps will narrow'.

Sir Liam proposes some 580 affiliates throughout the UK, who would be at the heart of a system of revalidation and regular checks on the competency of all medics. For the first time, trust chief executives will be responsible for ensuring the doctors they employ are officially cleared as fit to practise, rather than merely being on the medical register. Chief executives will have to make joint statements with their affiliates on the re-licensing of all doctors, and re-certification for those on the specialist or GP registers. Re-licensing will be based on a 360-degree feedback, administered by an independent body.

Doctors who fail revalidation will 'spend a period in supervised practice or out of practice' while a rehabilitation plan is put in place, the report says. Revalidation will happen at least every five years.

Re-licensing and re-certification are Sir Liam's answer to criticism of the earlier GMC proposals for revalidation. These were suspended after Dame Janet Smith, chair of the Shipman Inquiry, said they were 'an expensive rubber-stamping exercise' that would not protect patients against rogue doctors.

When dealing with questions about a doctor's performance, affiliates will have the power to place a 'recorded concern' on a doctor's entry on the medical register, to agree a rehabilitation package of training and supervision, or refer doctors to the central GMC.

NHS leaders gave a cautious welcome to the idea of the affiliate role. NHS Employers deputy director Alastair Henderson says: 'There are a lot of questions we need to work though about how those [roles] would operate' within the management structures of NHS trusts.

The report proposes a new statutory clinical governance and patient safety committee, to which the chief executive and affiliate would report. A DoH spokesperson said 'affiliates will interact with trust management in this forum' but there is little detail yet available.

Affiliates will not be trust board members, unlike medical directors, but will be 'paired' with lay advisers, trained in regulatory and disciplinary procedures, to ensure their work is seen to be independent of professional loyalties. Both the affiliate and the member of the public would operate within a team including existing complaints staff - and would offer to see patients who complain about a doctor.

Robert Naylor, chief executive of University College London Hospitals foundation trust, says affiliates would need to work closely with clinical and medical directors. They 'must not be a bolt-on' to existing clinical governance arrangements. 'The devil will be in the detail,' he adds. 'They must not be external investigators but must be within the clinical structures that trusts have.'

Mr Henderson says: 'We could have issues of conflict between the affiliate as an employed member of the organisation and the management structures of the trust - how does the medical director in charge of the medical staff interact with the GMC affiliate?'

But he insists the affiliates would not pose 'a threat' to existing medical directors.

Former GMC president Sir Donald Irvine says there has to be a 'mutually supportive' relationship between affiliates and medical directors. Sir Donald added: 'It has always been the case that we needed a strong local presence. The workplace is where it happens.'

Jan Forster, director of primary care at Sunderland Teaching primary care trust, agrees: 'We would welcome a closer working relationship between the GMC and local PCTs so that decisions affecting doctors' ability to work could be integrated from a professional registration and a local list management perspective.'

NHS Alliance chief executive Mike Sobanja says the key issue would be making the role supportive and formative. An adversarial approach 'has the potential to damage relationships and lessen an open culture and clinical engagement - something we need to avoid at all costs'.

Mr Henderson says NHS Employers 'will be involved in detailed discussions with the GMC and profession' to flesh out the detail of the reforms by the time the consultation period ends in November.

But Sir Donald wants even more radical change than the CMO proposes. He says the GMC needs to transform from a representative body of the profession to a standard-setting organisation. 'It needs people, both professional and lay, who care passionately about making sure patients have good doctors,' he says. The current climate of suspicion means it will be unable to make that change without completely disbanding, he adds.

While the GMC may be smarting from the heavyweight criticism of Sir Liam and Sir Donald, senior managers have not escaped without censure. In Good Doctors, Safer Patients, Sir Liam says: 'While most chief executives are committed in their mission statements to the quality of the patient's experience, in reality most do not lose sleep over this compared to ensuring that they are fulfilling financial balance and productivity targets.'

But Mr Sobanja, a former NHS chief executive, hits back: 'I think the attitude that chief executives only focus on money and activity is offensive, inaccurate and unhelpful. If chief executives have centred on this recently it is because it is being driven from the centre. I always thought my job was to improve the health of the population first, and while doing that deliver targets and balance the books - that is why the post of chief executive is so intriguing and difficult.'

Mr Naylor says: 'I don't think chief executives are focused on the bottom line rather than quality - that only happens when the organisation is out of control.'

Whether criticism of managers is justified or not, the reaction of doctors will be crucial to the success of the proposals. There is a real risk the medical profession could fail to come on board, most pointedly by not volunteering as affiliates. Sir Liam argues the post will be prestigious. But Mr Sobanja warns the job could be 'a poisoned chalice'.

BMA chair James Johnson says: 'This would place a huge responsibility on one person. It seems unlikely many people would want to take on a burden such as this. I believe this will be one of the most difficult recommendations to implement.'

A key question will be who pays for this? The affiliates will be doctors who are already working for PCTs, acute and other NHS trusts, but the extra work could be 'onerous', Mr Henderson believes. 'There are some fairly practical questions about how much time this takes and who pays for it. If you have a doctor who has volunteered to do this and it takes half their week, where does the backfill come from?' The DoH expects the affiliate role to take up to half of a doctor's time in the average acute trust. Sir Liam's estimate is that the local affiliate teams, including administrative support, will cost£1.6m to set up, and£29m a year to run.

The report says the DoH will foot only part of the overall bill for the reforms. The cost of medical regulation will double, to up to£156m a year. The DoH will fund between£17m and£19m, while the NHS will be charged up to£41m. Doctors will have to pay an extra£18m in GMC fees.

But Sir Liam points out: 'These additional costs are relatively modest as the price of assuring high quality and safe medical practice.' Perhaps he was thinking of the£28m cost of the four inquiries into dangerous doctors, including Shipman, which formed the starting point.

Key recommendations

• The burden of proof for General Medical Council proceedings will change from the criminal law standard of 'beyond reasonable doubt' to the civil standard of 'the balance of probability'.
• This will close the loophole where concerns about a doctor may not meet the requirement for a GMC investigation but may still be causing serious concern to employers.
• The GMC will no longer be prosecutor and judge. Instead, it will investigate and bring cases where a doctor is accused of being unfit to practise. A new independent tribunal will decide whether the case is proven.
• Clear standards will be set for generic and specialist medical practice and incorporated in doctors' contracts.
• GMC powers will be devolved to local level through doctors working as licensed GMC affiliates.
• A twin-track system of regular checks on doctors' competence will be set up - re-licensing for all doctors and re-certification for those on the specialist or GP registers.
• Procedures will focus on the rehabilitation of those poorly performing doctors who are not deliberately seeking to harm patients.
• There will be greater public and patient involvement, with GMC affiliates in decisions about fitness to practise, and with the royal colleges in the process of re-certification.

www.dh.gov.uk/cmo

Non-medical regulation

A review of the regulation of the other health professionals was published alongside the chief medical officer's report and is also out for consultation. It recommended:

• Regulation should form one consistent framework across the different professions.
• It should be linked more closely with employers' own procedures.
• Consultation on more independent adjudication of fitness-to-practise cases.
• Standardised workplace appraisal across professions and employers.
• Revalidation for all registered professionals.
• The Healthcare Commission should kite-mark employers who can deliver reliable revalidation processes.
• A single investigation process and source of advice for complainants at local level.