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Regulatory reform: a perspective from the Pharmacists Defence Association

Understanding the context for regulatory reform

Healthcare work is as rewarding as it is challenging. Young people embark on their journeys into healthcare professions with that sense of commitment and vocation to make a difference to people’s lives. It’s not just a job.

The overwhelming majority of healthcare professionals work tirelessly to serve their patients and communities to their best. This was graphically illustrated during the Covid-19 pandemic and we are all familiar with the scenes of multidisciplinary teams of professionals caring for patients tirelessly despite substandard PPE and being overwhelmed with wave after wave of new patients. Many healthcare professionals (including a disproportionate number of BAME professionals) succumbed to Covid-19 which may have been acquired whilst tending to their sick patients.

This is the context in which I believe regulatory reform for healthcare professionals should be understood.

Regulation as a support mechanism

Regulation, in this context should always be seen as a mechanism to create the right support structures from point of entry to training, during training, throughout a working life in healthcare and all the way to retirement to enable that sense of commitment and vocation to thrive and prosper. This would be balanced by mechanisms that enable practitioners who have made an error or stumbled to learn from their errors to be helped to stay in practice safely and, when this is absolutely not possible, to ensure that they cannot put patients in harm’s way.

The role of regulators and appropriate regulation is key to facilitating this process and many of the reforms are thus welcome. The current Government proposals are wide ranging but in summary they seek to:

“… devolve many of the decisions about day to day procedures to the regulators themselves, whilst ensuring that they continue to meet their overarching objective to protect the public”

The reforms are centred around four key areas:

  • Education and Training
  • Registration
  • Fitness to practise
  • Governance and Operating Framework

Indeed, the Law commission report in 2014 envisaged and proposed many of these as part of a range of interconnected reforms building in appropriate checks and balances. The risk with the current proposals is that whilst Government has accepted some of the Law Commission recommendations it has rejected others.

Picking and choosing from Law Commission recommendations

The rejection of a number of recommendations surrounding the role and powers of the Professional Standards Authority (PSA) is the biggest concern as these provided the requisite oversight to counterbalance the new proposed regulatory powers.

The Law Commission in its 2014 report specifically noted:

“.. such is the importance of the Authority’s role in the new legal framework, that the Government must ensure that sufficient resources are available to fund the Authority’s expanded role.”

Resources of course cannot mean mere monetary resources. In this context resources also mean legal power to ensure that regulatory performance, just as registrant performance, does not harm the public or undermine confidence in the healthcare professions.

The checks and balances proposed by the Law Commission recommendations are thus lost when you accept some changes whilst rejecting others that are integral to act as that counterbalance.

The Law Commission specifically recommended an enhanced oversight role for the Professional Standards Authority to ensure that the powers regulators had were used proportionately, fairly and consistently in their overarching responsibility to protect the public. In its response to the Law Commission report the Government stated:

“..the Government intends to consider further the balance between primary legislation and rules, regulations and accompanying safeguards and oversight arrangements, and within this it will need to consider the PSA’s role further.”

Some regulators themselves recognise the importance of balance and an effective oversight for the powers they hope to receive. In their 2017 submission to the Government consultation Promoting professionalism, reforming regulation the GMC commented:

“However, the increased autonomy we seek in policy and operations must be accompanied by other checks and balances to ensure that regulators’ powers are exercised appropriately. That should include (but not be limited to) strengthened measures of accountability.”

We can illustrate the benefits of an extended oversight role for the PSA using two specific examples.

The value of independent oversight

Firstly, The Law Commission recommended that the PSA be given a specific power to investigate complaints about the ways in which a regulator has exercised its functions. The Government confirmed in its 2015 response to this Law Commission recommendation that it:

“… would make a provision for similar powers”

This power may have been especially relevant in the following example. The PSA was recently inundated with concerns about problems around the process of the registration exam set by the GPhC (the pharmacy regulator) for pharmacists. The Covid-19 pandemic had led to a series of delays and modifications to the exam process and caused an immense amount of stress to young students about to enter the register of their chosen profession. Whilst understanding that the pandemic posed an exceptional challenge to regulators as it did to students the handling of the exam by the GPhC which oversees the exam in GB was markedly different to the handling by the Pharmaceutical Society of Northern Ireland which oversees the exam in Northern Ireland.

The PSA issued the following statement in March 2021 following the receipt of a substantial number of complaints:

“We should be clear that we have no power to intervene or require any changes to be made to the registration assessment taking place later this month. Nor can we investigate or take action on individual cases.”

If we contextualise this situation to members of the public contacting the PSA about concerns they made to a regulator or regulators about the care they or a relative had received what impact would this have?

The report following the Morecombe Bay Inquiry (MBI) made recommendations for  both the NMC and the GMC. There were, of course, wider systemic problems identified by the MBI including warnings issued by both the system regulators the CQC and Monitor. Reforms around system regulation (especially in the evolving NHS landscape) are outside the scope of this consultation as are concerns expressed in the Francis and other reports also about the role and accountability of non-registrant managers and senior staff.

Secondly, the PSA currently has a power to refer any decisions of fitness to practise panels to the higher courts. At present Section 29 powers are used when challenging a panel adjudication which is “insufficient to protect the public”. Any investigation is a cause for stress not only for healthcare professionals but also for complainants. The accepted outcomes proposed by the reforms are welcome because they have the potential to ensure proportionality and fairness for all parties without the need for panel hearings.

Extending the PSA’s Section 29 power to accepted outcomes

However, as a check to the system there also needs to be some straightforward mechanism for any outcome to be appealed including ‘accepted outcomes’. This is where an extension of the PSA Section 29 power to include cases closed by case examiners may be appropriate.

There are a number of issues around appeals against adjudications. The Bawa-Garba case highlighted the complex balance that needs to be struck and how both public and professional confidence can be undermined with an inappropriate challenge to an independent adjudication.

In summary, we welcome many of the suggested reforms. However, we need to ask whether the omission of certain recommendations of the Law Commission for the oversight of regulators may reduce both public and professional confidence in a reformed regulatory system.


 

Our first look at Government proposals to reform professional regulation, Let's get it right for public protection, can be read here.

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Disclaimer

Please note the views expressed in these blogs are those of the individual bloggers and do not necessarily reflect those of the Professional Standards Authority.