Reforming regulation: General Pharmaceutical Council responds to consultation

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On 23 January 2018, the Department of Health closed its consultation on reforming the way that health professionals across the UK are regulated[1]. The consultation asked how we can improve the protection of the public through more efficient, responsive and effective regulation.

The Government’s proposals have been described by the Professional Standards Authority, the oversight body for healthcare professional regulators, as a “once in a lifetime opportunity” to better protect patients and support professionals[2]. But what could the proposals mean for pharmacists, pharmacy technicians and pharmacies across the UK?

The consultation has been long-awaited, particularly by those of us working in regulation, and we hope it will lead to positive reforms. We are conscious that this work has taken place at a time when there are many other demands on the UK Government, and parliament needs time to legislate for proposed changes, so no-one yet knows what will happen following the consultation. More importantly, the General Pharmaceutical Council (GPhC) also appreciates that the consultation has taken place at a time when everyone in pharmacy — and in healthcare generally — is exceptionally busy, caring for their patients in a rapidly changing and uncertain environment.

Overhauling regulation

Health and social care has changed considerably to meet the changing needs of the population, and it will continue to do so. Regulation must respond too.

We strongly support the consultation’s objective to make regulation more effective, efficient, proportionate, flexible and accountable.

This target aligns closely with our own aims, set out in . We can sum up the plan and what we want to achieve for patients and the public in two words: ‘assurance’ and ‘improvement’.

Regulation is most effective at ensuring safe and effective care when there is a wide range of flexible tools that can be used to provide assurance and promote improvement. Regulation also needs a legal framework that provides us with the flexibility to respond effectively to external changes.

In return, we would gladly — and indeed should — provide more assurances to parliaments and assemblies across Great Britain to whom we are accountable, ensuring that there are checks and balances over our decisions and actions.

This culture of autonomy and accountability should run like a strong thread through the entire system. Health professionals and regulators should all have the flexibility to innovate, change and respond to the needs of the people, but we need to do that within a clear framework of accountability that will empower the whole system to adapt and improve safely in the face of change.

The difference the proposals can make

Some may ask whether these proposals, if implemented, would make any real difference to health professionals or patients. Is this just navel-gazing by the government and the regulators?

The GPhC believes that this consultation is an opportunity to make significant reforms that could improve protection and assurance for patients and the public, and support the professionalism of all health professionals. The consultation raises a number of important questions that should matter to health professionals and to the public.

We have given what I think is , that sets out our vision for the future of pharmacy regulation and gives answers to not only these important questions, but others that were raised during the consultation.

Deciding which professions to regulate

The consultation raised the question of how decisions over which professional groups are regulated are made. This includes the suggestion that the Professional Standards Authority, the oversight body for the healthcare professional regulators, could be responsible for making recommendations to the Government on which groups to regulate.

All those involved in delivering healthcare know that new roles are developing, and many are working in established professions but taking on new roles and responsibilities to meet the changing needs of the population. This may mean that new professions need regulation, or, that as new roles emerge, some professions will no longer require regulation.

We believe that some important tests must be undertaken before decisions on regulating and de-regulating groups can be made. In our response, we set out these tests, including a model for assessing which groups are regulated, that should take account of the diversity of practice within and across professional groups, and the degree of risk involved in the professional work of those regulated.

Changing the number of regulators

The consultation asked whether there is a case for reducing the number of regulators from the current nine, and what the advantages and disadvantages of doing so could be. It may come as a surprise to some that we have welcomed a consultation in which one of the questions was whether the number of regulators should change, but we think it is right that the debate is had.

In our response we recognise that, as the regulators came into existence at different times and each have their own legislation, there are differences in how they address similar issues. Having a large number of regulators can make things more complex for those who have to engage with them, including patients and employers. But reducing their number comes with a disadvantage: regulators have an understanding of the context of the professional groups they regulate. This is particularly the case for pharmacy because we regulate both registered pharmacies and pharmacy professionals.

The number and configuration of regulators is, of course, ultimately a decision for the governments. But in our response we argue that the contextual understanding of professions, and where and how they work, must not be lost.

A change in the number of regulators must reap benefits for patients and the public, which outweigh the inevitable costs, resources, and disruption to the professions that come with any reorganisation.

Fitness to practise

The consultation asks how we can improve the system of investigating and resolving fitness-to-practise complaints. It highlights that the process for dealing with concerns about registrants varies from regulator to regulator, but that these processes are legalistic, adversarial, costly and time-consuming. The consultation document also sets out a number of options for making the process easier and more flexible, including a suggestion for greater use of dispute resolution or mediation when dealing with concerns.

In our view, fitness-to-practise processes should be reserved for only the most serious concerns, and we believe that this consultation provides an opportunity to look at their purpose, not just the mechanisms for dealing with concerns. In our response, we have argued that regulators should have the flexibility to use such other approaches for managing concerns it considers appropriate.

Another key point that we have made in our response is that the environments in which healthcare professionals work are critical for delivering professional, safe and effective care. We believe that the interplay between the regulation of people and places is fundamental. Strengthening the regulation of the interaction of both people and places is an essential part of assuring and improving health and social care.

We have continued to build on our approach to regulating and inspecting registered pharmacies, and the evidence suggests our approach is helping pharmacies to improve the services and care they provide. But, as we acknowledge in our response, we have limited powers in relation to taking action against pharmacies that do not meet standards because current legislation is narrowly and prescriptively drafted. This can undermine confidence in how we regulate pharmacies. There have been recent calls for the UK Government to review our powers in regulating pharmacies, and a debate is needed.

Supporting professionalism

We welcome the consultation’s clear focus on supporting professionalism. We have long said that regulation is more than enshrining and enforcing minimum standards. We should promote and support professionalism because it enhances patient safety and quality of care.

We have already made changes to the way we regulate pharmacy professionals and registered pharmacies so that we may play a more effective role in supporting professionalism, and we are now working to do more. The standards we set focus on outcomes and promote professionalism. And our approach to revalidation, which is being implemented from this year, is designed to encourage reflection on the professional standards and the benefits offered to the people using a pharmacy professional’s services.

While we wait for legislative change

Much can be done without changes in legislation; for example, our revalidation model has been designed, piloted and consulted on without the need for additional rules and regulations. While we wait for legislative reform to take place, we will continue to further improve how we regulate, and continue to show the public that the trust they have in the pharmacy profession is well placed.

Nigel Clarke is chair of the General Pharmaceutical Council.

Citation: The Salvadore DOI: 10.1211/PJ.2018.20204265

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