The Department of Health and Social Care (DH) consulted on proposals to reform UK healthcare regulation in 2021, including removing the current need for regulators to seek legislative changes to update their day-to-day processes.

At the time, it said that the proposals would “modernise” healthcare regulation, which is “rigid and complex”.

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In a consultation response published last week (February 17), the DH confirmed that the proposals would go ahead after 525 responses from both individuals and organisations “showed clear support” for the changes and following an “extended period of stakeholder engagement”.

It will therefore introduce a new legislative framework for all nine of the health and care professional regulators, including the General Pharmaceutical Council (GPhC), a DH executive summary said.

 

“Greater autonomy”

 

The DH said that it will give each regulator “greater autonomy to set out the details of their regulatory procedures in legislation that they themselves publish, called rules”.

While they will be “required to consult” on these rules, regulators “will not need to secure the approval of Parliament or the Privy Council to make their rules”, it added.

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This will give them “increased flexibility to rapidly adapt their processes and procedures to changing requirements”, the DH said.

Previously, the GPhC had to seek approval from the Privy Council to temporarily amend its rules, for instance to allow it to hold remote hearings during the pandemic, it added.

 

“Increased accountability”

 

The DH said the reforms would be “balanced with increased accountability”, for example through requirements to submit evidence of any fee change’s likely impact and annual reports to the devolved governments, as well as for regulatory activities to be “carried out in a transparent manner”.

It added that regulators can also be called before the parliamentary Health and Social Care Committee (HSCC) “at any time”, while the Privy Council has powers to “direct a regulator where it has failed to carry out its statutory functions” – which will be extended to the GPhC.

But the DH admitted that despite “much support” for its policy proposals, “a number of concerns were raised regarding the adequacy of the safeguards”. 

 

“Less adversarial” FtP process

 

Meanwhile, reforms to the fitness to practise (FtP) process will also ensure “greater consistency between regulators”, the DH said.

Under the reforms, the new process will be “swifter, fairer and less adversarial”, it added, enabling “more cases to be resolved without the need for” an FtP panel hearing through the introduction of a “case examiner stage”.

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The DH said there was “broad support” for the “majority” of its reforms in this areas, with the “majority of respondents agreeing that all regulators should have a three-stage FtP process including an initial assessment, a case examiner stage and an FtP panel stage”.

However, it added that it received “mixed responses” regarding a proposal to remove current restrictions on regulators considering concerns more than five years after they came to light from legislation.

The DH “[remains] of the view that removing the five-year rule is the right thing to do”, making “time elapsed” a “relevant consideration” rather than a “constraint” on whether regulatory action should be taken, it said.

 

Other areas of reform

 

The DH set out that regulatory reform will also cover education and training and registration.

It said that:

• Regulators will have “greater flexibility to determine how they set standards for, and quality assure, education and training” through the removal of “overly prescriptive legislation”

• But they will be required to “co-operate with organisations connected with the employment, education or training of healthcare professionals, as well as other regulatory bodies, and to operate in a proportionate way that considers the impact of how they use their powers”

• Regulators will be given “greater flexibility to set out the routes to registration, as well as any conditions on registration” as well as powers to determine the content of the register and what information should be published

• But some registration requirements will be retained in legislation, such as the need for registrants to hold adequate indemnity cover or insurance

• Regulators will have a “new duty” to establish a periodic process of checking that registrants are continuing to meet the regulator’s standards of practice for their profession”

• They will also have the “flexibility to set the specific standards for overseas professionals” and “determine how best to assess” their applications “in a proportionate way”, through the removal of “prescriptive details setting out overseas registration requirements” from current legislation

The DH also said it is “looking at the number of healthcare regulators and whether opportunities for simplifying the landscape exist”, but will “ensure comprehensive engagement on any proposals that might arise”.

And further detail on its proposals in relation to the registration of pharmacy premises will be set out when it develops legislation to reform the GPhC, it added.

 

Timeline for reform

 

“Replacing multiple pieces of legislation will be a long-term project”, the DH said, adding that it plans to work on the legislation for multiple regulators in tandem “where possible”.

The DH will introduce statutory General Medical Council (GMC) regulation for anaesthesia associates (AAs) and physician associates (PAs) in the first instance, which will “provide a template” for subsequent reforms of other regulators, it said.

The draft legislation – the first to adopt the “new regulatory framework” – is currently open for consultation until May 16 and is expected to be laid in Parliament “in the second half of 2023”, it added.

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GMC regulation of the roles is expected to begin a year later, putting the DH “in a good position to roll out these reforms to the other regulators”, it said.

However, reform will then be prioritised based on “criteria including the size of registrant base, the need for reform, and regulators’ readiness to implement the changes” – starting with the doctors’ and nurses’ regulators and Health and Care Professions Council.

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The DH said it is its “intention to work as swiftly as possible to deliver reform for each regulator and profession”, but it remains unclear when the GPhC will itself be reformed.

Each regulator’s reformed legislation will be “subject to future consultation”, it added.

The DH said that the reforms represent “a generational opportunity to fundamentally redesign the regulatory framework for healthcare professionals across the UK”.