Anaesthesia associates and physician associates

The House of Lords is due to consider the draft Anaesthesia Associates and Physician Associates Order 2024 on 26 February 2024. The order would provide for the regulation of anaesthesia associates and physician associates by the General Medical Council (GMC). The order requires the approval of both Houses of Parliament and the Scottish Parliament before it can become law. The House of Commons and the Scottish Parliament have both approved the order already.^[1]

Three members of the House of Lords have tabled motions relating to the order:

Baroness Bennett of Manor Castle (Green) to move that this House declines to approve the draft Anaesthesia Associates and Physician Associates Order 2024 because it represents a significant constitutional change in regulation of healthcare professionals by omitting parliamentary oversight and approval for regulating anaesthesia associates and physician associates; and fails to address concerns within the medical profession about the supervision and titles of the roles.

Baroness Finlay of Llandaff (Crossbench) to move that this House regrets that the draft Anaesthesia Associates and Physician Associates Order 2024 refers to “associates” rather than “assistants”, which would more properly reflect the role, scope and responsibilities of such staff and reduce patient confusion.

Baroness Brinton (Liberal Democrat) to move that this House regrets that the government has failed to respond adequately to concerns over provisions in the draft Anaesthesia Associates and Physician Associates Order 2024 about (1) the regulation of ‘physician associates’ and ‘anaesthesia associates’ by the General Medical Council instead of another regulator, and (2) the use of these professional titles, which risks confusion for patients over the difference between doctors and other healthcare professionals, with potential implications for patient safety.

Baroness Bennett’s motion is ‘fatal’, meaning that if the House of Lords agreed to it, the order would not become law. The other two motions are ‘non-fatal’ regret motions that would allow the House to express an opinion on the order without blocking it from becoming law.

1. What are physician associates and anaesthesia associates?

Physician associates (PAs) and anaesthesia associates (AAs) are healthcare professionals who work under the supervision of a medically qualified doctor or anaesthetist.^[2] The types of tasks that PAs undertake are:^[3]

• taking medical histories from patients
• performing physical examinations
• diagnosing illnesses
• seeing patients with long-term chronic conditions
• performing diagnostic and therapeutic procedures
• analysing test results
• developing management plans
• providing health promotion and disease prevention advice for patients

Most PAs currently work in general practice, acute (internal) medicine and emergency medicine.

The types of tasks that AAs undertake are:^[4]

• reviewing patients before surgery and assessing them for anaesthesia
• taking a medical history and clinical assessment allowing for an anaesthesia plan to be created
• inducing, maintaining and waking up patients from anaesthesia under appropriate supervision
• using anaesthesia techniques/agents, medications and specialist equipment
• interpreting and monitoring clinical readings and patients’ parameters during anaesthesia and responding appropriately
• initiating and managing medications, fluid and blood therapy during surgery
• identifying potential issues during surgery and anaesthesia, taking action and seeking appropriate support when required
• ensuring there is a plan for patients following their operation and that it is carried out
• being involved in the teaching, supervising and assessing of other team members
• supporting innovation, audit and research within the anaesthetic department

To train to become a PA, applicants generally need to have completed an undergraduate degree in a bioscience-related subject, or to be a registered health professional such as a nurse or midwife.^[5] PAs must then complete postgraduate training that usually lasts two years and involves many aspects of an undergraduate or postgraduate medical degree, focused principally on general adult medicine in hospital and general practice rather than specialty care. A small number of higher education institutions have also introduced integrated Master of Physician Associate programmes which offer a more direct route to becoming a PA, through a four-year programme integrating undergraduate and postgraduate study into one course.^[6]

To train to become an AA, applicants must have a biomedical or biosciences degree, or be a registered healthcare professional—such as a nurse or operating department practitioner—with at least three years’ full-time post-qualification work experience.^[7] They must complete full-time postgraduate training lasting around two years, with most of the time spent on clinical placement.

PA and AA qualifications do not entitle the holders to prescribe medications. However, a small number of PAs and AAs can do so with the support of their employer, on the basis of a qualification gained in another regulated healthcare profession such as nursing.^[8] The government is currently working with representatives from the professions, NHS England, the devolved administrations and professional bodies to develop the case for extending prescribing responsibilities to these roles.^[9] The case would then need to be considered by the Commission on Human Medicines, an advisory non-departmental public body.

PAs and AAs have been working in the NHS since 2002 and 2004 respectively.^[10] When the roles were first introduced, they are were known as physician assistants and physicians’ assistants (anaesthesia).^[11] The terminology for PAs changed from ‘physician assistant’ to ‘physician associate’ in 2014.^[12] The Royal College of Physicians states that this name change was backed by the government “as it was strongly suggested from within the DHSC [Department of Health and Social Care] that the term ‘assistant’ would hold the profession back from becoming regulated, as it was perceived at that time that ‘assistants’ did not need to be regulated”.^[13] The government was still referring to ‘physicians’ assistants (anaesthesia)’ in February 2019,^[14] but by July 2019, it was using the term ‘anaesthesia associate’.^[15] This name change seems to have taken place at the time the government decided to regulate AAs (for more on this see section 2).

As of June 2023, NHS workforce data showed there were 73 full-time equivalent (FTE) qualified AAs and 1,508 FTE qualified Pas working in NHS trusts and other core organisations in England, as well as a further 1,707 FTE qualified Pas working in GP practices and primary care networks.^[16] There are plans to expand these numbers considerably: the ‘NHS long term workforce plan’ published in June 2023 said that NHS England will incrementally expand the number of PA training places to over 1,500 per year by 2031/32, eventually establishing a workforce of 10,000 Pas by 2036/37.^[17] AA training places are set to be increased to 280 per year by 2031/32, with an estimated workforce of around 2,000 by 2036/37.^[18]

PAs and AAs are not currently subject to statutory regulation. However, the Faculty for Physician Associates holds a voluntary register for PAs.^[19] The Royal College of Anaesthetists does likewise for AAs.^[20]

2. What changes is the government proposing in the draft order?

The government is proposing that AAs and PAs should be registered and regulated by the GMC. The GMC is the body that regulates doctors by maintaining the medical register (a list of doctors who meet the requirements to work in the UK), setting the standards of patient care and professional behaviour that doctors need to meet, investigating where there are concerns that patient safety or the public’s confidence in doctors may be at risk, and taking action if needed.^[21]

The order would give the GMC similar responsibilities in relation to AAs and PAs by giving it powers to:^[22]

• register qualified and competent associates (the order provides for a single register divided into two parts, one for AAs and one for PAs)
• set standards of registration, education and training, and continuing professional development and conduct for associates
• approve associates’ education and training programmes
• operate fitness to practise procedures for associates

Paragraphs 7.8 to 7.28 of the government’s draft explanatory memorandum accompanying the order explain in more detail how these provisions would work. The fitness to practise arrangements would consist of a three-stage process, with an initial assessment stage, a case examiner stage and a panel stage, with appeals mechanisms at each stage.

The order would also make it an offence for someone, with intent to deceive, to:

• use the title ‘anaesthesia associate’ or ‘physician associate’ if they were not registered as such with the GMC
• falsely represent anyone to have an approved qualification (which will cover associates’ courses) or be registered
• make a false representation as to the content of the register
• procure, or attempt to procure, the inclusion or exclusion of information in the register

The order would come into force on 13 December 2024, except for the provision making it an offence to use the title of ‘anaesthesia associate’ or ‘physician associate’ without being registered. There would be a two-year transition period before this would take effect. The order would extend and apply to England and Wales, Scotland and Northern Ireland.

The government has said that regulation of AAs and PAs is “a significant step in embedding these associate roles in the multidisciplinary healthcare workforce”.^[23]

The draft order follows consultation both on regulating PAs and AAs and on the regulation of healthcare professionals more broadly. In 2016, the then health secretary, Jeremy Hunt, said he planned to consult on whether PAs should be regulated.^[24] The government ran a consultation on the regulation of medical associate professions in the UK in 2017.^[25] It published its response to the consultation in February 2019.^[26] This reported that 95% of respondents thought that PAs should be subject to statutory regulation, and 84% of respondents thought that physician assistants (anaesthesia) (as they were referred to in the consultation, also shortened to PA(A)s) should be subject to statutory regulation. The document summarised the case for regulating them as follows:

PAs: The majority of respondents supported our initial proposal that statutory regulation is proportionate for PAs. A recurrent theme from the comments we received was that respondents noted that PAs are often alone with vulnerable patients, making autonomous diagnostic and treatment decisions, without the direct supervision of a doctor. These circumstances, particularly when coupled with a direct entry route to training and a planned increase in numbers in the primary care workforce in England, create a compelling case for statutory regulation for this group.

PA(A)s: The consultation process has provided additional clarity on the practices and the level of clinical autonomy afforded to PA(A)s. For example, we understand that there is potential for PA(A)s to have a high level of autonomy at critical points in a patient’s care pathway. This, together with the high-risk interventions that they perform and the lack of assurance currently in place given the direct entry route into the role, means that we are persuaded that statutory regulation is proportionate for PA(A)s.^[27]

The government said it would introduce statutory regulation for the two roles and would continue work to evaluate which regulator—the GMC or the Health and Care Professions Council (HCPC)—would be most appropriate to take on the regulation of these roles. The HCPC currently regulates art therapists, biomedical scientists, chiropodists/podiatrists, clinical scientists, dietitians, hearing aid dispensers, occupational therapists, operating department practitioners, orthoptists, paramedics, physiotherapists, practitioner psychologists, prosthetists/orthotists, radiographers, and speech and language therapists.^[28] In July 2019, the government asked the GMC to take on the regulation of PAs and AAs.^[29]

More broadly, the government has been consulting on reforming the legislative framework across regulated health and care professions in the UK. In 2014, the Law Commission published recommendations for a new single legal framework for the regulation of all health and social care professionals. These included, among other things, new powers for regulators to make their own rules and consistency across the regulators in the way fitness to practise hearings are conducted.^[30] The Law Commission said the legal framework was “fragmented, inconsistent and poorly understood” and making even relatively minor changes to regulators’ rules and regulations could be “cumbersome and expensive”. In response, the government published a consultation in 2017 entitled ‘Promoting professionalism, reforming regulation’. This sought views on matters such as designing a “more responsive model of professional regulation”, considering whether the number and set up of healthcare regulatory bodies was delivering effective and efficient public protection and ensuring regulatory bodies had a “consistent and flexible range of powers”.

In its response following this consultation, published in July 2019, the government said that “too much detail about the regulators’ day-to-day functions is set out in legislation which is subject to the agreement of Parliament”.^[31] The government argued this added “unnecessary delay and complexity when making simple operational changes” and this “hinders the regulatory bodies’ ability to be responsive to a fast-changing healthcare environment”. The government said it would provide regulators “with the autonomy to set more of their own operating procedures leading to more responsive regulation”. The government also said that regulators would be provided with “broadly consistent powers to handle fitness to practise cases in a more responsive and proportionate manner”, including enabling them to resolve cases without a full panel where appropriate.

The government published a further consultation on its proposals in 2021, incorporating proposed reforms on governance and operating frameworks, education and training, registration and fitness to practise.^[32] This consultation also sought views on introducing statutory regulation of PAs and AAs by the GMC. The government published its response to the consultation exercise in February 2023.^[33] This showed that 86% of respondents agreed with the proposed approach to the regulation of AAs and PAs. Of the 14% that disagreed, some of the main arguments given were that:

• regulatory oversight should be by an alternative regulator to the GMC, for example HCPC or another separate body, so that the GMC maintains its focus on the regulation of doctors
• the need to maintain a clear distinction between the scope of practice for doctors and that for AAs and PAs
• training opportunities for doctors should not be impacted by the professional development requirements for AAs and PAs^[34]

The government confirmed it intended to go ahead with drafting legislation to give the GMC the power to regulate AAs and PAs under the new regulatory framework.^[35] On the broader reforms to the regulation of healthcare professionals, the government said that through a series of statutory instruments it would give each regulator “near identical powers through broadly similar legislation”:

In particular, we will provide each regulator with greater autonomy to set out the details of their regulatory procedures in legislation that they themselves publish, called rules. Regulators will be required to consult on their rules but will not need to secure the approval of Parliament or the Privy Council to make their rules, giving increased flexibility to rapidly adapt their processes to changing requirements.^[36]

The government said the draft order bringing AAs and PAs under the regulation of the GMC would be the first to be based on this new regulatory framework and would be used as a template for the reforms of all the other healthcare professions regulatory bodies. The government said it would continue to work on drafting a separate piece of legislation to reform the GMC’s regulatory framework for doctors, including provisions to facilitate the transition from the current framework to the new one. It said over the following couple of years it would start working with the HCPC and the Nursing and Midwifery Council to develop reformed legislation for their professions. Further changes for the remaining regulators (the General Chiropractic Council, the General Dental Council, the General Optical Council, the General Osteopathic Council, the General Pharmaceutical Council and the Pharmaceutical Council of Northern Ireland) would follow after that.

A draft version of the legislation relating to AAs and PAs was published the same day for consultation.^[37] The government published its response to this in December 2023, setting out where it had amended the drafting of the order in response to points made in the consultation.^[38] The government said that as a result of these changes, the legislation now contains drafting that “enjoys broad support from stakeholders and implements review and appeal mechanisms that will ensure that where a decision is challenged it can be considered and, where necessary changed quickly without requiring escalation to a court”.^[39]

3. What has the response been?

Responses to the proposed new legislation reflect wider debates around the roles of PAs and AAs. The British Medical Association (BMA), the trade union and professional body for doctors, has expressed strong concerns that the roles are not well understood by the public. It argues that:

A central tenet of well-functioning teams is that patients and clinicians have a clear understanding of the skills, qualifications and, where relevant, the limitations of those providing care. Patients should always know who is treating them and when this is—and is not—a medically qualified doctor.

Across the medical profession concerns have been raised that medical ‘associate’ roles unhelpfully blur the distinction between doctors and non-medically qualified professionals. Our own BMA Patient Liaison Group, and feedback on tragic cases, report the high level of the public’s misunderstanding. Patients and their families are often unaware they have not been seen or assessed by a doctor; such confusion is understandable […] Physician and anaesthetic associates do not hold a medical degree, and neither are they medically trained. They are not doctors.^[40]

The BMA opposes the GMC being the regulator for PAs and AAs, arguing that “the possibility for increasing patient confusion […] is self-evident”.^[41] It believes that the HCPC would be a more appropriate body to regulate these roles. The BMA also maintains that naming the roles as ‘associates’ rather than ‘assistants’ is “highly misleading and confusing to the public”. It has urged the DHSC to change the professional titles back to ‘physician assistant’ and ‘physician assistant (anaesthesia)’ or ‘anaesthesia assistant’ in future legislation on patient safety grounds. Commenting on the legislation, the BMA said that by pressing on “despite the overwhelming opposition of the medical profession”, the government was “failing to take seriously the safety concerns that have been raised about the choice of regulator”.^[42] It also believed that “by supporting the impression that PAs can do everything doctors can do, the government is opening the way to more patient safety incidents along the tragic lines we have already seen”. The BMA highlighted, for instance, the case of Emily Chesterton, who died from a blood clot after two appointments with a PA who told her she had a calf strain.^[43] Ms Chesterton’s mother said her daughter did not know she had not seen a doctor.^[44]

More broadly, the BMA has also argued that the planned workforce expansion of PAs and AAs “challenges what it means to be a doctor, reflects how the medical profession has been devalued, and demonstrates how the health system is seeking to undermine it in favour of colleagues with less training, skills and expertise”.^[45]

The Association of Anaesthetists, a membership body representing anaesthetists, said its membership had “significant concerns about the roll out of the AA project”, including that the “huge expansion” of AA numbers in the NHS long-term workforce plan “with no concomitant expansion in numbers of doctors in anaesthesia” looked like “replacement of doctors with AAs, rather than employing AAs to complement the anaesthesia team”.^[46] The association argued that “AAs are valuable members of the anaesthesia team in addition to doctors, but they are not the solution to the current workforce crisis”. On regulation, the association agreed that all healthcare professionals should be subject to mandatory regulation as a “non-negotiable requirement”. However, the association was concerned that regulation by the GMC “potentially further blurs the distinction between doctors and AAs”. It called for AAs and PAs to be presented on a separate register from doctors to “provide absolute clarity for patients and others accessing the registers” and “protect everyone from accidental or deliberate misrepresentation”.

The relevant royal colleges have spoken in favour of regulating AAs and PAs but have expressed some concerns about wider issues relating to these roles and the impacts on doctors. The medical royal colleges are professional bodies for doctors in a certain specialty and are regulated by the GMC.^[47] They design the curricula doctors must take during specialty training and the examinations doctors must pass to progress to a consultant or GP post.

The Royal College of Anaesthetists supports GMC regulation of AAs.^[48] However, it has also advised NHS England to “proceed cautiously in relation to expansion as there is not yet sufficient data about the potential impact on anaesthetic training and other factors relating to integration [of AAs] within [anaesthetic] departments”. At an extraordinary general meeting in October 2023, the college voted to ask the clinical directors network to pause recruitment of AAs until the college had carried out a survey and consultation and the impact on doctors in training had been assessed and reviewed.^[49]

The Royal College of General Practitioners described it as “positive” that the GMC is proceeding with the professional regulation of PAs in all settings.^[50] However, it maintained that PAs “must not and do not replace GPs and do not mitigate the need to urgently address the shortage of GPs”.

The Royal College of Physicians (RCP) said it was “supportive of the physician associate (PA) role as part of multidisciplinary healthcare teams”.^[51] However, it also recognised there was “a range of views and some strong feelings about the PA profession and accept that there are issues that need to be resolved”. This included increasing patients’ knowledge of the PA role and ensuring there was more clarity on the scope and practice of PAs. Dr Sarah Clarke, president of the Royal College of Physicians, said the organisation had been lobbying for the regulation of PAs for five years.^[52] The RCP is currently surveying its members asking for their views about the PA profession.^[53] The results are due to be discussed at an extraordinary general meeting of the RCP’s council in March 2024, where motions relating to PA scope of practice, accountability and expansion will be discussed.

Bodies representing AAs and PAs have welcomed the prospect of regulation by the GMC. The Association of Anaesthesia Associates said that regulation of AAs was “long overdue”, and something it had been working towards since 2008.^[54] It said it agreed that the GMC was the most appropriate regulator to take this forward as “AAs work within a medical specialty, are employed by anaesthesia departments and should be expected to work to the same high standards that our medical colleagues adhere to and the public should expect”. The Faculty of Physician Associates (FPA) said that regulation of PAs would “enable multidisciplinary teams to work more efficiently”.^[55] It believed that PAs were “one aspect of a future innovative NHS to overcome the challenges the whole workforce is facing”. To address some of the concerns raised around the ‘associate’ title, the FPA published guidance in October 2023 setting out how PAs should take all reasonable steps to inform patients and staff of their role and avoid confusion of roles.^[56]

The GMC itself described the order as a “significant milestone” in its becoming the regulator of PAs and AAs.^[57] It argued that the development of the roles “should help the health service deal with ongoing pressures, and bringing them under GMC regulation would “ensure PAs and AAs have the knowledge and skills to work safely in the UK”.

4. Parliamentary scrutiny of the draft order

4.1 House of Commons

The House of Commons considered the draft order in a delegated legislation committee on 17 January 2024. Andrew Stephenson, minister for health and secondary care, said that AAs and PAs were “already a valued and integral part of the multidisciplinary healthcare team”, but regulating them would “increase the contribution that AAs and PAs can make to the UK healthcare sector, while improving patient safety and professional accountability”.^[58] He said the order would provide a “high-level framework” for regulation and give the GMC autonomy to set out the details of its regulatory procedures in rules.

Addressing some of the concerns around PAs and AAs, Mr Stephenson said he was clear that their role was “to work with doctors and not to replace them”. He said the NHS long term workforce plan set out an aim to double the number of medical school places to 15,000 by 2031/32, and to deliver an additional 60,000 doctors by 2036/37. He said he hoped this would “address the mistaken belief that PAs and AAs will replace doctors within our NHS”.^[59] He also argued that giving the GMC responsibility for regulating AAs and PAs in addition to doctors would “enable a more coherent and coordinated approach to regulation, and make it easier for employers, patients and the public to understand the relationship between the roles of associates and doctors”.

Karin Smyth, shadow minister for health, said that regulation of AAs and PAs was “long overdue”.^[60] She recognised that they played “an important role as part of a flexible and diverse workforce”, but she was pleased the minister had made clear they should never be seen as a replacement for doctors. Ms Smyth asked the minister for reassurance on various points, including:^[61]

• stakeholder consultation by the GMC
• ensuring patients had clarity and awareness of who was treating them
• what support and supervision AAs and PAs would be given
• how the draft order might impact on career progression and retention in the NHS
• whether the GMC was the best regulator to define core capabilities expected of AAs and PAs
• whether the legislation would be reviewed over the two-year transition period in which AAs and PAs need to register
• what safeguards there would be around fitness to practise decisions taken by the regulator, including decisions to remove or reduce restrictions on a registrant found to present a possibly serious risk to the public

Mr Stephenson said the DHSC had met the BMA and other stakeholders to develop the policy behind the legislation, and following engagement and consultation had made a number of amendments to the draft order to ensure it would “empower regulators to be able to deliver new regulatory processes that would better serve patients and their registrants”.^[62] On the question of professional titles, which several MPs raised during the debate, Mr Stephenson maintained that the physician associate title had been “well established” in the UK since 2014 and the government had no plans to change it.^[63] He referred to documents published by the National Institute for Health and Care Excellence, the GMC and the FPA that all set out the importance of healthcare professionals introducing themselves to patients and properly explaining their role. He said NHS England had also produced materials for patients to be shared through GP practices to “support patient awareness and understanding of the PA role”. He reiterated the government’s view that the GMC was the right regulator, following a consultation on this in 2019.^[64] He repeated that the GMC could take a holistic approach to the education, training and standards of associate and doctor roles, and he hoped this would allow concerns around junior doctor training places to be addressed appropriately.

The House of Commons formally approved the draft order on 22 January 2024.^[65]

4.2 House of Lords Secondary Legislation Scrutiny Committee

The House of Lords Secondary Legislation Scrutiny Committee (SLSC) has drawn the draft order to the special attention of the House on the ground that it is politically or legally important or gives rise to issues of public policy that are likely to be of interest to the House.^[66]

The SLSC commented that “unfortunately the [government’s] explanatory memorandum (EM) assumed that the role of these associates is generally known” and did not explain what they are.^[67] The DHSC provided the committee with supplementary material to explain the role of AAs and PAs.

The SLSC highlighted that giving the GMC direct powers to make and amend standards and procedures would mean there was no parliamentary oversight of this process. Paragraph 5(1)(a) of schedule 3 to the draft order would require the GMC to publish any rules it made under the order and any standards it determined under article 3(1). Article 3(1) would require the GMC to determine standards applicable to PAs and AAs. Article 3(2) specifies that the standards must relate to:

• education and training
• knowledge and skills
• experience and performance
• conduct and ethics
• proficiency in the English language
• such other matters as the GMC may prescribe in rules made under paragraph 2(2)(a) of schedule 4 (this paragraph would empower the GMC to prescribe the standards in rules)

The DHSC told the SLSC that the GMC intended to fulfil this duty by publishing all rules on its website.^[68] Drafts of the rules would be published for consultation. The DHSC confirmed that once the order took effect, the making and changing of such rules would no longer be laid before Parliament. The DHSC said that while the order “seeks to increase the number of areas that the GMC has autonomy over in respect of its day-to-day functions”, it would also introduce checks and balances to ensure the new powers were used “reasonably and proportionately”.^[69] These included:

• a duty to consult with relevant parties on changes to rules
• a duty to cooperate with other parts of the healthcare sector as a means of preventing divergent practices that would negatively impact other stakeholders
• a duty to produce annual reports to Parliament on the exercise of the GMC’s functions and how it had met its statutory duties

The DHSC said that these duties would also apply in future to other regulators as the new regulatory framework was extended to other healthcare professions.

The SLSC said it had “no concerns about the policy intention” of registering and regulating AAs and PAs given it was “in line with previous practice” and the GMC was an experienced regulator.^[70] However, it said the order represented a “significant constitutional change in the way that system of regulation is to be delivered by removing direct parliamentary oversight”. It concluded that the explanatory memorandum to the order should have been “more explicit on this point and on what safeguards remain”.

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