Susan Pollitt

Minister of State for Health (Secondary Care) 

39 Victoria Street 
London 
SW1H 0EU 

13 November 2024 

Our ref: 

HM Coroner Joanne Kearsley 
The Coroner’s Office 
2nd and 3rd Floor 
Newgate House 
Newgate 
Rochdale 
OL16 1AT 

By email: 

Dear Ms Kearsley  

Thank you for the Regulation 28 report of 31st July 2024 sent to the Department of Health 
and Social Care about the death of Mrs Susan Pollitt. I am replying as the Minister with 
responsibility for Secondary Care. 

Firstly, I would like to say how saddened I was to read of the circumstances of Mrs Pollitt’s 
death, and I offer my sincere condolences to her family and loved ones. The 
circumstances your report describes are incredibly concerning and I am grateful to you for 
bringing these matters to my attention.  

The report raises concerns over the role of physician associates (PAs) in the NHS, in 
particular: 

•  The lack of a regulatory body with oversight of PAs and the voluntary nature of the 

current register. 

•  The lack of a national framework as to how PAs should be trained, supervised and 

deemed competent.  

•  The limited understanding and awareness of the role of a PA giving rise to 

confusion as to whether the practitioner is a doctor. 

•  Concerns around the competency form used in relation to the insertion of ascetic 

drains and wider aspects of care such as taking consent, risk factors and aftercare. 

In preparing this response, my officials have made enquiries with NHS England and the 
General Medical Council (GMC) who we understand have also provided a response, to 
ensure we adequately address your concerns. 

We are clear that all healthcare professionals must only practise within their competence 
to ensure they are providing safe and effective care. PAs must always work under the 
supervision of a fully trained and experienced doctor, working with them, not replacing 
them. The concerns raised about PAs show that, whilst the underpinning rationale for the 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 introduction and deployment of PAs is valid, the integration of the roles has not generated 
the conditions needed for public and professional trust.  

The report raises concerns over the lack of a regulatory body with oversight of PAs and 
highlights the voluntary nature of the current PA managed register. We are clear that 
statutory regulation is necessary for PAs and anaesthesia associates (AAs) and the UK 
and Scottish parliaments approved legislation in early 2024 which provides a legal duty for 
the GMC to regulate PAs and AAs from December 2024. Regulation will provide a 
standardised framework of governance and assurance for the clinical practice and 
professional conduct of these roles. The GMC will set standards of practice, education and 
training, and operate fitness-to-practise procedures, ensuring that PAs and AAs meet the 
standards that we expect of all regulated professionals and that they can be held to 
account if serious concerns are raised.  

Once regulation begins, the current PA managed voluntary register will close. The GMC 
expects the vast majority of practising PAs and AAs to join the register within the first six 
months of regulation, and they will be required to do so within two years of regulation 
commencing.              

Your report also raises concerns around the lack of a national framework for PAs relating 
to training, competence and supervision. I agree that it is imperative for patient safety that 
the competence and supervision requirements for all healthcare roles are widely 
understood. As highlighted above, once regulation begins, the GMC will set the outcomes 
that need to be achieved through education and the knowledge and skills that will be 
expected of newly qualified PAs and AAs. The GMC will also set the standards of care and 
professional behaviour expected of PAs and AAs. All healthcare professionals are required 
to only practise within their competence to ensure they are practising safely, lawfully and 
effectively. Ahead of regulation, the GMC has published advice for doctors who supervise 
PAs and AAs, alongside updating its clinical governance handbook to set out how 
organisations that employ PAs and AAs should ensure appropriate deployment and 
supervision.   

NHS England has produced a central summary and repository of guidance on the 
deployment of PAs and AAs in the NHS. This has been proactively promoted across the 
NHS and to the Royal Colleges, trade unions, regulators, patient groups and the devolved 
nations. This includes role descriptions, expectations on deployment and a core 
capabilities framework, alongside links to a Code of Conduct, GMC guidance on standards 
and a set of principles concerning PAs, released by the Academy of Medical Royal 
Colleges.  

NHS England has an established working group with the Royal Colleges, including the 
Royal College of Physicians and the Royal College of General Practitioners, which is 
supporting the development of guidance for medical associate professions.  With the 
introduction of statutory regulation and the guidance that NHS England has already pulled 
together, the core elements of the national framework will be in place once GMC 
regulation starts.  
NHS England is also considering how to define and develop career pathways for PAs and 
AAs working beyond the initial period of practice. A consultation on a draft Career 

 
 
 
 
 
 
 
 
 
 
 
 Development Framework was conducted earlier this year, and NHS England is now 
determining next steps. The implementation of this framework will allow PAs and AAs to 
develop in their roles and provide clarity for employers on how to safely maximise the 
capabilities of experienced PAs and AAs.  

NHS Employers has also issued guidance for employers, setting out actions for employers 
to take when recruiting and deploying medical associates.  

In relation to the specific competency form you mention relating to the insertion of ascetic 
drains, we note that you have also written to the Faculty of Physician Associates. As the 
form has been developed by them, they will be best placed to respond on this point. 
However, it is worth reiterating that, as set out in NHS England’s guidance on the 
deployment of PAs in the NHS: “PAs must always work within their competencies; and 
must be supervised appropriately. Employers must ensure that the overall responsibility for 
supervision of PAs is by a named senior doctor.” 

You highlight the limited awareness and understanding of the PA role, including the lack of 
a distinct uniform and the use of ‘Physician’ in the title. We agree that more can be done to 
improve awareness of the PA and other associate roles. NHS England has developed a 
communications plan, which will work to improve understanding of the role of PAs and AAs 
across the NHS and the public.  

An important part of being a healthcare professional is ensuring that the people they come 
into contact with understand who they are. All healthcare professionals should follow the 
National Institute for Health and Care Excellence (NICE) guidelines which state that 
healthcare professionals directly involved in a patient's care should introduce themselves 
and explain to their role to the patient. More specifically, useful supportive guidance has 
been published by the Faculty of Physician Associates to help NHS staff and patients 
better understand the PA role. This guidance - Physician associate title and introduction 
guidance for PAs, supervisors, employers and organisations - gives PAs, supervisors, 
employers and organisations a structured and standardised way of using the physician 
associate title. 

We understand from NHS England that there is currently no nationally adhered to uniform 
standard in the NHS for any role. NHS Supply Chain is currently working to introduce a 
nationally standardised approach to uniforms for some clinicians, which is in piloting stage. 
NHS Supply Chain has confirmed that it recognises the potential benefit of developing a 
standardised national approach to uniforms for medical professionals including PAs and 
will engage with these groups in the future.  

I welcome the GMC’s response to your report, which also highlights broader issues around 
clinical governance and the respective responsibilities on others including the consultant in 
charge, the resident doctor and the hospital. NHS England regional colleagues in the 
North West have also been sighted on the report and are undertaking system/local 
assurance in respect of some of the issues arising from this case. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 While the actions I have set out above go some way to respond the significant concerns 
that you and others have raised, I am considering further work in this area and my officials 
will write to you in due course. 

I hope this response is helpful. Thank you for bringing these concerns to my attention.   

Yours sincerely,  

MINISTER OF STATE FOR HEALTH

Faculty of Physician Associates 
Royal College of Physicians 
11 St Andrews Place 
Regent’s Park  
London NW1 4LE 

Joanne Kearsley 
Senior coroner  
HM Coroner for the district of Manchester North 
Newgate House 
Rochdale OL16 1AT 

Ref: 

25 September 2024 

Dear Ms Kearsley 

Faculty of Physician Associates response to Regulation 28 report to prevent future deaths  

The Faculty of Physician Associates (FPA) notes with concern the content of the Regulation 28 report for the 
prevention of future deaths related to the death of Susan Pollitt. 

We send our sincere condolences to her family.  

We note the circumstances of death and factors that you have assessed as contributing to her death. Below 
we address the matters of concern that you have outlined.  

1.  There is no regulatory body with oversight of physician associates. It is understood that this is 

currently the subject of consultation by the General Medical Council. 

We share the concern raised that there is no regulatory body for physician associates (PAs).  

The FPA was established by the Royal College of Physicians (RCP) in 2015. This was to give PAs a professional 
home, set standards and, importantly, oversee the PA Managed Voluntary Register (PAMVR) pending formal 
regulation. It is disappointing that the regulation process has taken so long.  

Since its inception, the FPA has lobbied successive governments for regulation. We have been disappointed by 
several delays to the statutory process, which led to the launch of the #RegulatePAsNow campaign in July 
2022. The initial Department for Health and Social Care consultation that set out the intention to regulate the 
profession was launched back in 2017. We contributed to the latest consultation by the General Medical 
Council (GMC) on how regulation will work in 2024, the outcome of which is yet to be published.  

Regulation is set to come into force on 13 December 2024, with ‘physician associate’ becoming a protected 
title on 13 December 2026. The FPA will close in December 2024, along with the PAMVR, which will remain 
static but searchable until March 2025.  

© Royal College of Physicians 
Registered charity no 210508 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Statutory regulation provides a welcome and overdue assurance for patient safety. When fully implemented, 
all PAs will have to be registered with the GMC to work in line with Good medical practice and be subject to 
fitness to practise procedures. 

2.  The PAMVR held by the FPA is voluntary. While employers are encouraged to check the register, 
there is no duty to do so, nor is it clear how the FPA would be made aware of any concerns 
relating to an individual physician associate. 

This statement highlights why formal regulation is so important. Neither the RCP nor the FPA has regulatory 
powers to mandate registration. In the absence of this, the FPA writes to employers on a regular basis 
reminding them of the existence of the PAMVR and, importantly, of the need to check that a PA is registered 
on the PAMVR before employment, as well as checking at regular intervals during their employment.  

We have also produced a leaflet that explains the PAMVR and can be shared with patients. Student PAs are 
advised that they should apply to the FPA for registration on the PAMVR post-qualification through university 
courses, as well as in FPA regular communications to student members.  

The FPA code of conduct is regularly shared with FPA members. Should an employer, patient or others have a 
complaint about a PA, they can advise the FPA through emailing 
. The FPA website sets 
out the complaints procedure here. Attached is the process to adjudicate complaints. 

3.  There is no national framework as to how physician associates should be trained, supervised and 
deemed competent. This is placing patients, physician associates and their employers at risk. The 
court heard that since the death of Mrs Pollitt, the Northern Care Alliance has put in place a local 
trust framework. Unlike all other clinical roles, there is no national guidance save for very recent 
guidance by the British Medical Association (March 2024) 

The FPA and its members are actively involved in writing PA-related guidance with medical royal colleges, 
academies and specialist societies and we want to help increase understanding of our role. We recognise that 
there are concerns about the lack of a post-qualification national career development and competency 
framework for physician associates. We are working with medical royal colleges and specialist societies as 
they develop their own pathways, including guidance of how PAs can be safely and effectively deployed 
within MDTs.  

The draft PA curriculum sets out guidance on the competencies expected from a newly qualified physician 
associate. This provides higher education institutions (HEIs) across all four UK nations with a standardised 
framework to ensure high-quality education for PA students. It is owned by the FPA and has been aligned to 
the GMC’s generic and shared outcomes for PAs and anaesthesia associates.  

PAs must complete the full university scheme of assessment before being put forward to sit the PA national 
exam (PANE). This national exam will change its name to the PA registration assessment (PARA) once 
regulation with GMC begins. This is mapped to the GMC-approved PARA content map and, prior to this, the 
core conditions framework. This assures competency at the point of qualification.  

Once a PA has passed the PANE (or, from 2025, the PARA), PAs, employers and clinical supervisors will be 
required to follow local policy and guidelines for PA training. The scope of practice of a PA is currently agreed 
on an individual basis.  

 
 
 
 
 
 
 
 
 
 
 The FPA believes that there should also be a national approach to creating a comprehensive framework. This 
would support employers and PAs, with specific emphasis on the role of the clinical supervisor, annual 
appraisal and routes of escalation if there are concerns about practice.  

4.  There remains limited understanding and awareness of the role of physician associates among 
medical colleagues, patients and their families. The lack of a distinct uniform and the title 
‘physician’ gives rise to confusion as to whether the practitioner is a doctor. 

We agree that there should be a national public and patient information campaign to create better awareness 
of the PA role. We will continue to work with other stakeholders, including the RCP Patient and Carer Network 
(PCN), to improve how we communicate the role and responsibilities of PAs. We welcome the opportunity to 
work collaboratively with others on this.  

In October 2023, the FPA published titles and introduction guidance for PAs, supervisors, employers and 
organisations. The guidance was drawn up with a multi-professional panel of stakeholders, including 
representation from the RCP PCN, to clarify the role of a PA within a multidisciplinary team. The aim is to 
ensure appropriate introductions to patients and explanation of the role, particularly highlighting that PAs are 
not doctors. We recognise that there is a continued need to inform the public, healthcare services and the 
clinical professions on the role and remit of physician associates.  

We acknowledge the lack of a distinct uniform. The medical associate professions were excluded from the 
National Healthcare Uniform Programme, and we would strongly support their inclusion in the future. We 
advise employers that distinct name badges with role are important, as well as consideration in local uniform 
policies. 

5. 

In June 2022, the physician associate had been signed off as competent for the insertion of ascitic 
drains. This sign-off was completed by a liver nurse specialist using a competency form which was 
provided by the FPA. While the competency form assessed the technical aspect of placing the 
drain, it did not include competency around the wider aspects of care such as taking consent risk 
factors and aftercare. 

There is currently no national framework for post-qualification competencies (including procedures). PAs 
increase their clinical skills and competencies post-qualification similarly to other healthcare professionals. 
The FPA e-Portfolio was launched in October 2023 for qualified PAs and uses workplace-based assessment 
(WBPA) or supervised learning event (SLE) forms. This also includes Direct Observation of Procedural Skills 
(DOPS) forms, which were first made available to FPA members in October 2021.  

Clinicians supervising a DOPS need to be competent in the procedural skill that is being assessed, and the 
associated management including consent and aftercare. A key component of a DOPS is the wider aspects of 
the procedure as shown in the attached document. It is important that the assessor is agreed by the clinical 
supervisor and has the appropriate knowledge and skills, including the wider aspects that you have noted. 
This should be emphasised to the supervising senior doctor. In addition, continued assurance as part of 
appraisal is required. We will review the DOPS form to see whether it can be enhanced, and we will take on 
board what has been raised by your report.  

 
 
 
 
 
 
 
 
 The FPA and any successor professional body for PAs will continue to work with the GMC, the NHS, specialist 
societies, royal colleges and other stakeholders to ensure that the practice and supervision of physician 
associates, as part of the multidisciplinary team, are safe.  

We hope that these explanations clarify the areas you have raised. We have highlighted where we are taking 
action and where we think action is required, including our support for a national approach to setting 
competencies and career development for PAs.  

Once again, our thoughts are with the family of Susan Pollitt, and we wish to share our sincere condolences 
with them. We will continue to work with our members and other stakeholders to make sure that the role of 
PAs within the multidisciplinary team is clear to our colleagues and the wider public.  

With best wishes, 

President  
Faculty of Physician Associates

20 September 2024 

Ms Joanne Kearsley 

HM Senior Coroner 

Greater Manchester North 

Sent by email: 

Dear Ms Kearsley 

Regulation 28: Report to Prevent Future Deaths (ref: 

)  

Thank you for your letter of 31 July 2024 enclosing your report into the death of Mrs Susan Pollitt. I am 
very sorry to hear of the tragic circumstances surrounding Mrs Pollitt’s death and I extend my condolences 
to her family and friends. I am responding as the Medical Director and Director of Education and Standards 
at the GMC.  

I have considered your report and the concerns it raises about the treatment Mrs Pollitt received at the 
Royal Oldham Hospital (ROH). The absence of statutory regulation of physician associates (PAs) may have 
contributed to the circumstances of her death.  Regulation by the GMC, which will begin at the end of this 
year, should help address several of the issues you have highlighted. This should, in turn, bring benefits 
for patients, patient safety, PAs themselves and those that employ and work alongside them.   

However,  based  on  your  report,  there  appear  to  be  wider  concerns  about  the  clinical  governance 
arrangements  at  the  Trust  including  the  roles,  supervision  and  relevant  policies  supporting  the  use  of 
ascitic drains and the deployment of PAs.  I will return to this at the end of my response. 

Lack of a regulatory body with oversight of PAs  

The  GMC  agrees  that  statutory  professional  regulation  of  healthcare  professionals  involved  in  the 
treatment of patients better protects the public. PAs are not subject to such regulation at the moment 
but, as you note in your letter, the GMC will become the regulator of PAs and anaesthesia associates (AAs) 
in December this year. 

I thought it would be helpful to outline the history of how the GMC was chosen to be the regulator of 
these professions, the work that we have done thus far to prepare for regulation and the next steps before 
we begin regulating PAs later this year.  

The GMC is a charity registered in England and Wales (1089278) and Scotland (SC037750). 
You are welcome to contact us in Welsh. We will respond in Welsh, without this causing additional delay. 

 
 
 
 
 
 
 In 2017, the Department of Health and Social Care (DHSC) consulted on which healthcare regulator would 
be most suitable to regulate one, some, or all the medical associate professions, which include PAs and 
AAs. Surgical care practitioners are the third profession in this group but are not included in those we will 
regulate. Following the consultation, the Government determined the GMC was most appropriate and 
formally asked us to take on the regulation of PAs and AAs which we agreed to do.  The UK and Scottish 
parliaments approved the legislation (Anaesthesia Associates and Physician Associates Order 2024) earlier 
this year and it has been granted Royal Assent. This means the GMC will become the regulator of PAs and 
AAs  from  December 2024  and, from  December 2026, they  will have  protected titles  in  law  (‘Physician 
Associate’ and ‘Anaesthesia Associate’). 

Regulation  will  bring  many  benefits  and  make  an  important  contribution  to  assuring  patients  and 
employers that PAs are safe to practise and can be held to account if serious concerns are raised about 
their  conduct  or  performance.  PAs  are  part  of  the  multi-disciplinary  team  and  make  decisions  about 
patient care affecting diagnosis and treatment. Although they work in regulated healthcare settings and 
must be supervised by a registered and licensed doctor, at present there aren’t any profession-specific 
mandatory  standards  for  their  pre-qualification  education,  training  or  conduct.  Nor  is  there  any 
professional accountability to a statutory body if their practice raises concerns that would warrant some 
action, and certainly not on a legally enforceable basis.   

Once  regulation  by  the  GMC  is  fully  in  force,  PAs  will  need  to  be  registered  with  us  and  they  will  be 
required to adhere to Good medical practice, our core set of professional standards that all our registrants 
(which currently only includes doctors) are expected to follow. Regulation allows us to take action in the 
event that an individual registered with us falls significantly below the standards we set and poses a risk 
to the public or public confidence. 

We recently consulted on the rules, standards and guidance needed to implement  the legislation that 
gives us the power to regulate PAs and we’re now considering the responses so that we can finalise our 
approach. Once regulation begins, we will have powers to:  

⚫ 

⚫ 

⚫ 

Set the standards of patient care and professional behaviours PAs need to meet. 

Set  the  outcomes  and  standards  that  students  qualifying  from  PA  courses  must  meet  to  achieve 
registration, and approve the curricula that courses must deliver. 

Set a two-part assessment of clinical knowledge and skills that a PA needs to pass before registration. 

⚫  Check  who  is  eligible  to  work  as  a  PA  in  the  UK  and  that  they  continue  to  meet  the  professional 

standards we set throughout their careers. 

⚫  Give guidance and advice to help PAs understand what’s expected of them. 

⚫ 

Investigate where there are concerns that patient safety, or the public’s confidence in PAs, may be at 
risk, and take action if needed. 

gmc-uk.org                                                                                                                                                                                                   2 

 
 
 
 In summary, we agree that the current lack of a regulatory body for PAs represents a risk to patient safety 
and believe the concerns raised in your report will be addressed once the GMC takes on this role. 

Existing voluntary register  

The existence of a managed voluntary register offers some assurance to employers that PAs have passed 
a national exam designed, set and delivered by the Royal College of Physicians of London.  However, it 
cannot assure the quality of the course they have studied, the outcomes they have achieved, or the clinical 
experience they gained during their studies. That is why we, the Faculty of Physician Associates (FPA) and 
many system partners welcome the introduction of a statutory register of PAs from December 2024. 

We anticipate that employers will make GMC registration a condition for their PAs in the same way as 
they have done up to now in relation to voluntary registration. Although GMC registration doesn’t become 
a  legal  requirement  for  practice  until  December  2026,  we  will  strongly  encourage  all  PAs  to  join  our 
register as soon as possible.  

I will leave it to the FPA to explain how they currently deal with concerns raised about a member of their 
voluntary register. The GMC currently has no power to investigate concerns raised about PAs as they are 
not yet regulated by us, and we have no role in determining the investigatory and disciplinary processes 
of the FPA. However, we can and will look at any outstanding concerns about an individual PA’s fitness to 
practise when considering their application for registration with us from December this year.  

It is also worth noting that, irrespective of whether a healthcare profession is regulated, each NHS trust 
has a duty to provide safe care to patients, and they also have a responsibility to ensure that standards 
are monitored and maintained. 

Guidance on training, supervision and assessing competence 

The issue of a perceived lack of national guidance surrounding the safe deployment of PAs has been raised 
in  recent  months.  Several  organisations  have  been  working  to  develop  guidance  appropriate  to  their 
specialty or responsibility. 

For example, NHS England has issued guidance to NHS Trusts and primary care providers in England on 
the safe and effective integration of PAs into departmental teams and GP practices respectively. It may 
also  be  helpful  to  see  NHS  England’s  supervision  guidance  for  primary  care  network  multidisciplinary 
teams,  which  sets  out  in  some  detail  the  key  principles  for  effective  supervision  within  GP  practices, 
including how to meet the regulatory requirements set by the Care Quality Commission (CQC). For their 
part, the CQC has also recently issued  guidance on supervising and overseeing PAs in general practice, 
and Health Education England’s Core Capabilities Framework for Medical Associate Professionals has been 
in place since 2022. 

We have also published our own advice for doctors who supervise PAs, and earlier this year we updated 
our clinical governance handbook to set out our expectation that organisations who employ PAs should 
make appropriate arrangements for their deployment and supervision. 

gmc-uk.org                                                                                                                                                                                                   3 

 
 
 
 Regarding PA education and training - once regulation begins in December 2024, we’ll have powers to set 
the standards for course providers and regularly check that they’re being met. We have already published 
a  range  of  guidance  to  support PAs  student  PAs and  course  providers  pending the  implementation  of 
regulation. From December 2024 we will be able to formally approve courses and curricula to ensure that 
PAs will have the clinical knowledge and skills needed to work safely once they qualify.  

In preparation for the start of regulation we have already asked course providers to update their courses, 
including their syllabus and assessments, using the relevant curriculum as a guide, and we are checking 
that this has been done through our education quality assurance process. We are also finalising updated 
guidance for PA students on professional standards and the process for approving PA curricula. 

Finally, we have been supporting the work that individual  royal colleges, and the Academy of  Medical 
Royal Colleges, are currently leading on developing a range of guidance on supervision and how PAs can 
safely develop their skills and competencies over time once they have qualified and registered with us. 
The Royal College of Physicians is currently consulting on their guidance and the Royal College of General 
Practitioners  plans  to  do  so  shortly.  We  are  also  encouraging  colleges,  NHS  employers  and  others  to 
ensure  that  all  guidance  being  produced  is  aligned  and  consistent  so  as  not  to  cause  confusion  for 
employers, supervisors or PAs themselves. 

Limited understanding and awareness of the PA role 

We agree it is vital that patients must always be clear about who is treating them and their role within the 
team. While PAs have been part of the UK healthcare workforce for around 20 years, the numbers are 
relatively  small,  so  it  is  even  more  important  that  they  are  always  clear  about  their  roles  and 
responsibilities with the patients they treat. 

Once again, regulation will be helpful in this context. Our professional standards say that PAs will have a 
responsibility to clearly communicate who they are and their role in the team, just as doctors must do 
now.  

In March this year we also announced that we would implement an alphabetical prefix for PA and AA GMC 
reference numbers and ensure the prominent labelling of profession type on our public-facing registers. 
This means that in future when patients search our registers it will be very clear whether an individual is 
a doctor, a PA or an AA not only because of the use of a prefix for PAs and AAs but also because the face 
of the register will actually spell out in full the professional title of each individual (‘Doctor’, ‘Physician 
Associate’, ‘Anaesthesia Associate’). 

The FPA also has guidance on ‘titles and introduction’ which provides a standardised way of using the PA 
title and highlights the importance of explaining it to patients and colleagues. 

The issue you raise about the need for distinct uniforms to help patients distinguish between professionals 
is for the NHS and employers to address.   

gmc-uk.org                                                                                                                                                                                                   4 

 
 
 
 
 Clinical governance 

Regulation is an important part of patient safety, but it alone cannot prevent future deaths. Good clinical 
governance  by  healthcare  providers  remains  the  most  important  factor.  Your  report  raises  significant 
questions that cannot be answered by those to whom the report is currently addressed, and are better 
explained by the trust:  

⚫  How was it possible for a junior doctor to decide a drain was required after the consultants had 

deemed it not to be required? 

⚫  Why was it decided Mrs Pollitt should remain on a respiratory ward (where likely there was little or 
no experience of managing the drain or of the nursing care required), rather than moved to a 
gastroenterology ward? 

⚫  How was the decision made to delegate this task to the PA without seeming to assess the 

competence of the PA or give clear instructions as to how it should be managed once inserted (i.e., 
not clamped and only left in situ for six hours)? 

⚫  What is the local policy for the use of ascitic drains that would address the above? 

⚫  What was the role of the consultant in overseeing the overall care of Mrs Pollitt? 

The FPA will be able to explain the purpose and intended usage of the competency form that was used 
to assess the skills of the PA in this case.  

We are pleased to note from your report that the NCA has put a local trust framework in place and will 
be  writing  to  them  to  request  sight  of  this  document  and  seek  our  own  assurances  around  clinical 
governance at the ROH. 

Thank you for the opportunity to comment on this report. I hope this information provides reassurance 
around the work we are doing to bring PAs into regulation. We hope that work, along with action from 
others, will help ensure a similar incident does not happen again. 

Yours sincerely 

Medical Director and Director of Education and Standards  
General Medical Council 

cc. 

, Secretary of State for Health and Social Care 
, DHSC 

and 

, President, FPA 

gmc-uk.org                                                                                                                                                                                                   5

Joanne Kearsley 
Senior coroner  
HM Coroner for the district of Manchester North 
Newgate House 
Rochdale OL16 1AT 

Ref: 

25 September 2024 

Dear Ms Kearsley 

Royal College of Physicians response to Regulation 28 report to prevent future deaths  

The Royal College of Physicians (RCP) notes with concern the content of the Regulation 28 
report for the prevention of future deaths related to the death of Susan Pollitt. 

We send our sincere condolences to the family of Susan Pollitt.  

The Regulation 28 report is addressed to the president of the Faculty of Physician Associates 
(FPA). The FPA is a managed faculty of the RCP. Considerable work is required to enhance the 
safety of the deployment of physician associates (PAs) as part of multidisciplinary teams. We 
therefore believe it is helpful that the RCP also submit a response to this report.  

Many of our fellows and members have significant concerns about the safe deployment of 
PAs, especially concerning regulation, scope of practice and supervision. The RCP held an 
extraordinary general meeting (EGM) to debate issues relating to PAs in March 2024.  

Following a vote of the RCP fellowship, the RCP is now calling for a limit in the pace and scale 
of the roll-out of PAs. We have called on NHS England to review its projections for growth for 
the PA role as set out in the 2023 NHSE Long Term Workforce Plan. 

The RCP also established a short life working group (SLWG) to make recommendations to RCP 
Council for how the EGM motions would be implemented. This group reported in May 2024. 
All recommendations are on track to be delivered by the end of the year. The RCP has now 
set up an oversight group for activity related to PAs (PA oversight group, or PAOG).  

To ensure that the PA workforce is able to contribute to patient care actively and safely, the 
RCP believes that considerable changes need to be made. This will require time, commitment, 
coordination, transparency, and above all, collaboration between the NHS, patient groups, 
royal colleges, the GMC, and medical associate professionals, including PAs. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Matters of concern and the RCP response 

1.  There is no regulatory body with oversight of physician associates. It is understood 
that this is currently the subject of a consultation by the General Medical Council. 

In the interests of patient safety, the RCP has campaigned for over 5 years for the regulation 
of PAs. It has been a long and unpredictable journey that will finally see the majority of 
regulatory provisions come into force in December 2024.  

, who is acting as RCP president, and 

, chair of the PAOG, 
continue to meet regularly with the GMC. We have written to NHS England to ask whether 
they intend to review the projections for growth in the PA workforce. Both the GMC and NHS 
England will attend an RCP Council meeting in November 2024 to discuss the post-regulation 
landscape for PAs.  

We responded to the GMC consultation on the regulation of PAs earlier this year, raising 
concerns around the content of the curricula for PA and anaesthesia associate (AA) 
postgraduate studies, issues around prescribing and medicines safety, the capacity of 
supervisors, and the impact of the PA role on training opportunities for resident doctors.  

We understand that the GMC believes that further development of scope of practice should 
be determined locally. The RCP disagrees. Scope of practice for PAs (and the obligations of 
supervisors to maintain within scope of practice working) should be determined nationally to 
reduce variation and enhance patient safety.  

This is key, and a widespread concern within the medical profession. It must be addressed to 
enable the PA workforce to work safely and successfully. 

2.  The Physicians Associate Managed Voluntary Register (PAMVR) held by the Faculty 
of Physician Associates (FPA) is voluntary. While employers are encouraged to check 
the register, there is no duty to do so, nor is it clear how the FPA would be made 
aware of any concerns relating to an individual physician associate. 

The response of the FPA is noted.  

The RCP has confirmed that the FPA will close in December, along with the PAMVR. The initial 
transfer of PAMVR data from the RCP to the GMC will begin on 31 October 2024. The GMC 
register will open on 13 December 2024, when regulation begins, but will continue to be 
voluntary for the first two years. The PAMVR will remain static, but searchable, until 31 
March 2025 when it will be closed. 

The post-EGM SLWG noted that the RCP is not, and has never been, a regulatory body. 
Holding the PAMVR has contributed to patient safety while the campaign for regulation was 
ongoing. The GMC starts regulation in December 2024 and there will be a transition period of 
two years while PAs join the register. From December 2026, it will become an offence to 
practise as a PA in the UK without being registered with the GMC. 

The FPA has written to all its members to update them with this information and to clarify 
that all PAs should move onto the GMC register as soon as possible.  

 
 
 
 
 
 
 
 
 
 
 
 
 3.  There is no national framework as to how physician associates should be trained, 
supervised and deemed competent. This is placing patients, physician associates 
and their employers at risk. The court heard that since the death of Mrs Pollitt, the 
Northern Care Alliance has put in place a local trust framework. Unlike all other 
clinical roles, there is no national guidance save for very recent guidance issued by 
the British Medical Association (March 2024). 

The RCP agrees with this concern.  

The RCP is developing draft guidance on safe and effective practice for employing PAs. The 
college recently carried out an external stakeholder consultation on the first draft of this 
guidance. Work is now taking place to review the consultation feedback, refresh the draft 
guidance, consider how fellows and members should be consulted, and take the final 
guidance to RCP Council for sign-off and publication by the end of 2024.  

The draft guidance is clear that only consultants, GPs, specialist or associate specialist doctors 
should be the named clinical supervisors of PAs. PAs should always clearly explain their role 
to patients, colleagues and supervisors; and they should progress within a scope of practice, 
following a nationally defined pathway with training and competency assessments agreed 
beforehand. 

Failings in scope of practice and supervision were important factors in the death of Susan 
Pollitt. The RCP is very concerned that capacity among senior doctor supervisors is extremely 
stretched and the effective implementation of guidance on supervision will be very difficult. 
The supervision of PAs must not be at the expense of the supervision of doctors.  

The PAOG is also hosting an online roundtable with other royal colleges, faculties and 
specialist societies to discuss next steps on developing a clinical scope of practice for PAs. 
This will have a specific focus on medical teams and the physicianly specialties.  

A comprehensive, national, safe and clear scope of clinical practice for PAs is essential. 
However, we note the following:  

>  There is insufficient central coordination or agreement within the NHS and among 
employers on how a national scope of practice should be developed and by whom.  

>  There is limited awareness of what a PA can safely do in a clinical setting upon 

completion of PA studies and no agreed mechanism for extended clinical practice.  
>  PAs are employed in a very wide range of clinical settings and specialties, and within 

both the NHS and private healthcare settings. 

System leaders, including the GMC, should take a leading role in developing and overseeing a 
national scope of practice for PAs. The RCP is strongly supportive of multidisciplinary 
working, but this must be supported by full regulation and competency assessment. We 
therefore strongly believe that a national framework for the employment and deployment of 
PAs is now required, with the understanding that national policy and guidance must be 
understood and delivered locally supported by good governance structures, including raising 
concerns.  

 
 
 
 
 
 
 
 
 
 
 4.  There remains limited understanding and awareness of the role of a physician 
associate among medical colleagues, patients and their families. The lack of a 
distinct uniform and the title ‘physician’ gives rise to confusion as to whether the 
practitioner is a doctor. 

The RCP recognises this concern. We acknowledge that there remains limited understanding 
of the role of PAs. This is supported by research from patient organisations, including 
HealthWatch England, which has found that only around half of patients (52%) in one survey 
agreed or strongly agreed that they ‘understood the difference between a physician 
associate and a doctor’.  

In October 2023, the FPA published titles and introduction guidance which makes it clear that 
PAs are not doctors, and that PAs should introduce themselves clearly and with a full 
explanation about their role in the healthcare team. The RCP was supportive of this guidance, 
which was disseminated widely to stakeholders.  

Working with our fellows and members, the RCP will continue to actively campaign to limit 
the pace and scale of roll-out of PAs in the NHS until we are reassured that there are safe 
systems in place for PA deployment. We have repeatedly made clear that PAs are not 
doctors, and they cannot and must not replace doctors. We have also called on the UK 
government and the NHS to develop and publish an evidence base and evaluation framework 
around the introduction of PAs. This should be a priority, and we are working with the RCP 
Patient Safety Committee to consider what more we can do to support this agenda.  

5.  In June 2022 the Physician Associate had been signed off as competent for the 
insertion of ascitic drains. This sign off was completed by a liver nurse specialist 
using a competency form which was provided by the FPA. Whilst the competency 
form assessed the technical aspect of placing the drain, it did not include 
competency around the wider aspects of care such as taking consent risk factors 
and after care. 

The RCP agrees with this concern.  

To be able to perform a procedure safely, the healthcare professional should be able to 
demonstrate the required knowledge and skills around the procedure (‘technical skills’) and 
non-technical skills. Non-technical skills are a combination of cognitive and social skills, 
demonstrated by individuals and teams to reduce risk, error, harm and improve human 
performance in complex systems. Those skills involve decision making, situational awareness, 
teamworking, leadership, perception of risk, escalation and communication including 
consent. The perception, comprehension and projection of technical and non-technical skills 
is key to patient safety at individual and team level of the healthcare team. 

The competency of any healthcare professional to undertake a procedure should be signed 
off by a competent supervisor who is able to make assessments of these skills.  

The competency form did not adequately take into account wider aspects of care, and there 
is currently no national framework for post-qualification competencies for PAs (including 
procedures).  

 
 
 
 
 
 
 
 
 
 
 This is why the RCP will continue to campaign for a limit to the pace and scale of roll-out of 
PAs in the NHS until we are reassured that there are safe systems in place for PA deployment.  

With best wishes, 

Clinical vice president  
Royal College of Physicians