David Benton - Contrasting regulatory models to promote best practices in
regulatory governance and performance
Hazel Bradley - Shared competencies between different health professions in an emerging health system
Jonh Chave - European responses to challenges facing health professional regulation
Niall Dickson - Reform of health professional regulation in the United Kingdom
Gilles Dussault - Challenges facing health professional regulation
Rhona Flin - Safe in their hands? Non-technical skills and competence assessment
André Gariépy - Competence-based approaches and professional regulation: a balancing act
Margaret Mungherera - Key challenges and experiences of health practitioner regulation in Africa, evolving scopes of practice and inter-professional collaboration
Ayala Parag - Regulatory Models: The Israel Experience
Annabel Seebohm - The impact of standardisation initiatives in Europe and global lessons for health professional regulation
Una Reid - Experience of approaches to measuring and regulating safety and quality of practice – challenges and successes
Chris Robertson - Reflections on the first three years of national regulation in Australia and future directions
Contrasting regulatory models to promote best practices in regulatory governance and performance
This paper will provide a high level synopsis of various part of a
research study that was undertaken to examine an international
comparative analysis of nurse regulatory models. The full study
- current trends and issues in regulation and how they can be
viewed from an opens systems perspective;
- the principles underpinning nurse regulation and contrasted
these with those used in other sectors such as finance and
- the development of a set of performance measures and
sought to illicit which of a range of models were best suited
to producing high performance across the measures; and
- the structure of legislation and to what extent this varied
based upon a set of features such as the legal tradition of the
jurisdiction, the model of regulation being used, the gross
national income category of the jurisdiction and the region of
This paper will highlight that differences in legislative structure
do exist. Many of the terms used within legislative acts are
poorly defined and vary in their definition from one jurisdiction
to the next.
In terms of measuring the performance of regulatory bodies
there are four major domains - legislation advocacy and
responsiveness - organisational and internal governance
- external governance and public accountability - and
responsibilities and functions.
That whilst there is an opinion that a stand-alone delegated
self-regulatory model delivers best results and that the small
amount of existing research evidence available does tend to
support this there is a need for more quantitative studies.
Shared competencies between different health professions in an emerging health system
South Africa is an emerging economy which has undergone
significant changes since the first democratic elections in
1994. The government health system, serving 85% of the
population, has reformed from a fragmented, hospi-centric
service to a primary health care approach based on the district
health system. This reform involved the establishment of
health districts and the appointment of a new level of health
managers, mostly health professionals, working at district level.
Recent initiatives have re-focussed energies on primary health
care and improving universal health coverage in a manner that
would have significant implications for the government and the
private health sectors.
In South Africa, the education and practice of human resources
for health are highly regulated by professional councils and
adapting to changing health system requirements and an
increasing disease burden is a priority. However, in line with
other countries, ensuring a sufficient and equitable distribution
of health workers throughout the country remains a challenge.
I used a participatory action research approach to explore the
emergence of district pharmacists, members of the district
management team, in Cape Town, by considering their roles
and related competencies. Partnering with a broad stakeholder
group comprising pharmacists and managers was considered
critical to developing shared learning and understanding that
would translate into action and change in the organisations.
My research identified five competency clusters for district
pharmacists, each with several competencies:
- professional pharmacy practice
- health systems and public health
- personal, interpersonal and cognitive.
Whilst professional pharmacy practice competencies
were valued, overall generic management and leadership
competencies, both technical and “softer” relational
competencies, were considered critical by managers and
pharmacists. Other health systems research carried out in South
Africa over the past few years identified similar competencies
for managers working at senior and middle management levels
and points to the need for health professionals to develop
generic competencies in management and leadership. In
response, several initiatives have been launched in the country
to facilitate the development of these competencies.
European responses to challenges facing health professional regulation
My presentation will focus on recent developments in relation
to professional regulation in Europe, in particular professional
regulation and the European internal market. It will cover the
approach of the European Commission to regulation, including
initiatives to challenge the level of professional regulation,
and the recent Directive on the Recognition of Professional
Qualifications (including the European Professional Card, alert
mechanisms, and language testing).
Finally the presentation will set out a vision of how professional
regulation can be reconciled with the need to increase access
to health services, but also to ensure that appropriate levels of
quality are maintained.
Reform of health professional regulation in the United Kingdom
Professional regulation in the UK has undergone something
of a revolution over the last 10-15 years. The General Medical
Council (GMC) has changed substantially over this period:
- it has moved from self-regulation to an independent model
of regulation, free of government intervention and directly
accountable to parliament
- the size of its council has significantly reduced from 104 to
just 12 members (half medical, half lay)
- from being dominated by the medical profession, the GMC
now works in partnership with patients and doctors. Patient
safety is its core focus
- the GMC’s adjudication function was separated from the rest
of the organisation into the Medical Practitioners Tribunal
- revalidation for all doctors was introduced in 2012 and has
now been operating for over a year.
These changes have been the result of a number of external
factors, not least the health care scandals that have arisen over
the years such as the Bristol Heart inquiry. As a result of the
Francis Report, following the independent inquiry into Mid
Staffordshire hospital, the issues of accountability and trust are
once again at the forefront of health care regulation in the UK.
The time is right for reform and the Law Commission Bill in
the UK is the vehicle for many of the legislative and regulatory
improvements the GMC is calling for. The Bill seeks to bring
together the disparate pieces of legislation that currently
underpin the activities of the nine separate professional health
care regulators in the UK into one overarching and simplified
Act. If the Bill is passed, health professional regulation in the UK
could look very different in the future.
The UK is not the only jurisdiction considering reform. From a
brief survey of a number of international regulators (including
New Zealand, Australia, Hong Kong, Singapore, Dubai, USA and
Abu Dhabi) it is clear that, despite their differing health care
models and contrasting political and cultural environments, the
appetite for regulatory reform is strong.
Challenges facing health professional regulation
There are many pressures on health professions at the moment,
and they have to decide how to react to them. Among these
pressures are the calls to adapt the education and training of
professionals as needs and demands of populations change.
There are also demands to become more efficient and to
keep up with organizational and technology advances. The
increased mobility of professionals and of consumers of services
also means that there is a growing need for regulation to
address issues of harmonization of qualifications, and of legal
responsibility. Above all, there will an increasing pressure to
provide equitable access to services to all people: this implies
the education, employment and retention of sufficient numbers
of professionals of the kind which correspond to the needs of
populations; that these professionals are accessible to all who
need their services and that their work meets professional
quality standards and expectations of users.
Professional organizations can just wait and see how the
environment will evolve and react in a piecemeal manner, they
can try to resist the changes, or they can take the lead and
respond before having new regulations imposed on them.
I will argue that health professional organizations would do
better to take the lead in building effective regulatory systems,
as an essential means of gaining and maintaining the trust of
patients, which is the foundation of professional development.
Safe in their hands? Non-technical skills and competence assessment
Many safety-critical tasks are characterised by teams of workers
dealing with significant risks, time pressure and increasingly
complex technology. In these domains, practitioners need both
technical and non-technical skills. The term non-technical skills
comes from European aviation and they can be defined as ‘the
cognitive, social and personal resource skills that complement
technical skills, and contribute to safe and efficient task
performance’. They are not new or mysterious skills but are
essentially what the best practitioners do in order to achieve
consistently high performance: the skills include situation
awareness, decision making, team work and leadership. There
are now methods for training and rating the non-technical
skills of surgeons (NOTSS) and anaesthetists (ANTS), with
applications being developed for other clinical specialists. In
this presentation, I will briefly outline the non-technical skills
approach and explain how this is now part of competence
assessment for a number of occupations, such as airline pilots.
I will then consider the practical and professional issues of
assessing non-technical, as well as technical skills, for the health
Competence-based approaches and professional regulation: a balancing act
This presentation will talk about the current context in the
regulatory world and the potential pitfalls of the competencebased
approaches. It will project the perspective of a
government oversight entity, specialized in the recognition of
professional competence by regulatory bodies.
Health professions are regulated for public safety and the
quality of services. The regulation schemes would set entryto-
practice requirements. In light of potentially competing
interests, a balancing act has to occur, generally under the
supervision and authority of governments and legislatures.
Governments have become more involved in the public
interest debate with regards to regulated professions and
their entry-to-practice requirements. They have committed
to more liberalisation of trade in services, translated in more
mobility and better qualification recognition for foreign trained
New policies and oversight mechanisms are being put in place
to insure that requirements are relevant and necessary for
protecting the public, that they are reasonable and applied in a
fair way. In some cases, self-governance has been removed from
the regulatory scheme.
The development of competence-based approaches
has brought a new and valuable understanding of the
knowledge and skills needed to practise a profession. These
approaches provide for an apparent precision, transparency,
comprehensiveness, and coherence. They could allow for a
reasonable comparison of competency profiles internationally.
Despite their positive features, the competence-based
approaches have not eased the delicate balancing act of
defining a profession and setting the bar for entry-to-practice
requirements, all in the public interest. On some aspects, they
have created new areas of concerns around the justification and
the fairness of the requirements and the assessment process
based on them.
Key challenges and experiences of health practitioner regulation in Africa, evolving scopes of practice and inter-professional collaboration
Key challenges for regulation of health professionals in Africa include the perception of governments about professional autonomy, clinical independence and self regulation of the health professions. Strategies to address these challenges include establishing an enabling legal framework, creating structures that ensure efficient decentralised functions supported by sufficient resources, and continued efforts to ensure all health professionals have an in-depth understanding of their ethical obligations and their rights to professional autonomy and clinical independence.
Evolving scopes of practice of health professionals and interprofessional collaboration in African countries also create regulatory challenges. Strengthening health systems is one means to achieve Universal Health Care and efforts to improve health human resources in African countries are increasingly targeted at the primary health care level. This presentation will explore some of the features of this context including provision of effective health care across diversity of primary health care problems and in situations of armed conflict.
Migration within the African continent and especially across borders creates a huge challenge for regulation but this can be addressed, at least in part, by regional collaboration. This presentation will provide an example of a regional interprofessional collaborative initiative.
Many other regulatory related challenges need to be addressed to ensure a sustainable and effective health system in Africa such as:
- the selection of students into health training schools
- curriculum issues especially around the teaching of clinical ethics
- ensuring health professionals remain competent through access to CPD - especially for health professionals in remote and rural areas.
Regulatory Models: The Israel Experience
History and Background:
Up until 2003 in Israel, only foreign graduates of professional education programs not recognized by the Ministry of Health were required to write a theoretical and practical government exam. From 2003 onward, all foreign graduates who studied in recognized graduate programs (Bachelor of Physical Therapy) were allowed to write the government exam. However, graduates of Israeli universities were not required to write the government exam, since the education process was deemed adequate. As part of the professional recognition process prior to being able to practise, the Ministry of Health provided all physiotherapists who met the government requirements, either by virtue of studying in an Israeli university or by passing the government exam, with a Certificate of Recognition of Professional Standing.
In July 2005, following a High Court Appeal, the Ministry was barred from providing the Certificate of Recognition of Professional Standing to both graduates of Israeli universities and foreign graduates. The period between July 2005 and July 2008 was devoid of regulation.
In July 2008, the Health Professions Act was passed. The Act provided a level playing field for all physical therapists. Under the Act, both graduates of Israeli universities and foreign graduates must all pass a professional government licensing exam. Essentially the Act provides “protection of title” and defines conditions for recognition of physical therapy graduates. These are outlined below. Physical therapy graduates who are recognized under the Act must pass a government exam in order to receive a professional certificate from the Ministry of Health. This certificate allows them to practice as physical therapists and to be employed as such.
Regulation in context - needs of Israeli Society and the future:
The number of physical therapists per capita in Israel is similar to that of other western countries – approximately 0.5 per 1000 people. There is a sense that the number of graduates per year greatly exceeds Israel’s needs. Certainly, at present there is a dearth of available jobs for physical therapists in the public sector. The demand for services is expected to grow with the aging of the population. In addition, the public healthcare system, will be forced to change in order to meet future challenges in service provision and remain sustainable, provide good quality of services and achieve good health outcomes for an aging population. However, these changes will not necessarily impact on the challenge in the regulation context. These challenges will remain, and include limitations created by the Act such as only Israeli citizens or those of permanent resident status are permitted to write the government exam and there is no recognition of foreign graduates without a Bachelor of Physical Therapy degree or graduates of programs that do not meet the educational level specified in the Act (minimum level of Bachelor of Physical Therapy). It is illegal to practice as a physical therapist in Israel without the professional certificate from the Ministry of Health. Unless Israel encounters an unexpected and sudden rise in the demand for services, it is questionable whether the Israeli government will be driven to make changes in legislation to accommodate foreign graduates.
The impact of standardisation initiatives in Europe and global lessons for health professional regulation
Current initiatives by the European Union affect health
professional regulation in several ways. The scene will be set by
explaining the European Union mandates in health care and
the internal market in order to understand the European Union
competencies according to the Treaty of Lisbon. Thereafter,
the European Union action shall respect the responsibilities
of Member States for the definition of their health policy and
for the organization and delivery of health services and health
care. The exercise of the health professions, along with all the
rules and regulations, which apply to their activities affects
the organization of health services and health care and is
therefore Member States` responsibility. Nevertheless, specific
examples show that health professional regulation is and will
be highly influenced by European Union initiatives. The focus
of the presentation will be on current standardisation initiatives
by the European Committee of Standardisation (CEN) in the
area of health services and its impact on health professional
regulation. A brief excursion on the role of international trade
agreements will hint at a potential international dimension of
Experience of approaches to measuring and regulating safety and quality of practice – challenges and successes
The government-sanctioned self-regulatory frameworks
or Councils under the Ministry of Health, mandated with
regulating the health professions in the interest of public
protection in Jamaica, with reference to the wider Caribbean is
All Councils share a similar focus, regulatory process,
governance and management structures.
Pathways to the registers differ and include Council
examination; educational institution examination; and
educational institution examination and internship endorsed
by the Council. Applicants must satisfy the Councils they are
competent and safe to practise in their respective scopes of
The indicators for measuring and regulating the safety and
quality of practice are: a) accreditation of the responsible
educational institutions; b) accreditation of programmes; c)
a registration examination; and d) mandating competence
assurance through continuing professional education and
The educational accreditation agencies are the Regulatory
Councils, the University Council of Jamaica and the Caribbean
Accreditation Authority for Medicine and Other Health
1. Regulation of all health professions;
2. Introduction of a single regional mechanism for registration
and monitoring of the practice of all categories of health
personnel; one result is the merging of competencies for
some health professions across the region;
3. National and regional education accreditation bodies;
4. Accreditation of parent education institutions and
5. Mutual Recognition Agreement for physicians and nurses;
6. Competency-based curricula;
7. Mandatory competence assurance programme for periodic
1. Keeping legislation and regulation current in context with
changing health profession education preparation;
2. Resourcing Councils to effect their responsibility efficiently
3. Selecting Council members to show a balance between the
regulated and the public, and competency of members;
4. Greater inter-councils collaboration allowing for proactive
risk management, given their shared focus of public
5. Fitness to practice and management of risks - disciplinary
management process, availability of evidence to support
6. Dynamic accreditation system that:
- provides evidence of the relevance of curricula output to
health services requirements, professional practice, and
- provides evidence of the impact of scopes of practice,
continuing professional education for recertification on
- monitors the regulated for compliance with the
mandatory competence assurance process.
7. A managed accreditation system for health care facilities to
assure the quality of professional services to the public;
8. Licensing of foreign qualified graduates.
Reflections on the first three years of national regulation in Australia and future directions
The agreement signed by the Prime Minister and First Minsters
of the day in 2008 provided the architecture for a unique and novel model of health practitioner regulation that has now
seen three full years of operation and has been the subject of
multiple external and internal reviews.
After a rapid transition to the start of the new scheme in July
2010, the early teething issues for management of registration
functions were relatively quickly resolved. Recent parliamentary
reviews have found that the early challenges are behind us
and that while there is further refinement that can be achieved
we have a good bill of health in this area and the changes
likely to result from the upcoming independent review led
by our Ministerial Council may be evolutionary rather than
What has been learned by AHPRA and the 14 National Boards as
well as from reviewers, advocates and critics of this significant
regulatory change and what are the likely modifications we
might anticipate will be made to the model in future years?
There are a number of key themes emerging from reviews and
our experience to date of implementation of the new scheme. It
is helpful to consider these along the lines of the core functional
areas of practitioner registration, notifications management and
accreditation of education.
The effective management of notifications about the health
performance and conduct of registered health practitioners
has been much more of a challenge to reestablish following
transition and the relationship between national and state
jurisdictions continues to be contested. This is an area where
change will continue to be demanded and possibly achieved in
the future refinements to the national scheme.