Regulation of Medicine

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Regulation of Medicine

• Prof Orla Sheils

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• Medicine a Profession
• Guidelines and Regulations

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• Major attributes of a profession
• Acquisition of learning prior to practice
• Requirement for continued learning after
  qualification
• Separate sense of identity
• Ethical code of conduct

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Statutory and non-statutory professions

• Statutory
• Profession is backed by law
• Law creates a regulatory body
• Supervisory and disciplinary powers
• Self-regulating with deference to the laws of the
  state

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Statutory and non-statutory professions

• Non-statutory
• More loosely affiliated
• Representing body without regulatory or
  disciplinary powers

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Examples

• Non-Statutory
• Physiotherapists
• Radiographers
• Occupational Therapists
• Speech Therapists
• Social Worker
• Dietician

• Statutory
• Doctors(Medical Practitioners Act 1978)
• Dentists (Dentists Act 1985)
• Nurses (Nurses Act 1985)
• Pharmacists (Pharmacy Act (Ireland) 1875,
  Pharmacy Act 1962)
• Opticians (Opticians Act 1956)

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Statutory Regulatory Bodies are responsible for

• Defining ethical guidelines
• Overseeing disciplinary issues and fitness to
  practice of members
• Generally suspension or removal from register is
  conducted under supervision fo the High Court
• Maintaining a register of practitioners

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Statutory Regulatory Bodies

• Created by a specific law which empowers them to
  oversee and regulate aspects of the profession.
• Medicine
• Medical Council
• Medical Practitioners Act 1978

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• The Medical Council protects the interests of the
  public when dealing with registered medical
  practitioners.
• The Council was established by the Medical
  Practitioners Act 1978 and commenced operation in
  April 1979.
• It shall be a function of the Council to give
  guidance to the medical profession generally on
  all matters relating to ethical conduct and
  behaviour

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• The Medical Council is funded exclusively by the
  annual payments of registered doctors no funds
  are received from government or other sources. 
• The annual retention fee for a fully registered
  doctor has been set at  475 from 1st July 2008.
• On 1st January 2008 there were, in total 18,316
  doctors, of the various registration categories,
  registered with the Medical Council.

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The principal roles of the Medical Council
include

• assuring the quality of undergraduate education
  of doctors
• assuring the quality of postgraduate training of
  specialists
• registration of doctors
• disciplinary procedures
• guidance on professional standards / ethical
  conduct

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Medical Council

• Elections held every 5 years
• 25 members - representatives
• Irish Medical Schools
• RCS (surgery and anaesthetics/radiology)
• RCPI (Medicine and Pathology and Obs and Gynae)
• Psychiatry, General Practitioners
• Medical Practitioners elected from the profession
• Ministerial Appointees

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Background

• In train for a number of years
• Part of a suite of healthcare professional
  legislation
• Ministers stated aims
• provide for a modern, efficient,
  transparent and accountable system for the
  regulation of the medical profession which will
  satisfy the public and the profession, that all
  medical practitioners are appropriately
  qualified and competent to practise in a safe
  manner on an ongoing basis.
• Lourdes Inquiry report
• Fully operational from 16 March 2009 (apart from
  Competence Assurance)

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Council Committees

• Objectives of the Council
• to protect the public by promoting and better
  ensuring high standards of professional conduct
  and professional education, training and
  competence among registered medical
  practitioners.
• Functions
• Registration
• Education programmes
• Standards for professional competence
• Establishing Committees to hear complaints
• Standards of practice i.e. ethics and conduct

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Make-up

• 25 members appointed in July 2008
• Chairman Dr. Kieran Murphy
• 6 elected medical practitioners
• Rest are mix of appointments by e.g. the
  Minister, Colleges etc
• Lay majority 12 medics13 lay people

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Council Committees

1. Preliminary Proceedings Committee (PPC)
2. Fitness to Practise Committee (FPC) with lay
   majority.
3. Education Training Committee
4. Health Committee

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It is an offence under the Medical Practitioners
Act for a doctor to falsely represent
himself/herself to be a registered medical
practitioner when they are not registered.
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Medical Council Register

• Register of Medical Practitioners
• Medical insurance companies require registration
  before insurance cover is given. 
• Registration is required to sign medical
  certificates and to issue prescriptions for
  certain categories of drugs. 
• Doctors are not entitled to recover in legal
  proceedings, fees charged for the provision of
  medical or surgical advice or treatment given
  when they were not registered.

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Registration

• Register of Medical Specialists
• contains the names of registered specialists. 
• Register of Medical Specialists is a voluntary
  register.  Only doctors who currently hold full
  registration in the General Register of Medical
  Practitioners may apply to have their names
  entered in the Register of Medical Specialists. 
• If a doctor removes his/her name from the General
  Register they are automatically removed from the
  Specialist Register.

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Specialist Division

• Rules to be published
• Automatic transfer if already on Specialist
  Register
• Completed training in a medical speciality
  recognised by Council
• Satisfactory evidence of specialist training by a
  Body approved under the Act
• Recognised qualifications or Certificate acquired
  rights in specialist medicine in a member state
  or in a 3rd country designated under EU Directive
  2005/36
• Completed programme of training and experience
  such to satisfy Council that can be registered in
  the specialist division

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Trainee Specialist Division

• Subject to Rules, not yet finalised
• Certificate of experience
• Individually numbered identifiable post approved
  by the Council
• Certificate from competent body of Member State
  plus individually numbered approved post
• Or person who does not fall into above categories
  who has passed PRES or has passed TRAS in past
  number of years
• Refugee status
• Notice of cessation within 14 days

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Visiting EEA Division

• Practitioners from Member States
• Temporary and occasional basis
• Declaration in writing of services in advance
• Attestation from competent authority
• Case by case basis

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General Division

• Any practitioner who does not fall within the
  other Registers
• Voluntary Removal
• Conditions

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• Register of Medical Specialists
• Expected to enrol once training is complete
• Public Document
• May be inspected by any member of the public 

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Medical Council - Education

• Assess Training and Education of training centres
• Input into curricula and level of experience
  deemed necessary
• Postgraduate Medical Board
• specific responsibility for postgraduate training.

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The Medical Practitioners Act, 1978, states that
it shall be the duty of the Council from time to
time to satisfy itself

• (a) as to the suitability of the medical
  education and training provided by any body in
  the State recognised by the Council for such
  purpose,
• (b) as to the standards of theoretical and
  practical knowledge required for primary
  qualifications,
• (c) as to the clinical training and experience
  required for the granting of a certificate of
  experience, and
• (d) as to the adequacy and suitability of
  postgraduate education and training provided by
  bodies recognised by the Council for the purposes
  of medical specialist training.

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Medical Council-Disciplinary Function

• Area which has occasioned much interest
• Combination of proactive and reactive/punitive
  approaches

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Registration

• 4 Registers
• Specialist Division
• Training Specialist Division
• Visiting EEU Practitioners Division
• General Division

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Medical Council-Disciplinary Function

• Proactive
• Publication of guidelines
• Benchmark for medical practice
• Competence Assurance
• Ongoing confirmation of clinical standards
• Continuing education
• Clinical audit

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Medical Council-Disciplinary Function

• Punitive/Reactive measures regarding misconduct
  or fitness to practice
• Censure or admonishment
• Attachment of conditions to continuing practice
• Suspension from the register
• Erasure from the register

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Complaints

• Grounds
• Old Act
• alleged professional misconduct or fitness to
  practise by reason of a physical or mental
  disability
• New Act
• professional misconduct
• poor professional performance
• relevant medical disability
• failure to comply with a condition of
  registration
• failure to comply with an undertaking
• contravention of the Act
• conviction for an offence triable on indictment
  within or outside of the State

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Professional Misconduct

• conduct which doctors of experience, competence
  and good repute, upholding the fundamental aims
  of the profession, consider disgraceful and
  dishonourable.
• Must have an element of moral failure or
  persistent recklessness/negligence

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Fair procedure and disciplinary matters

• Irish Constitution declares the administration of
  justice is reserved to judges.
• Court requires to know that any decision was
  based on reasonable and if fair procedures were
  followed in making the decision.

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Fair procedure and disciplinary matters

• Delay
• Timely investigation, as delay can hinder a
  persons ability to defend themselves.
• Notice
• Requirement for due notice so a person can
  prepare a defence
• Hearing
• Generally presented by barristers
• Cross-examination

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Fair procedure and disciplinary matters

• Reasons
• Full reasons regarding any decision must be
  provided to facilitate appeal if appropriate
• Prejudice and Bias
• Unfair if a person has already made up their mind
• Bias- more subtle, financial interest, personal
  or political position
• Proportionate nature of censure
• Punishment should fit the crime

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Definition of Professional Misconduct

• conduct which doctors of experience, competence
  and good repute consider as disgraceful or
  dishonourable and/or
• conduct connected with his or her profession
  which the doctor concerned has seriously fallen
  short by omission or commission of the standards
  of conduct expected amongst doctors.

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• PREVIOUSLY INFAMOUS CONDUCT OR
• MORAL TURPITUDE REQUIRED
• Allinson case

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B. Poor Professional Performance

• Definition
• a failure by the practitioner to meet the
  standard of competence (whether in knowledge and
  skill or the application of knowledge and skill
  or both) that can reasonably be expected of a
  medical practitioner practising medicine of the
  kind practised by the practitioner.

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C. Relevant Medical Disability

• Definition
• a physical or mental disability including
  addiction to alcohol or drugs which may impair
  the practitioners ability to practise medicine or
  a particular aspect thereof

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Preliminary Proceedings Committee

• Decide if complaint is vexatious or trival
• If sufficient cause for further action
• Refer to another body or authority
• Ask complainant to verify issues
• Notify medical practitoner
• Practitioner should make representations

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• If no further action
• ? Refer to Council
• If further action required
• ? Mediation
• ? Fitness to Practise Committee
• ? No ability to refer to Health Committee

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Fitness to Practice Hearings

• Notice of Inquiry
• Held In public
• Private hearing in full or in part in certain
  circumstances
• Standard of proof
• - beyond all reasonable doubt
• Video link
• Undertakings by practitioner

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Report to Council

• FPC reports to Council on findings
• Not a full re-hearing
• Council can dismiss the complaint or impose
  sanctions
• Advice/admonishment/censure
• Censure and fine up to 5,000
• Transfer to another division of the Register
• Attachment of conditions
• Suspension
• Erasure
• Prohibition from applying for restoration for a
  certain period

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Follow on from Council

• Appeal period 21 days
• High Court full rehearing on Appeal
• Confirmation of High court required for sanctions
  other than censure/admonishment
• Other bodies notified
• Publication

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Section 60

• ? Immediate suspension
• ? Ex parte application to High Court
• ? In private
• ? Affidavit evidence
• ? Court can order immediate suspension and
  other ancilliary orders

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Medical Council-Disciplinary Function

• Disciplinary decisions regarding suspension or
  erasure from register MUST be approved by the
  High Court.
• Council can request an immediate order of the
  Court, enforcing suspension if it is deemed to be
  in the public interest.

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Competence assurance

• Part II of the Act not yet in force
• Scheme not yet set up
• Performance in practice, concensus statement
• 3 fold framework
• A) Continuing quality assurance
• - 50 hours per year with PGTB
• - CME
• - Clinical Audit/Peer Review

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Competence Assurance

• B) Professional Practice Review
• - pilot study with 350 GPs
• - questionnaire for patients and peers
• - roll out to other specialities
• C) Performance assessment
• - if concerns are expressed about a doctor
• - 2 trained and 1 lay assessor

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Irish Healthcare system

• Mix of public and private funding.
• Everyone is entitled to free public inpatient and
  outpatient care in public hospitals should they
  wish to avail of them.

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Irish Healthcare system

• Administration and delivery of services
• Legislature
• Minister
• Department of Health and Children
• Health Service Executive and regional health
  authorities
• Others e.g.
• Irish Medicines Board
• Health Research Board
• Comhairle ns nOispidéal
• IBTS

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HSE

• Up until January 2005, public health and personal
  social services in Ireland were delivered by a
  network of ten health boards, located throughout
  the country.
• Health and personal social services in Ireland
  are now delivered by the Health Service
  Executive, through a network of Local Health
  Offices, health centres and clinics.

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HSE

• Each Health Service Executive Administrative Area
  is responsible for the provision of health and
  social services in its area.
• They provide many of the services directly and
  they arrange for the provision of other services
  by health professionals, private health service
  providers, voluntary hospitals and
  voluntary/community organisations.

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Duty of HSE to provide services

• The HSE Area is obliged to provide certain
  services, e.g., family doctor (GP) and public
  hospital services.
• There are other services that they may provide,
  e.g., home helps and other community care
  services.
• A significant part of the HSE Area's overall
  budget is allocated to those services that are
  obligatory.

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Suggested Reading

• Clinical Practice and the Law
• Simon Mills
• Law and Medical Ethics
• Mason, McCall Smith, Laurie
• Medicine Ethics and the Law
• Deirdre Madden
• http//www.medicalcouncil.ie