Regulation of Medicine

Prof Orla Sheils

•Medicine – a ProfessionGuidelines and Regulations

• 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

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

Statutory and non-statutory professions

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

disciplinary powers

Examples:

• 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)

• Non-Statutory• Physiotherapists

• Radiographers

• Occupational Therapists

• Speech Therapists

• Social Worker

• Dietician

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

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

• 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”

• 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.

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

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

Background

In train for a number of years• Part of a suite of healthcare professional legislation

• Minister’s 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)

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

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 medics;13 lay people

Council Committees

1.Preliminary Proceedings Committee (PPC)

2.Fitness to Practise Committee (FPC) with lay majority.

3.Education & Training Committee

4.Health Committee

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.

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.

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.

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

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

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

General Division

•Any practitioner who does not fall within the other Registers

•Voluntary Removal

•Conditions

• Register of Medical Specialists Expected to enrol once training is complete

• Public Document May be inspected by any member of the public 

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.

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.

Medical Council-Disciplinary Function

• Area which has occasioned much interest

• Combination of proactive and reactive/punitive approaches

Registration

•4 Registers

Specialist DivisionTraining Specialist DivisionVisiting EEU Practitioners Division

General Division

Medical Council-Disciplinary Function

• Proactive: Publication of guidelines

• Benchmark for medical practice

Competence Assurance• Ongoing confirmation of clinical standards• Continuing education• Clinical audit

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

Complaints

Grounds• Old Act

alleged professional misconduct or fitness to practise by reason of a physical or mental disability

• New Acta.professional misconductb.poor professional performancec.relevant medical disabilityd.failure to comply with a condition of registratione.failure to comply with an undertakingf.contravention of the Actg.conviction for an offence triable on indictment

within or outside of the State

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

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.

Fair procedure and disciplinary matters

• Delay Timely investigation, as delay can hinder a person’s

ability to defend themselves.

• Notice Requirement for due notice so a person can prepare a

defence

• Hearing Generally presented by barristers Cross-examination

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

Definition of Professional Misconduct

i. conduct which doctors of experience, competence and good repute consider as disgraceful or dishonourable and/or

ii.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.

PREVIOUSLY “INFAMOUS CONDUCT” OR “MORAL TURPITUDE” REQUIRED

• Allinson case

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”.

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”

Preliminary Proceedings Committee

Decide if complaint is vexatious or trival

• If sufficient cause for further actionRefer to another body or authorityAsk complainant to verify issues

• Notify medical practitoner• Practitioner should make representations

• If no further action

Refer to Council

• If further action required

Mediation

Fitness to Practise Committee

No ability to refer to Health Committee

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

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

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

Section 60

Immediate suspension

Ex parte application to High Court

In private

Affidavit evidence

Court can order immediate suspension and other ancilliary orders

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.

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

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

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.

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

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.

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.

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.

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