Global Differences in Regulatory Models

1. Global Differences in Regulatory Models A European Perspective

2. Address by Eugene Donoghue Chief Executive Officer and Registrar An Bord Altranais (Nursing Board), Ireland at CLEAR (Council for Licensure, Enforcement and Regulation) Conference, San Antonio, Texas. January 11th 2002

3. Thank you for the invitation to address this conference . I hope that my contribution will add to your knowledge of regulation in Ireland, which I propose to present in the context of regulations governing the movement of health professions in Europe.

4. Original regulatory legislation in Ireland was derived from United Kingdom judicial systems. From the 19th century and the beginning of the twentieth century laws were enacted in Ireland regulating health care professions, and such legislation focused primarily on the establishment of standards in the education and training and the establishment of a register of practitioners. Boards were appointed by the government which included representation from the professions.

5. After independence was established in 1921 these regulatory laws for nurses and midwives continued until in 1950 the Irish Government passed a Nurses Act which established An Bord Altranais and put in place systems regulating Education and Training, the Maintenance of a Register, Fitness to Practice Procedures and Guidance to the Profession.

6. This Nurses Act was further revised in 1985 when for the first time elected nurses and midwives held a majority on the Regulatory Board.

7. History of RegulationMedical Act,1858; Medical Act, 1886; Medical Act, 1927;Medical Practitioners Act, 1978.Pharmacy Act (Ireland)1875;Pharmacy act,1951; Pharmacy Act, 1962Dentist’s Act, 1878; Dentists Act, 1921; Dentists Act1928; Dentists Act, 1985. Nurses Act,1917, Midwives Act, 1919; Midwives Act 1944; Nurses Act,1950; Nurses Act 1985.

8. The general role of the Nursing Board is to Promote high standards of professional education and training and professional conduct among nurses.

9. Various models of regulation exist in the member states of the European Union. Each country has a designated Competent Authority for a profession The Competent Authority is an independent regulatory body in some states. Some are incorporated into Government Health Departments and some are administered by Local Authorities.

10. The Irish Nursing Board consists of 29 members (17 elected by the profession and 12 appointed by the Minister for Health and Children) and holds office for five years. Included in the Ministerial appointments are two representatives of the public, and medical, educational and service interests.

11. The Board is self financing from annual fees charged to nurses to have their name retained on the Register. This accounts for approximately 90% of the Board’s income. Currently there are 62,000 nurses names on the register (50,000active, 12,000 inactive). The Act provides for the removal from the Register of names of nurses who do not pay fees.

12. The Act provides for the establishment of a Statutory Fitness to Practice Committee which requires the committee to enquire into allegations of professional misconduct or unfitness to practice because of physical or mental disability.

13. Findings of the committee are reported to the Board whose role it is to administer sanctions. These range as follows: • Removal from the Register, • Suspension from the Register, • Attachment of conditions, • Advise, Admonish or Censure. • Decisions of the Board effecting a nurse’s employment are not effective until confirmed by the High Court. • A nurse has right of appeal against decisions for up to 21 days after the Court has confirmed the decisions of the Board.

14. Inquiries are held in camera, and appeals are heard in open court. In general the Irish constitution provides that only the High Court can impose sanctions which effect a citizen’s right to earn a living. Regulatory Bodies operate within the limits of the constitution.

15. Anurse may apply to the Board at any time to have her/his name restored to the register and The board may at any time remove in whole or in part the conditions attached to the retention of the name of any person on the register.

16. In providing guidance to the profession the Board publishes a Code of Professional Conduct for each Nurse and Midwife The Board has also published a Scope of Practice Framework which empowers nurses and midwives to practice in accordance with their education and training, experience and competence. Currently the Board is examining in consultation with others the regulation of Nurse and Midwife Prescribing.

17. Ireland is obliged by virtue of membership of the European Union and Directives enacted by the Union to put in place systems for the mutual recognition of diplomas, certificates, and other evidence of formal qualifications of nurses and midwives, doctors, pharmacists and dentists.

18. European Union Member StatesAustria, Belgium, Denmark, Finland,France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom.

19. Countries at immanent Pre-accession stage:Cyprus, Czech Republic, Estonia, Hungary, Poland, and Slovenia.

20. Other Pre-accession countries: Bulgaria, Latvia, Lithuania, Malta, Romania, and Slovakia

21. Member States are obliged to apply DirectivesSectoral Directives (No.80/154/EEC and No.77/452/EEC)which stipulate for particular professions the duration and content of programmes leading to Registration throughout member states andGeneral Systems Directives which provide member states with legal requirements which must be satisfied in processing applications of professionals from other member countries in accordance with their own national standards

22. The Irish Government is currently proposing to introduce legislation regulating a range of other ancillary professionals, e.g. Psychologists, Physiotherapists,Occupational Therapists etc. and these in time will come under a regulatory system controlling the movement of professionals.

23. Process for Registration Applications are appraised on an individual basis and verification of compliance with European Law is sought independently from the Competent Authority in the country of origin Applications from outside the European Union are assessed individually and applicants must supply to the competent authority: a current registration certificate(license), employment history, two character references and passport number.

24. Process for Registration (cont’d) Nurse applicants from some countries who are otherwise qualified to enter the Register are required to undertake a period of orientation and assessment in a hospital approved by the Board and a recommendation is required from the Director of Nursing before full registration is granted.

25. Current Developments Currently serious questions are been raised in relation to sectoral regulation of professions in the European Union. The accession of at least thirteen new Eastern European states is immanent which will substantially pressurise administrative systems operating sectoral directives in the European Union. Consultation proposals recommend the introduction of national systems of regulating the movement of professionals (General Systems Directive).

26. Irish and UK Professionals Bodies and some professional bodies in other European countries are concerned about the administrative and legal implications of this. They are satisfied that the current systems provide for a common standard for public protection throughout the Union and the requirement on each member state to ensure that such standards are applied. In the United Kingdom major changes are been implemented in reforming regulatory systems for health professionals following public concerns raised in recent years concerning the effectiveness of these systems.

27. Government in the UK is clearly stating that public confidence in professional self regulation has been dented and that for regulation ‘to be effective it must be open, responsive and accountable, focussed on protecting patients and the public rather than solely on professional staff. They state that regulation also needs to be flexible to take account of changes to the way in which staff work and care is delivered in the future’. (Ref. Modernising Regulation- the New Nursing and Midwifery Council, A Consultative Document, August 2001)

28. A new United Kingdom Nursing and Midwifery Council will come into being this April 2002 and will replace the United Kingdom Central Council for Nursing, Midwifery and Health Visiting. It will have a membership of 23 ( 12 elected and 11 lay members appointed by the Government).

29. The central aims of the legislation are to: • treat the health and welfare of patients as paramount; • collaborate with and consult with stakeholders; • be open and proactive in accounting to the public and • the professions for its work; • and

30. to reform structure and functions by: • giving wider powers to deal effectively with individuals who pose unacceptable risks to patients; • creating a smaller Council, comprising directly elected practitioners and a strong lay input, charged with strategic responsibility for setting and monitoring standards of professional training, performance and conduct; • streamlining the professional register; providing explicit powers to link registration with evidence of continuing professional development. (Ref. Establishing the New Nursing and Midwifery Council, April 2001)

31. There is a strong influence of United Kingdom legislation in relation to regulation of professions throughout the world. In Ireland the government proposes to review legislative regulatory instruments by 2003 and during the following five years to examine the principle of self regulation. (Health Strategy, Quality and Fairness- A Health System for You, Department of Health and Children, Ireland, 2001).

32. In conclusion, I question whether we as regulators are as pro-active as we should be in leading the modernisation of regulation. Governments who have the ultimate responsibility for public protection react with legislative changes when systems fail. If we as regulators have not considered likely weaknesses, problems and trends and reported on them then we will be less likely to be in a position to influence developments in professional regulation.

33. References for further Information: See web pages;nursingboard.ie doh.ie ; doh@prolog.uk.com europa.eu.int/comm/index_en.htm