Develop a Regulatory Body

PROFESSIONAL REGULATORY BODY COMPOSITION AND GUIDELINES FOR BOARD APPOINTMENT/ELECTION

A regulatory body must be set up and given powers by statute (a written law passed by a legislative body). The purpose of the regulatory body is to:

• primarily to protect the public, not the professionals
• provide guidance and oversight over the profession of optometry

A regulatory body:

• Will have a regulatory board
• May also have committees in place (i.e. complaints, discipline, quality assurance)

The Regulatory Body will put in place rules and regulations to implement the statute. It will further define the statute on how the profession operates and how the Regulatory Board also operates.

It is mandatory for optometrists who want to practice in a country to be registered/licensed with the Regulatory Body and to comply with their rules, regulations, professional standards, and codes of ethical conduct.

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COMPOSITION OF THE REGULATORY BOARD

Depending on the governing rules of a country, the members of the Regulatory Board will be elected or appointed.

Appointment/elections of the members who serve on the regulatory board:

• must be a transparent process
• usually conducted under the authority of the government health authority/other relevant body
  • the government/health professions council usually announces/publishes openings by issuing a call for nominations
  • the national association and all other registered optometrists should be aware of this call
  • appointments to the Board are not done by the national association, as this is conflict of interest. The association could nominate a number of optometrists for each opening to the public official/department/electoral officer who is facilitating the appointments or election
  • Any registered member may nominate a colleague to serve on the regulatory body
• the relevant authority that oversees the process for appointment or election of regulatory board members must finalize and make available the list of those appointed or elected to the profession and public through all relevant platforms.

Although a practitioner may be nominated through their respective association, university, group practice etc., if appointed or elected to the regulatory board, they must ensure that they do not feel obligated to serve the interests of the group that nominated them. It is important that the members of the regulatory board act independently and serve as good role models within the profession.

Qualifications to be considered when nominating optometrists to serve on the Regulatory Board should include:

• reputation amongst their colleagues
• professional skills and competence
• ethical behavior
• leadership skills
• length of time in practice (usually a minimum of 5 years)

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Common Regulatory Board Structure

• usually, a minimum of 5 and a maximum of 12 members
• optometrists should always be in the majority
• the balance of members are generally representatives from the public or medical community (depending on regulations in the country)

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Terms of Office

• Set length of a term served (i.e., 3-5 years)
• Set maximum terms that a member may serve (i.e., 2-3 terms)
• Terms of members should be staggered to retain institutional knowledge (provide continuity of history involving past actions) e.g., it may be decided to always retain 25% of old members with each new Board

An inaugural meeting of the Board should be held shortly after the Board is appointed/elected.

Usual procedures at this initial meeting:

• members are provided with the expectations of them during their tenure on the Regulatory Board
  • They may also be provided with a “Charter for Professional Board Members” which outlines codes of good governance
• members take an oath/sign a declaration to exercise their mandate diligently and maintain the highest standards of integrity within their expected mandate
• members shall elect from amongst them a chairperson and vice-chairperson

if the regulatory body does not have an administrative secretariat, the members may elect a secretary.

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COMMITTEES/SUB-COMMITTEES

Many Regulatory Boards also use a committee structure to carry out much of the work of the Board.  Usually at least one Board member will sit on each committee.

Committees:

• may be mandated by statute (i.e.professional conduct, quality assurance)
• may be working committees established and decided on by the Board (i.e., finance)
• are responsible to the Board for the work that they do
• do not set policy but rather make recommendations to the Board, which may or may not be adopted
• members are chosen for their knowledge and expertise in the area that the respective committee oversees.

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RULES AND REGULATIONS

When developing rules and regulations it is important to seek legal advice to ensure compliance with the relevant Health Acts within the country.

Rules and regulations should cover:

• definitions in the documentation
• application and qualification/testing requirements for registration/licensing
• setting and monitoring of education standards
• requirements for continued licensure, auditing of education and practice standards
• the Code of conduct and ethics for the profession and regulatory board
• complaint, investigative and disciplinary functions

Once approved by a vote of the Regulatory Board, they are usually sent out widely for consultation for a set time period (30-90 days).  Comments will be addressed, and changes can be made if the Board feels it is appropriate. The new rules and regulations are then sent to the appropriate legislative authority for signature. When finally enacted, all practitioners have an obligation to know and abide by all the rules and regulations that govern their professional practice.

The health terrain is always changing, and even exciting developments/innovations may need the Board to protect the public from potential negative impact of these changes. As these may not have been there when the rules/regulations were developed, the Regulatory Board can advocate on behalf of itself for changes to the relevant Health Acts/legislation as they feel is necessary.

Develop Rules & Regulations

DEFINITIONS

ACTS:

An Act is a law (legislation) that is made for the country and is passed by the legislative branch of parliament (government) or equivalent. The Act sets out broad legal policy and has to be aligned with the constitution of the country.

REGULATIONS:

The Regulations describe the specific directives or statutes to implement that laws that fall under the Act. Regulations are enforced by law.

RULES:

Rules are the guidelines on how to correctly apply the regulations. They outline the principles that govern the professional conduct of an individual in an organization.

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DEVELOPING THE OPTOMETRY ACT

As optometry is a health profession, the Optometry Act will be part of the Health Act (or similar) in a country. It will need to be prepared by the group of practitioners/association that will be representing the profession. This is a legal process so should ideally be done in conjunction with a lawyer and then presented to the Health Ministry or equivalent department/body. The Act defines the profession of optometry in that country and the scope of the profession by setting out the broad legal/policy principles that the regulations and rules must align with. The Act will also give legal authority to the Optometry Statutory Regulatory Body that will be formed to govern the profession of optometry in the country.

If the Act needs amendment, it can only be amended by another Act of Parliament/legislative or equivalent body. As the Act does not give too much detail, Regulations, Rules and Codes of Conduct in Health (called “subsidiary legislation”) are developed to describe details that are covered by the Act. They will always be tested against the Act before they are published in the Government Gazette to become legal.

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DEVELOPING THE OPTOMETRY REGULATIONS

The regulatory framework provides the details on how the Act will be implemented. An example is that the optometry guidelines will define the registration requirements and provide the limitations of clinical scopes of practice in accordance with levels of education such as ocular diagnostic or therapeutic licensure.

To start to develop regulations, the regulatory body must conduct research on the education requirements to be an optometrist and how optometry is practiced around the world. Specific attention must be paid to countries with similar health systems as their respective country.

Once the registration requirements and details on the different categories of licensure are defined, there should be engagement with other relevant stakeholders eg. relevant allied health care bodies and higher education councils to get input that will strengthen the regulations.

When the regulations are drafted, the regulatory body must issue the proposed regulations and send out for public comment. Each regulation must be listed and include an explanation, objective and justification for its inclusion. Usually a period of ~3-6 months is allowed for the public comment phase. Public input is an important step in the process of rulemaking. It ensures transparency by enabling the public to comment on regulations which will impact on their lives as well.

Thereafter, the regulatory body must again engage with legal experts to incorporate the relevant public comments, finalize the regulations and submit to the Ministry of Health or legislative/equivalent body for legal promulgation.  When the final copy is sent to the Ministry or legislative/equivalent body, it must also include information on how the Regulatory body dealt with the public comments. Final optometry regulations will eventually be published in the Government Gazette.

As regulations are authorized and governed by law, if there is a need at any time to amend the regulations, the regulatory board cannot merely amend it themselves. It can only be done by notice in the Government Gazette, so the entire legal process must be done.

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DEVELOPING THE OPTOMETRY RULES

The Rules are the actual “how to” practice the profession of optometry in the country. The regulatory body introduces rules that are aligned with the regulations (legal framework) for optometry. It is important that the protection of the public remain central in the development of the rules as they must not be crafted to benefit the practitioner against the public good. The regulatory body should engage with the professional associations, practitioners, medical insurance bodies, educators, public and private health sectors and other appropriate stakeholders to help get wide input in defining the rules that will guide optometry. These may be within the areas of:

1. PRACTITIONER REGISTRATION FEES AND PROCEDURES
2. MININUM CLINICAL PRACTICE COMPETENCIES/GUIDELINES
3. CODES OF CONDUCT AND DISCIPLINARY PROCESSES
4. CONTINUOUS PROFESSIONAL DEVELOPMENT
5. CLINICAL TRAINING STANDARDS
6. HOW THE REGULATORY BODY IS ORGANIZED AND CONDUCTS BUSINESS

If a practitioner/institution violates a rule, the regulatory authority may implement relevant sanctions eg. cautioning or suspending a practitioner/deregistering an institution providing inferior quality education.

Amendments to the optometry rules may be approved by the governing body (Council/Board/College) without having a need to go through a legal process. They should ideally be periodically reviewed to keep up with changes in the health context in the respective country.

In countries where the optometry Regulatory Body falls under a larger multidisciplinary health professions council then there may be a set of generic ethical rules which apply to all health professions. Addition to those, the optometry regulatory body will draft their own specific rules and submit them as recommendations to the overarching regulatory body (Council/Board/College). At this level the optometry body will need to motivate for the inclusion of new rules/amendments and engage in debate/defense and eventually the rules will need to be passed by the higher authority. All optometrists registered with the Regulatory body to practice their profession are bound by the rules and codes of conduct.

RULES AND REGULATIONS Graphic