Regulatory Development Process

Regulations are a form of law, often referred to as delegated or subordinate legislation. Like Acts, they are legally binding and usually state rules that apply generally, rather than to specific persons or things. Regulations are made in order to carry into effect the purposes and provisions of an Act. Authority to make regulations must be expressly delegated by an Act.

Regulations generally offer a greater degree of flexibility than acts or "primary" legislation since regulations are not subject to the same legislative process involved in making or amending statutes. This flexibility is important in the area of assisted human reproduction (AHR) so that the federal government's oversight framework can keep pace with scientific and medical advances. The government must be able to respond quickly to these advances in order to effectively govern AHR activities, thus ensuring the protection of the health and safety of the people of Canada.

Health Canada is committed to following the Government of Canada's Federal Regulatory Policy PDF in developing options and recommendations for AHR. The Policy is designed to ensure that the use of the Government's regulatory powers serves the public interest and results in the greatest net benefit to Canadian society. The Government must weigh the benefits of alternatives to regulations - and of alternative regulations - against their cost, and focus resources where they can do the most good.

Regulations made under federal acts have to meet the requirements of the regulatory process. The Statutory Instruments Act and the Statutory Instruments Regulations provide the basic elements and requirements of the regulatory process. By following this process, government departments can better ensure that ministers have the appropriate information on which to base decisions regarding regulations.

What are the steps involved in the regulatory process?

The main steps of the regulatory process are the following:

• Initiation of public consultations;
• Conception and drafting of proposed regulations as well as other documents that constitute the regulatory submission package, such as the Regulatory Impact Analysis Statement (RIAS);
• Review by the Department of Justice;
• Ministerial approval for prepublication;
• Consideration by the Regulatory Affairs and Orders in Council Secretariat (RAOIC) at the Privy Council Office and Treasury Board;
• Prepublication of the proposed regulations and RIAS in Canada Gazette, Part I and comment period;
• Parliamentary review of proposed regulations;
• Analysis of comments received and departmental preparation of final proposal;
• Final review by the Department of Justice;
• Ministerial approval for publication;
• Consideration by RAOIC and Treasury Board;
• Approval, promulgation and registration by the Governor in Council;
• Publication of final regulations and RIAS in Canada Gazette, Part II
• Coming into force of regulations;
• Parliamentary review by the Standing Joint Committee on the Scrutiny of Regulations.

What is the Regulatory Impact Analysis Statement (RIAS) and what is included in it?

The RIAS is the text that accompanies the proposed regulations and explains in simple terms the intent of the proposed regulations, in particular:

• what the regulatory proposal is meant to achieve;
• what alternatives to regulation were considered;
• what the anticipated benefits and costs of the regulations are;
• what consultations were carried out;
• what constitutes the department's response to concerns raised; and
• what mechanisms will ensure compliance with the regulations once they are in place.

Parliamentary Review of Proposed Regulations

In addition to the standard regulatory process, the AHR Act requires that the proposed regulations be laid before both Houses of Parliament for referral to an appropriate committee of each House for review prior to the regulations becoming law. Once the regulations are laid before Parliament, a regulation may not be made before the earliest of (a) 30 sitting days; (b) 160 calendar days; or (c) the day after the appropriate House of Parliament Committee has reported its findings. These time frames allow for Parliamentary Committees to undertake in-depth studies of the proposed regulations enabling substantive input at an early stage in the process. The Minister will take into consideration recommendations made by either Parliamentary Committee, and will provide an explanation to Parliament for any recommended change not incorporated into the regulations, should this be the case.