The purpose of this part is to institutionalize and support public participation in governance as ascribed to by Constitution of Kenya 2010.
Public participation is a critical element and an enabler of the Good Regulatory Practices. In applying public participation in development of regulatory instruments i.e. the Laws, the Regulations/Rules and guidelines, the regulator and the stakeholders should ensure that the principles of good regulatory practice are followed. These principles include:- legality, consistency, independence, impartiality, proportionality, flexibility, clarity, efficiency and transparency.
The Board will notify and update its stakeholders and the public of any planned rulemaking activities on pending and completed statutory actions. This decision on the form and manner of the means through which this will be achieved will depend on the area of rulemaking and may include: email, website, letters, stakeholder meetings.
Stakeholder and Public involvement in Rule Making
- The Board may take some preliminary steps before issuing a proposed rule; information may be gathered through unstructured processes and informal conversations with people and organizations interested in the issues.
- If the Board receives a “Petition for Rulemaking” from a member of the public, it may decide to announce the petition in the “Regulatory Instruments Register” and accept public comments on the issue.
- During the preliminary stages of rulemaking the Board may publish an “Advance Notice of Proposed Rulemaking” in the Regulatory Instruments Register to get more information. The Advance Notice is a formal invitation to participate in shaping the proposed rule and starts the notice‐and-comment process in motion.
- Anyone interested (individuals and groups) may respond to the Advance Notice by submitting comments aimed at developing and improving the draft proposal or by recommending against issuing a rule.
- Depending on the issues, the proposed rules may be developed through a negotiated process. In a negotiated process, the Board shall invite members of interested groups to meetings where they attempt to reach a consensus on the terms of the proposed rule. If the participants reach agreement, the Board may endorse their ideas and use them as the basis for the proposed rule.
- Stakeholder participation may take different forms such as attending Parliamentary committee hearings, setting up meetings with the Cabinet Secretary or departmental heads, organizing workshops, seminars or retreats, using the media to outline the issues and similar entities to lobby, publication of extracts in newspaper articles or other online platforms and making contributions during public fora and submitting written opinions and memoranda.
Guidelines Development and Review
The Board from time to time domesticates guidelines through adoption or adaptation of but not limited to; Guidelines developed under collaborative framework with other speciality medical societies such as ICH, PIC/S, Collaborative framework with WHO, and Guidelines developed by other NMRAs, Regional Blocs, WHO and other recognized institutions.
The Board explores international best practices in guideline development and applies reliance, regulatory convergence, cooperation and recognition in the development and review of guidelines.