Health Canada Consultation: Proposed agile regulations and guidance for licensing drugs and medical

• As its mission, the BMC seeks timely access to a comprehensive range of medically necessary, safe, and effective drugs and other treatments, informed by patient-driven evidence and values, and delivered equitably and affordably to all patients in Canada. [...] The following standing goals drive the BMC’s advocacy and inform its positions: • Effective models for meaningful, proactive, and impactful patient engagement in health and pharmaceutical policy development, recommendations and decision making, where patients and patient organizations are recognized as legitimate and integral contributors and patient-informed evidence is valued and incorporated. [...] Positions and Issues for Consideration: The BMC supports the direction and goals of Health Canada’s regulatory modernization effort, including the proposed agile regulations and guidance for licensing drugs as outlined in the consultation materials, and acknowledges the dedication and commitment of all officials involved in this initiative. [...] The following points are offered regarding the current proposed regulations and for future consideration through implementation and review phases: Ongoing patient engagement processes: • We encourage Health Canada to explore improved patient engagement in concert with the patient community to develop processes which are meaningful and will enable patients to be heard and to contribute to increasin. [...] The BMC seeks timely access to a comprehensive range of medically necessary, safe, and effective drugs and related treatments, informed by patient-driven evidence and values, and delivered equitably and affordably to all patients in Canada.