Karen Proud, President Consumer Health Products Canada Future of Consumer Health Product Regulation WSMI AFAMELA Conference on Self-care and Self-medication, October 5th 2015 Karen Proud, President Consumer Health Products Canada

Spectrum of Products under the Food and Drug Regulations

Which one is the natural health product? Product Regulations Food and Drug Regulations

Which one is a cosmetic? Natural Health Food and Drug Regulations Product Regulations Food and Drug Regulations Cosmetic Regulations

Which one is a drug? Natural Health Product Regulations Canadian Consumer Product Protection Act & Regulations Food and Drug Regulations

Minister announces Consultation on a Consumer Health Product Framework June 9 2014 Lower risk products are to be separated from Rx drugs and are to move under a separate framework for consumer health products Appropriate oversight based on risk Consistent and aligned approach to regulation Safety is 1st priority Reduce red tape where it makes sense Consumer Health Products: OTCs, NHPs, Cosmetics, Disinfectants Minister of Health Rona Ambrose

Consumer Health Product Framework OTCs, NHPs, cosmetics & disinfectants *New* Non-prescription drug Regulations Policies & Guidance documents Product Reclassification Decisions Operational Improvements

Why are new OTC Regs needed? CHPs are regulated under several sets of regulations. Food and Drug Regulations, Natural Health Product Regulations, Cosmetic Regulations Some requirements are considerably more stringent than others, products of similar risk can be subject to very different requirements. Food and Drug Regulations are not flexible enough to account for a drug's relative benefit, harm and uncertainty profile for lower risk products like OTCs. OTCs are subject to disproportionate requirements The best elements of the Food and Drug Regulations combined with experience gained from administering regulations such as the Natural Health Products Regulations will inform the creation of a modern, comprehensive and risk-based set of regulations for OTCs.

Big Picture Impact Health Canada recognizes the value of self-care and acknowledges the evolving health landscape and increasing consumer demand for more self care options. Health Canada recognizes the economic benefits of self care. “need to reduce overall healthcare system costs by promoting self-care options”. Calls for an integrated governance approach to consumer health products that brings together Health Canada, provincial and territorial governments and stakeholder to address: point of sale issues, ensure consumer access to safe products, and; to promote informed self-care and the need for self-care options. From the 10,000 ft view, the strategic importance of the CHP Framework is that it formally recognizes the value and economic benefits of self-care and that consumers are demanding more self-care options. This is something we are very supportive of as we have seen the benefits of other regulators doing so before us and the positive impacts it has had on self-care. For example, in 2000, the Department of health UK established self-care as a key pillar of their patient-centered healthcare system, which paved the way for policy changes to promote switch, develop new regulations and process changes to remove regulatory burden on the OTC industry by the MHRA. 5 years later they reported that supporting self-care lead to improved health and quality of life and significant impacted the use of healthcare services, with fewer Dr and emergency visits. This is the kind of vision we would like to move toward in Canada, and recognizing self-care in this way is only the first step. Another interesting aspect of this Framework is that it calls on stakeholders to address point of sale issues to promote self-care and encourage access to safe products. This is something we are very excited about as well, because we understand this to mean that health Canada wants to take a leadership role to change how the provinces determine the conditions of sale for products, once they have been approved for self-care by health Canada. Currently, the provinces can establish additional conditions of sale on a product, that designate it to be sold behind the pharmacy counter, in front of the pharmacy counter or permit it to be sold in any retail outlet. This system has created many retail challenges and we agree that it’s time for modernization to keep pace with the evolving health landscape.

Highlights Risk-based regulations that are separate from the Rx Drug Regulations. (Ie. no more “new drug” vs. “old drug” paradigm) Regulatory approach recognizes the benefits, harms and uncertainties by considering the nature, intended use and exposure of the product. Oversight proportional to the type and amount of evidence submitted that requires review. Automated licensing for products to streamline review for applicants attesting to pre-cleared information (ie. monographs, labeling standards, acceptable ingredient lists, test methods etc.) Maintaining science-based approach to OTC regulation Retaining the existing GMP standard and Establishment Licensing system as one option in a risk-based approach to Establishment Licenses so OTCs can continue to export under MRAs. Risk-based attestation system for brand name assessments Direct to consumer OTC sampling

Timeline CHP Framework announced in July 2014 Consultation on the proposal for OTC Regs closed in Feb 2015 2016: Potentially consult on Regulatory Text. Final Regulations & Coming-into-Force 2016/2017

Karen Proud Karen.proud@chpcanada.ca Thank you!