How Regulatory Frameworks Increase Access to Non-Prescription Medicines

Non Prescription Product Benefits Allows management of many health conditions conveniently and successfully Improves general health and quality of life Saves health systems valuable resources Saves consumers time and money Fulfills consumers growing desire to treat their own medical conditions Nine out of 10 consumers view self-care as a vital part of preventing both minor ailments and chronic health conditions and managing their symptoms.1 Patients who are more actively engaged in their health care experience better health outcomes and lower costs.2 1 Bowman-Busato, J., & Pavlickova, A. The Epposi Barometer: Consumer Perceptions of Self Care in Europe (October 2013). Retrieved from http://selfcare.epposi.org/pdfs/EPPOSI-Self-Care-Barometer-Report-2013-EN.pdf. 2 James, J. (February 14, 2013). Health Policy Brief: Patient Engagement. Health Affairs. Retrieved from https://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=86.

Unique Attributes of Non Prescription Products History of safe use Active ingredient (API) not usually protected by patents Stability profile / quality attributes of active ingredients – well known Product information must be consumer friendly Consumer choice based on development of brands and the advertising of those brands Regulation Needs to Recognize These Unique Attributes

Wide Variety of Nonprescription Products OTC Drugs (with and without pre-approval) Dietary (food) supplements Herbal medicines/ botanicals Specific medicines Complementary medicines Probiotics Natural health products Medical devices Cosmetics

Regulatory Frameworks that Support Self-care Registration Processes 1 Minimum effective regulation Processes that facilitate medicine rescheduling Defined Scheduling Criteria/Classifications 2 Advertising/Labeling Policies to Improve Knowledge and Health Literacy 3 Convergence (Harmonization) 4

Registration Processes 1

Pathways Proportionate to Risk Cosmetics Established Standards Increasing Risk Increasing Regulatory Requirements Increasing review time Food Supplements Notification Traditional Herbal Medicines Abbreviated Requirements Simplified Registration Bibliographic application Medicines with Well Established Ingredients Medicines for Established OTC Indications Full Dossier New OTC Ingredients New OTC Indications

Simplified Pathways Well-Established Substances Notification Processes Abbreviated Requirements OTC Monographs Listed Drugs Simplified notification Well established Use Traditional herbal medicines

According to US NDC Directory US Experience According to US NDC Directory 46,000+ OTC drugs 33,000 OTC monograph (no preapproval) 3000+ OTC generics (abbreviated requirements) Approx 600 OTC NDA drugs (pre-approval)

Efficient Use of Resources Benefits Efficient Use of Resources Speed to Market Industry Eliminates duplication of preclinical and clinical work Resources available for new ingredients/technology HA Limited HA resources can be applied to new ingredients/ technology Focus on product development (quality)

Regulatory Processes OTC Classification Clear Requirements for OTC status Well defined Registration requirements Legislation Detailed guidelines Periodic review of OTC ingredients Mechanisms for discussion and feedback from HA Meetings Scientific advice

Current OTC Criteria Condition is self diagnosable Illness is self‐limiting Product has a wide safety margin Self treatment will not mask serious underlying conditions Product can be used safely without medical supervision Consumers comprehend the label and understand the warnings Low potential for misuse, abuse or dependence

Expanding the OTC Framework Is the illness life threatening Can the management of the condition/disease be enhanced by greater access to products available without prescription Can the pharmacist assist in the management of the disease Can patients adequately self‐monitor (through the use of a device or technology) and self‐treat asymptomatic diseases Is the illness stable over the recommended treatment period Is the treatment regimen simple and easy to follow or does it require dose titration What is acceptable compliance/non‐compliance for treatment of the disease/condition ASMI Position Paper: Increasing Access to Medicines to Enhance Self Care. October 2009.

Defined Scheduling Classifications 2

OTC Scheduling Australia/NZ UK US Pharmacist Only Pharmacy Only General Sales General sales OTC Stepwise approach promotes OTC availability Confirm safety in OTC setting before unrestricted availability

Progressive Medicine Switches 2003–2013 Country Adapted from: Gauld, N, et al. Widening Consumer Access to Medicines through Switching Medicines to Non-Prescription: A Six Country Comparison.(Sept 2014). Plos One.

Advertising/Labeling Polices 3

Advertising/Labeling Product Information (Labels, Leaflets, Advertising) Brand awareness Information about medicine and proper use Standards to ensure ads truthful and not misleading Do not cause risk by encouraging inappropriate behaviors

Consumer Communication Increases choice, and increasing choice widens access; Raises patient’s awareness of their condition and their treatment options; Improves understanding of how to use the medicine; Provides efficacy and safety information Provides information on quality, reliability and consistency; Helps with recognition where there are multiple choices

Advertising Trends Voluntary Codes of Practice Pre-release Government (France) Industry (PAGB – UK) Independent Bodies (ASC – Canada) Post publication (adherence to advertising codes) Mexico, Germany, Japan, US

Convergence (Harmonization) 4

Convergence Efforts Focused on Drug requirements and Dossiers ASEAN; PANDRH; SADC; GCC Cosmetics ASEAN Nutritionals EU, Eurasian, ASEAN, Pacific Alliance

Benefits of Convergence Faster Access to Medicines Better Use of Limited Resources Reduced Duplication Minimize Use of Animal Testing Fewer Clinical Trials Needed

Regulatory Frameworks that Support Self-care Approval Processes 1 Defined Scheduling Criteria/Classifications 2 Advertising/Labeling Policies 3 Harmonization 4