1. How Regulatory Frameworks Increase Access to Non-Prescription Medicines

2. 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
2 James, J. (February 14, 2013). Health Policy Brief: Patient Engagement. Health Affairs. Retrieved from

3. 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

4. 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

5. 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

6. Registration Processes1

7. 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

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

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

10. 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)

11. 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

12. 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

13. 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.

14. Defined Scheduling Classifications2

15. 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

16. 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.

17. Advertising/Labeling Polices3

18. 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

19. 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

20. 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

21. Convergence (Harmonization)4

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

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

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