1. Removing regulatory barriers to widespread use of the diaphragm as a potential HIV prevention method Naomi Lince Ibis Reproductive Health

2. The MIRA Trial Ortho All-Flex diaphragm & Replens ® gel Ortho All-Flex diaphragm & Replens ® gel n=4500 n=4500 South Africa and Zimbabwe South Africa and Zimbabwe Funded by the Bill and Melinda Gates Foundation Funded by the Bill and Melinda Gates Foundation UCSF, Ibis Reproductive Health, UZ-UCSF, MRC, PHRU UCSF, Ibis Reproductive Health, UZ-UCSF, MRC, PHRU

3. Current diaphragm use Approved in family planning programs worldwide Approved in family planning programs worldwide Relatively few current users Relatively few current users –US: < 2% –South Africa & Zimbabwe: <1% Much research indicating acceptable as contraceptive method Much research indicating acceptable as contraceptive method

4. Overview WHO recommendations for use WHO recommendations for use Regulatory status in US, RSA & Zimbabwe Regulatory status in US, RSA & Zimbabwe Impact of regulation on access Impact of regulation on access A medical device is, “an instrument [or] apparatus..[which is] intended to affect the structure or function of the body AND does not achieve its primary purpose through chemical action.”

5. Medical device regulation Based on legislation which: Based on legislation which: –Defines categories of products and roles of involved parties –Establishes standards to ensure safety, quality and efficacy –Creates agencies responsible for regulation –Provides enforcement mechanisms Drug regulation  device regulation Drug regulation  device regulation

6. WHO recommendations for contraceptive use 1. Use method in any circumstances 2. Generally use method 3. Use not recommended unless other more appropriate methods are not available or not acceptable 4. Method not to be used

7. WHO recommendations for contraceptive use Diaphragm alone is a 1 except for: Diaphragm alone is a 1 except for: – Parous women (2) – History of TSS (3) – UTI (2) – Allergy to latex (3) Diaphragm with N9 spermicide is a 3 when high risk of HIV or HIV+ Diaphragm with N9 spermicide is a 3 when high risk of HIV or HIV+

8. US Food and Drug Administration Regulates drugs and devices Regulates drugs and devices Device classification Device classification –I (Low risk; general controls) –II (Moderate risk; general & special controls) –III (High risk; general controls & premarket approval) Diaphragm is class II Diaphragm is class II Classification based on advisory input Classification based on advisory input

9. Medicines Control Council Medicines and Related Substances Control Act (1965) Medicines and Related Substances Control Act (1965) Pharmacy Act (1974) Pharmacy Act (1974) Regulates drugs Regulates drugs Medical device regulation drafted but not effective Medical device regulation drafted but not effective

10. Medicines Control Authority of Zimbabwe Drugs and Allied Substances Control Act (1969) Drugs and Allied Substances Control Act (1969) Medicines and Allied Substances Control Act (1997) Medicines and Allied Substances Control Act (1997) Regulates drugs Regulates drugs Considering medical device regulation Considering medical device regulation

11. Regulations improving access Regulatory authorities established to protect the public Regulatory authorities established to protect the public Improve access to safe, high quality products Improve access to safe, high quality products Encourage activities leading to increased availability and affordability of products Encourage activities leading to increased availability and affordability of products Contribute to greater global access Contribute to greater global access

12. Potentially impeding access Diaphragm fitting requirement Diaphragm fitting requirement –Based on advisory input –May be a barrier to access Labeling for use with spermicide Labeling for use with spermicide –HIV/STI vs. contraception vs. dual use Often easier to increase rather than ease restrictions Often easier to increase rather than ease restrictions More research necessary to ensure access isn’t unnecessarily impeded More research necessary to ensure access isn’t unnecessarily impeded

13. Summary Diaphragm is currently approved for use in most FP programs, yet legislation and regulations for use are not common. Diaphragm is currently approved for use in most FP programs, yet legislation and regulations for use are not common. Regulations must be evidence-based, updated in a timely fashion and adequately enforced to facilitate access. Regulations must be evidence-based, updated in a timely fashion and adequately enforced to facilitate access. Easing restrictions may contribute to wider access. Easing restrictions may contribute to wider access. Further research and dialogue is necessary to determine appropriate level of regulation. Further research and dialogue is necessary to determine appropriate level of regulation.

14. Conclusion A regulatory base exists which could be used to regulate medical devices if desired. A regulatory base exists which could be used to regulate medical devices if desired. Legislation and regulation are not the only factors affecting access. Legislation and regulation are not the only factors affecting access. Ensuring access requires coordination of efforts by all involved. Ensuring access requires coordination of efforts by all involved. Previous work with other technologies can inform this process. Previous work with other technologies can inform this process.

15. Acknowledgements Bill and Melinda Gates Foundation Bill and Melinda Gates Foundation MIRA Team MIRA Team Kelly Blanchard, Katy Backes and Teresa Harrison at Ibis Reproductive Health Kelly Blanchard, Katy Backes and Teresa Harrison at Ibis Reproductive Healthwww.cervicalbarriers.orghttp://cidea.ucsf.eduwww.ibisreproductivehealth.org