1. www.global-campaign.org Making the Ethical Feasible: Assuring future access to care to those who sero-convert in microbicide trials Anna Forbes, MSS XVI International AIDS Conference August 15, 2007

2. www.global-campaign.org The Global Campaign for Microbicides unifying platform for 55 partners & 250 NGO endorsers Mobilize Demand & Investment –Generate political will through constituency building, awareness raising and legislative advocacy Policy Advocacy –Create a supportive policy, provider and user environment for the timely development, introduction and use of microbicides Accountability –Ensure that as science proceeds the public interest is protected and the rights and interests of trial participants, end-users and communities are represented and respected

3. www.global-campaign.org Flashpoint – trials are discontinued

4. www.global-campaign.org Global Campaign Role in Ethics Help give voice to community and civil society perspectives on trial design and ethics issues Help forge consensus around ethical debates that could delay progress Negotiate difficult line between urgency of the HIV epidemic and maintaining rigorous ethical standards Build capacity in the activist/community sector for ethical deliberation and debate

5. www.global-campaign.org Campaign’s ethics work 1997-2006 1997 – 1 st International Ethics Consultation on Microbicides 98-04 consultations & meetings with global civil society partners; WHO/UNAIDS, IAS, IAVI, etc. 2004 – 2 nd Consultation on Ethical Issues in the Clinical Testing of Microbicides (64 experts from 12 countries)

6. www.global-campaign.org 2005 Steering Committee drafted Consensus Statement because: Failure to guaranteed access to ART for sero-converters has been a “deal breaker” Access to even basic prevention and care is very limited in many settings where trials are being done Uncertainty about expectations was creating donor and investigator skittishness about cost & viability of trials

7. www.global-campaign.org Consensus emerging: new view of access to care –Not an ethical “mandate” but morally praiseworthy and politically necessary –Can be a policy commitment based on ethical aspirations and political realities –Need new procedures to incorporate stakeholder’ input and negotiate decisions –Need to broaden focus to other care-related issues, as well

8. www.global-campaign.org What’s involved in assuring access? Care and prevention package must be negotiated with host community before trial starts Durable MOUs and funding mechanisms needed because of future ART needs (after trial ends) Referral arrangements need to be monitored and actively supported –Providing transportation, advocate/liaison available

9. www.global-campaign.org “Who do we write the check to?” Need reliable mechanisms to create explicit and durable agreements for long term care provision Could be created by a task force of: clinicians, people living with HIV/AIDS, civil society advocates, health economists, legal and insurance experts and Providers with relevant experience (e.g. Pharm Access or MSF)

10. www.global-campaign.org What else besides ART? Provision of key sexual and reproductive health services Overall effort to “rachet up” local standard of care to reduce global disparities Collaborative efforts to assure that host communities get preferential access to any product proven effective

11. www.global-campaign.org Shared responsibilities Joint literacy training Community literacy for researchers Research literacy for communities Joint advocacy efforts –Research can’t correct health disparities BUT –Activists, researchers and host communities can jointly advocate to governments and funders to do this

12. www.global-campaign.org 2006 and beyond….. GCM is organizing a Task Force to: –Examine current models for operationalizing access to HIV care for those who seroconvert in clinical trials –Explore novel options for creating durable agreements for future access to care –Exercise will draw examples from both the microbicide and HIV vaccine worlds