DRAFT AGENDA Regional consultation on access to direct-acting agents (DAAs) for hepatitis C virus (HCV) treatment Dates: February 25 and 26, 2015 (Wednesday & Thursday) Venue: Rembrandt Hotel, Sukhumvit Soi 18, Bangkok Consultation objectives:
Identify current and anticipated DAAs to advocate for. Understand how anti-diversion measures affect marginalized groups, undermine access and scale-up of HCV treatment. Review the implementation of the sofosbuvir voluntary licenses, developments on the patent application rejection in India, and potential timelines for initiation of generic production. Strategize how to respond to proposals for anti-diversion measures, and increase community awareness of their potential negative impact on access and implications for patients’ rights.
Day 1: 25 February 2015, Wednesday (Moderator: Paul Cawthorne) 9:00- 9:30
Registration
9:30 – 9:35
Welcome to participants: Dr. Nicolas Durier, Director of Research, TREAT Asia/amfAR
9:35 – 9:40
Overview of the agenda and objectives of the consultation: Giten Khwairakpam, TREAT Asia/amfAR
9:40-10:30
Key DAAs and review of advocacy priorities and challenges: - Overview of DAAs and potential pan-genotypic regimens - Access to compassionate use programs in developing countries for advanced liver disease - How to manage local regulatory requirements for importation for “named patient” programs - Why we have to follow local registration processes of key DAAs - Snapshot of patent barriers with an emphasis on recent developments in India - Voluntary licenses and how they apply to currently available and future DAAs - Plans for local DAA production in developing countries – hope on the horizon Leena Menghaney, MSF Access Campaign
10:30-10:50
Coffee break
10:50-11:20
Short overview: Gilead’s anti-diversion plan and how it impact local distribution and access Leena Menghaney, MSF Access Campaign
11:20-12:30
Pakistan’s anti-diversion measures through private distributors - How it is being implemented - Its negative impact on treatment access and implications for patients’ rights. - Current and future responses from civil society and country governments - Developments with regards to future generic production Hafiz Aziz Ur Rehman, Pakistan (40 minutes max presentation and 30 minutes open discussion)
12:30-1:30
Lunch break 1
1:30-2:30
Anti-diversion measures through Egyptian Ministry of Health HCV treatment centers - How they are being implemented - Their negative impact on treatment access and implications for patients’ rights - What other negotiating countries and civil society can learn from Egypt and should do to address as and when needed in their own context - Developments in local generic sofosbuvir production Heba Wanis, Egypt (40 minutes max presentation and 20 minutes open discussion)
2:30-3:00
Briefing from Indonesia on negotiations with Gilead, the patent situation, progress on sofosbuvir registration, and current access challenges (presentation and discussions broadly based on pre-set questions sent) Sindi Putri, IAC, and Suhendro Sugiharto, PKNI
3:00-3:20
Coffee break
3:20-3:50
Situation in Vietnam on negotiations with Gilead, the patent situation, progress on sofosbuvir registration, and current access challenges (presentation and discussions broadly based on pre-set questions sent) Thanh Huong Nguyen, SCDI
3:50-4:20
Developments in Thailand on use of sofosbuvir in the national HCV treatment program -Progress on negotiations with DAA manufacturers -Opportunities to use DAAs in the Thai national program Paul Cawthorne and Giten Khwairakpam
4:20-5:00
Open discussion on Day 1 and plans for the Day 2 -Paul Cawthorne
Day 2: 26 February 2015, Thursday (Facilitator: Paul Cawthorne) 9:30-12:30 (Coffee break from 10:30 to 10:50).
12:30-1:00
Strategies for improving access to DAAs - What issues are we likely to face in accessing DAAs? - What can we do to address pre and post grant oppositions both at the national and regional levels? - What should we do to prepare and inform our national decision-makers and stakeholders to address anti-diversion in our countries? - What can we do with Gilead or other pharmaceuticals? - What can WHO be asked to do to proactively advocate (themselves and with civil society) for national HCV programs to be more widely initiated? - Where are areas where civil society should intervene at the national level? - What support is required to facilitate national actions? - What can be done from a regional level? Summary of discussions, review of the way forward on the regional strategy(ies), and closing Giten Khwairakpam. TREAT Asia/amfAR
2
