Global Campaign Europe: Making it better, stronger and more strategic Rebekah Webb, Coordinator Global Campaign for Microbicides

Welcome to PATH Ferney Program for Appropriate Technology in Health (PATH) PATH’s mission is to improve the health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviour Administrative home for the Global Campaign

Strategy Meeting Goals: To improve GCE advocacy and coordination To share approaches, experiences and best practices To discuss and strategise the future direction for GCE

Warm-Up Exercise What do you want to have achieved with respect to microbicides in 2 years’ time? What would make you smile?

Last year we asked: What is GC Europe? Coordinating Advocating Supporting Mobilising Awareness raising/promoting Collaborating Alliance New effort Focal point Reminding people Motivating Sustaining “Not really a campaign – more a policy + advocacy collaboration”

Overview of Microbicides State of Play Huge progress in last 5 years Multiple products in trials – two years from now, first efficacy results for 3 different strategies Promising new strategies for design/delivery Funding is increasing steadily International recognition of the potential role for microbicides

Overview  Despite the hype, still a long way to go Current trials may not show effectiveness Estimated $280 million needed over 10 years to get a vaginal microbicide Rectal will cost about two-thirds of this amount Other research needs must be funded too (e.g. microbicides for positive women) The field is not prepared yet for the next stage

QUIZ Q - Which European country is the largest donor to microbicides research? A – the United Kingdom ($14.5 million annually)

QUIZ Q - Which European country leads the world in terms of contribution to microbicides as a share of GDP? A – Ireland and the Netherlands

Four Strategies Vaginal Defence Enhancers BuffergelMay be contraceptive Surface-acting agents SavvyKills pathogens; probably contraceptive Entry and fusion inhibitors Carraguard, PRO 2000, Cellulose sulphate (Ushercell) Some block all, others HIV; may allow conception Replication inhibitors TMC120 (Dapirivine) Tenofovir ARV stategy; may allow conception

Trials Six products in Phase 3/2B (vaginal endpoint) Total of 14 products in clinical trials – some with more than one formulation Over 20 others behind that (no funding to push them on or not good enough to take on?) Rectal trials beginning

5 Products Furthest Along Buffer Gel ReProtect LLC Feb ,220 womenSouth Africa, Malawi, Tanzania, Zambia, and Philadelphia Carraguard Population Council Mar ,270 womenSouth Africa – 3 locations Cellulose sulfate Global Microbicide Project Oct women Mar ,574 women Nigeria Benin, Burkina Faso, India, Kenya, South Africa, Uganda PRO 2000 (.5%) Indevus Pharmaceutical, Inc. Feb ,220 womenSouth Africa, Malawi, Tanzania, Zambia, and Philadelphia PRO 2000 (.5% and 2%) Indevus Pharmaceutical, Inc ,920 womenSouth Africa, Uganda, Zambia, Tanzania Savvy Biosyn, Inc Mar ,142 womenNigeria (and Ghana)

Priorities for the field Broaden the pipeline Ensure success in clinical research Improve regulatory landscape Allocate sufficient funding Manage resources well Create dedicated research programs

What is needed Contract mechanisms between governments and small biotechs to boost early research Increased private sector investment EMEA - clear standards for evidence and data required

Regulatory issues Tightrope between approving too quickly or too slowly How can regulatory approaches anticipate and review data and still get products to people quickly

EU Member States Donors = NORWAYS WEDEN DENMARK N’LANDS IRELAND UK Targets = BELGIUM GERMANY FRANCE ITALY

Other pan-European models EATG IPPF-EN IAVI European partners AIDS Action Europe EuroNGOs European Women’s Lobby

Should we join other networks? Financial constraints on what we can put in (no revenue from partners) Need to get microbicides onto their agendas – easier at the table Many of our partners are members of these networks Will our partners feel that they don’t have to raise microbicides because we are now there?

European Working Group Consisting of all the partners in Europe Selected smaller group - elected or self-selecting? Responsibilities: fundraising, strategy, advice, material creation and support to secretariat staff TOR

Projects pending Finnish Presidency Meeting (Nordpol, IPPF-EN?) European tour of the exhibit (European Commission, EP, Interact, Cairde, AIDS Fonds, Nordpol, Kumulus, Sensoa) Rectal microbicides advocacy (NFI, HIV Denmark?) Positive Women Working Group Comprehensive responses at UNGASS and IEPFPFD, WAD etc - all Working Groups on target populations NSWP collaboration (GCM) EATG collaboration (GCM)