1. GLOBAL HEALTH SECURITY text Looking Ahead: Strategies for Building a Platform Pandemic Influenza Vaccines: Building a Platform for Global Collaboration David Nabarro January 30 th 2007

2. GLOBAL HEALTH SECURITY text 2 2 Pandemic Vaccines have Potentially a high public health value and huge social and economic benefits, low commercial value for developers and manufacturers There is not agreement on the optimal product The market is uncertain There are risks for manufacturers in scaling up production Regulatory, Intellectual Property challenges lie ahead There are deep concerns about equity of access: there will be public pressure for equity of predictable and prompt access to vaccines Pandemic vaccines do not have the potential to result in sustained multi-billion dollar markets Pandemic Influenza Vaccines Not an easy prospect for Manufacturers

3. GLOBAL HEALTH SECURITY text 3 3 Need for faster research and development to develop better vaccine production technologies Need to shorten lead times and manufacturing cycles of existing vaccines Need to factor in the inevitable redundancy in the product – short shelf life, reduction in potency due to antigenic drift Need for global coverage And so on…. To respond manufacturers and researchers will need adequate incentives Finance for strategic R and D; finance to reduce manufacturers’ risks Are there Investors convinced that the cost is worthwhile? Pandemic Influenza Vaccines The Public Health Imperative

4. GLOBAL HEALTH SECURITY text 4 4 l Potential Stakeholders: – R and D groups – Manufacturers – Regulators – Governments – International Bodies l Potential value of a global platform – A meeting place where open (and critical) dialogue is possible – An opportunity for structured exchanges to tackle difficult issues (strategies to find solutions, together) – A grouping of committed partners determined to move forward in synergy: an INITIATIVE Pandemic Influenza Vaccines Why a global platform might help

5. GLOBAL HEALTH SECURITY text 5 5 l An Initiative for Action means having – Common Vision and Goal – Agreed Strategy (product, development, manufacture, distribution, administration, control) – An Implementation Process – Attention to Access and Distribution Issues – Backing to make it happen Pandemic Influenza Vaccines Platform for Talk or Initiative for Action: which way to go?

6. GLOBAL HEALTH SECURITY text 6 6 l Components – Increase use of seasonal influenza vaccine – Increase production capacity for pandemic vaccines, independent of seasonal vaccine use – Research and develop new technologies and new vaccines  comprehensive analyses of existing problems; global overview of generic solutions; strategic basis for a new initiative Pandemic Influenza Vaccines WHO Global Action Plan to Increase Access to Pandemic Vaccines Strategy for a New Initiative

7. GLOBAL HEALTH SECURITY text 7 7 l Challenge 1: Ensuring there is worldwide political support for international attention to pandemic vaccines (funding follows a political wind) l Challenge 2: Selection of technology : Speed and cost of production, streamlined regulatory review. safety and intellectual property issues, administration route l Challenge 3: Establishing the demand : Need for developing as well as developed countries to agree on potential demand in a context of uncertainty: willingness to stockpile, to vaccinate before a pandemic, to “guarantee” supply to poor countries l Challenge 4: Clarifying the supply potential – specifically the potential for steady state manufacture, for surge in the event of pandmeic: determining the risks that industry will face l Challenge 5: Preparing an initiative: Options for different partners to work together on (a) Demand analysis, (b) R and D, (c) Intellectual Property Protection, (d) Production, (e) Regulation and PMS, (e) Distribution issues, (f) Advance Purchase l Challenge 6: Structure and programme for the Initiative Pandemic Influenza Vaccines Establishing an Initiative: Challenges to be addressed