AIM 2030 Access to Innovative Medicines Draft concept for a new World Bank-led multi-stakeholder initiative August 2014, Andreas Seiter

What is AIM 2030? An initiative to maximize access to innovative medicines for priority diseases in low- and middle income countries (LMICs) Innovative = less than five (?) years since first market introduction. Older medicines can be included if there is a public health interest and a clear access barrier due to non-availability or high price Focus on medicines with proven and relevant added therapeutic value over existing standard treatment Several work streams to address important access barriers Partnership between stakeholders that hold the key to improving access, led by the World Bank Complementary to other activities focusing on access to well established and widely available essential medicines

AIM 2030 – Three Main Work Streams AIM 2030 Financing Regulation Delivery

AIM 2030 – Potential Metrics Average time from first launch to availability in markets representing 80% of target population? Number and/or % of important NCEs launched with a “good practice” access strategy Percentage of total target patient population covered by access program Number of companies having signed up to an “Access” compact Identified a model to pay for novel antibiotics that does not reward overuse (“subscription” model?) Mobilizing US$ XX million p.a. for new financing models that make innovative medicines affordable …

AIM 2030 – Financing Work Stream Innovative or established financing and payment mechanisms for new essential medicines (examples Advance Market Commitments, AMFm, voucher schemes, e-voucher via mobile phone) Working with innovator companies to develop “best practice” access models for populations that can not afford new medicines (lowering cost of drugs) Develop business models that de-link sales volume from profitability (for example for novel antibiotics)

AIM 2030 – Regulation Work Stream Strengthening medicines regulatory authorities in LMICs in all dimensions of their role necessary to ensure functioning national markets for medicines Potential buy-down model for investments into regulatory strengthening, based on externally verifiable milestones (example WHO Assessment Tool, ISO 9001 certification) Regulatory harmonization between countries to reduce unnecessary barriers to market entry Organizing joint reviews for important new medicines to accelerate national decision making

AIM 2030 Delivery Work Stream Assess manufacturing capacity for licensed products and help countries upgrade their manufacturing industry for medicines if it makes economic sense Assist countries in establishing effective downstream supply chains for making essential medicines available without interruption (performance metrics, transparency, alignment of incentives) Develop innovative approaches to disease management to ensure efficient use of new, expensive treatments in a limited resource context

AIM 2030 – Potential Partners Bilateral and private donors with an interest in innovative medicines WHO and regional health organizations Innovating pharmaceutical companies and their associations, including those in developing countries/regions (example ANDI in Africa) Universities and Think Tanks active in this space, including “Access to Medicine Index” Civil Society organizations active in this space Implementing agencies/partners in countries (public and private, national and international) Regional development banks, other regional agencies involved in this field

Summary – AIM 2030 An initiative to maximize Access to Innovative Medicines for priority diseases in low- and middle income countries (LMICs) Potential Metrics Average time from first launch to availability in markets representing 80% of target population? Number and/or % of important NCEs launched with a “good practice” access strategy Percentage of total target patient population covered by access program Number of companies having signed up to an “Access” compact Identified a model to pay for novel antibiotics that does not reward overuse (“subscription” model?) Mobilizing US$ XX million p.a. for new financing models that make innovative medicines affordable Financing Work Stream Innovative or established financing and payment mechanisms for new essential medicines (examples Advance Market Commitments, AMFm, voucher schemes, e-voucher via mobile phone) Working with innovator companies to develop “best practice” access models for populations that can not afford new medicines (lowering cost of drugs) Develop business models that de-link sales volume from profitability (for example for novel antibiotics) Regulation Work Stream Strengthening medicines regulatory authorities in LMICs in all dimensions of their role necessary to ensure functioning national markets for medicines Potential buy-down model for investments into regulatory strengthening, based on externally verifiable milestones (example WHO Assessment Tool, ISO 9001 certification) Regulatory harmonization between countries to reduce unnecessary barriers to market entry Organizing joint reviews for important new medicines to accelerate national decision making Delivery Work Stream Assess manufacturing capacity for licensed products and help countries upgrade their manufacturing industry for medicines if it makes economic sense Assist countries in establishing effective downstream supply chains for making essential medicines available without interruption (performance metrics, transparency, alignment of incentives) Develop innovative approaches to disease management to ensure efficient use of new, expensive treatments in a limited resource context Potential Partners Bilateral and private donors with an interest in innovative medicines; WHO and regional health organizations; Innovating pharmaceutical companies and their associations, including those in developing countries/regions (example ANDI in Africa); Universities and Think Tanks active in this space, including “Access to Medicine Index”; Civil Society organizations active in this space; Implementing agencies/partners in countries (public and private, national and international); Regional development banks; other regional agencies involved in this field (example NEPAD)