Patent Pooling and the Experience of the MPP
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Patent Pooling and the Experience of the MPP – A model for sharing the value of innovation to ensure access MPP's ED Greg Perry's presentation at IFPMA event on January 29, 2014.
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Patent Pooling and the Experience of the MPP
- 1. Patent Pooling and the Experience of the MPP– A model for sharing the value of innovation to ensure access
- 2. The MPP Background Created to increase access to quality, appropriate medicines for people living with HIV in developing countries Works by addressing a key challenge in HIV medicines access: the need to share patents Founded at the request of the international community in 2010 through the innovative financing mechanism UNITAID Endorsed by WHO, the UN High Level Meeting on AIDS, and the Group of 8 as a promising approach to improving access to HIV medicines
- 3. The Treatment Gap 35.3 million people live with HIV worldwide and will eventually need treatment 26 million need treatment now* 9.7 have it *According to the WHO Source: UNAIDS, WHO
- 4. MPP: Driving Innovation and Access for Developing Countries MILLIONS WAIT FOR LIFE-SAVING HIV TREATMENT. How can we deliver? Share Patents • “Pool” patents & technology through a collaborative voluntary licensing system • Create win-win solutions for all stakeholders Advancing innovation, access, and public health Reward Innovation Spur New Innovation • Ensure continued incentives for innovation • Facilitate innovations targeted at developing countries • Enable development of new fixed dose combinations that address treatment needs • Promote development of adapted formulations for children Ensure Access • Accelerate availability of more affordable versions of new ARVs in developing countries • Ensure access to innovative products in developing countries
- 5. Needed HIV Medicines Newer medicines recommended by the World Health Organization Fixed-dose combinations simplify treatment, increase adherence Special formulations needed for children living with HIV At this moment in time, the world faces both a great challenge and a great opportunity in the fight against the HIV epidemic.
- 6. Increased Patenting of ARVs in Developing Countries Median number of developing countries in which basic patents on ARV were filed (out of 75) 40 35 30 25 20 15 10 5 0 Pre-1995 ARVs Post-1995 ARVs Source: Medicines Patent Pool Patent Status Database on Selected ARVs 6
- 7. How the MPP works PATENT HOLDERS GENERIC MANUFACTURERS SubLicences Licences PEOPLE LIVING WITH HIV Medicines ROYALTIES Prioritise HIV Medicines Invite patent holders to negotiate Negotiate public-health licences Sign agreements Sub-licence to generics Manage licensees Increase access
- 8. Promoting FDCs through Patent Sharing Generic access Generic access Patented Generic access Generic access Patented, but licensed to MPP • Fixed-dose combinations improve treatment adherence for adults and children alike U • But face particular patent challenges: • Patents on just one component can have impact on access to entire regimen • There are also patents on the combinations themselves
- 9. The Public Health Perspective • MPP seeks public health orientated licenses covering: – Widest number of developing countries – Highest proportion of PLWHIV – Non-restrictive terms to ensure competition – Tech transfer provisions – Flexibility to use in combinations – Full transparency of terms (These go beyond traditional B2B licensing agreement between generic and originator )
- 10. MPP: Partnership Model Pharmaceutical Industry Governments IGOs Medicines Patent Pool People Living with HIV
- 11. Results to-date • Licenses signed on 7 priority ARVs, including WHO preferred 1st line treatment for both adults and children • 6 ARV manufacturers have licensed from the MPP and are working on the development and registration to cover up to 100 to 118 developing countries. • 1 hybrid agreement includes price reduction (90%) of brand product covering 138 countries 11
- 12. Work In Progress • Started negotiation for a key WHO preferred pediatric treatment. • In advanced negotiation for the two most important awaited new ARVs. • Finalizing agreements with 2 HIV manufactures to develop and manufacture paediatric medicines.