VOLUNTARY PATENT POOLING FOR PUBLIC HEALTH A Model For Innovation And Access

THE MEDICINES PATENT POOL Created in 2010 to increase access to quality, appropriate medicines for people living with HIV in developing countries The MPP is a public health voluntary licensing mechanism that partners with all key stakeholders (governments, patent holders, generic manufacturers, civil society and community/patient groups) Initially focused on HIV alone (and Hep B in the case of TAF and TDF), has now expanded to HCV and TB Endorsed by WHO/WHA, the UN High Level Meeting on AIDS, the G8 as a promising and innovative public health approach The MPP was founded and remains fully funded by UNITAID

PATENT HOLDERS Licences Sub- Licences Medicines GENERIC MANUFACTURERS PEOPLE LIVING WITH HIV, HEPATITIS C OR TUBERCULOSIS ROYALTIES THE MEDICINES PATENT POOL: A PUBLIC HEALTH VOLUNTARY LICENSING MECHANISM

1.Accelerating availability of new medicines in developing countries 2.Facilitating development of needed formulations 3.Promoting robust market competition for new patented medicines KEY OBJECTIVES OF MPP LICENCES

KEY FEATURES OF MPP LICENCES Non-exclusive, non-restrictive to encourage competition Transparent – all licences are public Wide geographical scope 55% to 80% of middle income countries covered Waivers for regulatory data exclusivity Tiered royalties where possible to enhance coverage Public-Private Market Segmentation to increase geographical scope

KEY FEATURES OF MPP LICENCES Compatibility with TRIPS flexibilities Requires generics to comply with stringent quality standards Company patent information disclosed Flexibility to create fixed-dose combinations Freedom to challenge patents Out-licensing management Sales allowed outside agreed territory if no patent infringement

Atazanavir Daclatasvir (HCV) IN-LICENSING: CONCLUDED AGREEMENTS Lopinavir Ritonavir (separate paediatrics and adults licences) Cobicistat Elvitegravir Emtricitabine Tenofovir Alafenamide* Tenofovir Disoproxil* Darunavir related Valganciclovir (pricing agreement) Solid dispersion nano technology for HIV Darunavir (paed) (non- assert) Raltegravir (paed) Abacavir (paed) Dolutegravir (paed) Dolutegravir (adults)

GENERIC INDUSTRY PARTNERS MPP is currently running more than 60 development projects with 13 development partners

In November 2016, the MPP’s mandate was expanded to work on new, patented hepatitis C and tuberculosis medicines with UNITAID funding First hepatitis C licence already signed to increase access to daclatasvir – a medicine in WHO’s Essential Medicines List MANDATE EXPANSION

Product(s) Licensed LICLMICUMICHICUndefinedTotal Abacavir (paediatric) Atazanavir Cobicistat Daclatasvir Dolutegravir (paediatric) Dolutegravir Elvitegravir Lopinavir/Ritonavi r (paediatric) Lopinavir/Ritonavi r (Africa) Raltegravir (paediatric) Tenofovir disoproxil fumarate Tenofovir alafenamide MPP LICENCES GEOGRAPHICAL COVERAGE

In November 2015, the MPP obtained a licence on daclatasvir (DCV) a new HCV drug recommended for genotypes 1, 2, 3, 4 Key features of the licence: Enables MPP to licence to multiple generic manufacturers Supply in at least 112 countries (including ~75 middle-income) Other countries may also be able to benefit (e.g. countries in which DCV not patented) Royalty-free: no royalties flowing back to the patent holder Licensees can combine DCV with other medicines to create combinations (e.g. DCV+SOF) Licensees need to meet strict quality assurance requirements (e.g. WHO Prequalification) Text of licence is public – available on MPP website MPP LICENCE ON DACLATASVIR

Medicines Patent Pool Licensors 12 ARV licences + 1 HCV licence 13 Licensees MPP licensees distributing generics 119 Countries Benefitted from generic competition through MPP agreements 63 New Countries Savings $195mn In formulation prices after MPP agreements 74% average drop MPP Impact Pointers Jan-2012 to Dec-2015 MPP Impact Pointers Jan-2012 to Dec API projects and 88 formulation projects are currently under development or planned 6 6 IMPACT OF MPP AGREEMENTS Review and independent assurance of impact by KPMG Serviced by MPP licensees 9.1mn Patient-years

NEXT STEPS MPP has adapted its governance structure to include experts in HCV and TB MPP is engaging with stakeholders in reviewing its prioritization process for HIV,HCV and TB

MEDICINES PATENT POOL