THE MEDICINES PATENT POOL APPROACH TO SCALE UP ACCESS TO HIV AND HCV TREATMENT. Esteban Burrone Head of Policy

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1 THE MEDICINES PATENT POOL APPROACH TO SCALE UP ACCESS TO HIV AND HCV TREATMENT Esteban Burrone Head of Policy

2 LEARNING FROM THE HIV RESPONSE

3

4 EVOLUTION OF AIDS DRUG PRICES: Source: MSF (2008) Untangling the Web of Antiretroviral Price Reductions. Geneva: MSF.

5 FUNDING TO PROCURE TREATMENT Today: Approximately 16 million people on treatment in low and middle-income countries (UNAIDS data) At approximately USD 90 per patient per year for 1 st line treatment (WHO GPRM) Spending on ARVs approximately USD 1.5 billion Without low cost medicines (hypothetical): At USD 10,000 per patient per year Having 16 million people on treatment would have costed: USD 160 billion Or. If we only had USD 1.5 billion, we would be able to procure ARVs for 150,000 people

6 WHAT HAPPENED? First wave of ARVs became available from multiple (primarily Indian) generic manufacturers at affordable prices Strong activism and community mobilization Development of comprehensive treatment programs Significant donor funding and gradual stepping up in domestic resources Etc, etc, etc

7 WHAT HAPPENED? First wave of ARVs became available from multiple (primarily Indian) generic manufacturers at affordable prices Strong activism and community mobilization Development of comprehensive treatment programs Significant donor funding and gradual stepping up in domestic resources Etc, etc, etc

8 PATENTS ON NEW HIV MEDICINES COULD HAVE DELAYED ACCESS TO THE NEW MEDICINES MEDICINE PATENT EXPIRY (key patents only) Abacavir 2018 Atazanavir 2018/2019 Dolutegravir 2026 Elvitegravir/cobicistat 2024/2028 Lopinavir/ritonavir 2016/2024/2026 Raltegravir 2022/2025 Rilpivirine 2022 Tenofovir Disoproxil Fumarate 2017/18 Tenofovir Alafenamide 2021

9 ACCESS ORIENTED LICENSING Access oriented licensing became the norm in HIV, and increasingly one of the main mechanisms for access to affordable HIV medicines in many LMICs Can be bilateral or through the Medicines Patent Pool (MPP) and they allow generic manufacturers to make generic versions of patented medicines and supply LMICs Until 2015, this model had only existed in HIV.

10 WHAT IS THE MEDICINES PATENT POOL? Public health organization created in 2010 to increase access to quality, affordable medicines for people with HIV in LMICs Works by addressing a key challenge in HIV medicines access: sharing patents Established and fully funded by Facilitates competition to reduce prices and enables innovation in the form of new FDCs and paediatric medicines

11 THE MPP MODEL THE MEDICINES PATENT POOL (MPP) First patent pool in public health PATENT HOLDERS GENERIC MANUFACTURERS SubLicences Licences PEOPLE LIVING WITH HIV, HEPATITIS C OR TUBERCULOSIS Medicines ROYALTIES Initially working only in HIV. Expanded to HCV and TB in November Works through access oriented licences.

12 KEY FEATURES OF MPP LICENCES Broad geographical scope including 55 to 80% of MICs Transparent all licences are public Non-exclusive and non-restrictive to encourage competition Includes waivers on data exclusivity Strict quality assurance Compatible with use of TRIPS flexibilities Enable sales outside territory if no patents

13 MPP LICENCES GEOGRAPHICAL COVERAGE Product(s) Licensed LIC LMIC UMIC HIC Undefined Total Abacavir (paed.) Atazanavir Cobicistat Daclatasvir Dolutegravir (paed.) Dolutegravir Elvitegravir Lopinavir/Ritonavir (paed.) Lopinavir/Ritonavir (Africa) Raltegravir (paed.) Ravidasvir * Sutezolid (global) All TDF TAF

14 BENEFITING ALL STAKEHOLDERS Patent holders Effective way to make available innovative products in resource poor settings; licence management to ease transaction costs Low-cost producers Simplified approach to the development of affordable versions of existing medicines, create needed new formulations Treatment providers and donors An ability to stretch budgets to treat more people with WHO-recommended medicines People living with HIV Gain faster access to quality, appropriate, affordable and life-saving treatments

15 APPLYING THE MODEL TO THE VIRAL HEPATITIS RESPONSE

16 PATENTS ON HBV AND HCV MEDICINES MEDICINE BRAND NAME PATENT EXPIRY MAIN PATENT (SECONDARY PATENTS) Tenofovir disoproxil fumarate (TDF) Viread 2017 (2018) Tenofovir alafenamide (TAF) Vemlidy 2021 Daclatasvir Daklinza 2027 (2030) Sofosbuvir Sovaldi 2024 (2028/2032) Sofosbuvir/ledipasvir Harvoni 2030 (2033) Sofosbuvir/velpatasvir Eplclusa 2031 (2034) Glecaprevir/pibrentasvir Maviret 2031 (2035) Sofosbuvir/velpatasvir/voxilaprevir Vosevi 2033 (2034) Source:

17 LICENCES FOR MARKETED VIRAL HEPATITIS B AND C MEDICINES Medicine(s) Tenofovir disoproxil fumarate (TDF) Tenofovir Alafenamide (TAF) Brand Name Viread Vemlidy Indication MPP Licence Hepatitis B (and HIV) Hepatitis B (and HIV) YES YES Countries 116 countries but few patents remaining are expiring in countries Daclatasvir Daklinza Hepatitis C YES 112 countries + Sofosbuvir Sovaldi Hepatitis C NO 105 countries Sofosbuvir/ledipasvir Harvoni Hepatitis C NO 105 countries Sofosbuvir/velpatasvir Eplclusa Hepatitis C NO 105 countries Source:

18 HOW TO FIND OUT WHICH COUNTRIES ARE IN LICENCES OR HAVE PATENTS ON A HEPATITIS MEDICINE? Most comprehensive source of information on the patent and licensing status of medicines for HIV, TB and Hepatitis in low and middle income countries Patent status data from over 110 low and middle income countries Covering 8 hepatitis C and 2 hepatitis B products Data exclusivity information from 15 countries Information on all relevant licences in LMICs

19 SEARCH EXAMPLE

20 MPP LICENCES IN HEPATITIS C: DACLATASVIR Product: Daclatasvir and combinations containing DCV (e.g. SOF/DCV) Geographical Scope: 112 countries (including ~ 75 MICs) Quality assurance: requirement to obtain approval from WHO PQ or stringent regulatory authority Royalties: royalty-free licence Transparency: licence public on MPP website

21 10 MPP sub-licensees working on the development, registration, manufacturing and/or distribution of DCV SUB-LICENSEES

22 TIMELINE FOR DACLATASVIR (DCV) Two years after MPP licence with BMS, multiple generics will be filing DCV and SOF/DCV for approval by WHO Prequalification (PQ) June 2014: DCV approved in Europe April 2015: DCV included in WHO EML April 2016: WHO guidelines recommend DCV Q4 2015: MPP signs licence with BMS Q4 2016: MPP licensees file DCV active ingredient with WHO Prequalification Q Q First MPP licensees filing DCV and SOF/DCV with WHO Prequalification

23 USD Per bottle PRICE DROPS IN INDIA Sofosbuvir Sofosbuvir/ledipasvir Daclatasvir Velpatasvir $450 $400 $384 $350 $330 $300 $285 $250 $205 $192 $200 $161 $169 $162 $143 $150 $108 $108 $97 $83 $93 $93 $100 $60 $92 $50 $55 $61 $61 $38 $30 $23 $0 Courtesy of Giten Khwairakpam (Treat Asia) Source: in collaboration with community networks in India

24 IS THE PROBLEM OF ACCESS TO AFFORDABLE, QUALITY-ASSURED MEDICINES SOLVED? NO! Local market authorization: low prices apply where there is competition. Many countries have no (or only one) locally registered product Quality assurance: Still only few companies have obtained WHO PQ for SOF, and none for other DAAs (DCV filings starting) Out of pocket payments: Without treatment programs, access price may still be too high for many Generic competition available in countries included in the licences or where products not patented (see MedsPaL.org) New drugs: new medicines like G/P could shorten treatment, facilitate treatment for specific populations

25 GLOBAL DONOR FUNDING FOR VIRAL HEPATITIS Some funding for HIV/HCV co-infection by Global Fund (e.g. Ukraine) UNITAID: project based funding EndHep 2030 Fund launched at World Hepatitis Summit 2017: Grant-making body to raise $ 1 billion Focus on capacity building and advocacy for sound public health policy development within the context of national health systems Managed by Rockefeller Philanthropy Advisors

26 HEPATITIS B TREATMENTS: TDF AND TAF Since at least 2011 most LMICs have had access to generic TDF In 2018 any remaining patents are expiring and generic TDF should be available globally Current generic price: USD 32 per year through international procurement (WHO GPRM) Price at which TDF is available in private markets in Sub-Saharan Africa: approx. USD 10 to USD 25 per month (source: patient groups) Procurement mechanisms for obtaining USD 32 price exist and can be used for TDF Generic TAF will be available from generics in 116 countries, with possibility of further price reductions (25mg vs. 300mg)

27 CONCLUSIONS - Access to affordable quality-assured medicines is key for elimination targets to be attainable - Medicines prices have come down considerably in many countries over past two years significantly reducing funding needs - Access-oriented licensing of hepatitis medicines have contributed significantly to price drops (as in HIV) - Challenges remain for actual access to quality-assured affordable medicines in-country - Access to affordable medicines can help trigger the response, but HBV example shows clearly not sufficient

28 Supported by: