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THE MEDICINES PATENT POOL APPROACH TO SCALE UP ACCESS TO HIV AND HCV TREATMENT
Esteban BurroneHead of Policy
LEARNING FROM THE HIV RESPONSE
Source: MSF (2008) Untangling the Web of Antiretroviral Price Reductions. Geneva: MSF.
EVOLUTION OF AIDS DRUG PRICES: 2000-2008
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 1st 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 billionOr….
• If we “only” had USD 1.5 billion, we would be able to procure
ARVs for 150,000 people
• 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…
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…
WHAT HAPPENED?
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
• 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.
ACCESS ORIENTED LICENSING
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
PATENT
HOLDERS
Licences
Sub-
Licences Medicines
GENERIC
MANUFACTURERS
PEOPLE LIVING
WITH HIV,
HEPATITIS C OR
TUBERCULOSIS
ROYALTIES
THE MEDICINES PATENT
POOL (MPP)First patent pool in public health
THE MPP MODEL
Initially working only in HIV. Expanded to HCV and TB in November 2015.
Works through access oriented licences.
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
MPP LICENCES GEOGRAPHICAL COVERAGE
Product(s) Licensed LIC LMIC UMIC HIC Undefined Total
Abacavir (paed.) 31 53 31 5 1 121 +
Atazanavir 31 52 32 3 3 122 +
Cobicistat 30 42 18 9 4 103
Daclatasvir 31 46 30 2 3 112 +
Dolutegravir (paed.) 31 53 31 5 1 121 +
Dolutegravir 31 53 6 2 0 92 +
Elvitegravir 30 42 17 8 3 100
Lopinavir/Ritonavir (paed.)
31 50 19 2 0 102
Lopinavir/Ritonavir (Africa)
26 17 10 2 2 57 +
Raltegravir (paed.) 31 50 9 2 0 92
Ravidasvir * 1 9 9 - - 19 +
Sutezolid (global) 31 53 56 78 0 All
TDF 30 46 23 9 4 112
TAF 30 46 23 9 4 112
BENEFITING ALL STAKEHOLDERS
People living with HIV
Gain faster access to quality, appropriate, affordable and life-saving treatments
Low-cost producers
Simplified approach to the development of affordable versions of existing medicines, create needed new formulations
Patent holdersEffective way to make available innovative products in resource poor settings; licence management to ease transaction costs
Treatment providers and
donorsAn ability to stretch budgets to treat more people with WHO-recommended medicines
APPLYING THE MODEL TO THE VIRAL HEPATITIS RESPONSE
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: www.medspal.org
LICENCES FOR MARKETED VIRAL HEPATITIS B AND C
MEDICINES
Medicine(s) Brand
Name
Indication MPP
Licence
Countries
Tenofovir disoproxil
fumarate (TDF)
Viread ® Hepatitis B
(and HIV)
YES 116 countries but
few patents
remaining are
expiring in 2018
Tenofovir Alafenamide
(TAF)
Vemlidy ® Hepatitis B
(and HIV)
YES 116 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: www.medspal.org
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
Information on all
relevant licences in
LMICs
Data exclusivity
information from 15
countries
www.medspal.org
SEARCH EXAMPLE
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
MPP LICENCES IN HEPATITIS C: DACLATASVIR
SUB-LICENSEES
10 MPP sub-licensees working on the
development, registration, manufacturing
and/or distribution of DCV
TIMELINE FOR DACLATASVIR (DCV)
June
2014: DCV
approved in
Europe
20152014 2016 2017
April 2015:
DCV
included in
WHO EML
Q4 2015:
MPP signs
licence
with BMS
April 2016:
WHO guidelines
recommend
DCV
Q4 2017- Q1 2018
First MPP licensees
filing DCV and
SOF/DCV with WHO
Prequalification
Q4 2016:
MPP licensees
file DCV active
ingredient with
WHO
Prequalification
Two years after MPP licence with BMS, multiple generics will be
filing DCV and SOF/DCV for approval by WHO Prequalification (PQ)
PRICE DROPS IN INDIA
$330
$161
$108 $108$83
$60$55
$384
$205
$169$143
$97 $93 $93
$92
$61 $61$38 $30 $23
$285
$192$162
$0
$50
$100
$150
$200
$250
$300
$350
$400
$450
US
D P
er
bo
ttle
Sofosbuvir Sofosbuvir/ledipasvir Daclatasvir Velpatasvir
Courtesy of Giten Khwairakpam (Treat Asia)
Source: www.hepcasia.com in collaboration with community networks in India
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
IS THE PROBLEM OF ACCESS TO AFFORDABLE, QUALITY-ASSURED MEDICINES SOLVED?
• 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
GLOBAL DONOR FUNDING FOR VIRAL HEPATITIS
• 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)
HEPATITIS B TREATMENTS: TDF AND TAF
- 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
CONCLUSIONS
Supported by:
www.medicinespatentpool.org
@MedsPatentPool
www.medspal.org
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