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