HIV Treatment Access

in Middle-Income Countries

Project by ITPC-led

Consortium and funded by

UNITAID

Solange Baptiste

May 11, 2015

ITPC

Global HIV/AIDS epidemic: MICs vs. LICs

2

Middle-income countries (MICs) comprise a growing share of the global HIV/AIDS burden, but have lower rates of antiretroviral (ARV) treatment coverage compared to low-income countries (LICs)

Proportion of people living with HIV by country income level

Source: Schwartländer, Bernhard. “What will it take to turn the tide?” UNAIDS/IMF, 2012. AIDSinfo Online Database and I-MAK analysis.

% of eligible

patients receiving

ARV treatment

(2013)

44%

42%MICs

LICs

HICs N/A

Why focus on middle-income countries?

3

“Ensuring universal HIV treatment access in middle-

income countries remains a major challenge”– 2013 UNAIDS Global Report on the AIDS Epidemic

• They are home to almost half of the world's population, 1/3 of people living on less

than $2 per day, and a large and growing share of HIV infections (currently 62%)

• They pay exorbitantly high ARV prices1, which makes closing the treatment gap

unaffordable. This is due to:

─ Patent monopolies: ARV companies file more patents in MICs than LICs, effectively

blocking generic competition which would dramatically lower prices. However, many of

these patents are unmerited.2

─ Exclusion from drug access initiatives: ARV companies offer tiered pricing or

generic licenses to LICs, but most MICs1 are excluded from these programs.

• They represent a large unmet need – no other global HIV interventions focus on

MICs

Source: World Bank, AIDSinfo online database and I-MAK analysis.

Notes: 1 Statements are most applicable to MICs outside of sub-Saharan Africa (SSA), as MICs in SSA are typically included in

originator drug access programs. 2 Many patents do not meet the lawful criteria for inventiveness. Under TRIPS, countries may

deny patents if a drug is not truly inventive, e.g. when companies make minor modifications and apply for follow-on patents – a

practice known as evergreening.

MIC intervention overview

4

Remove patent barriers to generic competition in four

focus MICs by reforming their patent laws, challenging

undeserved patents, and advocating for the selective use of

compulsory licenses1.

Increase access to more affordable generic ARVs,

generating $150M annual savings across the four

countries, which can be used to treat 130,000 additional

patients.

Influence other countries to follow these precedents and

achieve similar results.

Objectives

Intended

outcomes

1 A compulsory license is an authorization granted by the government to use another's intellectual property without the consent

of the patent holder, while paying a reasonable royalty to the patent holder. Subject to certain conditions, the TRIPS agreement

allows developing countries to issue compulsory licenses for medicines if the country cannot otherwise access the medicine at

an affordable price.

Focus countries of intervention

5

Figure 3: Map of project countries

Focus countries selected based on:

• Disease burden: Countries comprise 1.3M people needing ARV treatment

• Impact potential: Large potential impact given significant overspend on ARVs

• Readiness for action: Poised for patent law reform given existing momentum and

partner support; local capacity for generic ARV production

• Capacity: Strong in-country leaders to challenge patents and reform laws

Argentina

Brazil Thailand

Ukraine

Country example: ARV prices in Argentina

6

Key ARVs in Argentina are priced 500-5000% higher than generic versions

(2013 data)

Source: MSF “Untangling the Web”, 16th Ed. Where prices were not listed, lowest prices in WHO GPRM used

Prices for target ARVs per patient per year (pppy)

$-

$2,000

$4,000

$6,000

$8,000

$10,000

ATV TDF/FTC LPV/r DRV RAL ETR

Lowest international generic prices

Branded prices in Argentina

Key second- and third-line ARVs

Argentina does not use TDF in first-line

therapy as recommended by the WHO,

citing cost-effectiveness as the primary

reason

• In other focus countries, price premiums for targeted ARVs are 200-2000%.

Coalition members: Country leadership

7

Fundación Grupo Efecto Positivo (Argentina)

• Promotes HIV treatment access through political/social

engagement and policy dialogue on ARV patents, working

with broad network of gov. & civil society partners

All-Ukrainian Network of PLWH (Ukraine)

• Largest PLHIV organization in Ukraine with strong

government relationships that intervenes on key ARV patent

litigations

Associação Brasileira Interdisciplinar de AIDS (Brazil)

• 25 year old organization, globally recognized as a leading

HIV and human rights NGO, with deep experience in patent

oppositions and law reform

AIDS Access Foundation (Thailand)

• Over 20 years experience working closely with government

and community, including on policy, free trade agreements,

compulsory license issuance, and patent litigation

Coalition members: Global leadership

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International Treatment Preparedness Coalition (ITPC)

• Global grassroots network of people living with HIV and

their supporters united in promoting access to treatment

• Pioneer in treatment access advocacy, community

education and capacity building around ARV access

Initiative for Medicines, Access & Knowledge (I-MAK)

• Expert team of lawyers and scientists that challenge

invalid drug patents to facilitate generic competition,

catalyze price reductions and improve access

• Provides technical support to country partners to

challenge patents and reform patent systems

• Leading global patent oppositions unit in the public

interest

Log Frame at-a-glance

GOAL (Impact) : Reduction in ARV treatment costs

Outcome : IP barriers to generic market entry are challenged

OUTPUTS

1: Inclusion of public health safeguards in draft patent law amendments

2: Prevention of TRIPS-plus provisions in patent laws

3: Public Health approaches to patent examination supported in beneficiary countries

4: Pre-grant oppositions/invalidation actions filed on priority ARVs

5: Opportunities for Compulsory Licenses identified

6: Functional information exchange platform to disseminate knowledge about IP

9

Plan of action

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File patent oppositions1 on key

ARVs that do not represent true

innovations

1

Reform patent laws to improve

patentability criteria/anti-

evergreening2 measures; expand

patent opposition mechanisms; and

strengthen compulsory licensing

grounds and procedures

2

Advocate for selective use of

compulsory licenses by

dialoguing with government and

pursuing necessary law reforms

3

Create technical working groups

and strategy guides to support the

success of IP interventions build

capacity with government & civil

society partners

4

1 Patent s can be opposed either before or after they are granted (known as pre-grant and post-grant oppositions) by providing patent offices with

evidence that the product does not demonstrate inventiveness and/or enhanced therapeutic efficacy. 2 Evergreening occurs when companies make minor product modifications and apply for follow-on patents.

Projected impact of intervention

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Financial impact Patient impact

Cost savings per ARV = ( current price -

generic price1) x # of patients taking the

drug

Additional patients treatable = total ARV cost

savings / average per-patient cost of

treatment

$150M annual

savings across 10

target ARVs

130,000 additional

patients2 treatable

with savings

1 Generic prices assume a premium above the lowest international generic prices. For Brazil and Argentina, a 230% premium is

assumed based on the average price difference between lowest international generic prices and locally-produced generic ARVs.

For Thailand and Ukraine, price premiums of 36% and 26% were calculated based on historical price premiums paid on ARVs in

publicly available procurement data.2 Assumes that all financial savings are reinvested in scaling-up treatment to additional patients.

Impact will be magnified as patent law reforms affect other

medicines and as additional countries follow these

precedents

Return on investment

12

$650M

10

$641M

$6M

200

50

0

Total

intervention

costs

5-year net present

value (NPV) of annual

savings in 4 focus

countries

107x

• Annual savings of $150M

across four countries

• Savings can treat an

additional 130,000 patients

with HIV/AIDS

• This represents an

investment of ~$45 for

each additional life saved

A $6M investment will drive significant impact for these four MICs,

representing an ROI of 107x

350

Process for Log Frame development – Internal

consortium

• Very involved coordination and thought

partnership process with many partners

• All partners developed workplans, budgets,

attended frequent calls, skype meetings

(bilaterally and as a full group)

• Issues specific to the nature of working in a

consortium of organizations that never worked

together formally

– Deciding what to do

– How to bring it all together

– Time constraints

– Budget congruency and negotiations

– Clarity needed on interpretation and presentation of data in

log frame13

Process for Log Frame development – With UNITAID

Challenges included:

• Process and log frame changed 2 to 3x – undue

burden

• Lack of clarity on who as the guide on log frames

(seemed to be a lack of internal UNITAID department

cohesion)

• During the project plan phase the log frame evolution

was smoother and we really credit being able to work

with Jane (and the M&E team) who were all working in

sync, coordinating together, providing feedback in a

timely manner, and offering concrete suggestions to the

finish line

• Request to consider last minute changes very carefully

especially for grantees working with many partners and

in many different countries.14

Thank You