Improving access and innovation in HIV treatment: the Medicines Patent Pool and other approaches IAC –25 July 2012

Different mechanisms to address IP challenges

Mariângela Simão Rights, Gender and

Community Mobilization Department UNAIDS

People receiving antiretroviral therapy versus the 2015 target and the number of AIDS-related deaths, low- and

middle-income countries, 2003–2011

AIDS-­‐related    deaths  

Es0mated  range    of  AIDS-­‐related  deaths  

People  receiving    an0retroviral  therapy  

2015  Target  

Eligibility for antiretroviral therapy versus coverage, low- and middle-income countries, by

region, 2011

The  area  of  the  larger  circle  represents  the  number  of  people  eligible  for  an4retroviral  therapy.  The  shaded  circle  and  percentage  represent  coverage  in  2011.  

Prices of first-line and second-line ARV regimens for adults in low-income countries, 2008–2011

Source:  Global  Price  Repor4ng  Mechanism,  World  Health  Organiza4on,  2012.  

FIRST-­‐LINE  REGIMENS  

SECOND-­‐LINE  REGIMENS  

Value for money: price reductions

- 57% - 53% - 41%

- 15%

Med

ian

trans

actio

n pr

ice

(US

$/pp

y)

0

700

TDF+FTC+EFV TDF+FTC+NVP TDF+3TC+EFV ZDV+3TC+EFV 3TC+NVP+ZDV

-60%

Prices of first-line regimens in low-income countries

Source: Global Price Monitoring Mechanisms, WHO 2012

2008 2011

The  vast  majority  of  people  living  with  HIV  will  be  in  middle  income  countries  

70%

34%

13%0%

20%

40%

60%

80%

100%

2000 2010 2020

High

Upper  middle

Low  middle

Low

Proportion of people living with HIV by countries’ income level category

Source: IMF (DATE), UNAIDS (DATE)

So we need diverse approaches so that...

o  “No one is left behind” o  How to increase coverage – upper middle income

countries; key populations, etc

o No double standards o Simpler to use, less toxic, heat stable drugs are

good for patients no matter where they live

o  People live long and better lives o Early diagnosis. Earlier treatment initiation(?) o Better drugs and monitoring kits o …………..

Addressing innovation and access to innnovation

o Improve  effec4veness,  tolerability  and  resilience  of  1st  line  regimens  

o BeIer  tools  to  assess  regimen  switch  needs:  PoC  VL  

o New  drugs  in  the  pipeline:  accelera4ng  entry  into  market    

o Ensuring  compe44on  for  innova4ve  products:  licensing  mechanisms  and  technology  transfer  o   Global  R&D  conven4on?  

Strategies and initiatives that can be utilized to reduce costs of treatment

•  Role for the UN supporting countries on the use of TRIPS flexibilities, access principles – guidelines, policy papers, issues briefs - avoid  TRIPS  +  measures  in  FTAs

•  UNITAID, CHAI, PEPFAR, GF,….

•  Local production and regulatory harmonization

•  Upcoming – consultation on pricing in upper middle income countries

What strategies could be utilized to reduce costs of treatment?

IP related issues and access o Voluntary licensing mechanisms - MPP o Other initiatives (?) o Compulsory licenses o Patent opposition (TDF in Brazil)

What strategies could be utilized to reduce costs of treatment?

IP related issues and access o Transfer  of  technology  o Analysis  of  patent  requests    

o Public  Health  lens  to  avoid  gran4ng  patents  for  applica4ons  that  don’t  fulfil  TRIPS  requirements  (novelty,  inven4ve  step  and  industrial  applica4on)  –  WHO’s  guidance  

o   “prior  consent”  mechanisms    

Successful country initiatives to cut the costs of ARV

Note:  (i)  At  an  exchange  rate  of  7.40  ZAR/USD,  the  savings  amounted  to  R  4.7  billion.  Sources:  (ii)  Massive  reduc,on  in  ARV  prices.  Johannesburg,  Government  of  South  Africa,  2010  (www.info.gov.za/speech/DynamicAc4on?pageid=461&sid=15423&4d=26211,  accessed  15  June  2012);  (iii)  Mutabaazi  I.I.  Scaling  up  an4retroviral  treatment  using  the  same  dollar:  cost  efficiency  and  effec4veness  of  TASO  Uganda  Pharmacy  Management  System  of  CDC-­‐PEPFAR  funded  program.  XIX  Interna,onal  AIDS  Conference,  Washington,  DC,  22–27  July  2012.  Note:  the  content  of  poster  discussion  abstracts  and  poster  exhibi4on  abstracts  for  the  XIX  Interna4onal  AIDS  Conference  is  embargoed  un4l  15:00  (U.S.  Eastern  Standard  Time)  on  Sunday,  22  July  2012;  (iv)  Viegas  Neves  da  Silva  F,  Hallal  R,  Guimaraes  A.  Compulsory  licence  and  access  to  medicines:  economic  savings  of  efavirenz    in  Brazil.  XIX  Interna,onal  AIDS  Conference,  Washington,  DC,  22–27  July  2012.  Note:  the  content  of  poster  discussion  abstracts  and  poster  exhibi4on  abstracts  for  the  XIX  Interna4onal  AIDS  Conference    is  embargoed  un4l  15:00  (U.S.  Eastern  Standard  Time)  on  Sunday,  22  July2012.  

Bridging the gap?