Presentation findings and recommendations on HIV, the law and treatment access.


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  • At end of 2010, 6 650 000 PWA receiving treatment globallyDespite this, less than 50% of PWA in need of treatment globally are receiving it, based on WHO revised guidelines of 350 CD4
  • Treatment 2.0 lists the taking advantage of TRIPs flexibilities as a key component of cost reduction
  • Presentation findings and recommendations on HIV, the law and treatment access.

    1. 1. Findings and Recommendations on HIV, the law and Treatment Access: HIV/AIDS practice Meeting Dubai, 12 January 2012 Tenu Avafia HIV/BDP, NY
    2. 2. Finding 1:TRIPS Flexibilities have increased generic competition Source: MSF (2010), Untangling the Web of Antiretroviral Price Reductions, 13th ed.
    3. 3. Finding 2: Generic Competition has resulted in increased treatment scale up • 22-fold increase in treatment in 7 years • At end of 2010, 6 650 000 PWA were receiving treatment globally, about 47% of those in need • Only 23% of children have access to ART • 2011 HLM commitment of 15 million by 2015
    4. 4. Finding 3: There is an Impending Treatment Crisis • India produces >85% of generic ARVs used by low and middle income countries globally • 2005 Indian Patents Act was amended to comply with TRIPS Agreement • 2010 UNDP study shows that more medicine patents being granted in India • Patenting of new medicines in India will affect availability of 2nd and 3rd generation ARVs in developing countries
    5. 5. Finding 4: Countries will have to use Flexibilities to Sustain and increase Treatment Levels • Up to 95% of PWA on ART still on first generation treatment • Because of resistance, switch to second generation ARVs: some under patent 3.4x times more expensive, 3rd generation up to 23.4 times more expensive • TRIPS flexibilities can reduce cost of treatment for Hep C, and NCDs e.g. Cancers, cardiovascular diseases • Recommendation: Countries should adopt and utilize the TRIPS public health flexibilities • Explore new TRIPS flexibilities and modalities e.g. South-south
    6. 6. Indonesia Oct 2004 GU (manufacture) -lamivudine, nevirapine 7-8 years (remaining patent term) 0.5% of the net selling value of ARVs to patent holder Malaysia Oct 2003 GU to import: didanosine; zidovudine; didanosine+zidovudine 2 years Offered 4% Thailand Nov '06 GU: to import/manufacture Efavirenz until 31 Dec. 2011 0.5% Thailand Jan '06 GU to import/manufacture: clopidogrel Patent expiry or no longer needed 0.5% Thailand Jan 2007 GU to import/manufacture : lopinavir/ritonavir Until 31st January 2012 0.5% of total sale value of the imported/locally produced Thailand Jan 2008 3 Government Use licence for cancer drugs Patent expiry or no longer needed 3-5% Brazil May 2007 GU to import efavirenz 5 years 1.5%
    7. 7. Finding 5:The Emergence of IP enforcement agenda is impeding access to treatment • Several TRIPS+ FTAs involving US, EU, Japan and EFTA countries • TRIPS + measures can impede the use of TRIPS flexibilities, often resulting in higher drug costs • UNDP model shows US CAFTA FTA resulting in 40% increase a year • DE resulted in 2 generic versions of LPV/r being de-registered in Ukraine • Recommendation: Countries should avoid signing TRIPS+ FTAs that impedes access to treatment
    8. 8. Finding 5 continued: IP Enforcement Agenda • Initiatives to use TRIPS Flexibilities could be endangered by proliferation of “anti-counterfeiting” legislation: – Tanzania, Subsidiary Merchandise Marks Act, 2008; – Kenya , Anti-Counterfeiting Act ,2008; – Uganda, discussing a Counterfeit Goods Bill since 2008, Revived in Parliament in late 2011 – Reports of Legislation being deliberated in some southern African countries • Draft EAC Anti-counterfeit Act being discussed • Several stakeholders have expressed concerns about impact • Recommendation: Countries when passing domestic legislation should not adopt measures that could impede access to treatment
    9. 9. Finding 6: Current IP system does not Stimulate innovation for ARVs, Communicable diseases, NTDs • Despite the global increase in patenting in recent years, there has been a decrease in innovation pipeline • Current IP system is not stimulating innovation for ARVs (FDCs and Pediatric) and NTDs • Recommendation: Countries should explore systems outside of current IP system to stimulate innovation in pharmaceutical products • IP system should only reward genuine innovation • Possibilities include patent pools, R&D treaty, open source innovation platforms
    10. 10. What can UNDP do in terms of: • Legislative review and reform • Judicial sensitization • Parliamentary training • Coordinating national working groups • Working with Patient groups/treatment advocates • Providing technical assistance