1. Access to Innovation: Making Generic Versions of Newer Antiretrovirals Affordable Focusing on middle income countries Leena Menghaney, MSF Access Camapign IAC, Melbourne, Room 203-204 Thursday 24 July, 14:30 – 16:00 Organised by International AIDS Society

5. KKL, IAS, 2013, Andrew Hill

6. UTW, 17 th Edition 2014

7. UTW, 17 th Edition 2014

8. Issues in middle income countries World Bank classification of countries Affected by TRIPS patent regime Lack of transparency on prices being paid by governments Pressure not to use TRIPS flexibilities combined with lack of political will Left out of geographical scope of voluntary licenses Lack of negotiation power/case by case basis Very high prices in middle income countries. Barriers to benefiting from generic competition

9. Use of TRIPS Flexibilities Countries can send out clear message with a few CLs Reserve IP incentive for new compounds i.e. active ingredients that represent a fresh contribution to the stock of products available for medicinal use But not all patent applications relate to new compounds. Majority are for existing drugs (new use, new forms and new formulations) These can be rejected as such inventions that are common knowledge and practice in the pharmaceutical field Reduce the patent terms by addressing evergreening

10. First CL in India Natco Pharma requested for a CL for the anti-cancer drug Nexavar (Sorafenib Tosylate), patented by Bayer Not for drug supplied to the Public sector but actually sold in The private sector Granted in March 2012: o Bayer’s import was grossly inadequate to the needs (hardly 2%) o No import in certain years o Price not reasonably affordable to the public. Bayer price 5210 USD for 120 tabs for a month; Natco 164 USD

11. Generic competition or tiered pricing short term gain – long term pain

12. Recommendations Systematic Data collection on drug prices in middle income countries Highlighting the problem Patent Reform in middle income countries (e.g. Argentina) Challenging the geographical scope of VLs – using it as a ground for a CL Global Fund should continue supporting middle income countries Challenging the World Bank classification of countries as not applicable to public health