1. MSF Experience with Access to Medicines Julia Hill Maseru, Lesotho Civil Society Consultation Meeting August 12, 2014

2. Why an Access Campaign? “Some of the reasons that people die from diseases like AIDS, TB, Sleeping Sickness and other tropical diseases is that life saving essential medicines are either too expensive, are not available because they are not seen as financially viable, or because there is virtually no new research and development for priority tropical diseases. This market failure is our next challenge." -- Dr. James Orbinski, president of MSF’s International Council, 1999 acceptance speech for Nobel Peace prize MSF Access Campaign

3. The problem still exists “We did not develop this product for the Indian market, let’s be honest. We developed this product for Western patients who can afford this product…” – Marijn Dekkers, Bayer CEO, on India’s issuing a compulsory license on Bayer’s cancer drug, sorafenib (2013) MSF Access Campaign

4. Unavailable Why don’t companies invest in R&D for certain diseases?

5. Unsuitable Why aren’t medical tools adapted to the environments where MSF works? MSF Access Campaign

6. Unaffordable MSF Access Campaign Why are some medicines so expensive? MSF Access Campaign

7. How to bring down prices? MSF Access Campaign

8. How does South Africa’s Patent System Affect Access to Medicines? MSF Access Campaign

9. A decades-old conflict… “Everyone has the right to have access to health care services” -Section 27 of the South African Constitution MSF Access Campaign

10. …is still underway in South Africa “Fix the Patent Laws” campaign started in 2011, 10 years after the Doha Declaration was signed Aims to have Dept. of Trade and Industry include pro- public health language in national IP policy in order to take advantage of TRIPS flexibilities in national laws Coalition: TAC, MSF, SECTION27, and more! MSF Access Campaign

11. MSF Access Campaign Treatment Action CampaignSECTION27 MSF Access Campaign

12. MSF Access Campaign Treatment Action CampaignSECTION27 MSF Access Campaign

13. Of identical applications, South Africa grants 100%, while US & European Patent Offices reject ~40%. MSF Access Campaign Treatment Action CampaignSECTION27 MSF Access Campaign

14. MSF Access Campaign Treatment Action CampaignSECTION27

15. What does this mean for the cost of specific medicines? MSF Access Campaign Treatment Action CampaignSECTION27 MSF Access Campaign

16. Cost comparison ARV regimens MSF Access Campaign Treatment Action CampaignSECTION27 MSF Access Campaign

17. Aripiprazole Aripiprazole - anti-psychotic (for schizophrenia, bipolar disorder)—one of the top-10 selling drugs globally Could have been off-patent in U.S. in 2009 (extensions run to 2015)—South African multiple pending patents (Otsuka, BMS) could run until 2033. Cost of a 10mg tablet R35.60 in South Africa over 35x higher than generics available in India. SA price (R3.56/mg) 20% higher than in Japan (R2.84/mg) If SA had India’s prices, over R29 million in savings annually that could be realized on one drug alone MSF Access Campaign

19. Oral contraceptive Bayer holds multiple patents on drospirenone clathrate/ethinyl estradiol (Yasmin) Pharmadynamics 2011 launch of generic product at ~30% lower price was halted through an interdict over secondary patent SA court case continues, even though generics available elsewhere, patent in question has been struck down in Europe and US. Pharmadynamics has incurred over R10million in legal fees, millions of rand in lost sales—will make it difficult to realize lower prices even if they are given right to launch product MSF Access Campaign

20. Effect of IP on diagnostics MSF Access Campaign

21. Pfizer’s initial linezolid patent in SA expires 2014 No alternative generic registered yet—MSF special access granted in June 2014. Linezolid Access Barriers PurchaserSupplierPrice (600 mg tablet) SA GovernmentPfizerR 287.9* SA Private SectorPfizerR 715.24** MSFHetero ~R70 *** * Expired SA DOH antibiotics tender **Single Exit Price ***only available to MSF in South Africa With mark-ups, MSF in South Africa paid approximately R123,000 per patient for a 6-month supply of linezolid Could a compulsory license have helped?

22. Will Linezolid’s Story Repeat with new TB drugs?

23. What Reforms Could SA Enact? Other countries have used these reforms to make their patent systems work in the interest of public health: Stricter patentability criteria Patent examination system Patent opposition Broad research exception Improve Compulsory Licensing & Parallel Importation mechanisms Publicly financed R&D, de-linkage principles The Dept. of Trade & Industry released a “Draft Policy on IP” for public comment in September 2013, expressing the need for these reforms MSF Access Campaign

24. The backlash: #PharmaGate “The overall campaign is aimed at delaying the finalization of the IP policy…” SF Access Campaign Treatment Action CampaignSECTION27 MSF Access Campaign

25. Big Pharma’s Arguments “Theme: Patents do not impede access to medicines…” “the draft…states ominously that IP protections ‘must not contradict public health policies’” “We do NOT want a debate over individual drug prices to become the focal point” “South Africa is now ground zero for the debate on the value of strong IP protection. If the battle is lost here, the effects will resonate.” “Proposed IP Policy Hurts the South African Economy… innovation will stall” MSF Access Campaign

26. Economic rebuttals IP ≠ investment: following adoption of TRIPS, 35 foreign pharmaceutical manufacturing plants shut down in SA SA realised less FDI than countries with “weaker” IP: India proactively adopted TRIPS flexibilities that protect local industry– as such India’s domestic pharma industry realised FDI of US$1 billion from April-June 2013; Novartis expands ops Pharmaceuticals are 5 th largest driver of SA trade deficit / R5billion spent on procuring pharmaceuticals by DOH in 2012 Cost driven by branded products – despite the fact that in quantity the majority of medicines are imported from India and majority of API from China. Every Rand spent on branded medicines is money diverted from the wider health system MSF Access Campaign Treatment Action CampaignSECTION27 MSF Access Campaign

27. “It’s not unrealistic to expect that new innovations ought to be priced at or below, in some cases, the prices that have pre-existed them.” --Andrew Witty CEO of GlaxoSmithKline London, 2013 “Great Myth” of the Industry: R&D costs $1 billion per drug Source: http://reut.rs/WJNDcWhttp://reut.rs/WJNDcW MSF Access Campaign Treatment Action CampaignSECTION27 MSF Access Campaign

28. Who pays for R&D? MSF Access Campaign Treatment Action CampaignSECTION27 MSF Access Campaign

29. Novartis’ Gleevec: 1. Early Research Costs: 50% National Cancer Institute 30% Leukemia and Lymphoma Society 10% Oregon Health Sciences university; Only 10% Novartis 2. Tax Credits: Orphan Drug Credit for Novartis 3. Product costs: Sales of Gleevec in 2012: $4.6 billion Estimated Novartis Investment in R&D: $38-$96 million Full return on investment every 13 days!!! How many times do we pay? MSF Access Campaign Treatment Action CampaignSECTION27 MSF Access Campaign

30. Medical Spending: IMS Institute for Healthcare Informatics “The Global Use of Medicines: Outlook Through 2016” Amount re-invested in R&D: http://www.phrma.org/sites/default/files/pdf/phrma_industry_profile.pdfhttp://www.phrma.org/sites/default/files/pdf/phrma_industry_profile.pdf “Re-Investing” in R&D? MSF Access Campaign Treatment Action CampaignSECTION27 MSF Access Campaign

31. What next? How can you help? Elections over—DTI, DOH have promised policy will be finalized. What happens in SA has an impact on products available in the region, and the battle for lower prices in “Middle Income Countries” like Lesotho We need more partners and more support! MSF Access Campaign Treatment Action CampaignSECTION27 MSF Access Campaign

32. Access & Innovation Resources Book: The Global Politics of Pharmaceutical Monopoly Power Book Patent Opposition Database Fix the Patent Laws (South African campaign) Fix the Patent Laws http://www.msfaccess.org/our-work/overcoming-barriers-to-access http://www.msfaccess.org/our-work/driving-medical-innovation

33. Please be in touch! http://www.msfaccess.org Julia.hill@joburg.msf.org @MSFJuliaHill http://www.fixthepatentlaws.org @FixPatentLaw #PharmaGate Thank you! MSF Access Campaign