Access to Affordable AIDS Treatment: The Fight for Cheaper Drugs

1. "You can tell the people that if they succeed in killing me, that I forgive and bless those who do it. Hopefully, they will realize they are wasting their time. A bishop will die, but the church of God, which is the people will never perish” "A church that suffers no persecution but enjoys the privileges and support of the things of the earth - beware! - is not the true church of Jesus Christ." From a letter to President Carter: "You say that you are Christian. If you are really Christian, please stop sending military aid to the military here, because they use it only to kill my people." Archbishop Oscar Romero

2. Combination therapy (HAART) revolutionzed the fight against AIDS in the US With deaths dropping 84% in the developed world

3. However, in the late 1990’s these drugs cost $10,000-15,000 per year!

4. Why so expensive?

5. Companies seek to recoup research costs And make profits while medicines are under patent

6. Companies seek to recoup research costs And make profits while medicines are under patent US drug patents give 20 years of protection, but they are applied for before clinical trials, so the effective life of a drug patent tends to be 7-12 years.

7. $10,000 to $15,000 per year is not very affordable if you are one of the 2.6 billion— 40% of the world’s population— living on less than US$2 a day. 2007 Human Development Report (HDR) United Nations Development Program

8. Five years after HAART therapy was introduced in the West, <8,000 people in all of sub-Saharan Africa were receiving the life-saving drugs Avert.org

9. A few nations (not the poorest) Took leadership roles in dealing With this crisis

10. A few nations (not the poorest) Took leadership roles in dealing With this crisis In 1996 the government of Brazil pledged provide free combination antiretroviral treatment by the end of the year. It said it would spend up to $45 million/year on protease inhibitors . Miami Herald (1996) 'Brazil to Offer Patients AIDS 'Cocktail' for Free Promising Drug Mix too Costly for Most', October 28

11. This made a big difference! By 2000 the number of people living with HIV in Brazil was less than half that once predicted and the number of AIDS deaths plummeted 50% Miami Herald (1996) 'Brazil to Offer Patients AIDS 'Cocktail' for Free Promising Drug Mix too Costly for Most', October 28

12. This made a big difference! By 2000 the number of people living with HIV in Brazil was less than half that once predicted and the number of AIDS deaths plummeted 50% "It makes a lot of sense to look at what Brazil is doing... Something they're doing is working." - Mbulelo Rakwena, South Africa's ambassador to Brazil Miami Herald (1996) 'Brazil to Offer Patients AIDS 'Cocktail' for Free Promising Drug Mix too Costly for Most', October 28

13. Big Pharma also made some concessions In 1996 Glaxo Wellcome cut the price of AZT by 75% after a trial in Thailand showed it was safe and effective at preventing mother-to-child transmission CNN (1998) 'Company to offer AZT at steep discount to third world', March 5

14. This was still much too expensive For patients in the developing world! In 1996 Glaxo Wellcome cut the price of AZT by 75% after a trial in Thailand showed it was safe and effective at preventing mother-to-child transmission CNN (1998) 'Company to offer AZT at steep discount to third world', March 5

15. Big changes required two things

16. Big changes required two things Cheaper drugs by avoiding patent protection More global investment in providing these free or at low cost

17. Big changes required two things Cheaper drugs by avoiding patent protection More global investment in providing these free or at low cost

18. Get Cheaper drugs by avoiding patent protection Round 1, 1999 South Africa passed legislation that enabled local companies to manufacture or import HIV/AIDS drugs at a fraction of the price of patented drugs. The US argued that this undermined patent rights. BBC News (1999) ' Africa AIDS drug trade dispute ends', September 18

19. The Pharma Empire strikes back 39 major pharmaceutical companies prosecuted the South African government for this legislation.

20. International pressure eventually affected this Patent litigation in 2001

21. International pressure eventually affected this Patent litigation in 2001 Major pharmaceutical companies withdrew their challenge of South African legislation after protests by the European Parliament and a petition against the action was signed by 300,000 people from over 130 countries

22. Get Cheaper drugs by avoiding patent protection Round 2, 2001 The Indian drug company Cipla offered to make AIDS drugs available at sharply reduced prices (<$1 per day!) to Doctors without Borders (Medecins Sans Frontieres) Kumar S. (2001) 'Indian company offers low cost AIDS drugs', the Lancet, 357:616 February 24

23. This spurred changes in pricing By Big Pharma

24. In essence it was a price war and patients won wow

25. Not everyone was impressed by Pharma’s offer ''…a victory, but a small one, much like an elephant giving birth to a mouse'’ Doctors without Borders (Medecins Sans Frontieres )

26. Generics mean the price of antiretroviral medication in resource-poor countries continues to plummet A year’s first-line drugs can now be bought for as little as $92.2 Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector", WHO, 2008

27. Generics mean the price of antiretroviral medication in resource-poor countries continues to plummet A year’s first-line drugs can now be bought for as little as $92.2 In 2007, generics accounted for 57% of the $131 million PEPFAR spent on anti-AIDS drugs. Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector", WHO, 2008

28. WHO

29. Prices of antiretroviral medication in the developed world remain high due to “Tiered pricing” Drug prices are calculated using formulas based on average income per head

30. Prices of antiretroviral medication in the developed world remain high due to “Tiered pricing” Drug prices are calculated using formulas based on average income per head "Preferential pricing is the only way we can meet both conflicting needs in the fight against AIDS. We can refinance our high research and development costs for innovative, new treatments by the established price system in industrialised countries and can offer affordable medicines to patients in poor countries who otherwise cannot afford antiretroviral medication" - Alessandro Banchi, chairman of Boehringer

31. “Tiered pricing” In reality aids.about.com/b/2006/03/08/how-much-do-hiv-drugs-cost.htm Updated March 2008

32. Patent issues continue to linger over the process In 1995 TRIPS - The Agreement on Trade Related Aspects of Intellectual Property Rights was accepted by all members of the World Trade Organization Because its implementation will have a huge impact on generic drug production, most developing countries (e.g. India) were given a 10-year transition period. Least developed countries have until 2016. Avert.org

33. Patent issues continue to linger over the process Since 2003 TRIPS has contained a waiver that allows ''compulsory licenses'' to be issued to override specific patent restrictions. With these, countries that suffer a serious health crisis but are unable to produce drugs at home can import generics from other nations

34. This is the big year for decisions “Most countries are in favour of extending the moratorium indefinitely, said Mysore, except for the United States and Switzerland. The European Union supported the extension of the moratorium, as well as Canada, he said.” “The patent system has made it is illegal to create generic versions of new ‘second’ and ‘third line’ ARVs, which have been recommended by the World Health Organisation and work much better than the older ‘first line’ drugs.” http://www.ip-watch.org/2015/10/07/ at-wto-health-advocates-see-benefit-from-trips-urge-waiver-for-ldcs/ http://stopaids.org.uk/access-to-medicines/

35. In 2002 WHO created a list of preferred AIDS drugs As part of its list of ESSENTIAL medicines

36. WHO also issued guidelines for when to start treatment: Stage 1 asymptomatic Stage II moderate weight loss and mild infections Stage III severe weight loss, chromic diarrhea or fever, TB, etc Stage IV wasting syndrome or severe opportunistic infections

37. Would you be happy with this if you were the patient? Stage 1 asymptomatic Stage II moderate weight loss and mild infections Stage III severe weight loss, chromic diarrhea or fever, TB, etc Stage IV wasting syndrome or severe opportunistic infections

38. The science you read about earlier this week Initiated a change in this approach!

40. Big changes required two things Cheaper drugs by avoiding patent protection More global investment in providing these free or at low cost

41. Public pressure grew to find Funds to help poor patients

42. Many players came together To push for more money

43. The World Health Organisation created the first global target for ARV treatment access in 2003. It called for 3 million people in developing countries to have access to treatment by the end of 2005, meeting 50% of estimated need.

44. Congress and the President Put US dollars behind the effort President George W. Bush signs the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 =up to $15 billion over 5 years

45. As of September 2007, PEPFAR estimates that it helped provide ART to approximately 1,445,500 people

46. Public health experts and nonprofit organizations have questioned some aspects of PEPFAR programs, including requirements mandating that one-third of prevention spending be directed towards abstinence-only programs.

47. Progress began well, but failed to accelerate. At the end of 2005 only 1.3 million people in low- and middle-income countries were receiving drugs, 40% of the target.

48. Not surprisingly, progress was uneven in different parts of the world. Only three African nations - Botswana, Namibia and Uganda - met their 50% targets.

49. If at first you don’t succeed….

50. July 2005 The Group of Eight (G8) (Canada, France, Germany, Italy, Japan, Russia, the UK and the US) pledged to work toward universal access to antiretroviral (ARV) treatment worldwide by 2010.