"You can tell the people that if they succeed in killing me,

"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

Combination therapy (HAART) revolutionzedthe fight against AIDS in the USWith deaths dropping 84% in the developed world

However, in the late 1990’sthese drugs cost $10,000-15,000 per year!

Why so expensive?

Companies seek to recoup research costsAnd make profits while medicines are

under patent

Companies seek to recoup research costsAnd 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.

$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

Five years after HAART therapy was introduced in the West,

<8,000 people in all of sub-Saharan Africawere receiving the life-saving drugs

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A few nations (not the poorest)Took leadership roles in dealing

With this crisis

A few nations (not the poorest)Took leadership roles in dealing

With this crisis

Miami Herald (1996) 'Brazil to Offer Patients AIDS 'Cocktail' for Free Promising Drug Mix too Costly for Most', October 28

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/yearon protease inhibitors .

This made a big difference!

Miami Herald (1996) 'Brazil to Offer Patients AIDS 'Cocktail' for Free Promising Drug Mix too Costly for Most', October 28

By 2000 the number of people living with HIV in Brazilwas less than half that once predictedand the number of AIDS deaths plummeted 50%

This made a big difference!

Miami Herald (1996) 'Brazil to Offer Patients AIDS 'Cocktail' for Free Promising Drug Mix too Costly for Most', October 28

By 2000 the number of people living with HIV in Brazilwas less than half that once predictedand 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

Big Pharma also made some concessions

CNN (1998) 'Company to offer AZT at steep discount to third world', March 5

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

This was still much too expensive For patients in the developing world!

CNN (1998) 'Company to offer AZT at steep discount to third world', March 5

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

Big changes required two things

Big changes required two things

Cheaper drugs by avoiding patent protection

More global investment in providing these free or at low cost

Big changes required two things

Cheaper drugs by avoiding patent protection

More global investment in providing these free or at low cost

Get Cheaper drugs by avoiding patent protectionRound 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

The Pharma Empire strikes back

39 major pharmaceutical companies prosecuted the South African government for this legislation.

International pressure eventually affected thisPatent litigation in 2001

International pressure eventually affected thisPatent litigation in 2001

Major pharmaceutical companies withdrew theirchallenge of South African legislation after protestsby the European Parliament and a petition against the action was signed by 300,000 people from over 130 countries

Get Cheaper drugs by avoiding patent protectionRound 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

This spurred changes in pricingBy Big Pharma

In essence it was a price warand patients won

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 )

Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector", WHO, 2008

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

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.

WHO

Drug prices are calculated using formulas based on average income per head

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

Prices of antiretroviral medication in the developed world remain high due to “Tiered pricing”

aids.about.com/b/2006/03/08/how-much-do-hiv-drugs-cost.htm

Updated March 2008

“Tiered pricing”In reality

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.

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Patent issues continue to linger over the process

Since 2003 TRIPS has contained a waiver thatallows ''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

Patent issues continue to linger over the process

In 2002 WHO created a list of preferred AIDS drugsAs part of its list of ESSENTIAL medicines

WHO also issued guidelines for when to start treatment:

Stage 1 asymptomaticStage II moderate weight loss and mild infectionsStage III severe weight loss, chromic diarrhea or fever, TB, etcStage IV wasting syndrome or severe opportunistic infections

Would you be happy with this if you were the patient?

Stage 1 asymptomaticStage II moderate weight loss and mild infectionsStage III severe weight loss, chromic diarrhea or fever, TB, etcStage IV wasting syndrome or severe opportunistic infections

Big changes required two things

Cheaper drugs by avoiding patent protection

More global investment in providing these free or at low cost

Public pressure grew to findFunds to help poor patients

"If we can get cold Coca Cola and beer to ever y remote corner of Africa, it should not be impossible to do the same with drugs." - J oep Lange, the President of the I nternational AIDS Society

Many players came togetherTo push for more money

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.

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

Congress and the PresidentPut US dollars behind the effort

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

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.

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.

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

If at first you don’t succeed….

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

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

Two months later, all United Nations Member States endorsed this goal by committing themselves to: "Developing and implementing a package for HIV prevention, treatment and care with the aim of coming as close as possible to the goal of universal access to treatment by 2010 for all those who need it"

In 2006, UNITAID an international drug purchase facilitywas established to ensure a stable source of funding for drugs to fight HIV/AIDS, malaria and tuberculosis.

"3 by 5 has helped to mobilize political and financial commitment to achieving much broader access to treatment. This fundamental change in expectations is transforming our hopes of tackling not just HIV/AIDS, but other diseases as well." - Dr Lee Jong-wook, WHO Director-General

This IS making a difference

This IS making a difference

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The trend is good but there is a long way to go

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The trend is good but there is a long way to go

WHO

The trend is good but there is a long way to go

WHO

The trend is good but there is a long way to go

WHO

97% of those treated are receiving 1st line drugs

WHO

What about those resistant to this combination?

WHO

Second line drugs are much more expensive

The US must continue to lead in this effort

On July 30, 2008, President Bush signed into law H.R. 5501, the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act.=up to $48 billion to combat the three diseases, including:$39 billion for: • PEPFAR bilateral HIV/AIDS programs

The US must continue to lead in this effort