The Politics of PatentsThe Politics of PatentsJason AndrewsJason Andrews

The Access GAPThe Access GAP2.4 Million2.4 Million people died of AIDS in sub people died of AIDS in sub

Saharan Africa in 2002 – yet only Saharan Africa in 2002 – yet only 50,00050,000 in in the region had access to medicines for the region had access to medicines for AIDS.AIDS.

485,000485,000 people died of AIDS in Asia in 2002 – people died of AIDS in Asia in 2002 – yet only yet only 43,00043,000 in the region had access to in the region had access to medicines for AIDS.medicines for AIDS.

(UNAIDS)(UNAIDS)

Treating AIDS in developing Treating AIDS in developing countries is infeasiblecountries is infeasible

►Africans can’t take AIDS medicines Africans can’t take AIDS medicines because they “don’t know what because they “don’t know what Western time is.”Western time is.”--Andrew Natsios, chief of US Agency --Andrew Natsios, chief of US Agency for International Development under for International Development under BushBush

Myth #1: People living in developing Myth #1: People living in developing countries can’t adhere to difficult pill countries can’t adhere to difficult pill

regimensregimens► Empirical data from a wide range of Empirical data from a wide range of

resource-poor settings show that people resource-poor settings show that people living in developing countries can be as living in developing countries can be as adherent, if not more, than those living in adherent, if not more, than those living in developed countriesdeveloped countries

► Surveys in Botswana, Uganda, Senegal and Surveys in Botswana, Uganda, Senegal and South Africa show 20% higher adherence South Africa show 20% higher adherence rates than USrates than US

► Survey in Sao Paulo, Brazil found equivalent Survey in Sao Paulo, Brazil found equivalent rates to study in San Diegorates to study in San Diego

Myth #2: Myth #2: It’s not the price of medicines, It’s not the price of medicines, it’s the lack of health infrastructureit’s the lack of health infrastructure

True that health infrastructure in poor True that health infrastructure in poor countries may often be limitedcountries may often be limited

But no particularly complex/ expensive But no particularly complex/ expensive training or infrastructure is required to run a training or infrastructure is required to run a successful treatment program (Paul Farmer, successful treatment program (Paul Farmer, Haiti)Haiti)

In all cases, the price of medicines is a key In all cases, the price of medicines is a key component of treatment accesscomponent of treatment access

““There is a lot of talk here about 'forecasting There is a lot of talk here about 'forecasting demand' for antiretrovirals in poor countries. demand' for antiretrovirals in poor countries. We should not forecast demand. The demand We should not forecast demand. The demand has always been there. We should forecast has always been there. We should forecast our own ability to stop ignoring demand." our own ability to stop ignoring demand." --Paul Farmer--Paul Farmer

Working in Haiti, Farmer and colleagues, Working in Haiti, Farmer and colleagues, working in sparse electricity and without CD4 working in sparse electricity and without CD4 counts have had better treatment results counts have had better treatment results than most US clinicsthan most US clinics

Myth #3: Patents don’t affect access to Myth #3: Patents don’t affect access to treatmenttreatment

► Then what happened in Brazil??Then what happened in Brazil??► In 1997, Brazilian government rolled out In 1997, Brazilian government rolled out

plan to treat every AIDS patientplan to treat every AIDS patient► To do so, they began producing generics in To do so, they began producing generics in

1998, and price of medicines has fallen by 1998, and price of medicines has fallen by an average of 79%an average of 79%

Success in BrazilSuccess in Brazil

► Brazil has already cut its AIDS death rate by Brazil has already cut its AIDS death rate by 50%50%

►Has half the number of HIV cases that World Has half the number of HIV cases that World Bank projected in 1994Bank projected in 1994

► AIDS patients are a quarter as likely to be AIDS patients are a quarter as likely to be hospitalized as beforehospitalized as before

► TB incidence has fallen by halfTB incidence has fallen by half►Health Ministry spent $444 million on AIDS Health Ministry spent $444 million on AIDS

drugs in 2000drugs in 2000►Decline in hospitalizations alone saved Health Decline in hospitalizations alone saved Health

Ministry $422 million from ’97 to ’99Ministry $422 million from ’97 to ’99

Generics, anyone?Generics, anyone?Not if we (and by “we” I mean Not if we (and by “we” I mean

“U.S.”) can help it“U.S.”) can help it

Costs of Major AIDS DrugsCosts of Major AIDS Drugs► Large disparity between price and Large disparity between price and

production costs provides big incentives for production costs provides big incentives for generics to enter marketgenerics to enter market

So what’s to keep countries from So what’s to keep countries from producing generic versions of AIDS producing generic versions of AIDS

drugs?drugs?

► U.S. patents don’t prohibit generic production in U.S. patents don’t prohibit generic production in other countriesother countries

► U.S. pharm companies must file patent in every U.S. pharm companies must file patent in every country in which they wish to protect their drug country in which they wish to protect their drug from generic productionfrom generic production

► But who is to keep developing countries from But who is to keep developing countries from violating the patents and producing generics??violating the patents and producing generics??

The World Trade The World Trade OrganizationOrganization

►The WTO signed the Trade-Related The WTO signed the Trade-Related Aspects of Intellectual Property Rights Aspects of Intellectual Property Rights Agreement (TRIPS)Agreement (TRIPS)

►Sets minimum standards for protection Sets minimum standards for protection of intellectual property by its membersof intellectual property by its members

►Member countries will be required to Member countries will be required to respect foreign patents filed in their respect foreign patents filed in their country, not produce generics without country, not produce generics without permission from the pharm companiespermission from the pharm companies

►Goes into effect in 2006, 2016 for least Goes into effect in 2006, 2016 for least developed countries (LDCs)developed countries (LDCs)

Some good news….Some good news….► TRIPS does have a provision in it that allows TRIPS does have a provision in it that allows

countries to produce generic drugs for countries to produce generic drugs for public health crisespublic health crises

►However, no country has done this, largely However, no country has done this, largely out of fear of being put on “trade watch list” out of fear of being put on “trade watch list” by US which would greatly decrease foreign by US which would greatly decrease foreign investment and severely hurt their investment and severely hurt their economieseconomies

►Developing countries wanted the language Developing countries wanted the language of this provision clarified and strengthened of this provision clarified and strengthened to protect themto protect them

► In months leading up to meeting of In months leading up to meeting of WTO ministerial meeting, the U.S. WTO ministerial meeting, the U.S. lobbied heavily against provisions that lobbied heavily against provisions that enabled generic production in public enabled generic production in public health criseshealth crises

Disaster Strikes… and the U.S. Disaster Strikes… and the U.S. takes a new look on compulsory takes a new look on compulsory

licenseslicenses►One month before the WTO ministerial One month before the WTO ministerial

meeting to address the questions meeting to address the questions raised about compulsory licensing in raised about compulsory licensing in TRIPS, Anthrax hits the U.S.TRIPS, Anthrax hits the U.S.

►As a result, the U.S. threatens to As a result, the U.S. threatens to violate the patent on Cipro unless the violate the patent on Cipro unless the German manufacturer made enough German manufacturer made enough doses available at a lowered pricedoses available at a lowered price

A Victory for the Developing A Victory for the Developing WorldWorld

►One month later, at the WTO One month later, at the WTO ministerial round in Doha, a resolution ministerial round in Doha, a resolution was passed stating that the TRIPS was passed stating that the TRIPS agreement should be interpreted in a agreement should be interpreted in a way such as to “protect public health way such as to “protect public health and, in particular, to promote the and, in particular, to promote the access to medicines for all”access to medicines for all”

The Empire Strikes BackThe Empire Strikes Back►With the Doha Declaration providing a With the Doha Declaration providing a

means for developing countries to means for developing countries to produce generics when public health produce generics when public health crises emerge, the U.S. sought other crises emerge, the U.S. sought other ways of protecting their pharm ways of protecting their pharm companiescompanies

►They began signing bilateral trade They began signing bilateral trade agreements with more strict rules agreements with more strict rules prohibiting generic production (TRIPS+)prohibiting generic production (TRIPS+)

And those without the meansAnd those without the means►What about smaller/poorer countries What about smaller/poorer countries

without the capacity for generic without the capacity for generic production?production?

►The TRIPS agreement is unclear on The TRIPS agreement is unclear on whether the countries will be able to whether the countries will be able to import generic medicines from other import generic medicines from other countriescountries

►Again, most countries are too afraid of Again, most countries are too afraid of U.S. trade sanctions to import genericsU.S. trade sanctions to import generics

Why all of this?Why all of this?

The Short AnswerThe Short Answer►Follow the $Follow the $►The Pharm industry, the biggest The Pharm industry, the biggest

Washington lobbiest and largest donor Washington lobbiest and largest donor to political campaigns, put pressure on to political campaigns, put pressure on the U.S. government to protect their the U.S. government to protect their interests through the WTOinterests through the WTO

Pharm Guide to dropping Pharm Guide to dropping $150M$150M

► ““The documents show that the trade association, the The documents show that the trade association, the Pharmaceutical Research and Manufacturers of America, known as Pharmaceutical Research and Manufacturers of America, known as PhRMA, will spend at least $150 million in the coming year.”PhRMA, will spend at least $150 million in the coming year.”

► ““The drug trade group plans to spend $1 million for an "intellectual The drug trade group plans to spend $1 million for an "intellectual echo chamber of economists”--a standing network of economists echo chamber of economists”--a standing network of economists and thought leaders to speak against federal price control and thought leaders to speak against federal price control regulations through articles and testimony, and to serve as a rapid regulations through articles and testimony, and to serve as a rapid response team.“response team.“

► ““At least $2 million, and perhaps $2.5 million, in payments to At least $2 million, and perhaps $2.5 million, in payments to research and policy organizations, "to build intellectual capital and research and policy organizations, "to build intellectual capital and generate a higher volume of messages from credible sources" generate a higher volume of messages from credible sources" sympathetic to the industry.”sympathetic to the industry.”

► ““In addition, the budget sets aside $17.5 million to fight price In addition, the budget sets aside $17.5 million to fight price controls and protect patent rights in foreign countries and in trade controls and protect patent rights in foreign countries and in trade negotiations.”negotiations.”

► ““$9.4 million for public relations, including "$1 million for inside-the-$9.4 million for public relations, including "$1 million for inside-the-Beltway advertising, $555,000 for placement of op-eds and articles Beltway advertising, $555,000 for placement of op-eds and articles by third parties," $600,000 for polling, $1.3 million for local publicity by third parties," $600,000 for polling, $1.3 million for local publicity in 15 states and $680,000 for media relations consultants.”in 15 states and $680,000 for media relations consultants.”

yes, there are some yes, there are some actual arguments for actual arguments for patent protection toopatent protection too

The Money ArgumentThe Money Argument►Pharm companies need money for Pharm companies need money for

R&D, can’t just give drugs awayR&D, can’t just give drugs away

Who pays?Who pays?

Blackmarkets?Blackmarkets?►Allowing developing countries to Allowing developing countries to

produce cheap, generic versions of produce cheap, generic versions of drugs used in developed countries will drugs used in developed countries will lead to a massive black market that lead to a massive black market that will undermine markets in developing will undermine markets in developing countriescountries

►As part of an agreement to allow As part of an agreement to allow generic production of a drug, generic production of a drug, developed countries could require that developed countries could require that countries take significant measures to countries take significant measures to prevent illegal export of the drugsprevent illegal export of the drugs

►Pills could be made a different Pills could be made a different color/appearance to make detection of color/appearance to make detection of generics easiergenerics easier

What they don’t know… fills our What they don’t know… fills our pocketspockets

►Pharmaceutical companies are worried Pharmaceutical companies are worried that if generics are produced in that if generics are produced in developing countries, people in the developing countries, people in the developed countries will learn how low developed countries will learn how low the cost of their production is the cost of their production is tarnishing the companies’ imagestarnishing the companies’ images

Sounds good to meSounds good to me

When all else fails, sue When all else fails, sue ‘em‘em

Pharm v. South African Pharm v. South African GovernmentGovernment

► In 1998, a group of 39 pharmaceutical In 1998, a group of 39 pharmaceutical companies filed a lawsuit challenging a companies filed a lawsuit challenging a 1997 law that enabled South Africa to 1997 law that enabled South Africa to issue compulsory licenses for issue compulsory licenses for production or importation of generic production or importation of generic essential medicinesessential medicines

►The Clinton Administration (and, most The Clinton Administration (and, most notably, Al Gore) supported the Pharm notably, Al Gore) supported the Pharm suitsuit

Talkin’ bout a revolutionTalkin’ bout a revolution► The South African The South African

Treatment Action Treatment Action Campaign lead Campaign lead thousands of thousands of activists and activists and HIV+ South HIV+ South Africans in Africans in protest of the protest of the pharmaceutical pharmaceutical companiescompanies

We’re outta hereWe’re outta here►On April 19, 2001, the Pharm On April 19, 2001, the Pharm

companies, not enjoying the negative companies, not enjoying the negative publicity they were getting from filing publicity they were getting from filing a suit aimed at preventing life-saving a suit aimed at preventing life-saving drugs from being imported to the drugs from being imported to the country with the most people suffering country with the most people suffering from AIDS dropped the suitfrom AIDS dropped the suit

They may have won the They may have won the battle….battle….

The U.S. continues to negotiate The U.S. continues to negotiate bilateral trade agreements, which bilateral trade agreements, which threaten the abilities of countries to threaten the abilities of countries to retain the right to generic productionretain the right to generic production

As of yet, no country has issued a As of yet, no country has issued a compulsory license, indicating that compulsory license, indicating that despite the WTO provision, most despite the WTO provision, most countries are still afraid to anger the countries are still afraid to anger the U.S. Trade RepresentativeU.S. Trade Representative

CampaignsCampaigns►Doctors Without Borders initiated a large Doctors Without Borders initiated a large

scale Access to Essential Medicines scale Access to Essential Medicines Campaign: Campaign: http://www.accessmed-msf.orghttp://www.accessmed-msf.org//

► Student campaign for changing university Student campaign for changing university policies to promote access to essential policies to promote access to essential medicines developed at universities (started medicines developed at universities (started at Yale): at Yale): www.essentialmedicines.orgwww.essentialmedicines.org

► Consumer Watchdog Organization with lots Consumer Watchdog Organization with lots of information on intellectual property and of information on intellectual property and health: health: www.cptech.orgwww.cptech.org

the endthe end