[Ip-health] Global Day of Action: Country-By-Country on the Kaletra Campaign

Burcu Kilic bkilic at citizen.org
Thu Nov 10 04:54:13 PST 2011

Dear All,

We have begun posting brief summaries of today's global Kaletra campaign actions, country-by-country, with quotes from country campaigners.  We are adding technical documents and filings as we receive them.  We are also beginning to post resource documents (some are also available in Spanish or Vietnamese) and campaign histories.

See: http://www.citizen.org/global-day-of-actions

Please feel free to send us your contributions.  Allies in Brazil, India, Peru and Colombia have resource pages as well -- please feel free to share!  There will be press releases or conferences in several countries.

Here is an initial short-form compilation of today's campaign actions, country-by-country, in alphabetical order.  We will continue to add and revise.



 "We decided to file another patent opposition because the monopoly could be extended from 2017 to 2024, if this patent is granted. The granting of undue patents must be avoided to signal that market strategies seeking unlimited monopoly shall not undermine the sustainability of responses to public health needs".

-- Renata Reis, coordinator of the Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/ Rebrip)

In Brazil, more than 50,000 people currently take lopinavir + ritonavir. The Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/ Rebrip) is filing an opposition to Abbott patent claims on the medicine's heat-stable form, which are not novel and do not contribute an inventive step.


"High treatment costs, as well as poor education, poverty, stigma, and information imbalances, make the voice and bargaining power of the people-living-with HIV community extremely weak in China. Many people living with HIV in China live in poverty, or become poor due to the heavy burden of treatment costs."

-- Jia Ping, Founder and CEO of China Global Fund Watch Initiative

China's GDP per capita in 2010 was around 4,000 U.S. dollars. But the gap between rich and poor is great, with a Gini Coefficient of 0.48. Currently, the market price of Kaletra in China is around 900RMB($150) per month for each AIDS patient ($1800 per person per year), which constitutes a heavy burden for people living with HIV/AIDS who have yet not been covered by the government free ARV treatment program.

China's reported HIV cases total 370,393, including 132,400 people receiving treatment and 68,315 reported deaths. The joint report of China's Ministry of Health, UNAIDS and the World Health Organization estimated 740,000 people live with HIV in China -- with 26,000 deaths in 2009.

People living with HIV in rural areas face exacerbated challenges, including poverty. In urban areas, many people living with HIV dare not disclose their health status, for fear of losing their jobs and livelihood due to stigma and social discrimination.

China Global Fund Watch Initiative and the Access to Medicines Research Group are sending a letter to Abbott requesting an open license, which would enable China to access affordable generic lopinavir + ritonavir.


"Acting in concert around the world, we will be better able to fight Abbott's abuses. This day of action marks our campaign's beginning. We will be expanding; working for access and open competition for more medicines and with allies in new countries as we move forward."

-- Luz Marina Umbasia, lawyer for Colombian treatment advocacy groups

In 2008, the price of Kaletra was about $4,000 per person per year. A civil society compulsory license campaign led directly to a new regulation for public interest licensing and government-ordered Kaletra price reductions of 54-68%.

Today, Kaletra costs about $1,000. The civil society coalition continues to seek an open compulsory license through renewed administrative requests and other avenues, including an ongoing "acción popular," analogous to a private attorney general lawsuit, in order to obtain the global low price of approximately $400 and inaugurate competition - which could reduce prices further still.


"There is, in our law, what is called compulsory licensing.  I, as President, can order that we issue a compulsory license for a given brand, so this medicine can be copied to make generics, and the people have access to this medicine, to health, to a cure for their illness.  And this is exactly what we are going to begin to do..."

"This is our vision of intellectual property.  It's not a mechanism to enrich the pharmaceutical or agrochemical companies.  It's a mechanism for development for the people."

-- Rafael Correa Delgado, President of the Republic of Ecuador

In 2009, Ecuador inaugurated a protocol for licensing patents to protect public health. In 2010, Ecuador issued its first compulsory license, for the HIV/AIDS medicine ritonavir, one of Kaletra's essential components.

Today, Ecuador is evaluating a new license request that would enable Ecuador to provide global-low cost lopinavir + ritonavir to its people.


 "Millions in the developing world depend on India for generic medicines at affordable costs. Restriction of generic drug production in India will have a devastating public health impact around the world and adversely affect the right to health of millions of patients."

-- Anand Grover, UN Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of health

India is the leading source of affordable HIV/AIDS medicine for the world today, including lopinavir + ritonavir.

Following oppositions by people living with HIV networks and others  in India, Abbott abandoned some of its patent applications relating to lopinavir and ritonavir.  A recent patent opposition by the Initiative for Medicines, Access and Knowledge defeated an Abbott patent application for heat-stable lopinavir + ritonavir that could have restricted the world's ability to access affordable generics.

Now, concerns surround new Abbott patent applications claimed to relate to lopinavir + ritonavir.


"Second-line treatment is an essential pillar in the fight against HIV/AIDS, but because of Abbott's monopoly pricing, Indonesia cannot afford it. This is why we're proud to take this step together with our friends around the world to stand up for our right to medicines."

-- Sindi Putri, International Treatment Preparedness Coalition Indonesia

In Indonesia, Kaletra costs $1000 ppy while in 2010 per capita GDP was $2,946. ITPC Indonesia and other Indonesian civil society groups are sending a letter to Abbott requesting an open license, which would enable Indonesia to access affordable generic lopinavir + ritonavir.

Additionally, the groups are meeting the officials from the Indonesian Ministry of Health to present a letter requesting the government make use of any patents necessary to provide generic lopinavir + ritonavir.


"For people living with HIV, we need life-long treatment. For us, it is a matter of life and death. So today we are leading a global movement for affordable HIV treatment because without affordable and accessible medicines, more of us will die."
--Edward Low, MTAAG+

In Malaysia, Kaletra costs 11,400 MYR (~$3,585) per person per year (ppy), while 2010 per capita GDP was $8,373.

The Malaysian AIDS Council is sending a letter to Abbott requesting an open license, which would enable Malaysia to import (or produce) affordable generic lopinavir+ritonavir in exchange for reasonable royalty payments to Abbott.


"In Peru, we have obtained one of the best prices in the region for lopinavir + ritonavir, through the availability of generics and competitive bidding.  But this situation could be changed by new patent applications.  The global campaign enables us to join forces to prevent patent-based monopolies, avoiding catastrophic effects for access to antiretroviral medicines."

-- Javier Llamoza, Health Action International Latin America-Caribbean (AISLAC)

Peru benefits from generic competition in the market for lopinavir + ritonavir, and has achieved comparatively low prices of $396 per patient per year. While this has enabled the government to provide treatment to over 3,000 patients a year, there is concern that Abbott is seeking a monopoly on lopinavir + ritonavir, as it has registered several patent applications claiming some relation to the medicine.

Health Action International Latin America and PROSA will send a letter to Abbott and the Ministry of Health expressing their concern and asking Abbott to retract its patent applications. Activists will also participate in a demonstration before the Ministry of Health.

Sint Maarten (Kingdom of the Netherlands)

"In some countries, including Sint Maarten and Curacao, the high costs of ARV drugs have been identified as a major obstacle to access to treatment. Our research conducted in 2008 showed that ARV prices on these islands are up to 17 times higher than the international reference prices. Without sustained access to antiretroviral drugs, the challenge of treatment cannot be met- and the ravage of the epidemic will continue. Dokters van de Wereld fights for the right to health of all human beings, especially the most vulnerable. This includes the right to have access to affordable HIV treatment. Therefore, we support this global access campaign initiated by health groups around the world."

-- Melissa Diaz, MD, MIH, Secretary of the board Dokters van de Wereld, the Netherlands

 On the Caribbean island of St. Maarten, Kaletra costs 7,644 NAf (~$4,361) per person per year (ppy). Many people living with HIV in St. Maarten are migrants, and much less economically advantaged than their Dutch counterparts.

The St. Maarten AIDS Foundation is writing Abbott to request an open license that would enable St. Maarten to import affordable generics.


"Extending the benefits of Thailand's compulsory licenses is important to improving healthcare services for migrant workers. No clause in the TRIPS Agreement restricts the use of flexibilities such as compulsory licensing to a particular population. The Ministry of Health should review its policy."

--Ms Supatra Nacapew, Director of Foundation for AIDS Rights and Chairperson of the Thai NGO Coalition on AIDS:

"At the recent UN High Level Meeting in New York City, Thailand announced a national AIDS plan with a mission to promote "access for all". Every person in Thailand has a right to access ARV treatment, whether they are Thais or migrant workers. Access to antiretrovirals under the compulsory licensing policy should be available to everyone."

--Mr. Apiwat Kwangkaew, Chairperson of the Thai Network of People Living with HIV/AIDS (TNP+)

"Basically it's all about rights: the rights of patients to access standard medical care. We need to break through legal restrictions on access to health care for migrant workers."

--Mr. Nimit Tienudom, Director of AIDS Access Foundation

In late 2006 and early 2007, the Thai government issued several compulsory licenses facilitating imports of generic antiretrovirals (efavirenz and lopinavir + ritonavir) and medicines for cardiovascular disease and cancer.

Migrant workers, however, receive limited health care services and must pay out of pocket for HIV/AIDS drugs. As part of the global campaign, Thai civil society organizations are working to extend the compulsory licenses to migrant workers.


"Licensing and competition could spur the development of new and improved ritonavir-based combination treatments against HIV/AIDS. If patent holders and the pharmaceutical industry will not negotiate, then health advocates will pursue compulsory measures to break their monopolies on lifesaving medicines."

-- Peter Maybarduk, Public Citizen

"When the U.S. government has funded the research that leads to the invention of a  new drug, U.S. consumers should not pay more for that drug than do consumers in other high income countries. If the Obama administration approves our petition, U.S. citizens, as consumers, employers and taxpayers, will pay billions less for drugs invented on grants from the NIH and other federal agencies.  If the Obama administration rejects our petition, we will continue to pay more, making our businesses less competitive in the global economy, when compared to other high income countries.   Our petition thus raises two issues.  1.  Given our budget deficits, why do we pay more than other high income countries for drugs invented on US government grants?   2.  How can our businesses compete when they pay more than other high income countries for government funded medical inventions?"

-- James Love, Knowledge Ecology International

United States taxpayers helped fund the invention of ritonavir, one of the components of Kaletra, through a grant from the National Institutes of Health. Despite the taxpayer contribution to its development, Abbott charges exorbitant monopoly prices for Kaletra, and Abbott's anti-competitive tying practice has stymied the development of alternative ritonavir-based combination treatments by other pharmaceutical companies.

Under the Bayh-Dole Act, the US government retains certain rights to protect the public's interests with regard to government-funded inventions.  In particular, the government retains a nonexclusive royalty-free license to practice the invention as well as "march-in" authority to require the patent holder or exclusive licensee to grant a license on reasonable terms under certain circumstances.

Knowledge Ecology International and other organizations will be asking the Department of Health and Human Services to issue a general policy that the government exercise its march-in rights where medical inventions are priced higher in the United States than in other high-income countries.

The march-in complaint will feature ritionavir, a drug invented on a government grant, but priced 3 to 8 times higher in the United States than in other high income countries.   This will be at least the eighth time the federal government has been asked to use its government rights in patents on medical inventions since the Bayh-Dole Act was passed in 1980.

The price of ritonavir at drugstore.com is $9.18 per 100 mg tab.  In Australia, the price is $1.30.  In Ontario, Canada, the price is $1.45.  In Denmark, the price is $2.79.  In the Netherlands, $1.26. In Norway, a country with a per capita income of more than $84,000, the price is $1.29.

Other pharmaceutical products in KEI's march-in request include an antibiotic and drugs to treat brain disease, cancer, diabetes, heart disease, HIV/AIDS, hypoxic respiratory failure (HRF), kidney disease, macular degeneration, pain, epilepsy, and psychiatric illness.


"We deeply thank the American people who have supported us through the PEPFAR program. This program has saved many people and given them a new life.  Many of us now have love, marriage and healthy, HIV-negative children.

"Although we have made significant progress in Vietnam, we are very worried about the future and many people still do not have access to treatment. Current projections suggest that in 2015 only about 50% of the 150,000 people in need of ARVs will receive treatment, and the number of PLHIV in need of treatment is projected to rise.

"The high price of second-line treatments in addition to costly medicines for Hepatitis B and C place a heavy financial burden on our shoulders. Many of us will not be able to afford it.

"This is why today we are sending letters to Abbott and the Ministry of Health. We need access to lower priced second-line treatment. We hope we will receive positive responses to our letters. Affordable second-line treatment is vital for the Vietnam HIV/AIDS community's ability to continue to make progress fighting this disease."

-- Dong Duc Thanh, Vietnam Network of People Living with HIV

In Vietnam, Kaletra costs $2,280 ppy, nearly double the country's 2010 per capita GDP of $1,191. Abbott's high cost monopoly limits the ability of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) to expand access to treatment in Vietnam.

Over 300 Vietnamese civil society groups sent a letter to Abbott requesting an open license that would enable Vietnam to provide affordable generics to its people. Additionally, Vietnamese civil society groups are sending a letter to the Ministry of Health requesting the government make use of any patents necessary to provide generic lopinavir + ritonavir.

Dr. Burcu Kilic
Global Access to Medicines Program
Public Citizen | Protecting Health, Safety and Democracy
TEL: +1 202-588-7792
1600 20th St NW, Washington, DC 20009
URL: http://www.citizen.org/access
Twitter: @burcuno

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