Groups Seek Generic Competition for Abbott’s Patented Lifesaving Treatments
WASHINGTON, D.C. – Today, public health groups in a dozen countries launch a campaign to challenge Abbott Laboratories’ monopolistic hold on lopinavir+ritonavir (also known as Kaletra or Aluvia), a critical HIV/AIDS medicine. The goal is to spur competition by generic drugmakers and thereby lower the medicine’s price, as well as to free up its components for new and improved combination treatments.
In countries from the U.S. to Vietnam, Brazil to Indonesia, health groups are aiming to break Abbott’s monopoly control over lopinavir + ritonavir. Campaigners say Abbott’s high prices are blocking expansion of AIDS treatment, and its anti-competitive practices are impeding new drug innovation.
The campaign comprises an unprecedented global effort to fight Big Pharma’s political power and improve access to lifesaving medicines.
In the United States, Vietnam and Indonesia, groups will ask their governments to authorize generic competition under rules providing for the government use of patents. In Brazil, lawyers will file formal challenges to Abbott’s patent claims, arguing that the company has not met national standards for patentability and therefore is not entitled to extend its patent monopoly. Colombian health advocates are pursuing a lawsuit for a compulsory license authorizing generic competition, as the government of Ecuador and health advocates in Thailand seek to expand licenses already in effect. In India, which is a key producer of generic anti-HIV medicines, civil society groups have successfully warded off Abbott’s efforts to monopolize lopinavir+ritonavir, and are continuing their work to keep these drugs off patent today. Peruvian groups will ask Abbott to abandon new patent applications (a demonstration is planned before the Ministry of Health). Treatment providers in Sint Maarten (Kingdom of the Netherlands) and Malaysia and health groups in China are filing request letters with Abbott seeking licenses to permit generic competition. More than 300 Vietnamese health groups have signed a similar letter to Abbott.
“Freeing these drugs for competition and co-formulation could save countless lives,” said Peter Maybarduk, director of the Global Access to Medicines Program at Public Citizen. “These medicines can be manufactured cheaply where patent barriers can be overcome. 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.”
Kaletra, also known as Aluvia, is a key part of HIV/AIDS treatment worldwide, especially for patients that have developed resistance to older drugs. An early-stage U.S. federal grant led directly to the invention of Kaletra’s essential component ritonavir.
Ritonavir can work as an effective booster with other drugs, but Abbott’s anti-competitive policy commonly prevents it from being used to enhance the effectiveness and lower the cost of other medicines. Today, Abbott asserts a high-priced monopoly in many countries, compromising the finances of public HIV/AIDS programs and limiting the world’s ability to expand HIV treatment and prevention. Despite the public’s investment in ritonavir, Abbott’s product tying likely has slowed HIV/AIDS drug innovation.
Expanding access to AIDS medications is now doubly important, as new scientific research shows that antiretrovirals serve a prophylactic purpose and can bring the epidemic to a halt. Earlier this week, Secretary of State Hillary Clinton unveiled a call for an “AIDS-free generation.” That depends in significant part on massively expanding distribution of AIDS drugs.
Generic competition has driven down global prices for AIDS drugs from more than $10,000 a year per person to less than $100. Yet, Abbott prices Kaletra at $400 in the world’s poorest countries, and much higher – from $1,000 to around $4,000 – in other developing nations. In the U.S., Abbott priced ritonavir alone at nearly $8,000 last year.
“The high cost of patented medicines is a major strain on our health systems,” said Sindi Putri, a treatment advocate in Indonesia. “This global day of action will launch competition campaigns in many countries, so we can work together for access.”
Ten years ago, the members of the World Trade Organization (WTO) affirmed that WTO patent rules “should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.” But the political power of the pharmaceutical industry has made it difficult for countries to use the safeguards available under patent rules. After Thailand issued compulsory licenses on AIDS, cancer and heart disease medicines, Abbott retaliated by withdrawing plans to sell several new drugs in the country, and the U.S. government attacked Thailand on a trade watch list. Many countries are hesitant to stand alone against this pressure.
“Acting in concert around the world, we will be better able to fight Abbott’s abuses,” said Luz Marina Umbasia, a lawyer who works on behalf of Colombian treatment groups. “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.”
For more information, visit: http://www.citizen.org/Kaletra-campaign
Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C.