[Ip-health] Washington and Huffington Posts re: U.S. pressure against Colombia leukemia drug CL

Steven Knievel sknievel at citizen.org
Fri May 20 07:59:02 PDT 2016


Dispute with Swiss drugmaker has Colombian officials worried about U.S. peace funding
By Carolyn Y. Johnson and Karen DeYoung May 18 at 8:52 PM 

Colombian officials are concerned that a dispute with the Swiss drugmaker Novartis over the patent and price of a groundbreaking cancer treatment could escalate and threaten U.S. funding for a pending peace deal that could end a half-century of war in the South American nation, according to leaked letters written by the Colombian Embassy.

In a letter last month to Colombia's health minister, an official with the Colombian Embassy in Washington said that Senate Finance Committee staffer Everett Eissenstat had warned him that a plan to override the patent on Gleevec, the top-earning cancer drug for pharmaceutical giant Novartis last year, could damage Colombia's reputation in the United States and interfere with U.S.-Colombian relations.

President Obama has made a $450 million commitment to aid implementation of the Colombian government's peace deal between the government and the leftist guerrilla group Revolutionary Armed Forces of Columbia (FARC). A spokeswoman for the committee said that funding for the peace deal was not discussed in the meeting between Andrés Flórez and Eissenstat.

Colombian Health Minister Alejandro Gaviria said in an interview with the Associated Press on Tuesday that he would give Novartis a few weeks to lower the price on the leukemia drug Gleevec (known as Glivec outside the United States) before allowing it to be made by companies other than Novartis. 

The move, called compulsory licensing, breaks the monopolies of foreign drugmakers and allows competitors to sell cheaper generic versions in the country.

In one letter, obtained by the patient-advocacy group Knowledge Ecology International, Flórez, the embassy's second-ranking official, wrote that the Senate staffer told him that even though Novartis is not an American company, the U.S. pharmaceutical industry was worried the case could become a "precedent."

In a separate letter to the Colombian foreign minister April 27, Flórez wrote that the U.S. trade representative had requested a meeting to discuss the government's patent plan.

A spokesman for the trade representative said that the requested meeting was held - after the release of an annual report that does not mention the patent issue in the section on Colombia - to discuss a broad array of issues related to intellectual property.

The Senate Finance Committee "has no jurisdiction over the Paz Colombia initiative and it was not discussed" at the meeting between Flórez and Eissenstat, the committee's counsel for international trade, said Julia Lawless, a spokeswoman for its chairman, Sen. Orrin Hatch (R-Utah).

The letters provide a window into the behind-the-scenes tensions that arise when countries try to force down drug prices by overriding pharmaceutical patents. For years, nations struggling with limited health-care resources have been using compulsory licensing to give residents access to affordable versions of treatments.

Compulsory licenses can be used on any patent, not just drugs. The United States has used them to bypass patent holders for products such as night vision goggles and lead-free bullets, for example. Public Citizen, a patient advocacy group that tracks the use of compulsory licensing for pharmaceutical firms, found that since 1995, more than a dozen countries have exercised compulsory licenses on drugs, largely for HIV and cancer treatments. The reasons given range from public-health emergencies to anti-competitive practices to public interest.

It is difficult to measure how widely used compulsory licenses are in health care. Some African countries have granted licenses for entire classes of HIV drugs. Between 2006 and 2008, Thailand granted compulsory licenses for three HIV drugs, a blood-clot prevention drug and three cancer drugs. It initially sought a compulsory license for Gleevec, but ultimately canceled it because it came to an agreement with Novartis. In its most recent round of compulsory licenses in 2012, Indonesia issued licenses for seven HIV drugs and a hepatitis B medication. Ecuador has at least nine compulsory licenses for drugs.

The pharmaceutical industry defends its patents, which allow companies to make money after they have heavily invested in research and development of a drug. After patents expire, other companies are allowed to make cheaper generic versions.

In an emailed statement, Novartis said it was "actively seeking a resolution to discussions around our Glivec patent in Colombia that benefits patients, innovation and the healthcare system."

Mark Grayson, a spokesman for the industry trade group PhRMA, said the organization could not comment about the situation in Colombia. Generally, he said, PhRMA believes that compulsory licenses should be used rarely, because if countries routinely bypass patents, it will undermine the incentive to do research and create new medicines.

The fights over these issues often create worries about international trade relations. Peter Maybarduk, director of the global access to medicines program at Public Citizen, spoke from Peru where he is currently working on a compulsory license for an HIV drug. He said that the Ministry of Health and the Ministry of Trade there are at odds because of concerns about the response of major businesses and trading partners.

"It's a very ugly politics with a lot of lives at stake," Maybarduk said. "When we give drug companies monopolies, then they're going to charge whatever they can."

Carolyn Johnson is a reporter covering the business of health. She previously wrote about science at The Boston Globe.
  Follow @carolynyjohnson

Karen DeYoung is associate editor and senior national security correspondent for the Washington Post.
  Follow @karendeyoung1


Dear Senator: Do You Really Want Cancer Drugs To Be Super-Expensive?

Public health organizations are asking GOP Sen. Orrin Hatch why he seems so protective of pharmaceutical profits in Colombia.
05/19/2016 06:20 pm ET 
Zach Carter Senior Political Economy Reporter, The Huffington Post 

WASHINGTON - In late April, a Colombian diplomat sent two letters to leaders in Bogotá warning that efforts to lower the price of a major leukemia treatment could undermine a peace plan designed to end a half-century of conflict with Marxist rebels. After talks with both Obama administration trade officials and a key aide to Sen. Orrin Hatch (R-Utah), Andrés Flórez of the Colombian embassy became convinced that the U.S. government was willing to cut off $450 million in peace funding to retaliate if Colombia curbed profits on Gleevec, a breakthrough cancer drug.

Neither Hatch nor the Office of the U.S. Trade Representative have denied pressuring Colombia over the medication or invoking the peace program in private talks. The Flórez letters were first published by the nonprofit group Knowledge Ecology International more than a week ago. 

Swiss pharmaceutical giant Novartis currently charges nearly double Colombia's per-capita income to provide a single patient with a one-year supply of Gleevec, also marketed as Glivec. By issuing a so-called compulsory license, the Colombian government could allow a generic competitor to provide a copy of the drug at a dramatically lower price.

On Thursday, Knowledge Ecology International and three other public health organizations wrote a letter to Hatch asking him to explain his position. Hatch chairs the Senate Finance Committee, which oversees U.S. trade policy for Congress.

"If these letters sent by the Embassy of Colombia are accurate, this is a highly inappropriate and wholly objectionable attempt to interfere with the right of the Colombian government to proceed with this compulsory license through threats and distortions," the letter reads. "In our view it is particularly unconscionable that this be tied in any way to funding ... to support the peace process."

Public Citizen, HealthGAP and Oxfam America also signed the letter. Hatch's office did not respond to a request for comment.

World Trade Organization treaties and the U.S. trade agreement with Colombia allow countries to issue compulsory licenses for generic drugs. Although American trade policy has consistently privileged the profits of major pharmaceutical companies for decades, the pact with Colombia includes unusually flexible terms on drug affordability. Novartis has reaped about $4.7 billion in Gleevec sales sales every year since 2012.

President Barack Obama pledged $450 million in peace funding to Colombia in February. The money would be spent helping the Colombian government fight the illegal drug trade and retraining members of the Revolutionary Armed Forces of Colombia rebel group, known as FARC.

Read the full letter from Knowledge Ecology International, Public Citizen, HealthGAP and Oxfam America here.

Steven Knievel
Campaign Coordinator | Global Access to Medicines Program
Public Citizen | Protecting Health, Safety and Democracy
TEL: +1 202-588-7769
1600 20th St. NW, Washington, DC 20009
URL: http://www.citizen.org/access  
Twitter: @PCMedsAccess

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