[Ip-health] Pharmalot: Malaysians Seek License For Abbott AIDS Drug

Steven Knievel sknievel at citizen.org
Mon May 21 16:51:14 PDT 2012

A bit more information on the Kaletra access situation in Malaysia: 

Only select groups of people living with HIV qualify for the subsidy provided by the Malaysian government for the second-line treatment they need (mothers confirmed of being HIV positive, infants confirmed of being HIV positive, persons infected through contaminated blood infusions or blood products, healthcare personnel infected through occupational exposure, and government personnel). All others who require second-line treatment must pay out of pocket for their medicine - one such person is Nazarius Celsus Dorus, who told us: 

"The doctor said that I had virological failure. The counselor came to me and we started talking. She informed me that I had to begin second-line treatment, namely, Kaletra. And what's more, I have to pay RM9501 per month! As someone who just started working to have to fork out 4/5 of my salary just to pay for medication, it was such a shock. Why is it so expensive??"

Read the rest of his statement here. 

The Malaysian AIDS Foundation - the charitable arm of the Malaysian AIDS Council (MAC) - has worked with Abbott to provide fewer than 60 people who are not eligible for government-subsidized second-line treatment with medicine through their Positive Audacious Living (PAL) scheme. MAC recognizes that this is insufficient to meet the needs of people living with HIV in Malaysia who require second-line treatment. 

Steven Knievel
Global Access to Medicines Program
Public Citizen | Protecting Health, Safety and Democracy
TEL: +1 202-588-7771
1600 20th St NW, Washington, DC 20009
URL: http://www.citizen.org/access 
Twitter: @PCMedsAccess

-----Original Message-----
From: Peter Maybarduk 
Sent: Monday, May 21, 2012 7:38 PM
To: ip-health at lists.keionline.org
Subject: Pharmalot: Malaysians Seek License For Abbott AIDS Drug

Malaysians Seek License For Abbott AIDS Drug http://www.pharmalot.com/2012/05/malaysia-an-abbott-hiv-med-a-compulsory-license/

By Ed Silverman // May 18th, 2012 // 10:11 am

Abbott Laboratories is facing a battle over its Kaletra HIV medication in yet another country. The Malaysian AIDS Council earlier this month requested that the Health Ministry issue a compulsory license so that lower-cost generic versions could be imported. The move comes after the group sought a license from Abbott last November, but apparently without any success.

In seeking a license, the group notes that the monthly cost for Kaletra is approximately $300, which is "prohibitively high for Malaysian patients living with HIV," they wrote in their letter. "Generics... are available at a fraction of this price on the global market. A government use license for Abbott's patents would authorize Malaysia to import these generics and provide them to the public through government programs" and offer a "second-line treatment at a low cost."


The move comes amid growing clashes between AIDS advocates and the drugmaker in several countries over Kaletra pricing. The advocacy groups maintain that prices charged for Kaletra are blocking expansion of AIDS treatment and drug innovation. And so, last fall, a coordinated global effort was begun in several countries in hopes of loosening the grip that drugmaker has on its Kaletra patents. 

One effort yielded a mixed result. An administrative judge in Colombia recently ruled that the drugmaker and the government health ministry improperly maintained the Kaletra price above the so-called reference price. At the same time, though, the judge declined to issue a compulsory license for the drug, an issue that prompted advocacy groups to file their lawsuit two years ago. Both sides are appealing (back story). http://www.pharmalot.com/2012/05/abbott-kaletra-pricing-and-aids-in-colombia/

There is a long-running history at work, by the way. Four years ago, Abbott agreed to settle a lawsuit charging a 400 percent price hike on Norvir - a component in Kaletra - that was undertaken some years earlier violated antitrust laws (see this). The move sparked shareholder resolutions, protests at Abbott headquarters, a boycott by hundreds of docs and attorney general investigations.

And five years ago, Abbott refused to sell new drugs in Thailand after the government issued compulsory licenses for several medicines, including Kaletra. Applications to market seven new drugs were yanked. The Thai government argued that needed meds were priced too high for most of it citizens and it had the right to override patents under provisions of a World Trade Organization agreement. Abbott subsequently relented by allowing a new pediatric version into the country (look here).

Abbott is not the only drugmaker, though, to be engaged in battle over compulsory licensing. Two months ago, India's Patent Office for the first time granted a generic drugmaker a compulsory license to make a copycat version of a patented medicine. The license was awarded to Natco, which can now make a generic of a Bayer kidney and liver cancer medication called Nexavar, although only for domestic distribution. Bayer is appealing (read this and this). 

We asked an Abbott spokesman for comment and hope to hear back shortly. Meanwhile, here is the letter that the Malaysian AIDS Council wrote to Abbott last fall. 

[UPDATE: An Abbott spokesman tells us that the drugmaker "doesn't have a patent for Kaletra in Malaysia. We've applied for a patent that has not been granted yet." He adds that Abbott is negotiating a contract with the government to supply the drug and runs programs to make it available to Malaysians but did not immediately have pricing information. Meanwhile, we have asked the Malaysian AIDS Council if it was aware of the the patent situation and will update you accordingly.]

[ANOTHER UPDATE: We asked Peter Maybarduk, who runs the Global Access to Medicines Program at Public Citizen, which has worked with AIDS patient advocacy groups in other countries, for a response. He wrote us to say that "I'm afraid the situation is a bit more complex than that. There is a patent application filed on Kaletra (in Malaysia) and a patent granted on a form of ritonavir (which is the generic name for Norvir, a component in Kaletra). These deter and could prevent competition. It is in the government's power to use generics. A license would ensure patent issues don't get in the way."]

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