E-DRUG: MSF: Access Denied to Crucial New HIV/AIDS Medicines
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Below please find MSF's Press Release from today and a briefing note on why Abbott could begin the registration process now. For additional information on MSF's order of heat-stable LPV/r and a complete briefing note on the barriers to accessing LPV/r in the field, please visit:
http://www.doctorswithoutborders.org/news/hiv-aids/kaletra_briefingdoc.cfm
Kate Evans
U.S. Coordinator, Campaign for Access to Essential Medicines
Doctors Without Borders/Medecins Sans Frontieres (MSF)
333 Seventh Avenue, 2nd Floor * New York, NY * 10001-5004 * USA
Tel: +1-212-655-3762
Cell: +917-331-9077
Fax: +1-212-679-7016
E-mail: kate.evans@newyork.msf.org
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For Immediate Release
Contact Kevin Phelan at 1-212-655-3763 or Michael Goldfarb at 1-212-763-5783
Access Denied to Crucial New HIV/AIDS Medicines
Urgent need in the developing world for Abbott Laboratories new version of lopinavir/ritonavir, a drug that does not require refrigeration
Lagos/Berlin/New York, March 15, 2006
People living with HIV/AIDS in developing countries cant get new and/or improved drugs that can make a critical difference, said the medical humanitarian organization Doctors Without Borders/Medecins Sans Frontieres (MSF). MSF also said that it refuses to accept the standard practice of drug companies to market less adapted drugs to African, Asian and Latin American countries while reserving improved or newly developed drugs for countries that can pay more. For this reason MSF is placing an order directly with the worldwide headquarters of Abbott Laboratories in Chicago for a new heat stable version of the drug called lopinavir/ritonavir, which the company right now only sells in the US at a price of US$9,687 (average wholesale price) per patient per year.
With temperatures regularly rising to nearly 40 Celsius, over 100 Fahrenheit, and with the numerous daily electrical blackouts, our patients can't use the old version of this drug, said Dr. Helen Bygrave, who works at MSF's AIDS treatment program in Lagos, Nigeria. It's a cruel irony that although this drug with no need for refrigeration seems to have been designed for places like Nigeria, it is not available here.
In November 2005, Abbott launched a new version of their boosted protease inhibitor, lopinavir/ritonavir in the US. Unlike the old version, this new one no longer requires refrigeration, making it much more suitable for use in the hot climates of many developing countries where MSF works. But when MSF inquired about the price and availability of this new product for its patients, Abbott responded that it would wait until the product was available in Europe before requesting marketing approval in developing countries. This means a potential delay of years before this drug reaches the people who can benefit from it most.
The drug lopinavir/ritonavir is a crucial component of antiretroviral therapy for patients that need to be switched to a newer second-line treatment regimen when drug resistance naturally develops after a few years on their first set of medications. World Health Organization (WHO) experts recommend this drug for use in second-line AIDS treatment.
At MSF's program in Khayelitsha, South Africa, 16% of the patients needed a new regimen after four years of treatment. Such data underline the acute and growing need for newer drugs. With over 60,000 patients on antiretroviral treatment, MSF says that its efforts to treat some patients that need access to newer drugs are being thwarted by drug company policies that take a "go slow" approach to making these new drugs available in developing countries.
Ibrahim Umoru, who receives treatment at the MSF clinic Lagos, has been taking the old version of LPV/r for five weeks but his drugs need to be refrigerated at a clinic that is far from his home. I can't afford the diesel fuel for a generator to run a refrigerator. And without a refrigerator, these temperatures turn the capsules into clumps that look like used chewing gum. I need the newer version.
Because Abbott is not making the drug available in developing countries, MSF today placed an order for its projects in Cameroon, Guatemala, Kenya, Malawi, Nigeria, South Africa, Thailand, Uganda, and Zimbabwe. Armed with evidence from industry experts that the new formulation is less expensive to make than the old one, they also demanded the lowest possible price, one that would be no more than the amount Abbott charges some developing countries for the old version.
In a letter to the CEO of Abbott, prominent doctors, researchers and AIDS organizations from around the world urged Abbott to make new lopinavir/ritonavir available âimmediatelyâ to patients in developing countries.
Abbott has been marketing this drug as Kaletra since 2000 â but the old version is a soft-gel capsule, which means more pills per day, meal restrictions, and need for refrigeration in hot climates.
The current crisis of access to lopinavir/ritonavir is a clear illustration that the drug access problem in developing countries is still acute. While the price of first generation ARV medicines has decreased considerably because of generic competition, the price of new life extending drugs which are likely to be patented in producing countries are dramatically higher than older drugs. This blocks access in poorer countries where most people suffering from AIDS reside. If drug access depends on the marketing policies of pharmaceutical companies, then the lives of millions of patients will remain threatened.
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Unnecessary Delays by Abbott:
The âCPPâ myth debunked
10 march 2006
MSF needs the new and improved version of LPV/r (lopinavir/ritonavir) for its AIDS projects now â the drug is a crucial component of second-line antiretroviral therapy, and is particularly important for use in many developing counties where MSF operates, since it no longer requires refrigeration, as the old version does. Today this heat-stable, fixed-dose combination is only available in the US.
However, Abbott has not begun the process of registering this drug in developing countries and claims that this process cannot begin until the drug is registered in Europe. This document explains why the company does not need to wait but instead could begin filing for registration in developing countries now.
Abbott claims that a Certificate of Pharmaceutical Product (CPP) must be issued from Europe in order to register the new formulation in developing countries. We claim that this is a choice. According to WHO, the CPP must be issued by the exporting country and therefore could be issued today by the US FDA.
What is a Certificate of Pharmaceutical Product? The CPP is one part of a multi-pronged strategy to improve national drug authoritiesâ ability to regulate products by creating a standard that clearly communicates a drugâs status with respect to marketing authority and manufacturing standards. Essentially the CPP says, âyes we (e.g. the US FDA) have registered this product as safe for sale in our country and we inspect and have confidence in the manufacturing practices of the producer.â Not all countries even require a CPP to register a drug for use, but those that do, require it from the exporting country. For instance, Abbott has said it will file for registration of the new LPV/r formulation in South Africa â the only developing country the company has slated for registration so far â where the drug regulatory authority does not require a CPP for registration. Abbott could file for registration in all developing countries, and if a country does require a CPP, it could be issued from the US drug regulatory authorities.
Reading Between the Lines: The facts about the CPP Abbott says it needs an EU CPP in order to register the drug in African countries, because the new version of LPV/r is manufactured in a plant in Germany. But the key point here is not where the drug is produced, but from which country it will be exported. Abbott may want to export this product from Europe instead of from the US, but this is a commercial decision, NOT a regulatory requirement. New LPV/r was approved by the US FDA in October 2005, and is available only in the US right now. MSF has confirmed that the US FDA inspects the manufacturing plant in Germany where the product is manufactured and has been assured that the FDA could issue a CPP.
The Bottom Line:
As not every country requires a CPP for registration, Abbott should immediately register the drug in those countries that do not require a CPP, and should obtain a US CPP to expedite registration in countries that do.
Does the CPP issue affect individual shipments, in the period before the drug is registered?
No. Because MSF and other organisations and institutions will obtain special authorization to get new LPV/r to HIV/AIDS projects, the CPP is a requirement related to registration but not special authorisation to import.