Geneva, 8 December 2009 — The Executive Board of UNITAID, the international health financing agency, will meet in Geneva on 14-15 December to decide on the future direction of the Patent Pool for AIDS medicines. International medical humanitarian organisation Médecins Sans Frontières (MSF) is concerned that a number of pharmaceutical companies are seeking to exclude developing countries categorised as ‘middle-income’ from benefiting from medicines made under licence from the Pool. If they are successful, people living with HIV/AIDS will be made to pay the price.
The Patent Pool has the potential to safeguard access to life-saving treatment for people living with HIV in the developing world, by lowering the cost of existing improved first-line and second-line treatments and accelerating the development and generic production of new and more affordable quality drugs, including new fixed-dose combination and child-friendly medicines.
“Countries like South Africa, Brazil, Peru, Thailand, India or China are considered lucrative emerging markets for pharmaceutical companies. But they are also countries with significant AIDS epidemics, and face rising drug costs. If they are excluded this will have drastic consequences for patients,” said Michelle Childs, Director of Policy/Advocacy at MSF’s Campaign for Access to Essential Medicines. “We’re concerned that UNITAID may give in to the companies’ demands and move away from its commitment to ensure access to medicines for people living with HIV in all developing countries.”
In the township of Khayelitsha, South Africa, MSF is witnessing the acute need for affordable, new AIDS medicines: 16 percent of patients in this MSF-supported project fail the first-line of HIV treatment within five years and need to take newer second-line drugs. But the prices of these newer medicines are dramatically higher: in some countries, switching a patient from a first- to second-line regimen increases the cost of treatment as much as seventeen-fold. A third-line regimen, for those failing second-line, is currently estimated to cost around US$2,300.
According to UNAIDS, beyond Africa, more than eight million people are currently living with HIV/AIDS in Asia, Latin America, Eastern Europe, and the Caribbean – many of these countries are classified as ‘middle-income’. If companies get their way and these countries are excluded from the scheme, the Patent Pool will fall far short of its promise.
“In Brazil, just one newer drug, atazanavir, is so expensive that it is eating up most of the government’s budget for AIDS medicines,” said Gabriela Chaves, MSF pharmacist in Brazil. “With increasing need for newer drugs, costs risk spiralling out of control. The consequences of being excluded from the Patent Pool will be paid by people living with HIV/AIDS.”
It is critically important that the UNITAID Board make explicit their original commitment that the Pool should be for the benefit of all developing countries and that the process for agreeing terms and conditions includes addressing the needs of patients in ‘middle-income’ countries.
“What’s at stake is the potential of the Patent Pool to defuse what’s being called the treatment timebomb,” said Michelle Childs. “In addition to the use of other public health safeguards like strict patentability criteria and compulsory licensing, a Patent Pool offers a voluntary solution. All patients, including those in middle-income countries, need to benefit."
Notes to the Editor
As part of an MSF campaign in support of UNITAID Patent Pool, over 280,000 letters were sent to pharmaceutical companies asking them to put their patents into the Pool.
MSF received responses from nine of the 10 companies who were the focus of the campaign, all of whom confirmed that they are engaged in discussions with UNITAID. A number of companies have made very positive statements about the potential of the Pool to help deliver the new formulations that are desperately needed. However, several companies wish to exclude so-called ‘middle-income’ countries from benefiting from the medicines made under licence from the Pool.
In June 2008, the UNITAID Board agreed in principle to establish a Patent Pool, subject to the approval of a detailed implementation plan. At the forthcoming meeting on 14 December, the Board will decide whether to approve the implementation plan, which includes the establishment of a licensing agency to administer the Pool. If approved, the licensing agency will seek to agree detailed licensing terms with patent owners and generic manufacturers. These terms will include which countries can manufacture and access the medicines made under licence from the Pool.
In a letter sent to the Chair of UNITAID, MSF has asked that UNITAID retain their original commitment to establish a Pool for the benefit of all developing countries.
At present, over four million people living with HIV/AIDS in the developing world receive antiretroviral therapy. An estimated six million people who are in need of life-saving treatment, are still waiting for access.
MSF operates HIV/AIDS programmes in around 30 countries and provides antiretroviral treatment to more than 140,000 HIV-piositive adults and children.