WASHINGTON, MARCH 8, 2017—Judit Rius Sanjuan, Doctors Without Borders/Médecins Sans Frontières’ (MSF) Access Campaign manager and legal policy advisor, delivered the following remarks at the United States Trade Representative's 2017 Special 301 Review hearing today.
Good afternoon. I would like to provide testimony on behalf of MSF.
I dedicate this testimony to Tobeka Daki and to the millions of women around the world who need access to affordable medicines. Tobeka died last year in South Africa because of the high prices demanded by pharmaceutical companies on cancer treatments.
MSF is an independent, international medical humanitarian organization that delivers medical care to patients in nearly 70 countries. We provide medical aid to victims of armed conflict, epidemics, natural and man-made disasters, and to others who lack health care due to social or geographic marginalization. Our work often focuses on the medical needs of populations living in developing countries, whose needs are often neglected, but increasingly we are also being asked to respond to the unmet health needs of patients living in countries considered high-income economies. Through our work, MSF witnesses the everyday impacts on people of having limited or no access to medicines because they are too expensive or they don’t exist.
As a medical treatment provider with more than 40 years of experience caring for vulnerable people, MSF is able to speak about the relationship between intellectual property (IP) rules, access to medicines and innovation. This includes key political, legal and commercial barriers that stand in the way of production, distribution and access to affordable and appropriate medicines, vaccines and diagnostics and that inhibit patient-driven medical innovation.
MSF would like to provide testimony to the USTR 2017 Special 301 Review process regarding the critical importance of respecting countries’ rights to uphold the public health safeguards enshrined in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and to implement these safeguards in national law, policies and practices to balance private commercial interests with the right to life and health.
Specifically, we would like to highlight the important role India plays in manufacturing lifesaving medicines and vaccines for millions of people around the world, and condemn pressure from the US government & pharmaceutical companies to undermine countries rights to issue TRIPS compliant compulsory licenses and other TRIPS flexibilities, including most recently to Colombia, Canada and Ukraine.
India
Thanks to price-lowering competition from India, millions of people around the world are able to access the affordable medicines and vaccines they need, including through programs funded by Ministries of Health, humanitarian treatment providers like MSF and US government-funded treatment and prevention programs, like the US President’s Emergency Plan for AIDS Relief (PEPFAR), the Global Fund to Fight AIDS, Tuberculosis and Malaria, and Gavi, the Vaccine Alliance.
This is possible, in part, due to the public health safeguards in India’s patent law and policies. We urge the USTR to respect legal safeguards such as India’s strict patentability criteria; its right to issue compulsory licenses when deemed necessary in the interest of ensuring the right to health; and a balanced approach in the enforcement of private IP protections. Additionally, USTR and pharmaceutical corporations’ TRIPS-plus demands such as data exclusivity that go beyond the WTO TRIPS obligations and create regulatory barriers in the registration of price-lowering generic medicines should not be requested to be implemented by India.
Colombia
US government has committed to respect the right of countries to use TRIPS flexibilities to promote more affordable access to medicines, at least on paper. We are deeply concerned by the interference by US government officials in an effort to prevent Colombia’s Minister of Health from issuing a compulsory license on secondary patents on a lifesaving cancer medicine to promote generic competition.
At a time when the high prices of medicines are a concern for countries all over the world, including here in the United States, countries’ efforts to ensure people can access the lifesaving medicines they need should not only be respected, but promoted more than ever.
Countries should not be penalized or discouraged from making use of the public health safeguards that are intended to protect access to medicines and which are legally permitted in accordance with international trade rules.
Conclusion
MSF recognizes the need to reward innovation and the need to finance research and development. We are a humanitarian medical organization that needs and welcomes biomedical innovation to improve treatment options for our patients. R&D is important, and someone needs to pay. However, the reality is that relying on high prices for medicines, backed up by intellectual property monopolies, is a flawed paradigm to pay for medical innovation. It creates both access problems due to high prices and, at the same time, it does not stimulate innovation for many of the diseases affecting people in developing countries, where patients have limited purchasing power or where drugs have to be used sparsely like antibiotics.
Yet new approaches to medical innovation are demonstrating that significant medical breakthroughs with access are possible—in particular, models of innovation that break the link between the cost of research and development and the high price of the end product.
I dedicate this testimony to Tobeka Daki and to the millions of women around the world who need access to affordable medicines. Tobeka died last year in South Africa because of the high prices demanded by pharmaceutical companies on cancer treatments.
MSF is an independent, international medical humanitarian organization that delivers medical care to patients in nearly 70 countries. We provide medical aid to victims of armed conflict, epidemics, natural and man-made disasters, and to others who lack health care due to social or geographic marginalization. Our work often focuses on the medical needs of populations living in developing countries, whose needs are often neglected, but increasingly we are also being asked to respond to the unmet health needs of patients living in countries considered high-income economies. Through our work, MSF witnesses the everyday impacts on people of having limited or no access to medicines because they are too expensive or they don’t exist.
As a medical treatment provider with more than 40 years of experience caring for vulnerable people, MSF is able to speak about the relationship between intellectual property (IP) rules, access to medicines and innovation. This includes key political, legal and commercial barriers that stand in the way of production, distribution and access to affordable and appropriate medicines, vaccines and diagnostics and that inhibit patient-driven medical innovation.
MSF would like to provide testimony to the USTR 2017 Special 301 Review process regarding the critical importance of respecting countries’ rights to uphold the public health safeguards enshrined in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and to implement these safeguards in national law, policies and practices to balance private commercial interests with the right to life and health.
Specifically, we would like to highlight the important role India plays in manufacturing lifesaving medicines and vaccines for millions of people around the world, and condemn pressure from the US government & pharmaceutical companies to undermine countries rights to issue TRIPS compliant compulsory licenses and other TRIPS flexibilities, including most recently to Colombia, Canada and Ukraine.
India
Thanks to price-lowering competition from India, millions of people around the world are able to access the affordable medicines and vaccines they need, including through programs funded by Ministries of Health, humanitarian treatment providers like MSF and US government-funded treatment and prevention programs, like the US President’s Emergency Plan for AIDS Relief (PEPFAR), the Global Fund to Fight AIDS, Tuberculosis and Malaria, and Gavi, the Vaccine Alliance.
This is possible, in part, due to the public health safeguards in India’s patent law and policies. We urge the USTR to respect legal safeguards such as India’s strict patentability criteria; its right to issue compulsory licenses when deemed necessary in the interest of ensuring the right to health; and a balanced approach in the enforcement of private IP protections. Additionally, USTR and pharmaceutical corporations’ TRIPS-plus demands such as data exclusivity that go beyond the WTO TRIPS obligations and create regulatory barriers in the registration of price-lowering generic medicines should not be requested to be implemented by India.
Colombia
US government has committed to respect the right of countries to use TRIPS flexibilities to promote more affordable access to medicines, at least on paper. We are deeply concerned by the interference by US government officials in an effort to prevent Colombia’s Minister of Health from issuing a compulsory license on secondary patents on a lifesaving cancer medicine to promote generic competition.
At a time when the high prices of medicines are a concern for countries all over the world, including here in the United States, countries’ efforts to ensure people can access the lifesaving medicines they need should not only be respected, but promoted more than ever.
Countries should not be penalized or discouraged from making use of the public health safeguards that are intended to protect access to medicines and which are legally permitted in accordance with international trade rules.
Conclusion
MSF recognizes the need to reward innovation and the need to finance research and development. We are a humanitarian medical organization that needs and welcomes biomedical innovation to improve treatment options for our patients. R&D is important, and someone needs to pay. However, the reality is that relying on high prices for medicines, backed up by intellectual property monopolies, is a flawed paradigm to pay for medical innovation. It creates both access problems due to high prices and, at the same time, it does not stimulate innovation for many of the diseases affecting people in developing countries, where patients have limited purchasing power or where drugs have to be used sparsely like antibiotics.
Yet new approaches to medical innovation are demonstrating that significant medical breakthroughs with access are possible—in particular, models of innovation that break the link between the cost of research and development and the high price of the end product.
Instead of unilateral trade pressure to create stronger monopoly protectionism for pharmaceutical companies and doubling down on a broken innovation system, the US government should seek to establish improved incentives and norms to fix the world’s broken research and development (R&D) system as committed in WHO negotiations over the last 10 years, at the 2016 UN Political Declaration on AMR and as recommended by the 2016 UN Secretary-General’s High-Level Panel on Access to Medicines.
Every country, including the US, has the right to take steps to increase access to medicines and implement a patent and health system in line with its public health needs. We strongly object to any pressure exerted by the US government, including through the Special 301 process, to try to pressure countries not to use legal flexibilities to protect public health.
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