Access to MedicinesA Role for Our Universities August 17, 2010 Universities Allied for Essential Medicines Presentation for Universidade de SÃO PAULO - USP
Why Access to Medicines?• 2 billion lack access to life saving drugs.• Ten million people die needlessly each year because they lack access to medicines: 1 in 3 have no access to medicines, rising to 1 in 2 in Sub Saharan Africa• Over 90% of these people live in developing countries and have to cover up to 90% of treatment costs• Essential drugs are either unaffordable, unavailable or inappropriate
A Fatal Imbalance• Over the past thirty years, global health has transformed at an unprecedented rate, with life expectancy increasing at an average of four months every year in developed countries.• However, with few exceptions, people living in developing countries have not benefited from this revolution.• Millions continue to die from preventable and treatable diseases, such as HIV/AIDS, malaria and tuberculosis; and many tropical diseases have been all but forgotten. .
Medicines unaffordable• Cost of medicines is the main barrier to accessing essential medicines• Pharmaceutical patenting in developing countries is the most important factor which leads to an increase in the price of medicines C . o s
Basic notions on patents• Patents confer a 20-year monopoly on a medicine product/process/formulation• International patents do not exist – patents are granted nationally or regionally• Drug patents allow their owners to exclude others from using or producing the drug until patent expiration (usually 20 years form the date patent is filed)• By excluding generic competition, patents keep prices high C . o s
HIV/AIDS• 33.2 million people living with AIDS• 2.1 million of these are children• 2007 – 2.5 million new infections and 2.1 million AIDS-related deaths• Only 31% of those who needed ARV treatment had access to it.(WHO/UNAIDS/UNICEF 2007)• 6.5 million people urgently in need of treatment but because of high prices only 1.3 million can afford treatment.• Nearly 80% of the 3 million who die each year from AIDS had no access to treatmentInformation quoted by Renata Reis, Marcela Foçaça Vieira and Gabriela Chaves in . “Access to Medicines and Intellectual Property in Brazil: A Civil Society Experience” in Intellectual Property Rights and Access to ARV Medicines: Civil Society Resistance in the Global South ABIA. 2009.
HIV/AIDS in Brazil in 1990s• Implementation of universal access to ARV produced some important results : 1997 – 2004 saw a 40% reduction in mortality and 70% reduction in morbidity.• 1993 – 2003, average life expectancy of AIDS patient rose by 5 years; reduction of 80% in hospitalizations (saving $2.3 billion)• How? - work of public health movement inputting into the reform of constitution in 1988, collaboration between state and PLWHA, creation of National AIDS Policy, creation of ABIA and GAPA leading to prevention campaigns and growing solidarity movements/role of civil society, legal developments especially Sarney Law which improved structure for purchasing medicines - but also largely due to ability to produce ARV medicines locally at lower cost .From Renata Reis, Marcela Foçaça Vieira and Gabriela Chaves. 2009. “Access to . Medicines and Intellectual Property in Brazil: A Civil Society Experience”
r Enter TRIPS… t f• World Trade Organisation officially began work 1 January o 1995• Included an agreement on intellectual property rights (Trade- Related Intellectual Property Rights) t• TRIPs provides a timeline within which all WTO members are obliged to allow product patents on pharmaceuticals c• Transitional periods for developing countries (2005), least a developed countries – LDCs (2016)• Includes exceptions to protect the public interest (public p health) m I . .
Impact of TRIPS on access to medicines• Before TRIPs, many developing countries (such as Brazil) did not allow product patents on pharmaceuticals.• Conscious policy decision that benefits of low cost access would outweigh potential negative impact that lack of patents would have on R&D.• TRIPs overturned this domestic public health policy making and countries are compelled to allow product patents in pharmaceuticals.• In Brazil these international agreements led to an overhaul of the existing legal regime which undermined the policy of universal access• Competition on manufacture of pharmaceuticals is only possible . through use of TRIPs exceptions/flexibilities by developing countries.• Implementation of TRIPS has rapidly eroded access to affordable . medicines internationally especially since 2005 when India introduced pharmaceutical patents.
Where do universities fit in?• Of the 21 drugs with the greatest therapeutic impact, 15 were developed using publically funded research, most of which occurs at universities. [The benefits of medical research and the role of the NIH. United States Joint Economic Committee, 2000]• Every single vaccine brought to market in the past 25 years has a contribution from university research. [Ashley Stevens, President of AUTM; Access to Medicines panel discussion, Yale University March 25, 2008]• More than 1/3 of HIV drugs introduced between 2002 and 2006 involve a university patent.• Universities are increasingly seen by pharmaceutical companies as the best (and cheapest) place to carry out discovery. Interesting data on the increased importance of licensing agreements to pharma sales www.pharmafield.co.uk/article.aspx?issueID=40& articleID=315 predicts that 26% of pharma sales by 2009 will come from licensing rather than in house R&D.
Where do universities fit in?• Though already significant role in drug R&D, the importance of universities in pharmaceutical discovery is projected to continue increasing with the growing importance of biologic drugs (e.g. cellular products that have the potential for achieving an exquisite target- specificity that is difficult or impossible to attain with many chemically- based drugs).• The vast majority of currently available biologic drugs were developed with significant university participation: Epogen (University of Washington), Insulin (University of Toronto), human growth hormone (UC Berkley), Remicade (NYU), Avastin (USC).• Universities have a critical role to play in the future of pharmaceutical innovation, and the decisions being made now regarding the patenting and licensing policies surrounding publicly funded research have important implications for the future of global public health.
Uuniversities Allied for Essential Medicines:Ask Vision Our OurUniversities and publicly funded research institutions will be part ofthe solution to the access to medicines crisis by promoting medicalinnovation in the public interest and ensuring that all peopleregardless of income have access to essential medicines and otherhealth-related technologies.
Universities Allied for Essential Medicines Our Mission: As a private non-profit organization rooted in a movement of university students, UAEM aims to • promote access to medicines for people in developing countries by changing norms and practices around university patenting and licensing • ensure that university medical research meets the needs of the majority of the world’s population • empower students to respond to the access and innovation crisis
Yale and d4T• In 2001, d4T costs $1,600/patient/year – Doctors Without Borders (MSF) seeks Yale’s permission to use generic d4t in South Africa – Yale balks, claiming its “hands are tied” by licensee – Students at Yale organize – NY Times editorial written by discoverer William Prusoff• March 24, 2001: Yale asks BMS to grant “patent relief” and price cuts• Generic competition drops the price of d4t in South Africa 96% within a year, allowing Médecins sans Frontières to scale-up HIV treatment programs across Africa
UAEM Member Universities• US (50) New chapters in Global South• Canada (11) University of Lagos, Nigeria• UK (14) National University of Singapore• Germany (7) National University of Rwanda• Norway(1) Makarere University, Uganda• Norway Weill-Bugando University• Australia (2) College of Health Sciences, Tanzania Institute of Medicine, Nepal And we hope now Brazil!
Why act?• Moral and ethical obligation• Commitment to creating and disseminating knowledge for the public good• University research is heavily funded by taxpayers• Maintain competitiveness in attracting talent – Top research scientists and students drawn to schools with demonstrated global public commitment• Global impact through institutional policies, not just scholarship
Consensus StatementSeed signatories: Jonathan Quick Former Director of Essential Drugs and Medicines Policy at the WHOPaul Farmer, Presley Professor of Medical Anthropology, Harvard University President and CEO of Management Sciences for Health Edwin Cameron, Justice, South African Supreme Court of Appeal John Sulston, Nobel Laureate in MedicineBernard Pecoul, Executive Director, Drugs for Neglected Diseases Initiative Zackie Achmat, Founder and Chairman, Treatment Action Campaign
Universities Know They Need to Change “Universities should strive to construct licensing arrangements in ways that ensure that these underprivileged populations have low- or no-cost access to adequate quantities of these medical innovations.” White Paper “In the Public Interest” AKA “The Stanford Nine Points”
World Health OrganizationThe Netherlands and Kenya, on behalf of theWHO African member states, explicitlyrecommended that UAEM’s policies be included inthe final WHO “Plan of Action” on IP and Health(2007)Endorsing countries included:Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde,Central African Republic, Chad, Comoros, Congo, Côte dIvoire, DemocraticRepublic of the Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana,Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali,Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tomeand Principe, Senegal, Seychelles, Sierra Leone, South Africa, Swaziland, Togo,Uganda, United Republic of Tanzania, Zambia, Zimbabwe
Obama-Biden Plan to Combat HIV/AIDS I support “the adoption of humanitarian licensing policies that ensure medications developed with U.S. taxpayer dollars are available off-patent in developing countries.”
Statement of Principles and Strategies for the Equitable dissemination of Medical Technologies Signed by Harvard, Yale, Boston, Brown, Oregon and Pennsylvania on 9 November 2009 “after campus student groups pushed for policies to make new drugs available at low cost to poor patients. The statement commits the schools to make “vigorous efforts” to promote global access to drugs through licensing strategies.” John Lauerman at Bloomberg.com “We agree that it’s important that our intellectual property doesn’t serve as a barrier -- and in some cases should be used as leverage -- to help ensure that drugs, vaccines and other technologies reach the developing world,” Maryanne Fenerjian, Harvard’s director of technology-transfer policy
Technology Transfer at Sao PaoloUSP is a public universityMissão Agencia USP de inovaçãoPromover a utilização do conhecimento científico, tecnológico ecultural produzido na Universidade de São Paulo em prol dodesenvolvimento sócio-econômico do Estado de São Paulo e do País.ObjetivosIdentificar, apoiar, promover, estimular e implementar parcerias comos setores empresariais, governamentais e não governamentais nabusca de resultados para a sociedade.
Examples of exciting (patented) Discovery at Johns USP discoveries at Hopkinshttp://www.patentes.usp.br/Catalogo/pdf/6.pdf last download 11 August 2010PI0502172‐3TITLE: FORMULATION PROCESS OF INCLUSION COMPLEX OF3‐(4‐BROMINE‐(1,1‐BYPHENYL)‐4‐IL)‐3‐(4‐BROMOFENIL)‐N,N‐DIMETHYL‐2‐PROPEN‐1‐A MINE AND ß‐CYCLODEXTRIN AND TRYPANOCIDAL ACTIVITY, ANTI‐ LEISHMANIASIS AND ANTI-MYCOBACTERIALACTIVITY.PI0805492‐4: TITULO: SIGILO ‐ DESCRIÇÃO: TERAPIA PARA PREVENÇÃO E TRATAMENT DA DOENÇA DE CHAGAS. TITLE: SECRET ‐ DESCRIPTION: PREVENTION THERAPY AND TREATMENT OF CHAGAS DISEASE. RESUMO: SIGILOPI0804314‐0: TITULO: SIGILO ‐ DESCRIÇÃO: FORMULAÇÃO FARMACÊUTICA E SEU USO, PARA DOENÇA NEGLIGENCIADA. TITLE: SECRET ‐ DESCRIPTION: PHARMACEUTICAL FORMULATION AND ITS USE FOR NEGLECTED DISEASE. RESUMO: SIGILOPI0802164‐3: TITULO: SIGILO ‐ DESCRIÇÃO: PROCESSO DE PRODUÇÃO DE NANO PARTÍCULAS PARA TRATAMENTO DE TUBERCULOSE POR MEIO DE AEROSSÓIS, INALADORES E NEBULIZADORES. TITLE: SECRET ‐ DESCRIPTION: PRODUCTION PROCESS OF NANOPARTICLES TO TREAT TUBERCULOSIS BY AEROSOL, INHALERS AND NEBULIZERS. RESUMO: SIGILO.
Examples of medical patents at USP Discovery at Johns Hopkinshttp://www.patentes.usp.br/Catalogo/pdf/6.pdf last download 11 August 2010PI0802285‐2: TITLE: SECRET ‐ DESCRIPTION: SYMBIOTIC FUNCTIONAL NURTURE PRODUCT WITH REDUCED CALORY CONTENT AND ITS MANUFACTURING PROCESS.PI0801094‐3: TITLE: SECRET ‐ DESCRIPTION: PREPARATION PROCESS OF MOLECULES TO PRODUCE BIOPROSTHESIS.PI0700698‐5: TITULO: USO DE BAIXAS DOSES DE DNA PLASMIDEAL NO CONTROLE DA RESPOSTA IMUNE E VACINA PARA TRATAR DOENÇAS AUTO‐IMUNES, INFLAMATÓRIAS, ALÉRGICAS E/OU INFECCIOSAS.TITLE: USE OF PLASMID DNA LOW DOSIS IN CONTROLLING THE IMMUNE RESPONSE AND VACCINE TO TREAT SELF-IMMUNE, INFLAMMATORY, ALLERGIC AND/OR INFECTIOUS DISEASES.PI0705395‐9: TITULO: SISTEMA DE DETECÇÃO DE PARVOVÍRUS, ANTÍGENO RECOMBINANTE, MÉTODO DE OBTENÇÃO DEANTÍGENOS E USO. TITLE: DETECTION SYSTEM OF PARVOVIRUS, RECOMBINING ANTIGEN, ANTIGEN OBTAINMENT METHOD AND USE.
What can USP do for Access to Medicines?• Follow its mission - The mission of USP is “do desenvolvimento sócio-econômico do Estado de São Paulo e do País.” A Global Access Licensing Policy is an essential step.• Invest Ethically - Make sure the hard work and investment of USP research pays off for the greatest number of people and the people who need it most.• Be part of the solution – a leader at the forefront not only of innovation, but also of access for all.