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GSIPA2M, Plenary 2, The role of civil society - Tahir Amin
- 1. Civil Society and Patent Oppositions Tahir Amin I-MAK
- 2. Who is civil society? Non- governmental, not-for-profit organizations formed by people around a common interest; it includes a wide range of organizations, networks, associations, community groups, and movements. CIVIL SOCIETY IS AN ESSENTIAL PARTNER IN EXPANDING DRUG ACCESS
- 4. The story so far
- 5. Beginnings of civil society patent oppositions 1995: TRIPs Flexibilities introduced 2005: Indiaโs new patent system includes public health safeguards as a result of civil society pressure 2006: Civil society actors filed patent challenges that enabled generic production of 4 key ARVs Generic suppliers begin to file their own patent challenges
- 6. 2006
- 7. Impact of successful patent challenges in India 51 โ 76% LPV/r 78% ABC 84 โ 89% NVP PRICE REDUCTIONS US$500 million in cost savings for lower-income country governments worldwide. Money that can be reinvested to treat more than one million people.
- 8. Today, civil society leads this work in nearly 50 countries, and has resulted in significant increases in medicines access and affordability โ the result of an ecosystem of actors
- 9. 2014-2017: Make medicines affordable coalitionโs legal interventions on 7 HIV drugs
- 11. The limitations of patent oppositions
- 12. Learning from the past & the way forward
Editor's Notes
- Examples: People living with HIV/HCV and treatment advocates: Delhi Network of Positive People, Red Latinoamericana por el Acceso a Medicamentos. Key affected populations and their organizations: Eurasian Harm Reduction Network, the Global Forum on MSM & HIV, Thai Drug Users Network. โข Implementing partners: Meฬdecins du Monde, Meฬdecins Sans Frontieฬres โข Technical and legal advocates: I-MAK, Treatment Action Group While there is often a perceived distinction between PLHIV networks and technical organizations, PLHIV and their advocates have built strong expertise and now lead work as experts. To illustrate, PLHIV networks often take the lead on technical advocacy, as was the case for the Treatment Action Campaign and the Asia-Pacific Network of People Living with HIV spearheading patent law reform. Essential partner notes: Make the issue a national and international public health priority Remove barriers to accessing medicines Drive and shape research agendas Create momentum for policy and programmatic changes at the national and global levels Many CSOs laid the foundation for demand creation, treatment literacy, service delivery and drug affordability for HIV/AIDS, creating a strong base from which other institutions were able to scale up treatment programs. Without civil societyโs work, the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) would not have been established. It was civil societyโs work that catalyzed and made possible the rapid treatment scale-up achieved by major global health actors including the GFATM, The United States Presidentโs Emergency Plan for AIDS Relief (PEPFAR), UNAIDS, the World Health Organization (WHO), UNITAID and the Clinton Health Access Initiative (CHAI). Advocacy has sustained the largest gains in the ARV access movement by creating the enabling environment for generic drug access. This impact is reflected in the cost savings of generic treatment to date catalyzed by civil societyโs advocacy
- In 2005, civil society successfully ensured that Indiaโs new patent system included public health safeguards, which allowed for patents to be challenged and prohibited re-patenting of known substances. Civil society actors including I-MAK, DNP+, LC, and MSF were then able to file patent challenges that enabled generic production of four key ARVs. Generic drug suppliers began to file their own patent challenges on ARVs after civil society set these precedents and held trainings for generic companies on how to file oppositions.
- Challenging patents on 3 ARVs alone in India has resulted in over half billion dollars in cost savings in 5 years for global purchases of these medicines โ money that can be reinvested to treat 1 million people. Impact calculations took into account originator price, total market share, average generic price paid, and patients on the ARV in generic-accessible countries.
- I-MAK has worked alongside five patient advocacy organizations since 2014 to reduce drug prices in Argentina, Brazil, Thailand, and Ukraine.*ย Legal interventions on seven HIV drugs in these four countries has so far enabled price reductions that have resulted in actual annualized savings of US$549 million per year. Annualized Impact = (branded price at start of intervention โ current generic price) * patients treated per year
- Transparency e.g. patent landscapes Short term and long term approach Is an upstream intervention that goes to the root of the current problem An intervention that could eventually open space for other policy solutions/reform, including defining what it is innovation/progress and the value we put on new medicines. Is a direct action that can be taken Goes to the heart of the power of pharmaceutical companies and how investors invest
- โOppositions take too long and do not provide generics with certainty in the market.โ filing oppositions works within the broken system rather than reforming it "Oppositions do not address the root cause " Patent oppositions are a targeted strategy to enable competition on a given drug product, and necessarily do not have the same reach and impact as a broader intervention, such as reforming patent laws themselves "Oppositions are anti-innovationโ Companies may back away from investing in new medicines if they doubt their ability to get patent exclusivity and ultimately profit from their investment. patent challenges have been pursued by private actors long before civil societyโs more recent efforts, used as a tool to support free market competition and ensure that monopoly rights are granted only within the intended parameters of intellectual property laws
- Momentum Long term game Even if we feel the patent system is not working, many donโt. Patent oppositions can be a critical tool to educating the public and driving efforts for reform in many ways.