Community Views on Intellectual Property as a Barrier to Access UNITAID Meeting – 4th OCT Sarah Zaidi, International Treatment Preparedness Coalition

WHO is ITPC? International – a worldwide organisation, primarily centred on the global South. Treatment – dedicated to enabling effective, affordable health care for all people living with HIV, with a focus on key affected populations. Preparedness – supporting HIV treatment and health literacy for individual and community decision- making, including building and sustaining comprehensive treatment-focused advocacy capacity Coalition – a network of people living with HIV, treatment activists and their supporters.

Intellectual Property Rights Legal systems adopt utilitarian tools such as IPR, of IP designed to encourage innovation on one hand and balance that with needs for diffusion and access Patents, Copyright, Trademark, are examples Trade-Related Aspects of Intellectual Property Rights (TRIPS 1995) is the most comprehensive of all the international IPR regimes in terms of scope and membership- all countries compliant by 2005 and less developed by 2016 Pharmaceuticals argue that innovation and development requires a strong IP regime

What is TRIPS? Sets minimum standards for intellectual property protection: patents, copyright, trademarks, etc. For most developing countries these standards are higher than the previous standards. Obliges all members to provide 20 year patents on pharmaceutical products. TRIPS makes no differentiation between life- saving and life-style medicines. TRIPS allows for certain flexibilities and safeguards (Doha Declaration).

What REALLY is TRIPS? Multinationals, research-based pharmaceuticals, key architects of TRIPS Medicines are treated like any other commercial commodity Commercial interests protected over public health Trade rights trump human rights

TRIPS+ Free Trade Agreement : bypass TRIPS, impose new restrictions, and come by many names (partnerships, agreements etc. ) Regional or bilateral agreements between Developed Countries (US/UK/Japan etc) or Regions (European Union) and a middle-income / low income country – Data exclusivity (monopolies on off-patent medicines) Focus on issue of clinical trials – originator companies want generic producers to submit their own data to prove safety and efficacy, obliging them to repeat clinical trials for commercial reasons from using data Delay in launch of generic / diminished likelihood of speedy competition, marketing and price reductions DE is five plus years Limitations on compulsory licenses No parallel importation & seizing goods in transit and other stronger enforcement mechanisms Patents may last for longer (20+5 years - ‘patent term extensions’ or ever greening)

Experience of FTA on Countries Jordan (US – 2001) Medicine prices have increased by 20% and in some cases by 600% One hospital alone has increased its medicine spending 6-fold, Over 25% of the Ministry of Health’s budget is now spent on buying medicines, Data exclusivity has delayed the introduction of cheaper generic versions of 79% of medicines Higher medicine prices are threatening the financial sustainability of government public health programs. Guatemala – (CAFTA – US) 840,000% increase in prices 77 brand-name drugs have data protection for either 5 or 15 years, including 5 protease inhibitors for HIV/AIDS Data Exclusivity 15 years for Kaletra

African countries currently in FTA negotiations: 2011 Click to edit Master text styles Second level Third level Fourth level Fifth level

Current Threat – European Union-India FTA SPIN European Commission claims: Policy will not weaken India’s ability to produce and export affordable meds. FACT 3 aspects of agreement that will have chilling affect on the Indian generic companies Data Exclusivity – delay in registration of generic medicine (up to 10- years) Stopping the flow of generic medicines through border measures (20 incidents of legitimate generic medicines transiting through European ports being detained, including second-line HIV meds for Africa) Killing of generic competition through stricter enforcement of IP (i.e. mandatory use of court orders when patent or trademark dispute emerges between generic and patent-holding company then generic manufacture would have to stop production even before case is heard in court)

Community Response Educate Organize Mobilize Engage Delhi, India (2nd March 2011), PLHIV groups mobilized a protest of persons to express their views to the MOH and Prime Minister In Busan, Korea (regional HIV conference) a second march

Effect of Generic Competition Source: MSF, Untangling the Web 2010

The Story of ARV Scale-Up

Next Scale-up? Benefits of treatment on prevention, TB, maternal mortality child mortality 6 million on ARVs need is 18 million and growing Costs are a concern given the current financial situation Need for optimal better, more-forgiving treatment regimens, 2nd line, pediatric Need to foster healthy generic production around the world (not only India) Need to address issues of quality of ARVs

Prices and Access Together we need to find strategies and policies that result in lower prices for essential life saving pharmaceuticals in all countries. Human rights must trump trade rights. We must determine what is acceptable rent (profit) on essential life-saving drugs.

Civil Society Interventions Pushing back against restrictive IP laws and policies that harm communities. Interventions include: Advocacy e.g. campaigning, media outreach, advocacy with decision-makers; Building capacity; Strengthening local, national, regional and global partnerships Lobbying around proposed and actual legislative proposals, filing patent oppositions, advocating for proper implementation of laws impacting access, advocating for compulsory licensing

Potential Roles for UNITAID to support the community-based movement for treatment access Support treatment literacy initiatives at the community level Issue institutional supportive letters for positions adopted by communities on major IP-promoting initiatives, including the TPPA and Free Trade Agreements Create systematic processes to increase meaningful participation in UNITAID’s activities from a wide range of civil society stakeholders, including People Living with HIV and advocates from across the Global South