Intellectual Property and Access to Affordable Medicines: TRIPS Plus

1. Intellectual Property and Access to Affordable Medicines: TRIPS Plus Judit Rius Sanjuan Doctors Without Borders/ Médecins Sans Frontières (MSF) Campaign of Access to Essential Medicines

2. Médecins Sans Frontières (MSF) • International medical humanitarian organisation, founded in 1971 • Field operations in over 65 countries. In 2009: • 7.5 million outpatient consultations • 292,000 hospital admission • 7.9 million vaccinated during meningitis outbreaks • 1.1 million confirmed malaria cases • 162,000 people on HIV anti-retroviral treatment • 1999 Launch of Campaign for Access to Essential Medicines • to improve access to existing medical tools that are unaffordable • to stimulate the development of urgently needed better tools

3. Why does MSF care about intellectual property? • We are treatment providers - Generic competition has brought the price of first line ART down by 99 • 80% of ARVs MSF uses are generics produced in India • Effects of IP are becoming evident in our field operations - Some newer HIV medicines already under patent: raltegravir ($1113 PPY), etravirine($913 PPY), many patents have been filed. • Protecting medicines with IP is leading to - Increase in cost of treatment - Threat to scale up – Threat to Improved care- Barrier to Innovation

5. The time for Doha Declaration is now “We affirm that the (TRIPS) Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all.” WTO Ministerial Declaration on the TRIPS Agreement and Public Health November 14, 2001

6. 2008 WHO Global Strategy & Plan of Action on public health, innovation and intellectual property (WHA 61.21): “Take into account in trade agreements the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights and including those recognized by the Declaration on the TRIPS Agreement and Public Health adopted by the WTO Ministerial Conference (Doha, 2001) and the WTO decision of 30 August 2003”

7. Additional Threat - TRIPS Plus • Variety of mechanism: Bilateral/Regional Trade Agreements, WTO Accession, ACTA, unilateral USTR Special 301 Lists, national legislations and regulations (e.g. anti-counterfeiting legislations), etc. • Example: current EU-India, EFTA-India & TPP FTA negotiations

8. Examples of TRIPS Plus measures • Data Exclusivity • Impose obligations concerning the subject matter or standards for granting of patents • Limit patent opposition processes • Patent - Registration Linkage • Patent Term extensions

9. EU/India FTA - IP Enforcement • Limiting Remedies: EU is asking to make injunctions mandatory – generic will be stopped from being produced or destroyed –, eliminating possibility of damages/compensation or imposing methods to calculate high damages • Border Measures: EU is asking increase the ability of customs officials to seize goods, including for medicines in transit between developing countries

10. EU/India FTA – Investment Chapter • Commission has asked the Council to modify the EU-India negotiation directives regarding the investment chapter • If IP is included, it would open a new arena for private litigation by companies against Indian gov. (investor to state dispute resolution)

11. TRIPS Plus - Who is going to be affected? • Raising the bar and imposing more restrictive IP norms will affect: • Patients and countries that pay for treatment (donors and developing countries) – undermine efforts to finance and support treatment • Countries/companies that produce generics • Countries that import generics • Countries/companies that want to produce generics

12. WHO / UNAIDS on TRIPS Plus • WHO: “From the perspective of public health and access to medicines, it is preferable not to grant data exclusivity. Moreover, there is no requirement under international law that countries grant data exclusivity; countries only have to provide for data protection” …. “TRIPS plus’ requirements have at times been incorporated in bilateral or regional free trade negotiations, in bilateral investment agreements and in other international agreements and treaties. From the perspective of access to medicines, this is a worrying trend; countries should therefore be vigilant and should not ‘trade away’ their people’s right to have access to medicines”.(Briefing Note Access to Medicines, WHO, March 2006) • UNAIDS: “In this current economic climate, resources for AIDS have already flattened and need for treatment continues to outstrip supply. Trade agreements that place additional burdens on the manufacture, import or export lifesaving medicines—so-called ‘TRIPS plus’ measures such as ‘data exclusivity—and incorrect interpretations of the term ‘counterfeit’ should be avoided.” (UNAIDs Press Statement “Trade agreements should not hinder efforts towards universal access to HIV prevention, treatment, care and support” December 2010)

13. Thank You! Judit Rius Sanjuan Médecins Sans Frontières (MSF) Campaign for Access to Essential Medicines judit.rius@newyork.msf.org More Information: http://www.msfaccess.org http://www.doctorswithoutborders.org