Getting the best treatment to the most people possible Enabling policies: threats & opportunities MSF Access Campaign

Funding crisis Impact on rt to health - not universal but rationed Impact on second-line and reluctance to bring in newer (better) treatment into first line -Starting with TDF but going forward with integrase inhibitors Particularly acute for middle income countries -Danger of losing community monitoring -Funding crisis for organisations who work on IP barriers

Neglected co-infections Among patients with AIDS, chronic HCV infection is associated with a 50% increase in mortality Hepatitis treatment for co-infected patients Reluctance to treat, price and regulatory issues

WTO Middle income countries Fencing in middle income developing countries Mis-use (ever-greening to obtain patents on older patents in MICs Less freedom to operate for generics undermines production Access – treatment available in LDCs not available in MICs Low income countries Big issue of 2016 implementation deadline for product patents LDCs to introduce product patents, need for extension NOT COUNTRY BY COUNTRY BUT ALL LDCs Issue of OAP and ARIPO just registering patents even before deadline

e.g. Linezolid patent in SA R676 per tablet in private sector (MSF price); R264 per tablet in public sector (available for R9.9 from Cipla) MSF wanting to use for patients failing DR-TB Up to R108,000 per patient (6 months) Basic patent until 2014; crystalized form II patent until 2022 (will block entry?)

Ever-greening Rejections due to local examination and application of strict patentability criteria 6 Credit for this particular slide: Lawyers Collective HIV/AIDS Unit, India

NOVARTIS 7 Novartis DROP the case kick off the campaign – protests timed with the court hearings to maintain public attention.

Growing movement – SA, Thailand, Argentina, Philippines - Examination system weeds out patent applications that should not be granted. Direct benefit with earlier expiry of patents on ARVs. Compulsory licensing China - key announcement of procedures India – applications by generic competitors South Africa – reforms needed

Why do we care? : Undermines access to affordable generic medicines by creating intellectual property (IP) barriers Affects – Production/Import/registration of cheaper generics What EU/US want: Patenting of known medicines (ARVs too) Prevent patent oppositions Patent extension, Patent linkage, Data Exclusivity IP enforcement measures Intellectual Property as Investment – Under “investment chapters” the companies get to sue the government directly – unlike WTO (for expropriation)

US and EU FTA negotiations expanding and now reaching a very crucial stage 2 nd Udyog Bhavan protest Oct 2010: Comment posted "I have never seen so many police people with batons and guns.“

VLs Threats or Opportunities “Creating generic monopolies” New business model – exclude middle income countries Do we know enough – secret deals Shrinking access even for Indian patients Conditions that block API (raw materials) access Undermine CLs Generics have to keep out of markets where there are no patent barriers -Venezuela: no patents granted, only applications filed. BILATERAL DEALS GETTING WORSE.

What we can do -Start Hep C treatment in some countries -Getting educated on new drugs -Patent oppositions on new drugs to prevent long monopolies - CLs needed for MICs - Defend India’s law - SA ‘Fix the Patent Law’ Campaign crucial - STOP the FTAs - VLs cannot be ignored