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 integraseinhibitors • 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 patientsReluctance to treat, price and regulatory issues

WTO

Middle income countriesFencing 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 countriesBig 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-TBUp 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

6Credit 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 licensingChina - key announcement of proceduresIndia – applications by generic competitorsSouth 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 measuresIntellectual 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

2nd Udyog Bhavan protest Oct 2010: Comment posted "I have never seen so many police people with batons and guns.“http://www.bbc.co.uk/news/health-11488711

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