getting the best treatment to the most people possible enabling policies: threats &...
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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.