Transcript Briefing HAD - Knowledge Ecology International

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
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
2
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 Innovation3
4
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
5
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”
6
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. anticounterfeiting legislations), etc.
• Example: current EU-India, EFTAIndia & TPP FTA negotiations
7
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
8
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
9
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)
10
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
11
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)
12
Thank You!
Judit Rius Sanjuan
Médecins Sans Frontières (MSF)
Campaign for Access to Essential Medicines
[email protected]
More Information:
http://www.msfaccess.org
http://www.doctorswithoutborders.org
13