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15 MILLION BY 2015?. Killing the Doha Declaration: One Free Trade Agreement at a time. ACKNOWLEDGMENT: Sanya Reid Smith for the table on ongoing FTA negotiations. An ever-tightening trade system. 1995: World Trade Organisation (WTO) is established

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killing the doha declaration one free trade agreement at a time
15 MILLION BY 2015?Killing the Doha Declaration: One Free Trade Agreement at a time

ACKNOWLEDGMENT: Sanya Reid Smith for the table on ongoing FTA negotiations

an ever tightening trade system
An ever-tightening trade system
  • 1995: World Trade Organisation (WTO) is established
  • All developing country WTO members have to sign the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)
  • Have to start granting patents on medicines – impact of patent monopolies on medicines is felt most directly in the case of HIV
  • Developing countries try to use provisions in TRIPS to facilitate access
  • South Africa: Incorporates access provisions in its patent law & is sued by 39 pharmaceutical companies
  • Global outrage forces countries to drop the case…and leads to the Doha Declaration
doha declaration
Doha Declaration

“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

even pepfar switches to generic medicines
“Hundreds of millions of dollars have been saved by switching to generic forms of the drugs and using trucks and trains to transport them, rather than planes.” – Eric Goosby, US Global AIDS co-ordinator

In 2007, 73% of ARVs delivered by pepfar and 93% delivered through pepfar’s Supply Chain Management System (scms) project were generic formulations. pepfar partners saved an estimated $64 million – a 46% reduction in the cost of drugs – by buying generic versions instead of innovator drugs.

PEPFAR saved an estimated $323,343,256 from 2005 to 2008 through the use of generic antiretroviral drugs (ARVs).

In 2008, there were 8 PEPFAR programs that procured at least 90.0% of ARV packs in generic form, and deliveries in Ethiopia, Haiti, Namibia, Rwanda, Tanzania, and Zimbabwe were more than 99% generic. 

Even PEPFAR switches to generic medicines
developing countries and the doha declaration
Developing Countries and the Doha Declaration
  • Developing countries have incorporated several TRIPS flexibilities in their laws
  • Compulsory Licences: Brazil, Thailand, Ecuador, Malaysia, Indonesia
  • Strict patentability criteria: India, Philippines, Argentina (restriction on patents on new forms and new uses of old medicines)
  • Country experience shows you have to use Doha Declaration fully to either be able to manufacture or to import generic medicines
  • Over the years, several TRIPS flexibilities have emerged and have been used by developing countries.
trips flexibilities the list
TRIPS Flexibilities: The List
  • Transition time (now only available to LDCs)
  • Compulsory licences (CLs)
  • CLs for Export (the August 30th Decision)
  • The bolar and research exceptions
  • Strict Patentability criteria
  • Drug price control and price negotiations
  • Full use of transition periods
  • Patent Oppositions
  • Using Judicial and Competition authorities
  • Etc….
free trade agreements and the doha declaration
Free Trade Agreements and the Doha Declaration
  • Several developing countries are negotiating free trade agreements (FTAs) with the US, EU, EFTA or Japan
  • FTAs cover a broad range of subjects: trade in goods, investment, competition, tariffs…
  • They also include Intellectual Property Chapters that feature demands far in excess of the TRIPS Agreement.
  • TRIPS-plus provisions undermine or even remove TRIPS flexibilities re-affirmed by the Doha Declaration
  • FTAs are international agreements that are legally binding. Developing countries will have to change laws and government will have to change policies based on international legal commitments in FTAs.
what does the eu want
Based on EU-India FTA negotiations: leaked text in 2009, 2010 and 2011 confirm TRIPS-plus demands by EU:

Patent Term Extension: Patent term to be greater than 20 years

Data Exclusivity: Monopoly on off-patent medicines

Enforcement measures: Public money used to enforce private rights; hampering judges ability to protect public health

Investment provisions: Allows MNCs to sue Indian government over health policies and laws

What does the EU want?
us re joins the fta party
Trans-Pacific Partnership Agreement: US, Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, and Vietnam.  

What does the US want:

Patents on new forms of old medicines

Exact opposite of Indian law provision Section 3(d) because of which there are no patents in India on lamivudine/zidovudine combination, tenofovir and nevirapine syrup

No pre-grant oppositions

Exact opposite of Indian law provision that allows health and PLHIV groups to challenge patent applications

Longer terms for patents and for data exclusivity

Investment provisions: Allows US companies to sue governments over health policies; in particular price control and negotiation mechanisms are under threat

Even developed countries in the deal worried: Australia, New Zealand finding their medical programmes under attack

US re-joins the FTA party
impact of ftas on access to medicines
Impact of FTAs on access to medicines
  • A Korean study concluded that the extension of patent term is likely to cost the Korean National Health Insurance Corporation what amounts toUS $529m for extending drug patents for 3 yrs and US $757m if it has to agree to a 4 yr extension (2006)
  • A 2007 Oxfam study found that data exclusivity imposed by the US-Jordan FTA , had delayed generic competition for 79 per cent of medicines newly launched by 21 multinational pharmaceutical companies between 2002 and mid-2006, that otherwise would have been available in an inexpensive, generic form.
  • A 2009 Health Action International study of the EU -Andean trade agreements on access to medicines in Peru, found that
    • Patent term extention by 4 years would lead to a 159 million USD increase in pharmaceutical expenditure in 2025.
    • At the same time, a 10-year test data exclusivity period, as proposed by the EU in Article 10.2 of the aforementioned subgroup, would lead to an increase of more than 300 million USD in medicines’ expenditure in 2025 and a cumulative increase in expenditure of 899 million USD for the same year.
ongoing fta negotiations4
Ongoing FTA Negotiations
  • Notes on table above:
  • This table does not include developing countries which already have TRIPS+ obligations, eg due to WTO accession/FTA
  • Not all the FTAs/WTO accessions will have all the TRIPS+ provisions
  • ‘?’ = not clear if : FTA negotiations will occur and/or the FTA will include TRIPS+ provisions that affect medicines
  • Inclusion in the table above does not mean there is a legal obligation to negotiate TRIPS+ obligations

22

expressions of concern about impact of trips on medicines
Expressions of concern about impact of TRIPS+ on medicines

Including by:

  • United Nations Special Rapporteur on the Right to Health
  • Global Fund
  • UNITAID
  • World Health Organisation, UNDP, UNAIDS
  • WHO’s Commission on Intellectual Property Rights, Innovation and Public Health,
  • UK Government’s Commission on Intellectual Property Rights
  • Global Commission on HIV and the Law
  • European Parliament
  • Norway’s withdrawal from EFTA-India negotiations

24

un special rapportuer on health
UN Special Rapportuer on Health
  • These agreements are usually negotiated with little transparency or participation from the public, and often establish TRIPS-plus provisions.
  • These provisions undermine the safeguards and flexibilities that developing countries sought to preserve under TRIPS.
  • Studies indicate that TRIPS-plus standards increase medicine prices as they delay or restrict the introduction of generic competition.
  • As FTAs can directly affect access to medicines, there is a need for countries to assess multilateral and bilateral trade agreements for potential health violations and that all stages of negotiation remain open and transparent.
developing countries push back
Developing Countries push back
  • With the growing global movement on FTAs, some developing countries are pushing back
  • Brazil has protested against EU’s TRIPS-plus demands
  • India has made public statements that it will not accept TRIPS-plus provisions
  • However, both civil society and governments must be vigilant
    • US and EU both claim to have provisions in the FTAs stating that they will respect the Doha Declaration
    • But with TRIPS-plus demands this makes little difference
  • Strong global PLHIV movement against FTAs are fighting to protect the Doha Declaration, the Right to Health and Access to Medicines
2011 mass rally groups from india nepal cambodia indonesia thailand malaysia in delhi
2011: MASS RALLY: Groups from India, Nepal, Cambodia, Indonesia, Thailand, Malaysia in Delhi
global week of action 6 th 10 th feb
Global Week of Action (6th – 10th Feb):
  • The action so far…letters to Indian PM, to the EC
  • 3rd Feb: Groups in Nepal demonstrate in front of the EC office
  • 6TH Feb: AIDS activists in the UK protest at EC offices
  • 7th Feb: ACT-UP Paris confronts Karel de Gucht
  • 8th Feb: Malaysian groups protest
  • 8th Feb: South African groups protesting in front of Indian embassy RIGHT NOW