Killing the Doha Declaration: One Free Trade Agreement at a time 15 MILLION BY 2015? ACKNOWLEDGMENT: Sanya Reid Smith for the table on ongoing FTA negotiations

Killing the Doha Declaration: One Free Trade Agreement at a time

15 MILLION BY 2015?

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

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

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“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

Importance of the Doha Declaration:

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.

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.

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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

• 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.

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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

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

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 to US $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.

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Ongoing FTA negotiations with developed countries:US, EU, Japan, EFTA

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Country Negotiating FTA with which developed country?

Algeria EFTA, EU

Antigua and Barbuda Canada?

Argentina EU

Bahamas Canada?

Bahrain Australia? EU, Japan

Barbados Canada?

Belize Canada?

Benin EU

Ongoing FTA Negotiations

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Bolivia Canada? EU

Brazil EU

Brunei EU?

Burkina Faso EU

Burundi EU

Cambodia EU? (EU-ASEAN)

Cameroon EU

Cape Verde EU

Central African Republic EU

Chad EU

China Australia? WTO Accession – TRIPS-plus!!!!!

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Colombia EU, USComoros EUCongo, Democratic Republic of EU

Congo, Republic of EUCook Islands Australia & New Zealand? EU

Costa Rica EUCôte d'Ivoire EUDjibouti EUDominica Canada?Dominican Republic Canada?East Timor EUEcuador Canada? EUEgypt EU


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El Salvador Canada? EUEquatorial Guinea EUEritrea EUEthiopia EUFederal States of Micronesia Australia & New Zealand? EU

Fiji EUGabon EUGambia EUGhana EUGrenada Canada?Guatemala Canada? EUGuinea EUGuinea-Bissau EU


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Guyana Canada?Haiti Canada?Honduras Canada? EUIndia Australia? Canada? EFTA, EU, Japan, New Zealand?

Indonesia Australia? EFTA? EU? JapanIran EUIraq EUIsrael EUJamaica Canada?Jordan EUKenya EUKiribati Australia & New Zealand? EU


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Korea, Republic of ACTA, Australia? Canada? Japan? New Zealand?

Kuwait Australia? EU, JapanLao People's Democratic Republic EU?

Lebanese Republic EULiberia EULibya EUMadagascar EUMalawi EUMalaysia Australia? EFTA? EU? US TPP? Japan

Mali EUMarshall Islands Australia & New Zealand? EU

Mauritania EUMauritius EU


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Mexico ACTAMongolia Japan?Montserrat Canada?Morocco ACTA, Canada? EUMyanmar EU? (EU-ASEAN)Nauru Australia & New Zealand? EU

Nicaragua Canada? EUNiger EUNigeria EUNiue Australia & New Zealand? EU

Oman Australia? EU, JapanPakistan EU? USA?



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Palau Australia & New Zealand? EU

Palestinian Territories EUPapua New Guinea Australia & New Zealand? EU

Paraguay EUPeru EU, JapanPhilippines EU? (EU-ASEAN, EU-Philippines), JapanQatar Australia? EU, JapanRussian Federation EFTA? EU/ WTO Accession??? Rwanda EUSt Kitts and Nevis Canada?Saint Lucia Canada?St Vincent and the Grenadines Canada?

Samoa Australia & New Zealand? EU


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Sao Tomé and Principe EUSaudi Arabia Australia? EU, JapanSenegal EUSeychelles EUSierra Leone EUSolomon Islands Australia & New Zealand? EU

Somalia EUSudan EUSuriname Canada?Syrian Arab Republic EUTanzania EU


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Thailand EFTA, EU? USA? TPP??? (EU-ASEAN)Togo EUTonga Australia & New Zealand? EU

Trinidad and Tobago Canada?Tunisia EUTurkey EUTuvalu Australia & New Zealand? EU

Uganda EUUkraine Canada? EUUnited Arab Emirates Australia? EU, JapanUruguay EUVanuatu Australia & New Zealand? EU


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Venezuela EU

Vietnam EFTA? EU, USA (TPP)YemenZambia EU

Zimbabwe EU

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

Some things to take note of…

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

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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• 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

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Indian groups protest; beaten up• DELHI

• North-East

• South

Global Movement

Protest in Indonesia

Protest in Malaysia

Protest in Korea

2011: MASS RALLY: Groups from India, Nepal, Cambodia, Indonesia, Thailand, Malaysia in Delhi

PLHIV Travel from all parts of Asia

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

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8th Feb, 8.30 amCoffins delivered to the EC office in Delhi

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Documents

Killing the Doha Declaration: One Free Trade Agreement at a time 15 MILLION BY 2015? ACKNOWLEDGMENT: Sanya Reid Smith for the table on ongoing FTA negotiations