trade laws about medicines
TRANSCRIPT
Access to Medicines: Trade and Intellectual Property Rights
Jennifer Flynn Amirah SequeiraManaging Director Coordinator
Health GAP SGAC
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The Greatest Tool on Earth: The Midwest Academy Strategy Chart
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Goals Resources Allies Targets Tactics
Long-Term Goal
Mid Range Goal
Short-Term Goal
4Taken into Account
Can Get Attention
3
6Power to have Major Influence on decision-making
8Active Participant in Decision-making
10Decisive Decision making Power or Influence
2Not on Radar
Die HardDie Hard Inclined TowardsActive SupportActive SupportInclined Towards
Accountable Global Economic & Health that is focused on human rights
Accountable Global Economic & Health that is focused on human rights
Market driven economyDeregulationPrivatization US Nationalism
Market driven economyDeregulationPrivatization US Nationalism
Who is our opposition?
SGAC
Who are our allies?
6. What opportunities are there for us to exercise power?
Who are
decision makers?
How are decisions made?
Power Analysis
What do we mean by access to medicines?
Access to essential medicines in developing countries is primarily dependent on price.
Patented, brand-name drugs are usually much more expensive than generic drugs.Why? A patent is a government-conferred monopoly (usually 20 years).
Monopoly = No competitors = Higher prices
Access to medicines in developing countries requires access to low-cost generic drugs.
Trade and Development Policy and HIV: Things you need to know
• IMF Policies• DOHA Declaration• WTO• TRIPS• Free Trade Agreements• Drug Seizures04/12/23 www.healthgap.org 5
Intellectual Property• Political in nature• Competing demands
from the developed and developing worlds
• The rights of companies against the rights of society
• Decisions about IP are not about simply finding ways to stimulate & reward innovation
• Profits over people
Loans from the International Monetary Fund Create Barriers to Access to
Medicines• The IMF should exit the development business • Eliminate the IMF's mission creep • Debt cancellation • No financial sector liberalization • Let developing countries pursue expansionary macroeconomic
policies • The IMF should not impede public spending through budget caps • IMF policies need to generate decent work • Transparency and access to information at the IMF is vital • Participation must open up
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Patent Hegemony:The WTO TRIPS Agreement
• 1994 WTO TRIPS Agreement: – Uniform global standards (the floor)– 20-year patent protection for pharmaceutical
products– Non-discrimination: fields of technology, imports
• Important flexibilities– Standards of patentability, exclusions, and
limited exceptions, e.g., early working and research
– Parallel importation– Compulsory licenses– Transition periods & patent mailbox
TRIPS Agreements (cont)
The World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property (TRIPS), adopted in 1995, sets the international minimum standard for intellectual property (IP) rules, which includes patent rules.
Most developing countries signed TRIPS, agreeing to adopt US-style patent rules for the first time.
“Flexibilities” allowing exceptions to patents (which allow the introduction of generic competition during the life of a patent) were also enshrined in TRIPS.
Common TRIPS-plus IP provisions in U.S. FTAs
Data Exclusivity: Provisions establishing special 5-10 year monopoly protections for pharmaceutical test data required to demonstrate drug safety and efficacy and to authorize a drug for use. May effectively bar compulsory licensing or generic competition for drugs that are not patent protected. A priority of Big pharma that is in most agreements.
Patent extensions: These provisions extend the 20 years of monopoly protection mandated by TRIPS.
Evergreening provisions: Obligations to extend patent protection to minor improvements in, or new uses of, older products (like Novartis attempted in India).
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Doha Declaration
• 2001: crisis in access to AIDS medicines, African countries fight back.
• 9/11 anthrax scare.• Doha Declaration on the TRIPS Agreement and Public
Health (Nov. 14, 2001)– “We agree that the TRIPS Agreement does not and should
not prevent Members from taking measures to protect public health. … [W]e affirm that the 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.”
• Paragraph 6 Decision (2003) – production for export.
The Doha Declaration (cont)The Doha Declaration on the TRIPS Agreement
and Public Health emphasizes was adopted unanimously in 2001 by all 150 WTO members.
TRIPS had left developing countries uncertain of their right to promote access to essential medicines. It was clear that there were conflicting understandings as to how developing countries could implement the sections relating to the “flexibilities” or exceptions to pharmaceutical patents. – The Doha Declaration "affirm[s] that the [TRIPS] The Doha Declaration "affirm[s] that the [TRIPS] agreement can and should be interpreted and agreement can and should be interpreted and implemented in a manner supportive of WTO implemented in a manner supportive of WTO members' right to protect public health and, in members' right to protect public health and, in particular, to promote access to medicines for particular, to promote access to medicines for all.all.””
Despite signing the Doha Declaration and ratifying the TRIPS Agreement , the U.S. government has adopted the position of Big Pharma and has sought to undermine public health safeguards by negotiating trade agreements that undermine these safeguards, and by pressuring and sanctioning countries that have used them.
How U.S. Undermines Doha The USTR’s Special 301 Report
Under Special 301, the Office of the U.S. Trade Representative (USTR) conducts an annual review of trading partners' intellectual property rules (IPR), and highlights those countries deemed to deny adequate protection for patents, copyright, trademarks, and other forms of IP.
Trade Sanctions can result from a Special 301 listing, but a special 301 listing alone can have a chilling effect on developing countries.
USTR has placed countries on these various Special 301 lists for pharmaceutical-related practices that are TRIPS compliant.
Generics and HIV/AIDS treatment
In the case of HIV/AIDS, the average cost of common first-line treatments just seven years ago was between $10,000-15,000 per patient per year in developing countries.
Today, these treatments are available for as little as $89 per patient per year under certain circumstances.
On average, generic competition for first-line AIDS treatments has reduced their price in developing countries by more than 98 percent.
IndiaPharmacy of the Poor
• India is now the major supplier of good quality generic medicines to developing countries for all medical needs.
• 85+% of ARVs for developing countries are sourced from India.
• Danger: industry concentration is growing and there is increased cooperation with Big Pharma.
U.S. Threatened India with Trade Sanctions During TRIPS Negotiations
• India was part of a developing country coalition trying to keep IPRs out of the General Agreement on Tariffs and Trade (precursor to WTO) negotiations.
• The U.S. used its Special 301 IPR Watch List to threaten India and other developing countries including Brazil and Thailand during the negotiations.
• Despite losing the battle to exclude IPRs, India held out for some key flexibilities and a 10-year transition period.
S. Africa Medicines Case• Medicines and Related Substances Control
Act of 1997.• 39 drug companies sue Mandela government• USTR Special 301 Watch List.• International Campaign
– Treatment Action Campaign– ACT UP/Health GAP zaps
Free Trade Agreements (FTAs)
Negotiating Bilateral and Regional Free Trade Agreements (FTAs)U.S. pursuing a strategy of entering “TRIPS-plus” FTAs that generally work to delay competition from generic drug companies - and to maintain higher prices for life-saving medicines - for a longer period of time than international minimum standards set by TRIPS.
U.S. has entered into at least 27 such deals since 1991.
Eg. CAFTA, U.S.-Jordan FTA, U.S.-Peru FTAm, U.S. S. Korea FTA, Trans Pacific Partnership.
Renewed Commitment by big PhARMA (and big business) to use FTA’s to maximize profit
Trans Pacific Partnership• Trans Pacific Partnership Free Trade Agreement being negotiated
right now;• 11 countries: US, Vietnam, Malaysia, Singapore, Peru, Chile,
Australia, Brunei, New Zealand, Canada (Mexico and Japan are negotiating)
• Deny people right to oppose patents before they’re granted;• Make clinical trial data corporate property for 12 years so generics
can’t be approved;• Allow drug companies to make minor changes to old medicines to get
new 20-year patent;• Let drug companies sue government agencies that set
reimbursement rates for public health programs if drug companies don’t like them.
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Customs Seizures of MedicinesNo Patent in India
No Patent in BrazilNo Patent in Nigeria
Manufacturing Fiction in the Netherlands
Dutch seizures of medicinesin-transit
• Almost twenty incidents where Dutch authorities have confiscated generic medicines in transit through Dutch ports from India to Latin America and Africa.
• One shipment included WHO prequalified ARVs purchased by UNITAID and headed to Nigeria.
• Patent holders initiate the request for seizures which are thereafter undertaken by untrained customs officials using the “manufacturing fiction.”
• One seizure included a claim of a trademark infringement because the drug used the name Amoxicillin which is the International Nonproprietary Name, which was similar to GSK’s brandname “Amoxil”.
• India and Brazil have brought a WTO complaint on these seizures.
What you can do!• Engage in campus activism when targets come as speaker’s
come to campus (Yale students pressured Obama to fire Zeke Emanuel!)
• Organize a rally outside your Member of Congress’ office.• FEB. 20th Hearing by Trade Rep in DC on Special 301 Watch
List. Help write testimony (and deliver it)• Meet with Congressmembers! So easy and no one does it.• Write articles for blogs and student papers (Obama has
readers for student papers)• Join an SGAC working group on fighting the TPP!• Next “Round” of negotiations for the TPP is March 4-13 in
Singapore. Solidarity actions?
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Contact Info
Jennifer Flynn Health GAP
Amirah SequeiraSGAC
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