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Trade Laws about Medicines


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Trade Laws about Medicines

  1. 1. Access to Medicines: Trade and Intellectual Property Rights Jennifer Flynn Amirah Sequeira Managing Director Coordinator Health GAP SGAC02/07/13 1
  2. 2. The Greatest Tool on Earth: The Midwest Academy Strategy ChartGoals Resources Allies Targets TacticsLong-TermGoalMid RangeGoalShort-TermGoal02/07/13 2
  3. 3. Accountable Global Accountable Global Economic & Health Economic & Health that is focused on Power Analysis Market driven economy Market driven economy Deregulation Deregulation that is focused on Privatization human rights Privatization human rights US Nationalism US Nationalism10DecisiveDecisionmaking Poweror Influence Who are decision makers?8Active How are decisions made?Participant inDecision-making Who is our opposition?6Power to haveMajor Influenceon decision-making Who are our allies?4TakenintoAccount3Can GetAttention 6. What opportunities are there for us to exercise power? SGAC2Not onRadar Die Hard Active Support Inclined Towards Inclined Towards Active Support Die Hard
  4. 4. 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.
  5. 5. Trade and Development Policy and HIV: Things you need to know• IMF Policies• DOHA Declaration• WTO• TRIPS• Free Trade Agreements• Drug Seizures02/07/13 5
  6. 6. 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
  7. 7. Loans from the International Monetary Fund Create Barriers to Access to Medicines• The IMF should exit the development business• Eliminate the IMFs 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 up02/07/13 7
  8. 8. 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 8
  9. 9. 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.
  10. 10. 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).
  11. 11. 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.11
  12. 12. 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] 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.”
  13. 13.  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.
  14. 14. 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.
  15. 15. 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.
  16. 16. India Pharmacy 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.
  17. 17. U.S. Threatened India with TradeSanctions 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.
  18. 18. 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
  19. 19. 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
  20. 20. 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.02/07/13 20
  21. 21. Customs Seizures of Medicines Manufacturing Fiction in the Netherlands No Patent in India No Patent in NigeriaNo Patent in Brazil
  22. 22. Dutch seizures of medicines in-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.
  23. 23. 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?02/07/13 23
  24. 24. Contact Info Jennifer Flynn Health GAP Amirah Sequeira SGAC amirah@studentglobalaidscampaign.org02/07/13 24