International Medical Patents and Human Rights: Developing Countries and Access to Pharmaceuticals

1. International Medical Patents and Human Rights:Developing Countries and Access to Pharmaceuticals Lalitha KristipatiDaniel SlabolepszyPoli3, 12:30pmFall Quarter 2011

2. WTO estimates 1.7 billion have inadequate or no access to medicines • Significant reason preventing solution:  • The inherent bias in all agreements towards pharmaceuticals • What is essential medicine? • What is universal access? • Why the focus on generics and their production? The Facts

3. Our proposal: • To achieve the greatest effect that results in greater access to essential medicines, a comprehensive outline and of a mandatory tiered pricing system of life-saving medicines for developing countries is necessary • Past Actions • Current Proposals How Things Stand

4. Universal access to HIV/AIDS treatment and care World Health Organization •  Missed Goals in: • 2006 • 2010 • New Goal: • Universal Access by 2015

5. Uniform standards and enforcement • Uniform goals • Allows for easier collaboration • Inefficient vs. Private Sector • Humanitarian • More Influence • One Goal Why IGO's?

6.                   Past Actions Aid Groups & NGOs Patent Infringement The TRIPS Agreement

7. Contributions made by: • WHO • NIH • Medecins San Frontieres (MSF) / Doctors Without Borders •  Based on highest need •  Lowest possible costs •  No international laws will limit distribution •  Not cost-effective, supplies are limited •  R&D is slow to be utilized •  Slow production & Execution Aid Groups & NGOs

8. Liberalism • Communal efforts put forth by various aid groups & NGOs • Single goal • Inability to adequately utilize group mentality; “group think” • Radicalism • Power resides with private corporations (“Big Pharma”): provide utilized resources: creates limitations for aid groups • Imbalance between those with greater influence and those without • Conflicting bias within various agents; changes in course of action • Realism • Voluntary efforts/Donations take away from economic opportunity • “Big Pharma” has little incentive to supply if capital gain is jeopardized. • Economic losses in creating low cost alternatives Aid Groups, IGOs & NGOs: Political Perspective Analysis

9. Agents: • WHO - World Health Organization • MSF / Doctors Without Borders • ONE, PeaceCorps, etc. • Thus Far: • The utilization of aid groups, non-profits, and volunteer organizations has heightened the publicity of the cause, but has failed to meet the goal of full and effective distribution. • These groups lack the necessary power needed to make change in the system • Supply rarely meets demand Aid Groups & NGOs:Key Agents, Outcomes, Effects

10. Countries that overtly began generic production: • Thailand • Brazil • South Africa • India • Levies and economic sanctions • South African lawsuit •  US tariffs on Thailand Infringing Patents

11. Political Perspective Analysis • Liberalism •  Int'l community of countries put together a patent System • Radicalism • Companies seeking to maintain their economic strength, end up trying to maintain exclusive rights to patents • Realism  •  Countries break int'l patent laws in seeking to resolve their own public health issues Infringing Patents

12. Key Agents, Outcomes, Effects • Agents: •  Int'l Corporations • Governments • Public • Corporations seek reprimands through int'l community and own government • US tariffs on imports of wood and jewellery from Thailand • Pharmaceutical Manufacturers Association of South Africa and 39 other int'l drug companies vs. South Africa • Sanctions •  Result: Countries end up giving up or dropping suits regarding patents resulting in no production being completed.  • Access to medicine remains a problem. Infringing Patents

13. Compulsory License clause: •  public-health emergency • Doesn't specify what constitutes such an emergency • Country must have domestic production capacity to produce generics • US & Canada: Anthrax - ciproflaxacin • Canada challenged Bayer Corp. • South African lawsuit • US tariffs on Thailand • Obvious Ambiguities The TRIPS Agreement

14. Political Perspective Analysis • Liberalism • International effort to systematize patents into 1 uniform system. Accomplished through international institutions • Radicalism • Favors corporations' interests over a solution to the problem • Realism • States are the ones who ultimately decide whether to utilize or adhere to the agreement depending on their interests. The TRIPS Agreement

15. Key Agents, Outcomes, Effects • Agents: • Countries around the World • World Trade Organization (WTO) •  States vs States  • States + Corp. vs States • Abiding by Agreement = Up to States • Not applicable to non-WTO members • Independent states lack legislation to support companies who try to utilize a compulsory license •  Result: Production of generics prevented • Access to medicines doesn't improve The TRIPS Agreement

16.            Current Proposals The Medicines Patent Pool Bill C-56 The WTO, TRIPS, & Amendments

17. - Creation of a mass index of drugs that target infectious diseases to be accessed at lower costs to underdeveloped nations. - Complies with World Bank pricing index.     - Backed by a number of pharmaceutical companies and NGOs (UNITAID, NIH, UN, Gilead, Merck, Aurobindo, etc.) - The chance of patent infringement does not exist in the pool - Lack of flexibility within the pricing index - Minimal incentive involved with voluntary participation The Medicines Patent Pool

18. Liberalism • Movement to start doing “good”  • Serves as a vehicle created by countries as a group to aid each other in a positive light. • Radicalism • Power concentrated in those who provide patent access • Creation of an imbalance between those who supply and those who refrain  • The existence of a disconnect between nations of differing economic standing (supply/demand) • Realism • Monopolization of new economic opportunity. The MPP gives little incentive for corporations to involve themselves if high reward is not likely. The Medicines Patent Pool:Political Perspective Analysis

19. - Agents • UNITAID • Members of the UN • Gilead, Merck, Aurobindo • - Thus far: • Lacks the prominence on the world stage necessary to accomplish effective supply • Has created a stir/push for companies affiliated with Gilead/Merk to now supply low-cost medications • Helps improve access to essential medication, but remains too small to be of significant The Medicines Patent Pool:Key Agents, Outcomes & Effects

20. TRIPS previously granted only domestic generic production • Called for issuing licenses for export only •  Developed nation with generic production capacity • 1st one •  Needed to be Amended first* Canadian Bill C-56

21.  Change the following: • Right of First Refusal • Has since been Amended but: • Set 'schedule' of meds • No currently used Meds in Canada allowed • Process for a license is too inefficient • Time and Money To meet it's potential...

22. Political Perspective Analysis • Liberalism •  Public was in favor of creating legislation to meet International goal of improving global health and access to essential medicines, as set by the WTO • Radicalism • Power remains concentrated on the supply side of the system: right of first refusal • Interest remains structural; the heightened availability of lower-cost drugs is unrealistic. • Realism • The flaws in the bill are directly correlated with the economic imbalance between supply and demand  Canadian Bill C-56

23. Actors: • Canadian Government and Pharamaceuticals • International Community •  "Right of 1st refusal" - > no incentive for licensee to produce generics • Results: • No production occurs despite the new legislature that allows it • No greater supply or availability of cheaper meds becomes available. • Positive result: C-56 sets international precedent Canadian Bill C-56

24. Importing Member must specify names and expected quantities • Confirm it's an Low Developed Country • Post it's plans publicly • Countries with production capabilities to export haven't passed legislation to allow such an action. Only: • Canada • Norway • Developing nations must specify allowance of a compulsory license The WTO, TRIPS, and It's Amendments

25. Revisted.... • Liberalism • International effort to systematize patents into 1 uniform system. Accomplished through international institutions. • WTO = Int'l institution • Radicalism • Favors corporations' interests over a solution to the problem • WTO is ineffective due to State's ultimately acting in their own self-interests • Realism • States are the ones who ultimately decide whether to utilize or adhere to the agreement depending on their interests. • Corporations' influence on policy leads to terms and clauses that favor them and that maintain their advantage or influence The WTO, TRIPS, and It's Amendments

26. Actors: • WTO • Individual States •  Terms within agreement are still ambiguous • Corporations dispute over whether a definition is met • Individual governments provide the court framework • Progress is stalled for developing nations • Can't make use of agreement • Result: Amendments fail to achieve the initial aim of the Agreement • Access to greater medicine is not achieved The WTO, TRIPS, and its Amendments

27.                   Our Proposal

28. Clarify missing definitions within TRIPS • which diseases? • which products? • which countries? -definition still too broad. What constitutes a "Low Developed Country (LDC)"? • New International Agreement? • Steps to Take • Administered and Enforced by whom? •  How to specify which medicines are "essential"? Amending Trips

29. Why will this work? • States are currently the ones who ultimately decide whether to conform to agreement • Mechanisms for generic production + Agreement exist • International Pressure • Corporations lose influence in decision-making process • Precedents : Canada, Norway... • Amendments/New Agreement viewed more as necessary • More likely to be passed • Specific definitions leave less ambiguities • Less litigation and dispute • Problem can begin to be truly resolved Amending Trips

30.               Questions?

32. 2001. "Patent protection versus public health." Lancet, November 10. 1563. Academic Search Premier, EBSCOhost (accessed October 18, 2011). •  Attaran, Amir. 2004. “How Do Patents And Economic Policies Affect Access To Essential Medicines In Developing Countries?.” Health Affairs 23, no. 3: 155-166. Academic Search Premier, EBSCOhost (accessed October 18, 2011). • Nelson, Roxanne. 2004. "USA urged to accept generic AIDS drugs." Lancet 363, no. 9416: 1205. Academic Search Premier, EBSCOhost (accessed October 18, 2011).  •  Orbinski, James. 2004. "Access to medicines and global health: Will Canada lead or flounder?." CMAJ: Canadian Medical Association Journal 170, no. 2: 224-226. Academic Search Premier, EBSCOhost (accessed October 18, 2011). •  MBM: full citation needs to be added in  • WHO Prequalification Program citation needed • http://www.avert.org/universal-access.htm • http://www.parl.gc.ca/Content/LOP/researchpublications/prb9946-e.htm  •  http://www.law.northwestern.edu/jihr/v5/n1/1/ •  http://www.law.northwestern.edu/jihr/v5/n1/1/Mercurio.pdf •  http://www.reuters.com/article/2011/10/11/us-aids-aurobindo-idUSTRE79A1RJ20111011 • http://www.wto.org/english/tratop_e/trips_e/intel2_e.htm •  http://www.medicinespatentpool.org/WHO-WE-ARE2/Background Sites Accessed