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

1
International Medical Patents and Human
RightsDeveloping Countries and Access to
Pharmaceuticals

• Lalitha KristipatiDaniel SlabolepszyPoli3,
  1230pmFall Quarter 2011

2
The Facts

• 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?

3
How Things Stand

• 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

4
World Health Organization
Universal access to HIV/AIDS treatment and care

•  Missed Goals in
• 2006
• 2010
• New Goal
• Universal Access by 2015

5
Why IGO's?

• Uniform standards and enforcement
• Uniform goals
• Allows for easier collaboration
• Inefficient vs. Private Sector
• Humanitarian
• More Influence
• One Goal

6
                  Past Actions
Aid Groups NGOs Patent Infringement The TRIPS
Agreement
7
Aid Groups NGOs

• 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
•  RD is slow to be utilized
•  Slow production Execution

8
Aid Groups, IGOs NGOs Political Perspective
Analysis

• 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

9
Aid Groups NGOsKey Agents, Outcomes, Effects

• 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

10
Infringing Patents

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

11
Infringing Patents
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

12
Infringing Patents
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.

13
The TRIPS Agreement

• 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

14
The TRIPS Agreement
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.

15
The TRIPS Agreement
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

16
           Current Proposals
The Medicines Patent Pool Bill C-56 The WTO,
TRIPS, Amendments
17
The Medicines Patent Pool
- 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
18
The Medicines Patent PoolPolitical Perspective
Analysis

• 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.

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The Medicines Patent PoolKey Agents, Outcomes
Effects

• - 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

20
Canadian Bill C-56

• 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

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To meet it's potential...

•  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

22
Canadian Bill C-56
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 

23
Canadian Bill C-56

• Actors
• Canadian Government and Pharamaceuticals
• International Community
•  "Right of 1st refusal" - gt 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

24
The WTO, TRIPS, and It's Amendments

• 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

25
The WTO, TRIPS, and It's Amendments
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

26
The WTO, TRIPS, and its Amendments

• 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

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                  Our Proposal
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Amending Trips

• 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"?

29
Amending Trips
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

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              Questions?
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Sites Accessed

• 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/researchpublicat
  ions/prb9946-e.htm 
•  http//www.law.northwestern.edu/jihr/v5/n1/1/
•  http//www.law.northwestern.edu/jihr/v5/n1/1/Merc
  urio.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/Ba
  ckground
•