Right to Health and Access to Medicines Practicum
Credit:
3 Credits
Time:
Fridays, 10am-12:40pm
Grading:
35% class presentations (2)
60% paper grade
5% participation
Professor
Sean Fiil-Flynn
In this course, students will work in teams to produce a report to the UN Special Rapporteur on the Right to Health and to the PanAmerican Health Organization related to implementation of the right to health with respect to medicine research and development
policies. The course will approach the topic of research and development broadly – including examination of a variety of “push” and “pull”
mechanisms and the impact of open access policies on education and knowledge dissemination.
This class will enroll a maximum of 16 students. Students will work in one or more teams to produce joint reports. The reports will follow
the general style and of a report from the Special Rapporteur to the United Nations. Students will have opportunities to receive guidance
and feedback from the Special Rapporteur and his staff and PAHO officials and staff, including during a special residency of the Special
Rapporteur at WCL.
The course will include site visits and expert consultations with leading experts in and outside of D.C.
Week
Topic
Reading
1
Jan 13
Introduction to
the Right to
Health
2
Jan 20
Right to Health
and Access to
Medicines
http://tinyurl.com/rt2healthhistory
Helfer & Austin, Human Rights and Intellectual
Property, Ch. 1 (focus on the sections on the human
rights institutions)
Gen. Comment No. 14, Right to Health
A. Global Inequities in Access to Medicines
Jonathan D. Quick, Editorial, Essential Medicines
Twenty-Five Years On: Closing the Access Gap, 18
HEALTH POL'y & PLAN. I, 1 (2003)
Medecins Sans Frontieres & Drugs For Neglected
Diseases Working Group, Fatal Imbalance-The Crisis In
Research and Development For Drugs For Neglected
Diseases (2002)
B. Human Rights Duties
Report of the Special Rapporteur on the Right to Health,
A/61/338 (2006), Part III, The Human Right to
medicines (paras 37-end)
Report of the Special Rapporteur on the Right to Health
(2009), The Right to Health and Access to Medicines,
Part I, Paras 1-22 (Pages 1-23).
African Commission Resolution on the Right to Health
and Access to Medicine
3
Jan 27
Right to health
and WHO and
PAHO
http://tinyurl.com/pahort2health
4
Feb 3
IP, Human
Rights and
Access to
Medicine
Helfer & Austin, Ch. 2
Report of the Special Rapporteur on the Right to Health,
The Right to Health and Access to Medicines (2009)
(Part II-end)
Correa, Carlos Correa, Implications of the Doha
Questions and
Assignments
Guests and Site
Visits
Invite Mihir Mankad
Due:
Chapter Essay- Human
Rights and Access to
Medicines
A. Scope of the Right
B. State Obligations
C. Violations
[TBA – Visit to
PAHO]
Declaration on the TRIPS Agreement and Public Health,
World Health Organisation, Health Economics and
Drugs, EDM Series No. 12 (2002)
TRIPS Part III (patents)
5
Feb 10
Human Rights
and Research
&
Development
Reference:
Flynn, Hollis and Palmedo, An Economic Argument for
Compulsory Licensing
A. Human Rights Duties
Thomas Pogge, Human rights and global health: a
research program (first part discussing human rights
duties)
William Fisher & Talha Syed, Global Justice in
Healthcare: Developing Drugs for the Developing World
(2007)
B. Surveys of options
PIJIP, Alternative Models of Financing Medical
Innovation
http://www.wcl.american.edu/pijip/go/innovationlitsurvey
Key references:
DiMasi JA, Hansen RW, Grabowski HG. The price of
innovation: New estimates of drug development costs.
Journal of Health Economics 2003;22:51–185.
6
DRAFT DUE
From Patents
to Prizes
James Love & Tim Hubbard, The Big Idea: Prizes to
Stimulate R&D for New Medicines (2007)
Pogge and Hollis, The Health Impact Fund: Pay-forPerformance:
Discussion/ In class
assignment
1. What are the human
rights duties associated
with designing R&D
policies?
2. Henry Grabowski
explains: “strategies for
stimulating R&D on
orphan drugs and
neglected diseases must
either work to lower the
costs of development
(“push programs”),
enhance the expected
revenues after market
launch (“pull programs”),
or utilize a combination
of both”
Create a chart
categorizing R&D options
as push or pull.
3. How do we analyze
various approaches from
a human rights
framework?
[Invite Thomas
Pogge and Aidan
Hollis]
Draft Due:
A. Human rights and
Prizes
[Visit James Love,
KEI]
http://www.yale.edu/macmillan/igh/files/IGHsubmissi
onV6.pdf
Patents and R&D Incentives: Comments on Hubbard and
Love Trade Framework for Financing Pharmaceutical
R&D by Joseph A. DiMasi & Henry G. Grabowski, (2004)
Three Proposals for Rewarding Novel Health
Technologies Benefiting People Living in Poverty: A
Comparative Analysis of Prize Funds, Health Impact
Funds and a Cost-Effective/Competitive Tender Treaty
by Thomas Alured Faunce & Hitoshi Nasu (2008)
Brook Baker, Skepticism about the Health Impact Fund
http://www.healthgap.org/trips/bakeronHIF.htm
7
8
9
Publicly
funded clinical
trials
Patent thickets
and Research
exemptions
Privatizing
Publicly
Financed
Research
References:
Health Impact Fund e-library
http://www.yale.edu/macmillan/igh/e-library.html
The Benefits and Savings from Publicly-Funded Clinical
Trials of Prescription Drugs, Dean Baker (2008)
Michael A. Heller and Rebecca S. Eisenberg, Can Patents
Deter Innovation? The Anti-Commons in Biomedical
Research
[Article on research exemptions; e.g. Reichman,
Eisenberg, . . .]
Anthony So et al, Is Bayh-Dole Good for Developing
Countries? Lessons from the US Experience, 6 PLoS
Biology 2078-2084 (October 2008)
Barratt, Amanda ‘Lessons from Bayh-Dole: Reflections
on the Intellectual Property Rights from Publicly
Financed Research and Development Act (2010) 35
Journal for Juridical Science 30-69 (South Africa)
http://cis-india.org/a2k/publications/pupfip/resources
(collection of news and academic articles)
SPRING
BREAK
Q. What are the
differences between the
models discussed?
What are their primary
strengths and
weaknesses?
[Visit CEPR]
Draft Due:
B. Human Rights and
Research Exemptions
[Invite Reichman to
address or visit
workshop].
[Invite Anthony So
to address or visit
workshop]
[Alt: Visit NIH]
[note: Friday before
spring break.
Consider moving
reading up to class 8
and using this class
for supervisions and
homework]
March 2122
POST DRAFT
PAPERS
CONFERENCE
10
March 23
11
March 30
12
April 6
SUPERVISIONS
13
April 13
Open
Educational
Resources and
Open Access
Journals
14
April 20
May 12
May 30
Health and Human Rights Conference with Anand
Grover
March 21 (afternoon): Opening Plenary
March 22 Morning: Plenary panel
March 22 Afternoon: Human Rights and Access to
Medicines Workshop
Presentations of work to Anand Grover and Renata Rais
(Brazil)
Students should make
every effort to attend the
afternoon of March 22.
TBA
University
Licensing
Proposals
Yochai Benkler, Commons-Based Strategies and the
Problems of Patents
Amy Kapczynski, et al., Addressing Global Health
Inequities: An Open Licensing Approach for University
Innovations
MIT Press, Opening Up Education
John Willinsky, The Access Principle
http://mitpress.mit.edu/books/willinsky/theaccessprin
ciple_theMITpress_0262232421.pdf
DRAFTS DUE
Grand Rounds
Presentation of
work product
FINAL PAPERS
DUE
Last Friday of Finals:
Workshop and Paper Presentations
(TBA. Potential joint workshop with Georgetown Law
Students)
[Amy Kapczynski]
[Representative of
UAEM]
How does lack of access
to essential learning
materials impact R&D for
medicines in developing
countries?
What other human rights
provisions could impact
knowledge dissemination
policies?
[Visit SPARC]
[tentatively to take
place at PAHO]
Invite PAHO, Special
Rapporteur and
area experts