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Access to Medicines

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Jennifer Sellin

on 30 October 2015

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Transcript of Access to Medicines

Access to Medicines
The Interface between Patents and Human Rights.
Does one size fit all?

A Human Right of Access to Medicines?
The TRIPS Agreement
Agreement on Trade-Related Aspect of Intellectual Property Rights
World Trade Organisation
161 members
"all or nothing" approach
Dispute Settlement Understanding
The Interface between Human Rights and Patents
South Africa
Dr. Jennifer Sellin
What are patents?
monopoly position for (generally) 20 years
Why do we have patents?
incentive to innovate
disclose new innovations
Article 12 International Covenant on Economic, Social and Cultural Rights (ICESCR):
"everyone has the right to the enjoyment of the highest attainable standard of
physical and mental health
Steps to be taken to include those necessary for:
(c) “the prevention, treatment and control of epidemic, endemic, occupational and other diseases;”
(d) “the creation of conditions which would assure to all medical service and medical attention in the even of sickness.”
164 State Parties

Article 6 of the International Covenant on Civil and Political Rights: the
right to life
Access to Medicines and Patents
1/3 of the world's population lacks access to medicines
Available, physically accessible and

Particularly for patients in developing countries
States parties' obligations?

Article 2.1. ICESCR:
"Each State Party to the present Covenant
undertakes to take steps
, individually and through international assistance and co-operation, especially economic and technical, to the maximum of its available resources, with a view to
achieving progressively the full realization
of the rights recognized in the present Covenant by all appropriate means, including particularly the adoption of legislative measures."

Obligations to respect, protect and fulfil: positive and negative duties
Core obligation to provide essential medicines: non-derogable
International obligations
Access to Medicines and Patents: What is the Connection ?
What is the Problem?
TRIPS Agreement
Minimum standards
patent protection for inventions in
fields of technology (art. 27)
exclusive rights (art. 28)
20 years patent term (art. 33)
Object and purpose?
to find a balance (articles 7 and 8)

-> How?
Transitional arrangements for developing countries/LDCs
So-called TRIPS Flexibilities, e.g. compulsory licensing
Doha Declaration on TRIPS & Public Health
2001 Doha Declaration on TRIPS And Public Health
the gravity of the public health problems afflicting many developing and least-developed countries
the importance of IP protection for the development of new medicine AND concerns about its effect on prices"
does not and should not
prevent members from taking measures to protect public health
Amendment TRIPS: article 31

South Africa is a developing country
young democracy
strong protection of human rights -> strong constitutional court
worsening HIV/AIDS epidemic
active civil society

South African Constitution:
explicit reference to "everyone's right to have access to ... health care services"

Minister of Health v. Treatment Action Campaign

the government's policy on Nevirapine was under review
the Constitutional Court delivered its ruling in 2002
violation of the right to health? yes: the government's policy was not reasonable

India is a developing country
but an up-and-coming economic power house
until 2005 it did not provide for (product) patents for pharmaceuticals
"pharmacy of the poor"
Indian Patents Act
section 3d: patent protection for only truly novel inventions

Novartis AG v. Union of India
the Patent Office declined to a grant a patent for Novartis' cancer medicine (Glivec)
Novartis challenged the Patent Office's decision and section 3(d): unconstitutional and in violation with TRIPS
The Supreme Court delivered its ruling in 2013
Upheld the constitutionality of section 3d
Uganda is a least-developed country
high poverty rates
high public health burden (HIV/AIDS, TB & Malaria)
= LDC -> until 2021 to fully implement the TRIPS Agreement
The Ugandan Patents Act
no obligation to implement the TRIPS Agreement, i.e. to provide patent protection for pharmaceuticals
however, currently reforming its Patents Act to comply with TRIPS standards
no manufacturing capacity -> dependent on imports
Full transcript