Intellectual Property, Human
Rights, and Access to Essential
Medicines
AUDREY R. CHAPMAN, PH.D.
UNIVERSITY OF CONNECTICUT HEALTH
CENTER
INTELLECTUAL PROPERTY AND HUMAN
RIGHTS MEETING
PANEL 1: IP AND HEALTH
FEBRUARY 21, 2013
Right to Essential Medicines: GC 14
 General Comment No. 14 (2000) of the UN
Committee on Economic, Social and Cultural Rights
identifies the provision of essential drugs, as from
time to time defined under the WHO Action
Programme on Essential Drugs as a core obligation
of state parties to the Covenant on Economic, Social
and Cultural Rights (para 43 [d]).
 Core obligations create an immediate duty and
therefore are not subject to the availability of
resources.
Issue
 Some two billion people, one third of the world’s
population, lack access to the essential medicines
necessary for their health care.
 Estimated improving access to essential medicines
could save some 10 million lives each year.
 Providing meaningful incentives for development
new medications for neglected diseases affecting
world’s poor could reduce disease burden even
further.
 Variety of studies identified IP restrictions as major
constraint.
Approaches Proposed to Overcome Bottleneck
 Efforts to identify and promote the human rights
responsibilities of pharmaceutical companies in
relation to access to medicines.
 Proposals to replace patenting with other incentives
for drug development.
 Broadening & implementing the flexibilities in
TRIPS Agreement that permit compulsory licensing
& parallel importing.
 To date none of these approaches been effective.
Statement of CESCR on IP & HR
 A HR approach vests responsibility in
state/government as the duty holder
 The Statement by the Committee on Economic,
Social and Cultural Rights on HR & IP (2001)
observes “International rules concerning intellectual
property should not necessarily be uniform if this
might lead to forms of intellectual property
protection inappropriate for development goals”
(para. 15).
 It also notes fundamental importance of integration
HR norms into enactment & interpretation IP law.
Statement of CESCR cont
 Emphasizes “that any intellectual property regime
that makes it more difficult for a State party to
comply with its core obligations in relation to health,
food, education, especially, or any other right set out
in the Covenant, is inconsistent with the legally
obligations of the State party” (para. 12).
 Important for state/govt to adopt a law or at least
make official statement indicating need for IP
standards it conforms with be consistent with its HR
obligations.
Alternative HR-Based Initiatives
 Adopt a legally-based national policy recognizing a
right to health or health care incorporating a right to
essential medicines
 Adopt a national drugs policy consistent with HR
obligations: Model of South Africa’s 1996 National
Drugs Policy with its goal of “ensuring an adequate
and reliable supply of safe, cost-effective drugs of
acceptable quality to all citizens of South Africa.”
 Review and amend all national patent laws to make
them consistent with a human rights approach
HR- Based Initiatives cont
 Better conceptualize the right to essential medicines
 Provide a clear definition of what is meant by essential drugs
 Develop a mechanism to identify a list of essential drugs
relevant to needs of country, such as reviewing and revising
the WHO Action Programme on Essential Medicines and
should include key drugs whether or not they are patented
 Institute a mechanism to monitor the availability & cost of
essential drugs in regions of the country in both public and
private health institutions.
 The law should identify the obligation of specific institutions in
the government(s) to ensure that essential drugs be available,
accessible, affordable, acceptable, and of good quality and be
explicit as to what that entails.
HR-Based Initiatives cont.
 Adopt higher standards of patent protection related
to pharmaceuticals– reduce number of easily
granted patents
 Govts should refuse to adopt “Trips plus” standards
IP protection
 Preclude “evergreening” of patents – new patents
when patent about to expire by making small
changes
 Preclude patenting new uses, forms, formulations, or
combinations of know medicines
HR-Based Initiatives cont
 Make policies regarding patent protection and free
trade agreements transparent
 Hold forums with representatives from civil society
to discuss IP and its role in access to essential
medicines
 Remove criminal sanctions for IP infringement
Maastricht Principles on Extra-Territorial
Obligations
 Drafted 2011 by group experts in international law & HR
convened by Maastricht Centre for HR & International
Commission of Jurists
 Central provision – all states must take action separately &
jointly thro international cooperation to refrain from conduct
which nullifies or impairs enjoyment & exercise of economic,
social & cultural rights
 Obligation for states take necessary measures ensure nonstate actors in position regulate, including TNCs & business
enterprises not nullify or impair enjoyment economic, social &
cultural rights in other states
 Implications for way developed countries promote interests of
transnational pharmaceutical corporations thro their IP &
trade policies
Exercise TRIPS Flexibilities
 Anand Grover’s 2009 report (A/HRC/12/12)
underscores important national laws, particularly of
developing countries and LDCs incorporate
flexibilities in TRIPS
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Make full use transition periods (already too late for most)
Define criteria of patentability
Issue compulsory licenses and provide for govt use
Adopt international exhaustion principle, to facilitate parallel
importation
Created limited exceptions to patent rights
Allow for opposition and revocation procedures
Exercise TRIPS Flexibilities cont.
 Freedom to exclude certain inventions whose
commercial exploitation is detrimental to human life
or health

Grover proposes exclude diagnostic, therapeutic, & surgical
methods for treatment of humans
 Make broad use of compulsory licenses to protect
public health and promote access
 Streamline and simplify laws and regulations to issue
compulsory licenses
 Adopt broad research exemption