Access to medicines in developing countries: Is

corporate responsibility compromised by current trade

agreements?
Ourania Koumi 2014*
* An earlier version of this essay was submitted as part of an ongoing examinable component counting towards the successful
completion of the second presentation of W822 Business and Human Rights Law and Corporate Social Responsibility course with
(Open University Business School U.K.). The literature list used to write this report is current until May 2014. The section Notes
on Methods attempts to place this report in context of developments just before the Access to Medicines Resolution which was
adopted by the UN Council of Human Rights in 2016.

Access to essential medicines should be made widely available if the right to health is to be
universally observed (UDHR 1948: Article 25; ICESCR: Article 12). Multinational
pharmaceutical companies (MNEs) may manufacture and produce medicines in bulk,
however, they do this primarily for commercial purposes so that their obligations towards
their shareholders are met (Zambellas 2012b:35-52). Moreover, to ensure commercial
success, MNEs protect medicines through a series of patenting, trademark and regulatory
rules (Ho 2012). MNEs are within their right to protect medicines they have developed
first through their right to property (UDHR 1948: Article 17), however, not all countries
required patent protection for medicines until patenting was made compulsory for
member states of the World Trade Organisation (WTO) via the Trade Related Agreement
for Intellectual Property Rights (TRIPS 1994; 2001).

Hence, human rights seem to be yet again in conflict with international laws and
regulations where business interests are at stake, while restricted access to essential
medicines which mostly affects developing countries, is a universal issue and a prime
obligation of states (Ruggie 2011a-b). However, MNEs have increasingly incorporated
human rights policies in their corporate social responsibility (CSR) agendas and have been
engaged in some elaborate medicine access programs since before 2000, according to UN
Human Rights and sector-specific frameworks (Hunt 2008; Ruggie 2011a; Kosla and Hunt
2012). The objective of this report is to evaluate the right to health as a fundamental
human right and to discuss how TRIPS, other free trade agreements (FTAs) and resulting
laws may act to restrict access to essential medicines in developing countries using a range
of developing countries as examples. Through this discussion, it becomes obvious that
FTAs protecting the intellectual property rights (IPRs) of medical compounds may
simultaneously imperil public health in developing countries. However, it also becomes
clear that national and commercial interests coincide in increasingly tightening IP
protection rules and therefore, it is in this framework that global governance (Zambellas
2012a; Ruggie 2011a-2014a) is called for innovative solutions to promote access to
medicines worldwide.

A. Why the need for discussing access to medicines, IP rights and corporate
responsibility?

Restricted access to medicines impacts the right to health which then may pose a direct
threat to human life, hence the UN Office of the High Commissioner for Human Rights
(OHCHR) see healthcare as fundamental human right and confirms the obligation of
states to ensure sustainable financing, availability and affordability of essential
medicines; price and quality control; dosage and efficacy of medicines; procurement
1
practices and procedures... (OCHCHR 2014). The right to health features prominently so
in UDHR (1948: Articles 3 & 25) and in the Millennium Goals (WTO 2008), while the
economic crisis has placed an additional strain in access to medicines and
pharmaceutical cost (WHO/WIPO/WTO 2013). Access to medicines is compromised in
developing countries on all four underlying determinants, namely availability of
functional public health infrastructure, accessibility to health facilities, acceptability and
of medical and scientific quality (WHO 2007: p.2). This has resulted in over one million
people dying in Africa in 2002 (Forman and Kohler 2012) and, according to more recent
data, 18 million deaths annually from Group I causes affecting the poor, a life expectancy
differential of 79.4 versus 49.2 years of age in developed countries versus the African
region, and high mortality rates in least developed countries compared with the rest of the
world (Pogge, Rimmer & Rubestein 2010).

Poverty is directly linked to poor health, exacerbated by lack of access to essential

medicines, which has three components. Firstly, pharmaceutical companies invest of
90% resources in research and development (R&D) for affluent and middle income
countries and on diseases affecting the poor, thus having cures for 10% of world
population (the 10/90 gap in Moraguri and Bright 2011:p. 101), although more recent
literature indicates a shift in R&D for middle income and developing countries needs
(Hogerzeil et al., 2014). Secondly, IP protected medicines cost more (Ho 2011: pp. 16-19;
Lopert & Gleesson 2013), therefore pricing is an issue especially following the 2008
economic crisis and, ironically, difficulty in meeting price constraints also affects
developed countries and MNEs funding health initiatives in the developing world. Finally,
lack of public health infrastructure or trained staff may be a problem in many developing
countries curtailing access (Pogge, Rimmer & Rubenstein 2010).

Some would, therefore, rightly argue that access to essential medicines for LDCs should be
treated as a basic human right. But, who should primarily bear that obligation? In both
current frameworks (WHO 2007; Ruggie 2011a/b) the states bear obligation to respect,
protect and fulfil the right to health, i.e. the state is obliged to refrain from interfering from
the enjoyment of, ensure that third parties (non-state actors) do not infringe on it and
taking steps to realize the right to health. Bachman et al. (2008) assessing the right to
health in 194 countries found that more than two thirds do not recognize it in their
constitution, only 54 that have ratified the IECSR include the right to health in their
constitution or one other statute and international recognition is even weaker than
national. Furthermore, legal recognition does not automatically suggest enforcement of
the right to health in health systems, while Bachman et al. conclude, given that the right to
health is a legally-binding obligation for states, a lot of work still needs to be done from
states to attain the right to health as aspired in UDHR. Hence, how can one expect MNEs to
assume the responsibilities of states? MNEs can, however, contribute to respecting the
right to health and with appropriate CSR programs to improving access to health in
developing countries.

2
B. Who are the stakeholders? A global Governance Framework

Figure 1 below shows the stakeholders and how these affect access to medicines or how
they could collaborate to for policy alignment to improve access to medicines (Ruggie
2014). Public governance includes the obligation of states to ensure the right to health,
civil governance represents IGOs and NGOs responsible for policy design, alignment,
voicing and framing the issue and providing a platform for constructive discussion and
corporate governance represents the responsibilities of MNEs as they currently stand.

Figure 1: Global Governance System for Access to Medicines (adapted from Ruggie 2014).

3
C. Why and how is access to medicines restricted?

Developing countries have currently agreed to join the WTO and, therefore, agreed to a
US-style health system regime by signing off TRIPS. Nevertheless, they are facing great
challenges adapting their national health systems, as, due to their resource-dependency,
they can do very little to influence the international environment. TRIPS was criticized by
the body of academia and civil governance combined (Reich 1987; Dutfield 2000;
Reichmann 2000; Abott 2002; Fellmeth 2004; Cameron 2004; Lopez & Gleeson ), from the
beginning, as it was reminiscent of U.S.s previously signed General Agreement on Tariffs
and Trade (GATT 1947) and North American Free Trade Agreements (NAFTA 1993;
Alvarado 2008) for favoring US corporations against poorer nations and for excluding the
civil society and unions from the negotiations (Elliot & Bonin 2002; Chomski 2011a/b).
Some critics claimed that pharmaceutical MNEs lobbied extensively to get TRIPS signed
from WTO members, specifically for securing IP protection for medicines amongst other
goods (Sell 2003 and Drahos 2002 in Ho 2011:xiv).

However, TRIPS contained some flexibilities from the beginning, for example TRIPS in
article 7 states the protection and enforcement of intellectual property rights should
contribute to the promotion of technological innovation and to the transfer and
dissemination of technology, to the mutual advantage of producers and users of
technological knowledge and in a manner conducive to social and economic welfare, and
to a balance of rights and obligations. Hence, under article 7, member states retain
flexibilities, including the ability to determine the grounds for issuing compulsory licenses
and for when to order government use, to allow parallel imports, to apply general
exceptions, such as early generic approval (Bolar exceptions) and to use transition
periods for developing countries, such as the one India made use of to adapt its national
legislation on (Gabble and Kohler 2014), and a longer extendible transition period for LDCs.
These flexibilities were re-affirmed by the Doha Declaration (TRIPS 20111/b) and were
used in a number of cases to improve access to medicines, such as the use of the 30 August
2003 mechanism in Rwanda, negotiation for lower prices and compulsory licenses for
antiretroviral drugs in Brazil, use of compulsory licenses in Thailand and the adaptation of
patentability criteria in India such that they align precisely with the needs of the state
(UNAIDS 2011; See Paragraph E).

Despite some encouraging examples which will be dealt with in detail in E below, studies
show poor patent-related amendments in national law of 142 countries, with the LDCs
scoring the lowest compared to higher income countries (Martin 2010; UNAIDS 2011).
There is now also an extensive body of evidence suggesting that bilateral trade
agreements under negotiation, like the Trans-Pacific Partnership and others contain
TRIPS-plus provisions which aim to restrict IP rules even further than TRIPS by extending
patents beyond the standard 20 years, limiting the ability of the state to issue compulsory
licenses and delaying testing, manufacturing and approval of cheaper generic versions,
forcing states to renounce on their strict patentability criteria and restricting parallel
imports thus preventing the cheaper supply of medicines (Sell 2011; EU-Marocco BIT 2014;
TPP 2013; 2014). However, TPP has yet a long way to go before it is signed (The Economist
2014).

4
D. Evaluation of TRIPS and FTAs: Case Studies

Rwanda was the only country having utilized a TRIPS-waiver in 2011 for being a highly
debated measure, however in Rwandas case it resulted in 21000 people being treated for
HIV at the most affordable price globally in 2003-2004 by importing an ARV from a
Canadian drug company and issuing a compulsory license via the Canadian Access to
Medicines Regime.

Brazil was the first state to demonstrate an effective use of TRIPS-flexibilities. By

threatening antiretroviral (ARV) drug makers that it will file for compulsory licensing, it
achieved reduction in price for a number of ARVs from 2001 to 2006. In 2007, it finally
issued a compulsory license which reduced the price of the imported generic version of the
drug to less than half ($045 per dose), saving the government approximately $1.2 billion on
ARVs between 2001 and 2005.

Other countries which have used compulsory licensing to import generic medicines include
Thailand, Indonesia, Malaysia, Mozambique, Zambia and Zimbambwe (Elliot 2012).

The battle by Novartis for patent rights of its anti-cancer drug Glivec (Gabble & Kohler
2014; Chandra 2010: Novartis v Union India & Others) in India, is an example of national law
being adapted to TRIPs to protect Indian citizens, but also to address global health
concerns. Indian property law had included a very strict definition of intellectual property
which excludes ever-greening, and only a new formulation which had significantly better
efficacy than the older should be granted patent. By winning the case, India achieved two
goals, firstly it proved that a state can exercise its sovereign right to enforce IP law to the
benefit of the nations public interest, in this case public health and to protect its generics
manufacturing market and, secondly, to facilitate access to affordable medicines. India has
denied patent to a number of prototype medicines since 2005, very effectively (The
Economist 2012).

It is evident, therefore, that TRIPs flexibilities although having been greeted with
scepticism in the beginning, they have served developing countries as long as they were
able to adapt their domestic IP law accordingly. On the other, hand critiques suggest that
these provisions are too complicated and will not work for less well-regulated developing
countries and cannot be used widely to replace IP protection strategies (Bradford-Kerry &
Lee 2007; Anon 2013; Dutfield G. 2008).

E. The case for and against IP rights for medicines

With regards to MNEs responsibilities to observe the right to health in addition to MNEs
alignment with civil and public governance mechanisms to ensure that their commercial
activities are aligned to global health objectives (see Figure 1 above), sector-specific
guidelines (Hunt 2008; Kosla and Hunt 2012: pp. 39-41) specifically draw the attention of
MNEs to patents and licensing (Guidelines 26-32) which should be according to the
interests of the WTO member, while mostly the guidelines prior to 26 are aligned with WHO
Factsheet and are a useful guide for CSR strategy implementation. Indeed Davidson (2012:
pp.53-59) has remarked many an occasion where pharmaceutical companies have
implemented CSR strategies regarding access to medicine programs, but without aligning
with the four prerequisites of availability, quality, accessibility and acceptability. Finally,
Guideline 33 has to do with pricing where the MNE has to apply pricing procedure
favorable to the cost-bearing ability of the WTO member state. With regards to supplying
developing countries with essential medicines, this is also organized by WHO and, as UN 5
Human Rights and sector-specific guidelines, it is a fairly aspirational scheme, where
because there is little enforcement or ability to sanction any wrongdoing, a lot of mistakes
happen leaving people in the developing countries with poor access to essential medicines
(Davidson 2012: p. 60; PQM 2013). The PQM report is full of examples of countries where
the market is full of counterfeit medicines, e.g. anti-malarials in African countries,
indicative of lax national regulation.

IP protection is believed to promote innovation and better quality of medicine which can
then become a generic once the patent expires (Taylor 2013), but it has been argued that,
for all the benefits of the pharmaceutical industry, which counts a dramatic increase in life
expectancy, the bulk manufacturing of medicines which can be sold to many people at once
in a certainly more equitable system than if the making of medicines was entirely left to the
state and the industrys contribution to the diagnosis, prevention and treatment of many
known diseases, essential medicines are still overpriced and unavailable especially to
developing countries.

Apart from the fact that there is scarce empirical evidence that any state or private funding
could ever replace the pharmaceutical MNEs capacity for R&D, economies of scale in
innovation and bulk manufacturing capability in order to cater for public health of a
population of 9.6 bn by 2050 and growing, health fund raising initiatives like the Health
Impact Fund and the Gates Foundation may complement IPR based provisions, although
even these initiative do not go without criticism (Pogge 2010; Lidell 2010), while
differential pricing and compulsory licensing are ways to combat high cost of medicines to
improve access as described in Paragraphs C and D above. Additional methods include the
patent pools where MNEs, NGOs and research institutes to pool resources together and
license the collective effort for access to essential medicines, e.g. Knowledge Ecology
International and Essential Inventions Inc. proposal for humanitarian patent pools, e.g.
HIV/AIDS pool (Nicol & Nielsen 2010:240-241) and open source drug discovery, although
this is done in a very small scale (Srinivas 2010). Experts, however, keep stressing the
importance of transparency, monitoring and accountability and a rigorous anticorruption
policy aligned with an integrated human rights/CSR strategy and corporate governance
for pharmaceutical MNEs, to reinforce recent published data of improved access to
medicines (Lee and Kohler 2012; Zambellas 2012d; Grover 2011; Attard 2014).

Conclusively, MNEs have a social responsibility to respect and contribute along with states,
which are primarily obligated to provide access to essential medicines for their citizens. IP
protection may raise the cost of medicines and, being the main method by which MNEs can
capitalize on their investment, render profit to their shareholders and lower the trade
deficit of their home countries, free trade agreements are negotiated on the basis of joint
MNE and state interests, therefore they may inhibit widespread access to medicines to
those who cannot afford to pay for patented medicines. However, IP protection secures
innovation and therefore ensures that cheaper generic versions will be available for future
generations, while trade agreements flexibilities allow states to exercise their right to
sovereignty as is appropriate. Finally, there are a number of viable alternatives to IP
protection which can be successfully employed to contribute to better access to medicines,
until a global international human rights law treaty can hold MNEs accountable for
observing the right to health at all times.

6
Note on Methods and Future Research
All references used for this report were peer-reviewed and by authors who publish
research on the topic of access to medicines, right to health, FTAs and corporate
responsibility, consistently since 1987. Literature searches were executed only using the
OU Library database by successively plugging in search words, like TRIPS, TRIPS & access
to medicines, intellectual property & access to medicines and then, successively whole
phrases from the question. Then, peer-reviewed and year filters were applied to end up with the
final list of references. 1987 was chosen as start date to give the author the chance to critically evaluate how
different FTA developed and a feeling of the debate they caused around the time they were being rolled out.

Despite investing 2/3 of total time on literature research for this report, reconciling FTAs
with human rights law and code of practice of MNEs (in paper or practice) deviates from
reaching the ideal state in every case study studied. However, states are primarily
responsible for observing right to health under the law, but this is also rarely respected to
an adequate standard.

The objectives of literature review was to (1) include policies, guidelines, academic
research and NGO critiques to evaluate all aspects of the debate, and (2) look at the
literature review since 1987 and see how the same authors would develop in, or maintain
the same, opinion about FTAs. The literature research strategy used revealed that only 2
out of more than 180, were positive about free-trade agreements and IP protection
regarding access to medicines, so there is a consensus amongst the majority of authors of
scepticism regarding FTAs. The majority of authors are very critical of the way MNEs lobby
to pass particular FTAs, while the responsibility of home states who back these FTAs is
highlighted but rarely critically evaluated.

We therefore conclude that there seems to be a co-dependent, sometimes viewed as

unhealthy, relationship between e.g. the U.S. administration and its U.S.- based
pharmaceutical MNEs, not always aligning with the requirements of human rights law for
observing corporate responsibility from either side: state and MNEs.

This short report presents obvious limitations not least based on the lack of clarity on
exactly how much power FTAs hold over soft law, like human rights frameworks, and how
they are supposed to be implemented from all sides of the debate, when patent protection
for medicines needs to be reconciled with the need for access to essential medicines in the
developing countries. Additional issues and their impact, like e.g. price pressures arising
for the latter intersection, changes in the political landscape preventing beneficial FTA
provisions to be singed, like TPP under President Trump, how MNEs adapt to apply
pressure on states, like Novartis appointing Indian-born employees in key senior
management positions since the 2010 incident, will need to be continuously evaluated in
future reports.

Our conclusions provide nevertheless a sufficient scan of a body of evidence which (a)
debunks the common intuitive belief that manufacturing medicines automatically means
that MNEs will spontaneously operate to respect right to health just because medicines
are a public good, and which (b) proves that however big pharma operates to reconcile
price to include IP protection, access to medicines as well as its profit targets, should be
shaped dynamically by state regulation and civil society discourse. In this context, the
Access to Medicines UN Resolution adopted by the UN Council for Human Rights in 2016
was a welcome development which opens a new chapter in balancing effective remedies
and due diligence in the collaboration of state, civil society and MNEs regarding this issue.
7
Table of Abbreviations

8
References

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Davidson A. (2012) Unit 10 The business of medicines in W822 Study Guide 3 module
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Voiculescu A. and Yanacopoulos H. (2011) Chapter 1 Human Rights in Business Contexts:
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Zambellas A. (2012d) Unit 13 Monitoring, enforcement and remedies in W822 Study Guide 3
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11
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ACTA (2011) Anti-counterfeiting Trade Agreement [online]. Available at

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Negotiations for a Deep ad Comprehensive Free Trade Area and access to medicines:
http://www.eatg.org/gallery/169639/CSF%20Letter%20EU-
Morocco%20DFTA%20and%20access%20to%20medicines.pdf (Accessed 28 February 2014).
EU-India BT (2014) EU India Bilateral Agreement in Negotiation [online]. Available at
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February 2014).
Grover A. (2009) Promotion and Protection of all human rights, civil, political, economic,
social and cultural rights, including the right to development: Report of the Special
Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of
physical and mental health, UN Doc. A/HRX/11/12 [online]. Available at
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(Accessed 28 February 2014).
Grover A. et al. (2012) Pharmaceutical Companies and Global Lack of Access to Medicines:
Strengthening Accountability under the Right to Health, Journal of Law,
Medicine and Ethics, pp. 234- 250.
Grover A. (2013) Report of the Special Rapporteur on the right of everyone to the enjoyment of
the highest attainable standard of physical and mental health: on access to medicines, UN Doc.
A/HRC/23/42 [online]. Available at
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23- 42_en.pdf (Accessed 28 February 2014).
Grover A. (2011) Report of the Special Rapporteur on the right of everyone to the enjoyment
of the highest attainable standard of physical and mental health: Expert consultation on access
to medicines as a fundamental component of the right to health, UN Doc. A/HRC/17/43
[online]. Available at http://www.lawyerscollective.org/files/HRC%20AMTC.pdf (Accessed
28 February 2014).
Hudson Institute (2013) The Pharmaceutical Industys Contributions to the United Nations
Millenium Development Goals, Center for Science ad Public Policy, pp. 1-21 [online].
Available at
http://www.hudson.org/content/researchattachments/attachment/1260/the_pharmaceutical
_indus try_s_contibutions_to_the_un_millennium_development_goals.pdf (Accessed 28
February 2014).
Hunt P. (2008) Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of
the Highest Attainable Standard of Physical and Mental Health, UN Doc. A/63/263.
Elliot R. and Bonin M. (2002) Patents, International Trade Law and Access to essential
medicines, Medicines Sans Frontiers, pp. 1-10.
NAFTA (1994) North American Free Trade Agreement between US, Mexico and Canada 12
[online]. Available at http://www.worldtradelaw.net/fta/agreements/nafta.pdf;
http://www.international.gc.ca/trade-agreements-accords-commerciaux/agr-acc/nafta-
alena/index.aspx?lang=eng (Accessed 28 February 2014).
OCHCHR (2014) Access to Medicines: A fundamental element to human health [online].
Available at http://www.ohchr.org/EN/Issues/Development/PAges/AccessToMedicines.aspx
(Accessed 28 February 2014).
OECD (2011) Guidelines for MNEs [online]. Available at
http://www.oecd.org/daf/inv/mne/48004323.pdf (Accessed 1 March 2014).
PQM (2013) Media Reports on Medicine Quality: Focusing on USAID-assisted Countries,
Promoting the Quality of Medicines Program, pp. 1-76.
Ruggie J. G. (2011a) Presentation of Report to United Nations Human Rights Council
Professor John G. Ruggie Special Representative of the Secretary-General for Business and
Human Rights, published 30 May 2011 [online]. Available at http://www.business-
humanrights.org/media/documents/ruggie-statement-to-un-human- rights-council-30-may-
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UNGPs (Accessed 1 March 2014).
Ruggie J. G. (2013a) Just Business [ebook], W.W. Norton & Company, London, U.K.
Ruggie J. G. (2013b) Reply to Albin HRW Progress in Corporate Accountability [online].
Available at
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Ruggie (2014a) Global Governance and New Governance Theory: Lessons from Business
and Human Rights, Global Governance, Vol. 20: pp. 5-17.
Ruggie J. G. (2014b) Multinational Corporations and Human Rights: Seminar for Watson
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Said M. El & Kaprynski E. (2014) Working Paper: Access to Medicines: the role of Intellectual
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Sell S. K. (2011) TRIPS was never enough: Vertical Forum Shifting, FTAS, ACTA and TPP, J.
INTELL, PROP. L., 18: pp. 446-478.
TPP (2013) TranPacific Partnership: Ongoing Negotiations between US and 12 countries in
Asia Pacific Region [online]. Available at (Accessed 28 February 2014): Office of the United
States Trade Representative website: http://www.ustr.gov/tpp
Wikileaks Leaked TPP draft texts IP Chapter: https://wikileaks.org/tpp/
The Economist article No end in sight, published 25 February 2014:
http://www.economist.com/blogs/banyan/2014/02/trans-pacific-partnership-0
Eyes on Trade, published 18 February 2014:
http://citizen.typepad.com/eyesontrade/patent_protectionism_access_to_medicines/;
http://www.citizen.org/tpp
UNITAID (2014) TPP: Implications for Access to Medicines at: http://www.ip-
watch.org/2014/02/26/unitaid-assesses-potential-implications-of-the-trans-pacific-
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Stamoulis A. (2013): Academic critique on TPP (see below)
MSF (2012) Trading away Health: Critique on TPP at
http://www.doctorswithoutborders.org/article/trading-away-health-trans-pacific-
partnership-agreement-tpp
13
TRIPS (1994) Agreement on Trade-Related Aspects of Intellectual Property Rights
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(Accessed 28 February 2014).
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(Accessed 28 February 2014).
MSF critique on DOHA Declaration : http://www.msfaccess.org/content/trips-trips-plus- and-
doha
Oxfam critique Public Health at Risk (2012) at :
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media-brief-july2012.pdf
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February 2014).
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February 2014).

Academic Literature on FTAs and Access to Medicines

Alvarado E. (2008) Poverty and Inequality in Mexico after NAFTA: Challenges, Setbacks and
Implications, Estudios Fronterizos, 9(17): 73-105.
Abbott F. M. (2002) WTO TRIPS Agreement and Its Implications for Access to Medicines in
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Attard J. (2014) Access to Medicine Index: Can a global scorecard framework increased
Access to essential medicines in developing countries?, Sanford Journal of Public Policy,
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Backmann et al. (2008) Health Systems and the Right to Health: An assessment of 194
countries, The Lancet, 372(12):2047-2085 [online]. Available at
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df (Accessed 28 February 2014).
Bradford-Kerry V. And Lee K. (2007) Debate: TRIPS, the Doha Declaration and paragraph
6 decision: what are the remaining steps for protecting access to medicines?, Globalisation
and Health, 3.(3): pp. 1-12.
Anon (2013) Inadequacy of TRIPS and the Compulsory License: Why Broad Compulsory
Licensing is not a viable solution to the access to medicine problem, Brookings Journal of
International Law, 38(3): pp. 1191-1230.
Cameron E. (2004) Inaugural Lecture: Patents and Public Health: Principle, Politics and
Paradox, Script-ed, British Academy Law Lecture and The University of Edinburgh, DOI:
10.2966/scrip.010404.517, British Academy 2004. All Rights Reserved, pp. 517-544.
Carter L. (2012) The Global Impact and Implementation of Human Rights Norms, Global
Business & Development Law Journal, 25: pp. 1-22.
Collste G. (2011) Specifying Rights: the Case of TRIPS, Public Health Ethics, 4(1): pp. 63-69.
Corlat B., Orsi F. and Almeida C. (2006) TRIPS and the international public health
controversies, Industrial and Corporate Change, 115(6): pp. 1033-1062.
Crump L. and Druckman D. (2012) Turnig Points in Multilateral Trade Negotiations on
Intellectual Property, International Negotiations, 17: pp. 9-35.
Cullen D. (2007) Data Protection: The new IP frontier: An overview of existing laws and
regulations,Journal of Generic Medicines, 5: pp. 9-25.
Drahos P. (2008) Trust me: Patent Offices in Developing Countries, American Journal of Law
and Medicines, 34: pp. 151-174.
Dutfield G. (2000) TRIPS-related aspects of traditional knowledge, CASE W. RES J. INTL.L., 32:
pp. 233- 275.
Dutfield G. (2008) Delivering Drugs to the Poor: Will the TRIPS Amendment Help?, American
Journal of Law and Medicine, 34: pp. 107-124.
El-Said H. and El-Said M. (2007) TRIPS-Plus Implications for Access to Medicines in
Developing Countries: Lessons from Jordan-US Free Trade Agreement, The Journal of World
Intellectual Property, 10(6): pp. 348-375.
Esmail L. C. and Kohler J. C. (2012) The politics behind the implementation of the WTO
paragraph 6 Decision in Canada to increase global drug access, Globalisation and Health, 8(7):
pp. 1-14.
Evans D. et al. (2006) Report: Assessing Regional Trade Agreements with Developing 15
Countries: Shallow and Deep Integration, Trade, Productivity and Economic Performance,
Sussex University #, DFID Project Number 04 5881, pp. 2-305.
Evans G. E. Strategic Patent Licensing for Public Research Organisations: Deploying
Restriction and Reservation Clauses to promote Medical R&D in Developing Countries,
American Journal of Law and Medicine, 34: pp. 175-223.
Faunce T., Bai J. and Nguyen D. (2010) Impact of the Australia-US Free Trade Agreement on
Australian medicines regulation ad prices, Journal of Generic Medicines, &(1): pp. 18-29.
Fellmeth A. X. (2004) Secrecy, Monopoly, and Access to Pharmaceuticals in International
Trade Law: Protection of Marketing Approval Data Under the TRIPs Agreement, Harvard
International Law Journal, 45(2): pp. 1-60.
Fitzpatrick W. M. and DiLullo S. A. (2012) Global IP Management: Preserving Intellectual
Property Rights and Combating Counterfeiting, CF 10(1): 116-141.
Gabble R. and Kohler J. C. (2014) To patent or not to patent?, Globalisation and Health, 10(3)
[online]. Available at http://www.globalizationandhealth.com/content/10/1/3 (Accessed 28
February 2014).
Gangil J, Thunga G. And Nagaich R. (2010) Do Intellectual Property Rights and Data
Exclusivity Encourage Innovation in the Pharmaceutical World?, Systematic Reviews in
Pharmacy, 1(2): pp. 190- 193.
Harris D. (2011) TRIPS after 15 years: Success or Failure as measured by compulsory
licensing, J.INTELL PROP. L., 18: pp. 368-397.
Heled Y (2012) Patents v. Statutory Exclusivities in Biological Pharmaceuticals: Do we really
need both?, Michigan Telecommunications and Technology Law Review, 18(41): pp. 419-
479.
Hogerzeil H. V. et al. (2014) Is Pharmaceutical Industry Improving with regard to access to
essential medicines?, The Lancet Global Health, Open Access, 2(3): pp. E139-e140 [online].
Available at http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(13)70159-
1/fulltext?rss=yes (Accessed 14 March 2014).
Ingram J. (2011) Eliminating Innovation: How Price Controls limit Access, The Journal of
Legal Medicine, 32: pp. 115-128.
Jain T. (2009) Compulsory Licenses under TRIPS ad its obligations for member states, The
Icfai University Press, All Rights Reserved, pp. 1-25.
Jasso-Aguilar R. and Watzkin H. (2011) Multinational corporations, the state and
contemporary medicine, Health Sociology Review, 20(3): pp. 245-257.
Jorge M. F. (2004) TRIPS-plus provisions in trade agreements and their potential adverse
effects on public health, Journal of Generic Medicines, 1(3); 199-211.
Krikorian G. P. and Szymkowiak D. M. (2007) Intellectual Property Rights in the Making:
The Evolution of Intellectual Property Provision in US Free Trade Agreements and Access
to Medicines, The Journal of World Intellectual Property, 10(5): pp. 388-418.
Lechin J. (2013) Canada and access to medicines in developing countries: Intellectual
property rights first, Globalisation and Health, 9: pp. 1-9.
Lichanda B., Luo M. and Zhang B. (2013) The road of generic medicines towards improving
the accessibility of essential medicines, International Journal of Research in Pharmaceutical
Science, 4(2): pp. 130-137.
Lopert R. and Gleeson D. (2013) The High Price of Free Trade: US Trade Agreement and
Access to Medicines, Journal of Law, Medicines ad Ethics (Spring 2013): pp. 199-233.
Mathews D. (2011) When Framing Meets Law: Using Human Rights to improve Access to
Medicines in the Developing World, The WIPO Journal, 3(1): pp. 113-128.
Martin D. (2010) Providing access to medical products at prices patients can afford is a
priority for the European Parliament, Journal of Generic Medicines, 7(4): pp. 304-308.
Mikkelsen-Lopez I. et al. (2014) Essential medicines in Tanzania : does the new delivery
system improve supply and accountability?, Health Systems, 3: pp. 74-81.
Miller J. E. (2013) From Bad Pharma to Good Pharma: Aligning Marker Forces with Good 16
and Trustworthy Practices through Accreditation, Certification and Rating, Journal of Law,
Medicine and Ethics, Fall 2013: pp. 601-610.
Morin J. (2009) Multilateralising TRIPS-plus Agreements: Is the US Strategy a Failure?, The
Journal of World Intellectual Property, 12(3): pp. 175-197.
Murumba S. (2013) Foxes and Hedgehogs at the Intersection of Human Rights And
Intellectual Property, Monash University Law Review, 38(1): pp. 119-147.
Nowrot K. (2012) Transnational Corporations as Steering Subjects in International
Economic Law: Two Competing Visions of the Future?, Indiana Journal of Global Legal
Studies, 18(2): pp. 803-841.
Oliver R. S. (2007) In the 12 years of NAFTA the Treaty Gave to Me ... What Exactly? An
Assessment of Economic, Social and Political Developments in Mexico Sicne 1994 and their
Impact o Mexican Immigration into the United States, Harvard Latino Law Review, 10: 53-
133.
OseiTutu J. J. (2012) Value Divergence in Global Intellectual Property Law, Indiana Law
Journal, 87: pp. 1638-1695.
Prussia K. S. (2006) NAFTA and the Alien Tort Claims Act: Making a Case for Actionable
Offenses Based on Environmental Harms and Injuries to the Public Health, American
Journal of Law and Medicies, 32(2006): pp. 381-404.
Rens A. (2011) Collateral Damage: The Impact of ACTA and the Enforcement Agenda on the
Worlds Poorest People, AM U. INTLL. REV., 26(3): pp. 783-809.
Powel S. J. and Low T. (2012) Beyond Labor Rights: Which Core Human Rights Must Regional
Trade Agreements Protect?, Richmond Journal of Global Law & Business, 12(1): pp. 91-187.
Reich M. R. (1987) Essential drugs: Economics and politics in international health, Health
Policy, 8: pp.39-57.
Reichman J. H. (2000) The TRIPS Agreement comes of age: Conflict or cooperation with
the developing countries?, CASE W. RES J. INTL.L., 32(44): 441-470.
Robertson H. (2008) Patent Rights & International Public Health: Orphan Drugs, Final
Thesis Dissertation submitted for the degree of Master of Science in The National University
of Singapore [online]. Available at
http://oatd.org/oatd/record?record=oai%5C:scholarbank.nus.edu.sg%5C:10635%5C%2F131
53 (Accessed 28 February 2014).
Said M. El (2012) The Morning After: TRIPS-Plus, FTAs and Wikileaks, AM. U. INTL L. REV.,
18(1): pp. 71-104.
Schrecker T. (2011) The Health Case for Economic and Social Rights: Against the Global
Marketplace,Journal of Human Rights, 10: pp. 151-177.
Sibanda OS (2012) Comparative Analysis of Access to Patented HIV/AIDS Pharmaceutical
Medicines through the Canadian and EU TRIPS Flexibilities Measures: Are they efficacious or
overly burdensome and ineffective measures?, PER / PELJ, 15(2): pp. 1-34.
Singer P. and Schroeder D. (2009) Ethical Reasons for Intellectual Property Rights Reform:
A Reportfor InnovaP2, The University of Melbourne, Australia, pp. 1-24.
Singh J. P. (2010) Development Objectives and Trade Negotiations: Moralistic Foreign Policy
or Negotiated Trade Concessions?, International Negotiations, 15: pp. 367-389.
So A. D. (2004) Editorial: A fair deal for the future: flexibilities under TRIPS, Bulletin of the
World Health Organization, 82 (11): 813-814.
Sridhar D. (2008) Improving Access to Essential Medicines: How Health Concerns can be
Prioritised in the Global Governance System, Public Health Ethics, 1(2): 83-88.
Stamoulis A. (2013) Trading away the future: An analysis of the Trans-Pacific Partnership,
New Labour Forum, 22(3): pp. 30-37.
Subban J. (2006) Scrutinised: The TRIPS Agreement and Public Health, MJM 9(2): pp. 152-
159.
Tetteth E. K. Pharmaceutical Innovation, Fair Following and the Constrained Value of TRIPS
Flexibilities, The Journal of World Intellectual Property, 14(2): pp. 202-226. 17
Taylor D. et al. (2014) Patients Needs, Medicines Innovation and the Global Publics Interests:
Achieving affordable universal care, enhanced public health and sustained investment in
better treatments, An Issue Guide for Medicine Users and Patient Representatives, UCL
School of Pharmacy [online].
Available at http://www.ucl.ac.uk/pharmacy/documents/patient-needs.pdf (Accessed 28
February 2014).
The Economist (2012) India drug patents Taking pains: Indian patent rules infuriate big
pharma [online]. Available at http://www.economist.com/node/21562226 (Accessed 28
February 2014).
Van Puymbroeck R. V. (2010) Basic Survival Needs and Access to Medicines: Coming to Grips
with TRIPS Conversion and Calculation, Journal of Law, Medicine and Ethics, Fall: pp. 520-
542.
Watson A. (2011) Does TRIPS increase technology transfer to the developing world? The
empirical evidence, Information and Communications Technology Law, 3(10): pp. 253-278.
Weatherall K. (2011) ACTA as a new kind of International IP lawmaking, AM. U. INTLL. REV.,
26(3): pp. 837-898.

Brazil Case Study

Adusei P. (2011) Exploiting Patent Regulatory Flexibilities to Promote Acces to

Antiretroviral Medicines in Sub-Saharan Africa, The Journal of World Intellectual Property,
14(1): pp. 1-20.
Anderson T. (2013) Patent Pools: An equitable approach to increasing innovations and
access to medicines globally, Global Health IM Residency Tract Health Policy Briefs 2013
[online]. Available at
http://www.residency.dom.pitt.edu/Program_Overview/tracks/docs/Global_Health_IM_Reside
ncy.pd f (Accessed 28 February 2014).
Bernieri R.C. (2006) Intellectual Property Rights in Bilateral Investment Treaties and
Access to Medicines: The Case of Latin America, The Journal of World Intellectual Property,
9(5): pp. 548-572.
Cohen J C. et al. (2005) TRIPS, the Doha Declaration and increasing access to medicines: policy
options for Ghana, Globalisation and Health, 1(17): 1-10.
Cox R. W. (2008) Transnational Capital, the US State and LATAM Trade, Third World
Quarterly, 29(8): pp. 1527-1544.
Galvao J. (2005) Brazil and Access to HIV/AIDS Drugs: A question of Human Rights and Public
Health, American Journal of Public Health, 95(7): pp. 1110-1116.
Snodgrass Godoy A. and Ceron A. (2011) Changing Drug Markets Under New Intellectual
Property Regimes: The View from Central America, Government, Politics and Law American
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TRIPS, Pharmaceutical Patents and Access to Essential Medicines: Seattle, Doha and Beyond,
in Moatti et al. Economics of AIDS and access to HIV/AIDS care in developing countries: Issues
and Challenges, Collection Sciences Sociales et Sida, Paris, pp. 39-67.
Moatti et al. (2003) Economics of AIDS and access to HIV/AIDS care in developing countries:
Issues and Challenges, Collection Sciences Sociales et Sida, Paris, pp. 1-478.
Oguamanam C. (2010) Patents and Pharmaceutical R&D: Consolidating PPP Approach to
Global Public Health Crises, The Journal of World Intellectual Property, 13(4): pp. 556-580.
Oliveira M. et al. (2004) Has the implementation of the TRIPS agreement in LATAM and the
Carribean produced intellectual property legislation that favours public health?, Bulletin of
the World Health Organization;82: pp. 815-821.
Repogle J. (2004) Feature: Central Trade pact may limit access to generics, The Lancet,
363(5):1612- 1613. 18
Salama B. and Benolliel D. (2010) Pharmaceutical patent bargains: the Brazilian experience,
CARDOZO J. OF INTL & COMP. LAW, 18: pp. 633- 685.
Santos A. (2012) Carving our policy Autonomy for Developing Countires in the WTO: The
Experience of Brazil and Mexico, Virginia Journal of International Law, 52(55): pp. 551-631.
Shadlen C. K. (2011) The Rise and Fall of Prior Consent in Brazil,The WIPO Journal, 3(1): pp.
103-112.Sun H. (2004) The Road to Doha and Beyond: Some Reflections on the TRIPS
agreement and Public Health, EJIL 15(1): 123-150.
Wilsdon T., Attridge J. Sauri L. and Kirkpatrick (2011) Evidence on Access to Essential
Medicines for the Treatment of HIC/AIDS, CRA Charles River Associates, pp. 1-135.
Olsen T.D. and Sinha A. (2012) Linkage politics and the persistence of national policy
autonomy in emerging power: patents, profits and patients in the context of TRIPS
compliance, Business and Politics, 15(3): 323-356.
Thach S. (2009) Patent standards under TRIPS and the Pharmaceutical Industries in Brazil
and India, Latin American Business Review, 10: pp. 237-261.
UNAIDS/UNDP/WHO (2011) Policy Brief: Using TRIPS flexibilities to improve access to HIV
treatment [online]. Available at
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1/JC2049_PolicyBrief_TRIPS_en.pdf (Accessed 28 February 2014).
Vachani S. and Smith N.C. (2004) Socially responsible pricing: Lessons from the Pricing of
AIDS Drugs in Developing Countries, CALIFORNIA MANAGEMENT REVIEW, 47(1): 117-142.
Whitteman A. L. (2010) Cross Retaliation under the TRIPS Agreement: An Analysis of Policy
Options for Brazil, N.C. J. INT'L L. & COM. REG., 36: pp. 187-231.
WIPO (2000) Patent protection and access to HIV/AIDS Pharmaceuticals in Sub-Saharan
Africa, WIPO, pp. 1-105.
Yu P. K. (2008) Access to Medicines, BRICS Alliances and Collective Action, American
Journal of Law and Medicines, 34: pp. 345-394.
Zaidi S. (2013) Policy Brief: Access Challenges for HIV Treatments Among People Living with
with HIV and KEY Populations in Middle Income Countries, The Global Network of People
Living with HIV, pp. 1- 28 [online]. Available at
http://www.msmgf.org/files/msmgf/Publications/Access_Challenges_for_HIV_treatment_KAP
s.pdf (Accessed 28 February 2014).

India Case Study

Bhattacharya R. (2008) Are Developing Countries Going Too Far on TRIPS? A closer look at
the new laws in India, American Journal of Law and Medicine, 34: 395-421.
Chaudhuri S. (2011) Working Paper Series: Multinationals and Monopolies : Pharmaceutical
Industry in India under TRIPS, Indian Institute of Management in Calcutta, India, WPS No
665, pp.1-39, in WHO Essential Medicines and Health Products Information portal [online].
Available at http://apps.who.int/medicinedocs/documents/s19026en/s19026en.pdf
(Accessed 28 February 2014).
Choudri A. (2010) Fighting FTAs, Educating for Action: The Challenges of Building
Resistance to Bilateral Free Trade Agreements, Journal of Alternative Perspectives in the
Social Sciences, 2(1): pp. 281-308.
Gopalakrishnan N. S. (2008) TRIPS Agreement and Public Health: An Overview of
International Issues, Journal of Intellectual Property Rights, 13(9): pp. 385-400.
Gupta R. (2004) TRIPS Compliance: Dealing with the consequences of drug patents in India,
Houston Journal of International Law, 26(3): pp. 599-648.
Duperon W. O. And Cinar E. M. (2010) Global Competition versus Regional Interests: FDI
and Pharmaceuticals in India, Journal of International Commercial Law and Technology, 5(4):
pp. 181-200.
Hassan E., Yaqub O. And Diepeveen S. (2010) Intellectual Property and Developing
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Countries: A review of the literature, Rand Europe, pp. 1-92.
Lee L. L. (2008) Trials ad TRIPS-ulations: Indian Patent Law and NOVARTIS AG. v Union of
India, Berkeley Technology Law Journal, 23 281-313.
Li X. (2008) The Impact of Higher Standards in Patent Protection for Pharmaceutical
Industries under TRIPS Agreement: A comparative study of China and India, The World
Economy, doi: 10.1111/j.1467- 9701.2008.01133.x, pp. 1367-1382.
MAhaduew R et al. (2013) Ensuring Access to Essential Medicines in Mauritious Using TRIPS
flexibilities: AN incomplete Picture of the Right to Health, ICITI, pp. 1-19.
Mathur S. K. (2008) TRIPS and Safeguard Mechanism: Impact of Mailbox Applications on
Affordability and Accessibility of Essential Medicines in Post 2005 Phase, November, Issue
26, South Bulletin, South Centre, Geneva, Switzerland [online]. Available at:
http://www.insouth.org/index.php?option=com_publicationz2&publicationz2Task=publicatio
nz2Det ails&publicationz2Id=168&Itemid=94 (Accessed 28 February 2014): not peer
reviewed.
Mathur S. K. (2007) TRIPS; Issues, Impact and the way forward in developing countries
including India, American Law & Economics Association Annual Meetings, American Law &
Economics Association 17th Annual Meeting. Available at:
http://law.bepress.com/alea/17th/bazaar/art7 (Accessed February 2014): not peer
reviewed.
Mey B. P. (2010) Unfettered Consumer Access to Affordable Therapies in the post-TRIPS Era:
A Dead end Journey for Patients? Kenya and India case studies, The Journal of Wold
Intellectual Property, 13(3): pp. 403-473.
Nair A. (2012) Postcard from India: Body Blow to Generics New Trade Rules with the EU look
set to threaten Access to low cost Generic Medicines for the Poor, Chemistry and Industry, p.
51.
Novartis (2012) FAQ on medical Progress [online]. Available at
http://www.novartis.com/downloads/newsroom/product-related-info-center/faq-on-
medical-progress.pdf (Accessed 28 February 2014).
Novartis (2013) Glivec Patent Case in India: Fact and Fiction [online]. Available at
http://www.novartis.com/newsroom/product-related-info-center/glivec.shtml (Accessed 28
February 2014).
Rai R. K. (2009) Effect of the TRIPS-mandated Intellectual Property Rights on Foreign
Direct Investment in Developing Countries: A Case Study of the Indian Pharmaceutical
Industry, The Journal of World Intellectual Property, 11(5/6): pp. 404-431.
Ravinetto R. et al. (2013) The global impact of Indian Generics on Access to Health, Indian
Journal of Medical Ethics, 10(2): pp. 118-120.
Rehman H. A. (2010) India, TRIPS-plus free trade agreements and the future of access to
essential medicines, Information & Communications Technology Law, 19(3): pp. 267-300.

Thailand Case Study

Bhumika M. (2007) The Policy Space Debate: Does a Globalised and Multilateral Economy
Contrain Development Policies?, Asia Program Special Report, No. 136: pp. 1-7.
Correa C. (2007) Constraining Policy Space in Intellectual Property, Asia Program Special
Report, No. 136: pp. 22-27.
Dent C. M. (2010) Freer Trade, More Regulation? Commercial Regulatory Provision in
Asia-Pacific Free Trade Agreements, Competition and Change, 14(1): pp. 48-79.
Glasser M. and Murphy A. (2010) Patient versus Patents: Thailand and the politics of access to
pharmaceutical products, Journal of Third World Studies, pp. 215-256.
Kobori S. (2002) TRIPS and the Primacy of Public Health, Asia-Pacific Review, 9(1): 10-19.
Nguyen T. A., Hassali M.A. and McLachlan A. (2002) Generic medicines policies in the Asia
Pacific region: ways forward, WHO South-East Asia J Public Health 2: pp. 72-4. 20
Oxfam (2014) Oxfam contribution to DG Trade civil society dialogue on access to medicines
and trade policies [online]. Available at http://www.oxfam.org.nz/report/free-trade-
agreement-between-the- usa-and-thailand-threatens-access-to-hiv-aids-treatment (Accessed
14 MArch 2014).
Rasiah R. (2003) TRIPS and Capability Building in Developing Economies: Critical Issues,
Journal of Contemporary Asia, 33(3): pp.338-362.
Thanitcul S. and Braslow M.L. (2013) Compulsory Licensing of chronic disease
pharmaceuticals in Thailand, Thai J. Pharm. Sci. 37: pp. 61-83.

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