The Journal of World Intellectual Property

doi: 10.1111/j.1747-1796.2010.00407.x

Exploiting Patent Regulatory ‘‘Flexibilities’’ to

Promote Access to Antiretroviral Medicines in
Sub-Saharan Africa
Poku Adusei
University of Ghana

The HIV/AIDS pandemic has reached a crescendo in Sub-Saharan Africa (SSA or Saharan region). This
disease threatens to exterminate the human race in the Saharan region. The situation is further exacerbated by
high prices of brand name antiretroviral medicines due to the prevailing international patent regime. And,
attempts to promote the manufacture and import of generic versions of antiretroviral drugs are sometimes met
with stiff resistance from pharmaceutical companies who own the patents. This article, therefore, seeks to
examine the subject of patent regulation of antiretroviral drugs in the light of the threat posed by HIV/AIDS
in SSA. It urges the exploitation of diverse patent regulatory mechanisms to promote access to antiretroviral
drugs in the region worst hit by the HIV/AIDS epidemic. Exploiting patent regulatory flexibilities implies the
use of: negotiations, compulsory licensing mechanisms, public-private partnerships, collaborative initiatives
among regional economic blocs, increased drug-pricing competition, and a rejection of TRIPS-Plus obliga-
tions, among others, to procure relatively cheaper versions of antiretroviral medicines for persons infected
with the virus. This will enable policy makers in the Sub-Saharan region to respond more effectively to expand
the capacities of HIV/AIDS-affected persons and make them more productive. It will further save the
healthcare systems in SSA from imminent collapse.
Keywords TRIPS ‘‘Flexibilities’’; HIV/AIDS; access to medicines; Sub-Saharan Africa

Sub-Saharan Africa (SSA or the Saharan region)1 is teetering on the brink of a human calamity. The
HIV/AIDS pandemic has engulfed, and continues to engulf, the Saharan region in an unprecedented
proportion. Despite recent claims of progress in the fight against the HIV/AIDS epidemic in some
parts of Africa, SSA still remains the epicentre of the disease (Joint United Nations Programme on
HIV/AIDS [UNAIDS] and World Health Organization [WHO], 2008). Conservative estimates
indicate that two thirds of the world’s HIV infection rate is in SSA, and more than three in four
(76%) AIDS-related deaths occur in that region (UNAIDS and WHO, 2007).2 Worse still, the
Saharan region accounts for 67% of the world’s least developed countries (LDCs) and millions of
people infected with HIV do not have access to medicines. As a consequence, being HIV positive in
SSA is rapidly becoming a death sentence. And there is ample evidence to support the fact that HIV/
AIDS has become a national emergency in parts of Africa.
On the flip side, the increase in the incidence of HIV/AIDS in SSA has escalated the demand
for antiretroviral medicines. Antiretroviral medicines, where they are accessible, can prolong the
lives of people infected with HIV (Crowley, 2010; Kuanpoth, 2007; Srivastava and Satyanarayana,
2009, p. 672). Antiretrovirals are therefore needed to promote the healthcare needs of millions of
people infected with HIV in SSA. But as it now stands, access to quality healthcare remains the
province of the few elite in SSA. The general population cannot afford to buy patented brand name
medicines and, most often, people on an antiretroviral regimen experience treatment interruptions
due to financial difficulties (Hoen, 2009, p. 5). Also, the sustainability of healthcare institutions is
under threat owing largely to the high cost of pharmaceutical products in the marketplace.

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Accordingly, access to medicines has become the most important issue on the agenda for policy
makers in SSA. Policy makers should put in place mechanisms to promote access to medicines that
prolong human lives, and increase the health and well-being of people living with HIV/AIDS.
Meanwhile, patents in the medicines that grease the wheels of life are owned by private
pharmaceutical companies, which regulate the prices of patented medicines on the market. This
private regulation of essential life-saving medicines, via pharmaceutical patents, makes the cost of
an effective antiretroviral regimen expensive. Stiglitz (2008, p. 1717) rightly notes that the
implementation of patent rules ‘‘makes it difficult for developing countries to get access to these
vital medicines at prices that they can afford’’. Needless to say, patents on pharmaceuticals
constitute a key factor in the quest for access to medicines in SSA.
Consequently, this article will explore mechanisms to promote affordability of and/or access to
antiretroviral medicines in SSA. Given the importance of human survival, an effective management
of the cost of anti-AIDS medicines in Africa must aim at reducing the cost of access to medicines
and making healthcare services available to the largest population possible. Conversely, a poorly
executed patent system can perpetuate high prices for medicines and hinder access to essential life-
saving medicines in SSA. To this end, countries in SSA should adopt effective mechanisms that
fully exploit all the ‘‘flexibilities’’ in the World Trade Organization’s (WTO’s) Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement or TRIPS),3 especially
with the recent ‘‘August 30’’ Decision4 of the WTO Council, which has culminated in the
permanent amendment to article 31 of the TRIPS Agreement.
By analysing these ‘‘flexibilities’’, the article proposes the adoption of diverse patent regulatory
mechanisms that promote access to antiretroviral medicines and lead to human development in
SSA. Such regulatory diversity should emphasize the use of negotiations, compulsory licensing
mechanisms, public–private partnerships, collaborative initiatives among regional economic blocs,
increased drug-pricing competition and a rejection of TRIPS-Plus obligations, among others, to
procure relatively cheaper versions of antiretroviral medicines for persons infected with the virus. A
major caveat, however, is that, although this article focuses on SSA, the analysis and its concomitant
regulatory recommendations could apply to any LDC, and, to some degree, any developing region
affected by the AIDS epidemic. Also, most countries in SSA cannot meaningfully exploit the
regulatory frameworks proposed herein unless steps are taken to develop domestic industrial and
technological capacities. In other words, there is an urgent need for investments into building the
technological knowhow of scientists and domestic infrastructure so as to achieve the realization of
some of the proposed regulatory mechanisms contained in this article.
Conceived of as above, the article will also focus on how domestic enforcement mechanisms
can be balanced against government policies to improve the lot of their citizenry. As Dinwoodie
and Dreyfuss explain:
Intellectual property law must strike a balance between sufficient levels of protection to
stimulate the desired social and commercial activity undertaken by first-comers, and
sufficient limits on those rights to ensure the maximum socially useful exploitation of that
activity. It partly achieves this balance substantively by allocating rights as between private
and public interests, that is, between producers and users of intellectual property. But
TRIPS, like any international agreement, must also deal with issues such as sovereignty,
diversity, and legitimacy that pervade international relations (2004, pp. 447–8).
To promote this socially desirable balance, this article will consider how regional economic
groups such as the Southern African Development Community (SADC), the Economic Commu-
nity of West African States (ECOWAS) and the East African Community (EAC) can take

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advantage of international patent rules to ensure that antiretroviral medicines reach the suffering
masses in SSA. This will enable policy makers in the Saharan region to respond more effectively to
expand the capacity of HIV/AIDS-affected persons to keep functioning and thus make them more
productive. It will further save the healthcare systems in SSA from imminent collapse.

International Patent Protection of Medicines Revisited

Any meaningful appraisal of the existing regulation of antiretroviral medicines deserves a closer
look at the prevailing international patent regime within the context of the TRIPS Agreement. The
Agreement emerged as part of the Uruguay Round of trade negotiations that ushered into force the
liberalized trade policies of the WTO in 1995. This Agreement sets the minimum threshold for
intellectual property (IP) rights protection and enforcement for all member states of the WTO.
Consequently, the TRIPS rules have, since entry into force, become the foundation of legitimacy
for patent systems across the globe. The key feature of TRIPS is that its rules confirm the
commitment of the international community to ‘‘achieve uniformity as to the nature of the [IP]
rights, combined enforceability and sanctions for breaches thereof’’ (Kihwelo, 2006, p. 673).
For instance, the TRIPS Agreement makes it obligatory for all members of the WTO to grant
a 20-year patent protection to pharmaceutical products and processes, among others.5 Also, the
grant of protection is extended to cover utility patents, otherwise known as ‘‘utility models’’.6 In
addition, TRIPS allows states to grant protection for medicinal test data, thereby creating an
additional form of monopoly for data needed to obtain marketing approval for medicines
(Timmermans, 2005).7 To this end, all new health-related products and processes, such as
medicines, vaccines and diagnostics, are enclosed in the ‘‘fence’’ of protection by the TRIPS-based
patent framework (Hoen, 2009, p. 2). The grant of such pharmaceutical patents confers exclusive
rights on the owner to make, use, sell and/or import protected medicines.8
Also, TRIPS contains extensive provisions that oblige states to provide effective and adequate
enforcement procedures against the infringement of IP rights (Drahos and Braithwaite, 2004).
1 January 2005 was the deadline for all developing countries to comply with TRIPS. LDCs have until
2016 to protect pharmaceutical patents in compliance with TRIPS,9 but, in reality, a number of those
LDCs in SSA comply with the treaty, to the extent that some have been compelled to assume more
obligations than the minimum standards required by TRIPS (Hill and Johnson, 2004, p. 7).
Besides the TRIPS requirements for a country to grant or enforce pharmaceutical patents,
there are also provisions that allow states to exclude inventions from patentability on the basis of
ordre public or morality, among others.10 Additionally, the TRIPS Agreement allows states to
make provisions for pharmaceutical patent exceptions in cases of emergency and extreme urgency,
public non-commercial use, anti-competitive use and the production of pharmaceutical products
for eligible states.11 For Gold and Lam (2003, p. 30), the use of non-commercial licence on grounds
of public health may offer SSA countries a ‘‘mechanism to proactively address the impact of patent
rights on their health care systems’’. Thus, on the strength of public interest considerations and also
on the basis of abuse of patent rights, states can limit the exercise of pharmaceutical patent rights in
their respective jurisdictions (Haugen, 2008, p. 346).
Finally, it is significant to point out that some scholars interpret the TRIPS Agreement as
limiting the use of the ‘‘flexibilities’’ under TRIPS to particular diseases, such as HIV/AIDS,
malaria and tuberculosis. This approach is, however, misplaced. Indeed, nothing in the TRIPS
Agreement limits the use of compulsory licences or other ‘‘flexibilities’’ to a narrow category of
diseases (Outterson, 2008, p. 281). To put matters to rest, paragraphs 1 and 5 of the Doha

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Declaration provide that ‘‘other epidemics’’ can form part of national emergency or other
circumstances of extreme urgency in domestic jurisdictions.

Patents and Access to Medicines: The Debate

Without doubt, there is an ongoing debate about the impact of the above patent rules on access to
medicines. There is also disagreement on the extent to which patents influence innovation (Gold et
al., 2004). For proponents of private patent rights, researching, developing and the subsequent
production of medicines require significant financial investment and, therefore, pharmaceutical
companies should be allowed to recoup their costs and make a profit (Boldrin and Levine, 2008,
p. 70; Gold et al., 2004).
Others justify the position that patentees should receive robust economic reward to spur
innovation and creativity (Gould and Gruben, 1996; Gutterman, 1993; Rapp and Rozek, 1990).
Trebilcock (1991, p. 111) notes that ‘‘if I spend considerable resources inventing a new product but
others are able to copy my idea without making any such investments and without reimbursing me,
I have little incentive to use my innovative talents in this fashion’’. The position of the
(International Federation of Pharmaceutical Manufacturers and Associations [IFPMA], 2008) is
that ‘‘[w]ithout patent protection, the world would have been deprived of the innovative medicines
which have saved countless of lives’’. The point here is that proponents of patents justify the grant
of monopoly as a necessary tool to induce firms to undertake pharmaceutical research and
development (Schumpeter, 1976, p. 102).
However, the above arguments proffered by proponents of pharmaceutical patents are only
half of the story. The other part comes from critics, who posit that patents are not necessary for
pharmaceutical research and development (Smith et al., 2009, p. 686; Stiglitz, 2008). Others also
contend that the existence of pharmaceutical patents leads to high prices of medicines on the
market (Boldrin and Levine, 2008, p. 69; Heller, 2008; Ostergard, 2003; Sell, 2003). This viewpoint
is confirmed by the WHO-Health Action International survey, which has predicted that essential
medicines will be very expensive and not universally available due to the prevailing patent regime
(Babar et al., 2007). The pharmaceutical industry is said to be the most profitable industry when
compared with the other industries, such that producers sometimes sell way above the cost (Temin,
1979, pp. 432–40). Angell (2004, p. 92) notes that the ‘‘[d]rug company profits are so large that one
will hope the companies would be willing to make less profitable [sic] but vital drugs as a social
service’’.
Heller (2008, p. 59), for his part, argues that patents contribute to a reduction in the capacity of
the pharmaceutical industry to generate new products. In support of this assertion is a report by
the US Government Accountability Office (2006), which has concluded that the ‘‘current patent
law discouraged drug companies from developing new drugs by allowing them to make excessive
profits through minor changes to existing pharmaceuticals’’. Temin (1979, p. 440) has also
remarked that the pharmaceutical companies incur huge costs on excessive advertising to sustain
a form of price-fixing cartel and monopolize the market, rather than focusing on real research to
produce new medicines. For instance, AstraZeneca is said to have spent half a billion dollars to
advertise Nexium alone (Angell, 2004, p. 78). In addition, pharmaceutical companies spend
millions of dollars on legal fees and other lobbying activities to ward off generic manufacturers
and potential infringers (Heller, 2008, p. 51).
This author adopts the perspective that researching and developing a new product should draw
inspiration from the social environment (Gold et al., 2008a). Therefore, claiming robust protection
for invention may create short-term benefits for the patent holder, but, in the longer term, is likely

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to create social inequities and imbalances (Gold et al., 2008a). As Gold et al. (2008a, p. 16)
poignantly observe:
the recognition that innovation is a social, collaborative phenomenon changes the way
that policy-makers, researchers, industry and technology consumers ought to view and
appreciate IP: as something to be shared and built upon rather than as something to
accumulate for its own sake.
In 2001, anti-TRIPS proponents achieved some breakthrough at the Fourth WTO Ministerial
Conference by pushing for the passage of the Doha Declaration on the TRIPS Agreement and
Public Health.12 This declaration affirms the sovereign right of governments to take measures to
promote access to medicines. For Hoen (2009, p. xvi), Doha signalled a sea change in thinking
about ‘‘IP as a social policy tool for the benefit of society as a whole, rather than [as] a mechanism
to protect limited commercial interests’’. The declaration thus triggered renewed efforts to exploit
the ‘‘flexibilities’’ in the TRIPS Agreement via compulsory licensing and parallel imports.
Still, Doha failed to allow for exports to countries that lacked domestic manufacturing
capacity; countries were thus allowed to use compulsory licences to produce medicines ‘‘pre-
dominantly’’ for the domestic market.13 Two years of additional negotiations resulted in the WTO
General Council’s decision on 30 August 2003 to allow for such exports and imports among
countries with and/or without manufacturing capacities. So far, only Rwanda has notified the
TRIPS Council and in fact utilized the ‘‘August 30’’ mechanism to import generic medicines, Apo
TriAvir, from Canada (Hoen, 2009, p. 37). Even with this Rwandan experience, the rigid nature of
the application procedures under Canada’s Access to Medicines Regime14 and the high cost of
Canadian generics as compared with that of India made the entire deal unattractive (Goodwin,
2008, pp. 580–3).
Furthermore, the issue as to whether the ‘‘August 30’’ decision promotes real flexibility will be
discussed below. Suffice it to say that, notwithstanding what Stiglitz (2008, p. 1717) calls ‘‘the
inflexibilities in these flexibilities’’, this article urges policy makers in SSA to pursue diverse
regulatory mechanisms to promote access to antiretroviral medicines in the region worst hit by the
HIV/AIDS epidemic. That the governments of the 48 countries in SSA need to pursue diverse
regulatory mechanisms to procure antiretroviral medicines for their citizenry is further discussed
below.

Regulatory Diversity as an Instrument for Social Benefits

The central goal of a patent system is to promote social benefits (Gold et al., 2004, p. 300). This
goal is confirmed by article 7 of the TRIPS Agreement, which provides that IP protection should be
seen a social policy instrument for societal benefits and the promotion of economic welfare. In this
regard, the pursuit of social benefits, such as the promotion of access to antiretroviral medicines in
SSA, should be made to trump individual reward.15 The success of such pro-access policies will,
however, depend on practical governmental interventions, flexible patent administration and
enforcement mechanisms and the building of alliances through institutional frameworks in SSA
to overcome access barriers.
Thus, as part of a multifaceted strategy to promote access to antiretroviral medicines, policy
makers in SSA must put in place practical measures that allow states to negotiate to make the
prices of essential medicines affordable; grant compulsory licences to allow third parties to produce
and/or sell antiretroviral medicines; allow parallel imports of medicines at reduced prices without
the consent of the patent holder; encourage and support the patent application and management of

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essential life-saving medicines; and promote sustainable financing mechanisms for pharmaceutical
research and development (Smith et al., 2009, p. 686). Twelve such pro-access mechanisms are
discussed in turn.

Negotiations
Although there is no legal requirement that countries must first resort to negotiations for licences
before exploring other pro-access mechanisms such as compulsory licences to tackle health
emergencies, adopting a non-confrontational approach to promote access to medicines will ensure
cooperation among governments and pharmaceutical patent holders. Governments should there-
fore negotiate with pharmaceutical patent holders for voluntary licences that will allow third
parties to market medicines and/or import generic versions of patented medicines in order to bring
down prices of antiretroviral medicines in SSA. Negotiation, as a non-confrontational mechanism,
will also promote better communication among patent stakeholders. This will, in turn, establish
trust among the interlocutors (Gold et al., 2008a, pp. 23–7; Morin and Gold, 2009).
Through negotiations, governments can also influence drug pricing in both domestic and
international arenas. This can be effectively undertaken by offering other trade-offs such as the
reduction of the cost involved in the application and management of patents for essential
medicines. There could also be other incentives that allow for easier access to a country’s market
with new antiretroviral medicines. For instance, through negotiations, GlaxoSmithKline (GSK)
and Boehringer Ingelheim (BI) granted licences in 2003 to the government of South Africa in
return for the payment of royalties not exceeding 5% (Hoen, 2009, p. 53).16 However, the use of
voluntary negotiation is without prejudice to the rights of governments to use compulsory licences
in drug-patent regulation.
Presently, pharmaceutical companies are beginning to accept the reality that patent protec-
tionism and continued confrontation with proponents of pro-access policies will not work. They
are therefore making some concessions to promote access to medicines. For instance, the Chief
Executive Officer of GSK has promised his organization’s commitment to slash prices on all
medicines in the poorest countries and supply less expensive medicines to the developing world
(Boseley, 2009). Also, GSK announced that it is willing to contribute to a patent pool for research
into neglected diseases in developing countries (Boseley, 2009). This proposal, however, excluded
antiretroviral medicines. Developing countries should see this proposal as an opportunity to open
further dialogue in order to build trust for the inclusion of antiretroviral medicines in the study.
Also, the governments of India and Brazil have expressed their displeasure with the Nether-
lands government’s seizure of generic medicines bound for developing countries (New, 2009).
Another seizure by the Dutch customs officials affected 49 kg of abacavir sulfate—a generic
antiretroviral drug—that was intended to be used for treating HIV/AIDS patients in Nigeria
(Srivastava and Satyanarayana, 2009, p. 672). For Outterson (2009), this seizure forms part of a
new secret anti-piracy agenda that is being used to delay global access to generic medicines.
However, these trade barriers can be resolved by resorting to negotiations and also making a
case for bilateral arrangements with the West to aid in the shipment of future consignments of
generic medicines to developing countries. This proposal is consistent with recent suggestions for
the use of negotiations rather than confrontation in resolving disagreements over access to
medicines (Gold et al., 2008a). Sometimes, all that it may take is to make a case that generics
constitute a meagre fraction of the global pharmaceutical market and also that generic production
is consistent with international law. It is worth emphasizing that the use of negotiations can clarify
and resolve the apparent lack of understanding by some policy makers in differentiating between
counterfeit medicines and generic medicines.

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Compulsory Licences for Domestic Production

The grant of compulsory licences for the purposes of local production of medicines is another
proven mechanism to contain the high cost of medicines. It involves licencing the use of a patented
invention to a third party or a government agency without the consent of the patent holder by
paying adequate compensation to the owner. In the same way, if efforts to secure voluntary
licences from pharmaceutical companies are being impeded, a compulsory licencing mechanism is
another effective option to explore in SSA. More importantly, paragraph 5 of the Doha
Declaration emboldens domestic governments to determine the grounds upon which such licences
are granted to tackle health-related emergencies. States are also not required to consult patent right
holders before issuing compulsory licences to address public health concerns.17 Notice must,
however, be given of the use as soon as reasonably practicable. This waiver of prior consultation is
aimed at avoiding inordinate delays in the issuance of compulsory licences in cases of national
emergency.
As a price leveraging instrument, countries in SSA must create national frameworks to
facilitate the use of compulsory licensing for the manufacture of antiretroviral medicines. This
may require changes to domestic patent regulatory frameworks that restrict the possibility of
granting sub-licences to third parties. For instance, between 1969 and 1992, Canada issued 613
compulsory licences as part of its cost-containment mechanisms (Hoen, 2009, p. ix). Through this,
price competition for medicines was promoted; it also helped to develop the capacity of the local
generic pharmaceutical industry (Hoen, 2009, p. 41). Also, countries such as India have, in the past,
used compulsory licences for the production of generics as leverage in price negotiations with
patent-holding pharmaceutical companies (Hoen, 2009, p. xvi). This propelled the generic
pharmaceutical industry in India to become the largest in the world. In short, the threats of the
use of compulsory licences can also induce the grant of voluntary licenses on reasonable terms and
ensure that the objective of actually using the invention is accomplished (Haracoglou, 2008, p. 59).

Parallel Imports
Parallel importation by countries that do not have domestic capacity to manufacture antiretroviral
medicines is another mechanism available for sourcing lower-priced medicines from abroad.
Parallel imports involve cross-border trade in patented products without the permission of the
patent holder. It allows countries that do not have the manufacturing capacity to purchase
medicines from other countries after comparing the prices in different markets (Smith et al., 2009,
p. 686). This power of governments to import relatively cheaper medicines from other markets
tends to force domestic distributors to reduce prices of medicines and also increase competition
(Kuanpoth, 2007, p. 204).
In the lexicon of IP law, this approach of importing lower-priced medicines from abroad falls
under the doctrine of exhaustion.18 This doctrine provides that the first sale of a patented drug
exhausts the public law rights of the patent holder for that item (Outterson, 2005, p. 209). This
exhaustion rule can operate at the domestic, regional or international level. It is worth noting that
international exhaustion provides more latitude for the resale of patented drugs without the
permission of the right holder. As Outterson (2005, pp. 209–10) opines, the international
exhaustion rule removes patent law barriers to cross-border trade in patented and generic
medicines.
In addition, Correa (2000, pp. 100–2) identifies two other grounds upon which generic
medicines manufactured and sold elsewhere can be imported into a country. These include: (1)
import of generic medicines in situations where there are no existing patents and (2) parallel import
of medicines put on the market with the authorization of the patent holder. Also, with the WTO

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Council’s ‘‘August 30’’ Decision, exploring the possibilities of parallel imports of generic medicines
has become a truly viable alternative for states to consider. This can be done without any challenge
by pharmaceutical patent holders.19
Indeed, countries in SSA have a lesson to learn from India. India, for instance, has embodied
the ‘‘August 30’’ Decision in its legislative framework as follows:
Compulsory licensing shall be available for manufacture of and export of patented
pharmaceutical products to any country having insufficient or no manufacturing
capacity in the pharmaceutical sector for the concerned product to address public
health problems, provided compulsory licensing has been granted by such country or
such country has, by notification or otherwise, allowed importation of the patented
pharmaceutical products from India.20
This progressive provision opens the door for countries in SSA to work together with India to
procure medicines at an affordable cost. All that is required of countries in SSA is that they should
have ‘‘by notification or otherwise [have been] allowed importation of patented pharmaceutical
products from India’’. The onus therefore rests on countries in SSA to take steps to notify the
TRIPS Council of their intention to make use of the ‘‘August 30’’ Decision. Because most of these
countries lack the expertise on matters pertaining to the use of compulsory licences and how to
determine reasonable royalty rates, guidance on such issues is sorely needed to make the TRIPS
‘‘flexibilities’’ meaningful.

Public/Private Sector Initiatives

The use of public–private partnerships is one mechanism to promote the development of and the
subsequent dissemination of antiretroviral medicines (Herder, 2008; Smith et al., 2009, p. 690).
With over US$80 billion worth of patented medicines including first-line antiretroviral medicines
expected to expire by 2010 (Sivaprakasam, 2005), a huge opportunity is presented to governments
in SSA and private entrepreneurs to target such medicines for the purposes of generic production.
Also, private–public initiatives can be used to manufacture other essential medicines, which,
according to WHO, include those medicines that satisfy the priority healthcare needs of the
majority of the population (WHO, 2004).
Thus, once those essential medicines are identified, the governments must assist the private
sector in establishing companies to boost the local production of generic medicines. This assistance
can come in the form of tax incentives to reduce the cost of pharmaceutical research and
development by generic producers. In making a similar argument, Kuanpoth (2007, p. 204) notes
that ‘‘prices can be reduced further by waiving taxes, duties and fees on both finished products and
raw materials; such waivers should probably also include packaging materials and non-active
ingredients’’. According to Rai (2008), such initiatives have been successfully undertaken in India
and the pharmaceutical industry has grown rapidly. This, however, requires countries in SSA to
build the capacities of the domestic pharmaceutical industry and scientists to take advantage of
some of the lessons from countries such as India.
Additionally, recent studies have suggested that patents cannot be the main mechanism for
financing innovation (WHO, 2004). Another way to achieve the de-linking of research and
development costs from drug pricing is through the setting up of an effective prize-system,
‘‘research guaranteed fund’’ and the use of public–private financing mechanisms (Stiglitz, 2008,
pp. 1720–3). This, it is argued, can promote a burden–benefit-sharing approach to patent
regulation of medicines, rather than over-reliance on a patent regime that is based on a
‘‘winner-takes-all’’ reward structure (Stiglitz, 2008). In the case of SSA, countries and regional

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economic blocs should work with philanthropic organizations such as the Gates Foundation, the
Clinton Foundation, International Dispensary Association and the Global Fund to commit
substantial resources to antiretroviral medicines research and development. Another example is
the joint initiative programme—the African Comprehensive HIV/AIDS Partnership—between the
government of Botswana, the Bill & Melinda Gates Foundation and Merck & Co Inc., which seeks
to support and enhance Botswana’s response to the HIV and AIDS epidemic through a
comprehensive approach to HIV/AIDS tuberculosis prevention, treatment, care and support
and impact mitigation.21 With such initiatives available, the use of patents as primary pricing
mechanisms can be avoided. Also, through private–public initiatives, cost could be saved on the
value of antiretroviral medicines procured from elsewhere.

Medicines’ Patent Pool and Other Collaborative Initiatives

Over the years, international efforts have been made to procure essential medicines for people who
cannot afford them. The Global Fund, the World Bank, PEPFAR (i.e. the US President’s
Emergency Plan for AIDS Relief) and the European Union (EU) have all financed the procure-
ment of health-related products. To some degree, these access support initiatives show the
willingness of Western governments and other philanthropic organizations to contribute to the
provision of medicines to countries in need. However, more needs to be done to ensure that a
sizeable number of people infected with HIV have access to antiretroviral medicines. The reality
now is that the Western support mechanisms have not succeeded in catching up with the surge in
HIV/AID fatalities in SSA.
This necessitates the adoption of other collaborative initiatives such as a patent pool to
promote access to fixed-dose combinations of antiretroviral medicines. Gold et al. (2008b) have
recently suggested that it is legally feasible to establish a patent pool of medicines targeted at fixed-
dosed combinations of antiretroviral medicines. As a result, there is an ongoing initiative by the
international drug agency UNITAID22 to establish a patent pool to boost innovation in and access
to antiretroviral medicines. It involves bringing a number of patent rights together so that they
become available on a non-exclusive basis to manufacturers and distributors of medicines, in
return for the payment of royalties. Indeed, co-funding medicine research and development costs,
through a patent pool, will make it easier for generic manufacturers to enter the market and also
lend sufficient voice to governments in matters pertaining to drug pricing to promote access (Gold
et al., 2008b). Patent pools can also provide mechanisms for free sharing of technical information
relating to pharmaceutical patents and lead to a more effective and efficient allocation of limited
resources (Haracoglou, 2008, p. 52).
Such a scheme therefore needs broader participation and contribution from countries as a tool
for managing issues relating to patents and access to medicines. After all, giant corporations have
recently enjoyed support from central governments across the globe in the form of ‘‘financial
bailouts’’. Similar support from governments should be offered to public-oriented entities, such as
UNITAID, which seek to promote access to antiretrovirals and research into diseases. Govern-
ments and pharmaceutical companies should therefore be educated about the need to make such a
contribution for the eventual support of the suffering masses.
Others have also suggested the use of blanket royalty schemes, as used in copyright, to
promote access to essential life-saving medicines in domestic jurisdictions (Heller, 2008, p. 72). This
can be done through governmental negotiations with private right holders to promote the mass
production of antiretroviral medicines, against the payment of royalties to right holders. In this
case, the approaches being adopted in copyright administration could be a guide.

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Taking the Doha Declaration and WTO Council’s ‘‘August 30’’ Decision Seriously
As indicated earlier, the Doha Declaration signalled a modest breakthrough in the quest to
facilitate access to medicines in developing countries. Under Doha, the production of medicines to
alleviate human suffering was to ‘‘be authorized predominantly for the supply of the domestic
market’’.23 This permission, however, failed to address the concern of countries that lack the
capacity to produce medicines in their domestic settings. Subsequently, the WTO Council decided
on 30 August 2003 to allow for the export of medicines manufactured under compulsory licences
into countries that lack domestic production capacity. This permission has culminated in the
permanent amendment to article 31 of TRIPS.24
Paragraph 2 of the ‘‘August 30’’ Decision sets out the conditions under which the obligations
under articles 31(f) and (h) of TRIPS are waived for the purposes of importation and exportation
of antiretroviral medicines. The requirements include a notification by the eligible importing
member state specifying names and quantity; confirmation of insufficient manufacturing capacity,
except in the case of LDCs; notification about the issuance of a compulsory licence by the
exporting country if the product is patented in the eligible importing member state; and
confirmation that the eligible product is protected by patents in the exporting country. Besides
other packaging requirements and the payment of an adequate royalty, the exporting member state
should notify the TRIPS Council of the quantity produced for export and other distinguishing
features of the products so as to avoid re-exportation (Goodwin, 2008, p. 572; Gopakumar, 2004,
p. 105). It is worth emphasizing that, so far, only Rwanda has taken steps to inform the TRIPS
Council that it intends to use the ‘‘August 30’’ waiver; Rwanda utilized the new mechanism to
import antiretroviral therapy, TriAvir, from Canada.
As indicated earlier, India has adopted a more progressive approach under its patent regime to
support countries that lack the domestic production capacity to have access to antiretroviral
medicines. As a consequence, countries in SSA should establish cooperation with India to procure
relatively cheaper antiretroviral medicines by resorting to the ‘‘August 30’’ waiver (Hoen, 2009,
pp. 22–3). Countries in SSA are also urged to ratify the new amendment to TRIPS and implement
it in domestic drug-patent regulatory frameworks to promote access to medicines. In doing so, the
Indian approach should be their guide.
One major concern with the ‘‘August 30’’ Decision, as Gopakumar (2004, p. 108) notes, is that
the ‘‘notifications, along with the additional conditions for the issuance of compulsory license and
safeguards against re-exportation, make the Decision a highly cumbersome and inoperable
mechanism with which to ensure the supply of cheap drugs to developing countries’’. To some
extent, the required processes impede the full realization of any benefits that the ‘‘August 30’’
Decision intended to confer. Worse still, in countries such as Canada, complex procedural
requirements in the issuance of compulsory licences, limits on available medication and other
regulatory approvals significantly undermine the purpose of the ‘‘August 30’’ Decision to facilitate
access to medicines (Goodwin, 2008, pp. 578–83). As Morin and Gold (2009) put it, the procedural
obstacles are too enormous to make the dictates of the ‘‘August 30’’ Decision realizable, especially
in Canada (Taylor, 2009). The point here is that extricating countries in SSA from complying with
such procedural, legal and institutional obstacles in the implementation of the decisions can
effectively promote access to antiretroviral medicines.

Avoiding TRIPS-Plus Obligations

This section establishes the point that adopting TRIPS-Plus obligations in the protection of
pharmaceutical products and processes impedes access to medicines in SSA, especially in LDCs
(Hoen, 2009, p. xvii; Timmermans, 2005, p. 70). Although LDCs are not obliged to grant or

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enforce pharmaceutical patents until 2016, the trend is that they go to extra lengths to assume
stricter obligations than the minimum standards required by TRIPS, a phenomenon commonly
known as TRIPS-Plus. These countries are sometimes deceived into accepting that higher
protection will better serve their interests in receiving increased investments and other support
from developed countries (Smith et al., 2009, p. 688). But, as they stand, TRIPS-Plus standards
have largely failed to fulfill technology transfer promises. Also, such high levels of protection for
pharmaceutical patents in particular prevent access to medicines in LDCs (Smith et al., 2009).
However, recent trends from the United States and the EU show disturbing signals: trade
agreements being negotiated with countries of the Southern African Customs Union (SACU) show
a push for TRIPS-Plus conditions (Hoen, 2009, p. 71). SACU’s insistence that issues of concern to
the United States, such as IP rights, should be negotiated and adopted in a follow-up agreement
has hampered the progress of negotiations as regards this regional agreement. Also, the European
Partnership Agreements (EPAs) with African, Caribbean and Pacific (ACP) countries impose new
TRIPS-Plus obligations that could have negative effects on access to medicines (Abbott and
Reichman, 2007).
These EU TRIPS-Plus demands include: (1) the acceptance of European IP treaties, which will
lead to more extensive protection of medicines in ACP countries, and (2) the implementation of EU
IP enforcement directives, which permit seizure of medicines (Abbott and Reichman, 2007). The
rules effectively compel domestic regulatory institutions in SSA to act as ‘‘patent police’’ so as to
enforce frivolous patents (Timmermans, 2005, p. 72). TRIPS-Plus obligations in the EPAs thus
sustain the dominant market position for pharmaceutical originator companies, and create
substantial obstacles to the introduction of generic medicines (Abbott and Reichman, 2007).
The US Free Trade Agreements (FTAs) with less developed countries have also produced
similar effects. For example, empirical research into the impact of the 2001 Jordan–US FTA shows
that its TRIPS-Plus rules impede the ability of the poor to have access to generic medicines (El-Said
and El-Said, 2007). Further, subsequent US FTAs with Morocco, Bahrain, Oman, Chile and
Singapore contain TRIPS-Plus provisions that delay the introduction of generic medicines and
increase the terms of patent protection in the latter countries (El-Said and El-Said, 2007, p. 451).
The point here is that US FTAs with developing countries have pushed the frontiers of
international patent law towards enhanced patent standards.
The stringent nature of TRIPS-Plus obligations is not the only issue of concern; they also stifle
the existing fragile ‘‘flexibilities’’ under TRIPS and the Doha Declaration (Krikorian and
Szymkowiak, 2007, p. 395). For Morin (2006), the imposition of TRIPS-Plus obligations via
bilateral FTAs represents the frontline of impeding access to affordable medicines in developing
countries. In the view of Waxman (2003), a member of the US Congress, the imposition of TRIPS-
Plus obligations on developing countries via bilateral trade agreements is ‘‘irresponsible and even
unethical’’. Developing countries should therefore negotiate to exclude such TRIPS-Plus obliga-
tions, which tend to affect public health programmes. Moreover, because the majority of countries
in SSA are least developed, they should avoid rigid compliance with TRIPS, not to mention
TRIPS-Plus obligations. This could be done if domestic policy makers in SSA understand their
international patent obligations, an issue that could be addressed through capacity-building
initiatives. However, the success of such capacity-building initiatives will depend on the participa-
tion of domestic civil society organizations and the affected communities in SSA. The participation
of civil society and communities affected by IP systems, including public interest non-governmental
organizations (NGOs) and academics with the knowledge and expertise to draw attention to
TRIPS flexibilities, will prevent proponents of strong patent rules from always having their way
(Matthews and Munoz-Tellez, 2006, p. 638).

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Making Use of Competition Law

The use of competition law can be another effective mechanism to check medicine pricing abuses
on the markets. In 2002, Treatment Action Campaign launched a complaint against GSK and BI at
the South African Competition Bureau.25 The complaint was that the companies engaged in
excessive pricing of antiretroviral medicines. On 16 October 2003, the Competition Bureau found
that the respondents had contravened the Competition Act 1998 of South Africa by abusing their
dominant positions. In particular, the respondents were held to have hindered competitors from
having equal access to the markets and engaged in excessive pricing and in an exclusionary act. In
further reference to the Competition Tribunal, the Competition Bureau recommended: (1) the use
of compulsory licences to allow third parties to market generic versions of GSK’s and BI’s patented
medicines, in return for the payment of a reasonable royalty; and (2) a 10% penalty on GSK’s and
BI’s annual turnovers in South Africa for each year that they are found to have violated the Act.
These measures forced the two companies to the negotiating table. Eventually, the companies
agreed to license four generic companies to produce, import, sell and distribute antiretroviral
medicines to other countries in SSA (Hoen, 2009, p. 53).
The lesson from this South African experience is that anti-competitive practices or conditions
adversely affect trade and dissemination of technology. Therefore, countries in SSA that do not
have competition legislation and institutions to check anti-competitive practices need such
regulatory frameworks. Also, NGOs need to play an important watchdog role of working with
governments to tackle practices that stifle access to antiretroviral medicines. Such a move, as
happened in South Africa, can force pharmaceutical companies to agree to voluntary settlements.
In the South African situation, GSK and BI granted voluntary licences to both private and public
sector marketers in return for royalties below 5%.

Taking Advantage of Expired Pharmaceutical Patents/Setting Standards for Pharmaceutical Patents

This section combines two mechanisms that could be explored to promote access to antiretroviral
medicines in SSA. As indicated earlier, one way to reduce the cost of medicines is to promote the
generic manufacture of medicines whose patents have expired or are about to expire. Most of the
earlier patented combinations of antiretrovirals might fall within the category of medicines whose
terms have expired or are about to expire. In that case, countries must reject granting protection to
‘‘evergreen medicines’’ that do not involve new innovation (Smith et al., 2009, p. 686). By this, high
standards should be set to avoid granting patents to ‘‘me-too drugs’’—drugs that extend patent
duration without a significant improvement in their efficacy (Angell, 2004, p. 75). This means that
patent examiners should be trained to interpret patentability requirements strictly before granting
pharmaceutical patents (Heller, 2008, p. 76). India, for instance, has raised the criteria for
patentability so as to prevent ‘‘evergreen patents’’ from being registered.26 In this case, applicants
are made to establish to a high degree of certainty that the medicine for which an application for a
patent has been made is more effective than those already being used for the same condition
(Angell, 2004, p. 75). Another example is the recent challenge to sections of Brazil’s pipeline
mechanism that makes it possible for drug patents to be approved, based on the date of first filing
in a foreign country.27 These public-spirited initiatives make it harder for inventors to receive
pharmaceutical patents for ‘‘me-too’’ medicines.
Moreover, avenues should be provided for patent opposition proceedings during patent
application processes because the court processes tend to be more expensive. In India, section
3(d) of the Patent (Amendment) Act 2005 allows the public to bring evidence for patent rejection to
the attention of the patent controller. This remedial measure aided the Indian Network of People
Living with HIV/AIDS and the Manipur Network of Positive People successfully to oppose GSK’s

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patent application for zidovudine and lamivudine in 2006 on the grounds that the patent claim in
question was not for a new invention (Hoen, 2009, p. 78). Therefore, if a country such as South
Africa, with the world’s highest HIV infection rate, lacks a requirement for pre-grant opposition
proceedings, then its patent administration deserves a rethink. For Drahos (2010, pp. 37–8), patent
offices must push for high standards of disclosure in order to deter the filing of bogus applications
and thus promote the public spirit of the patent social contract. This will, however, require that
patent offices in SSA are resourced to improve their internal procedures for checking patent quality
(Drahos, 2010, p. 295).

Overcoming the Fear of Litigation/Targeted ‘‘Piracy’’

It is not always the case that once a patent has been granted, the patentee will opt to enforce it. A
case in point is the Myriad patents in Canada (Gold and Carbone, 2008). Although Myriad
genetics are protected in Canada, the Utah-based patent holder has not yet enforced the patents
against clinics that use the patented testing process. Presumably, the same situation will apply if
countries in SSA target the production of first-line antiretroviral medicines. The reason is that
pharmaceutical companies have already recouped significant profits from the first-line antiretro-
viral regimen and have now focused their attention on the more expensive second-line anti-
retroviral regimen. The fact that the pharmaceutical companies have focused their attention on
second-line antiretroviral medicines might have influenced the decision by the Dutch customs
officials to seize quantities of abacavir sulfate—a second-line antiretroviral medicine—bound for
Nigeria in 2008. It follows that pharmaceutical patent holders may be unwilling to litigate or adopt
harsh measures to stop the generic production of first-line antiretroviral medicines as compared
with the generic manufacture of second-line antiretroviral medicines.
Also, enforcing patent rights via domestic judicial systems in most countries in SSA may not be
lucrative. Indeed, no serious-minded pharmaceutical patent holder would like to use the Zimbab-
wean judicial system to litigate for patent infringement against the government. Additionally, the
fact that private patent holders lack legal standing before the WTO’s Dispute Settlement Board
will require aggrieved right holders to proceed through a WTO member state. In most cases, those
member states will weigh the economic harm and its international reputation and opt not to take
any action besides the usual rhetoric. Helfer succinctly expresses this point as follows:
Governments litigate only a subset of TRIPS disputes that rights holders bring to their
attention. In some cases a state may decline to file a complaint because it fears a WTO
countersuit. In others, it may refuse to do so because the probability of success is low or
because victory will only marginally benefit domestic industries. In still others,
geostrategic factors unrelated to trade or intellectual property may lead governments
to refrain from litigating (Helfer, 2008, p. 44).
This is a lacuna that developing countries in SSA should exploit to their advantage. Like ‘‘a
carcass that fears no knife’’,28 countries in SSA should not fear the threats of legal suits in
promoting targeted ‘‘piracy’’ for first-line antiretroviral medicines. This is because the fear of legal
suits can weaken the ability of domestic state agencies to adopt TRIPS-compliant laws with vast
latitude to promote access to affordable medicines for the masses.
Related to the above is the suggestion by Abbott (2005, p. 100) that in countries that face
significant health crises, a period of benign neglect in enforcing pharmaceutical patent rights might
also be encouraged. On the other hand, Merges and Kuhn (2009) suggest the use of ‘‘standards
estoppel’’, in which intentional non-assertion of a patent in the presence of its widespread violation
should create immunity from patent infringement. Even though this latter proposal is not likely to

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receive support within the WTO system, it provides a useful pro-access mechanism for domestic
judicial systems to explore.

Expanding the Scope of TRIPS Exclusion for LDCs

Currently, the TRIPS Agreement excludes LDCs from protecting or enforcing pharmaceutical
patents within their jurisdictions. Perhaps, the moratorium will need to be extended beyond the
2016 deadline because the current approach will not be able to address the myriad of problems in
most LDCs. Also, making a case for extension alone will not be enough meaningfully to integrate
those countries into the international trading system. According to Yu (2003, p. 135), ‘‘had the
level of intellectual property protection been adjusted to reflect the countries’ needs, interests, and
conditions, those transitional provisions in the TRIPS Agreement might not have been need’’.
LDCs, due to their lack of production capacities, depend on middle-income countries such as India
and Brazil in procuring generic medicines for their citizenry. But because Brazil and India are not
excluded from TRIPS obligations, the realization of the objective for excluding LDCs from
international obligations under TRIPS will remain unfulfilled.
By suggestion, countries that can supply sufficient antiretroviral medicines should be identified
and given ‘‘differentiated opportunity’’ to assist LDCs. In other words, the TRIPS-related
‘‘flexibilities’’ can effectively ameliorate the conditions in SSA if middle-income countries such
as India and Brazil are allowed to operate under a flexible drug-patent regime to assist the world’s
poor (Hoen, 2009, p. 62). This regime must target essential life-saving medicines, such as
antiretroviral medicines, that are sorely needed for human survival in the world’s poorest region.
The boundaries of these ‘‘life-saving medicines’’ have been delineated by the practice guidelines of
WHO and other international NGOs such as Médecins Sans Frontières.
Also, there are suggestions for the use of effective price discrimination to enable the large
pharmaceutical companies to charge a low price to Africans without lowering the price they charge
rich Westerners (Boldrin and Levine, 2008, p. 70). Differential pricing can support innovation into
antiretroviral drugs, while, at the same time, improving public access (Outterson, 2005, p. 195). In
addition, others have sagely argued for the adoption of south–south cooperation among developing
countries to implement the TRIPS ‘‘flexibilities’’ (Musungu et al., 2004). Indeed, paragraph 6 of the
‘‘August 30’’ Decision supports such initiatives for ‘‘harnessing economies of scale for purposes of
enhancing purchasing power for, and facilitating the local production of, pharmaceutical products’’.
A united stand is therefore required among regional economic blocs such as EAC, ECOWAS and
SADC to undertake such south–south cooperation. Because the majority of each union’s membership
is least developed, they should use bilateral/regional administration to aid in the importation of
generic antiretroviral medicines into their respective countries. This will, however, require strong
political will and determination from governments in SSA to counter powerful interest groups that
may want to frustrate such initiatives. It will also require building of industrial and human capacities
to facilitate the manufacture of medicines at cheaper rates in SSA. In addition, a state must weigh its
needs and technological capacity in order to find a blend of options (including those discussed above)
that can better facilitate access to medicines within its jurisdiction.
Most often, a lack of understanding of international obligations is the bane of policy makers in
overcoming access to medicine barriers in SSA. The contribution of this article is that it draws the
attention of policy makers in SSA to the need to take practical steps to implement the existing
TRIPS ‘‘flexibilities’’, no matter how inadequate they may be. The proposals herein can be
implemented through legislative and institutional reforms across countries in SSA. Implementation
must also be embodied in a domestic policy guide on access to medicines. This guide must set out
clear avenues to explore to promote access to medicines for impoverished populations.

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The proposed multifaceted strategy further illustrates the point that years of counter-
narratives relating to the negative impact of strict drug-patent frameworks have opened new
vistas for fresh dialogue over the effects of patents on access to medicines. Pharmaceutical patent
holders are beginning to accept the need for the injection of real flexibility into the commercializa-
tion of patented products and processes. This creates an avenue for policy makers in SSA to engage
the pharmaceutical patent holders further in order to make antiretroviral medicines accessible and/
or affordable to millions of people in their respective countries. Doing nothing about the challenges
that confront persons infected with HIV/AIDS in having access to medicines is not a viable option
to pursue in SSA.

Concluding Remarks
The fact that there are TRIPS ‘‘flexibilities’’ is hardly a novel idea in discourses on drug-patent
regulation. Yet, practical implementation of the ‘‘flexibilities’’ has eluded policy makers in SSA.
This article has therefore stressed that having elaborate provisions on the statute books do not in
themselves promote access to medicines unless those ‘‘flexibilities’’ are effectively utilized. It argues
for the exceptions built into the TRIPS Agreement, the Doha Declaration and the ‘‘August 30’’
Decision to be taken seriously. As a start, policy makers must take practical steps to implement and
exploit diverse regulatory mechanisms to promote access to antiretroviral medicines. It can be
undertaken via the development of a domestic pro-access guide, which emphasizes the use of
voluntary negotiations, compulsory licensing, scrapping of patent protection in LDCs, avoidance
of TRIPS-Plus obligations, public–private partnerships and the use of competition law, among
others. Such a diverse approach will provide the necessary breakthrough to enhance access to
medicines in SSA, and liberate countries in that region from being prisoners of their own patent
systems. Because countries have diverse backgrounds, a state may need to invoke more than one
strategy in tackling the HIV/AIDS quandary. Also, the above diverse regulatory mechanisms can
be used to aid in the procurement of medicines other than antiretroviral medicines.
Finally, the argument for the actualization of the above pro-access regulatory mechanisms is
hinged on the adage that ‘‘half a loaf is better than no bread’’. The article, however, does not
overlook the fact that post-TRIPS ‘‘flexibilities’’, which convinced optimists to conclude that a new
era of IP is emerging (Gold et al., 2008a), deserve further evaluation to inject real flexibility into the
prevailing international patent and institutional frameworks to make access to antiretroviral
medicines sustainable. It is only through such recalibration that we can safeguard the fundamental
right to health of the citizens of SSA. As Nnamuchi (2008, p. 10) aptly notes, ‘‘to contend that an
individual possesses the right to life in the absence of the ingredients necessary for its sustenance
(such as health care) is, on many levels, vacuous’’. For Sen (1999, p. 3), making healthcare services
available and/or accessible to persons infected with HIV will expand their capability and
substantive freedoms and make them more productive. Access to antiretroviral medicines will
also go a long way towards ameliorate crumbling healthcare systems and ensure sustainable human
development in SSA. The above suggestions resonate with Adam Smith’s (2003 [1776], pp. 110–1)
observation that ‘‘[n]o society can surely be flourishing and happy, of which the far greater part of
the members are poor and miserable’’.

About the Author

Poku Adusei, LL.B., B.L. (Ghana), LL.M. (Alberta), is a Lecturer at the Faculty of Law,
University of Ghana, and a Doctoral candidate at McGill Faculty of Law, Montreal, Canada;
e-mail: aduseipoku@hotmail.com

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Notes
I am extremely grateful to the Associate Editor of JWIP and the anonymous reviewers for their comments
on earlier versions of this article. I also thank the University of Ghana for the research grant support.
1 Sub-Saharan Africa comprises 48 developing and least developed countries. These countries are also
referred to as ‘‘less developed countries’’ in this article.
2 These statistics aside, malaria still remains the number one killer disease in SSA. This does not, however,
negate the possibility that the HIV/AIDS epidemic in SSA could surpass the threat of malaria in the near
future.
3 The TRIPS Agreement Annex 1C of the Agreement establishing the WTO, signed in Marrakesh,
Morocco on 15 April 1994, 33 ILM 81.
4 WTO General Council, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement
and Public Health, WT/L/540 (30 August 2003).
5 Article 27.1 of the TRIPS Agreement.
6 See part II of Ghana’s Patents Act 2003; article 27.3(b) of the TRIPS Agreement.
7 Article 39.3 of the TRIPS Agreement. The protection of data further disables generic producers from
entering the market until the end of the exclusivity period.
8 Article 28 of the TRIPS Agreement.
9 Paragraph 7 of the Doha Declaration. This deadline applies to pharmaceutical patents. For other
patentable products and processes, the deadline is 1 July 2013.
10 Article 27.2/27.3 of the TRIPS Agreement.
11 Article 31 and 31bis of the TRIPS Agreement.
12 WTO Doc. WT/MIN(01)/DEC/2, 41 ILM 755 (2001).
13 Article 31(f) of the TRIPS Agreement.
14 Government of Canada, Report on the Statutory Review of Sections 21.01–21.19 of the Patent Act 2007
hhttp://camr-rcam.hc-sc.gc.ca/index_e.htmli [Accessed May 2010].
15 See Integrating Intellectual Property and Development Policy (2002), Report of the Commission on
Intellectual Property Rights, Department for International Development, London. Available at hhttp://
www.iprcommission.orgi [Accessed May 2010]. On page 6, the report provides: ‘‘In particular, there are
no circumstances in which the most fundamental human rights should be subordinated to the requirements
of IP protection’’.
16 Admittedly, this voluntary licence became possible after the two pharmaceutical companies were found
‘‘guilty’’ by the South African Competition Bureau for abusing their dominant market positions.
17 Article 31(b) of the TRIPS Agreement.
18 See Article 6 of the TRIPS Agreement.
19 Paragraph 5(d) of the Doha Declaration.
20 Section 92(A) of the Indian Patent (Amendment) Act 2005.
21 See hhttp://www.achap.orgi [Accessed May 2010].
22 UNITAID is a 2006 collaborative initiative under the aegis of the WHO to scale up access to treatment
for HIV/AIDS, malaria and tuberculosis.
23 Article 31(f) of the TRIPS Agreement.
24 See ‘‘Members OK amendment to make health flexibility permanent’’. Available at hhttp://www.wto.org/
english/news_e/pres05_e/pr426_e.htmi [Accessed May 2010]. See hhttp://www.wto.org/english/tratop_e/
trips_e/amendment_e.htmi [Accessed May 2010] for a list of those countries that have now ratified TRIPS.
25 For a detailed narrative of this complaint, see Hoen, 2009, pp. 52–4.
26 See section 3(d) of the Indian Patent (Amendment) Act 2005.

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27 See articles 230 and 231 of Brazil’s Industrial Property Law 1996. On this challenge, see hhttp://www.ip-
watch.org/weblog/2008/01/22/challenge-raised-to-constitutionality-of-brazilian-pipeline-patents/i
[Accessed May 2010].
28 This is a Ghanaian proverb, which is literally interpreted to mean: ‘‘he who is down should fear no fall’’. This
point should, however, not be misinterpreted as advocating for a violation of international obligations.

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