Unfettered Consumer Access to Affordable Therapies in the Post‐TRIPS Era: A Dead‐End Journey for Patients? Kenya and India Case Studies

• Date: 01 May 2010
• Author: Brenda Pamela Mey
• DOI: http://doi.org/10.1111/j.1747-1796.2009.00392.x
• Published date: 01 May 2010

Unfettered Consumer Access to Affordable

Therapies in the Post-TRIPS Era: A Dead-

End Journey for Patients? Kenya and India

Case Studies

Brenda Pamela Mey

Ludwig-Maximilians University of Munich

Increasing access to essential medicines has become an international priority, given the rapid

spread of intractable diseases such as HIV/AIDS, tuberculosis and malaria. It follows that

the quests to improve the global quality of healthcare and achieve health equity present a

challenge for many countries, especially those that have been hard hit by deadly pandemics

and whose populations are also still without essential drugs. Consequently, many countries

have stepped up efforts to remove the obstacles to the availability and affordability of

essential medicines. The Agreement on Trade-Related Aspects of Intellectual Property Rights

(TRIPS) contains f‌lexibilities that can be used as tools for enhancing access to cheap

medicines and for controlling drug pricing. However, these f‌lexibilities are not necessarily

a panacea and cannot singly solve the problem of limited access to essential medicines. Put

differently, cheaper medicines cannot reach the poor without the infrastructure to deliver

them. For this to become a reality, commitment on the part of the member countries to adopt

comprehensive and cooperative measures to tackle the burdensome barriers that limit access

to critical medicines is needed. It is only then that the f‌lexibilities in TRIPS can be optimized

and a real difference made in the lives of poor patients across the developing world.

Keywords TRIPS; Kenya; India; access to medicines

Introductory Comments

The emergence of new forms of knowledge has completely changed the global

intellectual property (IP) landscape. These changes have forced countries to

streamline their IP policies and laws to mirror the international standards of

protection and enforcement required by the key international treaties regarding

IP. It is, nevertheless, the promulgation of the Agreement on Trade-Related Aspects

of Intellectual Property Rights (TRIPS) (World Trade Organization [WTO], 1994)

in 1994 that was the real catalyst for change of IP systems in most developing and

developed countries. TRIPS greatly increased the responsibility of the WTO

member governments to enact clear and enforceable IP laws at the national level

that would enable them not only to comply with international standards governing

the use, the protection and the enforcement of intellectual property rights (IPRs)

but also to step up efforts to remove the major obstacles that limit the availability

and affordability of the essential medicines. Indeed, for most WTO developing

The Journal of World Intellectual Property (2010) Vol. 13, no. 3, pp. 403–473

doi: 10.1111/j.1747-1796.2009.00392.x

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member states, such as Kenya and India, whose populations still do not have

regular access to essential drugs, improving access to and affordability of essential

medicines has given rise to the rapid and devastating dilemma presented by diseases

such as HIV/AIDS, tuberculosis and malaria, and other intractable infectious

diseases, which have become the main priority (Bansal et al., 2009, p. 300). Bearing

in mind the foregoing, this comparative study analyses, in the next few paragraphs,

some of the issues surrounding access to the affordability and availability of

essential medicines in the post-TRIPS era. In so doing, the next section of the

article begins by outlining the basis for the comparative study, and is followed by a

review of the history of patent laws in Kenya and India. The following section

analyses the Doha Declaration on the TRIPS Agreement and Public Health (as the

Declaration) (World Intellectual Property Organization [WIPO], 2001) as an

international strategy for improving access to medicines. In ‘‘Extant Laws in Kenya

and India Allowing Access to Essential Drugs’’ and ‘‘Other Strategies for Gaining

Access to Life-saving Drugs’’, the extent to which Kenya and India have made use

of the f‌lexibilities in TRIPS as conf‌irmed by the Declaration and the Decision of the

General Council of 30 August 2003 on the Implementation of paragraph 6 of the

Declaration (the Decision) (WTO, 2003) to secure affordable access to essential

medicines is thrashed out. The section ‘‘India Plugged into the TRIPS Fold’’

discusses some of the key amendments to the Indian patent law, analyses their

implications and the resulting court dispute between Novartis and India. The

section ‘‘Suggestions for Health Reforms in Kenya’’ puts forth an argument to

the effect that the limited availability and affordability of life-saving medicines

cannot be explained away merely by the f‌laws in TRIPS, the Declaration or the

Decision. It is maintained that there are other factors that have contributed to this

problem. These factors are discussed, and some practical suggestions that could

help strengthen the patent regimes in Kenya and India and improve access to the

essential medicines in both countries are put forward. The conclusion emphasizes

the need to remove the legal, economic and administrative barriers to the accessi-

bility and affordability of life-saving medicines, and to prepare for the new

challenges likely to be presented by the post-2005 scenario. 1 January 2005 marked

the end of the transitional period given to developing countries to comply with the

TRIPS.

Why a Comparative Study of Kenya and India?

The comparative components of this study are based on several premises. First, in

comparison with the pharmaceutical industries in other developing countries such

as Kenya, the Indian pharmaceutical industry is the largest and most advanced, and

is ranked fourth in terms of volume, and thirteenth in terms of value in the global

market. The Indian pharmaceutical industry has come a long way from importing

almost every type of drug from global players to breaking grounds in the medical

research history by making bulk drugs for almost all therapy segments (Saranga

and Phani, 2009, pp. 2–4). Using the copycat technique of reverse engineering,

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Unfettered Consumer Access to Affordable TherapiesBrenda P. Mey

process patents and price controls, as well as through the implementation of good

manufacturing practices among other strategies, India succeeded in producing

quality generic versions of almost every new drug developed in other parts of the

developed world, and exporting them to over 65 countries including Kenya.

Moreover, the manufacture of generic versions of patented medicines enabled India

to compete with other pharmaceutical companies not just in India but also abroad,

and resulted in good revenues (Mueller, 2007b, p. 542). However, in accordance

with articles 65 and 66 of TRIPS, January 2005 marked the end of the transition

period granted to developing countries such as India to comply with the provisions

of the agreement on product patents for pharmaceutical inventions. It should be

noted, however, that the introduction of product patents in countries such as India

does not mean that the generic competitors who had offered strong price competi-

tion in the past through the manufacture of cheaper generic versions of branded

drugs cannot continue producing these kinds of drugs. The Decision, as will be seen

later, waived among other things WTO member states’ obligations under article 31.f

of TRIPS, thereby making it possible for generic copies of medicines specif‌ically

made under compulsory licences to be exported to countries with inadequate drug-

manufacturing capacity. The Decision is yet to be ratif‌ied by two-thirds of the WTO

member states, and, as such, is still in force. In effect, this means that the production

of generic versions of drugs patented in developed countries can continue under the

Decision for as long as the importing and exporting countries comply with the

conditions and procedures listed for issuing compulsory licences (Sampath, 2006,

p. 695). Second, although Kenya and India were former British colonies, they were

operated under very different social, political and legal conditions. Nevertheless,

they inherited every item of governance including parliamentary democracy and

civic administration, and their entire common law legal systems (IPRs legislations

and practices included) from their colonial ruler Britain. The result of this colonial

legacy was not only similarities between the IP laws in both countries but also an

interesting panoply of differences in the content, legislative format and the

numbering of the provisions of their IP and other laws (Worku, 1990, pp. 38–42).

As an example, before the coming into force of Kenya’s Industrial Property Act

1989 (IPA 1989), (WIPO Collection of Laws for Electronic Access [CLEA], 1989)

and the Industrial Property Act No. 3 2001 (IPA 2001) (Kenya Law Reports [KLR],

2001), Kenya had an IP system that was not just wholly dependent on the British

patent system, but that also remained unrevised for several years. Additionally, as

far as the domestic innovators were concerned, the IP system represented a tool for

importation of foreign IP into Kenya for use by British nationals. They further

contended that the British patent system contained hardly any provisions for the

protection of the rights of Kenya’s industrial property owners or for the evaluation

of patentable works that were created in the country (Nyakundi and Mnjama,

2007). Similarly, India, whose IP laws, similar to Kenya’s, also mirrored Britain’s,

inherited a colonial product patent system dating back to 1856, which was

eventually replaced by the Indian Patents Act 1970 (Apfelthaler et al., 2008,

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Unfettered Consumer Access to Affordable Therapies Brenda P. Mey