Your World of Legal Intelligence
 United Kingdom | +44 (0) 20 7284 8080

Revisiting the Trips Regime: Rwanda-Canadian ARV Drug Deal ‘Tests’ the WTO General Council Decision

Document Cited authorities 3 Cited in Related
Vincent
Published date01 September 2009
DOI10.3366/E0954889009000395
Pages240-269
AuthorRebecca Amollo
Date01 September 2009

On 17 July 2007, the world was awakened to Rwanda's notification of the World Trade Organisation's (WTO) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) that it plans to import the HIV-drug TriAvir from Canada's giant pharmaceuticals company, Apotex. Two months later, Canada issued a compulsory licence allowing Apotex to use nine patented inventions for manufacturing and exporting TriAvir to Rwanda. On 4 October 2007, Canada notified the Council for TRIPS of the compulsory licence. In September 2008, Apotex said it will ship seven million antiretroviral pills to Rwanda to treat 21,000 patients. Against this backdrop, this article uses the Rwandan–Canadian drug deal to examine the utility of the WTO General Council Decision in making ARV drugs more accessible to Low and Middle Income Countries so far. In doing so, the article's analyses rely on the regime of the Canadian Access to Medicines Regime which was enacted after the WTO Decision. The author discusses some of the issues arising from the deal in light of the effectiveness of the General Council Decision in solving the problem of access to antiretroviral drugs within the right to health and HIV/AIDS context. The article also raises questions relating to the willingness of developing countries to take benefit of the TRIPS flexibilities and the obligation of developed countries to ensure that the flexibilities become a reality.

INTRODUCTION

When Rwanda announced its intention to import generic drugs from Canada, Stephen Lewis, had this to say:

This is a significant step…Forgetting all the negotiations and shenanigans over the last few years, we can begin to save lives. That is what is crucial.1

Medical News Today, ‘GSK Gives Consent to Canadian Drug Company to Manufacture Generic Antiretroviral For Rwanda’. Available at http://www.medicalnewstoday.com/articles/79445.php. Stephen Lewis is the former United Nations Special Envoy for HIV and Aids in Africa. 17 July 2007. Accessed 21 August 2008.

He also said elsewhere

The logjam has been broken …by the government of Rwanda's request for the Canadian generic drug. It is very dramatic and very important because the dream of this legislation …was that it would save lives. That's what it was all about, that Canada would produce the generic drugs that would allow countries to keep their citizens alive.2

M. Rimmer, ‘Race against Time: The Export of Essential Medicines to Rwanda’ Public Health Ethics (2008): 89–103: 14.

The saying goes that if one cannot invent, at least one can copy. For many sub Saharan countries, copying technologies for producing antiretroviral treatment (ARVs) remains a distant aspiration. Africa constitutes about 10 per cent of the world's population but is home to over 70 per cent of the people living with HIV.3

UNAIDS, Report on the Global AIDS Epidemic (Geneva, UNAIDS 2008).

In 2006, it was estimated that approximately 2 million people were reported to have lost their lives as a result of HIV/AIDS related illness.4

Ibid.

Women have been the worst hit by the epidemic, constituting about 50 per cent of the world infection rate and about 60 per cent of the total rate in Africa.5

Ibid.

In many African countries, access to treatment and care for people living with HIV remains a great challenge. Of the approximately 4.6 million people in need of treatment, only about 23 per cent of them are receiving it in the region.6

Ibid.

 The problem is not limited to HIV/AIDS alone. Other diseases such as tuberculosis and malaria continue to pose great threats to lives on the continent

There is a stark disparity in access to pharmaceutical products between dev eloped and developing countries. Developing countries make up approximately 80 per cent of the world's population but only represent approximately 20 per cent of global pharmaceutical consumption.7

J. C. Cohen, M. Gyansa-Lutterodt, K. Torpey, L. C. Esmail and G. Kurokawa, ‘TRIPS, the Doha Declaration and Increasing Access to Medicines: Policy Options for Ghana’, Globalization and Health (2005): 1–17.

Transnational corporations own approximately 90 per cent of technology and product patents in the world, and up to 80 per cent of technology and product patents in developing countries. This persisting inequity has been attributed to lack of resources, skill inadequacy, market failures, high drug costs, weak or corrupt institutions, government failures and income differences.8

M. R. Reich, ‘The Global Drug Gap’, 287 Science (2000): 1979–81.

All these factors combined result in less than effective pharmaceutical purchasing and distribution systems thus impeding availability of ARVs. One of the issues attending accessibility to ARVs within the context of many sub Saharan countries is the intellectual property regime. The regime of the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement has been widely criticised for further impeding access to ARVs.9

The TRIPS Agreement is Annex 1C of the Marrakesh Agreement Establishing the World Trade Organisation, signed in Marrakesh, Morocco, on 15 April 1994.

Availability within the context of HIV/AIDS has been argued to entail life saving drugs, procurement strategies of ARVs, and financing the extending initiatives.10

D. Mushayavanhu ‘The Realisation of Access to HIV and AIDS-Related Medicines in Southern African Countries: Possibilities and actual Realisation of International Law Obligations', in F. Viljoen and S. Precious (eds), Human Rights Under Threat: Four Perspectives on HIV, AIDS and the Law in Southern Africa, PULP (2007), p. 127.

The point has been advanced in the same vein that failure to innovate, transfer technology, produce, procure and import drugs are some of the major barriers attributed to availability of medicines.11

ibid.

 It has further been argued that improving and sustaining access to antiretroviral treatment (ARVs) by people living with HIV/AIDS (PLWHAs) is a practical way to strengthen HIV prevention, care, treatment and support. This position has received support from several circles including at the international human rights law level where the UN Committee on Economic, Social and Cultural Rights (CESCR Committee), the body charged with the responsibility of interpreting and monitoring the treaty, has elucidated on what access to medicines means within the right to health.12

See General Comment 14 2000, ‘The Right to the Highest Attainable Standard of Health’ (art. 12 of the Covenant) UN Committee on Economic, Social and cultural Rights. Twenty-Second session), U.N. Doc. E/C.12/2000/4 (2000).

 This will be dealt with later in this paper. Against this backdrop, this paper argues, inter alia, that since most countries in the sub Sahara continent are not yet able to produce ARVs locally, at the very minimum, states must make effort to procure their availability to their citizens. This duty is accompanied by the obligation of the international community to cooperate in this bid. This paper uses the recent Rwanda-Canadian drug deal to illustrate some of the issues surrounding this bid, especially under the WTO TRIPS system. The paper highlights some of the issues arising from the deal that could be considered in assessing the utility of the WTO Decision in making ARVs more accessible to Medium and Low Incomes Countries (LMICs), especially those in sub Saharan Africa. Some of the critical questions arising within this debate include: without the capacity to produce ARVs, what should a sub-continent threatened by an epidemic do in order to make available AIDS drugs? Does the Canadian Access to Medicines Regime represent a beacon of hope in this regard? Do the TRIPS regime and its subsequent modifications offer any real solutions to least developed countries particularly in sub Saharan Africa? The paper concludes that the WTO system is neither expeditious, nor a solution because of the unnecessary rigours accompanying its procedures. In the same vein, the paper critiques the Canadian Access to Medicines law, and makes some recommendations in that regard ACCESS TO ARVS: THE DUTY TO PRODUCE AND PROCURE AS A COMPONENT OF THE RIGHT TO HEALTH

The right to health has been dogged with definitional difficulty. Historically, health care systems were developed on a curative or clinical model of health. However, recently, advances in epidemiological research have sensitised policy and law makers to the importance of public health interventions and preventive strategies of health promotion.13

See generally, A. R. Chapman and S. Russell (eds), Core Obligations: Building a Framework for Economic, Social and Cultural Rights, Intersentia (2002).

It can however be argued that such definitional problems attend all human rights and particularly those affirming economic, social and cultural human rights. Different terms have therefore been used to describe rights concerning health care.14

B. Toebes The Right to Health as a Human Right in International law, Intersentia (1998); B. Toebes The Right to Health in International Law, Intersentia-Hart (1999), pp. 22–4; B. Toebes ‘Towards an improved understanding of the international human right to health’, 21 Human Rights Quarterly (1999): 661–3 in C. Ngwena and R. J. Cook, ‘Rights Concerning Health’, in D. Brand and C. H. Heyns (eds), Socio Economic Rights in South Africa, Pretoria University Law Press (2005). See a criticism of a ‘right to health’ as opposed to a ‘right to health care’ in R. Macklin, Against Relativism: Cultural Diversity and the Search for Ethical Universals in Medicine, Oxford University Press (1999), p. 235.

 The terms ‘right to health’, ‘right to health protection’ or ‘ right to health care’ have all been advanced as sufficiently conveying the notion of entitlement to the protection of health and the provision of heath care under international law and domestic legal systems.15

There appears to be no necessary conflict between the terms ‘right to health’, ‘right to health...

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT