Trade-Related Aspects Of Intellectual Property Rights Flexibilities Research Articles

Going It Alone or Acting as a Collective? Evaluating the East African Community Policy on Implementing TRIPS Obligations

AbstractThe grim realities of the COVID-19 pandemic have resuscitated discussions about the effectiveness of the flexibilities entrenched in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for improving access to medicines. This article revisits this vexed issue by examining whether a regional approach to implementing TRIPS obligations could deliver a better outcome for access, especially in low- and middle-income countries, where manufacturing capacity is almost non-existent. Using the East African Community (EAC) as a case study, the article critiques recommended implementation options under the EAC policy on TRIPS flexibilities, concluding that, if significantly implemented, these recommendations could yield a better outcome for access.

Trade-Related Aspects of Intellectual Property Rights Flexibilities and Public Health: Implementation of Compulsory Licensing Provisions into National Patent Legislation.

The protection of intellectual property (IP) rights, given international legal effect through the World Trade Organization (WTO) Trade-Related Aspects of IP Rights (TRIPS) Agreement, has long been a contentious issue. In recent years, the long-standing debate on IP rights as a barrier to the access of affordable medicines has been heightened by the global vaccine inequity evidenced during the COVID-19 pandemic. The TRIPS Agreement contains a number of flexibilities that WTO members can exploit in order to accommodate their policy needs. Among these is the mechanism of compulsory licensing, whereby patent licenses may be granted without consent of the patent holder in certain circumstances. TRIPS Article 31bis created a special mechanism for compulsory licenses specifically for the export of pharmaceutical products to countries with insufficient manufacturing capacity. We analyzed domestic patent legislation for 195 countries (193 UN members and two observers) and three customs territories. We analyzed patent legislation for provisions on compulsory licenses, including those defined in Article 31bis of the TRIPS Agreement. We identified 11 countries with no patent legislation. Of the 187 countries with domestic or regional patent laws, 176 (94.1%) had provisions on compulsory licensing and 72 (38.5%) had provisions implementing TRIPS Article 31bis. The results of this study have highlighted the gap in the implementation of TRIPS flexibilities in countries' national patent legislation, especially in least-developed countries. Although it will not fully solve patent barriers to the access of medicines, implementation of compulsory licensing (and specifically those for the import and export of pharmaceutical products) will provide governments with another tool to safeguard their population's public health. Further discussions are needed to determine whether the WTO can provide effective responses to future pandemics or global crises.

Lessons from India and Thailand for Cambodia's future implementation of the TRIPS Agreement for pharmaceutical patents

AbstractCambodia is expected to graduate from least developed country (LDC) status in the near future, at which time it will be required to make patents available for pharmaceutical products and processes to meet its obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Given its impending transition from LDC status, there is a need to balance Cambodia's intellectual property (IP) policies and regulations with public health priorities to ensure access to affordable life‐saving medicines. This will be critical to achieving universal health coverage, one of the United Nations' Sustainable Development Goals. This paper examines Cambodia's IP laws and regulations to identify provisions which could reduce access to affordable generic medicines when it starts to grant patents for pharmaceuticals. It systematically compares Cambodia's IP laws and regulations applicable to patents with those of Thailand and India—two developing countries which have had some successes in preserving access to medicines despite the introduction of pharmaceutical patents. It identifies lessons for Cambodia from the experiences of Thailand and India in implementing TRIPS and using TRIPS flexibilities such as compulsory licensing to ensure access to a sustainable supply of affordable generic medicines. India's experience of implementing TRIPS offers a practical and valuable lesson in applying TRIPS for the greatest public benefit. Thailand, although it has not utilised TRIPS flexibilities as extensively as India, also offers valuable lessons in adapting and interpreting IP law to ensure sustainable access to generic medicines, especially in relation to compulsory licencing. Key recommendations for reform for Cambodia include strengthening the use of preventive and remedial TRIPS flexibilities and removing criminal sanctions for patent infringements. Cambodia should reject any TRIPS‐plus provisions in its patent legislation, avoid membership of bilateral or plurilateral trade agreements that include TRIPS‐plus provisions and avoid signing patent treaties and agreements designed to facilitate the granting of patents.

From Necessity to Flexibility: A Reflection on the Negotiations for a TRIPS Waiver for Covid-19 Vaccines and Treatments

AbstractThis article critically examines the proposed waiver of intellectual property (IP) rights for COVID-19 vaccines under the World Trade Organization Agreement's Trade-Related Aspects of Intellectual Property Rights (TRIPS), which was initiated in October 2020 when the pandemic raged and vaccines were unavailable. However, the landscape has now changed and the waiver may no longer be necessary. The Outcome Document, introduced in the TRIPS Council in May 2022, along with Ministerial Decision of June 2022 recognizes this by focusing on easing the requirements to use TRIPS-flexibilities to accomplish wider and cheaper access. In so doing, the Ministerial Decision reinforces the notion that TRIPS flexibilities can be a useful part of the policy toolkit, even in times of crisis. After providing an overview of the context and outlining justifications for the waiver proposal, the article analyses and identifies key implications and possible effects of the Ministerial Decision. The article concludes that while the Document may not be a perfect solution to the issue of access to vaccines, flexible application of TRIPS-flexibilities is a better resolution in the current environment, especially given the need for further innovation to combat COVID-19 and future pandemics.

The COVID-19 Pandemic and the TRIPS Waiver: Patents and Flexibility

The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides for global minimum standard patents. These patents potentially limit access to products and processes for the surveillance, tracking, diagnosis and treatment of COVID-19. A possible solution currently under consideration is a TRIPS waiver of the implementation, application and enforcement for the prevention, containment or treatment of COVID-19. This article addresses the ways that TRIPS patents might be mediated including through TRIPS flexibilities. The article argues that there are sufficient means of derogating from patents (and potentially copyright, industrial designs and undisclosed information), although they alone will not resolve the access problems. The article concludes that the key patent problem is the transfer of know-how and that developing new ideas about addressing these patent know-how transfers is the presently unaddressed challenge.

TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines.

Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, the current medical R&D system requires significant trade-offs between innovation and high monopoly prices for patented drugs that restrict patient access to medicines. Since its implementation, few amendments have been made to the original TRIPS agreement to allow low- and middle-income countries (LMICs) to facilitate access by generic manufacturers through flexible provisions, such as compulsory licensing and parallel import. Although a useful policy tool in theory, the routine use of TRIPS flexibilities in LMICs in the procurement of new essential medicines (EMs) is regarded as a ‘last resort’ due to strong political response in high-income countries (HICs) and new trade agreements’ restrictions. In this context, access-oriented biomedical Public-Private Partnerships (PPPs) have emerged. More recently, leading multilateral health organizations have recommended different types of intellectual property (IP) interventions, voluntary biomedical patent pools, as strategies to reduce prices and increase the diffusion of novel EMs in LMICs. Nevertheless, the recent Ebola and COVID-19 outbreaks highlight growing concerns regarding the use of TRIPS flexibilities and the limited success of voluntary mechanisms in promoting access to medicines in the Global South amidst health crises. This review aims at describing the state-of-the-art empirical research on IP-related options and voluntary mechanisms applied by emerging PPPs to guarantee timely and affordable access to EM in LMICs and reflect on both models as access paradigms. Some suggestions are put forward for future research paths on the basis of these analyses and in response to contemporary debates on waiving key IP rights on COVID-19 therapies, diagnostics, and vaccines.

Vaccine nationalism and equitable access to COVID-19 pharmaceuticals: TRIPS Agreement under trial (again)

PurposeThe purpose of this study is to contribute towards the debate about global access to COVID-19 vaccines, therapeutics and diagnostics.Design/methodology/approachThe global scramble for COVID-19 vaccine and other related pharmaceutical products have once again exposed the limitations of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). High-income countries are claiming a lion’s share of the first available batches of the COVID-19 vaccine in total disregard of the consequences such approach would have on the low-income countries that lack both the manufacturing wherewithal and the financial resources to purchase the vaccine and other products needed to combat the pandemic. This paper reviews the existing TRIPS Flexibilities and analyses their limitations with respect to equitable access of pharmaceutical products in times of health emergencies. This paper then considers the unique challenges that have been brought to the fore by the COVID-19 pandemic. Finally, this paper analytically explores some options that have been proposed so far that the World Trade Organization (WTO) or governments can take in the immediate to near term to facilitate equitable access to COVID-19 pharmaceutical products and technologies. This research is non-empirical, desk-based research. It is, therefore, based on the literature review of existing body of work that is relevant to the topic under discussion. Mindful of the epistemological challenges that are always associated with desk-based research, part of the methodology of this work is to seek support from related empirical studies based on different philosophical underpinnings but that confirm the working hypothesis of this research.FindingsThis paper finds that there is still a need for a comprehensive reform of TRIPS Agreement to streamline the voluntary licencing system which is an important tool for low-income countries’ access to affordable pharmaceuticals. However, for purposes of dealing with COVID-19, WTO members should consider establishing pooled Licencing Facilities and procurement strategies via already existing political, economic or regional trade groupings.Originality/valueThis research is original. All sources have been acknowledged. This research synthesises different research papers and applies different viewpoints to the debate on the impact of the TRIPS Agreement on equitable access to COVID-19 vaccines, therapeutics and diagnostics.

The role of intellectual property rights on access to medicines in the WHO African region: 25\u2009years after the TRIPS agreement

BackgroundIt is now 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medicines, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by the Ebola and COVID-19 pandemics. The World Health Organization’s (WHO) mandate to work on the interface between intellectual property, innovation and access to medicine has been continually reinforced and extended to include providing support to countries on the implementation of TRIPS flexibilities in collaboration with stakeholders. This study analyses the role of intellectual property on access to medicines in the African Region.MethodsWe analyze patent data from the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI) to provide a situational analysis of patenting activity and trends. We also review legislation to assess how TRIPS flexibilities are implemented in countries.ResultsPatenting was low for African countries. Only South Africa and Cameroon appeared in the list of top ten originator countries for ARIPO and OAPI respectively. Main diseases covered by African patents were HIV/AIDS, cardiovascular diseases, cancers and tumors. Majority countries have legislation allowing for compulsory licensing and parallel importation of medicines, while the least legislated flexibilities were explicit exemption of pharmaceutical products from patentable subject matter, new or second use of patented pharmaceutical products, imposition of limits to patent term extension and test data protection. Thirty-nine countries have applied TRIPS flexibilities, with the most common being compulsory licensing and least developed country transition provisions.ConclusionsOpportunities exist for WHO to work with ARIPO and OAPI to support countries in reviewing their legislation to be more responsive to public health needs.

The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic

The structure of global intellectual property law as incorporated in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is implicated in the current lack of COVID-19 vaccines, medical equipment, medicines and diagnostics (hereafter, ‘health-technologies’), which are needed to combat the pandemic. Although equitable access to vaccines is in the moral, political and economic interests of the global public and requires global solidarity, the phenomenon of COVID-19 ‘vaccine nationalism’ has brought into sharp relief the misalignment of current legal and financial incentives to produce and distribute vaccines equitably. The crisis further demonstrates the failure of high-income countries (HICs) to realise the promise they made at the time of the TRIPS negotiations in 1994, that by agreeing to the terms of TRIPS, lower and middle-income countries (LMICs) would benefit from technology transfer and the building of productive capacity. As such, the current crisis is revealing not only of inadequacies of how to deal with global emergencies, but also of deficiencies within the international ‘patent bargain’ itself. This paper elucidates the legal issues surrounding the ‘TRIPS waiver’ proposal initially put forward by India and South Africa in October 2020, which, as of May 2021, is supported by more than 60 states, and which has received statements of support from the World Health Organisation (WHO). We analyse the different intellectual property rights relevant to the proposal – focusing primarily on patent rights and trade secrets – which are most relevant to the present COVID-19 vaccine context. We explain why the existing TRIPS flexibilities around compulsory licensing are incapable of addressing the present pandemic context adequately, both in terms of procedure and legal substance.The extent of the current health crisis posed by COVID-19 is as undeniable as the current global response is untenable. Given the ongoing absence of sufficient engagement by the pharmaceutical industry with proposed global mechanisms to share intellectual property rights, data and know-how to address the pandemic, we argue that mandatory mechanisms are needed. The TRIPS waiver is an essential legal instrument in this context for enabling a radical increase in manufacturing capacity, and hence supply, of COVID-19 vaccines, creating a pathway to achieve global equitable access. We make two arguments to this effect: first, the TRIPS waiver is a necessary and proportionate legal measure for clearing intellectual property (IP) barriers in a direct, consistent and efficient fashion, enabling the freedom to operate for more companies to produce COVID-19 vaccines and other health technologies without the fear of infringing another party’s IP rights and the attendant threat of litigation; and second, the TRIPS waiver acts as an important political, moral and economic lever towards encouraging solutions aimed at global equitable access to vaccines, which is in the wider interest of the global public.

Role of public health and trade for achieving sustainable development goals

The United Nations General Assembly adopted “2030 agenda” for Sustainable Development Goals (SDGs) with the objective of “transforming our world.” Provision of health and trade services is central in SDGs. This study focuses on broad objectives of public health and trade, which would significantly contribute to satisfying the health and trade‐related targets of the SDGs. The paper outlines the key provisions in recent trade agreements that constrain policy space for implementing universal health coverage. It focuses on actions of relevance to health innovations and access to health products with the contribution of health and trade policies. Regarding innovation, short‐term, mid‐term and long‐term measures are proposed concerning the General Agreement on Trade in Services, Agreement on Subsidies and Countervailing Measures and Agreement on Trade‐Related Aspects of Intellectual Property Rights (TRIPS). For intellectual property, four actions are proposed, which are empiric assessments; adoption of an integrated approach; intensive use of the TRIPS flexibilities and agreeing on the meaning of pharmaceutical innovation.

TRIPS Flexibilities on Patent Enforcement: Lessons from Some Developed Countries Relating to Pharmaceutical Patent Protection

Authority for national judiciaries to issue permanent and preliminary injunctions is required by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Articles 44 and 50. But the TRIPS Agreement does not require the issuance of injunctions in any particular circumstances, and does not harmonize the laws on which national jurisdictions derive their injunctive relief authorities. Thus, countries remain free to refuse prohibitory injunctive relief for adjudicated or likely patent infringement, particularly if “reasonable compensation” is offered in the form of an “ongoing royalty” or an “interim royalty” payment, which acts similarly to a compulsory license. This paper explains the existing legal standards for permanent and preliminary injunctions in the United States and Canada and discusses trends regarding the issuance or denial of injunctions for pharmaceutical patents in those jurisdictions (with occasional reference to other common-law jurisdictions). Although judges in these jurisdictions more routinely deny preliminary prohibitory injunctions, legislation linking generic pharmaceutical regulatory approvals to the patent system and imposing stays of such approvals normally avoid the need for such preliminary injunctions. Consistent with the TRIPS Agreement, developing country judges may make different choices, based on the ability to provide reasonable compensation for harms or based on a different weighing of the importance of assuring affordable access to medicines relative to providing innovation incentives.

The Trans-Pacific Partnership’s patent linkage: Unfriending or befriending the right to biologics?

The World Trade Organization brought Intellectual Property Rights into the multilateral trading system. The adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which formed part of the Agreement Establishing the World Trade Organization, established a minimum level of protection with respect to various forms of Intellectual Property Rights. However, in the aftermath of its adoption, several Free Trade Agreements, which include Intellectual Property Rights provisions of different potency, have come into existence. These Free Trade Agreements have given rise to what is commonly known as TRIPS-plus IP provisions. The provisions may renege on States’ obligation to promote access to biologics, medicines which are derived from proteins through biotechnological process. In this light, one recent Free Trade Agreement is the Trans-Pacific Partnership Agreement, which requires its Parties to implement a number of TRIPS-plus obligations, including data exclusivity and patent linkage. Against the aforementioned backdrop, this article focuses on patent linkage and explores whether the provision allows the Trans-Pacific Partnership Parties to utilize TRIPS flexibilities to promote the right to biologics. In doing so, the article provides potential responses to the question, does patent linkage deter the realization of the right to biologic? With the purpose to do so, while the first section provides a concise introduction into the agreement, the second section discusses the TRIPS standard on patent. While the third part demonstrates the nature of obligations enshrined in the Trans-Pacific Partnership’s rule on patent linkage, the fourth section investigates the obligations’ implication on the right to biologics. The last section provides the conclusion.

Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001-2016.

Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important.

THEORIES OF INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES IN THE SOUTHERN AFRICAN DEVELOPMENT COMMUNITY (SADC)

Despite the adoption of the World Trade Organization (WTO) Doha Declaration on the Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS) and Public Health in 2001, which unequivocally affirmed WTO members’ rights to use compulsory licences and other TRIPS flexibilities to access essential medicines, thirteen years on, developing countries and least developed countries are still grappling with access to medicines issues and a high disease burden. Despite some well-researched and eloquent arguments to the contrary, it is a trite fact that patents remain an impediment to access to medicines by encouraging monopolistic prices. In the Southern African Development Community (SADC), a number of possible solutions to the access to medicines problem, such as local manufacturing of pharmaceuticals, using compulsory licences, using parallel importation and investing in research and innovation, have been raised. This paper looks at the possibility of solving the SADC access-to-medicines problem through rewarding innovation and investment into diseases of the poor, by applying the rewards theory of patents. After an initial exposition of theories of intellectual property in general, the paper specifically looks at the rewards theory and contextualizes it to the SADC situation, and comes to the conclusion that the theory may point to one of the viable solutions to the access-to-medicines problem in the region.

TRIPS and the Balance between Private Rights and Public Well-being

Adherence to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) has had varied impacts across the world, and concerns of adverse effects on public well-being, especially in the context of the pharmaceutical sector, are largely debated. In this article, we analyze the effects of TRIPS on public well-being in the context of the pharmaceutical sector. We look at the policies of China, India and Brazil (three major players in the global pharmaceutical industry) and their usage of the TRIPS flexibilities. China, which has not used the TRIPS flexibilities, has benefited from technology transfer and foreign direct investment (FDI) in research & development (R&D). The need for FDI in R&D in India and Brazil as potential destinations for research on neglected tropical diseases (NTDs) is brought out. We conclude that the effects of TRIPS on public well-being are critical for countries which do not have the ability to use the flexibilities. At a time when trade and investment treaties are mostly aimed at stricter commitments on intellectual property rights (IPR) than TRIPS, such countries need to negotiate appropriate investment and knowledge-sharing commitments from their developed counterparts so as not to be adversely affected by agreeing to demands on bending IPR laws.

Brazil's implementation of TRIPS flexibilities: ambitious missions, early implementation, and the plans for reform

The flexibilities introduced in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement were aimed at providing the developing countries with the option to adopt suitable measures to address access to patent-protected pharmaceutical products. The flexibilities include the grant of compulsory licences, exceptions to the exclusive right conferred by patent, allowing for parallel imports, and defining the criteria of patentability to achieve the goal of public health. While these flexibilities are available to all developing countries, only a few have implemented the flexibilities into their patent legislation. This paper examines the TRIPS compliant patent laws introduced in Brazil in the post-TRIPS era. It will be argued that the TRIPS Agreement was implemented too soon in Brazil, and the TRIPS flexibilities, although available had not been fully utilised due to pressure from transnational pharmaceutical corporations backed by developed countries, fear of exclusion from major trading blocs, and also due to a gap in the knowledge economy. It will also be argued that the World Trade Organization did not create a level playing field in the TRIPS negotiation in the lead up to the entry into force of the Agreement in 1995, which effectively handed over the advantage to the developed countries, thereby creating a two-tier system in the intellectual property rights arena and making it impossible for developing countries and least-developed countries to achieve the objective of access to affordable medicines.

The make or buy debate: Considering the limitations of domestic production in Tanzania

BackgroundIn order to ensure their population’s regular access to essential medicines, many least developed countries and developing countries are faced with the policy question of whether to import or manufacture drugs locally, in particular for life-saving antiretroviral medicines for HIV/AIDS patients. In order for domestic manufacturing to be viable and cost-effective, the local industry must be able to compete with international suppliers of medicines by producing sufficiently low cost ARVs.MethodsThis paper considers the ‘make-or-buy’ dilemma by using Tanzania as a case study. Key informant interviews, event-driven observation, and purposive sampling of documents were used to evaluate the case study. The case study focused on Tanzania’s imitation technology transfer agreement to locally manufacture a first-line ARV (3TC + d4T + NVP), reverse engineering the ARV.ResultsTanzania is limited by weak political support for the use of TRIPS flexibilities, limited production capacity for ARVs and limited competitiveness in both domestic and regional markets. The Ministry of Health and Social Welfare encourages the use of flexibilities while others push for increased IP protection. Insufficient production capacity and lack of access to donor-financed tenders make it difficult to obtain economies of scale and provide competitive prices.ConclusionsWithin the “make-or-buy” context, it was determined that there are significant limitations in domestic manufacturing for developing countries. The case study highlights the difficulty of governments to make use of economies of scale and produce low-cost medicines, attract technology transfer, and utilize the flexibilities of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The results demonstrate the importance of evaluating barriers to the use of TRIPS flexibilities and long-term planning across sectors in future technology transfer and manufacturing initiatives.

The Dog that Barked but Didn’t Bite: 15 Years of Intellectual Property Disputes at the WTO

Hope as well as fear was running wild when in 1995 the multilateral trading system incorporated the protection of intellectual property (IP) rights. As one author put it, “the [IP] component of the WTO [World Trade Organization] Agreement represented a revolution in international intellectual property law.” This article provides a reality check 15 years after the fact with a particular focus on how the WTO performed in terms of settling IP disputes under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It compares conventional expectations associated with the creation of TRIPS and WTO dispute settlement to (i) the number and types of TRIPS disputes actually filed and decided, (ii) institutional and substantive decisions and interpretations reached by WTO panels and the Appellate Body in their application of the TRIPS agreement and, finally, (iii) the status of implementation of adverse WTO rulings under TRIPS. The article offers a number of hypotheses that may explain these descriptive results centered on (i) the rather unique features of WTO dispute settlement, (ii) the TRIPS Agreement itself as compared to other trade agreements and (iii) an escalating cycle of IP-skepticism, due in no small part to the hard-line position taken by many IP industries themselves, and culminating in the 2001 Doha Declaration on TRIPS and Public Health which confirmed and slightly expanded TRIPS flexibilities in the context of the access to essential medicines debate. The core message of this article is that based on 15 years of operation both the hopes and fears traditionally linked to TRIPS and WTO dispute settlement, not just in 1995 but to this day, were and continue to be largely exaggerated. TRIPS as conventionally portrayed by many is in this sense “the dog that barked but did not bite”. A caveat to this core message is, however, that it says something about the role and impact of formal dispute settlement under TRIPS, less about the broader changes brought about by the TRIPS agreement, in particular, sweeping (and often costly) legislative amendments in many developing countries, monitoring through the TRIPS Council and bargaining “in the shadow” of TRIPS both to weaken and to strengthen global IP protection (be it in the Doha Declaration on TRIPS and Public Health, certain preferential trade agreements, WIPO or the WHO).

Soaring antiretroviral prices, TRIPS and TRIPS flexibilities: a burning issue for antiretroviral treatment scale-up in developing countries

The achievement of significant reductions in the price of antiretroviral drugs constitutes one of the main economic pillars of antiretroviral treatment scale-up in developing countries. Today this economic pillar is threatened. The prohibitive prices of newer first-line and second-line regimens have created a watershed in relation to the prices of earlier first-line treatments. These price increases are closely related to the World Trade Organization's Agreement on the trade-related aspects of intellectual property rights (TRIPS) that imposes an important barrier to generic competition. Intellectual property flexibilities foreseen by the TRIPS agreement allow the manufacture and supply of affordable generic versions of new generations of antiretroviral under certain conditions. However, the capacity to supply a specified list of generics under such conditions is tight and the utilization of such flexibilities in their current form remains complex and unattractive. The TRIPS agreement currently constitutes a significant barrier to providing access to new antiretroviral at affordable prices in developing countries. If the debate on initiatives for increased flexibility of intellectual property rights does not become more extensive or obtain the overwhelming support of the international community, serious consequences are to be expected in terms of the fight against AIDS in most of the developing countries.

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

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.