A fair deal for the future: flexibilities under TRIPS.

Developing countries are failing to make full use of flexibilities built into the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to overcome patent barriers and, in turn, al low them to acquire the medicines they need for high priority diseases, in particular, HIV/AIDS. First-line antiretroviral (ARV) drugs for HIV/MDS have become more affordable and available in recent years, but for patients facing drug resistance and side-effects, second-line ARV drugs and other newer formulations are likely to remain prohibitively expensive and inaccessible in many countries. The problem is that many of these countries are not using all the tools at their disposal to overcome these barriers. Medicines protected by patents tend to be expensive, as pharmaceutical companies try to recoup their research and development (R&D) costs. When there is generic competition prices can be driven down dramatically. The TRIPS Agreement came into effect on 1 January 1995 setting out minimum standards for the protection of intellectual property, including patents on pharmaceuticals. Under that agreement, since 2005 new drugs may be subject to at least 20 years of patent protection in all, apart from in the least-developed countries and a few non-WTO Members, such as Somalia. Successful AIDS programmes, such as those in Brazil and Thailand, have only been possible because key pharmaceuticals were not patent protected and could be produced locally at much lower cost. For example, when the Brazilian Government began producing generic AIDS drugs in 2000, prices dropped. MDS triple-combination therapy, which costs US$10 000 per patient per year in industrialized countries, can now be obtained from Indian genetic drugs company, Cipla, for less than US$ 200 per year. q-his puts ARV treatment within reach of many more people. Several newer AIDS drugs and formulations of existing drugs are urgently needed in developing countries but are not available because pharmaceutical companies are choosing not to sell them, and no generic versions of these are available. For example, there is a new formulation of the ARV combination therapy lopinavir/ritonavir, which unlike its predecessor does not need refrigeration. This would be useful in Africa, where temperatures are high and electricity supplies irregular, but Medecins Sans Frontieres (MSF) says it is not available there at all. Another example is Gilead Sciences' Tenofovir, a brand-name drug which has significantly fewer side-effects than some older ARVs and was added to WHO's list of prequalified medicines, recommended for UN agencies to purchase for use in developing countries. Tenofovir is, however, virtually unavailable in Africa although it can be an effective second-line ARV, according to Ellen 't Hoen, Director of Policy and Advocacy at MSF. Most AIDS patients eventually need to switch to second-line treatment because of side-effects and drug resistance. However, according to MSF, while the US company has announced a price of US$ 208 per person per year in 97 countries, the product is only registered in 10 of those. Many developing countries cannot pay the normal price for this drug. For example, in Brazil it is US$ 2600 per patient per year and that is the price for just one of three drugs in combination treatment. Following the TRIPS Agreement, there was growing concern and evidence that patent rules might restrict access to affordable medicines for people in developing countries, particularly for HIV/MDS, tuberculosis and malaria. "Ibis led to the November 2001 Doha Ministerial Declaration which stated: "The (TRIPS) Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all." The Declaration refers to a number of flexibilities, including the right to grant compulsory licences and to permit parallel importation (see box). …

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

Using a doctrinal legal research approach, this paper analyzes the legal framework governing patents in Tanzania to evaluate its effectiveness in leveraging the opportunities provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to support public health. The findings reveal that Tanzania does not fully capitalize on the public health-related flexibilities within the TRIPS Agreement. Notably, it omits key public health-sensitive flexibilities, such as the transitional period and the Bolar exception, which are critical for promoting public health. The paper highlights that Tanzania undermines its public health interests by failing to fully exploit the relevant TRIPS flexibilities. Therefore, it is recommended that Tanzania seize the opportunities presented by the TRIPS Agreement by temporarily excluding medicines from patent protection while developing comprehensive patent legislation that incorporates all available options relevant to public health concerns.

The adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) represented a global solution to the concerns of protecting intellectual property rights (IPRs). To many, however, the TRIPS approach to globalizing the higher standards of intellectual property has raised some in-built controversies. The major controversy surrounding TRIPS is directed at its ramifications of disregarding the ‘North–South divergent perspective’ on the scope of protecting IPRs. During the TRIPS negotiations, the IPR-using developing and least developed countries (LDCs) vigorously protested against the uniform and strict IPR protection under TRIPS by arguing that such stringent standard-setting would harm their development prospects. Interestingly, the drafting of TRIPS reconciled such concerns by including a range of safeguards and options that World Trade Organization (WTO) members can exploit in their implementation of the Agreement. The conclusion of TRIPS thus results in pushing the developing countries and LDCs to what Carolyn Deere, a Senior Researcher at the University of Oxford's Global Economic Governance Programme calls ‘a second battle’, ie the battle of exploiting the flexibilities of the TRIPS.

Vaccine apartheid: global cooperation and equity

The Iranian government is working to develop its national intellectual property (IP) law to engage with the international IP system, prepare for membership of the WTO, and fulfil its obligations under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Joining the WTO – even at the same level of obligation as current Members – may require a substantial adjustment in national law and corresponding industrial policy. The impact of bringing national law into baseline or ‘normal’ TRIPS Agreement compliance should not be underestimated. Compared to the TRIPS Agreement, Iran’s IP system is far from compliant. A number of items required in TRIPS are not yet protected in Iran. Even for items covered by law in Iran, many are not in compliance with TRIPS. To comply with TRIPS, Iran has a challenging agenda of reform.

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) established the first multilateral understanding of what constitutes a standard for ‘adequate’ and ‘effective’ protection of intellectual property rights, and established a new mechanism for monitoring and reviewing how these standards are met. The policy and legal framework defined by the TRIPS Agreement has, in the two decades since it entered into force, progressively gained acceptance as a legitimate, balanced and transparent set of standards. Since then, however, two parallel sets of negotiations have revisited the standards defined by TRIPS: the multilateral WTO accession negotiations, and bilateral and regional trade negotiations outside the WTO. In each case, TRIPS standards have been further elaborated, and timelines for their implementation altered, in a manner that produces a layering of rules upon the foundation of TRIPS. However, the institutional, legal and policy implications of these two lines of development contrast sharply. This chapter reviews the main lines of development of rules relating to intellectual property in the accession processes, and contrasts these with the parallel developments outside the WTO. It concludes with an analysis of the policy and practical lessons that can be derived from contrasting these two processes.

The Uruguay Round of Multilateral Trade Negotiations concluded in 1994 with the signing of around 60 agreements, annexes, decisions, and understandings including the umbrella agreement that established the World Trade Organization (WTO 2010). Besides establishing a framework for dispute settlement and trade policy reviews, the agreements covered the following major areas. The General Agreement on Tariffs and Trade (GATT) that existed since 1947 was brought under the WTO. The Agreement on Trade-Related Investment Measures (TRIMs) and the General Agreement on Trade in Services (GATS) were signed as a part of the deal to establish the WTO. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) became a foundation block for the WTO (Maskus 2000b). The TRIPS agreement sets minimum standards for intellectual property protection in all member countries. In recent years, regional and bilateral agreements on investment, free trade, and other disciplines have forced developing countries to raise protection standards for intellectual property beyond what is required under TRIPS. These higher protection standards, known in the literature as TRIPS-plus conditions, restrict access to medicines and jeopardise public health in developing countries (Malhotra and Grewal 2008). The Intergovernmental Working Group on Public Health, Innovation and Intellectual Property calls for ensuring that bilateral trade agreements do not incorporate TRIPS-plus provisions that reduce access to medicines (WHO 2006a).

Trade, TRIPS, and pharmaceuticals

This paper analyzes the main economic issues of intellectual property rights (IPRs) protection in the context of the World Trade Organization (WTO). A retrospective view on the establishment of the TRIPS (trade-related aspects of intellectual property rights) Agreement, a still controversial accomplishment of the Uruguay Round of trade liberalization, is provided. The paper reviews the economic rationale for the harmonization of IPRs, drawing both on economic theory considerations as well as emerging empirical evidence. The logic of linking IPR protection and trade in the context of the WTO is also re-examined. Some specific attention is devoted to the implications of TRIPS for agricultural and biotechnology innovations. The impact that IPR protection can have in promoting growth and development, and the relation of IPRs with other economic policies, is discussed. The paper concludes with an analysis of the prospects for more (or less) IPRs-related consensus in the current round of WTO negotiations.

The article analyses the global public goods approach to COVID‐19 technologies, embedded in 2020 affirmations by the World Health Assembly (WHA), the UN Human Rights Council and G20 on broad immunization against COVID‐19. After identifying the access to COVID‐19 tools (ACT) Accelerator members, the UN efforts are identified, focusing primarily on the UN human rights bodies, acknowledging how these and the WHA have mutually reinforced each others' efforts. The article finds that the global public goods terminology appeared in UN resolutions in 2020, while wording that included vaccines—on an equal footing as medicines—appeared in 2016, and recognition of generic medicines appeared in 2019. The so‐called Trilateral Cooperation on IP and public health between two UN specialized agencies and the World Trade Organization (WTO) has increased awareness of the flexibilities within WTO's TRIPS Agreement. These flexibilities are explained. With notable exceptions, like India, these flexibilities are not widely applied in domestic legislation. A different emphasis characterizes the millennium development goals era as compared to the sustainable development goals era, and this shift is explained by applying relevant theories. Among pro‐TRIPS developed countries there is an acknowledgment of obstacles created by the IP system, but their overall position has not changed.

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

This paper argues that the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement is not solely responsible for the lack of access to medicines (ATM) in Low and Middle-Income Countries (LMICs). ATM is a complex global health governance issue influenced by various factors, including intellectual property laws, trade agreements, domestic policies, and manufacturing capacity. While the TRIPS Agreement provides flexibilities to address public health concerns, such as compulsory licensing and parallel imports, their effective implementation is hindered by several challenges. This paper emphasizes the need for a multifaceted approach to address ATM, involving domestic policy reforms, international cooperation, and investment in domestic manufacturing capacity. By leveraging these strategies, LMICs can enhance access to essential medicines and improve health outcomes for their populations.

Purpose – The paper aims to examine whether the panel and parties of China – Intellectual Property Rights could have applied the general principle of necessity developed under Article XX of the General Agreement on Tariffs and Trade and Article XIV of the General Agreement on Trade in Services. This paper specifically seeks to examine applicability of the general principle of necessity in the World Trade Organization (WTO) tribunal's analysis of the provisions of the Berne Convention, which is incorporated by Article 9 of the Trade‐related Aspects of Intellectual Property Rights (TRIPS) Agreement.

On 28 June 2018, the World Trade Organization (WTO) circulated the Panel Reports of the highly awaited Australia-Tobacco Plain Packaging disputes, adopted by the Dispute Settlement Body (DSB) on 27 August 2018. The decision was highly anticipated and significant in two aspects. First, it reaffirmed that the right to use a trademark is not a positive right; and tobacco plain packaging law does not come in conflict with relevant provision of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Second, it was perhaps the last opportunity for giant tobacco companies to set aside the law related to tobacco plain packaging. This article aims to analyze trade mark issues related to the Panel Reports on Australia’s tobacco plain packaging. The first section will provide a general background and briefly summarize the main findings of the Panel Reports. The second section will analyze the main arguments of parties and the Panel findings on the trade mark issues. Finally, the last section presents the most significant lessons and questions which require further attention.