Trade and IPR in Iran: TRIPS Issues and Challenges

When the Uruguay Rounds concluded in 1994, many countries signed on to the trade agreements creating the World Trade Organization (WTO) in hopes of benefiting from a system of trade rules “dedicated to open, fair and undistorted competition” (1). WTO members also undertook to implement the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Developing countries, major development agencies and civil society raised concerns over whether TRIPS might limit access to affordable, essential medicines. The Doha Declaration on the TRIPS Agree-ment and Public Health, adopted at the WTO ministerial conference in 2001, responded to these concerns: it empha-sized that the TRIPS Agreement should not stand in the way of member govern-ments acting to protect public health and affirmed governments’ right to use the Agreement’s flexibilities (2).Oliveira et al. (pp. 815–821) pro-vide insight into the flexibilities under TRIPS that provide public health safe-guards and how they are coming under challenge despite the Doha Declaration. Their article on the implementation of TRIPS in Latin America and the Carib-bean gives a snapshot of the key areas where TRIPS flexibilities important for public health must be reflected in a country’s national legislation. Their work is particularly timely because negotiations for the Central American Free Trade Agreement (CAFTA) have been concluded (though the Agreement is not yet ratified), while efforts to move forward a United States free trade agree-ment (FTA) with Andean countries and the Free Trade Area of the Americas continue.These FTAs have sought to curtail the flexibilities under TRIPS, such as compulsory licensing or parallel imports. Have they, though, placed at risk the potential role of generic competition or weakened public sector negotiating leverage? To highlight an area of growing concern, the United States has prioritized the creation or expansion of “exclusive rights” over pharmaceutical test data in FTA negotiations (3). Under Article 39.3 of the TRIPS Agreement, WTO mem-bers must protect test data, submitted to national drug regulatory authorities for pharmaceutical registration, against “unfair commercial use”. While TRIPS does not specify how this is to be done, the United States has insisted in the FTA negotiations that countries provide at least five years of data exclusivity. Instead of generic competitors submitting bio-equivalence data, they must repeat costly tests for marketing approval, which may deter generic entry. This may also raise ethical questions, as generic manufac-turers would be forced to repeat human subject trials on drugs known to be bioequivalent.Data exclusivity provisions apply whether or not a medicine is patented, but the most serious impact is likely to be on drugs that are not under patent. In such cases, data exclusivity will create a “patent-like” barrier that will prevent generic entry during the entire period of exclusivity (4). If a drug is patented, the government could issue a compul-sory licence to overcome the patent bar-rier, but data exclusivity might prevent its market approval. This is the possible situation emerging under the CAFTA, where data exclusivity rules may delay generic competition effectively for up to ten years (5). Such FTAs are not only TRIPS-plus, but may also go beyond requirements under United States law.As developing countries seek lower barriers to their agricultural exports and greater foreign direct investment, can TRIPS flexibilities be safeguarded? How can the playing field for negotiations be levelled? First, developing countries should refuse to accept TRIPS-plus provisions in FTAs. Barring this, they should avail themselves of what the United States practises under government use provisions through non-voluntary licences and what other countries do to prevent patent abuse (6). Secondly, developing country governments deserve fair access to independent, technical assistance and counsel of their own choosing in these negotiations. In recent Andean FTA negotiations, this basic principle of fairness was undermined when the United States delegation prevented the Colombian Government from seating an adviser at the negotiation table. Ministries of trade should also ensure representation of ministries of health in negotiations that will affect public health and ac-cess to medicines. Thirdly, the public health community should insist that evidence be provided and results tracked to document whether the promised gains or the potential public health risks from stronger IPR protection are realized. The reciprocal benefits of technology transfer should be as measurable as the United States monitoring of TRIPS compliance under the Section 301 “watch list”.Finally, regional economic blocs might consider collective approaches to applying the use of public health safe-guards under TRIPS as they have for ne-gotiating price reductions and procuring pharmaceuticals. Ten countries in Latin America banded together to reduce the price of antiretroviral drugs and HIV di-agnostic tests with agreements from both originator and generic manufacturers (7). Such regional groups might benefit from exercising coordinated use of the public health safeguards under TRIPS (8).The paper by Oliveira and her col-leagues provides a useful starting frame-work for flexibilities under TRIPS, but a framework for fairness will require more. Only by taking into account the concerns of public health in trade agree-ments will we ensure that all countries have a fair deal for the future. O

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). …

The World Trade Organisation (WTO) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has reawakened old arguments over the impact of the intellectual property (IP) system on public access to essential medicines. As used here, essential medicines are those needed in symptom management, palliative care, and in the treatment of infections, such as human immunodeficiency virus (HIV), malaria, tuberculosis, and sleeping sickness in places like sub-Saharan Africa. Some argue that patents will further inhibit access to these medicines in sub-Saharan Africa. Others, however, argue the opposite. The latter maintain that patent protection under TRIPS can promote the growth of the pharmaceutical industry in places like sub-Saharan Africa. Moreover, they assert that pharmaceutical patents are not responsible for the limited access to essential medicines in sub-Saharan Africa. Instead, they trace the problem of access to non-patent factors, such as poverty, the lack of supportive infrastructure, and poor governance. This paper set out to assess these contrasting arguments, with a view to determining the actual impact that pharmaceutical patents may be having on access to essential medicines in sub-Saharan Africa. Keyword search of electronic databases was conducted, in addition to a review of relevant literature from print sources. A manual analysis then followed. It was found that, rather than a single set of factors, both patent and nonpatent factors combine to inhibit access to essential medicines in sub-Saharan Africa. It is imperative for sub-Saharan African countries to review current tariff and taxation policies, take steps to improve the supply of vital infrastructure, and strengthen their overall healthcare systems. They should also ensure that their IP systems are supportive of public healthcare needs. Equally important, is that TRIPS and the IP system should be more supportive of sub-Saharan Africa’s struggle to bear its disease burden, rather than focusing narrowly on profit maximisation for pharmaceutical companies. Sub-Saharan Africa also needs increased international financing, private-public collaboration in research, and the sharing of benefits in order to cater effectively for the health needs of its citizens. Key words: Trade-related aspects of intellectual property rights (trips), essential medicines, sub-Saharan Africa, pharmaceutical, patents, access, malaria, human immunodeficiency virus/ acquired immunodeficiency syndrome (HIV/AIDS).

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.

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.

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).

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.

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

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

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.

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.

Today it is widely recognized that a uniform global intellectual property (IP) system requiring a high level of protection is inherently unjust and affects countries differently depending upon their level of technological and economic development. This article analyzes the functioning of the current international treaty framework having intellectual property connections — the TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights) Agreement, the World Intellectual Property Organization (WIPO), the Convention on Biological Diversity, bilateral trade and investment agreement and UNESCO Convention on the Protection and Promotion of the Diversity of Cultural Expressions — from the perspective of how it could promote a more socially and economically just international intellectual property framework. The article also brings forth some new initiatives which have been proposed to address some of the most critical issues related to the current system: providing an alternative to a patent-driven inventive system for medical research and development and a treaty proposal for access to knowledge and technology. The article points out that the problems faced by developing countries with regard to, for example, access to medicines, can be similar to those faced by those developed countries that are net importers of patented medicines. The main message of this article is that it is no longer possible to maintain a unitary IP system at the international level without grave economic and social losses to, in particular, developing countries. What is needed is a more fragmentary IP protection framework making it possible for each country to adapt it to its national level of economic, technological and social development.

Vaccine apartheid: global cooperation and equity

Trade, TRIPS, and pharmaceuticals

The article critically examines the political economy of intellectual property (IP), and the encounter within TRIPS between traditional knowledge holders and a Western-led international IP law regime that is turning ever more global. Patents, copyright and trade marks are protected by intellectual property rights. The international regime which governs these is based on Western thinking around ownership and has most recently culminated in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). TRIPS is an attempt to harmonize and enforce intellectual property on a global scale. But this globalizing IP regime has difficulty accommodating the more localized interests of developing countries and indigenous communities who find themselves rich in traditional knowledge (TK). For a number of reasons, TK is not easily accommodated by Western IP law categories. Therefore, TK often remains unprotected by law, and this can lead to uneven commercial and cultural exploitation of agricultural, medicinal and biodiversity-related knowledge, as well as of expressions of folklore in music, dance, song, designs, stories, artwork and handicraft. The article calls for a renewed focus on moral philosophy in addressing the power relations and the negotiations between different IP interests. A brief history of Western IP law is included to illuminate these interests, and global IP law is challenged to develop novel self-reflexive identities to reflect heterogeneity and difference. At the same time, the interests of traditional knowledge holders are discussed, and an attempt is made to group these into categories including articulations for remuneration, recognition, and return of traditional knowledge. The article suggests that these various articulations themselves use, directly or indirectly, traditional Western categories of intellectual ownership and protection. The article further argues that in circumstances in which the international IP law regime is associated with an over-homogenized legal self-identity, and with legal-legislative imperialist practices, a global regime should build cultural bridges and incorporate legal hybridities and heterogeneous identities.