Declaration on the Trips Agreement and Public Health - Essay Example

DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH by Student’s Name Course Name Course Institution Professor’s name Date Introduction The World Trade Organization’s Agreement on Trade-Related aspect of Intellectual Property Rights (TRIPS) of 2001 tries to find a consistent set of intellectual property protection in member countries to offer greater strength in international financial affairs. Critics state that the TRIPS agreement offers unreasonably strong defense of intellectual property rights that serves to stop the sick in developing countries from accessing inexpensive essential drugs (DiMasi, Hansen & Grabowski, 2003). Socio-political aspects play a vital role in the uncontrolled spread of diseases in underdeveloped countries. Abbott and Van Puymbroeck (2004) argue that, the lack of essential infrastructure in developing countries, for example roads as well as access to sickbays, the desertion of the typically considerable rural residents and essential sanitation to avert the increase in diseases, are all worries that ought to be addressed to control the public health disasters facing these nations (EC, 2003). Corruption, Government instability and inadequacy are reasons that worsen the state of affairs. Medical as well as scientific problems are an additional burden on these developing countries (Ellen & Hoen, 2009). Treatments for a number of the most disturbing diseases for instance AIDS and malaria are not available. Prevention plans are falling on deaf ears because of the time-honored view as well as societal stigma. With not so many exceptions, insufficient education of the public provides to achieve these counter-productive concepts. The deficiency in health care experts to oversee complicated drug treatments and guarantee proper observance with instructions is an additional challenge. The profitable side of this matter cannot be overlooked. Pharmaceutical firms are just that, they are profit-making bodies and per se have a profit aim (Beall, 2010). Even though the principles of their situation can be continuously disputed, they see their main duty to be towards their investors as well as the shareholders. As a result, the pharmaceutical trade has intense their study and expansion efforts in spots that are expected to be gainful, for example drugs for state established in developed areas. Schistosomiasis, Malaria and other related diseases do not give the possibility for profitable returns and as a result are frequently ignored in business research. Of all the disputes that face developing countries in relation to public health, not any has acquired so much attention as the legal aspect of the crisis (EC, 2003). It has been constantly disputed on one side that severe intellectual property legislation maintains the prices of the drugs to be too high and due to this; they are less available to individuals who require them the most. The other side challenges that intellectual property acts are needed to promote innovation as well as create reward motivations for pharmaceutical firms to spend in risky research as well as development (Beall, 2010). Background of the World Trade Organization (WTO) and the Trade-Related aspect of Intellectual Property Rights (TRIPS) WTO The World Trade Organization (WTO) is the one that controls international trade among its member countries. It is the only organization of its kind in the globe and as a result has remarkable power over global trade strategy (WTO, 2012). While multilateral and bilateral free trade treaties are present and are permitted under the World Trade Organization stipulations, no other arrangement has had as much of an influencing force during globalization and liberalization of trade impediments as the set of treaty that consist of the WTO. The World Trade Organization permits representatives of member nations to collaborate and to have the agreements that are essential to the execution of the WTO and the growth of international trade WTO, 2003. Examples of three such agreements are: GATS (the General Agreement on Trade in Services), GATT (the General Agreement on Tariffs and Trade) as well as the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement. TRIPS The TRIPS agreement has taken part in an important task in the discussion on giving access to fundamental medications to nations of the developing world. TRIPS is a World Trade Organization agreement that was settled on in the Uruguay Round of negotiations from the year 1986 to the year 1994 by the members of the World Trade Organization (eighty percent of the world’s countries and the huge majority of the globe’s trading countries) that lays down certain set of laws concerning intellectual property rights (Machemedze, 2003). Immediately the member nations agree to the conditions, it turns out to be a legal agreement of the World Trade Organization that has to be approved by member nation’s governments in their individual legislatures. The result of this is to make a world standard of intellectual property protection. The aim of the TRIPS agreement is to set up a consistent set of rules across the world that would offer sufficient standards of protection for intellectual property in addition to providing greater stability and predictability in global economic affairs (Machemedze, 2003). At this position, it is significant to know that the TRIPS agreement affects all types of intellectual property: from trade secrets to copy rights (Wegner & Harold, 1993). However, this study will center on the TRIPS agreement in relation to patent protection; and its effect on the availability of drugs. Intellectual Property Rights (IPRs) Before the introduction of the details on pharmaceutical patents in connection to the TRIPS Agreement and the Doha Declaration, a very short outline of why IPRs are present may be helpful (WTO, 2001; WTO, 2010). IPRs and Patents in general are employed to give a particular exclusionary right that cannot in any way be given to the possessor of intangible belongings on a cutthroat market (Beall, 2010). The owner or inventor is given this right as the nature of the possessions otherwise permits it to be utilized by several producers at the same period, as the property is not independently appropriable (Holyoak & Torremans, 2001). One of the support that this argument receives is the moral right an innovator has to utilize his own creation. Currently the debate for protecting IPRs mainly emanates from a monetary point of view, as the cost of Research & Development is usually high, while the cost for distributing information from the owner to a manufacturer which is outside the owners control is significantly high (CIPR, 2002). People using this fiscal row for protection of IPRs are of the opinion that, the protection of invention is necessary for economic progress. Conversely history exhibits that most of the states with the highest level of pharmaceutical innovation industries had already grown to a considerable size (Holyoak & Torremans, 2001). Since the cost of R & D for pharmaceuticals are considerably high and the market for drug products is equally competitive and global, the above opinions lie at the center of the discussion on pharmaceutical copyrights as stated by CIPR (2002). Analysis At the Doha WTO Ministerial Conference Of the 9TH TO 14TH November 2011, the World Trade Organization member countries took the extraordinary step of taking on a special declaration on matters associated to the treaty and Public Health. Debate on this declaration was among the exceptional matters at the Conference, which opened a new circle of trade discussions on a wide range of matters (Kerry & Lee, 2007). This was the initial result of a procedure that happened in early 2001 when, upon the call of the African Group, the Council for TRIPS decided to deal particularly with the connection between the TRIPS Agreement and Public Health (WTO, 2001). The African Group’s request, held up by other developing nations, revealed growing apprehensions about the repercussions of the TRIPS Agreement (mainly the Agreement's requirements on patents) regarding access to drugs. The HIV calamity in sub-Saharan African nations, the efforts by the pharmaceutical organizations, supported by a few governments, to block the realization of TRIPS-compatible actions by the South African Government, as well as the criticism brought by the United States of America in opposition to Brazil in connection to compulsory licenses, were alleged as a sign of a conflict involving the acknowledgment of intellectual property rights (IPRs) and vital public health goals (Maskus & Keith, 2000; Ayodele, 2008). Even though one of the acknowledged objectives of the TRIPS Agreement was to decrease tensions taking place from intellectual property protection, the intellectual property protection for pharmaceuticals and its results on public health, as well as access to treatments in particular, continued to be a highly contentious issue (Gervais & Daniel, 1998). The Doha Declaration on TRIPS and Public Health, Paragraph 1 acknowledges the magnitude of the public health issues affecting several developing and least-developed states, particularly those resultant from tuberculosis, HIV/AIDS, malaria and other epidemics (Mercurio 2007). In this context, some developed nations tried to limit the extent of the Declaration to the HIV/AIDS predicament, the adopted text reveals the distress of developing nations and Least Developed Countries on the effects of the TRIPS Agreement regarding the public health in general, with no limitation to particular illnesses. The reference to a few detailed “epidemics” does not conclude that the Declaration is restricted to them. It takes up any “public health problem”, taking in those that may be resulting from illnesses that have an effect on the citizens in both developed and developing countries, such as cancer or asthma (WTO, 2010). Effectiveness of the TRIPS Agreement in alleviating public health problems in the developing world since 2001 Various factors have brought about the discussion on TRIPS and access to drugs, directly or indirectly affecting the provisions of the Doha Declaration (WTO, 2003). Among these factors is the South African case in defense of patent right holders’ claims against action by the South African Government. Big Pharma vs. Nelson Mandela’s trade row in South Africa In the beginning of 1998, the South African Pharmaceutical Manufacturers Association (SAPMA) plus 40 mainly corporation drug manufacturers got a suit against the South African Government, on claims that the Medicines and Related Substances Control Amendment Act No. 90 of the year 1997 (“Amendment Act”) was in violation of the South African constitution as well as TRIPS Agreement. The Amendment Act sets up a legal framework to raise the accessibility of inexpensive medicines in South Africa. Provisions incorporated in the Amendment Act are basic replacement of off-patent medicines, obvious pricing for all drugs, as well as the parallel importation of patented drugs (Mrazek, 2002; Scherer & Watal, 2001). At the beginning of the lawsuit, the drug corporations were capable of relying on the support of their home administrations. The United States had put demands on South Africa by holding back the benefits of trade as well as intimidating further trade approvals, intending to compel the South African government to revoke the Amendment Act. In the year 1998, the European Commission also joined the United States in putting more pressure on South Africa to revoke the legislation (Commission on Intellectual Property Rights, Innovation and Public Health, 2006)). AIDS activists successfully drew attention on these policies, greatly humiliating then-presidential candidate Al Gore (Mrazek, 2002). Faced up at the election campaign public meetings about his personal participation in the disagreement, protesters accused Al Gore of taking away the lives of babies in Africa. Because of rising pressure from the public, the United States altered its strategies at the end of the year 1999 (Correa & Carlos, 2000). By the time the case at last got to the courtroom in May 2000, the drug corporations could not count on the support of their governments. Activists in main cities asked the drug companies to let go of the case. Several parliaments and governments around the globe, together with the European Parliament, insisted that the drug companies pull out from the case. The lawful action now became a public relations tragedy for the drug corporations. In the course of the court procedures, it became obvious that the most controversial segment of the Amendment Act was founded on a plan legal text created by the WIPO Committee of Experts, a reality that made it hard for the drug corporations to retain the spot that the Amendment Act dishonored South Africa’s compulsions under international law (WIPO editor, 1997). In the end, the tough international public anger over the drug companies’ legal dispute of a developing nation’s medicines law as well as the companies’ weak legal place made the companies to drop the case unconditionally in April 2001. The extensively revealed South African court case conveyed two major subjects out into the global arena. First, the understanding of the flexibility of TRIPS as well as their application for public health rationales needed clearing up to ensure that developing nations were capable of using its provisions with no the threat of political or legal challenge. Second, it was clear that developed nations, which used trade powers to protect the interest of their international industries, could not apply pressure without consequences at home. The Doha Declaration has considerable positive aspects, in spite of the compromises created by developing nations for its adoption. The Declaration restates the right of WTO Members countries to employ the TRIPS flexibilities to the fullest degree possible for the reason of protecting public health as well as upholding access to drugs (WTO, 2003). The extent of the Declaration unlimited to the effects of patents on public health, however it affects all Intellectual Patent Rules (IPRs) that are in the scale of the TRIPS Agreement, for example the test data defense (Matthews & Duncan, 2002). Furthermore, the declaration is applicable for a few public health problems as well as epidemic. Concerns of the Drug companies in the Doha Declaration The clear declaration of likelihood to take priority over patent rights to promote the availability and affordability of drugs in section 15C, makes up a considerable derogation to the TRIPS sought to have Section 15C affirmed unconstitutional since it gave extra liberty to the government to decide on the state of affairs under which rights under the patents act ought to be curtailed and since it authorized the administration to verify the extent to which rights awarded under the patents act should apply (WTO, 2010; Hestermeyer, 2007 ). The pharmaceutical firms also disputed that Section 15C was as good as depriving patent owners of their rights in addition to violating the non-discrimination clause of Article 27 TRIPS (Correa & Carlos, 2000). The appeal was ultimately neglected in April 2001 in the face of strong open opposition from the public. Médecins Sans Frontières (MSF), together with non-governmental organizations (NGOs), devised the following worries associated to TRIPS: An increase in patent protection lead to high drug costs. The amount of new fundamental medicines under patent protection will rise, but the medicines will continue to be out of reach to individuals in developing nation due to high prices (DiMasi, Hansen & Grabowski, 2003). Consequently, the access gap connecting developed and developing nations will broaden (Correa & Carlos, 2000). Enforcement of WTO set of laws will have a harmful effect on home manufacturing ability and will eliminate a source of innovative, generic, quality medicines on which developing nations depend (Dugger, 2007). It is not likely that TRIPS will support sufficient R&D in developing nations for illnesses such as tuberculosis and malaria, because poor nations frequently do not offer enough profit potential to motivate R&D ventures by the pharmaceutical companies. Developing nations are under pressure from developed countries as well as the pharmaceutical industry to put into practice patent legislation, which goes past the responsibility of TRIPS. This is regularly known as “TRIPS plus.” (Correa & Carlos, 2000) TRIPS plus is a non-technical expression that refers to attempts to expand patent life past the twenty-year TRIPS minimum, to limit the enforced licensing in manners not necessary by TRIPS, to tighten patent protection, or to have limits on exceptions that ease rapid introduction of generics (Adams & Brantner, 2006). Industrialized nations as well as World Intellectual Property Organization (WIPO) give expert help to aid nations become TRIPS-biddable. This technical support, however, does not take into consideration the health requirements of the people in developing nations. Both of these establishments are under strong pressure to progress the interests of big firms that possess patents and other intellectual property rights. How TRIPS interfere with the Public Health Policy The general grievance made from developing nations concerning IP is that it has changed too far in favor of manufacturers (Shiva & Vandana, 2001). In the case of medicines, this implies that IPRs have moved too far towards the defense of the pharmaceutical patents proprietors. As per the critics, IPRs are not intrinsic, natural rights and must not be seen as such (Bermudez, Oliviera & Chaves, 2004). This discussion revolves around the general subject of the private rights as well as monopoly approved through patents, as countered to the social benefits public interest obtaining from science and technology. Because of this disagreement, patent laws that are tough for defending private interest are therefore weak for defending the public concern, at least initially. When focusing at the real problems of the accessible agreements, the most significant sections of the TRIPS Agreement concerning pharmaceutical patents according to Bermudez, Oliviera & Chaves, (2004) are 31 (other use without authorization of the right holder), 30 (exceptions to rights conferred) and articles 28 (rights conferred). Among the issues sloved by the Doha Declaration is the obligatory licensing policies under TRIPS, as stipulated in Article 31(f).43. Article 6 of the Doha Declaration allowed the member states till the end of the year 2002 to address the particular issue. By the end of this deadline, all associates of the World Trade Organization, with the exception of United States, had acknowledged a draft offered by the Chairman of the Council for TRIPS (ACP, 2003). On the other hand, since an accord could not be arrived at, a resolution is still on the program for the WTO. Still under the best conditions, simply lightening the public health calamity in various parts of the developing globe to a perceptible degree will be hard to attain. The situation needs international collaboration on a large scale to not only guarantee that the developing nations have access to fundamental drugs but to also generate incentives to motivate (or directly fund) R & D into new drugs as well as vaccines to take care of the diseases that mainly have an effect on the developing nations (Adams & Brantner, 2006). It is regrettable that a number of high profile NGO’s have concerted their sweat in putting the blame on the pharmaceutical industry and the copyright regime for deteriorating the crises. While these groups have spent significant financial resources and knowledgeable effort directing much of the argument over the access to vital drugs in the developing countries on the problem of copyrights protection of drugs to the activities of the pharmaceutical sector and the patent system, the unceasing indictments and subsequent publicity have not been useful in saving the situation. On the contrary, they have been very contentious, debatably extending the period between the Doha Ministerial and the application of the Agreement and obscuring longstanding impediments to improving the health as well as the lives of millions of people in the developing world (Mercurio, 2007). So as to control the dilemma and even hope to ease suffering, all interested parties must understand that the patent protection is only one of many aspects that influence the health of the developing countries. Other critical factors, for instance, the lack of medical facilities, poor living conditions, as well as proper infrastructure, undernourishment, and the lack of methods for administrating and distributing medicine, have to be addressed in order to ease the public health predicament. Somewhere in the previous decade, significant facts for instance inadequate levels of foreign assistance, the appallingly low levels of medical infrastructure in developing nations, in addition to apparent absence of political spirit in some developing states to ease the suffering were disregarded as the debate had its focus on TRIPS (Mercurio, 2007). Therefore, even if infrastructure, aid from developed nations as well as political will in developing nations is not even slightly adequate to alleviate the declining health conditions in the developing nations, the international debate sidetracked key financial resources, logical efforts as well as negotiating capability on a secondary matter. According to Lehman, a renowned expert in the patent field, AIDS activists has caused a huge harm to the issue of giving assistance to people in the unindustrialized world by leading an inconsistent focus on the issue of patent (Lehman, 2003) Predicaments such as tuberculosis, HIV/AIDS, and others absorbing a great deal of the developing nations are a very genuine and rising problem in various developing countries. But the fact is that, if control of patent did not exist, most of the unindustrialized states would still not have access to essential drugs. Importantly, ninety five percent of the pharmaceutical products on the WHO Essential Drug List (for instance medicine to treat tuberculosis, AIDS as well as malaria) are off-patent. Because of the elasticity given in TRIPS and strengthened by Paragraph 7 of the Doha Declaration and renunciations given in 2002 by the Council for TRIPS, the grace time for developing countries adjourning enactment of Sections 5 (patents) and Section 7 (private information) in in association with drug merchandises and the marketing privileges thereof have been extended until the year 2016 as stated by Sekalala (2010). This means that Less Developed Countries do not at present have to give patent protection for pharmaceuticals. To illustrate this, as of the year 2003, out of the 15 ARVs (antiretroviral) drugs used for managing AIDS, patent attention is less than twenty percent, with one hundred and seventy two patents out of the seven hundred and fifty nine that could ideally apply (Waning, Diedrichsen & Moon,2010). Moreover, of the fifty-two African countries, only South Africa possesses patent guard for more than 50 per cent of its AIDS medicines, with fifteen patents out of a potential sixteen (Waning, Diedrichsen & Moon, 2010). Importantly, twenty five percent of the nations do not offer patents and the remaining have an average of four patented drugs, with more than a dozen variant triple-therapy concoctions used to fight HIV/AIDS having no patents (Waning, Diedrichsen & Moon, 2010). Therefore, while the majority of African nations do not copyright most drugs used to manage AIDS as well as the majority of nations in sub-Saharan Africa lacks patent protection for any of the medicines, the AIDS menace persist infecting and killing millions of people each year in the world (Waning, Diedrichsen & Moon, 2010). Fascinatingly, a number of members of the medical and the public domain also challenge the view that patent protection has aggravated the HIV/AIDS predicament or significantly hindered access to important drugs. According to Mercurio (2007), it appears that, patents and patent policies are not key obstacles to management access in and of themselves. Up till now the developing countries continues to endure without sufficient supply of the required drugs, imploring the question what are the major causes of, or more suitably, what are the obstacles to resolving, the ongoing crises and poor access to life-saving drugs in the developing nation. This study suggests two major solutions for the continuing public health predicaments in the developing nations: 1. Access to accessible drugs have to increase; and 2. Reasons to uphold the development of new vaccines as well as drugs have to increase. Part IV gives an elaboration on these two matters by addressing some barriers currently present in addition to offering suggestions and indicatives in an effort to lessen the suffering and to have a resolution on the public health crises. Conclusion At the same time as the Doha Declaration and Paragraph 6 decision, assert important values under the TRIPS agreement, concerning the safeguard of public health within international trade law, major challenges continue to be experienced (Abbott and. Van Puymbroeck, 2004). The lack of development in executing TRIPS flexibilities to develop access to drugs, and the spread of TRIPS-plus measures via regional and bilateral trade agreements, need concerted consideration. Low and Middle Income Countries (LMICs) that depend on access to export markets in industrialized nations have been pressured to prioritize trade more than public health protections (Dugger, 2007). Influential trading countries, standing in on behalf of international pharmaceutical firms, have gained from a "divide and conquer" approach (Oxfam, 2012). The test of improving access to drugs for Low and Middle Income Countries therefore stands at a serious crossroad (Nexis, 2011). One alternative is for the international community to let the Doha Declaration to turn out to be a pawn in the high political views of trade strategy, crushed by the increase of TRIPS-plus measures intended to push access to drugs by the unfortunate even further out of reach (Sekalala, 2010). The other alternative is to stand true to the public health protections accessible found in the TRIPS agreement. This would denote a confirmation of those main beliefs, setting them apart and over trade discussions, along with commitment of adequate resources to realize their potential. References Abbott, F. M. and. Van Puymbroeck, R. V. 2004. 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