The TRIPS Agreement has played a central role in the debate on developing countries` access to essential medicines. The TRIPS Agreement is a WTO agreement negotiated in the Uruguay Round from 1986 to 1994 by WTO Members (80% of the world`s nations and the vast majority of the world`s trading nations) which lays down certain rules on intellectual property rights (5). Once member countries have accepted the provisions, it becomes an official WTO agreement, which must be ratified by the governments of member countries in their own parliaments. As a result, a global standard for the protection of intellectual property is created. Agreements ratified by the WTO set certain minimum standards; Member States reserve the right to go beyond the provisions of the agreements as long as national legislation does not call into question the conditions laid down in the WTO agreements. Article 7 (Principles) and Article 8 (Objectives) are well represented in the text of the WTO TRIPS Agreement, but played a secondary role in the explanatory memorandum of the Dispute Settlement Body (DPO). This gap is exacerbated when considered by considering three key factors. First, the breakthrough by TRIPS negotiators to include broad declarations of intent in the operational text. Secondly, the strengthening of these provisions in 2001 in the Doha Declaration on TRIPS and Public Health. Finally, the literal incorporation of these provisions into other international intellectual property instruments, in particular the Trans-Pacific Partnership, the Anti-Counterfeiting Trade Agreement and the WIPO Development Program.
Taken together, these factors require further examination of the meaning and application of Articles 7 and 8. This article aims to contribute to this investigation by subjecting the individual elements of each determination to a detailed textual analysis. As will appear, necessity, adequacy, consistency and good faith are legal principles set out in Articles 7 and 8. In addition, those provisions recognise a crucial principle of interpretation, that of national regulatory autonomy. This includes, but goes beyond, compliance with national policy decisions, recognition of a state-centred benchmarking methodology that must guide the implementation of the TRIPS Agreement and other agreements in which they have been incorporated. To implement this recommendation, Article 28.1(b) of the TRIPS Agreement, which sets out the rights of process patent holders, should be amended. This paragraph states that the rights of a process patent holder extend to the product obtained from the process and are not limited to the process itself, effectively removing the concept of a process patent from the TRIPS Agreement (6). In accordance with Article 31 of the TRIPS Agreement (6), the rights of patent holders may be circumvented in certain situations. Specifically, member governments have the power to license a party wishing to commercialize a patented invention without the consent of the patent owner. Unless there is a « national emergency », the proposed licensee must make reasonable efforts to apply for a voluntary licence (6).
If the patent holder refuses to grant a license, a non-exclusive license may be granted by the government. Therefore, subject to other provisions of the TRIPS Agreement, compulsory licensing allows generic manufacturers to manufacture and sell patented medicines at a fraction of the price that patent holders would obtain, since only the costs of producing the drug and not the costs of research and development should be covered. Criticisms of the provisions on compulsory licences refer to point (f) of that article, which states that compulsory licences must be used `mainly for the supply of the internal market of the Member State authorising such use` (6). These critics argue that this clause makes it extremely difficult for developing country governments to issue compulsory licenses to combat public health crises, as it would require medicines to be manufactured in developing countries where there is little infrastructure to support this highly developed industry (7). The TRIPS Agreement is an agreement on minimum standards that allows Members to provide more comprehensive protection of intellectual property if they so wish. Members are free to determine the appropriate method for implementing the provisions of the Agreement in their own legal system and practice. In particular, the TRIPS Agreement requires WTO Members to grant copyrights that include authors and other copyright holders as well as holders of related rights, i.e. performers, producers of phonograms and broadcasting organizations; geographical indications; designs; Integrated circuit design schemes; patents; new plant varieties; Trademarks; Undisclosed or confidential trade names and information. The TRIPS Agreement also establishes enforcement procedures, remedies and dispute settlement procedures.
The protection and enforcement of all intellectual property rights must be consistent with the objectives of contributing to the promotion of technological innovation and the transfer and dissemination of technology, for the mutual benefit of producers and users of technological knowledge and in a manner conducive to social and economic well-being and the balance of rights and obligations. The terms of the TRIPS Plus Agreement, which prescribe standards other than TRIPS, were also reviewed. [38] These free trade agreements contain conditions that limit the ability of governments to introduce competition for generic manufacturers. In particular, the United States has been criticized for pushing protection far beyond the standards prescribed by the TRIPS Agreement. U.S. free trade agreements with Australia, Morocco, and Bahrain have expanded patentability by requiring patents to be available for new uses of known products. [39] The TRIPS Agreement allows for compulsory licensing at a country`s discretion. The terms of the TRIPS Plus Agreement in the U.S. free trade agreements with Australia, Jordan, Singapore, and Vietnam have limited the use of compulsory licenses to emergencies, antitrust remedies, and non-commercial public use cases. [39] Criticism of the TRIPS Agreement exists at several levels. There are those who criticize the implementation of its provisions in sovereign countries, there are others who criticize the provisions of the TRIPS Agreement, and there are still others who criticize its existence.
Subsequent criticisms of the TRIPS Agreement will be framed from the perspective of the following neutral principles in order to make the recommendations as relevant and applicable as possible to the current situation: The TRIPS Agreement is the ideal point on the World Trade Organization`s punch bag. Just or not, the TRIPS agreement is supposed to be a monstrosity of modern capitalism. Noam Chomsky, a renowned academic, says: « There is nothing liberal about [the TRIPS agreement]. It is a highly protected system designed to ensure that private tyrannies, such as corporations, monopolize the technology and knowledge of the future. (14) Dr Zafar Mirza, executive coordinator of The Network, a Pakistani health advocacy group, asks: « You talk about harmonising trade policy, but no one says a word about harmonising global socio-economic conditions. All countries are at different stages of development, how could they be regulated by the same law? (15) These remarks contrast sharply with those quoted above by senior officials. Why is one group so strongly opposed to the TRIPS Agreement, while another shows seemingly infallible support? The second part of this article attempts to reconcile these two points of view. The provisions of the TRIPS Agreement range from trivial to controversial. The conditions include a minimum period of patent protection of twenty years from the date of the patent application. It is important to note that the TRIPS Agreement also invalidates the use of process patents by stating that patent protection of a process extends to the product of that process. In addition to these provisions, the TRIPS Agreement provides for two mechanisms to deal with international public health crises: compulsory licensing and parallel imports (5). The Agreement on Trade-Related Aspects of Intellectual Property Rights, which sets minimum standards for the protection and enforcement of intellectual property rights for WTO Members, remains one of the most controversial international agreements on intellectual property that has entered into force.
Although this agreement takes a very problematic approach to super-size-fits-all, it contains a number of safeguards and flexibilities to facilitate economic development and protect the public interest. In particular, Articles 7 and 8 set out explicit and important objectives and principles that can play an important role in the interpretation and implementation of the Agreement. In addition to the basic intellectual property standards created by the TRIPS Agreement, many countries have concluded bilateral agreements to introduce a higher standard of protection. This set of standards, known as TRIPS+ or TRIPS-Plus, can take many forms. [20] The general objectives of these agreements are as follows: The disadvantage of process patents (and the likely reason they are excluded from use under the TRIPS Agreement) is that they only allow research-based pharmaceutical companies to maintain a patent monopoly until a second developer finds a more efficient way to produce the drug. This would generally reduce the duration of the patent monopoly to which the discovering company is entitled; However, it offers other companies the opportunity to make higher profits by improving the drug in question. .