A 2003 agreement eased the requirements of the domestic market and allows developing countries to export to other countries where there is a national health problem as long as the exported medicines are not part of a trade or industrial policy. [10] Drugs exported under such a regime may be packaged or coloured differently to prevent them from harming the markets of industrialized countries. Council Decision 94/800/EC on the conclusion, on behalf of the EU, of agreements concluded in the framework of the Uruguay Round multilateral negotiations (1986-1994) The TRIPS Agreement is an agreement on minimum standards which allows Members to guarantee, if they so wish, broader protection of intellectual property. Members are free to determine the appropriate method for implementing the provisions of the Agreement in their own legal and practical order. The TRIPS Agreement introduced intellectual property rights into the multilateral trading system for the first time and remains the most comprehensive multilateral agreement on intellectual property to date. In 2001, developing countries, concerned about the industrialized countries` insistence on an overly narrow interpretation of TRIPS, launched a round table that resulted in the Doha Declaration. The Doha Declaration is a WTO declaration that clarifies the scope of TRIPS and, for example, states that TRIPS can and should be interpreted with the aim of “promoting access to medicines for all”. TRIPS conditions that impose more standards beyond TRIPS were also discussed. [38] These free trade agreements contain conditions that limit the ability of governments to create competition for generic drug manufacturers. In particular, the United States has been criticized for encouraging protection far beyond the standards imposed by TRIPS.
U.S. free trade agreements with Australia, Morocco, and Bahrain have extended patentability by requiring patents to be available for new uses of known products. [39] The TRIPS Agreement allows for the issuance of compulsory licences at the discretion of a country. The more ad hoc conditions provided for in the free trade agreements between the United States and Australia, Jordan, Singapore and Vietnam have limited the application of compulsory licenses to emergency situations, antitrust measures and cases of non-commercial public use. [39] Since the entry into force of the TRIPS Agreement, it has been the subject of criticism from developing countries, academics and non-governmental organisations. While some of this criticism is directed at the WTO in general, many proponents of trade liberalization also see TRIPS as bad policy. The wealth concentration effects of TRIPS (the movement of money from people in developing countries to copyright and patent holders in developed countries) and the imposition of artificial shortages on citizens of countries that would otherwise have weaker intellectual property laws are common bases for such criticism. Other criticisms focused on TRIPS` failure to accelerate the flow of investment and technology to low-income countries, an advantage advanced by WTO members before the agreement was created. World Bank statements indicate that TRIPS has not been able to tangibly accelerate investment in low-income countries, although this has been done for middle-income countries.
[33] The long periods of validity of patents under TRIPS have been examined to indicate that they excessively slow down market entry for generic drug substitutes and competition in the market. In particular, the illegality of preclinical studies or the filing of samples for approval until a patent expires has been held responsible for the growth of a few multinationals and not producers in developing countries. With regard to the application of the Agreement, the industrialized countries had one year to bring their legislation and practices into conformity with the Agreement. This period has been extended to 5 years for developing countries and countries that have moved from a centrally planned to a market economy, and to 11 years for the least developed countries. .
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