TRIPS is unique in these anti-intellectual property agreements because WTO membership is a “package agreement,” meaning that WTO members are not free to choose between agreements. They are governed by all multilateral WTO agreements, including trips. On 14 November 2001, the WTO issued a landmark declaration in Doha, Qatar. Member State governments have agreed to an independent declaration on the membership agreement and its role in reducing public health crises around the world (9). The ON TRIPS agreement was the subject of three main concerns, which were raised in the Doha Declaration (5). First, there were doubts as to whether Member States would set out the TRIPS agreement in a way that would promote public health. To address these doubts, Member States reaffirmed, in paragraph 4 of the declaration, the compatibility of the agreement with public health and the right of Member States to interpret the agreement with a view to improving public health crises. The TRIPS agreement played a central role in the debate on access to essential medicines for developing countries. TRIPS is a WTO agreement negotiated by WTO members (80% of global nations and the vast majority of world trade countries) during the Uruguayan round of negotiations from 1986 to 1994 that sets out certain rules on intellectual property rights (5). As soon as Member States approve these provisions, it will become a formal WTO agreement, which will have to be ratified by the governments of the Member States in their own parliaments. The result is the creation of a global standard for intellectual property protection. 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 set out in the WTO agreements. However, the argument put forward today is that data exclusivity is a precondition for the TRIPS agreement.
The data exclusivity approach gives the initiator exclusive rights to its test data and prevents regulators from relying on test data for the registration of generic substitutes. Prior to the introduction of the TRIPS AGREEMENT, most countries authorized the authorisation of generic drugs on the initiator`s test data. Once the test data was submitted by the initiator, the regulators were able to rely on the data to approve subsequent applications for similar products or to support the demonstration of prior approval of a similar product in another country.