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. The 2002 Doha Declaration reaffirmed that the TRIPS Agreement should not prevent members from taking the necessary measures to protect public health. Despite this recognition, less developed countries have argued that flexible TRIPS provisions, such as compulsory licensing, are almost impossible to enforce. Less developed countries, in particular, cited their young domestic manufacturing and technology industries as evidence of the imprecision of the policy. These agreements are expected to have the greatest impact on the pharmaceutical sector and access to medicines in the commercial aspects of intellectual property rights (TRIPS). The TRIPS Agreement has been in force since 1995 and is the most comprehensive multilateral agreement on intellectual property to date. The TRIPS Agreement introduced global minimum standards for the protection and enforcement of almost all forms of intellectual property rights (IPRs), including those relating to patents. International agreements prior to TRIPS did not establish minimum standards for patents. At the time of the start of negotiations, more than 40 countries around the world did not grant patent protection for pharmaceuticals.

The TRIPS Agreement now requires all WTO members, with a few exceptions, to adapt their legislation to minimum standards for the protection of intellectual property rights. In addition, the TRIPS Agreement introduced detailed obligations on the enforcement of intellectual property rights. However, it is now argued that data exclusivity is a requirement of the TRIPS Agreement. The data exclusivity approach gives the author exclusive rights to his test data and prevents regulatory authorities from relying on the test data to register generic substitute substances. Prior to the entry into force of the TRIPS Agreement, most countries allowed reliance on initial trial data for the approval of generic medicines. Once the test data was submitted by the initiator, the regulatory authorities were able to rely on the data to authorise subsequent applications for similar products or to rely on evidence of prior authorisation of a similar product in another country. Generic drug manufacturers only need to prove that their product is chemically identical to the brand, the original product, and that it is bioequivalent in some countries. This approach has enabled generic medicines to be brought to market quickly without registration fees. Under the data exclusivity approach, no competing manufacturer can rely on this data for a specified period of time, once it has submitted initial test data. Data exclusivity could therefore be an obstacle to the effective use of compulsory licences, as the importation of the generic medicinal product would be delayed by the length of the exclusivity period or the time required for a new compilation of trial data.

The public interest in restricting data protection is to promote competition and to ensure that data protection does not become a means of blocking the timely entry of generic medicines at affordable prices for public health. The TRIPS Agreement is an agreement on minimum standards that 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 Agreement on trade aspects of intellectual property rights (TRIPS) is an international agreement between all member states of the World Trade Organization (WTO). It establishes minimum standards for the regulation of different forms of intellectual property (IP) by national governments, as applied to nationals of other WTO member countries. [3] TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) between 1989 and 1990[4] and is managed by the WTO. . . .