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”. In addition to the obligation of Member States to protect integrated circuit layouts in accordance with the provisions of the IPIC Treaty, the TRIPS Agreement specifies four points and/or builds on this provision. These points concern the term of protection (ten years instead of eight years, Article 38), the applicability of protection to articles containing integrated circuits that infringe the law (last paragraph of Article 36) and the treatment of innocent offenders (Article 37(1)). The conditions set out in Article 31 of the TRIPS Agreement apply mutatis mutandis to the granting of a compulsory or non-voluntary licence of a layout design or to its use by or for the government without the authorisation of the rightholder instead of the provisions of the IPIC contract on compulsory licences (Article 37(2)). 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. Work of the TRIPS Council The TRIPS Council manages the TRIPS Agreement. It is composed of all WTO members. Follow the link above to search for minutes of Council meetings, reports to the WTO General Council and other TRIPS Council documents. However, the agreement leaves countries different periods to delay the implementation of its provisions. These delays define the transition from before the entry into force of the Agreement (before 1 January 1995) to its application in the Member States.

The main transitional periods are as follows: Members may, however, choose to implement laws offering broader protection than that required by the Agreement, as long as the additional protection is not contrary to the provisions of the Agreement. . . .