Although almost all WTO agreements are binding on all members, the GPA is an exception to the “single obligation” of a multi-lateral agreement within the WTO that countries may decide whether or not to join. The IP provisions contained in these agreements may delay the entry into the market of cheaper generic drugs and biosimilars, this allows high prices to be maintained over a long period of time, affecting public spending on medicines and/or consumer wallets, depending on the health system of each country [1,2,3,4,5,6,7,8, 29]. Footnote 8 They can also “imprison” a high level of intellectual property protection in order to prevent or limit reforms, since the revision of trade agreements generally requires the agreement of all contracting parties. Whether specific provisions in specific agreements will have these effects depends on many factors, including the national intellectual property laws in force in Member States, the details of their health and pharmaceutical systems and markets, and the decisions of dispute resolution bodies in the event of complaints. 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. Chapters that are part of the architecture of the agreement, but which, apart from other parts of the text, would not have an impact on pharmaceutical policy, were not included in the framework. These include chapters on dispute resolution and exceptional chapters. Each agreement contains the health exception under Article XX point b) of the General Agreement on Tariffs and Trade (GATT XX, point b), and applies it to the obligations of a narrow subset of chapters. GATT XXb) may be invoked by parties who wish to defend a measure that would otherwise be contrary to the agreement as “necessary for the protection of human, animal or plant life or health”, provided that they can demonstrate that the measure “does not constitute a means of arbitrary or unjustified discrimination between countries where conditions are identical or a disguised restriction on international trade”. The likelihood that a health measure will be determined by a dispute resolution body so as not to violate an agreement when the GATT XX (b) exemption is invoked is difficult to predict and depends on the details of the measure, its application and context.
In order to encourage the development of patent and other ip systems in other countries, the U.S. government strongly supports the implementation and compliance of membership or bilateral IP agreements that offer MORE TRIPS protection through the annual audit procedure 301. This process, which was designated in accordance with the relevant provision of the Trade Act 1974 as amended, examines in depth the adequacy and effectiveness of intellectual property protection in more than 70 countries. It reflects the U.S. government`s ongoing commitment to aggressive enforcement of intellectual property protection and is conducted in close consultation with relevant industry groups. On April 30 each year, the United States is committed to ensuring adequate and effective protection of mental protection measures and fair and equitable access to the market. The United States also commits to implementing and enforcing the TRIPS agreement, other WTO agreements and its bilateral and regional agreements, as it also believes that a strong and open international trading system will allow all countries to benefit in this interdependent world.