More than a decade after World Trade Organization member states approved the first legislative amendment to a WTO agreement, the amendment to the international intellectual property agreement came into force. Five other MEPs have ratified the amendment in recent days, moving supporters above the minimum needed for the amendment to promote the export of medical devices to be manufactured under compulsory licence. The list and card of members who have accepted the minutes of amendment to the TRIPS agreement are available here. Acceptance has increased considerably in recent years, members are becoming familiar with the practical impact of the CHANGE in TRIPS: in the last two years, about 37% of adoption instruments have been tabled as a result of a review of the benefits of entry into force in the WTO General Council. Members who do not yet have to accept the TRIPS amendment have until the end of December 2017. In the meantime, they can refer to the 2003 decision to exempt access to affordable medicines from third countries. Least developed countries are not required to apply for patents on medical devices by 2033 under a recent WTO agreement. The initial amendment was put forward by the African group. In recent years, some observers have asked members to amend the agreement to make it more effective before it is included. Some LDCs, such as Uganda and Mozambique, are developing their own generic drug production capacity. The amendment to the WTO Agreement on Trade-Related Intellectual Property Rights (TRIPS) is the first since the WTO agreements opened in 1995.
The TRIPS agreement was amended by the Protocol of 6 December 2005, which came into force on 23 January 2017. The amendment introduces a new Article 31bis in the agreement, as well as an annex and annex. These provide the legal basis for WTO members to grant compulsory special licences for the production and export of affordable generic drugs to other members who are unable to produce enough medicines for their patients. According to the WTO, members who do not yet accept the TRIPS amendment have until the end of December 2017 to do so. (1) At the WTO Ministerial Meeting on 14 November 2001, the “DECLARATION on TRIPS and Public Health” (Doha Declaration) was adopted. (Note 1) Compulsory Licenses When a patent has been issued, parties other than the patent holder are generally not allowed to produce, sell or import products related to the invention of the patent without the patent holder`s licence. However, a government may authorize a third party to use a patent invention under certain conditions, even without the patent holder`s permission, which is called a mandatory license. Article 31, point (f) of the TRIPS agreement authorizes compulsory licences “primarily for the supply of the internal market.” This is the first compulsory licence for the export of medical devices.