After more than eleven years, the amendment to the Intellectual Property Rights Agreement has finally come into force. On 6 December 2005, the General Council of the World Trade Organization (WTO) adopted the protocol amending aspects of trade-related intellectual property rights (TRIPS) (Article 31bis) and opened it up for adoption by Member States. The protocol provided additional leeway for the granting of mandatory special licences for the export of medicines, which was first established by a 2003 member decision, the Doha Declaration. 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 way in which African countries will benefit more from this legal order is uncertain at this time. First of all, it is not known why only 20 African countries have ratified this amendment to the TRIPS agreement, given that its provisions are specifically designed for the countries of this continent. The absence of internal legislative changes would also be a problem, since Article 31bis of the TRIPS agreement is not self-sustaining for some countries, meaning that it will not come into force immediately without the implementation of the necessary subsidiary laws in each country.
This amendment is the first amendment to a WTO agreement since the organization`s inception. It applies to all members who have accepted it. Members who do not accept them currently have until December 31, 2021 or at a later date, as the Ministerial Conference may do. They benefit from the waiver (2003 decision) until a member accepts the amendment. 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. On 6 December 2005, WTO members approved amendments to the WTO Intellectual Property Agreement (TRIPS) to finally adopt a decision on patents and public health, originally adopted in 2003. This was formally included in the TRIPS agreement after the adoption of the PROTOCOL amending the TRIPS agreement by two-thirds of WTO members. The amendment came into force on January 23, 2017 and replaced the waiver for members who accepted the amendment. When the 2001 WTO Ministerial Conference adopted the Doha Declaration on TRIPS and Public Health, it recognized the importance of compulsory licensing for access to medicines. Ministers also acknowledged that the TRIPS agreement presented significant obstacles to the effective application of compulsory licences for the supply of medicines by countries that do not have sufficient production capacity.