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The amendment to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) marks the first time since the opening of the WTO Agreement in 1995 that the WTO Agreements have been amended. “As important as trade policy is, health and well-being must be a priority,” said Amina Mohamed, Kenya`s Minister for Foreign Affairs, who chaired the WTO General Council when the amendment was adopted in December 2005. “WTO members recognize this and have demonstrated how seriously they take health issues by ratifying and adopting an amendment to WTO rules that will facilitate access to essential medicines in low-income countries.” In August 2003, WTO members agreed to remove a significant barrier to imports of affordable medicines: they waived the restrictions in the TRIPS Agreement to supply the local market mainly when generics are manufactured under compulsory license. The system established by the Decision allows importing developing countries and least-developed countries that face public health problems and are unable to produce generics to apply for such medicines from manufacturers in third countries under compulsory licensing agreements. Normally, most medicines manufactured under compulsory licence can only be made available on the domestic market of the country where they are manufactured. This amendment allows exporting countries to grant compulsory licences to generic suppliers solely for the purpose of manufacturing and exporting the necessary medicines to countries without production capacity. Members decided to amend the TRIPS Agreement specifically to adapt the rules of the global trading system to the public health needs of people in poor countries. This action follows repeated calls from the multilateral system to adopt the amendment, the most recent being the high-level session of the United Nations General Assembly on the elimination of AIDS in June 2016. The TRIPS Council reviews the system of special compulsory licences annually and reports to the WTO General Council on how it has been implemented and applied, its operational context and the status of the TRIPS amendment. Discussions have become more detailed since 2010, after Canada and Rwanda used the system, and now cover a wider range of topics such as the system`s operational requirements. Since 2005, the system has also been the subject of an annual series of WTO capacity-building workshops on TRIPS and public health. The WTO press release can be found here. It contains a link to videos of various key players talking about the importance of adopting the amendment.

In addition to the entry into force of the amendment to the TRIPS Agreement in January 2017, another important development has been the significant increase in the number of pharmaceutical exporting countries adopting the necessary legislation to use the system for export. With more than 50 members adopting such legislation, informal estimates indicate that the system now covers about 80% of the world`s current pharmaceutical export capacity. More than a decade after World Trade Organization member states approved the first legal amendment to a WTO agreement, the amendment to the International Intellectual Property Agreement has entered into force. Five other MEPs have ratified the amendment in recent days, bringing supporters above the minimum needed to implement the amendment to boost the export of medicines manufactured under compulsory licence. This is the first amendment to a WTO agreement since the organization`s inception. It applies to all members who have accepted it. Members that have not yet adopted it have until 31 December 2021 or a later date that the Ministerial Conference may have decided to do so. For them, the derogation (the 2003 decision) applies until a member accepts the amendment.

The five new members that informed the WTO in recent days of the ratification of the amendment were: Burkina Faso, Nigeria, Liechtenstein, the United Arab Emirates and Vietnam. On 6 December 2005, WTO members agreed to definitively incorporate the 2003 Waiver Decision into the TRIPS Agreement. In accordance with general WTO rules, this amendment was then to be formally adopted by two-thirds of WTO Members. After the pace of assumptions recently increased rapidly, the amendment came into effect on January 23, 2017. This additional flexibility to protect public health is therefore an integral part of the TRIPS Agreement; As a result, this new procurement tool is now comparable to other flexibilities in the agreement that are directly related to public health. “This is an extremely important change. There is legal certainty that generics can be exported at reasonable prices to meet the needs of countries that do not have pharmaceutical production capacity or whose capacity is limited. In this way, it helps the most vulnerable to access medicines that meet their needs and helps fight diseases such as HIV/AIDS, tuberculosis or malaria, as well as other epidemics. I am pleased that WTO members have now honoured their commitment and implemented this important measure,” said WTO Director-General Roberto Azevêdo. In video statements available here, some of the key players share their thoughts on changing the TRIPS Agreement.

In recent days, the WTO Secretariat has received notifications from five Members indicating that they have ratified the Protocol amending the WTO TRIPS Agreement. These notifications – from Burkina Faso, Nigeria, Liechtenstein, the United Arab Emirates and Vietnam – have brought to two-thirds the number of WTO members that have now ratified the amendment. The two-thirds threshold was necessary to formally incorporate the amendment into the TRIPS Agreement. The current list and map of Members that have adopted the Protocol amending the TRIPS Agreement is available here. .

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