The Council’s decision extends until January 2033 the period during which key provisions of the WTO’s intellectual property agreement, the TRIPS Agreement, do not apply to pharmaceutical products in LDCs. This means LDCs can choose whether or not to protect pharmaceutical patents and clinical trial data before 2033. The decision also keeps open the option for further extensions beyond that date.
The latest extension, the second specifically applied to pharmaceutical products for LDCs, is in line with directions set by WTO ministers in the 2001 Doha Declaration on the TRIPS Agreement and Public Health. It also follows the adoption of the new UN Sustainable Development Goals (SDGs), which affirm the right of developing countries to utilize TRIPS Agreement flexibilities to ensure access to medicines for all.
WTO Director-General Roberto Azevêdo hailed the TRIPS Council's decision.
“This decision by the TRIPS Council represents a clear and unambiguous signal that WTO members are committed to addressing the needs of the organization's poorest members. With the concerns of least developed countries at centre stage next month at our Nairobi Ministerial Conference, now is the time for WTO to build upon this momentum in other areas of our work,” said Director-General Azevêdo.
WTO members, speaking in the TRIPS Council, unanimously welcomed the decision. A wide spectrum of members recalled the benefits of this extension for public health outcomes in LDCs, in light of the continuing challenges faced by these countries.
Ambassador Shameem Ahsan of Bangladesh, coordinator of the LDC group in the WTO, described the decision as “historic,” adding that it “will assure the LDCs the necessary legal certainty to procure or to produce generic medicines for those who need it most but do not have any access.”
This step, responding to a request tabled by LDC members of the WTO (IP/C/W/605), comes just a month after the UN General Assembly adopted the SDGs as a framework for global action up to 2030.
SDG Goal 3 on ensuring healthy lives and promoting well-being for all at all ages includes the target of providing “access to affordable essential medicines and vaccines”, and in that context recalls the affirmation in the Doha Declaration on the right of developing countries to use to the full the provisions in the TRIPS Agreement regarding flexibilities to protect public health, and, in particular, provide access to medicines for all.
The need to take full account of the special needs and circumstances of the LDCs is recognized expressly in the TRIPS Agreement itself, and this recognition runs through many areas of the WTO’s work. LDC members are already exempted from applying all substantive TRIPS standards until 2021, a period that may also be extended.
Today’s decision is expected to be followed by a related General Council decision, on the recommendation of the TRIPS Council. The General Council is expected to extend an existing waiver for LDCs concerning exclusive marketing rights for pharmaceuticals, and to agree to a new waiver for LDCs regarding ‘mailbox’ measures for receiving patent applications in this field. These two waivers will complement and buttress the effect of the decision to exclude obligations concerning pharmaceutical patenting, and will also run until 2033.
Further information on TRIPS and public health is available here. Information on intellectual property in the WTO, news and official records of the activities of the TRIPS Council, and details of the WTO’s work with other international organizations in the field can be accessed here.