The long push for manufacturers to lift intellectual property rights on COVID-19 vaccine production appears to be making headway with the United States, European Union, India and South Africa reaching a consensus on key terms of the agreement.
There is a tentative agreement among the four World Trade Organisation members that still needs formal approvals from the parties before it can be considered official, a proposed document reviewed by Reuters suggests.
Some elements of the consensus deal including whether the length of any patent waivers would be three years or five years would apply only to patents for COVID-19 vaccines, which would be much more limited in scope than a broad proposed WTO waiver that had won backing from the United States.
The document authorises use of “patented subject matter required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic”.
It said IP rights would also be waived for ingredients and processes necessary for COVID-19 vaccine manufacture, a move aimed at granting critical know-how to many countries lacking expertise, especially for advanced mRNA-type vaccines.
The text contained several limitations, including that the waiver is only available to WTO member countries that exported less than 10 percent of global exports of COVID-19 vaccine doses in 2021.
The tentative agreement does not include COVID-19 treatments or tests, and the limitations would likely exclude China from any waiver, a source familiar with the negotiations said.
The text, which was produced in negotiations last week, was being circulated to officials in Brussels, Washington, Johannesburg and New Delhi before being presented to other WTO members. Adoption of the IP waiver by the consensus-driven organisation is far from certain.
USTR spokesman Adam Hodge said the informal discussions among the four principal parties had not yet resulted in agreement, but had produced a promising compromise and consultations were continuing.
“The difficult and protracted process has resulted in a compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome,” Hodge said in an emailed statement.
The tentative deal comes after months of negotiations over how to accelerate COVID-19 vaccine production in developing countries, where vaccination rates have lagged far behind wealthy countries.
In talks brokered by WTO director general Ngozi Okonjo-Iweala, the United States, EU, India and South Africa broke away from negotiations among the organisation’s 164 members to try to craft an agreement.
Objections from some countries with large pharmaceutical sectors, including Switzerland and Britain, had stalled progress in negotiations among the larger group. India and South Africa had first proposed the WTO vaccine IP waiver in 2020 as the COVID-19 pandemic exploded.
A spokesperson for pharmaceutical industry trade group PhRMA said efforts to waive intellectual property commitments are unnecessary and harm efforts to end the pandemic. Voluntary technology transfer and partnerships have helped vaccine makers to target production of 20 billion doses in 2022, more than enough for the world, she said.
The refusal to waive IP rights was seen as a threat to the adoption of the mRNA vaccine production technology that Nigeria and some other African countries are set to receive.
Tedros Ghebreyesus, director-general of the World Health Organisation (WHO) had raised the concern that the technology transfer could fail to realise the goal of producing vaccines at scale locally, ditching the ultimate bid to attain self-sufficiency in non-producing countries including Nigeria.
“The flexibility of the trips agreement is there to be used during emergencies. If not now, then when? We need to throw out all this stuff to achieve the 70 percent vaccine coverage target by the middle of this year as well as the minimum target for testing treatment and PPE coverage,” Ghebreyesus said at the Ports to Arms global summit on vaccine equity in Abuja.
South Africa and India over a year began to push for a temporary waiver of intellectual property rights under the TRIPS agreement for the duration of the pandemic, before about 60 other WTO members bought in.
The waiver according to the WTO would cover obligations in four sections of the TRIPS agreement including section one on copyright and related rights, section four on industrial designs, section five on patents and section seven on the protection of undisclosed information.