The United States, the European Union, India and South Africa have agreed on the key elements of a long-sought intellectual property exemption for COVID-19 vaccines, according to a proposed text reviewed by Reuters.
Sources familiar with the talks described the text as a preliminary agreement between the four members of the World Trade Organization, which still lacks formal approvals from the parties before it can be considered official. Any agreement must be accepted by the WTO’s 164 member states in order to be adopted.
Some elements of the consensus agreement, including whether the length of any patent exemptions will be three years or five years, still need to be finalized, according to the text. It would only apply to patents for COVID-19 vaccines, which would be much more limited in scope than a widely proposed WTO exemption that had won backing from the United States, according to the document.
The document allows the use of “patented material required for the production and delivery of COVID-19 vaccines without the consent of the licensee to the extent necessary to counter the COVID-19 pandemic”.
It said IP rights would also be waived for ingredients and processes needed to manufacture COVID-19 vaccines, a move aimed at providing critical know-how to many countries lacking expertise, especially for advanced mRNA-type vaccines.
The text contained several restrictions, including that the exemption is only available to WTO member countries that exported less than 10% of global exports of COVID-19 vaccine doses by 2021.
The preliminary agreement does not include COVID-19 treatments or tests, and the restrictions are likely to exclude China from any dispensation, said a source familiar with the negotiations.
The text, which was produced during negotiations last week, was circulated to officials in Brussels, Washington, Johannesburg and New Delhi before being presented to other WTO members. The adoption of the IP dropout by the consensus-driven organization is far from certain.
USTR spokesman Adam Hodge said the informal discussions between the four main parties had not yet resulted in agreement, but had produced a promising compromise, and consultations continued.
“The difficult and lengthy process has resulted in a compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome,” Hodge said in an email statement.
A WTO spokesman did not immediately respond to a Reuters inquiry into the negotiations.
The preliminary agreement comes after months of negotiations on how to speed up the production of COVID-19 vaccines in developing countries, where vaccination rates have lagged far behind rich countries.
In negotiations mediated by WTO Director-General Ngozi Okonjo-Iweala, the United States, the European Union, India and South Africa broke out of the negotiations among the organization’s 164 members in an attempt to reach an agreement.
Objections from some countries with large pharmaceutical sectors, including Switzerland and the United Kingdom, had halted progress in the negotiations among the larger group. India and South Africa had only proposed the WTO vaccine IP exemption in 2020 when the COVID-19 pandemic exploded.
A spokesman for the pharmaceutical industry trading group PhRMA said efforts to waive intellectual property obligations are unnecessary and hurt efforts to end the pandemic. Voluntary technology transfer and partnerships have helped vaccine manufacturers target production at 20 billion doses by 2022, more than enough for the world, she said.