In a significant development, the European Union has proposed a draft resolution urging the World Health Assembly to voluntarily pool intellectual property as part of a plan to ensure “equitable access” to vaccines, treatments, and other medical products for combating the pandemic.
The move, which anticipates the WHA will hold a virtual session next month, comes after the World Health Organization Director General last week endorsed the idea of creating such a pool to collect patent rights, regulatory test data, and other information that could be shared for developing drugs, vaccines, and diagnostics.
The concept was proposed last month by Costa Rican government officials amid mounting concerns that some Covid-19 medical products may not be accessible for poorer populations. By creating a voluntary mechanism under the auspices of the WHO, a pathway could be used to attract numerous governments, as well as industry players, universities, and nonprofit organizations.
The draft also suggested the WHA, which is a decision-making body of the World Health Organization, work with the World Intellectual Property Organization, the Medicines Patent Pool, Unitaid, UNICEF, the Coalition for Epidemic Preparedness Innovations, the Global Fund to fight Aids, TB and Malaria, and Gavi, the Vaccine Alliance.
By pursuing such a resolution, the EU provides a mandate to establish a voluntary pool and, in the process, also underscores a stark contrast with the U.S., which wants to end its funding to the WHO, noted Thiru Balasubramaniam of Knowledge Ecology International, an advocacy group that focuses on the intersection of intellectual property and access to medicines.
The voluntary pool approach, however, is distinct from simultaneous efforts being promoted by several dozen advocacy groups and academic experts that are urging countries to make greater use of compulsory licensing. This is a tactic that, over the years, some cash-strapped governments have pursued in response to the high cost of medicines, triggering battles with drug makers over patent rights.
A country may grant a compulsory license to a public agency or a generic drug maker, allowing it to copy a patented medicine without the consent of the brand-name company that owns the patent. This right was memorialized in a World Trade Organization agreement known as the Trade-Related Aspects of Intellectual Property Rights, or TRIPS.
“The whole fight out there between those who think pools are the way to go and those who say licensing is the way to go comes down to whether you make it voluntary for a firm or have the state decide,” said Ken Shadlen, a political scientist at the London School of Economics, who studies the global pharmaceutical industry and patent issues, and signed the letter concerning licensing. “Some believe you can’t rely on firms to act voluntarily.”
The idea of a voluntary pool has already won support from Unitaid and the Medicines Patent Pool, a United Nations-backed agency that licenses HIV, tuberculosis, and hepatitis C treatments from drug makers and provides access in lower-income countries. The MPP deliberately expanded its mandate to include Covid-19 products.
Over the past month, though, lawmakers in Chile and Ecuador passed resolutions urging their governments to explore licensing. Canadian lawmakers passed a bill to speed the process of issuing licenses. Germany extended the right to suspend patents rights. And Israel approved a license for a pill, prompting the manufacturer to relinquish patent rights and waive restrictions to generic supplies on a global basis.