Seeking to widen access to medical products for combating Covid-19, the Costa Rican government has asked the World Health Organization to create a voluntary pool to collect patent rights, regulatory test data and other information that could be shared for developing drugs, vaccines and diagnostics.
The move comes amid a worldwide race to fight the novel coronavirus, but also mounting concerns that some products may not be accessible for poorer populations. By establishing a voluntary mechanism under the auspices of the WHO, Costa Rican officials are hoping to create a pathway that will attract numerous governments, as well as industry, universities and non-profit organizations.
“Given the urgency of this matter, Costa Rica proposes that the WHO develop an initial concise memorandum of understanding” on sharing technologies funded by the public sector and other institutions, wrote Costa Rican President Carlos Alvarado Quesada and Health Minister Daniel Salas Peraza in a March 23 letter to WHO Director General Tedros Adhanom Ghebreyesus.
They added that the pool should allow free access or licensing on “reasonable and affordable terms, in every member country,” but specific assets that would be shared and the terms for doing so can be determined later. The officials also asked the WHO to create a database of research and development activity related to Covid-19 products, including estimates for clinical trial costs and any subsidies provided by governments and charities (and here is the official announcement).
A WHO spokeswoman wrote us that Tedros will respond directly to Costa Rica. She added that the “WHO is committed to promoting measures that ensure equitable and affordable access to health technologies for all people who need them, including safe and effective technologies arising from current COVID-19 research.”
To an extent, the effort builds on moves by countries to consider compulsory licensing for unaffordable medicines. A country may grant a 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.
The new pandemic, however, has ratcheted up this sort of activity. Just over the past week, lawmakers in Chile and Ecuador passed resolutions urging their governments to explore licensing. Separately, Israel approved a license for an HIV pill, prompting the manufacturer to relinquish patent rights and waive restrictions on generic supplies on a global basis.
However, a voluntary pool of the sort envisioned by the Costa Rican officials goes much further by seeking to pull in technologies from a larger number of players, rather than on a drug-by-drug, country-by-country basis. In doing so, they hope to create more equitable access and avoid the sort of disjointed affordability that has typified some products.
“This is not an attack on intellectual property. It’s the right magnitude of response given the magnitude of the problem. It’s a big problem and you have to think big,” said Jamie Love, who heads Knowledge Ecology International, an advocacy group that tracks access to medicine and patent issues. The group worked with Costa Rican officials on the crafting the idea.
“People will contribute and buy into it this if it’s in their interest. Under current circumstances, the answer should be yes. You want people to be able to combine treatments, for instance, that can be beneficial without worrying about acquiring rights. This can provide the freedom to operate and that’s part of innovation. And if you want capacity and lower prices, you better think about opening up access. Otherwise, we’re stuck in our rooms for the rest of our lives.”
The issue emerged late last month in the U.S., in fact, when Secretary for Human and Health Services Alex Azar initially testified before Congress and refused to commit to ensuring that any Covid-19 product that is researched with taxpayer funds would be accessible to Americans. He subsequently backtracked, but by then a debate emerged over access to medical products in a time of a pandemic.
Whether the idea will catch on, though, is uncertain, at best.
We asked PhRMA, the trade group that represents drug makers in the U.S. and dvamed, a trade group for device makers, for comment and will update you accordingly. Both PhRMA and the International Federation of Pharmaceutical Manufacturers and Associations last week arranged media briefings where different company executives discussed plans for fighting Covid-19.
Thomas Cueni, who heads the IFPMA, wrote to say: “Given the gravity and urgency of the Covid-19 pandemic, the biopharmaceutical industry has not wasted any time or spared any effort in using its skills, technology and resources to bring safe and effective treatments, vaccines and diagnostic to patients around the world as a matter of utmost urgency. While voluntary pooling of intellectual property and other assets can be a tool to stimulate R&D and facilitate access under certain conditions, its effects to address the current situation will likely be very limited.”
Meanwhile, one physician who has studied models for prescription drug pricing suggested the proposal arrives at a precipitous moment.
“This raises an interesting question, because we’ve become completely hypnotized by a model that says we only get new treatments from private corporations that create them – and that’s the innovation model,” said Peter Bach, who heads the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center.
“But there’s a trade-off, because when we depend on for-profit industry, we won’t necessarily get treatments that promote health to the extent needed. Evidence suggests we’re moving toward narrower treatments for narrower populations, but societies aren’t necessarily gaining. It’s clearly inefficient,” he told us.
“We have to ask ourselves if we’re at an inflection point in public health, and if so, do we want to pursue a collective action aimed at solving a collective health issue, one that challenges private incentives? And if we did that, can we get more health gains?
[UPDATE: A comment was added from the International Federation of Pharmaceutical Manufacturers and Associations].