When the Biden administration announced support for waiving international intellectual-property (IP) protections for COVID-19 vaccines, a move strongly supported by India, it might have seemed like a recognition, considering the grave situation in that country, that the world will not truly be safe from COVID-19 until all countries can vaccinate their populations.
But then reality hit: World Trade Organization (WTO) negotiations on such a proposal may not conclude until December. Any manufacturing made possible by a WTO agreement would not result in actual shots in arms for months following that. Expanding production of these novel vaccines requires the costly and time-consuming process of transferring knowledge to new manufacturing partners and building their new production lines.
An actual WTO agreement to waive IP rights is quite unlikely to make any difference against COVID-19 in the meaningful time frame: between now and the point, sometime in 2022, when existing manufacturers have made enough safe and effective vaccines to cover the world. The Biden administration’s move looks right now like a gift to activists and developing-country leaders who have spent decades assailing the global IP regime. It has the chance to hurt incentives for developing the COVID-19 therapeutics we still need and new drugs for other global health challenges, such as tuberculosis.
But there is one productive path forward: if this threat works as a way to bring drugmakers on board with a bolder plan to vaccinate the world.
The original vaccine makers already have incentives to expand manufacturing, including through technology transfers, because it means more of their product can be sold at a time when demand for it far exceeds supply. But their value calculus is not straightforward. For large manufacturers such as Pfizer and Johnson & Johnson, even supplying the world with COVID-19 vaccines is not a transformative business opportunity: The vaccines are not high-priced, they have a lot of competition, and new vaccine production lines may not be a useful long-term investment. Working with new manufacturing partners around the world also comes with some risk of teaching them valuable trade secrets.
So even when there is money to be made on expanding production with new partners, it’s conceivable that drug companies will decide against it or not move quickly enough. We have some precedent for how this can work. As the HIV/AIDS pandemic exploded in the 1990s, the effective drugs we had for treating HIV were prohibitively expensive for low-income countries, so they were essentially sold only in wealthy countries. Two things happened: First, some countries, such as South Africa and Thailand, threatened to break the patent rights for these drugs, which could fairly easily be made around the world. Then, the U.S. government and private foundations went to drugmakers with a proposal: We’ll help poor countries buy billions of dollars’ worth of HIV drugs, and we’ll help you get a form of FDA approval so that we can use U.S. government funding for those drugs. But you need to lower your prices substantially for these purchases — and you can do that without affecting pricing in wealthy countries by licensing production in countries such as India, as they eventually did.
In other words, there were carrots and sticks. Threats against their IP plus government purchases brought drugmakers into an agreement that wouldn’t deliver windfall profits but would ultimately save millions of lives.
That is the only productive way forward for the Biden administration’s efforts: Use both carrots and sticks to give manufacturers even stronger incentives to expand production now. The threat of weakening vaccine makers’ international IP rights could drive them to voluntarily license that IP — not just patents, but manufacturing know-how — more broadly and quickly than they might otherwise. By joining the WTO debate and pushing drug companies to do more voluntary licenses, we may also be able to help ensure that this IP-sharing happens in a way that does not help countries that abuse the international IP system, such as China, take advantage of this process. This process will be lengthier and more complicated than expanding manufacturing of HIV drugs, because vaccines are so much more complex, but the expansion needs to happen.
We can and should provide a lot of the carrots needed to make it happen, many of which Luciana Borio and former FDA commissioner Scott Gottlieb have outlined. The U.S. should make more big financial commitments now to expand production — ideally, here in the U.S., but abroad if necessary — to vaccinate the world as soon as possible. Building capacity within the U.S. and our allies to vaccinate the world is not just a valuable investment in global leadership; building and maintaining these capabilities will keep us safer from the next pandemic. We can deploy regulatory expertise to help more manufacturers meet standards here in the U.S. and around the world, and we can help coordinate sensible rules around liability protections. Because scarce materials are a major impediment to expanded production, we have to work with other nations and with drugmakers to ensure that the materials needed for vaccine production go where they can be used to make safe vaccines soonest. We might even need to support more manufacturing capacity than is necessary to produce doses for the world’s 7 billion people, because speed matters, and some efforts will inevitably fail or be delayed.
Providing upfront purchase guarantees, delivering assistance from regulators, making big bets across a broad portfolio of possibilities, and closely coordinating supply chains is, in fact, a proven strategy. It’s what Operation Warp Speed did to deliver enough vaccines for our entire population faster than nearly any other country has.
What’s needed now is a global Operation Warp Speed. Of course, this might be a bit easier if President Biden had not decided to memory-hole Operation Warp Speed’s extraordinarily successful public–private partnership and replace world-class industry experts with leaders who have no experience at all in vaccine manufacturing.
Just as with the original Operation Warp Speed, government and the private sector need to come together to do things faster than any of them would normally think possible. The way in which the Trump administration dealt with practical realities rather than ideological talking points — working with the private sector but not shying away from necessary fights — is the right path forward.