Biden agreed to waive vaccine patents. But will that help get doses out faster?

Demonstrators hold a rally on May 5, 2021, on the National Mall in Washington, DC, calling on the US to share vaccine formulas with the rest of the world. | Saul Loeb/AFP via Getty ImagesVaccinating the world will be tough. Here’s what intellectual property waivers can and can’t do. The Biden administration has announced that it will work with the World Trade Organization (WTO) to negotiate a deal to suspend intellectual property rights associated with the Covid-19 vaccines — a surprise move for the administration, which had initially resisted taking such a step. The reversal came as Covid-19 deaths are mounting in India and elsewhere. The vaccination program in the US is going well, but much of the world is still waiting for vaccines, which has made the role of pharmaceutical companies and intellectual property in the global vaccine effort the subject of intense debate. There is unanimous agreement on one thing: There is a lot of work to be done to speed up vaccine manufacturing and vaccinate the world. As the WTO’s General Council meets this week, patents have risen to the top of the agenda. India and South Africa have asked the WTO to waive intellectual property (IP) rules relating to the vaccines so that more organizations can make them. The case for waivers is simple: Waiving IP rights might enable more companies to get into the vaccine-manufacturing business, easing supply shortages and helping with the monumental task of vaccinating the whole world. The case against them: Taking IP rights from vaccine makers punishes them for work that society should eagerly reward and disincentivizes similar future investment. Opponents have also argued this step would do very little to address the vaccine supply problem, which has largely been the result of factors such as raw material shortages and the incredible complexity and tight requirements of the vaccine-manufacturing process. The debate has raged for the last several weeks — with Bill Gates as a notably outspoken defender of IP rights — but recently intensified as the Covid-19 crisis in poor countries worsens. Wednesday’s announcement unambiguously puts the US on record in support of such a waiver — a reversal from its previous position. “The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines,” US trade representative Katherine Tai said in an announcement. Done correctly, making the IP associated with these vaccines available to the world can be a good first step — the more information-sharing here, the better. But it’s a small thing to do at a time when bigger commitments are needed. Waivers might help, but ending the pandemic worldwide is going to require so much more. While the Biden administration’s decision is a positive development, but debates over intellectual property can also distract the world from the policy measures that could really end the pandemic: building our vaccine-manufacturing capacity, committing to purchase the doses the rest of the world needs, and working directly with manufacturers to remove every obstacle in their path. Patents, trade secrets, and what you need to know to make a vaccine To unpack what the Biden administration’s move means, it’s important to understand the role patents play in vaccine manufacturing. When a pharmaceutical company makes a drug, it applies for a patent. The patent protects its intellectual property for a fixed amount of time, typically 20 years, after which others can make “generic” versions of the drug, which are generally a lot cheaper. Simple enough, right? When it comes to Covid-19 vaccines — and many modern pharmaceutical products — the situation is much more complicated than that. First, a modern vaccine is often in a web of different intellectual property rights, with the vaccine manufacturer having purchased the rights to some elements of its vaccine from either other pharmaceutical companies or researchers. The lipids (shells that contain the mRNA molecules) used for mRNA vaccines, for example, are licensed to Pfizer and Moderna, but other companies have the rights to them. Patents held by the vaccine companies are actually a fairly small share of what’s going on in this IP web. It’s better to talk more broadly about all of the intellectual property that goes into a vaccine: licensing deals, copyrights, industrial designs, and laws protecting trade secrets. The other complication is that, while there are legal barriers to copying the existing vaccines, that’s not what’s really making them impossible for other companies to start manufacturing. Experts I spoke with emphasized that, generally speaking, the world’s entire supply of critical raw materials is already going into vaccines, and there are no factories “sitting idle” waiting for permission to start making them. What’s more, changing a factory’s processes to produce a new kind of vaccine is a difficult, error-pro

May 6, 2021 - VOX
Demonstrators hold a rally on May 5, 2021, on the National Mall in Washington, DC, calling on the US to share vaccine formulas with the rest of the world. | Saul Loeb/AFP via Getty ImagesVaccinating the world will be tough. Here’s what intellectual property waivers can and can’t do. The Biden administration has announced that it will work with the World Trade Organization (WTO) to negotiate a deal to suspend intellectual property rights associated with the Covid-19 vaccines — a surprise move for..