The Growing Calls for Vaccine Liberalization

The Growing Calls for Vaccine Liberalization

In The Washington Post, Matthew Kavanagh and Madhavi Sunder of Georgetown University called for the Biden Administration to end its objection to a pending waiver of intellectual property rights enforcement before the World Trade Organization:

At the World Trade Organization on Wednesday, the United States and a small number of wealthy countries with ready access to vaccines blocked a proposal by India and South Africa to temporarily waive countries’ obligation to enforce patents on covid-19 technologies, including vaccines, during the pandemic. The Biden administration should drop its objection, and WTO members should pass the waiver — quickly.

I have written previously about the importance of not overstating the role of patents or other barriers created by intellectual property laws in the undersupply of vaccines. There are also serious issues associated with lack of manufacturing capacity more broadly and even then a mass vaccination program in the throes of a pandemic is a significant logistical undertaking.

One problem I have with this view, however, is that simply because something isn’t the thing stopping the end of the pandemic, or even the greatest barrier, doesn’t mean it isn’t worth doing. For example, early on in the pandemic Peter Seuderman of Reason wrote about distillers who wanted to use their skills to make hand sanitizer. (As it turns out, due to the CARES Act’s imposition of user fees on non-prescription drug manufacturers to fund the FDA’s regulatory operations, many distillers who did make hand sanitizer are now facing surprise bills).

Had the FDA declared that distillers should go full steam ahead and switch to manufacturing hand sanitizer without fear of regulation, would things be better than they are today? Perhaps, but not by much. But it would be ridiculous, especially in an all-hands-on-deck moment like a pandemic, to say something shouldn’t be fixed because it won’t solve the problem.

Kavanaugh and Sunder also make the crucial point that while it is certainly true that the mRNA vaccines are a new technology which is vastly more complicated to replicate than small-molecule drugs, there’s a fix to this:

[T]he United States and other opponents argue that even if generic drug companies get the patents, there is nobody who can make them. They suggest technology using mRNA underlying some of the new vaccines is so complicated that even respected generic drug companies cannot make the vaccines. This leads us to the next necessary step: tech transfer.

If patent rights are waived, companies around the world, such as Biovac in South Africa or Cipla in India, could rapidly retool their manufacturing capacity to make these vaccines, with experts at the ready to help. But they also need the recipe. While a patent is supposed to explain how to make a product, many of today’s pharmaceutical patent filers intentionally obscure this information. Therefore, the companies making these vaccines should share exactly how they make them.

Sharing technology with low- and middle-income countries is standard practice for many medicines. Gilead Sciences shared technology to help manufacturers based in Egypt, India and Pakistan to make and sell remdesivir as a covid-19 treatment last year; a company co-owned by Pfizer has done the same for HIV drugs. Vaccines are harder to engineer than AIDS drugs, so sharing tech is essential.

It’s not enough to just waive IP rights and call it a day. Affirmative steps must be taken to share this technology. As I wrote in The Hill:

While the United States should immediately reverse its position [opposing the waiver], reluctance on the part of other nations with powerful pharmaceutical lobbies may still prevent such measures from going forward. If such is the case, then the Biden administration should pursue more aggressive measures like compulsory licensing of coronavirus-related intellectual property to outside drug manufacturers. To sweeten the deal, additional payments should be made to American pharmaceutical companies to share all necessary knowledge — including, but not limited to patents — with firms around the world. [Emphasis added]

Finally, I want to point out the op-ed’s appeal to correct the wrongs of the pharmaceutical industry during the HIV/AIDS crisis:

Two decades ago, in the midst of the AIDS crisis, the WTO’s Doha Declaration affirmed intellectual property rules “should not prevent members from taking measures to protect public health.” But the clarification of the right of nations to issue compulsory licenses and make generic medicines came too late: More than 5 million people in low- and middle-income countries died from AIDS waiting for the WTO to clarify its rules.

Stinginess with IP has a very real body count, and this has not been forgotten by nations around the world, including those pushing for the waiver at the WTO. As I argued, “If the Biden administration wants to repair the United States’ global image, it can do so by releasing the knowledge that has already been paid for many times over. Such a move will, in turn, pay for itself many times over–in lives, money, and goodwill.”

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By |2021-03-15T11:12:35-07:00March 15th, 2021|Blog, Intellectual Property|