As public health experts debate how to best convince the vaccine hesitant among us to line up and get the shot, India has become a global hot spot with COVID-19 infections running at more than 300,000 per day, a variant strain prevalent that may be far more easily transmissible with still less than 5% of its population fully vaccinated.
With this backdrop, it is clearly in America’s interest to help India, Brazil and other low-income nations obtain more vaccines at an affordable cost, but the Biden administration’s recent decision to support a waiver of private sector patent rights is an ill-advised and ultimately ineffective way of doing so.
The Biden administration implies that the global vaccine shortage ought to be seen as a binary choice of either innovation or access. In fact, these are complementary, even mutually dependent, objectives.
Specifically, the Biden administration has said that it supports a waiver of intellectual property rights held by Pfizer/BioNTech, Moderna and other manufacturers of products used in the diagnosis, treatment of and vaccination against Covid-19. U.S. Trade Representative Katherine Tai has said she will work with other World Trade Organization member states to negotiate the particulars that would allow overseas manufacturers to make the vaccine without fear of patent infringement.
Some have said that this declaration is not particularly meaningful, because it will take time to hammer out the details and it is likely to be very limited in effect. In other words, this announcement is more political appeasement for progressives who are disappointed that the administration is not aggressively pursuing drug price controls, rather than posing a meaningful threat to the industry.
That may well be the case. First, the government has not said that it will exercise “march-in” rights or otherwise suspend patents domestically, and so it does not appear to directly affect the rights of companies and inventors in the United States. Second, a targeted patent waiver during a pandemic doesn’t expand or rely upon the existing international framework that allows compulsory licensing in cases of genuine public health emergency under the 2003 Doha Declaration.
But even though it may have limited long-term impact, it is not wise. The United States government has been the bulwark against the international evisceration of intellectual property rights for generations. Article I of the American Constitution grants Congress the power to protect discoveries, and the Congress did so in the Patent Act of 1790. In the international sphere, the U.S. Trade Representative has led the way in negotiating bilateral and multilateral trade and investment treaties that have enshrined the American perspective in support of patents, while protecting American workers from unfair foreign competition.
These principles are vital. It is this very protection that offers critical incentives for inventors and investors that results in new medicines.
There are circumstances in which a temporary suspension of patent rights is warranted. For example, Brazil threatened compulsory licensing during the AIDS crisis for HIV treatments and leveraged that threat to negotiate a steep discount from manufacturers. More recently, GlaxoSmithKline licensed tuberculosis vaccine rights to the Gates Foundation for testing and distribution in low-income countries in response to a World Health Organization initiative.
But in the context of a global pandemic, we need policy solutions that actually will spur increased vaccine manufacture and distribution. Rather than a broad waiver of vaccine patent rights, the United States government should begin to export excess supplies currently on hand to countries in need and encourage Pfizer and Moderna to license manufacturing rights and technology know-how to third parties.
Consider the approach taken by Gilead Sciences in the international distribution of its catalogue of drugs for HIV and AIDS. As two former Gilead executives have reminded us, the company maintained its global patent rights, but licensed its product manufacturing rights and technology know-how to low cost generic manufacturers in India and elsewhere to assure access to life saving drugs. This kind of voluntary, targeted private sector approach is far preferable to a global remedy imposed by government actors.
The United States has leveraged its position by practicing a kind of vaccine nationalism that favors local manufacturers and limits exports. There are ongoing shortages of components necessary to make vaccines, too few qualified manufacturing sites and an insufficient number of trained personnel to run those plants.
We should work to help alleviate these problems. But a patent waiver will not solve them.