Health

What’s needed to turn the IP waiver into Covid-19 vaccines – STAT


The Biden administration’s announcement to support an intellectual property (IP) waiver for Covid-19 vaccines was a monumental step toward improving the access to them in low- and middle-income countries. But without further action, it will be little more than a symbol.

The waiver allows companies to produce Covid-19 vaccines without fear of being sued by the entity that holds the IP for the technology.

It had been backed by more than 100 countries and by 110 members of the U.S. Congress. This broad support reflected a growing intolerance of the global inequity that is helping fuel the ongoing Covid-19 crisis.

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As of late April, low-income countries had received only 0.3% of the global vaccine supply, while a handful of wealthy countries had obtained 81%. The reversal of the U.S.’s long-standing defense of global IP rules signaled acknowledgement that current vaccine suppliers cannot produce vaccine doses fast enough — or potentially cheap enough — to rapidly end the pandemic.

To turn the administration’s decision into action, World Trade Organization countries must rapidly pass the IP waiver, implement technology transfers, repurpose global manufacturing capacity, and boost production of raw materials. All of these require considerable global collaboration, not to mention the financial and political commitment of high-income countries.

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WTO decisions depend on consensus of its 164 member states. While the U.S. support for the waiver is significant, several countries with strong pharmaceutical industries remain in opposition, including the United Kingdom, Canada, Australia, Japan, and the European Union countries. Although the U.S.’s decision will certainly put pressure on them to support the waiver, negotiations to finalize waiver details — expected to be stalled by pharmaceutical demands — could last months at a time when thousands of people are dying from Covid-19 every day. Swift consensus is needed.

To unleash the full impact of an IP waiver, governments and companies must offer technology transfers, share know-how, and provide logistical support. Previous examples illustrate the illusion of just waiving intellectual property: While Moderna stated it would not enforce patent protections during the pandemic, its pledge has had little consequence in the absence of meaningful mRNA vaccine technology transfer.

Small-molecule drugs, like some antiretroviral therapies, can be easy to reverse engineer. Vaccines aren’t. Scaling production requires collaboration between both originator vaccine companies and recipient manufacturers. In May 2020, the World Health Organization created the Covid-19 Technology Access Pool to facilitate such transfers and data sharing. To date, the pool is still empty.

Waiving IP rights for Covid-19 vaccines is an opportunity to catalyze transfer mechanisms. But it will require originator companies to engage in transfers on principles of social good, and high-income countries to leverage their market power and domestic regulations to compel or incentivize originator companies to cooperate.

Currently many idle suppliers can’t begin vaccine production until they upgrade and repurpose existing manufacturing capacity for new technology. Opponents often argue that this step is the true barrier to rapid scale-up. One high-profile detractor, BIO President and CEO Michelle McMurry-Heath, argues that “handing [needy countries] the blueprint to construct a kitchen that — in optimal conditions — can take a year to build will not help us stop the emergence of dangerous new Covid variants.”

This argument ignores two core truths: In many cases, manufacturing capacity needs only repurposing which can take mere months. And Covid-19, at the current global response and vaccination rates, will be a threat for years.

Both truths suggest that we pass the blueprint and build the kitchen.

Facilitating structures to transfer technology and capacity are already in place. The WHO launched the mRNA technology transfer hub model last month to provide manufacturers in low- and middle-income countries with the financial, training, and logistical support needed to scale up vaccine manufacturing capacity. Scores of manufacturers in these countries have already expressed interest. This initiative, however, requires recipient manufacturers to acquire the IP necessary for mRNA technologies— which is currently missing.

Even as new manufacturers seek to begin making Covid-19 vaccines, raw materials and essential components for making them are falling short. Failed supply chains have already limited Covid-19 vaccine production in the U.S. and India. While an IP waiver will help with these bottlenecks, additional effort is required to repurpose manufacturing sites to produce vaccine-making materials. For example, mRNA vaccines require an expensive agent to cap the mRNA; it is currently produced under patent by a single company, TriLink. As demand for the cap increased, the company expanded its U.S. facilities instead of licensing out its technology to other manufacturers that could easily produce the cap, ultimately controlling the limited supply.

Biden’s support of the IP waiver may help the WTO achieve consensus on the waiver and spark global solidarity to overcome the dangers of vaccine nationalism. It can certainly foster goodwill. But actually turning the waiver into vaccine doses will require mobilization, investment, and advocacy for tech transfers, upgraded manufacturing capability, and strengthened supply chains.

As the world continues to hover on the precipice of one of the most momentous challenges of modern times, we have the tools, know-how, and ability to respond rapidly and effectively accelerate vaccine production. What we now need is global collaboration and political will.

Parsa Erfani is a Fogarty Global Health Scholar at Harvard Medical School and the University of Global Health Equity. Lawrence Gostin is a professor at Georgetown University Law Center, director of the school’s O’Neill Institute for National and Global Health Law, and director of the World Health Organization Center on National and Global Health Law. Vanessa Kerry is a critical care physician at Massachusetts General Hospital, director of the Program for Global Public Policy at Harvard Medical School, and CEO of Seed Global Health, a nonprofit that trains health workers in countries with critical shortages.


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