Can the TRIPS waiver save the world?

INSIGHTS

Can the TRIPS waiver save the world?

Author: Andrea Taylor

The US threw its weight into the ring on the side of the TRIPS waiver this week, surprising many. There is still a long road ahead for the waiver, which much be agreed through discussion and consensus. With vocal opponents (including Germany), this is unlikely to happen before December. But if it does go through and intellectual property (IP) protections are waived, will it make a difference?

The short answer is maybe, but not this year. The TRIPS waiver is important because of what it stands for; it is a concrete action for which people can advocate, on behalf of global equity. And it is safe to say that the record profits recently reported by several Covid-19 vaccine makers have undercut industry’s opposition. But the need is most acute in the next six months and the waiver is unlikely to help.

This is not lost on US leaders and this decision may be more about optics than impact. But it also signals that the US has decided to be a global leader on vaccine equity and could mean that the administration will support dose sharing and accelerate exports to poorer countries from US manufacturers, both of which would be more meaningful actions in the short-term.

The TRIPS waiver in brief

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was launched in 1995, in order to protect IP in global trade, including copyrights, trademarks, patents, and trade secrets across all industries (not just pharma). It integrated and added to earlier agreements and set out minimum standards for intellectual property protection among World Trade Organization (WTO) member countries. TRIPS-related disputes are subject to WTO’s dispute settlement procedures.

The proposed waiver, supported by more than 100 countries, would temporarily remove global protection of intellectual property for innovations that address Covid-19 infection. The goal is to increase manufacturing, making it possible for drug makers around the world to start churning out doses of Covid-19 vaccines without having to negotiate technology transfer and licensure deals with vaccine developers.

We are not optimizing the capacity we already have

Calls for the TRIPS waiver are based on the assumption that IP is holding up global production. Our review of the evidence, however, does not support this.

Our data on vaccine manufacturing show that most Covid-19 vaccines using traditional platforms, such as viral vector and inactivated virus, did use tech transfer deals to set up global manufacturing networks. AstraZeneca has agreements in place to manufacture Covid-19 vaccine in 16 countries, Novavax and Sputnik V in 11 countries, Sinovac in 6 countries. But many of these manufacturing partners (particularly those in middle-income countries) are delayed in starting or operating at only partial capacity because knowledge transfer is difficult and raw materials are in short supply.

For mRNA vaccines, like Moderna and Pfizer-BioNTech, the picture is even more complicated. Very few manufacturers (and none in LMICs) are equipped to manufacture mRNA vaccine, with or without access to intellectual property.

Setting up manufacturing takes longer than we think

Starting from scratch to set up new manufacturing through access to IP is not an immediate fix. And right now, we need to be focused on an immediate fix. Retrofitting or building new plants takes a long time. Running test batches, quality checks, audits and regulatory approval of manufacturing sites also takes a long time. Starting that process now is not likely to produce more doses this year, when they are most needed.

The capacity gap is more than IP

Patents and written trade secrets alone do not provide the information, expertise, or equipment needed to produce vaccines. It would be significantly more difficult to force the sharing of specialized expertise required to apply the information. Without investment in knowledge exchange and skill development, as well as physical equipment, the intellectual property in written form cannot cover the capacity gap. To succeed, any waiver of IP must be embedded within a larger transfer of know-how and infrastructure development, which is unlikely without bringing pharmaceutical companies along as willing partners.

The world is on fire

When the pharma industry says the waiver will “undermine our global response to the pandemic,” most of us can agree that yes, that is precisely the point. Our analysis of vaccine data indicate that response has not been particularly successful and a pivot is certainly indicated.

But it is the next six months that are most critical. Right now, the immediate need is to increase the production of equipment and raw materials needed to fuel existing technology transfer deals so that manufacturers who have already spent months learning the recipes and gaining the expertise can get to work.

There is a real risk that this discussion about patents and IP is distracting us from focusing on the crisis at hand. We are essentially arguing over who is allowed to make fire engines while we watch the world burn. Right now, we need to make sure we can get water flowing through every hose we have.

In the medium- to long-term, we do need to develop regional manufacturing hubs, with capacity to make drug substance as well as fill-finish, across Africa, Latin America, and South and Southeast Asia, so that we do not end up in the same place next time. An IP waiver may or may not help this effort. But right now, we need to focus on goals with immediate impact: maximizing production where it is ready to go, dose sharing, and funding Covid-19 response (including vaccine purchase) for lower-income countries.

INTERESTING TRENDS

Significant updates, news, and trends we saw last week:

• The US changed course, announcing support for the TRIPS waiver, which would allow a temporary waiver of intellectual property for Covid-19 related drugs and vaccines (see above for our take on this).
• WHO approves Sinopharm for emergency use listing (EUL), making it eligible for COVAX supply.
• Numbers for low-income country vaccine purchases dropped significantly this week, reflecting the decision by the African Union to cancel its order of Oxford-AstraZeneca vaccine from the Serum Institute. Given the supply constraints facing COVAX, the AU decided to purchase from other makers, rather than compete with COVAX for the SII-AstraZeneca doses.
• Moderna agrees to supply COVAX with 500 million doses, including 34 million in late 2021.
• Novavax finalized their deal with COVAX for 350 million doses, with delivery scheduled to begin in Q3 of 2021 (these doses were already counted in COVAX supply forecasts but had not yet been finalized)
• Canada became the first country to approve use of Pfizer-BioNTech vaccine in children, ages 12-15. A decision on the same is expected by the US early next week.
• Pfizer-BioNTech increased their 2021 manufacturing projection to nearly 3 billion doses.
• Janssen (J&J) vaccine starting to ship from South African firm Aspen Pharmacare. Aspen has an annual capacity of 200 million doses. Half of the doses will go to the African Union, 31 million doses will stay in South Africa, and the remainder will be exported outside of Africa.
• The EU is negotiating the largest Covid-19 vaccine deal yet, for 1.8 billion doses from Pfizer-BioNTech.  
• Pfizer-BioNTech will donate doses to Olympic delegations to ensure immunity prior to the opening ceremony on July 23.

For more information on our research on Covid-19 vaccine supply, please see https://launchandscalefaster.org/COVID-19.