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US support for vaccine waiver welcome, but more needed

Jomo Kwame Sundaram

KUALA LUMPUR -- Thanks to President Biden, the US now supports a suspension of intellectual property (IP) rights to increase vaccine supplies. However, without vaccine developers sharing tacit technical knowledge for safe vaccine mass production, it will be difficult to rapidly scale up vaccine output.

Waiver delayed is waiver denied

The CEOs of Pfizer and Astra Zeneca had recently asked the US President to reject the waiver request. Nevertheless, on 5 May, US Trade Representative (USTR) Katherine Tai announced US support for a vaccine waiver. The hope is that many, mainly rich countries will now stop opposing the developing country waiver proposal.

The World Trade Organization (WTO) Trade-Related Intellectual Property Rights (TRIPS) waiver request by South Africa and India also includes COVID-19 tests, treatments and personal protective equipment (PPE), albeit only for the duration of the pandemic.

Meanwhile, the WHO Access to COVID-19 Tools Accelerator (ACT-A) remains grossly underfunded, and thus unable to achieve most of its objectives. Many developing countries are still not even able to effectively do mass testing to ascertain those infected and follow up measures.

The developing world also faces huge supply gaps, and hence, long delays in treatment. Many ‘frontline workers’ in poor countries remain poorly protected. All this, of course, adversely compromises the world’s ability to contain the pandemic.

Foot dragging for profit

The waiver request is clearly very specific, modest and limited. Affordably producing the other non-vaccine needs is still desperately needed. Involving patents, they are immediately actionable. Hence, it is crucial for the US to support the full waiver request.

As the WTO waiver requires unanimous approval by its members, there is likely to be much foot dragging. Furthermore, even if WTO member states eventually reach a consensus on approving the waiver in principle, there is probably going to be further procrastination in negotiating details.

The WTO Director-General hopes to get a decision by December despite the likely difficulties of achieving consensus. Already, the European Union has registered doubts. Hence, many fear the new US position is unlikely to boost supply quickly.

Vaccine monopolies not yet IP dependent

Getting vaccine developers to actually share the technical information required to rapidly scale up vaccine production can be challenging. After all, no successful vaccine developer has joined the WHO COVID-19 Technology Access Pool (C-TAP) initiative to share such knowledge.

There are likely to be many changes to experimental vaccines in response to new knowledge, mutations and problems. Hence, IP per se may not be the most urgent obstacle to improving access to vaccines, even without developers ‘evergreening’ patents.

Patent details must be filed within 18 months, effectively an eternity in trying to contain the COVID-19 pandemic. But patent disclosures do not contain ‘trade secrets’ and other ‘tacit’ technical knowledge essential for quickly increasing vaccine output.

Vaccine profits kill

Pfizer’s CEO now projects a steady massive revenue stream as COVID-19 becomes endemic, e.g., requiring vaccine boosters. Unless the pandemic is globally contained, it will continue to threaten the world. While reducing the likelihood of severe infection, existing vaccines do not provide full protection against infection.

Vaccine developers -- especially the major pharmaceutical transnational corporations -- have already been dictating prices and other terms to customers. However, as their monopoly powers are not yet reliant on patents, suspending their IP rights does not ensure urgent access to COVID-19 vaccines.

Monopolies allow companies to almost unilaterally determine prices. ‘Super-profits’ can thus be secured with patents. Despite pioneering anti-trust law over a century ago, the US -- the largest producer and market for many patented products -- has no laws against ‘price gouging’, implying few checks on pricing practices.

Last week, Pfizer announced that prices of vaccines sold to the European Union will increase by 60% although development of its vaccine was heavily subsidised by the German government. Earlier, it announced an increase in sales revenue of over 70%, pushing up its share price and executive remuneration.

The current vaccination delay has been projected to cause an additional 2.5 million deaths! Delays are likely to allow more virus mutations, further setting back global herd immunity. This will mean many more infections and deaths as well as economic and other losses due to the pandemic and policy responses.

TRIPS discourages knowledge sharing

Until TRIPS, there were many technology transfer agreements with developing country governments, voluntarily negotiated by companies. But since 1995, TRIPS has induced more reluctance to share knowledge, retarding technological progress.

Refusal to share technology is the biggest stumbling block to rapidly ensuring global access to vaccines. Multilateral cooperation is urgently needed, not corporate or national greed.

But not a single major company has signed up to C-TAP, the WHO initiative for knowledge sharing to address the pandemic, ignoring Dr Anthony Fauci’s appeal to them to do so.

Meanwhile, Bill Gates and others misleadingly claim that developing countries do not have the capacity or ability to produce vaccines safely. Presuming developing countries’ lack of competence and capacity, without bothering to verify, provides yet another excuse for further delay.

In fact, many developing countries have previously produced vaccines. Of course, not all will be able to produce particular vaccines due to their specific technical requirements.

Existing COVID-19 vaccines are still experimental, only receiving conditional approval for emergency use. The urgent need to mitigate the severity of pandemic infections with such vaccines, after only Phase Two trials, is also the pretext for indemnity clauses in sales contracts.

Globalisation in recent decades has involved internationalisation of supply chains, with even high-tech corporations establishing sophisticated facilities in poor developing countries. But suddenly, developing countries are all dismissed as wanting.

Accelerate vaccinations for all

Late last month, President Biden reiterated his presidential campaign pledge to share COVID-19 “technology with other countries” and to “ensure there are no patents to stand in the way of other countries and companies mass producing those life-saving vaccines”.

The Biden administration must use its discretionary powers to accelerate needed progress. Besides making clear US WTO TRIPS waiver support for tests, treatments and PPE, the US has to compel vaccine companies to share the knowledge needed to quickly scale up safe vaccine production.

The 1980 Bayh-Dole Act applies to Moderna’s vaccine, publicly funded by Operation Warp Speed. The US government can require Moderna to fully honour President Biden’s original promise to share vaccine technology. After all, Moderna has promised not to profit from the pandemic.

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