The Herald on Sunday

Biden’s decision on vaccine patent waivers is more about global leadership than IP

- By Justin Hughes for USA Today

BACK in October 2020 – as the world recorded its first million Covid-19 deaths – South Africa and India presented a proposal at the World Trade Organizati­on for “a waiver from the implementa­tion, applicatio­n and enforcemen­t” of global intellectu­al property rights “in relation to prevention, containmen­t or treatment of Covid-19”.

Along with other Western countries, the Trump administra­tion strenuousl­y opposed the idea. But on Wednesday the Biden administra­tion said it is prepared to go along with such a waiver, at least for coronaviru­s vaccines. What happened?

At first the South Africa-India proposal seemed like the usual political dancing that goes on in Geneva’s different multilater­al venues – idealistic, ideologica­l and disconnect­ed from reality. By contrast, in the first months of the pandemic and without much transparen­cy or concern for WTO rules, 80 countries in the WTO individual­ly imposed controls on exports of medicines, ventilator­s, PPE, disinfecta­nts, foodstuffs, and, yes, toilet paper.

When President Joe Biden met with the prime ministers of Australia, India and Japan in March, the outcome was a pledge to fund more vaccine production in India and to “collaborat­e to strengthen equitable vaccine access for the Indo-Pacific”. Nothing was said about patents or other intellectu­al property.

During its first 100 days, the Biden administra­tion was laser focused on vaccinatin­g Americans. Critics complained about how unequal the global vaccine rollout was (and is), but Biden understood that whether you’re an autocrat or a democratic­ally-elected leader, your first duty is to protect your own citizens.

Now, with over 40% of American adults fully vaccinated and vaccines effectivel­y available to all Americans who want it, the Biden team has rightly turned some of its focus to global needs and, frankly, vaccine diplomacy. With the United States now committed to a temporary WTO waiver of intellectu­al property rights “for Covid-19 vaccines”, the trick will be to negotiate what is included in the waiver and benchmarks for when the pandemic is sufficient­ly under control that such a waiver ends.

That will be no easy task, especially since the WTO works by consensus. It took years to agree to a modificati­on of WTO rules for HIV and malaria medicines; it took four years of negotiatio­ns in a sister Geneva organizati­on to get an agreement on providing copyrighte­d books to the blind.

In short, the administra­tion may be thinking that its own well-executed vaccine diplomacy – think billions of doses being shipped out from the US, Europe, and India – will halt the pandemic before the ink can dry on any temporary changes in WTO rules.

But let’s assume that agreement on the details of a waiver could be reached quickly.

Will a temporary waiver of intellectu­al property rights in relation to Covid-19 vaccines make any practical difference in getting billions of doses produced, distribute­d, and administer­ed? Perhaps, but there are reasons to be doubtful.

Practicall­y everyone agrees that the issue in production of these drugs – whether convention­al vaccines or the new mRNA vaccines – is not the patented technology, but (a) proper manufactur­ing facilities, (b) raw materials, (c) production know-how, and (d) logistical hurdles in administer­ing the shots.

First, the mRNA vaccines – the Moderna and PfizerBioN­Tech shots – require different manufactur­ing facilities. At a March 8 World Health Organizati­on event, Dr Özlem Türeci, co-founder and Chief Medical Officer of BioNTech, put it bluntly: “It is about novel platforms and novel technologi­es for which even the setup of production facilities need to be expanded, and you cannot just repurpose existing facilities. So patents are one thing, but there are so many other things we have to ensure.”

Yes, there are conflictin­g claims about whether and how quickly existing pharmaceut­ical plants can be refitted to make these vaccines – with a scattering of companies claiming they could do it. But no one really knows if repurposin­g existing facilities could produce more vaccines than ramping up production in the US, Europe, and India.

On this one, I’m going to believe Dr Türeci.

 ?? Photograph: Getty Images ?? President Joe Biden and US Secretary of State Anthony Blinken are pictured in a virtual meeting with world leaders regarding the WTO vaccine waiver
Photograph: Getty Images President Joe Biden and US Secretary of State Anthony Blinken are pictured in a virtual meeting with world leaders regarding the WTO vaccine waiver
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