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Biden agreed to resign vaccination patents. However does that enable you to get the cans out sooner?

The Biden government has announced that it will work with the World Trade Organization (WTO). Negotiating a deal to suspend the intellectual property rights associated with the Covid-19 vaccines – a surprising move for the government, which initially refused to take such a move.

The reversal came as the death toll from Covid-19 increased in India and elsewhere. The US vaccination program is going well, but much of the world is still waiting for vaccines, which has made the role of drug companies and intellectual property in global vaccination efforts an issue of intense debate.

They all agree on one thing: there is much work to be done to speed up vaccine production and vaccinate the world. Patents are high on the agenda at this week's WTO General Council meeting. India and South Africa have asked the WTO to abandon the intellectual property (IP) rules on the vaccines so that more organizations can manufacture them.

The case of exemptions is simple: by surrendering intellectual property rights, more companies could get into vaccine manufacturing, remove supply bottlenecks, and help with the monumental task of vaccinating the world. The case against them: acquiring intellectual property rights from vaccine makers penalizes them for the work society should zealously reward and negatively impacts similar future investments. Opponents have also argued that taking this step would do very little to address the vaccine supply issue, largely due to factors such as raw material scarcity and the incredible complexity and rigorous requirements of the vaccine manufacturing process.

The debate has raged for the past few weeks – with Bill Gates a particularly outspoken defender of intellectual property rights – but has recently intensified as the Covid-19 crisis deepens in poor countries.

With Wednesday's announcement, the US is clearly registered for such a waiver – a reversal from its previous position. "The government is a firm believer in the protection of intellectual property, but supports the removal of this protection for COVID-19 vaccines in the service of ending this pandemic," US sales representative Katherine Tai said in an announcement.

Done right, making the IP associated with these vaccines available to the world can be a good first step – the more information that's shared here, the better. But it's a small thing at a time when bigger commitments are required. Waivers may help, but ending the pandemic around the world will require much more.

While the Biden government's decision is a positive development, intellectual property debates can also distract the world from the policies that could really end the pandemic: building our vaccine manufacturing capacity, obliging us to buy the cans, the the rest of the world needed. and work directly with manufacturers to remove any obstacle in their path.

Patents, trade secrets, and everything you need to know to make a vaccine

To understand what the Biden government's move means, it is important to understand the role patents play in the manufacture of vaccines.

When a drug company makes a drug, it counts for a patent. The patent protects his intellectual property for a set period of time, typically 20 years, after which other "generic" versions of the drug can be made, which are generally much cheaper.

Easy enough right?

With Covid-19 vaccines – and many modern pharmaceutical products – the situation is much more complicated.

First, a modern vaccine is often on a network of diverse intellectual property rights, with the vaccine manufacturer having acquired the rights to some elements of its vaccine Vaccine from another drug company or researcher.

For example, the lipids (shells that contain the mRNA molecules) used in mRNA vaccines are licensed to Pfizer and Moderna, but the rights to them are owned by other companies. Vaccine company patents are real a pretty small part of what's going on in this ip web. It's better to talk more generally about all of a vaccine's intellectual property: license agreements, copyrights, industrial designs, and trade secret laws.

The other complication is that while there are legal barriers to copying the existing vaccines, that's not what This makes it really impossible for other companies to start manufacturing. Experts I spoke to stressed that, in general, all of the world's supply of critical raw materials is already going into vaccines and there are no factories "sitting idle" waiting for permission to start manufacturing. In addition, changing a factory's processes to produce a new type of vaccine is a difficult and error-prone process. This went wrong, for example, when a facility that switched to Johnson & Johnson vaccines spoiled millions of doses.

Moderna is an instructive example here. The pharmaceutical company made a lively announcement in the fall that it would not enforce its Covid-19 vaccine patents. Despite this move, there is still no generic Moderna vaccine, and none of the experts I spoke to believed one was on the horizon. (It turned out to be good for Moderna – get the PR bump out of the announcement without suffering the financial penalties.)

In the long run, a world where everything Moderna, Pfizer, Novavax, AstraZeneca, and Johnson & Johnson knew about making their vaccines were freely available online would make it easier for other manufacturers to make vaccines. This would also make them cheaper and more accessible to countries struggling to get them.

At a meeting this week, the WTO is examining applications from India and South Africa to waive the patents for the duration of the emergency. Most countries have their own patent laws, but international agreements on how to enforce their patents – and disputes when countries suspect each other of ignoring IP concerns – are usually brokered by the WTO.

Although the announcement by the Biden administration is a win for the pro-waiver side, the US is not the only country that needs to be persuaded for the WTO to agree on a patent waiver. For their part, the EU, Great Britain, Japan and Switzerland have expressed their opposition. But the US has an influence on these debates, and the U-turn by the Biden administration could well be decisive.

The case against IP waivers

Many global health researchers, Bill Gates (and the Bill and Melinda Gates Foundation), and some members of the Biden administration have vocalized against the abandonment of intellectual property rights to the Covid-19 vaccines, generally with two arguments.

First, they argue society should want drug companies to invent vaccines like they did for Covid-19, and waiving rights will make this less likely in the future by making similar projects less attractive investment targets. Second, they claim patent waivers will set this precedent without speeding up vaccine manufacturing.

"That would be a terrible precedent for the industry," Geoffrey Porges, research analyst at investment bank SVB Leerink, told the New York Times. “It would be extremely counterproductive in the extreme because it would tell the industry, 'Don't work on something that is really important to us because if you do, we'll just take it away from you. & # 39; "

Perhaps the most prominent among those who have taken this stance is Bill Gates. "What is holding things back in this case is not intellectual property," Gates said in a controversial interview on Sky News. "It's not that there is an unused, licensed vaccine factory that makes magically safe vaccines. You have to run the experiments on these things, and every manufacturing process has to be looked at very carefully."

Instead of intellectual property, so Gates' argument, the problem is deep technical know-how: the important thing Details of the Process that goes into making a vaccine. This is a particularly critical problem for the Pfizer and Moderna mRNA vaccines, which were manufactured using a new technology. (The mRNA vaccines give the body instructions on how to make the spike protein on the coronavirus. From there, the body can recognize it and fight it off. This is different from the vaccines we are all familiar with and the ones Exposing patients to a dead or weak virus, or part of a virus, to boost the immune system.)

Moderna and Pfizer not only know the exact formula of their vaccines, but also know a myriad of procedural details to successfully manufacture them: device modifications, temperature settings, troubleshooting common problems, different types of errors and what problems they indicate, etc. By not using IP protection this information is not available.

This is not an instance of Bill Gates posting a message. it was consistently the attitude of his foundation. Last year Oxford was persuaded to partner with AstraZeneca in vaccine production. This partnership has been heavily criticized for holding back the potential of the Oxford vaccine for wider and cheaper sharing as AstraZeneca expanded production more slowly than hoped.

Why would global health attorneys want partnerships with for-profit pharmaceutical companies?

They claim that if the world predictably foregoes patents on sufficiently critical drugs and vaccines, it will be harder for companies to attract investment as they work on these issues. And vaccines that have been developed without a pharmaceutical partner – for example by a university – may not be lucky enough to be manufactured on the required scale. "At our foundation, we believe IP is fundamental to innovation, including the work that helped make vaccines so quickly," wrote Mark Suzman, CEO of the Bill and Melinda Gates Foundation, in February.

"At the start of the pandemic, the Gates Foundation had many bright minds thinking about how to structure funding and incentives to accelerate vaccine development," said Justin Sandefur, a senior fellow at the Center for Global Development, a nonprofit think tank Based in London and Washington, DC, told me. “To their credit, they worked on it very early on. You have convinced yourself that IP is important. "

The Bill and Melinda Gates Foundation isn't the only one who believes intellectual property matters, or waivers would be a bad idea. Vaccine manufacturers "are already working closely with competitors and generic drug companies, including through voluntary licensing, contract manufacturing and proactive technology transfer," argued Rachel Silverman of the CGD in a debate hosted by the CGD on renouncing intellectual property. "Watering down that commercial incentive can diminish their interest in voluntary horizontal collaborations, which are already what matters."

The case for IP waivers

The case for IP waivers is that while there are definitely many other barriers to vaccinating in the world, it is better to remove even one than to leave it in place. As part of an unconditional effort to get the vaccine to everyone, the world should do everything in its power to overcome some of the restrictions that are delaying vaccines, even if it will take additional steps to make this particular move have a big impact Difference.

"It is a question of where the burden of proof is in this situation," Sandefur told me. “The standard line you hear is, 'Well, there aren't that many factories that can. & # 39; And I can't refer you to the (specific) factory ready to produce AstraZeneca, but we want to release the market to make the discovery happen. "

If you really want to get something done, it makes sense to solve all sorts of problems, even if that isn't the biggest or most significant obstacle. And while the vaccines are really incredibly difficult to make, those from Novavax, Johnson & Johnson, and AstraZeneca aren't quite as unreachable as the mRNA vaccines from Pfizer and Moderna, and years of that battle lie ahead of us Too difficult or even impossible to dismiss, pull through and get generics off the ground a little faster.

What is implied in this argument is that there is actually little chance of seeing any benefit from waivers. However, proponents of waivers argue that there isn't much of a chance of harm either. If it is true that other companies cannot easily manufacture the vaccines, the IP waivers will not undercut the sales of the existing companies or affect future research and development. Conversely, IP waivers can only detract from profits for existing companies if they are successful in incentivizing more vaccine development. If that actually happened, it would be worth it.

Some proponents of IP exemptions have argued that the debate is essentially a matter of class struggle: Gates and Big Pharma versus the global poor. But there are passionate advocates of poor people's interests on both sides of the IP waiver debate: Many experts who have spent their careers fighting for the world's poor also see IP waivers as a counterproductive step. Bright minds disagree on whether this approach will actually improve access to vaccines where it is most needed and whether it will affect our preparedness for the next pandemic.

What the intense focus on IP waivers is missing

Whether they were for or against IP exemptions, everyone I spoke to agreed on one thing: IP exemptions are far less important than just funding poor countries' direct access to vaccine.

Many people who do not speak out against IP waivers still warn against advocating for them as it could distract from better solutions. Silverman called advocacy for waiver "an inefficient use of limited global advocacy / political capital for vaccine access". IP is "not the point in the medium term," tweeted Amanda Glassman, director of global health at CGD, on Wednesday.

Her focus: calling on governments to give Covax money so that there is a clear demand for more production. Covax is said to be buying vaccines for the world but has found them rare. The vast majority of vaccines were distributed in rich countries. Despite the devastating consequences of the pandemic in poorer countries, the richer countries have been stingy with Covax and more resources are needed to be successful.

"I think giving up IP protection is almost as much a public relations move as anything else," told me Derek Lowe, a medical chemist who works on drug discovery in the pharmaceutical industry. "There are a lot of people who believe that the only thing holding back the generic vaccine is the patents. The Biden government said," Okay, let's see. "

Indeed, the attention the patent waiver debate has garnered over the past week has obscured an important point: there is no ploy to make vaccines widely available. This requires commitments to buy billions of cans once companies make them, and months of hard work to remove the supply bottlenecks that are slowing production. Even if companies can make generic versions of vaccines, they won't do so without dedicated buyers – and this is where it becomes really important to help poor countries buy.

In other words, It would be a mistake to go on a winning lap after the Biden administration announced it. Even when legal obstacles are addressed, myriad practical obstacles remain between here and vaccinating the world. If IP waiver is a first step, great. However, there are still many steps to be taken to conquer Covid-19 in all parts of the world.

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