Sandra Sánchez-Oldenhage
President
PharmAdvice
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Expert Contributor

Double-Bind Dilemma on Waiving Vaccine Patents: Damned or Doomed

By Sandra Sánchez | Tue, 06/15/2021 - 14:50

Woefully, COVID-19 continues to wreak havoc worldwide. The coronavirus variant is now contributing to India’s surge and has already spread to the US, UK and elsewhere. More mutations will continue to emerge if the pandemic is not brought under control. While COVID-19 vaccination programs are well underway in the Western world, and life is moving slowly toward “normality,” for some countries, the pandemic is creating new levels of devastation.

The inequality in access to COVID-19 vaccines between rich and low-income countries has become impossible to ignore. According to UNICEF data, up to March 30, 86 percent of all doses given worldwide were administered to those in high and upper-middle-income countries, while just 1 percent of shots have been given to those in the world’s poorest. 

Not only have rich countries inoculated their populations 25 times faster than poor countries, but they have “refused” to share stockpiles until their own needs have been met. Meanwhile, poor countries have barely fully vaccinated about 2 percent of their population.

It is clear that COVID-19 vaccines are key to ending the pandemic. From a humanitarian, moral and pragmatic perspective, the countries must unite to ensure fair and rapid access to these vaccines, worldwide. As health and political leaders have stressed: no one is safe until we are all safe.

Closing this gap is a moral imperative and it is in everyone’s interest too. The severe shortage of vaccines coupled with the hoarding by wealthy countries, as the pandemic ravages poor nations, has brought the issue of patents to the fore.

In October, India and South Africa submitted a proposal to the World Trade Organization (WTO) to waive drug companies’ intellectual property (IP) rights for COVID-19 vaccines and treatments under the Trade-Related Aspects of Intellectual Property Rights treaty. The waiver would allow vaccine makers in poorer countries to produce vaccines without facing legal action from the companies that hold patents on the products.

Proponents of the waiver argue that waiving IP agreements “would expand global manufacturing capacity,” allowing production to ramp up “unhindered by industry monopolies that are driving the dire supply shortages and blocking vaccine access.” The logic of the argument seems clear and intuitive. Sure, Big Pharma would lose money but this is a pandemic, and human life comes before private profit.  

But it is not that simple. Unfortunately, waiving patents alone will not have a decisive impact on vaccine inequality, supply, or the health crisis. It may be morally correct but it will not solve the problem.

There is no question that boosting global manufacturing and distribution of vaccines should be an overriding priority but the argument over intellectual property is missing a crucial point. IP waivers, by themselves, will not get the job done. There are several costly and lengthy roadblocks to be addressed before global supply is solved and equitable vaccine access can be reached.

Satisfying this need is complicated. Sadly, technical, logistical, regulatory and trade issues are the biggest barriers standing in the way of increasing vaccine production and deployment. Expanding production capacity is thus not immediate, and certainly would not instantaneously happen just because IP protection has been waived.

Merely allowing other drugmakers to produce COVID-19 vaccines does not mean they could. Because of the technical complexity of manufacturing coronavirus vaccines, waiving intellectual property rights, by itself, would have little effect. Vaccines are harder to make than ordinary drugs. Instead, to produce the vaccine, manufacturers need access to the developer’s “soft” IP – the proprietary formulation, cell lines, manufacturing processes and so forth. Yes, you do need both – sharing technology as well as waiving IP. This decision of waiving patents alone will do nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials. 

The key point is that patents are not the only bottleneck, or even the central one. Even if governments waived patents, companies would still lack the capability to start production fast, the personnel, specialized technology, critical inputs and raw material, which are already in limited supply, regulatory approvals and manufacturing techniques to produce at scale. Then there are the justified concerns about maintaining quality control, which only adds time and cost to the endeavor.

Very few countries have the facilities or the capability to start this production fast. Factories and distribution networks would have to be built. But even if they did have the facilities, tech transfer is very difficult; it is not as if you have a formula and you just go and reproduce it. This process takes months, if not years. Transferring the manufacturing process from one facility to another always takes significant resources, as staff at the new site need to be trained in every aspect of production and quality assurance, plus certifications need to be obtained. On top of this, skills are also required in the clinical, legal, commercial, and regulatory aspects. Even grimmer, in some countries, the regulatory framework for vaccine production, quality and safety measures would have to be modified or created.

Furthermore, the mRNA vaccines – the ones most countries want – are especially hard to make because they are new technology that requires dedicated, costly, and scarce equipment.

It is worth mentioning that major COVID-19 vaccine makers, as well as several countries with a surplus of vaccines, have already made deals to contribute doses to the global vaccine-sharing initiative COVAX but vaccine hoarding, export bans and insufficient production capacity remain obstacles in the scheme’s ambitious goal to provide the world’s poorest countries with over 2 billion doses by the end of the year.

However, suspending or eliminating IP rights to vaccines could potentially remove the incentive for drug companies to conduct research in needed therapeutic areas or to take risks to find solutions for the next health emergency. At the end, it could undermine a vital global response and possibly compromise innovation. As explained before, waiving IP rights alone will not eliminate the current vaccine supply issues and in contrast could set a precedent to address health crises in the future. Patent rights are crucial to spur innovation and investment that leads to new products that address unmet medical needs. 

Waiving IP is unlikely to be a short-term solution to rapid vaccine manufacturing and deployment and could lead to long-term obstacles for vaccine development. The proposal may put companies off working on vaccines. The vaccine space has only recently grown from being a very narrow field, comprising just a few companies at the start of the century, so the threat of losing developers is real. We need to have as many incumbents in the field as possible to sustain diverse academic-commercial partnerships. As witnessed during the current pandemic, this diversity has already helped create a range of COVID-19 vaccines in record timing. We would not want to put this collaboration at risk in the future.

What should be done then?

Governments would need to act to eliminate all the other obstacles to increased production and distribution of COVID-19 vaccines. Extending strong financial support for the main developer corporations to expand their own production and distribution in low-income countries should be the first line of attack. But the fastest way to scale up will often be by repurposing other companies’ existing factories, under license and under the main developers’ supervision. Building entirely new facilities would take longer. Nevertheless, key to mention is that manufacturers are at an enormous disadvantage without the originator’s cooperation to help them set up their process and kick-start production. The process must go through a lengthy trial and error phase to avoid an expensive failure at the end.

Countries would have go the extra mile to work on accelerating regulatory approvals; and support enlarging the distribution capacity of low-income countries, many of which are struggling to get shots into arms even when they have the vaccines. Advocating for current and long-term commitments to increasing these skills and capacity around the world could be a more successful way of increasing the number of countries manufacturing vaccines in the long term, compared to waiving IP rights just like that. 

As we have seen throughout this year, even experienced companies are running into problems scaling up production. This only reinforces my comment that vaccines are extremely complex formulations. Given the emergency we are in, this is why companies that are normally competitors are working together to produce them. Some have even already shared technology with qualified partners around the world and could potentially be producing billions of vaccines this year – maybe enough to vaccinate the world – if governments helped them smooth out trade barriers, regulatory hurdles and removed disruptive export controls and restrictions on the raw ingredients and other materials required to produce doses. 

Such partnerships, including health innovations developed from academic research, rely on IP and are potentially open to give qualified commercial partners exclusive access to knowledge. Enacting an IP waiver risks bringing levels of uncertainty across the vaccine field and possibly other therapeutic areas, because without the exclusive rights to a product, it is less clear if developing it will lead to a return on investment.

Without a doubt, scaling up vaccine production is an imperative for equitable global access and an end to the pandemic. But it is smart incentives for sharing knowledge, not the indiscriminate elimination of intellectual-property rights, that will get us to the finish line.

Photo by:   Sandra Sanchez