To Waiver Or Not To Waiver? The COVID-19 Vaccine and Intellectual Property Debate:

The debate surrounding intellectual property rights and life-saving pharmaceuticals is nothing new. As we reach the 16-month mark of the global COVID-19 pandemic with only 4.4% of the world population fully vaccinated, this debate has yet again arisen its head – causing fierce and fiery international contest, with relatively distinct teams: wealthy, developed nations vs poorer, developing nations.

From Biden to Boris, Macron to Merkle, and even from Putin to the Pope(!) – the world’s leaders have all given their two pence on the issue thus far, but with the debate still developing and its arguments still active, the question remains: Should there be an international waiver on COVID-19 vaccine patents?

The Basics:

What is a Patent?

Pharmaceutical corporations producing vaccines usually safeguard their work through powerful intellectual property mechanisms such as patents. Such protections prohibit the unlawful infringement of original innovations and gives the companies an exclusive monopoly on production on a patented product or process.

However, patent protection is only temporary (patents last a maximum of 20 years in the UK). Patents are also territorial in nature, meaning that a patent is only enforceable in the country that it is registered in.

Patents allow creators to be financial rewarded for their work, and incentivises innovation and creation – one driving factor behind the speedy search for a COVID-19 vaccine!

What is a Waiver?

In the COVID-19 context, a waiver would help nations overcome stern legal IP hurdles by preventing companies such as Pfizer, AstraZeneca, and Johnson & Johnson from gaining a monopoly. This would allow countries to produce their own cheaper, generic COVID-19 vaccines and treatments.

The TRIPS Agreement:

The Trade Related Aspects of Intellectual Property Rights Agreement (that’s a mouthful!) is an international trade agreement between each of the World Trade Organisation’s (WTO) 164 members, and forms one of the three founding and fundamental elements of the WTO.

It is through a waiver of this agreement that COVID-19 vaccines would become temporarily unpatentable and therefore, open for reproduction by all nations. Although TRIPS conditions have been waived before, if accepted and approved, this would be the most expansive waiver since the TRIPS’ 1995 enactment!

With the basics now covered, let’s get into the argument of both sides – and their “teams”

Arguments FOR a Waiver on COVID-19 Vaccine Patents:

Those in favour of an international waiver on COVID-19 vaccine patents forward that, amidst a major global pandemic, the world must utilise all the means at its disposal together to end the covid-crisis ASAP! The submission is that companies utilising IP to protect their vaccine from replication by others are ultimately obstructing equitable, universal access to COVID-19 vaccines.

Advocates in this corner include WHO, India, South Africa, and over a 100 other (mostly developing) countries. In a “monumental” move, the United States joined this side within the last month, and China is now also open to talks, both of whom were previously against a waiver on the TRIPS agreement.

And so, the “teams” begin to take shape, and one can’t help but notice the financial lopsided-ness (with the exception of the US and China) of this particular side.

Why Waive COVID-19 Vaccine Patents? The Submissions:

• Emergency circumstances: As we are amidst an international health crisis infecting 158 million people globally, the call for a dissolution of IP rights attached to the covid vaccines has been a popular argument. However, a waiver isn’t just a simple, trivial preference of states – it is a response to an unforeseen international emergency and an attempt to save millions of lives globally.
• Easier access to vaccines in poorer, developing nations: Many lower-income nations are currently facing stark vaccine shortages. Thus far, 1 in 4 people in high-income countries have received a vaccine shot, compared to 1 in 500+ in lower-income nations. Very telling, don’t you think? The argument here is that prohibiting the COVID-19 vaccines from being patented or protected by other IP protections (like undisclosed information and copyright) is the only way to ensure fair and affordable access for all to COVID-19 drugs, and that the current IP protections under TRIPS are operating as a barrier to accessing critical products required to tackle the pandemic. Approving a patent-waiver would allow states to copy patented drugs, processes, and pharmaceuticals to make their own versions, boosting the global production of vaccine doses while simultaneously reducing their cost. Therefore, a patent-waiver could be a crucial element in improving the vaccination rate in poorer countries and balancing the scales – ensuring that rich and poor alike both have equal access to potentially lifesaving COVID-19 drugs.
• Global herd immunity: This submission can be summed up with the saying: “strength in numbers”. There are real concerns that allowing the virus to spread in poorer nations enhances the risk of new COVID-19 mutations cropping up that may be vaccine-resistant – rendering our current vaccines useless. And just think where that would leave us…
• Preventing prolonging the pandemic and its effects: Refusing to proactively address the international vaccine shortage through a waiver of IP vaccine rights means that states are wilfully prolonging the COVID-19 pandemic and all its consequences. Waiving such protections would open manufacturing and distribution capabilities, enabling populations to become vaccinated quicker. This would assist in tackling the pandemic and restoring the damage it has done.
• Protection of life, not commerce and systems: Does refusal of a COVID-19 vaccine patent-waiver mean that IP systems, commerce and innovation are prioritised over the lives of real people? A waiver would increase timely access to lifesaving medical tools – but contenders to the waiver, looking at the bigger picture, value upholding commerce and IP systems over the health of real people in the debate. The argument is made that such a refusal signifies a startling statement that even amid a grave global health crisis, legal protections, policies, and procedures prevail, in the interest of companies, and to the demise of the average person, and must be rectified.

Arguments AGAINST a Waiver on COVID-19 Vaccine Patents:

Not everyone thinks that an IP waiver is the solution. As you can imagine, members of this corner are largely the vaccine-producing pharmaceutical companies, many of whose share price already dipped this month since the media reported that numerous governments were discussing plans to waive patent protection on the vaccines (Moderna fell a whopping 8.9%!).

Despite their willingness to engage in talks, the EU and wealthy, industry-driven nations such as the UK, Germany and Switzerland have also spoken out against a patent-waiver, alongside powerful groups like Big Pharma – once against highlighting contrast in wealth, power, and influence of both sides.

Why Should We Not Waive COVID-19 Vaccine Patents? The Submissions:

• Disincentive for future innovation: The biggest hurdle against a patent-waiver is that the removal of particular IP protection means that companies cannot reap the financial rewards of their innovative endeavours. Certain IP protections, like those under TRIPS, provide creators with economic certainty through preserving competition and enhancing market value of the patented-product. This incentivises companies to develop new, cutting-edge drugs, technologies, and products. But it’s feared that once those protections are lost through a waiver, such a move would disrupt market forces and undermine commercial and innovative efforts towards new vaccines. Additionally, due to the vague wording of TRIPS, a waiver would impede innovation in a range of industries – not just the covid-driven pharmaceutical sector. It’s these competitive financial incentives that drove the creation of COVID-19 vaccines at such a quick, and successful international pace in the first place. Rather than focusing on science and innovation to solve the COVID-19 crisis, anti-waivers believe those seeking to waive a patent are actually undoing the very system that exists to stimulate development in times of global crises, and therefore, are impeding genuine efforts towards tackling the pandemic.
• Doubts concerning production and manufacturing capability: The manufacturing processes required to make a vaccine are complex, and the removal of protection doesn’t guarantee speeding COVID-19 vaccine production – companies must have the tech, skills, experts, factories and the materials to actually produce the vaccine. Supporting evidence for this can be seen in the 2020 Johnson & Johnson study, where the company assessed 100 potential manufacturing partners but concurred that only 10 had the ability to make the vaccine dose. (This was no doubt a speedy assessment though, as it traditionally takes 5-7 years for a pharmaceutical production partner to be approved). Furthermore, Moderna waived their patent rights in October 2020, but recently remarked the scarcity of corporations able to replicate and obtain approval of the shot.
• Quality and safety issues: Several anti-waiver advocates have also raised concerns about whether opening vaccine production to all would compromise the quality and safety of the drugs. If you were given a Mary Berry recipe, but were not told the ingredients or the method, could you make it as well as Mary Berry herself? Probably not – I definitely couldn’t! This corner fears that sharing IP attached to COVID-19 pharmaceuticals could lead to quality issues, safety concerns and inadequate production, and should not be left to a free-for-all.
• Creates new set of trade and policy exchanges: There’s worry that waiving TRIPS will have no effect on actually increasing vaccine production but will generate fresh trade and policy issues. Firstly, the vague wording of the proposed TRIPS waiver encompasses not only the COVID-19 vaccines, but any drugs and medicines used to treat patients with COVID-19, meaning that even drugs in existence before the pandemic could lose crucial IP protections. The language is so broad that there are also concerns the waiver may even extend to non-drug products, such as marks and respirators, raising stern fears of IP abuse by foreign companies. Secondly, a waiver would require months of negotiation and would need a unified agreement from all states of the WTO, raising all sorts of international trade and policy challenges.
• A waiver cannot resolve the vaccine shortage: Waiver-critics argue that a waiver does not necessarily address the true sources of the current vaccine shortage: supply chains, trade barriers and scaling up production. Even if new companies and factories began to produce a vaccine, it would be constrained by numerous bottlenecks, such as export controls delaying trade and the restricted supply of certain raw materials due to supply chain issues. In reality, a free-for-all vaccine-production would only further exacerbate this problem, as more companies would be looking for the same limited supply of materials that simply aren’t there, and increased trade would generate increased delays – working as a hindrance to vaccine production rather than a help. Thus, it’s debated that access to IP is not what’s impeding COVID-19 vaccine production, but other logistical factors at play, including the unwillingness of richer countries to share vaccines and the general challenge in scaling up production and distribution. Therefore it follows that an IP waiver is not what’s needed for these issues to be resolved.

Concluding Thoughts:

Disparity in access to the COVID-19 vaccines between rich and low-income countries remains the central issue to both sides of this debate. While there is some understandable argument to be made for market-incentives, there is no doubt that the practice has inhibited equitable access to vaccines. This has been highlighted by recent UNICEF statistics that reported while 86% of administered doses thus far have been given to high and upper-middle income nations, only 1% of vials have been handed out to the 29 poorest countries in the world. The hoarding of lifesaving vaccines by wealthier countries only worsens this, leaving disadvantaged, developing states struggling to obtain doses and unable to legally reproduce them.

This raises wider questions into the efficiency of the current vaccine research and development structure in dominant jurisdictions, who use the public purse to fund the groundwork of vaccine R&D, before releasing it to the industry and letting companies fight for the rights – with market forces their referee. The pandemic has shown that this model needs vast restructuring. In the meantime, one wonders about the possibility of a collaborative, international, publicly-financed push towards producing a global vaccine. Here, the public would be the “company” shareholders, using common publicly-financed labs and resources. This would, hopefully, reduce the likelihood of corporate “villains”, selfishing stashing the vaccines for themselves. Could this be an alternative solution?

The fight against COVID-19 has highlighted the power (speedy vaccine production) and the pitfalls (unequitable vaccine distribution) of intellectual property law amidst an international emergency.

There’s some truth in saying that nobody is protected until everyone is protected. But is an intellectual property waiver on COVID-19 vaccines the solution? Is it necessary? Or should there be other avenues pursued to maximise global protection from the virus?

What do you think?

Chantelle is a recent BCL graduate from the National University of Ireland Galway, and is currently undertaking a Masters of Law. Chantelle has a keen interest in intellectual property law, international business & human rights, and international public law. Chantelle intends to pursue her professional solicitor qualifications and has aspirations to work internationally in the field of business and human rights.