{"id":4217,"date":"2021-05-12T10:16:11","date_gmt":"2021-05-12T08:16:11","guid":{"rendered":"https:\/\/sg.se\/?p=4217"},"modified":"2022-10-24T14:49:04","modified_gmt":"2022-10-24T12:49:04","slug":"in-the-fight-to-vaccinate-the-world-a-global-patent-waiver-misses-the-point","status":"publish","type":"post","link":"https:\/\/sg.se\/en\/in-the-fight-to-vaccinate-the-world-a-global-patent-waiver-misses-the-point\/","title":{"rendered":"In the fight to vaccinate the world, a global patent waiver misses the point"},"content":{"rendered":"\n

After a challenging 18 months, the coronavirus pandemic is beginning to be brought under control in developed countries where the rollout of vaccines against COVID-19 has been successful. However, the question of access to vaccines worldwide, in particular in the developing world, has now become paramount. Many of the vaccines that have been successful in developed countries are protected by intellectual property rights, which enable companies producing the vaccines to limit their use. But are these rights stifling the production and distribution of vaccines in places with the most need, and will the proposed global patent waiver help to increase access in those countries?<\/em><\/p>\n\n\n\n

Protecting vaccines with intellectual property<\/strong><\/p>\n\n\n\n

Vaccines work by simulating the threat of an infection to provoke a response from the body\u2019s immune system. This response enables the body to recognise and respond to agents related to the disease that the body encounters in future, and thus prevents infection and spread of the disease in the community. This is the sort of innovation that is protectable using intellectual property rights (IPRs).<\/p>\n\n\n\n

Various IPRs are applicable for vaccines and vaccine-related technologies, not least patent protection. Patents can cover a vaccine\u2019s active components, such as virus particles or vectors, or the vaccine\u2019s formulation, including the combination of medicinal components. They may also cover methods of manufacture, devices for vaccine administration or dose regimens. In order to get a patent, an invention has to be disclosed in sufficient detail to be reproduced. In return, the patent gives the patent holder a short-term monopoly (usually at least 20 years) in markets where the patent has been granted.<\/p>\n\n\n\n

There are also other forms of protection available to vaccine developers. For example, it is not uncommon that know-how related to the vaccine manufacturing process is protected using trade secrets. Trademark protection allows companies to protect their brand. Other protection includes clinical test data protection, which may prevent third parties from using clinical trial data to gain marketing approval for the manufacture of generic products.<\/p>\n\n\n\n

So vaccine developers can protect their technology using various IPRs. But why do they want to do this, especially during a global pandemic?<\/p>\n\n\n\n

The patent bargain<\/strong><\/p>\n\n\n\n

Patents allow their owners to control production of protected technology in certain jurisdictions in exchange for disclosing how that technology works. Whilst vaccine formulations could be kept as trade secrets, there are two main motivations for vaccine producers to patent their technology \u2013 safety and reward.   <\/p>\n\n\n\n

All coronavirus vaccines are complex biological products, and therefore not trivial to reproduce. In addition, many currently approved COVID-19 vaccines are highly sensitive to contaminants and require strict temperature control. This means that significant know-how and investment are required to ensure the clinical safety and efficacy of any reproduction of the vaccines. Patents prevent manufacturers without these resources from bringing potentially unsafe vaccines to market. By owning a patent protecting their technology, vaccine developers can employ commercial devices such as licensing, where use of the methods and formulations covered by the patent is allowed in return for a royalty, to control vaccine production and distribution by careful selection of licensees. This control can help to ensure safe and high-quality rollout of vaccines by trusted partners.<\/p>\n\n\n\n

Furthermore, patents allow their owners to generate capital, for example through marketing their products or licensing the technology to other manufacturers. In the case of vaccine developers, this allows them to obtain a return on the significant R&D investments required for vaccine development. This capital can be used directly to fund further research, and acts as an incentive for companies to invest time and resources into vaccine development. Absent this incentive, vaccine innovation may occur at a much slower speed, if at all.<\/p>\n\n\n\n

There is undoubtedly a need to speed up production and distribution of COVID-19 vaccines in a safe and efficient manner. Whilst the monopolies provided by patents have advantages for patent owners, they would appear restrict the rollout of vaccines around the world. Is this really the case and, if so, what can be done?<\/p>\n\n\n\n

Global patent waiver: a short-sighted solution<\/strong><\/p>\n\n\n\n

Last year, a proposal<\/a> led by India and South Africa was made to the World Trade Organisation (WTO) to allow the suspension of patents and other IPRs linked to the response to COVID-19 until global immunity is achieved. The proposal was initially resisted by higher-income countries, but a waiver of vaccine-related IPRs has now been backed by some significant stakeholders, including the US government, the EU, and Tedros Adhanom, Director-General of the World Health Organisation (WHO). It is understood that over 100 of the 164 WTO member states are currently in favour of this \u201cpatent waiver\u201d. However, whilst the proposal has honourable intentions, there are serious questions over whether such a waiver would address the underlying issues.<\/p>\n\n\n\n

On its face, it seems clear that an enforced waiver on patents would permit an increase in the production of vaccines, as some of the legal restrictions on potential manufacturers would be lifted. However, these legal restrictions are not a factor in many areas of the world that currently have the most need for vaccines. Patents are granted on a country-by-country basis, and many of the jurisdictions where patent protection is generally sought and enforced (i.e., the developed world) have already seen a successful rollout of vaccines. In many countries in the developing world, very few are granted each year (for example, in Chad<\/a>, a single patent was granted in 2019, and in Eritrea<\/a>, none at all). It is extremely unlikely that patents protecting vaccines would exist or be enforced in these countries. As such, patents are not a significant obstacle to vaccine rollout.<\/p>\n\n\n\n

Even in countries where patents are a more important part of the economic landscape, there are questions about whether vaccine manufacture could take place safely and efficiently, even with a patent waiver. In many of these countries, the technology and know-how required to produce the vaccines may be lacking. Without the proper regulation that is provided by the patent system, there is a risk that clinical safety is compromised. Furthermore, access to the raw materials needed to produce the vaccines is not necessarily available in the required quantities. These issues may lead to a lack of companies willing or able to scale up manufacture in the manner required, even if a patent waiver was enforced. Indeed, whilst Moderna pledged not to enforce its COVID-19 vaccine patents while the pandemic lasts, it has recently noted<\/a> a lack of companies willing to take advantage of this.<\/p>\n\n\n\n

A patent waiver would also mean that companies that have invested in vaccine development are not adequately rewarded for their dedication of time and resources. Without such a reward, there is a risk that these companies are discouraged from investing in response to future health emergencies. If these companies know that there is little reward for developing effective vaccines quickly, they would have little motivation to do so when the next pandemic comes around. Any disincentives against investment in vaccine development now could therefore have a significant negative effect on global health beyond the current pandemic. Having also seen the SARS and MERS epidemics (caused by other coronaviruses) in the last 20 years, it is possible that the next emergency is just around the corner, and there will be a need for these companies to provide the necessary technology.<\/p>\n\n\n\n

So if a global patent waiver is not the answer, what else can be done to accelerate global vaccine production and distribution safely and efficiently?<\/p>\n\n\n\n

Alternative solutions<\/strong><\/p>\n\n\n\n

As far as IPRs are concerned, one option is the use of voluntary licensing. This would allow vaccine developers to share the know-how required to produce their vaccines with other manufacturers at low to zero cost. In this way, developers have oversight over how their vaccines are being produced, ensuring safety and efficacy, whilst lightening the financial burden on the licensees. AstraZeneca has already signed local manufacturing agreements with some of the worst affected countries such as India and Brazil, and other vaccine developers could well follow suit. Such agreements have already successfully been used to combat the HIV epidemic, where generic manufacturers were able to produce and sell low-cost versions of HIV drugs in the developing world. However, any licensing agreement is contingent on vaccine developers having rights in place to license, which is not the case in many countries.<\/p>\n\n\n\n

A similar but more drastic option is the ability of individual governments to issue compulsory licenses of granted patents. Under a compulsory license, a national authority grants permission to other manufacturers to implement the protected invention provided certain conditions are met. This mechanism already exists without the need for the proposed global waiver. However, as with voluntary licensing, many countries may simply lack the IPRs to license in the first place. Furthermore, the use of compulsory licensing may not be as cost-effective as voluntary licensing, and could dissuade developers from investing in and developing health technologies in a similar way to a global waiver.<\/p>\n\n\n\n

Outside of the use of IPRs, knowledge-sharing projects such as COVAX<\/a> may represent a way forward. The COVAX project, co-led by the WHO, aims to accelerate the development and manufacture of COVID-19 vaccines through collaboration, and to guarantee fair and equitable access for every country in the world. COVAX provides a platform to support the research, development and manufacture of vaccines, and assures that participating countries, regardless of income levels, will have equal access to these vaccines once they are developed. However, there is criticism that COVAX has moved too slowly to have a significant impact.<\/p>\n\n\n\n

Another option that will certainly be taken is continued R&D, with the aim of developing vaccines that are simpler to mass-produce, can tolerate higher temperatures for prolonged periods, and are effective against new variants of the coronavirus. This could alleviate some of the supply chain concerns at issue with the current vaccines, and would enable safer and more efficient distribution, especially in lower-income countries. The WHO has recently added the Sinopharm vaccine, which has less stringent storage requirements, to its vaccine emergency use listing. However, it is still not clear if this vaccine is any better suited for manufacture in low-resource settings. <\/p>\n\n\n\n

However, none of these approaches address the most pressing issue in the developing world: the lack of know-how and infrastructure for production and delivery of vaccines. The expertise required to produce the complex biological formulations that make up the vaccines simply does not exist in many low-income countries, and this can only be addressed by proper education and training. Furthermore, the infrastructure necessary to manufacture, transport and store these vaccines does not exist across much of the developing world. Without investment in know-how and infrastructure at a local level, this will remain the significant factor in preventing vaccine rollout in these countries. It is not clear where the responsibility lies for this investment: with governments and international bodies, vaccine companies, philanthropic organisations, or elsewhere. However, without the required resources, it will simply not be possible for vaccines to effectively reach large parts of the population in low-income countries. There is no form of agreement on intellectual property that can address these more socioeconomic issues.<\/p>\n\n\n\n

What might the future hold?<\/strong><\/p>\n\n\n\n

It is well known that vaccination has made an enormous contribution to global health. Smallpox and rinderpest (which affected cattle) have been eradicated and polio may be close to eradication. These examples show that if a vaccine is successful in preventing infection and spreading of a disease, global vaccine coverage may eventually even eradicate it. It can be hoped that a similar outcome is achievable with COVID-19.<\/p>\n\n\n\n

However, a global waiver on vaccine patents is unlikely to help reach this goal. Such a waiver does not address the underlying issues of vaccine coverage in the developing world, and further risks unsafe vaccines flooding the market and disincentivising future innovation. In the context of the current pandemic, a global waiver would likely have more negative consequences than positive ones. A softer approach, such as maintaining IP protection for vaccines while allowing the WHO to enforce voluntary licensing agreements, may partially address the shortfall in some lower-income countries. However, without the know-how and infrastructure to produce vaccines locally in the developing world, progress will be slow.<\/p>\n\n\n\n

In the meantime, variants of the coronavirus have started to appear and the virus continues to spread. Now is the time for economic and political institutions to find a way to ensure that manufacturers around the world can produce vaccines safely and efficiently in pursuit of some level of global immunity. This would help both to address the current situation, and to provide a roadmap for how to deal with future pandemics.<\/p>\n\n\n\n

No matter which solution is eventually chosen, it is important that it provides both the necessary incentive for development and the flexibility for safe global vaccination. It is clear that intellectual property protection is an important tool for striking this balance.<\/p>\n\n\n\n

Written by:<\/strong> Ed Lobb<\/a>, Erik Brostr\u00f6mer<\/a> and Rikard Roos<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

After a challenging 18 months, the coronavirus pandemic is beginning to be brought under control in developed countries where the rollout of vaccines against COVID-19 has been successful. However, the question of access to vaccines worldwide, in particular in the developing world, has now become paramount. Many of the vaccines that have been successful in… Read more \u00bb<\/a><\/p>\n","protected":false},"author":3,"featured_media":4218,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[],"tags":[],"class_list":["post-4217","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t