This article adopts a bibliographical overview approach to examine the global disparities in access to COVID-19 vaccines and the role of intellectual property (IP) rights in limiting access for low-income countries. IP rights prevent less developed countries from producing generic versions of their own vaccines and lead to high acquisition costs. The article further explores the opposition to IP waivers which is one of the challenges in providing access to vaccines to low-income countries. To resolve this, a comprehensive approach is outlined, emphasizing investment in local production, supply chains, and distribution networks, in which the European Union can play a pivotal role.
Keywords: COVID-19 pandemic, vaccination strategies, intellectual property rights, health inequalities, counteractive initiatives
The COVID-19 pandemic has profoundly impacted the world, affecting nearly every aspect of daily life and causing widespread illness, death, and economic disruption. The sudden emergency in late 2019 quickly spread globally, prompting widespread concern and action from governments, public health organizations, and communities alike. Despite the challenges posed by the virus, the scientific and medical communities worked tirelessly to develop vaccines and treatments to combat the pandemic and protect public health. Researchers achieved a remarkable feat in just a few months by developing safe and effective vaccines against SARS-CoV-2 (Parker & Murray, 2022).
After two years of implementing a mass vaccination solution and strategy, only 66% of the world’s population has been fully vaccinated. Developed countries have the highest vaccination coverage, with 68% of Americans and 76% of UK citizens fully vaccinated. Conversely, less developed countries, particularly in Africa, have the lowest recorded rates. For example, only 36% of South Africans and 30% of Nigerians are fully vaccinated (Holder, 2023). The gap that represents the unequal distribution of vaccines is due to one of thecontentious issues in the global fight against COVID-19 - intellectual property (IP) rights.
Figure 1: Holder (2023) provides an interactive map displaying the global percentage offully vaccinated populations.
Challenges and Opportunities for Vaccine Access: Navigating Patent Regulation
Intellectual Property (IP) rights, such as vaccine patents, limit access to vaccines for low-income countries for two main reasons. First, IP rights prevent less developed countries from producing a generic version of the vaccine because the patent holders have been granted exclusive rights to produce and sell the vaccine. In other words, other companies can only reproduce the vaccine formula for their citizens once the patent expires. The expiry date isusually around eight years, during which the only way for low-income countries to haveaccess to vaccines is through purchase. This leads to the second reason, the high cost ofvaccine supply. Due to the holder's monopoly over pricing, less developed countries cannot afford to buy the products (Sekalala et al., 2021).
Opposition to IP Waivers
As IP rights contribute to inequalities in global health, the European Union sought to facilitate low-income countries’ access to COVID-19 vaccines. One way of doing this was through participation in the COVID-19 Vaccines Global Access (COVAX) initiative, which aims to ensure equitable access to vaccines worldwide and to provide vaccines to resource-poor countries. The EU institutions and Member States pledged €3,283 million andcontributed 308.2 million doses to the initiative (European Parliament, 2022). Despite the efforts of the EU and other global actors, COVAX failed to achieve its goal of vaccinating at least 30% of each world economy by the end of 2021.
One reason is that pharmaceutical companies prioritized sales to prosperous countries over COVAX due to higher profitability. This resulted in a limited supply of vaccines for populations in need. More specifically, 120 million of the 994 million doses were distributed for COVAX at the same time as 1,800 million doses were allocated to wealthier countries through non-transparent bilateral agreements (Reliefweb.int, 2021). There are confidentiality clauses that shield the agreed prices from being disclosed. This affected the cost of vaccinesfor COVAX, which some speculate was multiplied by five. Moreover, many high-income countries have secured large quantities of vaccines through advance purchase agreements, which has further reduced the supply of vaccines.
In response to the above, India and South Africa proposed to WHO that IP rights for COVID-19 vaccines, treatments, and diagnostics be temporarily suspended to make them more accessible and affordable. The proposal was supported by some countries and organizations, such as the EU, and opposed by some developed countries and pharmaceutical companies. Both India and South Africa stressed that the waiver of IP rights on vaccines should be temporary and that IP rights act as a catalyst for innovation and competitiveness (Euractiv.com, 2022).
However, the vaccine industry challenged this notion, arguing that removing IP barriers would not necessarily make vaccines more accessible and affordable. They cited several reasons, including the complex production technology, the lack of production capacity insome countries, and the challenges of ensuring quality control and securing funding (Plotkinet al., 2017). Therefore, while waiving IP rights may be a step in the right direction, it is unlikely to be a complete solution. A more comprehensive approach is needed to address the various technical, financial, and logistic challenges.
Overcoming Barriers to Vaccine Access
This approach has to be tailored to the specific challenges faced in different countries andjurisdictions. In some African regions, war, instability and conflict make vaccine distributionand access even more challenging. This is the case in Ethiopia, where conflict lasted from2020 to 2022, or in South Sudan, where the war has recently been declared over (Acharya etal., 2021) . Negotiating potential ceasefires to distribute vaccines in such zones would be the most effective intervention strategy.
Concerning technical challenges, as mentioned earlier, most African countries lack the technological infrastructure and the expertise to develop vaccines, even if licensed. There are several ways to address these challenges. Firstly, governments and international organizations could invest in increasing the production capacity to enable vaccine manufacturing at the local level. This involves establishing infrastructure such as laboratories, procuring adequate machinery and supplies, and investing in the training and development of human resources, with a strong focus on the future generation of expert vaccinologists.
Government funding should also be directed to R&D and the pharmaceutical industry as a whole. Since investments and launch programs require substantial funding, key stakeholders, such as the EU, could provide financial support. In addition to state financial support, non-profit organizations and universities also have a crucial role to play. They can help developing countries increase their production capacity by transferring technology and sharing their know-how.
Furthermore, these institutions may employ various IP management strategies to facilitate access to technology for emerging economies. They can sublicense the technologies throughnon-exclusive licenses and by applying geographical restrictions. This ensures that companies in the developing world can manufacture vaccines at an affordable cost for their local market whilst still respecting the intellectual property rights of the patent ownership.
When a country cannot produce its own vaccine, humanitarian and white knight clauses could ensure affordability and accessibility in critical and emergency situations (Padmanabhan et al., 2010). The white knight clause could have been of particular help to developing countries during the COVID-19 era but was not applied. This clause typically evokes price-caps mechanisms or other measures to prevent high prices. Ultimately, to ensure that vaccines reach those most in need, key stakeholders should strengthen their partnerships to improve supply chains and distribution networks while maintaining accountability and transparency.
Although the scientific and medical communities have worked tirelessly to develop vaccines and treatments, challenges remain in achieving global immunisation coverage. The issue of IP rights and their impact on access to vaccines has been controversial, with some advocating temporary waivers of IP rights to facilitate the production and distribution of vaccines in low-income countries. However, waiving IP rights alone is unlikely to resolve the challenges. A comprehensive approach is needed to address low-income countries' technical, financial, and logistical challenges. This approach includes investment in local manufacturing, R&D, infrastructure, human resource development, technology transfer and support.
Concludingly, global leaders and institutions must work together to ensure accessibility and affordability. With a strong commitment to upholding human rights and eliminating health inequalities, the EU could play a decisive role in this regard. It has already proposed a new framework for IP and vaccines, amending its compulsory licensing and allowing third parties to use a patented invention without the consent of the patent holder in times of crisis. This framework would ensure that everyone has access to vaccines regardless of location, income, or social status. This time, the EU has to take action with utmost commitment; it is only by implementing these policies and strategies that we can help ensure that health security becomes a reality for all, leaving no one behind in the global response to future outbreaks.
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