Waiving Patents for COVID19 Vaccines: Solution or Threat for pandemic control?

Dario Trapani1, MD, prof Richard Sullivan2, MD, prof Giuseppe Curigliano, MD, PhD1,3*

Affiliation:

1. Division of Early Drug Development for Innovative Therapies, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
2. Institute of Cancer Policy, School of Cancer & Pharmaceutical Sciences, King's College London & Guy's and St Thomas' NHS Trust, London, UK.
3. Department of Oncology and Hematology (DIPO), University of Milan "La Statale", Via Festa Del Perdono 1, 20122, Milan, Italy.

Today public health security requires global co-operation and action. Nowhere is this more apparent than in the drive to rapidly create new vaccines against SARS-COV-2 virus. COVID19 vaccine development efforts have also reignited the never-dormant debate on the legal barriers of access to essential medicines posed by the intellectual property (IP) rules (1).

The global aim has always been to deliver 70% immunization coverage of the world population requiring 11 billion doses of vaccine (2). To date around only 1.5 billion doses have been administered.  

The vast majority (>80%) have been used or stockpiled in a select group of high-income countries. Only six upper middle-income countries have achieved theoretical coverage of 20%, assuming that most people have been vaccinated twice. No low-income countries have achieved >20% coverage of vulnerable populations, and only Bhutan and Mongolia have achieved this in lower-middle income group.

This means that high-risk groups, including many frontline health workers are facing the pandemic without access to immunization. An unacceptable inequality reflected in the nuances of vaccine nationalism and lingering attitudes of colonization in global health (2).

Deployment of different types of vaccines, global supply chains and allocation and significant issues with misinformation, poor national policy-making has compounded a sense that whilst the technology of COVID-19 vaccination has been a success the global politics has been a failure (2).

The global picture is, however, complicated by a lack on data in many settings, highly variable policies around procurement and national distribution and a failure to re-examine whether strategies (the choice of vaccines or prioritized vulnerable groups), have succeeded in mitigating severe COVID-19.

Interventions to prevent and control global health threats qualify for essential healthcare and fall propter bonum commune according to certain human rights law theories, recognizing equal dignity of all persons, and enacting equitability in the access to essential vaccines.

In the aim to accelerate development, production and equitable access to COVID-19 diagnostics, therapeutics and vaccines, multiple nations and World Health Organization (WHO) launched a cross-discipline partnership to enable resource and knowledge-sharing (i.e., Access to COVID-19 Tools Accelerator) (3). The Accelerator includes a COVID-19 Vaccine Global Access (COVAX) pillar, aiming to rapidly scale up the delivery of at least 2 billion doses of vaccines in 2021, covering 20% of the population, to address high-risk target groups through a scheme of fair distribution (3).

Although this would be a substantial achievement, it might be insufficient to timely deliver the goals set out in original planning, (2) COVID-19 vaccination is estimated to result in stronger economic growth, yielding a return of $16 for every $1 invested in accelerated global vaccination, an excellent value for public money invested (4). However, for many countries the additional costs of purchasing, despite COVAX, and delivery to their populations has not delivered a solid economic case for investment, particularly in countries with far more pressing health issues than COVID-19.

Despite these realpolitik issues, access to vaccines has become the sine quo non issue for global health and triggered an unprecedented wave of diplomacy aimed at expanding manufacturing and access.

In October 2020, a delegation of  ~100 Members of the World Trade Organization (WTO) led by India and South Africa (SA), and co-sponsored by several low- and middle-income countries (LMs), presented a proposal for a temporary waiver of certain IP obligations in response to COVID-19, at the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS).(2)

The WTO Members noted that a rapid scale-up of capacity might be hindered by IP rights (IPRs), and institutional and legal difficulties can be faced when using certain flexibilities of the TRIPS agreements – particularly when restricting the scope and applicability to specific scenarios, for example to import-export pharmaceutical products only in case of insufficient domestic manufacturing capacity.

Recalling the imperative of global solidarity amidst pandemic, the delegates requested to the WTO General Council a waiver from specific TRIPS Agreements – including, but not limited, to patents related to COVID19 vaccines. It is no coincidence that India and SA led the proposal, supported by several LMs, for the large capacity of pharmaceutical production, the emergence of one clinically severe VOCs (i.e., ‘SA VOC’ or 501Y.V2) and representing the populations with the lowest immunization coverage, respectively.

The cause for IP waivers has been supported, albeit with many caveats, by the US Senate and supported by The People’s Vaccine Alliance (https://peoplesvaccine.org), a coalition of 50 organizations, including African Alliance, Oxfam and UNAIDS.

In the Alliance’s view, the production constraints resulting from a lack of technology sharing, and the barriers due to IPRs are the central issue as to why global COVID-19 manufacturing and distribution has been so unequal. In their view instead of relying on voluntary licensing by companies, IP waivers could expedite policy options, including in the context of the WHO Accelerator.

IPRs waivers as a solution to COVID-19 vaccine deficits and unequal distribution have not been without their detractors (1). The opponents argue that vaccines have complex manufacturing procedures, that commonly do not fall under a single patent or one technology, and that the establishment of de novo manufacturing capacity in some LMs will be unreliable to tackle the current pandemic.

IPRs portend research and development (R&D) benefits, and nurture the chain of investments on innovations, to accelerate the discovery of health solutions. Comments were addressed on the pandemic priorities, on the need to reinforce supply chains and support countries in the procurement and delivery of vaccines to people, with a negligible impact of IPRs: lack of evidence showing benefits of IP waiver on population health was claimed, especially for vaccines (1).  

One more element to account when linking IPRs to the innovation, is the financing mechanism of R&D. A recent study found that public funding accounted up to 99% of the investments for R&D of ChAdOx, the Oxford-AstraZeneca COVID19 vaccine.(5) While the company is participating to the COVAX actions and has pursued mutual contractual IP agreements with Indian manufacturers, it is in general unclear how it should be recognized the public contributions and risk-taking in the R&D of governments and charitable donations, and if IP waivers and other regulated no-profit agreements should naturally apply in such cases (1,3).

WHO for example, has shaped some agreements different from IP waiver, such as clauses for companies in the SOLIDARITY trial (NCT04647669) concerning equitable distribution, affordability, and transparency, including the publication of trial data. Also, Gilead Sciences has signed non-exclusive license agreements with pharmaceutical manufacturers in LMs for the anti-SARScov2 drug remdesivir (3).

WHO has eventually called to action the global community to voluntarily share knowledge, IP, and data necessary for COVID19 (i.e., Technology Access Pool) (3). The WHO Pool approach aims to bundle various license agreements with generic producers, to increase the pharmaceutical volume and improve efficiency. However, no voluntary contribution from industry has been so far reported (3).

Whether the health innovation will be sacrificed or preserved on the altar of the IP waivers is unknown, but for sure some degrees of TRIPS flexibilities and no-profit sustainable agreements will accelerate the pandemic control. What is clear is that voluntary call to solidarity has resulted in variable levels of ‘first-me’ nationalism in the vaccine delivery, and negligible open sharing of know-how.

In this call for human rights, priority must align to global health imperatives.

Bibliography

1. World Trade Organization (2021). Director-General Ngozi Okonjo-Iweala calls on COVID-19 vaccine manufacturers to increase production in developing countries. Available at: https://www.wto.org/english/news_e/news21_e/dgno_09mar21_e.htm  (last access 20 April 2021).
2. Katz IT, Weintraub R, Bekker LG, Brandt AM. From Vaccine Nationalism to Vaccine Equity - Finding a Path Forward. N Engl J Med. 2021 Apr 8;384(14):1281-1283. doi: 10.1056/NEJMp2103614. Epub 2021 Apr 3. PMID: 33830709.
3. World Health Organization (2021). What is the Access to COVID-19 Tools (ACT) Accelerator, how is it structured and how does it work? Available at: https://www.who.int/publications/m/item/what-is-the-access-to-covid-19-tools-(act)-accelerator-how-is-it-structured-and-how-does-it-work ((last access 20 April 2021).
4. International Monetary Fund (2021). April 2021 Fiscal Monitor Report. Available at: https://www.imf.org/en/Publications/FM (last access 20 April 2021).  
5. Cross S, Rho Y, Reddy H, Pepperrell T, Rodgers F, Osborne R, Eni-Olotu A, Banjerjee R, Wimmer S, Keestra S. Who funded the research behind the Oxford-AstraZeneca COVID-19 vaccine? Approximating the funding to the University of Oxford for the research and development of the ChAdOx vaccine technology. MedRxiv preview (2021) at: https://www.medrxiv.org/content/10.1101/2021.04.08.21255103v1.full.pdf