Waiving COVID-19 vaccine intellectual property rights
South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP rights waiver and why it is being supported; how it could impact the pharma, biotech and biopharma industries if approved; and whether it is the best solution to correct vaccine distribution inequalities and improve treatment of COVID-19 patients globally. In this first article, Hannah explores the details of the IP rights waiver, highlighting reasons for its request and subsequent support.
In a move that has simultaneously sparked admiration and outrage, the US Biden-Harris Administration announced on Wednesday 5 May that it would support a temporary waiver of intellectual property (IP) provisions in the hope it would allow developing nations to produce their own COVID-19 vaccines developed by pharmaceutical companies.
The US Trade Representative Katherine Tai announced the news in a statement. She said: “This is a global health crisis and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines. We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen.”1
This announcement was made after Tai had met with Pfizer’s Chief Executive Officer (CEO) and Chairman, Dr Albert Bourla and Dr Ruud Dobber, head of US business at AstraZeneca, on 27 April to discuss the waiver. Unsurprisingly, the declaration has resulted in a tidal wave of objections from pharma companies, particularly Pfizer, whose CEO released an open letter stating categorically that such a waiver would not improve the supply situation but would instead create more problems.2
In this first article within a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss what the IP rights waiver is, why it is was requested and has garnered support.
What is the IP rights waiver for COVID-19 vaccines and why does is exist?
Under World Trade Organization (WTO) rules, the organisation can invoke a waiver of certain IP rights on technologies that could help combat an exceptional global crisis, such as the COVID-19 pandemic.3 To this end, on 16 October 2020 India and South Africa presented a proposal to the WTO Trade-Related Intellectual Property Rights (TRIPS) Council. The proposal asks that the WTO allows its members to waive four categories of IP rights – copyright, industrial designs, patents and undisclosed information – under the Agreement of TRIPS until the majority of the world population receives effective vaccines and develops immunity to COVID-19.4,5 The request applies to COVID-19 drugs, vaccines, diagnostics and other technologies for the duration of the pandemic.
As of November 2020, Eswatini, Kenya, Mozambique and Pakistan officially co-sponsored the proposal, which approximately 100 countries have now welcomed or fully supported.3 However, several of the WTO’s larger members, including Australia, Brazil, Canada, the EU, Japan, Norway, Switzerland, the UK and the US had withheld their support. Following the US’s decision to reverse their decision on the proposal, these other countries have come under pressure to lend their support to the temporary waiver also.
Why is it believed that the waiver is necessary?
There is currently a huge disparity in countries’ levels of COVID-19 vaccination, dependent on wealth. In September 2020, Oxfam reported that wealthy nations representing just 13 percent of the world’s population had bought up 51 percent of the promised doses of leading COVID-19 vaccine candidates.6 While the US and UK have now fully vaccinated almost half of their population,7 other countries, such as smaller African nations, have administered far less than one dose per person in their population.8 As a result of this disparity, while case numbers in the UK and US continue to decline or have stabilised at a comparatively low level, countries such as India, Pakistan, Bangladesh, Indonesia and the Philippines, which had all reported a significant drop in infections, have recently undergone a third wave of COVID-19 cases.9 Additionally, Canada and European countries such as Germany, France, Italy, Poland and The Netherlands are also experiencing a third wave.9 Across Europe, less than 20 percent of the population is fully vaccinated and only 43 percent of people aged 18 years and older have had their first dose.10
In their proposal, India and South Africa argued “an effective response to the COVID-19 pandemic requires rapid access to affordable medical products including diagnostic kits, medical masks, other personal protective equipment and ventilators, as well as vaccines and medicines for the prevention and treatment of patients in dire need.”4 They stated that the global demand brought on by the pandemic has created acute shortages in many countries, preventing them from effectively responding to the pandemic and thus resulting in many avoidable deaths and putting the lives of health and other essential workers at risk. They also argued that this threatens to prolong the COVID-19 pandemic and exacerbate the wide-reaching damages it has caused.
The proposal also states that “there are several reports about intellectual property rights hindering or potentially hindering timely provisioning of affordable medical products to patients…”4 and Médecins Sans Frontières (MSF) added that treatment providers and governments have faced IP barriers over drugs, masks, ventilator valves and reagents for testing kits.5 The proposal adds that there are “significant concerns” surrounding how novel diagnostics, therapeutics and vaccines for COVID-19 will be made available within a practical timeframe, in sufficient quantities and at a reasonable price to meet global demand.4
despite existing TRIPS flexibilities that facilitate sharing of knowledge and production of medicines, developing countries may face institutional and legal difficulties when using them”
The supporters of the waiver argued to the TRIPS Council that enforcing it would negate barriers to the timely access to affordable medical products – including vaccines and medicines – and to the scaling-up of research, development, manufacturing and supply of essential medical products. The waiver covers four obligations in four sections of Part II of the TRIPS Agreement — Section 1 on copyright and related rights, Section 4 on industrial designs, Section 5 on patents and Section 7 on the protection of undisclosed information related to prevention, containment or treatment of COVID-19.4 It would last for a specific number of years, as agreed by the General Council, until widespread vaccination is in place globally and most of the world’s population is immune. Members would review the waiver annually until its termination.
During the TRIPS Council meeting, the proponents of the waiver also argued that, despite existing TRIPS flexibilities that facilitate sharing of knowledge and production of medicines, developing countries may face institutional and legal difficulties when using them. This includes the special compulsory licensing mechanism provided for in Article 31bis, which they claim leaves them with no option other than a “cumbersome and lengthy process for the import and export of pharmaceutical products”.4 They concluded that it is time for the WTO and its members to act and take collective responsibility, prioritising people’s lives over all else.4
Other arguments supporting the TRIPS waiver
MSF recently stated that it was billions of dollars of public sector resources and philanthropic funding that supported the R&D behind what companies now seek to commercialise via IP.3 For example, the European Commission awarded €602.3 million to support research and innovation projects to tackle the pandemic, with over €108 million going into vaccine development, as of beginning of January 2021. A further €21.4 million in grants will be awarded in 2021.11 MSF also stated that Moderna announced it would not enforce its patents on its mRNA vaccine during the pandemic after losing a patent dispute and failing to disclose the US federal funding it received in the patent applications. In addition to this promise, Moderna must also share all IP, including the necessary technology, data and knowledge, so other manufacturers can scale up production of these vaccines.3
Furthermore, MSF reports that companies are choosing not to engage with voluntary schemes for equitable vaccine, treatment, diagnostic and technology distribution, such as the World Health Organization (WHO)’s COVID-19 Technology Access Pool (C-TAP) initiative.12 Highlighting this issue, the Director General of WHO, Dr Tedros Adhanom Ghebreyesus, and Mr Carlos Alvarado Quesada, President of the Republic of Costa Rica, recently called on the industry once again to contribute to C-TAP.13 MSF also said that by refusing to sign agreements with COVAX – the vaccine distribution pillar of WHO’s Access to COVID-19 Tools (ACT) Accelerator – and instead seeking direct agreements with vaccine manufacturers, countries had undermined the purchasing power and application of the entire WHO fair allocation framework.3 Additionally, MSF argues: “As long as COVAX primarily competes with high income countries to secure supply from the same limited number of [IP-holding] manufacturers, rather than increase the number of suppliers, the problem of global scarcity of COVID-19 vaccine doses will not be resolved. Global efforts should prioritise increasing the number of suppliers.”3
Whether the arguments are right or wrong – to be explored in greater details in subsequent articles – essentially, those in favour of the IP rights waiver assert the following four key points:
- Increasing production by sharing technology, knowhow and other proprietary information should expand the supply of medicines, vaccines, diagnostics and other technologies, thus helping countries gain access to necessary measures to combat the pandemic
- Significant public investment has gone into the development of these products, so is it right for pharma, biotech and other large corporations to profit from them?
- The idea that until COVID-19 is under control globally, efforts to combat it in isolated areas are meaningless because variants of concern that could overcome current interventions continue to emerge – ie, “no-one is safe until everyone is safe”
- Sharing is “the right thing to do” – people’s lives should be prioritised over future profit and financial gain.
- Statement from Ambassador Katherine Tai on the Covid-19 Trips Waiver | United States Trade Representative [Internet]. Ustr.gov. 2021 [cited 24 May 2021]. Available from: https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver
- Bourla A. An Open Letter from Pfizer Chairman and CEO to Colleagues [Internet]. Pfizer.com. 2021 [cited 24 May 2021]. Available from: https://www.pfizer.com/news/hot-topics/why_pfizer_opposes_the_trips_intellectual_property_waiver_for_covid_19_vaccines
- WTO COVID-19 TRIPS waiver proposal [Internet]. Médecins Sans Frontières; 2020 [cited 24 May 2021]. Available from: https://msfaccess.org/sites/default/files/2020-12/COVID_TechBrief_MSF_AC_IP_TRIPSWaiverMythsRealities_ENG_Dec2020.pdf
- WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19 [Internet]. 2020 [cited 24 May 2021]. Available from: https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True
- India and South Africa proposal for WTO waiver from intellectual property protections for COVID-19-related medical technologies [Internet]. Médecins Sans Frontières; 2020 [cited 25 May 2021]. Available from: https://msfaccess.org/sites/default/files/2020-11/COVID_Brief_WTO_WaiverProposal_ENG_v2_18Nov2020.pdf
- Vaccinations in United Kingdom [Internet]. Coronavirus.data.gov.uk. 2021 [cited 25 May 2021]. Available from: https://coronavirus.data.gov.uk/details/vaccinations
- Small group of rich nations have bought up more than half the future supply of leading COVID-19 vaccine contenders | Oxfam International [Internet]. Oxfam International. 2021 [cited 26 May 2021]. Available from: https://www.oxfam.org/en/press-releases/small-group-rich-nations-have-bought-more-half-future-supply-leading-covid-19
- Tracking Coronavirus Vaccinations Around the World [Internet]. Nytimes.com. 2021 [cited 17 May 2021]. Available from: https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html
- Latif A. 3rd COVID-19 wave takes toll on Asia-Pacific [Internet]. Aa.com.tr. 2021 [cited 25 May 2021]. Available from: https://www.aa.com.tr/en/asia-pacific/3rd-covid-19-wave-takes-toll-on-asia-pacific/2192252
- COVID-19 Vaccine Tracker [Internet]. vaccinetracker.ecdc.europa.eu/. 2021 [cited 28 May 2021]. Available from: https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab
- EU research and innovation in action against the coronavirus: funding, results and impact [Internet]. European Union; 2021 [cited 25 May 2021]. Available from: https://ec.europa.eu/info/sites/default/files/research_and_innovation/research_by_area/documents/ec_rtd_eu-research-innovation-against-covid.pdf
- IFPMA Statement on the “Solidarity Call to Action to realize equitable global access to COVID-19 health technologies through pooling of knowledge, intellectual property and data” – IFPMA [Internet]. IFPMA. 2020 [cited 1 June 2021]. Available from: https://www.ifpma.org/resource-centre/ifpma-statement-on-the-solidarity-call-to-action-to-realize-equitable-global-access-to-covid-19-health-technologies-through-pooling-of-knowledge-intellectual-property-and-data/
- Quesada C, Ghebreyesus T. The President of the Republic of Costa Rica and the Director-General of the World Health Organization call once again on all WHO Member States to actively support the COVID-19 Technology Access Pool (C-TAP) [Internet]. Who.int. 2021 [cited 8 June 2021]. Available from: https://www.who.int/news/item/27-05-2021-the-president-of-the-republic-of-costa-rica-and-the-director-general-of-the-world-health-organization-call-once-again-on-all-who-member-states-to-actively-support-the-covid-19-technology-access-pool-(c-tap)
Big Pharma, Biologics, Drug Development, Drug Manufacturing, Drug Markets, Industry Insight, Patents, Regulation & Legislation, Research & Development (R&D), Supply Chain, Technology, Therapeutics, Vaccines, Viruses
Access to COVID-19 Tools (ACT) Accelerator, AstraZeneca, COVAX, Médecins Sans Frontières (MSF), Moderna, Oxfam, Pfizer, The European Commission (EC), The World Health Organization (WHO), World Trade Organization (WTO)