IP EnforcementIP Licensing
Intellectual Property Rights: A serious impediment to global immunization, or a mere red herring?
The science is in: Get inoculated and reduce your chances of contracting the coronavirus (“COVID-19”). Vaccination against COVID-19 is our only way of achieving herd immunity and take us out of this pandemic[i] [ii]. As more and more countries – mostly advanced economies[iii] – ramp up their vaccination drive and approach post-pandemic normalcy, experts[iv] and health officials[v] are warning against the vaccine disparity faced by those in emerging and developing economies. India, which has lately emerged as the ground zero of this pandemic, is reeling from a combination of – bureaucratic incompetence, ill-equipped healthcare, and rich countries blocking access to essential raw materials and hoarding emergency vaccines[vi].
Earlier last year, India and South Africa proposed[vii] a waiver to the World Trade Organization (‘WTO’) on patent, industrial design, copyright, and protection of undisclosed information from COVID-19 related affordable medical products including vaccines and medicines, or ramping up research, development, manufacturing, and supply of medical products up until global herd immunity is achieved (ten-years from the date of adoption of the waiver). Since the initial proposal, over a hundred developing economies have supported this waiver – with a small yet powerful group of rich countries withholding support from the waiver[viii] – calling it ineffective and counterproductive to the ambition of global immunization and the very science which helped develop vaccines against this virus, respectively. This article explores what the proposal sets out and the opposition that it faces, and how IP rights on key technology and technical know-how on affordable, biosimilar drugs, and biomedical research does indeed impede the current capacity to produce COVID-19 related diagnostics and vaccines.
IP Rights Waiver: The WTO proposal and some context
In light of exceptional circumstances, the ‘waiver from certain provisions of the Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) agreement for the prevention, containment and treatment of COVID-19’ proposes[ix] a waiver on the implementation, application, and enforcement of various IP rights provided under the TRIPS agreement[x]. The proposal also highlighted the institutional and procedural limits posed by the requirement of compulsory licensing of pharmaceuticals on ‘individual merit’[xi]. The precision in produced and exported licensed pharmaceuticals[xii] – leading to delay in the availability of life-saving drugs, medicinal raw materials, and vaccines. Notably, the Doha Declaration recognized[xiii] the urgency of finding an ‘expeditious solution’ to the inherently protracted nature of Article 31[xiv] – taking into cognizance the frail and underdeveloped medical infrastructure predominant in developing and least-developed countries.
Members of the WTO agreement may have certain obligations waived off by the Ministerial Conference with the support of three-quarters of its members[xv] in the event of an unforeseeable exceptional circumstance[xvi]. Even though an ‘exceptional circumstance’ is not defined or described under the agreement; however, both Articles IX. 3 (a) and (b) recognize and insinuate that under certain uncompromising situations – it is essential to adopt principles of non-compliance while interpreting the waiver with great care and subjecting it to strict disciplines[xvii].
On the flip side, certain countries (most of them developed and vaccinated) are contending that waiving IP rights off of COVID-19 vaccines and pharmaceuticals disincentivize its R&D and diminish the high safety and quality standards expected to be maintained if mass-produced. Moreover, they contend that waiving important patents and other IP rights has very little to do with the increased production of COVID-19 vaccines and treatments.
The COVID-19 pandemic – deemed as the greatest public health crisis in over 100 years[xviii], has ravaged millions of lives globally[xix] and has caused exceptional economic loss, and deprived many of their social liberties. Looking beyond the official data and statistics of the damage caused by this pandemic, to say that exceptional circumstances require exceptional measures would be an understatement. As more and more emerging and developing economies begin to face the brunt of IP rights and obligations associated with emergency use pharmaceuticals and vaccines, it is inconceivable to keep up with the protocols in this hour of dire needs. Rather, countries – rich in particular – must work in collaboration to come up with novel ways of increasing accessibility of vaccines, drugs, diagnostics, and other essential raw materials at an equitable rate.
Is the current predicament out-turn of commercialized IP rights or a disastrous global medical supply chain?
Long answer short: It is an unbridled combination of both factors. This section will expound on this detrimental synergy.
Globally, within a year since the announcement of this pandemic – several vaccines have been approved[xx], while several others await their approval. To have so many vaccines approved within a year of a pandemic as deadly and life-disruptive as this is a big accomplishment indeed. Now when the problem finally appeared to have a solution, the solution more so its equitable accessibility has a problem.
Opposing nations – mostly on behalf of their pharmaceutical industry and their trade associations, collectively believe that a waiver on IP obligations dilute the scientific, innovative, and life-saving discoveries that IP protection incentivizes[xxi]. Moreover, the current IP roadblocks impeding accessibility have barely anything to do with the supply of vaccines, drugs, and diagnostics, and that IP impediments are simply hyperbolized and used as a deflection strategy from the real issues at stake. The U.S. Chamber of Commerce[xxii], concurring on this sentiment wrote that:
“During this time, transparent and predictable intellectual property rights have formed the legal and economic basis for an unprecedented level of highly successful collaborations between government, industry, academia and NGOs.
The Chamber supports decisive and bold action to remove regulatory and trade barriers in order to boost the global distribution of treatments and vaccines, including support of global vaccine programs such as COVAX[xxiii]. Proposals to waive intellectual property rights are misguided and a distraction from the real work of reinforcing supply chains and assisting countries to procure, distribute and administer vaccines to billions of the world’s citizens. Diminishing intellectual property rights would make it more difficult to quickly develop and distribute vaccines or treatments in the future pandemics the world will face.”
Since its initial opposition against the waiver, it had a drastic change of heart around the present IP rights hindering vaccine manufacturing and distribution[xxiv]. However, as noble as this shift may seem on the paper, and as the US might make you believe, for this measure to have materialized on the ground – instead of conforming with the pre-existing “text-based negotiations” and cognizing with the “consensus-based nature of the institution” – it should have diagnosed that this very protocol cripples the expansion of vaccine manufacturing and distribution in the first place – if even that were the core intention or just another philanthropic façade from America.
From very early on in this pandemic – voluntary licensing measures have often been touted by some pharma companies and health experts to ensure rapid availability, accessibility, and affordability of COVID-19 therapeutics[xxv]. Since then, for example, India’s COVISHIELD (aka the “Oxford vaccine”) voluntarily licensed the vaccine of AstraZeneca[xxvi] in order of making vaccines that work against the virus more accessible and affordable to low-and-middle-income countries and beyond. However philanthropic AstraZeneca’s voluntary agreements may seem prima facie – its shady charity and inherently constrained terms of the agreement is shrouded in unreasonable confidentiality[xxvii] [xxviii].
Since the global pharmaceutical industry is rife with heavy patenting and other IP barriers – non-exclusive IP privileges and monopolies – gives it the upper hand in determining supply, production, distribution, and pricing, thereby choking generic competition – which invariably affects countries with a not-so-sophisticated and developed medical infrastructure, much more so under dire public-health crisis. Strategic patenting, which, under a normal circumstance would be perceived as incentivizing and fostering innovation and growth, can, on the other hand, prove to be detrimental and anti-competitive[xxix]. For example, in the past, patented drugs have undercut the accessibility of HIV/AIDS and Hepatitis drugs in several African countries due to their high pricing and compliance to various IP obligations (such as TRIPS)[xxx]. In reality – this disparity is counterproductive to the very efforts put into making these life-saving vaccines and drugs when, in fact, the people who desperately need them in due time would have to make several other compromises until they can finally access them[xxxi].
While concerns are raised around the future of scientific innovation and technical dissemination around vaccination know-how, threats by an IP waiver are genuine and legitimate; however, it is also vital to understand that such protectionist policies and approach could delay the cause of global immunity not just against the current pandemic but – the pandemics to come. And certain patents and IP barriers are certainly protectionist when viewed in light of the current situation.
Although, administrative incompetence and dilapidated medical infrastructure overwhelm the current state of COVID despair found in certain countries. Better-off countries – in terms of overall COVID management, at least in good conscience – must consider doing more than simply a TRIPS waiver. An exceptional circumstance does indeed necessitate exceptional efforts, trade-offs, and collaboration, transcending any geopolitics, tariff barriers, or innovation-fostering regulations. Vaccination policy, around the world, should be driven by science, and the science on vaccination is pretty resounding: vaccination is our only way of achieving herd immunity and taking us out of this pandemic.
Bedotroyi Gupta, Intellectual Property Rights: A serious impediment to global immunization, or a mere red herring?, Metacept-Communicating the Law, accessible at https://metacept.com/intellectual-property-rights:-a-serious-impediment-to-global-immunization,-or-a-mere-red-herring?
 Australia, Brazil, Canada, the EU, Japan, Norway, Switzerland, Germany and the UK.
 With manufacturers
in India, Brazil, China, Argentina, and Indonesia.
[i] The Lancet, Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: An observational study using national surveillance data (May. 5, 2021).
[ii] COVID-19 Vaccines: Further Evidence of Success (May. 10, 2021), GOV.UK, https://www.gov.uk/government/news/covid-19-vaccines-further-evidence-of-success.
[iii] Coronavirus (COVID-19) Vaccinations, https://ourworldindata.org/covid-vaccinations.
[iv] Cem Cakmakli, Selva Demiralp, Sebnem Kalemli-Ozcan, Sevcan Yesiltas and Muhammed Yildirim, ‘The Economic Case for Global Vaccinations: An Epidemiological Model with International Production Networks (Jan. 2021)’, Centre for Economic Policy Research, London.
[v] World Health Organization, https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-148th-session-of-the-executive-board#:~:text=I%20need%20to%20be%20blunt,in%20the%20world’s%20poorest%20countries.&text=Vaccine%20equity%20is%20not%20just,a%20strategic%20and%20economic%20imperative.
[vi] Michael Penn, If Rich Countries Don’t Share Their Vaccines, the Pandemic Could Stretch on for Years (Feb. 24, 2021), Duke Global Health Institute, https://globalhealth.duke.edu/news/if-rich-countries-dont-share-their-vaccines-pandemic-could-stretch-years.
[vii] World Trade Organization, https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True.
[viii] Sam Meredith, Rich countries are refusing to waive the rights on Covid vaccines as global cases hit record levels (Apr. 22, 2021), https://www.cnbc.com/2021/04/22/covid-rich-countries-are-refusing-to-waive-ip-rights-on-vaccines.html.
[ix] Supra note 4.
[x] Trade-Related Aspects of Intellectual Property Rights, Part II – Standards concerning the availability, scope, and use of Intellectual Property Rights, https://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm.
[xi] Trade-Related Aspects of Intellectual Property Rights, Part – II § 5, Art. 31.
[xii] Article 31bis, Annex to the TRIPS agreement, https://www.wto.org/english/docs_e/legal_e/31bis_trips_annex_e.htm.
[xiii] The Doha Declaration on TRIPS and Public Health Ten Years Later: The State of Implementation (Nov. 1, 2011) No. 7, Find under ‘the Paragraph-6 system’, https://www.southcentre.int/wp-content/uploads/2013/06/PB7_-Doha-Declaration-on-TRIPS-and-Health_-EN.pdf.
[xiv] Supra note 11, (b) “… In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly.”
[xv] World Trade Organization, https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/WT/L/93.pdf&Open=True.
[xvi] Marrakesh Agreement Establishing the World Trade Organization, Article IX § 3 (a) & (b).
[xvii] WTO Article – IX (Jurisprudence), https://www.wto.org/english/res_e/publications_e/ai17_e/wto_agree_art9_jur.pdf.
[xviii] Cami Mondeaux, CDC Director: COVID-19 is the greatest public health crisis in over 100 years (Apr. 1, 2020), https://kslnewsradio.com/1922346/cdc-director-covid-19-is-greatest-public-health-crisis-in-over-100-years/.
[xix] World Health Organization, https://covid19.who.int/.
[xx] Jeff Craven, COVID-19 Vaccine Tracker (Apr. 23, 2021), Regulatory Affairs Professionals Society, https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker
[xxi] International Federation of Pharmaceutical Manufacturers & Associations, https://www.ifpma.org/resource-centre/pharma-innovation-delivers-covid-19-solutions-beyond-expectations-but-calls-for-the-dilution-of-intellectual-property-rights-are-counteproductive/
[xxii] U.S. Chamber of Commerce, https://www.uschamber.com/press-release/us-chamber-statement-proposed-wto-ip-rights-waiver.
[xxiii] CEPI, https://cepi.net/covax/.
[xxiv] Office of the United States Trade Representative, https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver.
[xxvi] AstraZeneca, https://www.astrazeneca.com/media-centre/articles/2020/astrazeneca-takes-next-steps-towards-broad-and-equitable-access-to-oxford-universitys-potential-covid-19-vaccine.html.
[xxvii] Governments Must Demand Pharma Make All, COVID-19 Vaccine Deals Public (Nov. 11, 2020), Medecins Sans Frontiers, https://www.msf.org/governments-must-demand-all-coronavirus-covid-19-vaccine-deals-are-made-public.
[xxviii] Charles Kenny, Release COVID-19 Vaccine Contracts (Feb. 10, 2021), https://www.cgdev.org/blog/release-covid-19-vaccine-contracts.
[xxix] Gurgula, O. Strategic Patenting by Pharmaceutical Companies – Should Competition Law Intervene? IIC 51, 1062-1085 (2020), https://link.springer.com/article/10.1007/s40319-020-00985-0#Sec9.
[xxx] Access to affordable medicines for HIV/AIDS and Hepatitis: The Intellectual Property Rights Context (2014), https://apps.who.int/iris/bitstream/handle/10665/204741/B5144.pdf?sequence=1.
[xxxi] More than 85 poor countries will not have widespread access to coronavirus vaccines before 2023 (Jan. 27, 2021), https://www.eiu.com/n/85-poor-countries-will-not-have-access-to-coronavirus-vaccines/.