The world is in a state of a global health emergency, where societies, economies, and livelihoods worldwide are in a dire situation .Globally as of 5th June 2021 there have been 172,242,4965 confirmed cases of COVID-19 including 3,709.397 death reported to WHO. And as of 1 st June 2021 a total of 1, 638,006,899 vaccine doses have been administered . [1] In this extraordinary ...
The world is in a state of a global health emergency, where societies, economies, and livelihoods worldwide are in a dire situation .Globally as of 5th June 2021 there have been 172,242,4965 confirmed cases of COVID-19 including 3,709.397 death reported to WHO. And as of 1 st June 2021 a total of 1, 638,006,899 vaccine doses have been administered . [1] In this extraordinary global health crisis we must ensure fair and equitable access to vaccines, and ensure every country receives them and can roll them out to protect their people through vaccination starting with the most vulnerable.
TRIPS Waiver[2], is seen as a credible and people-centred option to ensure as many safe and effective vaccines to as many people as fast as possible. This is obviously because the proposed waiver is likely to have two important trigger effects to ensure vaccine equity ., viz.,
Firstly , it would remove barriers of access to Covid-19 drugs, vaccines and other treatments. Relaxing TRIPS would enable developing countries with insufficient or no manufacturing capacity to freely import pharmaceutical products. Sans patent linkages in the regulatory process, emergency approvals would be readily available to generic producers of patented medicines . It will allow for easier technology transfers, less stringent licensing terms and increased access of vaccine manufacturers across the world to raw materials needed to make and deploy vaccines.
Secondly the related effect would be to make processes and products, adopted by countries to vaccinate their populations, immune from claims of illegality under the IP law .
The US announcement of support[3] for text-based negotiations has boosted the chance of launch of the negotiation especially in the wake of TRIPS Council Meeting scheduled on 8 and 9 June, 2021
The US explicit support has brought about positive responses from Australia, Canada, New Zealand etc. expressing more willingness to negotiate, while there are EU countries like Germany who have expressed their reservations.
On 21st May, 62 WTO members submitted a revised proposal[4] .The revised proposal seeks at least three years waiver of TRIPS obligations on copyrights, industrial designs, patents, trade secrets and enforcement of intellectual property related to COVID19 health products. However, the US announcement mentioned about waiving IP only on vaccines, while the revised waiver proposal covers vaccines, diagnostics, PPE kits, therapeutics, medical devices, raw materials, components, and the methods and means to manufacture them. Henceforth The TRIPS Council Meeting on 8 and 9 June, 2021 would be very crucial and decisive to ensure equitable access to vaccines .
Will the meeting be impacted by the recommendations of the WHO independent panel especially the one which is calling the WTO and WHO to bring voluntary licences and technology transfers arrangement for covid-19 vaccines within three months[5]?
It must be noted that early on in the pandemic the World Health Organization (WHO) launched the COVID19-Technology Access Pool (C-TAP) initiative calling on pharmaceutical companies to commit to transparent non-exclusive global voluntary licensing. However, this initiative has been rejected by the global biopharmaceutical companies. The voluntary bilateral contracting approach is the preferred choice of pharmaceutical corporations holding the technology for it allows them to control production and supply to markets, which they consider lucrative for their future profits[6].
INEQUITABLE ACCESS FOR VACCINES
The failure to respond in a timely manner to TRIPS waiver which was submitted way back in October 2, 2020 undermines the legitimacy and credibility of the WTO. Why are we still side-lining the fact that large amount of public funding was pumped into covid vaccine research?[7] Don't we have a duty to protect the safety of citizens who financed the vaccines in the first place?[8] Moreover most pharmaceutical companies have benefitted from these large amount of public funds invested in R&D, trials and spent on procurement, with little to no accountability and conditions attached to guarantee access[9].
To stop the disease and end the pandemic the world needs universal vaccination [10] . Vaccine equity is the challenge of our time[11], If TRIPS acts as a barrier it is extremely urgent to adopt a human rights perspective on TRIPS waiver . However the debate between advocates of a conflict approach and those asserting a coexistence approach to the intersection of human rights especially right to health and intellectual property is unlikely to be resolved anytime soon[12].We don't have time to wait either .
TRIPS WAIVER AND RIGHT TO EQUITABLE ACCESS TO VACCINES
In this extraordinary unprecedented times when people's lives are at stake human rights especially right to equitable access to vaccines implied in right to health [13]enjoy a superior moral and legal claim over the IPRs. `
And since the virus does not recognise or respect borders all the countries must firmly agree to support the temporary waiver of intellectual property rights to produce vaccines. It is nobody's case that a patent waiver is a magic wand that will solve all problems of production and distribution in the immediate future [14].
It is time to realize governments' core and collective responsibility to collaborate and address monopolies on technologies concretely. The way forward should be to remove barriers towards the development, production and approval of vaccines, therapeutics and other medical technologies necessary for the prevention, containment and treatment of the COVID-19 pandemic, so that more manufacturers, especially from developing countries, may independently contribute to the global supply[15].
Global supply should not be dependent on the purely commercial prerogatives and exclusive rights of pharmaceutical companies holding the technology. There is simply too much at stake. In the context of WTO, temporarily waiving relevant intellectual property rules that reinforce monopolies, is an important contribution that the WTO as a rule-based multilateral institution can make on this matter in the pandemic, alongside reaffirming and supporting the full use of existing public-health-safeguarding flexibilities of the TRIPs agreement [16].
CONCLUSION
Current inequalities in access are morally untenable and profoundly injurious to right to health and access to equitable vaccines Vaccines must be administered in every country , as a symbol of hope for overcoming both the pandemic and the inequalities that lie at the root of so many global health challenges. Scientific barriers, legal barriers, logistical barriers and TRIPS regulatory barriers will not bring back the countless lives that were lost. . A suspension of pharmaceutical monopolies, even temporary, is what the world needs. It would mark a crucial turn in the right direction, in this moment of exhaustion and panic. People or profit . It is high time to decide.
Prof.(Dr.)Bismi Gopalakrishnan is Dean Faculty of Law at Mahatma Gandhi University.Views are personal.
[1] https://www.who.int/covid-19/vaccines
[2] On 2 October 2020, South Africa and India submitted a joint communication to the TRIPS Council at the WTO, titled "Waiver from certain provisions of the TRIPS agreement for the prevention, containment and treatment of COVID-19". The proposal requests a waiver to be granted to WTO members so that they do not have to implement, apply or enforce certain obligations related to COVID-19 products and technologies under Section 1 (copyrights and related rights), 4 (industrial design), 5 (patents) and 7 (protection of undisclosed information) of Part II of the TRIPS Agreement The waiver proposed by South Africa and India was presented and discussed on 16 October at WTO TRIPS Council meeting. During the session, Kenya and Eswatini joined South Africa and India to become official cosponsors to the proposal and nearly 100 countries welcomed and showed support overall for the waiver, while nine WTO members, including the EU, did not support the proposal. List of supporters and opponents of the TRIPS waiver proposal on 16 October: - Cosponsors: Eswatini, India, Kenya, South Africa - In full support: Argentina, Bangladesh, Egypt, Indonesia, Mali, Mauritius, Mozambique, Nepal, Nicaragua, Pakistan, Sri Lanka, Tunisia, Venezuela, Holy See, UNAIDS, WHO - Welcomed and supported the general need for further discussions: Chad (least-developed countries (LDC) Group), Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Jamaica (African, Caribbean and Pacific countries (APC) Group), Nigeria, Philippines, Senegal, Tanzania (Africa Group), Thailand, Turkey - Opposed or did not support: Australia, Brazil, Canada, EU, Japan, Norway, Switzerland, United Kingdom, United States
https://www.wto.org › docs_e › legal_e › 27-trips_03_e
[3] 6th May,2021
[4] IP/C/W/669/Rev.1
[5] Bilateral agreements that have been signed to date contain restrictive terms and conditions that reinforce vertical control of technology-holding companies, artificially limit production and supply to constrain global supply options and are mostly un-transparent with governments and the public learning about the limits imposed post-facto, if ever. For instance, Astra Zeneca almost entirely relies on one manufacturer in India, which it has licensed, for the supply of its vaccine to low and middle income countries including the COVAX Facility, and consequently billions of people are now primarily dependent upon the vaccine supplies from one company in India. Most of the existing bilateral agreements to produce COVID-19 vaccines are contract manufacturing agreements through which the contracted entity manufactures on behalf of a licensor that maintains full control over the use of its technology, the volume of production and where and at what prices vaccines may be supplied. Although contractors may help ease some production pressure in the short term, the model cannot guarantee sustainability because contractors have no legal rights to independently produce and supply the concerned technologies worldwide. It is observed from publicly available information that in some agreements the technology holder maintains control over the vaccine component and prevents the licensee from manufacturing the vaccine component, hence creating dependency on the technology holder for the supply of the vaccine component , while others contain territorial restrictions . These agreements also depend on the willingness of the technology holder to license at all and as such are failing to mobilise global manufacturing capacity and diversifying supply options, on transparent terms that prioritize boosting global supply of the vaccine components and the final product. For instance, Moderna and Pfizer have yet to enter into license agreements with developing country manufacturers allowing for technology transfer and manufacture to supply developing countries.
[6] An example of this expectation of future profits is Pfizer's stated intention to shift some production to manufacturing booster doses for rich countries even while some low and middle income countries have not had an initial vaccine and to raise its vaccine price to an estimate $150-175 per dose in what it considers the post-acute-pandemic phase.
[7] Proof of Public and non-profit funding for the research, development, and production of leading vaccine candidates (as of February 3, 2021)Source: Oliver J Wouters , Challenges in ensuring global access to COVID-19 vaccines : production, affordability, allocation and deployment https://www.thelancet.com ›
[8] For example The UK government provided £2.2 million in funding to Professor Sarah Gilbert (University of Oxford) "for vaccine development and trials"; this works out to roughly $2.9 million, based on August 8, 2020, exchange rate. The UK government also provided £0.4 million in funding to Dr Sandy Douglas (University of Oxford) for "research into vaccine manufacturing capabilities"; this works out to roughly $0.5 million, based on August 8, 2020, exchange rate. The University of Oxford received £20 million from the UK government for vaccine development; this works out to roughly $26.1 million, based on August 8, 2020, exchange rate. The University of Oxford received funding from CEPI to accelerate development of its vaccine: "CEPI provided initial funding for the Oxford project to support the manufacture of vaccine materials required for preclinical and phase 1 testing." The CEPI portfolio website indicates that this initial funding "was up to US$ 1.1 million" and goes on to note that the organisation provided an "additional US$383 million" The additional $383 million was to expand production capacity for the manufacture and delivery of 300 million doses to COVAX. Deal 6 ($1.2bn): AstraZeneca will get up to $1.2 billion in funding from BARDA4 "for the development, production and delivery of the vaccine, starting in the fall. The development programme includes a Phase III clinical trial with 30,000 participants and a paediatric trial." AstraZeneca "reached a $750m agreement with CEPI and Gavi [as part of the COVAX Facility] to support the manufacturing, procurement and distribution of 300 million doses of the potential vaccine, with delivery starting by the end of the year." AstraZeneca has reached pre-order agreements with the United States, Brazil, European Union, United Kingdom, and Japan. The company has also researched a licensing agreement with the Serum Institute of India and South Korea's SK Bioscience to expand production capacity, among other partners. The Serum Institute of India, which is expected to produce up to 1 billion doses of the AstraZeneca-Oxford vaccine for low- and middleincome countries, has received funding from the Gates Foundation to scale up production of COVID-19 vaccines at risk. The Lemann Foundation, a non-profit organisation in Brazil, is providing funding (100 million reais, or $18 million) for the construction of a production plant for the AstraZeneca / Oxford vaccine; the funding is going to 7 Fiocruz (Oswaldo Cruz Foundation). Separately, the Brazilian federal government put aside 1.9 billion reais ($356 million) for purchasing and producing the vaccine. The Carlos Slim Foundation, a Mexican non-profit organisation, struck a deal with AstraZeneca to expand access to the company's vaccine in Latin American countries (excluding Brazil). As part of this deal, the Carlos Slim Foundation will provide funding to build production capacity for the vaccine in Argentina and Mexico
[9] For instance, Pfizer and Moderna are expecting vaccine revenue of between $15-30 billion in 2021
[10] Nishanth Sirohi, Right to equitable access to COVID-19 vaccination — if not now, then when? Health Express, April 09, 2021
[11] Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), reported that, of the 832 million vaccine doses administered, 82 per cent have gone to high- or upper‑middle-income countries, while only 0.2 per cent have been sent to their low-income counterparts. In high‑income countries alone, 1 in 4 people have been vaccinated, a ratio that drops precipitously to 1 in 500 in poorer countries.
[12] Laurence R. Helfer ,Human Rights and Intellectual Property: Conflict or Coexistence? Minnesota Intellectual Property Review Volume 5 Issue 1 Article 2 2003
[13] As per Article 12 of the ICESCR, everyone has a right to enjoy the "highest attainable standard of physical and mental health." Article 15 (1)(b) of the ICESCR recognises the right "to share in scientific advancement and its benefits." Article 15(1)(c) provides the right "to the protection of the moral and material interests resulting from any scientific, literary or artistic production." In other words, Article 12 provides for human right to health and a derivative right to adequate access to essential medicines when read with Article 15(1)(b), which provides a sick person with a right to benefit from scientific progress and Article 15(1)(c), which encourages scientific innovation and artistic creativity and allows people to profit from these . See, Aurora Plomer The Human Rights Paradox: Intellectual Property Rights and Rights of Access to ScienceHuman Rights QuarterlyVol. 35, No. 1 (February 2013), pp. 143-175 https://www.jstor.org/stable/23352255 See also Audrey R. Chapman, A Human Rights Perspective on Intellectual Property, Scientific Progress, and Access to the Benefits of Science, Panel Discussion on Intellectual Property and Human Rights at 3 (Nov. 9, 1998) (characterizing ICESCR Article 15 as "the most neglected set of the provisions within an international human rights instrument whose norms are not well developed"),athttp://www.wipo.int/globalissues/activities/1998/humanrights/ papers/pdf/chapman.pdf
[14] Aanchal Magazine , Prabha Raghavan Explained: Intellectual property waiver for Covid-19 vaccinesThe indian Express , May 11, 2021
[15] Letter to DG WTO by civil society members dated 13th April 2021.
[16] Ibid