It was on October 2, 2020, that India and South Africa first moved a proposal in favour of waiving off certain provisions of the TRIPS Agreement in the World Trade Organisation (WTO) to tackle the COVID-19 pandemic. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, which came into force in January 1995, deals with issues of intellectual property rights (IPR) like copyright, patents, protection of undisclosed information or trade secrets among others.
The reason behind the proposal: to quickly scale up production and meet the demand for COVID-19 related vaccines, therapeutics, drugs etc. âThere are several reports about intellectual property rights hindering or potentially hindering timely provisioning of affordable medical products to the patients,â India and South Africaâs proposal from October 2020 noted.
Recently, the Indian ambassador to the WTO, Brajendra Navnit broke down the math with regards to vaccine production, in an online panel organised by Third World Network (TWN). According to estimates, around 11 billion doses are needed to vaccinate 70% of the worldâs population, if two shots are to be administered per person, to achieve herd immunity. âThis requires a 1.5 billion vaccine production capacity per month, if we take just 5 billion doses for the adult population alone. But right now, we donât even have 400-500 million production capacity per month,â Navnit said in the panel discussion called âHigh level dialogue: TRIPS waiver â If not now, then when?â
As a second wave of the pandemic has hit many countries, including India, and with over 3 million deaths from COVID-19 globally, India and South Africaâs proposal has garnered support from over hundred countries. The two initiators are now working to submit a revised text. This proposal will reportedly include that the waiver is for a limited time only so as to address concerns of the European Union and others who have been opposing it.
On May 5, the US administration which earlier had issues regarding the TRIPS waiver, decided to support the proposal put forward by India and South Africa. This, after India's Ambassador to the US Taranjit Singh Sandhu, along with the diplomats from South Africa, had been meeting US lawmakers and officials regarding the proposal. In fact, US President Biden had promised during his campaign that he wouldn't allow patents to stand in the way of vaccine production if the US managed to develop one first.
There has also been mounting pressure to make vaccine technology sharing easier by removing IPR barriers. It has, unsurprisingly, been opposed by pharmaceutical trade associations.
Scaling up vaccine production
There are now several vaccines available in the global market against COVID-19 that have proven efficacy and have necessary approvals. These have been produced by Moderna, Pfizer, Bharat Biotech and AstraZeneca (in collaboration with Oxford University), to name a few. However, at present, these companies have only entered into voluntary agreements and licenses to scale up production with other entities. The arrangement between UK pharmaceutical company AstraZeneca and Pune-based Serum Institute of India to produce Covishield is one such example.
âHowever, the problem is that voluntary agreements and licensing are not transparent, and are confidential. We do not know what are the terms and in whose interest these are,â said KM Gopakumar, the legal advisor to TWN, an independent non-profit international research and advocacy organisation working in issues pertaining to development, developing countries and North-South affairs.
Gopakumar added, âCompanies that have vaccine tech are not in a position to meet global demand. Instead of everyone coming out with their own vaccine â which will take time â you can scale up production by diversification of manufacturers. Tech holders should share it with potential manufacturers.â
Sakthivel Selvaraj, Director, Health Economics, Financing and Policy at the Public Health Foundation of India (PHFI) argued that in the country like India, which is grappling with a deadly second wave of coronavirus infections and many states have alleged vaccine scarcity, we can no longer rely on just one or two manufacturers to meet the inoculation demand. âFor many years now, India has been producing around 60% of the worldâs vaccines. If that is the case, what is the reason that only two manufacturers are allowed to make COVID-19 vaccines during a public health emergency?â he asked.
Not just India, there are underutilised manufacturing capacities in other developing countries too that could be mobilised to meet vaccine demands now, pointed out Kathleen Van Brempt, Belgian member of the European Parliament for Vooruit and trade coordinator for Progressive Alliance of Societies and Democrats Groups in the European Parliament, during the TWN panel. âMost of them have been saying that they can produce up to 1 billion doses, but are not able to because they do not have the ârecipeâ (as it is under patent protection and IPR of certain big pharmas). This is an artificial scarcity, and can be addressed,â she said.
Dr Els Torreele, medical innovation and access expert, and Visiting Fellow at the Institute for Innovation and Public Purpose, University College London, told TNM that while IPR is not the only roadblock to scale up vaccine production, it is an important one. âIt would pave the way to mobilise existing capacities and expand them through investing resources and technological support. Current COVID-19 vaccine producers have shown that when know-how and resources are available, it can be done in less than a year â so that can definitely be multiplied elsewhere. The sooner we start, the sooner this expansion of manufacturing capacity will be reality," she said.
So, why isnât it happening?
The proposal by India and South Africa has been facing opposition, largely from wealthier, developed countries as well as pharmaceutical lobbies because it is in their commercial interest as opposed to developing countries. This has been documented earlier as well â a WHO bulletin noted in 2013 that âthe potentially detrimental effects of various aspects of the TRIPS package on public health and development, particularly in low- and lower-middle-income countries.â
Further, those opposing the TRIPS waiver have been arguing that the flexibilities within the agreement should suffice, apart from voluntary licensing by innovating pharma companies. One of the flexibilities that the TRIPS Agreement allows for is that of compulsory licensing, which, according to WTO, is when âa government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself.â While the TRIPS Agreement itself does not specifically list the grounds on which compulsory licensing may be invoked, the Doha Declaration on TRIPS and Public Health, which happened in 2001, said that countries can determine the grounds themselves, and also determines what constitutes a ânational emergencyâ.
However, that isnât enough, according to experts. Gopakumar explained that the flexibilities usually only apply to patents, and not to trade secrets. He said, âThe difference between the two is that in a patent, one may not disclose exact details of the technology being used, but a trade secret would reveal exactly what is being used.â So, manufacturers, unless they are the originators, may face difficulties, and lose time in getting more information. Gopakumar added, âCompulsory licensing is product and patent specific. We donât know in case of COVID-19 which product is going to work 100%. We still donât know the range of patents involved in a medical product. And innovation is still happening. If the IPR regime continues, an innovator will not be able to use patented technology. Therefore, we have to look at a larger IPR and TRIPS waiver to speed up and scale up.â
Another argument against the waiver is there is little evidence that there are manufacturers who are ready to make additional vaccines if it werenât for IPR restrictions. âBut thanks to our April 14 meeting with vaccine producers [at WTO], it came to light that there is capacity for manufacturing over a billion doses. As for quality and efficacy â these will be maintained because there are regulatory authorities,â Indian ambassador Navnit said.
Dr Torreele concurred. âWhy would sharing compromise efficacy? Itâs the other way around, the secrecy and lack of clinical trial data and design transparency may be harmful for [public] health,â she said.
Will pharma companies suffer huge losses?
Ultimately, it boils down to the billion-dollar question â literally. Pharma companies have been arguing that IPR and patents are at the heart of innovation, and so is the investment and money that goes into it. However, will IPR waivers really be unfair to big pharmaceuticals and send them into losses. Not at all, say experts.
Sakthivel pointed out that while pharma companies are no doubt the fulcrum of innovation and put major money into R&D, the main chemicals and blockbuster drugs are discovered in public health labs. âPharma companies pick up the drugs from the public sector to build a product of it and market it. There are, no doubt, cost, time and investment involved, but the initial molecules of it come from public health labs, which use the taxpayersâ money. So, why should pharma companies have freedom and monopoly over it,â he argued.
Contrary to what some are positioning this tussle as an ideological one around IPR, American Congresswoman Jan Schekowsky said during the TWN that it was simply about money and profits. âWe are at war with a virus, yet what we are seeing is war profiteering,â she said.
Navnit looked at it from a global economics point of view, which would affect all economic activity, including big pharma. He said, âIf you take the requirement of 10 billion vaccine doses, and say, price one dose at $10, we are talking of products of $100 billion commercial value immediately being required in the global market. One percent drop in global economic output costs us $850 billion.â And estimates indicate that due to the pandemic, the global economy contracted by 4.5% last year, which means losing trillions of dollars. âSo, when you put $100 billion on table [for vaccines] and commit to it for the next 4-5 years, it is nothing compared to what is being lost in global output if the pandemic were to continue,â he added.
Further, it is not that an IPR waiver will leave pharma companies penniless. Sakthivel said that national governments could look at giving certain royalties to the innovator and originator companies. For instance, India issued its first compulsory licence allowed under its own patent laws in 2012 for a cancer drug Nexavar made by Bayer. The license was given to Natco, which made the drugâs price fall from Rs 2.84 lakh a month, per patient, to Rs 8,800 per month, per patient, making it drastically affordable, in comparison. Natco paid Bayer 6% royalty on sales.
Gopakumar questioned why the Indian government hasnât used this mechanism to scale up the completely homegrown Covaxin, developed by Bharat Biotech. âWe have over a century of vaccine manufacturing history. We successfully used vaccination programmes like the pulse polio campaign. We also have biotechnology companies which can contribute. More producers would automatically mean more affordability too. But since there are only two firms producing, we have no choice but to be at their mercy, at their prices," he said.
Sakthivel called the patent system a âcruelâ one, with an âincentive structure aligned to big pharmaceuticals.â He said, âWe need to move away from proprietary ways of patenting to a more open-source way of making medicines. The pandemic is an opportunity to set right this system of monopoly and patents.â
Timely sharing of health tech saves lives
The opposition to an IPR waiver under the TRIPS Agreement comes even when there are examples from the past of the importance in making healthcare, treatments and medicines affordable and accessible in a timely manner.
Take the breakthrough discovery of penicillin. The antibioticâs production needed to be scaled up after World War II. Production was increased massively in the US due to collaboration between the American government and American pharmaceutical firms. It is crucial to note though, that Oxford University, where a team first isolated penicillin and proved its clinical effectiveness, did not patent protect it, domestically or internationally.
In the more recent past, we have seen how the production of generic and affordable ARV (Antiretroviral) medication during the peak of HIV/AIDS pandemic helped immensely. In fact, a study done a decade after the Doha Declaration on TRIPS and Public Health found that of the 24 verified compulsory licenses invoked in 17 countries, most occurred between 2003 and 2005, for HIV/AIDS related medicines, in upper-middle-income countries. In India, it was pharma giant Cipla that reverse engineered several exorbitantly priced drugs to make them affordable in India, and produced affordable ARV medication.
Now, in the grips of a deadly pandemic, advocates of affordable public health and medicine say it all really comes down to one thing â saving lives. And for that, we need more vaccines, faster.
âCOVID-19 is a global problem, so we need a global solution. No optimal advantage will come from anything if this is not done by others too. For instance - India cannot isolate; people travel, trade, move about,â said Gopakumar.
âThereâs a need to share existing supplies, and share technology and knowhow to allow many more countries and manufacturers to produce their own supplies. COVID-19 vaccines should be considered global health commons, not private property of some companies,â asserted Dr Torreele. âAnd it is up to governments, especially those who have invested massively in the research and manufacturing by pharmaceutical companies, to use that leverage and enforce the needed sharing of IPR and knowhow. This is a pandemic, and weâre all in this together â there is no space for business priorities, greed, or nationalism,â she added.